The BONEBRIDGE bone conduction hearing implant system is intended for the following patients and indications: · Patients 12 years of age or older. · Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) should be better than or equal to 45 dB HL. · Bilateral fitting of the BONEBRIDGE is intents having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 3 kHz, or less than 15 dB at individual frequencies. · Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., singlesided deafness or "SSD"). The pure tone average air conduction hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz). · The BONEBRIDGE for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS. · Prior to receiving the device, it is recommended that an individual has experience with appropriately fit air conduction or bone conduction hearing aids.

Device Description

The BCI Lifts are optional accessories that can be implanted together with the BONEBRIDGE Bone Conduction Implant (model BCI 601 or BCI 602). They are attached to the fixation wings of the BCI and serve as a spacer to increase the distance between the fixation wings and the skull bone. The devices can be used if the necessary drill depth for the BCI implant cannot be achieved for anatomical reasons. They are attached to the fixation wings of the BCI implant to reduce the necessary drill depth for the Bone Conduction - Floating Mass Transducer (BC-FMT) in the skull bone.

AI/ML Overview

This document is a 510(k) summary for the BCI Lifts, which are accessories for the BONEBRIDGE bone conduction hearing implant system. The purpose of this submission is to request clearance to update the materials of the BCI Lifts from PEKK to PEEK.

Here's an analysis of the provided text in relation to the requested information:

1. Table of acceptance criteria and the reported device performance:

The document focuses on demonstrating bioequivalence and functional equivalence of the new material (PEEK) for the BCI Lifts compared to the existing material (PEKK). It does not present specific quantitative acceptance criteria or performance metrics in a tabular format as one might expect for an AI/ML device. Instead, it describes general categories of evaluation.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	"The BCI Lifts made of PEEK have been evaluated and shown to be biocompatible." (Per ISO 10993-1)
Sterilization	"The BCI Lifts made of PEEK have been evaluated as per AAMI TIR28:2016 and it was concluded that the new Lifts can be adopted into the existing sterilization of the BCI Lifts (PEKK) without further study."
Mechanical Properties (Material)	"An assessment and comparison of the mechanical properties of the two materials was performed." (Implies equivalence was established, but no specifics given).
Performance (Device-Level)	"Performance testing was performed on BCI Lifts made of PEEK according to existing test methods."
Torque/Force Stability (with BCI implants)	"Testing of the new BCI Lifts with the BCI implants was performed according to existing test methods that covered: Torque/Force Stability." (Implies satisfactory performance, but no specific values).
Dynamic Impact at 2.5J (with BCI implants)	"Testing of the new BCI Lifts with the BCI implants was performed according to existing test methods that covered: Dynamic Impact at 2.5J." (Implies satisfactory performance, but no specific values).

The overall conclusion is that the new material is "at least as safe and effective" as the predicate.

2. Sample size used for the test set and the data provenance:

The document describes "bench testing" and evaluations of materials and devices. It does not provide specific sample sizes (e.g., number of units tested) for these engineering tests. There's no indication of clinical test sets or data provenance (country of origin, retrospective/prospective) because this submission is about a material change, not a new clinical indication or AI/ML algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable to this 510(k) submission. This submission does not involve an AI/ML device that requires human expert review for establishing ground truth on image data or similar diagnostic tasks. The evaluation is focused on material science and mechanical engineering properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. As there's no expert review of data for ground truth establishment relevant to AI/ML, there's no adjudication method described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This 510(k) is not for an AI/ML device that assists human readers. It's for a change in material for an implant accessory.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" in this context is established through industry standards and established engineering test methods for biocompatibility (ISO 10993-1), sterilization (AAMI TIR28:2016), and mechanical performance (e.g., torque/force stability, dynamic impact). This is not a "ground truth" in the clinical AI sense.

8. The sample size for the training set:

Not applicable. There is no training set mentioned or implied as this is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable. There is no training set or clinical ground truth in the context of an AI/ML device. The "ground truth" for the engineering tests mentioned is inherent in the established test methods and material science principles.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 9, 2020

Med-El Elektromedizinische Geraete GmbH Stephanie Haselwanter Team Leader, Global Registrations, RA Fuerstenweg 77a Innsbruck, Tirol 6020 Austria

Re: K201983

Trade/Device Name: BCI 602 Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) Regulation Number: 21 CFR 874.3340 Regulation Name: Active implantable bone conduction hearing system Regulatory Class: Class I, reserved Product Code: PFO Dated: July 14, 2020 Received: July 17, 2020

Dear Stephanie Haselwanter:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Malvina Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201983

Device Name BONEBRIDGE

Indications for Use (Describe)

The BONEBRIDGE bone conduction hearing implant system is intended for the following patients and indications: · Patients 12 years of age or older.

· Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) should be better than or equal to 45 dB HL.

· Bilateral fitting of the BONEBRIDGE is intents having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 3 kHz, or less than 15 dB at individual frequencies.

· Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., singlesided deafness or "SSD"). The pure tone average air conduction hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

· The BONEBRIDGE for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

· Prior to receiving the device, it is recommended that an individual has experience with appropriately fit air conduction or bone conduction hearing aids.

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)

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Image /page/3/Picture/1 description: The image shows the logo for MED-EL, a company that specializes in hearing implants. The logo is in red and features the company name in a bold, sans-serif font. The "O" in MED-EL is stylized with a circular design that resembles an ear. The logo is simple, modern, and easily recognizable.

K201983-510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR§807.92

l. Submitter

Applicant:

MED-EL Elektromedizinische Geräte GmbH Fuerstenweq 77a 6020 Inssbruck AUSTRIA Phone +43 577 88 5622 Fax: +43 577 88 5690

Contact Person:

Stephanie Haselwanter Team Leader, Global Registrations, Regulatory Affairs MED-EL Elektromedizinische Geräte GmbH Fuerstenweg 77a 6020 Innsbruck AUSTRIA Phone +43 577 88 5622 Fax: +43 577 88 5690

II. Date Prepared

July 14th, 2020

lll. Device

Trade Name: BONEBRIDGE BCI Lifts BCI 602 Lifts (1 mm) BCI Lifts (1 mm) BCI Lifts (2 mm & 3 mm) BCI Lifts (4 mm)

Generic/Common Name: Active Implantable Bone Conduction Hearing System

Classification: Class II, 21 CFR§874.3340

Classification Panel: Ear, Nose, and Throat

Product Code: PFO

IV. Predicate Devices

Trade Name: BONEBRIDGE BCI Lifts K191457 BCI 602 Lifts (1 mm) DEN170009

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BCI Lifts (1 mm) BCI Lifts (2 mm & 3 mm) BCI Lifts (4 mm)

Generic/Common Name: Active Implantable Bone Conduction Hearing System

Classification: Class II, 21 CFR§874.3340

Classification Panel: Ear, Nose, and Throat

Product Code: PFO

Purpose of Submission V.

The purpose of this premarket notification is to request clearance to update the materials of the BCI Lifts.

VI. Device Description

The devices can be used if the necessary drill depth for the BCI implant cannot be achieved for anatomical reasons. They are attached to the fixation wings of the BCI implant to reduce the necessary drill depth for the Bone Conduction - Floating Mass Transducer (BC-FMT) in the skull bone.

Image /page/4/Picture/12 description: The image shows a cochlear implant in two different states. In the first state, the implant is shown with two small, beige-colored pieces detached from the main body, indicated by red arrows. In the second state, these pieces are attached to the main body of the implant, completing the assembly. The implant has a circular design with a metallic finish and some text on it.

VII. Intended Use & Indications for Use

The BONEBRIDGE bone conduction hearing implant system is intended for the following patients and indications:

Patients 12 years of age or older. ●
Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) should be better than or equal to 45 dB HL.
. Bilateral fitting of the BONEBRIDGE is intended for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 3 kHz, or less than 15 dB at individual frequencies.
. Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or "SSD"). The pure tone average air conduction

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Image /page/5/Picture/1 description: The image shows the logo for MED-EL, a medical device company specializing in hearing implants. The logo is in red and features the company name in bold, sans-serif font. A stylized, circular graphic is placed between "MED" and "EL", possibly representing an ear or sound wave. The overall design is clean and modern, reflecting the company's focus on technology and healthcare.

hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5. 1. 2 and 3 kHz).

The BONEBRIDGE for SSD is also indicated for any patient who is indicated for an airconduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
Prior to receiving the device, it is recommended that an individual has experience with ● appropriately fit air conduction or bone conduction hearing aids.

VIII. Technological Characteristics

BONEBRIDGE is an active implantable bone conduction hearing system. BONEBRIDGE is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.

The update to the materials of the BCI Lifts does not affect the BONEBRIDGE system intended use, fundamental operating principles or functional characteristics.

IX. Materials

The following new material is in direct and prolonged contact. The material has been evaluated per ISO 10993-1 and shown to be biocompatible and safe for human use:

PEEK (polyetheretherketone). ●
In addition, performance testing has established the equivalence of the new BCI Lift material to the existing material. Overall, the testing performed demonstrates that the BCI Lifts made of PEEK are at least as safe and effective as the BCI Lifts made of PEKK.

X. Performance Data

In order to demonstrate the equivalence of the updated BCI Lifts with the existing BCI Lifts, the change of the material has been evaluated and tested to establish technical equivalence with the existina BCI Lifts.

Possible effects of the change on biocompatibility, sterilization and device performance were assessed as follows:

Biocompatibility: The BCI Lifts made of PEEK have been evaluated and shown to be biocompatible.
. Sterilization: The BCI Lifts made of PEEK have been evaluated as per AAMI TIR28:2016 and it was concluded that the new Lifts can be adopted into the existing sterilization of the BCI Lifts (PEKK) without further study.
. Performance: The equivalence of the updated BCI Lifts to the existing BCI Lifts has been evaluated through bench testing as follows:
- An assessment and comparison of the mechanical properties of the two materials was O performed.
- Performance testing was performed on BCI Lifts made of PEEK according to existing O test methods.
- Testing of the new BCI Lifts with the BCI implants was performed according to existing O test methods that covered:
  - Torque/Force Stability .
  - I Dynamic Impact at 2.5J

It is concluded that the candidate BC! Lifts are substantially equivalent to the currently marketed predicate devices.

XI. Conclusion

Based on the indications for use, technological characteristics, and non-clinical bench testing results, the updated BCI Lifts have been shown to be substantially equivalent to the predicate

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Image /page/6/Picture/1 description: The image shows the logo for MED-EL, a company that specializes in hearing implants. The logo is in red and features the company name in a bold, sans-serif font. A stylized, circular graphic is placed between the two parts of the name.

devices. The updated BCI Lifts are at least as safe and effective for their intended use as the predicate devices.

Regulation Number and Section

§ 874.3340 Active implantable bone conduction hearing system.

(a)
Identification. An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must characterize any adverse events observed during implantation and clinical use, and must also demonstrate that the device performs as intended under anticipated conditions of use.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:
(i) Performance data must validate force output in a clinically relevant model.
(ii) Impact testing in a clinically relevant anatomic model must be performed.
(iii) Mechanical integrity testing must be performed.
(iv) Reliability testing consistent with expected device life must be performed.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6) Performance data must demonstrate the wireless compatibility, electromagnetic compatibility, and electrical safety of the device.
(7) Software verification, validation, and hazard analysis must be performed.
(8) Labeling must include:
(i) A summary of clinical testing conducted with the device that includes a summary of device-related complications and adverse events;
(ii) Instructions for use;
(iii) A surgical guide for implantation, which includes instructions for imaging to assess bone dimensions;
(iv) A shelf life, for device components provided sterile;
(v) A patient identification card; and
(vi) A patient user manual.