(268 days)
Not Found
No
The device description and summary of performance studies focus on the mechanical properties and surgical use of a passive middle ear implant and associated sizers. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is a medical implant intended to restore sound transmission and treat hearing defects, which are therapeutic functions.
No
The device is a passive middle ear implant intended to restore sound transmission, not to diagnose a condition. The sizers are surgical tools used to determine the correct prosthesis size, which is part of the treatment, not diagnosis.
No
The device described is a physical implant (tympanoplasty total prosthesis) and surgical tools (sizers), not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a passive middle ear implant used for the replacement of ossicular chain components to restore sound transmission. This is a surgical implant, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description reinforces that it's a total ossicular replacement prosthesis that restores mechanical sound transmission.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
The device is a surgical implant and associated surgical tools (sizers) used directly in the human body to treat a physical condition (ossicular chain defects).
N/A
Intended Use / Indications for 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.
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:
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.
Product codes
ETA
Device Description
The MED-EL "Passive Middle Ear Implants" (PMEIs) 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.
mXACT Total Prosthesis Offcenter: Cannulated "stem" for optimized stability on the stapes footplate. Headplate is oval with optional bending possibility. Material is Medical grade titanium. Sterile / Single-Use: Yes.
mXACT Total Prosthesis Center: Cannulated "stem" for optimized stability on the stapes footplate. Headplate is round with optional bending possibility. Material is Medical grade titanium. Sterile / Single-Use: Yes.
mXACT PRO Total Prosthesis Kit: System/Kit content: 1 mXACT PRO Total Prosthesis + 7 Sizers for total prostheses. Headplate is Oval & length adjustable (through snap-mechanism). The surgeon can move the "shaft" inside the headplate to the desired functional length, afterwards the connection between headplate and shaft is fixed through the snap-mechanism inside the headplate. As a last step the overlapping titanium shaft of the prosthesis is cut-off with a scalpel. mXACT PRO Total Prosthesis: Medical grade titanium. Sizer for total prosthesis: Polypropylene. Sterile / Single-Use: Yes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Middle ear
Indicated Patient Age Range
patients of all ages
Intended User / Care Setting
Qualified ENT surgeons only, with adequate skills to perform otological surgeries.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was conducted to assess the performance data for a determination of substantial equivalence.
Non-clinical tests conducted: MRI environment according to ASTM F2119, F2052, F2182 (MRI Conditional at 1.5T, 3.0T and 7.0T); Biocompatibility according to EN ISO 10993; 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 dB HL: 1/92 patients = 1.1 % (11.3 dB HL)
Number of (recommended) revision surgeries: 3
Number of (potential) device dislocations/extrusions: 1
Total 4 AEs in 4 patients: 2 Medical related AEs, 2 Clinical/surgical related AEs
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3495 Total ossicular replacement prosthesis.
(a)
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.(b)
Classification. Class II.
0
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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.
1
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
2
assistance/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
3
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.
4
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: +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.
2.0 Device Names [807.92(a)(2)]
Table 1 Device/Trade Names of MED-EL PMEIs Tympanoplasty Total Prostheses
| Device/Trade
Name | Generic category
& Medical Specialty | Classification | Product
code | Regulation
(CFR) |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------|-----------------|---------------------|
| mXACT Total
Prosthesis
Offcenter | Middle ear, Prosthesis,
Total Ossicular
Replacement Prostheses
(Ear, Nose & Throat) | Class II | ETA | 874.3495 |
| mXACT Total
Prosthesis
Center | Middle ear, Prosthesis,
Total Ossicular
Replacement Prostheses
(Ear, Nose & Throat) | | | |
| mXACT PRO
Total Prosthesis
Kit | Middle ear, Prosthesis,
Length -Adjustable and
Total Ossicular
Replacement Prostheses
(Ear, Nose & Throat) | | | |
6
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 | ||
| Offcenter | N/A | |
| N/A | ||
| mXACT Total Prosthesis | ||
| Center | TTP- | |
| Tuebingen | ||
| Type AERIAL | ||
| Total | ||
| Prosthesis | ||
| K972585 | Duesseldorf | |
| Type AERIAL | ||
| Total | ||
| Prosthesis | ||
| K972585 | ||
| mXACT PRO Total | ||
| Prosthesis Kit | TTP- VARIAC | |
| System Total | ||
| 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
Name | mXACT
Total Prosthesis
Offcenter | mXACT
Total Prosthesis
Center | mXACT PRO
Total Prosthesis Kit |
|----------------------|-----------------------------------------|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Image: mXACT Total Prosthesis Offcenter | Image: mXACT Total Prosthesis Center | Image: mXACT PRO Total Prosthesis
mXACT PRO Total
Prosthesis:
+
Sizers for total prostheses:
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
Components
and
Accessories | N/A | | System/Kit content:
1 mXACT PRO Total
Prosthesis + 7 Sizers for
total prostheses |
|------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Coupling
structure | Cannulated "stem" for optimized stability on the stapes footplate | | |
| Headplate | Oval wih
optional bending
possibility | Round with
optional
bending
possibility | Oval & length adjustable
(through snap-mechanism)
The surgeon can move the
"shaft" inside the headplate
to the desired functional
length, afterwards the
connection between
headplate and shaft is fixed
through the snap-
mechanism inside the
headplate. As a last step
the overlapping titanium
shaft of the prosthesis is
cut-off with a scalpel. |
| Material | Medical grade titanium | | mXACT PRO Total
Prosthesis:
Medical grade titanium
Sizer for total prosthesis:
Polypropylene |
| Sterile / Single-
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.
8
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
/ Predicate
Device | "mXACT Total
Prosthesis
Offcenter" | Predicate Device
[A]
"TTP-Tuebingen
Type AERIAL
Total
Prosthesis"
(K972585) | "mXACT Total
Prosthesis Center" | Predicate Device
[B]
"Duesseldorf Type
AERIAL Total
Prosthesis
(K972585) | "mXACT PRO Total
Prosthesis Kit" | Predicate Device [B]
"TTP-VARIAC System Total
(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:
1x Total ossicular replacement prosthesis | | |
| | | | | | 7 Sizers | 1 Sizer Disc (including 8
Sizers) |
| | | | Design: | | | |
| | | | The mXACT
headplate works with
a snap-closing
mechanism | TTP-VARIAC headplate
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
8 Sizers |
| Functional
lengths [mm] | 3.0, 3.25, 3.5, 3.75,
4.0, 4.25, 4.5, 4.75,
5.0, 5.5, 6.0, 6.5,
7.0 | 3.0, 3.25, 3.5,
3.75, 4.0, 4.25,
4.5, 4.75, 5.0,
5.25, 5.5, 6.0,
6.5, 7.0 | 3.0, 3.25, 3.5, 3.75,
4.0, 4.25, 4.5, 4.75,
5.0, 5.5, 6.0, 6.5, 7.0 | 3.0, 3.25, 3.5,
3.75, 4.0, 4.25,
4.5, 4.75, 5.0,
5.25, 5.5, 6.0, 6.5,
7.0 | Length adjustable total prosthesis can be adjusted
to a functional length from 3.00 to 7.00 | |
| | | | | | Sizers functional length: | |
| | | | | | 3.0, 3.5, 4.0, 4.5, 5.0,
6.0, 7.0 | 3.0, 3.5, 4.0, 4.5, 5.0,
5.5, 6.0, 7.0 |
| Shaft Ø [mm] | Staged diameter:
0.2 / 0.25 | 0.2 | Staged diameter:
0.2 / 0.25 | 0.2 | 0.20 | |
| Headplate
dimensions
[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
titanium ASTM F67
(stem and shaft) &
ASTMF136
(headplate); | Medical grade titanium
ASTM F67 |
| Biocompatible | Yes (EN ISO 10993) | | | | | |
| Surgical Tools
(mandatory) | n/a | | | | Titanium Micro Closing
Forceps &
Cutting Forceps | |
| Surgical Tools
(optional) | Tympanoplasty
Sizers for total
prostheses | ACSizer Disc Total.
Malleus Handle
Cavity Bending
pliers.
Cartilage Punch | Tympanoplasty
Sizers for total
prostheses | ACSizer Disc Total.
Malleus Handle
Cavity Bending
pliers.
Cartilage Punch | Tympanoplasty Sizers
for total prostheses
(included in the Kit) | ACSizer Disc Total
(included in the Kit).
KURZ Titanium
Tweezers
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.
11
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 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