mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit

K241269 · MED-EL Elektromedizinische Geräte GmbH · ETA · Jan 17, 2025 · Ear, Nose, Throat

Device Facts

• Record ID: K241269
• Device Name: mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit
• Applicant: MED-EL Elektromedizinische Geräte GmbH
• Product Code: ETA · Ear, Nose, Throat
• Decision Date: Jan 17, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3495
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The passive middle ear implant - tympanoplasty total prosthesis is intended to be used for replacement of components of the ossicular chain, if at least the stapes footplate is present and functional. The tympanoplasty total prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles totally. The tympanoplasty prosthesis is a medical device for single use delivered in sterile condition.

Device Story

Passive middle ear implants (PMEI) restore sound transmission from tympanic membrane to oval window in patients with ossicular chain defects. Devices consist of titanium prostheses (offcenter, center, or length-adjustable kit) implanted by ENT surgeons during standard otological surgery. The mXACT PRO kit includes sizers to determine functional length; the prosthesis is then adjusted and fixed via a snap-mechanism. The device acts as a mechanical bridge replacing ossicles. Benefits include restoration of conductive hearing. Clinical outcomes are measured by postoperative pure tone average air-bone gap (PTA4 ABG).

Clinical Evidence

Multicenter, retrospective, single-subject repeated measures PMCF study (n=92 for audiological outcomes, n=102 for safety). Primary endpoint: postoperative PTA4 ABG ≤20 dB achieved by 53.3% of patients. Mean BC-PTA4 pre/post-surgery: 19.6 dB HL / 17.5 dB HL. Adverse events (n=4) included 3 revision surgeries and 1 dislocation/extrusion. Results demonstrate safety and effectiveness comparable to state-of-the-art devices.

Technological Characteristics

Materials: Medical grade titanium (ASTM F67, ASTM F136) and polypropylene (sizers). Design: Total ossicular replacement prosthesis with fixed or adjustable functional length (3.0-7.0 mm). Attachment: Cannulated stem for stapes footplate. MRI: Conditional at 1.5T, 3.0T, and 7.0T. Sterilization: Gamma radiation. Biocompatibility: EN ISO 10993 compliant.

Indications for Use

Indicated for patients of all ages with congenital or acquired ossicular chain defects (e.g., chronic otitis media, traumatic injury, malformation, cholesteatoma) or inadequate conductive hearing from previous middle ear surgery, provided the stapes footplate is present and functional.

Regulatory Classification

Identification

A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.

Predicate Devices

• TTP-Tuebingen Type AERIAL Total Prosthesis (K972585)
• Duesseldorf Type AERIAL Total Prosthesis (K972585)
• TTP-VARIAC System Total (K990923)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the date January 17, 2025. The month is January, the day is the 17th, and the year is 2025. The text is in a simple, sans-serif font. The date is centered on the image.

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

Re: K241269

Trade/Device Name: mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit Regulation Number: 21 CFR 874.3495 Regulation Name: Total Ossicular Replacement Prosthesis Regulatory Class: Class II Product Code: ETA Dated: December 16, 2024 Received: December 16, 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 (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 combination https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies 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.

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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 820.70) 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 (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-device-advice-comprehensiveregulatory-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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (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-devices/device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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) K241269

### Device Name

mXACT Total Prosthesis Officenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit

# Indications for Use (Describe)

# INTENDED USE:

The passive middle ear implant - tympanoplasty total prosthesis is intended to be used for replacement of components of the ossicular chain, if at least the stapes footplate is present and functional. The tympanoplasty total prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles totally. The tympanoplasty prosthesis is a medical device for single use delivered in sterile condition.

### INTENDED USER

The tympanoplasty 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 tympanoplasty prosthesis is indicated to treat patients with:

- congenital or acquired ossicular chain defects (e.g., chronic otitis media, traumatic injury, malformation, cholesteatoma)

- inadequate conductive hearing from previous middle ear surgery
The total ossicular replacement prosthesis is indicated, if at least the stapes footplate is present and functional.

### Tympanosplasty Sizers for total prosthesis

(Note that the tympanosplasty Sizers are packaged together with the mXACT PRO Total Prosthesis conforming the mXACT PRO Total Prosthesis Kit).

### INTENDED USE

The tympanoplasty Sizers are intended to be used during a total ossicular replacement surgery to determine the required functional length of the MED-EL tympanoplasty prosthesis.

The tympanoplasty Sizers are optional, single-use surgical tools for intraoperative transient use only and delivered in sterile condition.

The Sizers for total prosthesis are intended to intraoperatively determine the distance between the footplate of the stapes and the tympanic membrane, thereby determining the required functional length of the MED-EL tympanoplasty prosthesis.

### INDICATIONS

The indications of the PMEI tympanoplasty total prostheses apply.

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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/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, conveying a sense of innovation and technology.

# 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: [phone] E-Mail: [e-mail]

FDA Official Correspondent: Elizabeth Gfoeller MED-EL Corporate Director, Regulatory Affairs Phone: [phone] E-Mail: [e-mail]

Date the Summary was prepared: 17th January 2025.

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

# Table 1 Device/Trade Names of MED-EL PMEIs Tympanoplasty Total Prostheses

| Device/Trade<br>Name | Generic category<br>& Medical Specialty | Classification | Product<br>code | Regulation<br>(CFR) |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------|-----------------|---------------------|
| mXACT Total<br>Prosthesis<br>Offcenter | Middle ear, Prosthesis,<br><b>Total</b> Ossicular<br>Replacement Prostheses<br>(Ear, Nose & Throat) | Class II | ETA | 874.3495 |
| mXACT Total<br>Prosthesis<br>Center | Middle ear, Prosthesis,<br><b>Total</b> Ossicular<br>Replacement Prostheses<br>(Ear, Nose & Throat) | | | |
| mXACT PRO<br>Total Prosthesis<br>Kit | Middle ear, Prosthesis,<br>Length -Adjustable and<br><b>Total</b> Ossicular<br>Replacement Prostheses<br>(Ear, Nose & Throat) | | | |

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Image /page/6/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 "D" in MED is a circular graphic with curved lines, possibly representing sound waves or the inner ear.

#### 3.0 PREDICATE DEVICES [807.92(a)(3)]

# Table 2 Predicate devices manufactured by Heinz Kurz GmbH

| MED-EL device | Primary Predicate Device A | Predicate Device B |
|-------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------|
| mXACT Total Prosthesis<br>Offcenter | | N/A<br>N/A |
| mXACT Total Prosthesis<br>Center | TTP-<br>Tuebingen<br>Type AERIAL<br>Total<br>Prosthesis<br>K972585 | Duesseldorf<br>Type AERIAL<br>Total<br>Prosthesis<br>K972585 |
| mXACT PRO Total<br>Prosthesis Kit | | TTP- VARIAC<br>System Total<br>K990923 |

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

The MED-EL "Passive Middle Ear Implants" (PMEls) Tympanoplasty Total Prostheses are total ossicular replacement prostheses which restore the mechanical sound transmission to the oval window.

They are offered in different designs and fixed or adjustable functional length 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/Trade<br>Name | mXACT<br>Total Prosthesis<br>Offcenter | mXACT<br>Total Prosthesis<br>Center | mXACT PRO<br>Total Prosthesis Kit |
|----------------------|-----------------------------------------|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Image: mXACT Total Prosthesis Offcenter | Image: mXACT Total Prosthesis Center | Image: mXACT PRO Total Prosthesis<br><br>mXACT PRO Total<br>Prosthesis:<br>+<br>Sizers for total prostheses:<br>Image: Sizers for total prostheses |

# Table 3 Description of the MED-EL PMEI Tympanoplasty Total Protheses

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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 a bold, sans-serif font. To the right of the name is a circular graphic with a swirl design inside.

| System/Kit<br>Components<br>and<br>Accessories | N/A | | System/Kit content:<br>1 mXACT PRO Total<br>Prosthesis + 7 Sizers for<br>total prostheses |
|------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Coupling<br>structure | Cannulated "stem" for optimized stability on the stapes footplate | | |
| Headplate | Oval wih<br>optional bending<br>possibility | Round with<br>optional<br>bending<br>possibility | Oval & length adjustable<br>(through snap-mechanism)<br>The surgeon can move the<br>"shaft" inside the headplate<br>to the desired functional<br>length, afterwards the<br>connection between<br>headplate and shaft is fixed<br>through the snap-<br>mechanism inside the<br>headplate. As a last step<br>the overlapping titanium<br>shaft of the prosthesis is<br>cut-off with a scalpel. |
| Material | Medical grade titanium | | mXACT PRO Total<br>Prosthesis:<br>Medical grade titanium<br>Sizer for total prosthesis:<br>Polypropylene |
| Sterile / Single-<br>Use | Yes | | |

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

The intended use and indications of the MED-EL PMEI Tympanoplasty Total Prostheses and of the predicate devices 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 Tympanoplasty Total Prostheses

# Intended Use

The passive middle ear implant – tympanoplasty total prosthesis is intended to be used for replacement of components of the ossicular chain, if at least the stapes footplate is present and functional. The tympanoplasty total prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles totally. The tympanoplasty prosthesis is a medical device for single use delivered in sterile condition.

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Image /page/8/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 the name is a stylized graphic element that resembles an ear or a sound wave, also in red. The overall design is clean and modern, reflecting the company's focus on innovation in hearing technology.

# Intended User

The tympanoplasty 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 tympanoplasty prosthesis is indicated to treat patients with:

- congenital or acquired ossicular chain defects (e.g., chronic otitis media, traumatic injury, malformation, cholesteatoma)
- inadequate conductive hearing from previous middle ear surgery

The total ossicular replacement prosthesis is indicated, if at least the stapes footplate is present and functional.

# Tympanosplasty Sizers for total prosthesis1

# Intended Use

The tympanoplasty Sizers are intended to be used during a total ossicular replacement surgery to determine the required functional length of the MED-EL tympanoplasty prosthesis. The tympanoplasty Sizers are optional, single-use surgical tools for intraoperative transient use only and delivered in sterile condition.

The Sizers for total prosthesis are intended to intraoperatively determine the distance between the footplate of the stapes and the tympanic membrane, thereby determining the required functional length of the MED-EL tympanoplasty prosthesis.

# Indications

The indications of the PMEI tympanoplasty total prostheses apply.

¹ Note that the "italic text" in this section shall be used if the tympanosplasty Sizers are packaged together with the mXACT PRO Total Prosthesis conforming the mXACT PRO Total Prosthesis Kit. Traditional 510(k) 510(k) SUMMARY

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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 bold, sans-serif font. The "O" in MED-EL is stylized with a circular design, adding a unique touch to the logo.

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

The MED-EL Passive Middle Ear Implants |PMEls) have the same technological characteristics | Le design | etc.) as the predicate devices identified in paragraph (a){3}. Hence, no differtiveness of the MED-EL PMEI Tympanoplasty Total 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 Tympanoplasty TOTAL Prostheses - Comparison with predicate devices

| MED-EL Device<br>/ Predicate<br>Device | "mXACT Total<br>Prosthesis<br>Offcenter" | Predicate Device<br>[A]<br>"TTP-Tuebingen<br>Type AERIAL<br>Total<br>Prosthesis"<br>(K972585) | "mXACT Total<br>Prosthesis Center" | Predicate Device<br>[B]<br>"Duesseldorf Type<br>AERIAL Total<br>Prosthesis<br>(K972585) | "mXACT PRO Total<br>Prosthesis Kit" | Predicate Device [B]<br>"TTP-VARIAC System Total<br>(K990923) |
|----------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Design | Image: mXACT Total Prosthesis Offcenter | Image: TTP-Tuebingen Type AERIAL Total Prosthesis | Image: mXACT Total Prosthesis Center | Image: Duesseldorf Type AERIAL Total Prosthesis | Image: mXACT PRO Total Prosthesis Kit | Image: TTP-VARIAC System Total |
| | mXACT features a slit-headplate design for optional bending possibility | | | System/Kit content:<br>1x Total ossicular replacement prosthesis | | |
| | | | | | 7 Sizers | 1 Sizer Disc (including 8<br>Sizers) |
| | | | Design: | | | |
| | | | The mXACT<br>headplate works with<br>a snap-closing<br>mechanism | TTP-VARIAC headplate<br>with plastic deformation | | |
| Attachment | Cannulated distal footing to be placed centrally on the stapes footplate | | | | | |
| | | | | | 1 length adjustable total prosthesis | |
| # of sizes | 13 | 14 | 13 | 14 | 7 Sizers | 1 Sizer Disc containing<br>8 Sizers |
| Functional<br>lengths [mm] | 3.0, 3.25, 3.5, 3.75,<br>4.0, 4.25, 4.5, 4.75,<br>5.0, 5.5, 6.0, 6.5,<br>7.0 | 3.0, 3.25, 3.5,<br>3.75, 4.0, 4.25,<br>4.5, 4.75, 5.0,<br>5.25, 5.5, 6.0,<br>6.5, 7.0 | 3.0, 3.25, 3.5, 3.75,<br>4.0, 4.25, 4.5, 4.75,<br>5.0, 5.5, 6.0, 6.5, 7.0 | 3.0, 3.25, 3.5,<br>3.75, 4.0, 4.25,<br>4.5, 4.75, 5.0,<br>5.25, 5.5, 6.0, 6.5,<br>7.0 | Length adjustable total prosthesis can be adjusted<br>to a functional length from 3.00 to 7.00 | |
| | | | | | Sizers functional length: | |
| | | | | | 3.0, 3.5, 4.0, 4.5, 5.0,<br>6.0, 7.0 | 3.0, 3.5, 4.0, 4.5, 5.0,<br>5.5, 6.0, 7.0 |
| Shaft Ø [mm] | Staged diameter:<br>0.2 / 0.25 | 0.2 | Staged diameter:<br>0.2 / 0.25 | 0.2 | 0.20 | |
| Headplate<br>dimensions<br>[mm] | Ø2.60 x 3.60 (oval and off-centric) | | | Ø2.60 x 3.60 (oval and centric) | Ø2.60 x 3.60 (oval and off-centric) | |
| Materials | Medical grade titanium ASTM F67 | | | | Medical grade<br>titanium ASTM F67<br>(stem and shaft) &<br>ASTMF136<br>(headplate); | Medical grade titanium<br>ASTM F67 |
| Biocompatible | Yes (EN ISO 10993) | | | | | |
| Surgical Tools<br>(mandatory) | n/a | | | | Titanium Micro Closing<br>Forceps &<br>Cutting Forceps | |
| Surgical Tools<br>(optional) | Tympanoplasty<br>Sizers for total<br>prostheses | ACSizer Disc Total.<br>Malleus Handle<br>Cavity Bending<br>pliers.<br>Cartilage Punch | Tympanoplasty<br>Sizers for total<br>prostheses | ACSizer Disc Total.<br>Malleus Handle<br>Cavity Bending<br>pliers.<br>Cartilage Punch | Tympanoplasty Sizers<br>for total prostheses<br>(included in the Kit) | ACSizer Disc Total<br>(included in the Kit).<br>KURZ Titanium<br>Tweezers<br>Micro Scissors |

Table 4 PMEI Tympanoplasty Total Prostheses - Comparison of Technical Characteristics

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Image /page/10/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 the letters "MED" is a stylized symbol resembling a cochlea, also in red.

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Image /page/11/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. A stylized graphic of a cochlea is placed between the "D" and "E" in MED-EL.

| Packaging | One length variant per package; Single-Use; Sterile | One length variable total ossicular replacement prosthesis + 7 Sizers for total prostheses. Single-Use; Sterile |
|-----------|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| MRI | MRI Conditional at 1.5, 3.0 and 7.0 T | |

Comparing the MED-EL PMEI Tympanoplasty Total Prosthed predicate device/s) manufactured by Heinz Kurz GmbH, the method of attachment, biocompatibility, packaging configuration and MRI compatibility are IDENTICAL.

The following features are considered EQUIVALENT: device design, number and dimensions of length varials 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.

Sizers that can be used optionally to intraoperatively dength of the prosthess to be used are available for both, the subject devices as well as for the identified predicate devices.

The MED-EL tympanoplasty Sizers are either available separately (Class ) or packaged together with the mXACT PRO Total Prosthesis conforming the mXACT PRO Total Prosthesis Kit. Nevertheless, for the predicate devices, also additional tools (Cartilage Punch, Malleus Hande Cavity Bending pliers, KURZ Titanium Tweezers, and Micro Scissors) are prosthesis length, the TTP-VARIAC System Total (Heinz Kurz GmbH) requires the surgeon to use special surgical tools for closing the headplate of the MED-EL mXACT PRO Total Prosthesis can be closed with e.g. standard delicate tweezers. As this is considered an improvement, no difference in safety and effectiveness is expected. The safety and effectiveness of the MED-EL mXACT PRO Total Prosthesis headplate was confirmed in non-clinical testing.

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Image /page/12/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 circular graphic with a swirl design, also in red. The logo is simple and modern, and the red color is eye-catching.

#### 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 Tympanoplasty Total Prostheses has been successfully demonstrated and the clinical outcomes of the MED-EL PMEL Tympanoplasty Total Prostheses are comparable to the predicate devices as per the state of the art for these types of devices.

The goal of ossicular replacement prosthesis is to close the postoperative pure tone average (PTA4) air-bone gap (ABG) to within 20 dB. According to the state of the art, as assessed in several systematic literature reviews and meta-analysis, 48.3-57.4 % of patients implanted with a total prosthesis achieve a postoperative PTA4 ABG ≤20 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 Tympanoplasty Total Prostheses in Europe:

- Audiological outcomes:
- O Number of patients: 92 (47 female, 45 male)
- Age: mean 40.3 ± 18.7 years (range 5-84) o
- Implanted ear: 48 right, 44 left o
- Follow-up: median 88.5 days (mean 88.3 ± 57.9; range 0-286 days) O
- Prosthesis type: 50 mXACT Total Offcenter, 22 mXACT Total Center, 20 o mXACT PRO Total
- % patients with a postoperative PTA4 ABG ≤20 dB: 53.3 % O
- o Mean BC-PTA« pre/post-surgery: 19.6 ± 11.3 dB HL / 17.5 ± 10.3 dB HL
- BC-PTA4 deterioration >10 dB HL: 1/92 patients = 1.1 % (11.3 dB HL) O
- Adverse events: .
- o Number of analyzed patients: 102 (52 female, 50 male)
- Age: mean 40.5 ± 18.8 years (range 5-84) O

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Image /page/13/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 name is a graphic of a stylized ear.

- Implanted ear: 54 right, 48 left o
- Follow-up: median 121.0 days (mean 219.7 ± 183.0; range 19-621 o davs)
- Prosthesis type: 57 mXACT Total Offcenter, 25 mXACT Total Center, 20 O mXACT PRO Total
- Number of (recommended) revision surgeries: 3 O
- Number of (potential) device dislocations/extrusions: 1 o
- Total 4 AEs in 4 patients: 2 Medical related AEs, 2 Clinical/surgical related o AEs

In the above mentioned PMCF investigation, the safety and effectiveness of the PMEI Tympanoplasty Total Prostheses was confirmed as demonstrated by postoperative PTA4 ABG <20 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 Tympanoplasty Total Prostheses are comparable to the current state of the art.

#### 9.0 Conclusion [807.92(b)(3)]

The results of the non-clinical testing demonstrate that:

- the MED-EL PMEI Tympanoplasty Total 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 Tympanoplasty Total Prostheses and the predicate devices manufactured by Heinz Kurz GmbH.

It can be concluded that the PMEI Tympanoplasty Partial Prostheses are substantially equivalent to the predicate devices manufactured by Heinz Kurz GmbH.