department of health & human services public ......product code: gex dated: january 4, 2016...
TRANSCRIPT
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center – WO66-G609 Silver Spring, MD 20993-0002
April 21, 2015 Clinical Laserthermia Systems AB ℅ Mr. David Makanani OMEDtech, LLC 1725 Signal Ridge Drive, Suite 150 Edmond, Oklahoma 73013 Re: K142216
Trade/Device Name: Tranbergcls Thermal Therapy System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: March 20, 2015 Received: March 24, 2015
Dear Mr. Makanani: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
Page 2 – Mr. David Makanani
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, For Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Indication for Use
510(k) Number: ___________
Device Name: $.%,&'.( !"# $)'.+%* $)'.%-1 #1/0'+
Intended Use/Indications for Use:
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Prescription Use: X AND/OR Over-The-Counter Use: NO(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)__________________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
510(k)
Clinical Laserthermia Systems, AB 223 81 Lund, Sweden
510(K) Page 5-2
510(K) SUMMARY
Date April 17, 2015
SUBMITTER: Lars-Erik Eriksson, CEOClinical Laserthermia Systems, ABScheelevagen 2Lund, Sweden 22381
CONTACT PERSON: David Makanani, CEOOMEDtech, L.L.C.1725 Signal Ridge Drive, Suite 150Edmond, Oklahoma 73013Tel: (405) 826-0713Email: [email protected]
DEVICE NAME:Classification Class IITrade Name TRANBERGCLS|Thermal Therapy SystemCommon Name TRANBERGCLS|Thermal Therapy SystemClassification 21 CFR 878.4810Product Code GEX - Powered Laser Surgical InstrumentReview Panel General and Plastic Surgery
PREDICATE DEVICE:K092197: BioTex, Inc.; PhoTex30 Diode Laser.
INTENDED USE: The Tranberg CLS Thermal Therapy System is indicatedfor use in surgical applications requiring the ablation,vaporization, excision, incision, and coagulation of softtissue in areas of surgery including: gastroenterology,general surgery, plastic surgery, genitourinary(urology), gynecology (GYN), neurosurgery,otolaryngology (ENT) head and neck, orthopedics,ophthalmology, pulmonology, and thoracic surgery.
DEVICE DESCRIPTION:
The TRANBERGCLS|Thermal Therapy System consists of three parts:
TRANBERGCLS|Mobile Laser
Clinic
TRANBERGCLS|Temperature SenApplicator Kit (The Applicator k
The mobile laser unit is provided with alaser light is locally applied by means ofpercutaneous procedure. The energy wtemperature. Tissue heating and lesionintegrated into the TRANBERGCLS|Therm
For a detailed description of the function
TECHNOLOGICAL CHARACTERISTIC ANDSubstantial equivalence of the TRANBERSeries, cleared under K092197.The CLS device is verified and validatedtogether with the Applicator kit clearedThe following table provides more detaequivalence:
Parameter
Product name TRANBERGCLSManufacturer Clinical LaserT
Sweden
cal Laserthermia Systems, AB 223 81 Lund, Sweden
510(K) Page 5-3
nsorkit is not included)
a laser generator operating at the wavelength 1064f a single use applicator kit through a less invasive suwithin the laser light is absorbed by the tissue resultiformation is controlled by a tissue temperature fee
mal Therapy System.
n and the usage of the laser module and its accessorie
D SUBSTANTIAL EQUIVALENCE:RGCLS|Thermal Therapy System is claimed to the Pho
to have the same performance as the predicate devd under K053087ailed information regarding the basis for the determ
S|Thermal Therapy System PhoTex 30 Diode LThermia Systems CLS, BioTex, US
nm. The generatedurgical orng in increased tissueedback system
es, view the IFU.
oTex 30 Diode Laser
vice when used
ination of substantial
Laser Series
Clinical Laserthermia Systems, AB 223 81 Lund, Sweden
510(K) Page 5-4
Intended use /Indications for use
“The Tranberg CLS Thermal TherapySystem is indicated for use in surgicalapplications requiring the ablation,vaporization, excision, incision, andcoagulation of soft tissue in areas ofsurgery including: gastroenterology,general surgery, plastic surgery,genitourinary (urology),gynecology (GYN), neurosurgery,otolaryngology (ENT) head and neck,orthopedics, ophthalmology,pulmonology, and thoracic surgery.”
“The PhoTex3 Diode Laser Series isindicated for use in surgical applicationsrequiring the ablation, vaporization,excision, incision, and coagulation of softtissue in areas of surgery including:gastroenterology, general surgery, plasticsurgery, genitourinary (urology),gynecology (GYN), neurosurgery,otolaryngology (ENT) head and neck,orthopedics, ophthalmology, pulmonology,and thoracic surgery.”
Device RegulatoryClassification
FDA 878.4810 FDA 878.4810
Product code GEX GEXDevice class 2 2510(k) No To be obtained K092197Diode lasergeneratorWavelength 1064nm
Adapted to indication for use of the laserapplicator / hand piece
980nm, 810nm or 940 nm
Output power 1W - 25W at output port 3W – 30W at output portOutput poweraccuracy
+/- 10% of selected value +/- 20% of selected value
Mode of operation Continuous wave or controlled by tissuetemperature monitored by a temperaturesensor
Continuous wave (CW), pulsed, or externalmodulation modes.
Output powerincrements
1W 0.5 W
Cooling TEC TECChannel(s) 1 1Output port SMA 905 SMA 905Aiming wavelength 635 nm 650 nmLaser typeIEC60825-1
Class IV Class IV
General technicalcharacteristicsPower source 100-240 V AC / 50-60 Hz 100-240 V AC / 50-60 HzOperatingtemperature range
15ºC to 28ºC 10-35 ºC
Average dimensions 540, 450, 180mm (width, depth, height) 16.0”x12,5”x8,0” (406x318x203)Weight 18 Kg 20 lbs (9,1kg)
Foot switchoperation
On/Off On/Off
Clinical Laserthermia Systems, AB 223 81 Lund, Sweden
510(K) Page 5-5
Emergency switch Yes YesKey activation oflaser output
Yes Yes
Remote Interlock Yes YesPower ON/OFFVisual Indicator
Yes Yes
Laser EmissionIndicator
Yes Yes
Internal Laser PowerMonitor
Yes Yes
Manual Reset Yes YesFiber InsertionInterlock
Yes Yes
Laser EmissionEnergy Monitoring
Yes Yes
AudioWarningSignal Level
Fixed at HIGH HIGH, MEDIUM, LOW, and OFF
Safety classificationFDA
Class II Class II
Pump for coolingliquid for applicator
Yes Yes
Temperaturesensors included
Yes No
Applicator kit(Laser fiber andTrochar)Interface Compatible with fiber optic delivery
accessory with a standard SMA905connector having a core fiber diameter of400 or 600 microns and a numericalaperture of at least 0.37.
Compatible with fiber optic deliveryaccessory with a standard SMA905connector having a core fiber diameter of400 or 600 microns and a numericalaperture of at least 0.37.
Performance The CLS device is verified and validatedto have the same performance when usedtogether with the Applicator kit clearedunder K053087
The BioTex device is verified and validatedtogether with the Applicator kit clearedunder K053087
PERFORMANCE TESTING - (NON-CLINICAL) BENCH:
The TRANBERGCLS|Thermal Therapy System has been determined through engineering bench testing to supportsubstantial equivalence with this device and the predicates. This testing showed the TRANBERGCLS|ThermalTherapy System to meet applicable ISO, IEC and FDA safety and performance standards,
Non-clinical bench performance testing completed:Engineering comparative temperature testingEngineering Verification and Validation Testing to the Product Requirement Specification
Clinical Laserthermia Systems, AB 223 81 Lund, Sweden
510(K) Page 5-6
Software testingUsability Engineering Testing - ISO 62366Electromagnetic Compatibility – IEC 60601-1-2 Collateral StandardElectrical Safety for Laser Equipment – IEC 60601-2-22 Particular StandardMedical Device Sterilization of Health Care Products – ISO 11135-1; Ethylene Oxide
PERFORMANCE TESTING – CLINICAL:
There are no clinical data submitted with this Notification.
CONCLUSION:
Based on the results of non-clinical testing, the TRANBERGCLS|Thermal Therapy System performs safely, asintended, and the comparative discussion of intended use, principle of operation, and technologicalcharacteristics, it is determined that the TRANBERGCLS|Thermal Therapy System is substantially equivalent topredicate devices.
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center – WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016Clinical Laserthermia Systems AB
Mr. David Makanani OMEDtech, LLC 1725 Signal Ridge Drive, Suite 150 Edmond, Oklahoma 73013 Re: K151569
Trade/Device Name: Tranberg CLS Laser Fiber Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: January 4, 2016Received: January 7, 2016
Dear Mr. Makanani:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
GDOC-2015-042
Page 2 – Mr. David Makanani
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Jennifer R. Stevenson -S
GDOC-2015-042
FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)K151569
Device NameTRANBERG CLS Laser fiber
Indications for Use (Describe)The TRANBERG CLS Laser fiber is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology, and urology at a wavelength of 1064nm.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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GDOC-2015-042
Clinical Laserthermia Systems, AB 223 81 Lund, Sweden
510(K) Page 5-2
510(K) SUMMARY
Date June 1, 2015
SUBMITTER Lars-Erik Eriksson, CEOClinical Laserthermia Systems, AB
Scheelevagen 2
Lund, Sweden 22381
CONTACT PERSON Lars-Erik Eriksson, CEO
Clinical Laserthermia Systems, AB
Scheelevagen 2Lund, Sweden 22381Tel: +4646152100Email: [email protected]
DEVICE NAMEClassification Class IITrade Name TRANBERGCLS|Laser fiberCommon Name TRANBERGCLS|Laser fiberClassification 21 CFR 878.4810Product Code GEX - Powered Laser Surgical InstrumentReview Panel General and Plastic Surgery
PREDICATE DEVICE:K053087, Visualase Cooled Laser Application System (VCLAS)
INTENDED USE: The TRANBERGCLS|Laser fiber is indicated for use to necrotize orcoagulate soft tissue through interstitial irradiation or thermal therapyin medicine and surgery in cardiovascular thoracic surgery (excludingthe heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, headand neck surgery, neurosurgery, plastic surgery, pulmonology,radiology, and urology, at a wavelength of 1064nm.
DEVICE DESCRIPTION:The TRANBERGCLS|Laser fiber is used to transfer laser energy from the laser unit to the location for thetreatment.
GDOC-2015-042
Clinical Laserthermia Systems, AB 223 81 Lund, Sweden
510(K) Page 5-3
The laser fiber is an optical fiber with a core of 550 mic and radial diffusor. The length is 3m and it has a standardconnector SMA 905 to fit the laser unit. The numerical aperture is at 0.22. The material in contact with humantissue is biocompatible.
The TRANBERGCLS|Laser fiber is delivered sterile and for single use only.
TECHNOLOGICAL CHARACTERISTIC AND SUBSTANTIAL EQUIVALENCE:
The following table provides more detailed information regarding the basis for the determination of substantialequivalence:
Table 5-1Equivalence Comparison
Laser fiber
Product name Tranberg CLS Laser fiber Visualase Laser fiber LDF
Manufacturer Clinical LaserThermia Systems CLS,Sweden
BioTex Inc., US
Intended use /Indications for use.
The Tranberg CLS Laser fiber is indicatedfor use to necrotize or coagulate softtissue through interstitial irradiation orthermal therapy in medicine and surgeryin cardiovascular thoracic surgery(excluding the heart and the vessels inthe pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology,general surgery, gynecology, head andneck surgery, neurosurgery, plasticsurgery, pulmonology, radiology, andurology, at a wavelength of 1064nm.
The LDF is indicated for use to necrotizeor coagulate soft tissue throughinterstitial irradiation or thermal therapyin medicine and surgery in cardiovascularthoracic surgery (excluding the heart andthe vessels in the pericardial sac),dermatology, ear-nose-throat surgery,gastroenterology, general surgery,gynecology, head and neck surgery,neurosurgery, plastic surgery,pulmonology, radiology, and urology, forwavelengths 800nm through 1064nm.
Device RegulatoryClassification
Accessory to powered surgical laserinstrument
Accessory to powered surgical laserinstrument
GDOC-2015-042
Clinical Laserthermia Systems, AB 223 81 Lund, Sweden
510(K) Page 5-4
FDA 878.4810 FDA 878.4810Product code GEX GEXDevice class Accessory to powered surgical laser
instrumentClass 2
Accessory to powered surgical laserinstrumentClass 2
510(k) No K053087Fiber core diameter: 550 μm 400 μm (200 – 1000)Numerical aperture: 0.22 0.37Fiber length: 3 m 3-12m standardProximal connector: SMA 905 SMA 905Wavelength: 1064 nm 532-1064nmLaser operationmode: Continuous Wave Continuous WaveDiffusing region length: 1 mm 7,5-30mmDiffusing tip assemblydiameter:
1.55 mm 0.6-1.4mm
Lesion Shape: Round Ellipsoidal / RoundMax power: 8 W for 550 μm 8 W for 400μmLesion volume (refer toReport DV-2015-024)
0,8 cm3 0,8 cm3
PERFORMANCE TESTING - (NON-CLINICAL) BENCH
The Tranberg CLS Laser fiber has been determined through engineering bench testing to support substantialequivalence with this device and the predicates. This testing showed the Tranberg CLS Laser fiber to meetapplicable ISO, IEC and FDA safety and performance standards,
Non-clinical bench performance testing completed:Engineering comparative temperature testingBiocompatibility
PERFORMANCE TESTING – ANIMAL/CLINICAL
There are no animal or clinical data submitted with this Notification.
CONCLUSION:
Based on the results of non-clinical testing, the TRANBERGCLS|Laser Fiber performs according to specifications,and as intended, and the comparative discussion of intended use, principle of operation, and technologicalcharacteristics, has determined that the Tranberg CLS Laser fiber is substantially equivalent to the predicatedevice.
GDOC-2015-042