INTENDED USE. The passive middle ear implant – stapesplasty prosthesis is intended to be used for replacement of the stapes arch or stapes arch and incus in case of a fixed stapes footplate. The stapesplasty prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles partially. The stapesplasty prosthesis is a medical device for single use delivered in sterile condition.

INDICATIONS: The stapesplasty prosthesis is indicated to treat patients with: - congenital or acquired defects of the stapes due to e.g., otosclerosis, congenital fixation of the stapes, traumatic injury, malformation of the ossicular chain or middle ear - inadequate conductive hearing from previous stapes surgery

Device Description

The MED-EL "Passive Middle Ear Implants" (PMEls) Stapesplasty Prostheses are partial ossicular replacement prostheses which restore the mechanical sound transmission to the oval window. A partial (stapedotomy) or total opening of the footplate (stapedectomy) is required. The distal end (=piston) of the device is placed into the opening of the inner ear. The other end of the prosthesis (=Loop or Clip) is coupled to the long process of the incus or to the handle of the malleus. They are offered in different designs, functional lengths and/or piston diameters to allow the surgeon to have more flexibility in terms of selecting the correct prosthesis according to the individual patient's anatomical needs, and the surgeon's surgical preferences and proficiency.

AI/ML Overview

The provided text describes the acceptance criteria and a clinical study demonstrating the performance of the Med-El PMEI Stapesplasty Prosthesis.

Acceptance Criteria and Device Performance

Acceptance Criteria (Goal of Stapes Prosthesis)	Reported Device Performance (Postoperative)
Postoperative PTA4 ABG ≤ 20 dB	91.7% of patients
Postoperative PTA4 ABG ≤ 10 dB	66.1% of patients
Low rates of device dislocations/extrusions	0% (0 out of 188 patients)
Low rates of revision surgeries	0% (0 out of 188 patients, 2 recommended)
Overall stable bone conduction thresholds	Mean BC-PTA pre/post-surgery: 26.6 ± 10.3 dB HL / 23.9 ± 10.8 dB HL; BC-PTA deterioration >10 dB HL: 5.4% (9/168 patients)

The study concludes that the safety and effectiveness of the MED-EL PMEI Stapesplasty Prostheses are comparable to the current state of the art based on these outcomes.

Study Details

Sample size used for the test set and the data provenance:
- Audiological outcomes: 168 patients (115 female, 53 male), mean age 46.4 ± 12.9 years (range 12-70). Implanted ear: 86 right, 82 left.
- Adverse events: 188 patients (127 female, 61 male), mean age 47 ± 13 years (range 12-82). Implanted ear: 98 right, 90 left.
- Data Provenance: Europe, multicenter, retrospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
The document does not explicitly state the number or qualifications of experts who established the "ground truth" (audiological outcomes, adverse events) for the clinical study. However, it indicates that the study was a Post-Market Clinical Follow-Up (PMCF) investigation, and audiological outcomes would typically be measured and interpreted by audiologists or ENT specialists.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not specify an adjudication method for the clinical outcomes.
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:
No, this was not an MRMC comparative effectiveness study. The device is a passive middle ear implant for surgical implantation, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable. The device is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth was based on:
- Audiological Outcomes Data: Postoperative pure tone average (PTA4) air-bone gap (ABG) measurements.
- Adverse Events Data: Recorded occurrences of adverse events, device dislocations/extrusions, and revision surgeries.
The sample size for the training set:
This question is not applicable as the device is a physical implant, not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established:
This question is not applicable.

Summary

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

January 17, 2025

Med-El Elektromedizinische Geräte GmbH Inés Román Santiago Senior Regulatory Affairs Fürstenweg 77a Innsbruck, Tirol 6020 Austria

Re: K241142

Trade/Device Name: mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis Regulation Number: 21 CFR 874.3450 Regulation Name: Partial Ossicular Replacement Prosthesis Regulatory Class: Class II Product Code: ETB Dated: December 19, 2024 Received: December 19, 2024

Dear Inés Román Santiago:

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 (the 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 available 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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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

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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,

Joyce C. Lin-S

for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices 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) K241142

Device Name

mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis.

Indications for Use (Describe) INTENDED USE:

INTENDED USE.

The passive middle ear impl

The passive middle ear implant – stapesplasty prosthesis is intended to be used for replacement of the stapes arch or stapes arch and incus in case of a fixed stapes footplate. The stapesplasty prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles partially. The stapesplasty prosthesis is a medical device for single use delivered in sterile condition.

INTENDED USER

The stapesplasty prosthesis is intended to be implanted by qualified ENT surgeons only, with adequate skills to perform otological surgeries. Replacement of the ossicular chain is a standard surgical procedure, no additional specific device training is mandatory or required for the safe and effective use.

TARGET PATIENT POPULATION

The target patient population for the passive middle ear implant are patients of all ages requiring reconstruction of the ossicular chain.

INDICATIONS:

The stapesplasty prosthesis is indicated to treat patients with:

congenital or acquired defects of the stapes due to e.g., otosclerosis, congenital fixation of the stapes, traumatic injury, malformation of the ossicular chain or middle ear
inadequate conductive hearing from previous stapes surgery

Type of Use (Select one or both, as applicable)

X 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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Image /page/5/Picture/0 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 bold, sans-serif font. To the right of the letters "D" and "E" is a circular graphic with curved lines, possibly representing an ear or sound waves. The overall design is simple and modern.

510(k) SUMMARY of Safety and Effectiveness MED-EL Elektromedizinische Geräte GmbH [As Required by 21 CFR 807.92(c)]

Submitter [807.92(a)(1)] 1.0

Manufacturer: MED-EL Elektromedizinische Geräte GmbH (hereafter MED-EL) Fürstenweg 77a, 6020 Innsbruck Austria

Contact Person:

Ines Roman Santiago MED-EL Regulatory Affairs Senior Specialist Phone: +43 577885786 E-Mail: ines.romansantiago@medel.com

FDA Official Correspondent: Elizabeth Gfoeller MED-EL Corporate Director, Regulatory Affairs Phone: +43 577885614 E-Mail: elizabeth.gfoeller@medel.com

Date the Summary was prepared: 17th January 2025.

Device Names [807.92(a)(2)] 2.0

Table 1 Device/Trade Names of MED-EL PMEI Stapesplasty Prostheses

Device/TradeName	Generic category& Medical Specialty	Classification	Productcode	Regulation(CFR)
mAXIS StapesProsthesis	Middle ear, Prosthesis,Partial OssicularReplacement Prostheses(Ear, Nose & Throat)	Class II	ETB	874.3450
mLOOP StapesProsthesis
mZAM StapesProsthesis
mFIX StapesProsthesis

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Image /page/6/Picture/0 description: The image shows the MED-EL logo in red. The logo consists of the word "MED" followed by a stylized image of a cochlea, and then the letters "EL". The cochlea image is a red circle with a white swirl inside.

3.0 Predicate Devices [807.92(a)(3)]

MED-EL device	Primary Predicate Device A	Predicate Device B
mAXIS Stapes Prosthesis		N/A
mLOOP Stapes Prosthesis		Kurz K-PistonK002221
mZAM Stapes Prosthesis	Detroit PistonK130512	SkarzynskiPistonK130512
mFIX Stapes Prosthesis		Clip PistonàWengenK021479

Table 2 Predicate devices manufactured by Heinz Kurz GmbH

Description of the Devices [807.92(a)(4)] 4.0

They are offered in different designs, functional lengths and/or piston diameters to allow the surgeon to have more flexibility in terms of selecting the correct prosthesis according to the individual patient's anatomical needs, and the surgeon's surgical preferences and proficiency.

Device/TradeName	mAXIS	mLOOP	mZAM	mFIX
	Stapesplasty Prosthesis
Design	Image: MAXIS design	Image: mLOOP design	Image: mZAM design	Image: mFIX design
	Spiral-shaped loop for easier application			Clip for standardized coupling
Couplingstructure	Loop band width =0.5mm(broad &perforated loop)	Loop band width= 0.3mm	Loop band width= 0.20mm	Clip band width=0.2mm
Material	Medical grade titanium
Method ofAttachment	Manually, with crimping			Manually, withclipping
Sterile /Single-Use	Yes

Table 3 Description of the MED-EL PMEI Stapesplasty

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Image /page/7/Picture/0 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 bold letters. To the right of the letters "MED" is a circular graphic with curved lines inside.

5.0 Statement of the Intended use [807.92(a)(5)]

The intended use and indications of the MED-EL PMEI Stapesplasty Prostheses and of the predicate device(s) manufactured by Heinz Kurz GmbH are substantially equivalent. Comparing the subject devices and the respective predicate devices, the same medical conditions or underlying pathologies can be treated, and the principal functionality of the devices is the same, hence no different questions of safety and effectiveness arise.

PMEI Stapesplasty Prostheses

Intended Use

The passive middle ear implant - stapesplasty prosthesis is intended to be used for replacement of the stapes arch or stapes arch and incus in case of a fixed stapes footplate. The stapesplasty prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles partially. The stapesplasty prosthesis is a medical device for single use delivered in sterile condition.

Intended User

Target Patient Population

The target patient population for the passive middle ear implant are patients of all ages requiring reconstruction of the ossicular chain.

Indications:

The stapesplasty prosthesis is indicated to treat patients with:

congenital or acquired defects of the stapes due to e.g., otosclerosis, congenital fixation of the stapes, traumatic injury, malformation of the ossicular chain or middle ear.
inadequate conductive hearing from previous stapes surgery.

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Image /page/8/Picture/0 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 bold letters. The "O" in MED-EL is replaced with a stylized ear symbol. The logo is simple and modern, and it effectively communicates the company's focus on hearing solutions.

6.0 Comparison on Technological Characteristics with predicate devices [807.92(a)(6)]

The MED-EL PMEIs have the same technological characteristics (i.e. design, material, chemical composition, etc.) as the predicate devices identified in paragraph (a)|3). Hence, no difference in safety and effectiveness of the MED-EL PME! Stapesplasty Prostheses as compared to the predicate device(s) from Heinz Kurz GmbH is expected. A summary of the technological characteristics is provided in the following table.

6.1 PMEI Stapesplasty Prostheses – Comparison with predicate devices

MED-EL Device /Predicate Device	"mAXIS StapesProsthesis"	PredicateDevice [A]"DetroitPiston"(K130512)	"mLOOPStapesProsthesis"	PredicateDevice [B]"K-Piston"(K002221)	"mZAM StapesProsthesis"	PredicateDevice [B]"SkarzynskiPiston"(K130512)	"mFIX StapesProsthesis"	PredicateDevice [B]"Clip PistonàWengen"(K021479)
Design	Image: mAXIS Stapes Prosthesis	Image: Detroit Piston	Image: mLOOP Stapes Prosthesis	Image: K-Piston	Image: mZAM Stapes Prosthesis	Image: Skarzynski Piston	Image: mFIX Stapes Prosthesis	Image: Clip Piston àWengen
	Broad, perforated & spiral-shaped loop		Spiral-shaped loop		Narrow band & spiral-shapedloop		Clip-type coupling structure
Attachment	Manually, with crimping					Manually, without crimping
# of sizes	27	24	28		27	16	18	16
Piston Ø [mm]	0.4 / 0.5 / 0.6		0.4 / 0.6		0.4 / 0.5 / 0.6	0.4 / 0.6	0.4 / 0.6
Functional lengths[mm]	3.5, 3.75, 4.0,4.25, 4.5, 4.75,5.0, 5.25 , 5.5	3.5, 3.75, 4.0,4.25, 4.5,4.75, 5.0, 5.5	3.5, 3.75, 4.0, 4.25, 4.5, 4.75,5.0, 5.25, 5.5, 6.0, 7.0, 8.0, 9.0,10.0		3.5, 3.75, 4.0,4.25, 4.5,4.75, 5.0,5.25 , 5.5	3.5, 3.75, 4.0,4.25, 4.5,4.75, 5.0, 5.5	3.5, 3.75, 4.0,4.25, 4.5,4.75, 5.0,5.25 , 5.5	3.5, 3.75, 4.0,4.25, 4.5, 4.75,5.0, 5.5
Loop width [mm]	0.50			0.30	0.20	0.25	0.20	0.25

Table 4: PMEI Stapesplasty Prostheses - Comparison of Technical Characteristics

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Image /page/9/Picture/0 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 replaced with a stylized ear symbol.

Materials	Medical grade titanium ASTM F67	Medical gradetitanium ASTMF136 (clip) andASTM F67(shaft, piston)	Medical gradetitanium ASTMF67
Biocompatible	Yes (EN ISO 10993)
Surgical Tools(mandatory)	N/A
Surgical tools(optional)	MED-EL does not offer any optional surgical tool for the PMEI Stapesplasty Prosthesis.The manufacturer of the predicate device(s) offers the "KURZ-Meter" as an optional surgical tool.
Packaging	One length/diameter-variant per package; Single-Use; Sterile
MRI	MRI Conditional at 1.5, 3.0 and 7.0 T

Comparing the MED-EL PMEI Stapesplasty Prostheses and their identified predicated by Heinz Kurz GmbH, the method of attachment, biocompatibility, packaging configuration and MRI compatibility are IDENTICAL.

The following features are considered EQUIALENT: device design, number and dimensions of length/diameter variants, materials in body contact. As there is no difference in technological characteristics, there is no difference in safety and/or effectiveness.

There is just one difference: the surgical tools. For intraoperative measuring of the required prosthesis length, Heinz Kurz GmbH provides the KURZ-Meter however MED-EL does not provide such a tool due to other optional surgical tools are available on the market that can be used to determine the required prosthesis length to be used during a well-established stapes replacement surgical procedure. Thus, as there is no difference in technological characteristics, there is no difference in safety and effectiveness of the MED-EL PMEI Stapesplasty Prostheses compared to the predicate devices from Heinz Kurz GmbH is expected.

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Image /page/10/Picture/0 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 bold, sans-serif font. To the right of the name is a stylized graphic of an ear, also in red. The logo is simple and modern, and the use of red conveys a sense of energy and innovation.

7.0 Non-clinical Test [807.92(b)(1)]

Non-clinical testing was conducted to assess the performance data for a determination of substantial equivalence.

The following tests were conducted:

. MRI environment according to ASTM F2119, F2052, F2182 с MRI Conditional at 1.5T, 3.0T and 7.0T
. Biocompatibility according to EN ISO 10993
- The performed evaluation provides objective evidence to support the o conclusion that the devices can be considered biocompatible for their intended use.
Shelf-Life testing according to EN ISO 11607
Sterilization Validation according to EN ISO 11137-1, EN ISO 11137-2. .
- Gamma Sterilization with a confidence sterility assurance level of <10 o
. Packaging Validation according EN ISO 11607
. Mechanical & other testing

Safety and effectiveness have been demonstrated with non-clinical testing, concluding that the design and performance requirements are met.

8.0 Clinical Test [807.92(b)(2)]

The benefit for patients of the PMEI Stapesplasty Prostheses has been successfully demonstrated and the clinical outcomes of the MED-EL PMEI Stapesplasty Prostheses are comparable to the predicate devices as per the state of the art for these types of devices.

The goal of a stapes prosthesis is to close the postoperative pure tone average (PTA4) air-bone gap (ABG) to within 20 dB, ideally to within 10 dB. According to the state of the art, as assessed in several systematic literature reviews and meta-analysis, more than 90 % of patients implanted with a stapes prosthesis achieve a postoperative PTA4 ABG ≤20 dB. A variable fraction of stapes prosthesis implanted patients (41.0-87.2 %) even achieves a postoperative PTA4 ABG to within 10 dB.

MED-EL conducted a large multicenter, retrospective, single-subjects repeated measures (each subject served as his or her own control) Post-Market Clinical Follow-Up (PMCF) investigation with the PMEI Stapesplasty Prosthesis in Europe:

Audiological outcomes: .
- o Number of patients: 168 (115 female, 53 male)
- Age: mean 46.4 ± 12.9 years (range 12-70) O
- Implanted ear: 86 right, 82 left o
- Follow-up: median 49.5 days (mean 64.6 ± 61.4; range 7-470 days) o
- Prosthesis type: 88 mAXIS, 50 mLOOP, 11 mZAM, 19 mFIX O
- O % patients with a postoperative PTA4 ABG ≤20 dB: 91.7 %
- % patients with a postoperative PTA4 ABG ≤10 dB: 66.1 % O
- Mean BC-PTA« pre/post-surgery: 26.6 ± 10.3 dB HL / 23.9 ± 10.8 dB HL o
- o BC-PTA deterioration >10 dB HL: 9/168 patients = 5.4 % (range 11.3-21.3 dB HL)

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Image /page/11/Picture/0 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. To the right of "MED" is a stylized graphic of a cochlea, also in red, which is a key component of hearing implants.

Adverse events: ●
- Number of analyzed patients: 188 (127 female, 61 male) o
- Age: mean 47 ± 13 years (range 12-82) റ
- Implanted ear: 98 right, 90 left o
- Follow-up: median 179.0 days (mean 246.4 ± 212.8; range 7-709 days) o
- Prosthesis type: 93 mAXIS, 64 mLOOP, 11 mZAM, 20 mFIX O
- Number of revision surgeries: 0 (2 recommended) o
- o Number of device dislocations/extrusions: 0
- Total 16 AEs in 13 patients: 7 Device unrelated AEs, 2 Medical related O AEs, 2 Clinical/surgical related AEs, 5 AEs "unknown", 0 Follow-up AE

In the above mentioned PMCF investigation the safety and effectiveness of the PMEI Stapesplasty Prostheses was confirmed as demonstrated by postoperative PTA4 ABG <20 dB rates and postoperative PTA ABG ≤10 dB rates comparable to the state of the art, low rates of device dislocations/extrusions and revision surgeries, and overall stable bone conduction thresholds, an indicator that residual inner ear hearing is not compromised after implantation with an ossicular replacement prosthesis. Safety and effectiveness of the MED-EL PMEI Stapesplasty Prostheses are comparable to the current state of the art.

9.0 Conclusion [807.92(b)(3)]

The collective result of the non-clinical testing demonstrates that:

the MED-EL PMEI Stapesplasty Prostheses meet the established specifications, . the design and performance requirements to ensure safety and effectiveness according to the intended use.
. there is no difference in safety and/or effectiveness between MED-EL PMEI Stapesplasty Prostheses and the predicate devices manufactured by Heinz Kurz GmbH.

It can be concluded that the MED-EL PMEI Stapesplasty Prostheses are substantially equivalent to the predicate devices manufactured by Heinz Kurz GmbH.

Regulation Number and Section

§ 874.3450 Partial ossicular replacement prosthesis.

(a)
Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.