AAMI CI86 Cochlear Implant Systems: Requirements for Safety, Functional Verification,

Labeling and Reliability Reporting:

Overview and Regulatory Implications from FDA’s Perspective

Vasant Dasika, Ph.D.

William Regnault, Ph.D.

US FDA: Center for Devices and Radiological Health (CDRH)

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No Disclosures

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Summary

• ANSI/AAMI CI86 2017 (Ed. 1) was published in July 2017

• Requirements of AAMI CI86 include:– Nonclinical regulatory submission content– Engineering design and validation– Labeling

• Reliability Reporting • Device Specifications

• Device manufacturers may choose to voluntarily comply with AAMI CI86

• Expected End-Goal: Increasingly innovative, safe, effective, appropriately labeled and reliable devices. Increased regulatory certainty leading to a shorter time to market

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BACKGROUND

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Background: Standards

• Standard: Set of guidelines that a manufacturer can voluntarily comply to

• FDA actively participates in the development of standards for medical devices. FDA recognizes numerous published standards.

• Association for the Advancement of Medical Instrumentation (AAMI): A healthcare technology nonprofit and standards developing organization

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Motivation for developing a US standard for CIs:Establish uniform guidelines for reliability reporting

• Manufacturer’s device-reliability reports have cited:– European consensus statement on internal device failures and explantation (no

authors listed, 2005)

– International classification of reliability for implanted cochlear implant receiver stimulators (Battmer et al., 2010)

– CI Soft Failures Consensus Development Conference Statement (Balkeny et al., 2005)

– ISO 5841-2:2000: Reporting clinical performance of cardiac pacemakers

• Limitations: Subjectivity was permitted in inclusion of data. E.g., not all explanted devices were reported (e.g., medical reasons) 6

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Motivation for developing a US standard for CIs:Limitations with Earlier Standards

• BS EN 45502-2-3:2010 Active implantable medical devices. Particular requirements for cochlear and auditory brainstem implant systems

• ISO 14708-7:2013 Implants for surgery -- Active implantable medical devices -- Part 7: Particular requirements for cochlear implant systems

• Limitation: Earlier standards more restricted in coverage

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Total Product

Life Cycle Vision

https://www.fda.gov/ohrms/dockets/ac/01/slides/3799s1_11_Feigal/sld002.htm

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Summary of AAMI CI86

Requirements

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A Manufacturer Shall Characterize a CI Device System in a Regulatory Submission

• General description of device, intended uses, and model designations• Inventory of system components• Interconnection between implantable and non-implantable parts• Wireless technology• System hardware• System software (including sound processing strategies)• Electrode specification and characteristics• Features of clinical fitting software• Electrical Stimulation

– Methodology/circuitry– Waveforms– Provisions for safe stimulation

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A Device Shall MeetDesign & Verification Requirements

• Electrical– Stimulation– Battery

• Thermal• Mechanical

– Safety of electrode array insertion

• Manufacturing– Case Robustness and Integrity

• Biocompatibility• Sterility, packaging, and shipment• Safe use in various intended environments (e.g., MRI)

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Requirements for Device Labeling

• Information on use, warnings, and hazards

• Specification sheets: a common set of information– Implant– Electrode– Sound-processing strategy– Sound processor– Remote-control

• Device reliability reports: uniformly generated– Use prescribed failure-analysis steps to categorize explants– Report cumulative explant rates; stratify by explant category & pt. age– Make publicly available on mfgr’s website, update 2x/year

– Manufacturers will provide documentation to clinics to assist troubleshooting, explantation & return of devices

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AAMI CI86 Recognized by FDA in 2017

• Applicants may utilize an FDA recognized standard in a premarket submission to FDA.

• Conformity to a recognized standard can minimize the amount of data and documentation and increase certainty in what is needed in a pre-market submission.

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AAMI CI86:Requirements across

Total Product Life Cycle

Device Engineering: Design, Testing &Validation

Regulatory Submission/Approval

Pt. Care- Guidance & Device Selection: Labeling, Specification Sheets & Reliability Reports

Reliability Reporting

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EXPECTED OUTCOMES

Device Engineering: Design, Testing &Validation

Regulatory Submission/Approval

Pt. Care- Guidance & Device Selection: Labeling, Specification Sheets & Reliability Reports

Reliability Reporting

SpurInnovation

Regulatory certainty, Time to market

Facilitate science-based selection of devices by patients & clinicians

RiskAnalysis

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Immediate Next Steps

• Transition periods of AAMI CI86– Design & test requirements (2 years)– Reliability Reporting

• New Implants (1 year)• Existing Implants (2 years)• Sound Processors (2 years)

• Other CI standards can consider harmonizing with AAMI CI86

• Begin work on Edition 2

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Future Directions

• Document will be revised every 5 years from 2017

• Academic/outside analyses welcome (e.g., on reliability reporting, specification sheets)

• Committee participation encouraged to improve document & ensure appropriate requirements, e.g., – Device indications for use– Include human-performance measures

• speech, music, psychophysical performance, PRO measures

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FDA Staff Acknowledgements

• Srinivas Nandkumar• Jim Kane• Jong Ho Won• Ting Zhang• Angie Khan• Sunny Park• Joyce Lin• Vasant Malshet• Oldooz HazratiYadkoori• Eric Mann• Leonid Livshitz• Audrey Zhou• Josh Guag

• Terry Woods• Sunder Rajan• Don Witters• Hamed Ghods• Pavel Takmakov• Ethan Cohen• Cristin Welle• Victor Krauthamer• Nancy Wersto• Shahram Vaezy• Leonardo Angelone• Howard Bassen• Jana Delfino• Donna Walsh

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FDA Staff Contact Information:

Vasant.Dasika@fda.hhs.gov

William.Regnault@fda.hhs.gov

Srinivas.Nandkumar@fda.hhs.gov

AAMI CI86 Document Link:

http://my.aami.org/store/detail.aspx?id=CI86-PDF

To join committee/questions for AAMI:

Colleen.Elliott@aami.org