(266 days)
Not Found
No
The device description and performance studies focus on mechanical properties and clinical outcomes of a passive implant, with no mention of AI or ML.
Yes
The device is described as a "passive middle ear implant" intended to "restore sound transmission" and replace components of the ossicular chain to treat "ossicular chain defects" and "inadequate conductive hearing." This indicates a therapeutic purpose aimed at treating a medical condition and restoring function.
No
The device is a passive middle ear implant designed to restore sound transmission by replacing components of the ossicular chain. It is a treatment device, not one that identifies or characterizes a disease or condition. The sizers are also surgical tools to determine the required length of the implant, not to diagnose.
No
The device is a passive middle ear implant and associated surgical sizers, which are physical hardware components intended for implantation and surgical use, not software.
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 components of the ossicular chain to restore sound transmission. This is a surgical intervention to physically replace damaged or missing parts of the ear.
- Device Description: The description reinforces that it's a partial ossicular replacement prosthesis that restores the mechanical sound transmission.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze samples from the body (like blood, urine, or tissue), or provide information about a patient's health status through in vitro testing.
- Surgical Tool: The Tympanoplasty Sizers are described as surgical tools for intraoperative transient use to determine the required length of the prosthesis. This is a tool used during surgery, not for in vitro diagnosis.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgically implanted prosthesis designed to restore function, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
INTENDED USE:
The passive middle ear implant - tympanoplasty partial 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 partial 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 tympanoplasty prosthesis is a medical device for single use delivered in sterile condition.
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 partial ossicular replacement prosthesis is indicated, if at least the stapes head and its stapes footplate are present and functional.
Tympanoplasty Sizers for partial prosthesis
(Note that the tympanosplasty Sizers are packaged together with the mXACT PRO Partial Prosthesis conforming the mXACT PRO Partial Prosthesis Kit).
INTENDED USE
The tympanoplasty Sizers are intended to be used during a partial 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 partial prosthesis are intended to intraoperatively determine the head 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 partial prostheses apply.
Product codes (comma separated list FDA assigned to the subject device)
ETB
Device Description
The MED-EL "Passive Middle Ear Implants" (PMEI) Tympanoplasty Partial Prostheses are partial 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 Partial Prosthesis: Round & "bell-shaped" for optimized stability on the stapes head. Oval with optional bending possibility. Medical grade titanium.
mXACT PRO Partial Prosthesis Kit: System/Kit content: 1 mXACT PRO Partial Prosthesis + 5 Sizers for partial prostheses. Universal clip for standardized coupling on the stapes head. 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 Partial Prosthesis: Medical grade titanium. Sizer for partial prosthesis: Polypropylene.
mCLIP Partial Prosthesis: Universal clip for standardized coupling on the stapes head. Round with optional bending possibility. Medical grade titanium.
mCLIP ARC Partial Prosthesis: Universal clip for standardized coupling on the stapes head. Round with a ball-joint connection to the shaft. The additional ball-joint allows the prosthesis to adapt itself to postoperative tympanic membrane movements (for example: caused by the healing process). Medical grade titanium.
All devices are Sterile / Single-Use.
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
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.
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.
The following tests were 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; The performed evaluation provides objective evidence to support the 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: 6/186 patients = 3.2 % (range 11.3-23.5 dB HL)
- Adverse events:
- Number of analyzed patients: 202 (98 female, 104 male)
- Age: mean 44.5 ± 18.7 years (range 5-84)
- Implanted ear: 107 right, 95 left
- Follow-up: median 275.0 days (mean 284.0 ± 176.9; range 0-666 days)
- Prosthesis type: 52 mXACT Partial, 16 mXACT PRO Partial, 72 mCLIP Partial, 62 mCLIP ARC Partial
- Number of (recommended) revision surgeries: 5
- Number of (potential) device dislocations/extrusions: 3
- Total 34 AEs in 21 patients: 7 Device unrelated AEs, 4 Medical related AEs, 15 Clinical/surgical related AEs, 8 AEs "unknown", 2 Follow-up AE
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 written out in full, with the month spelled out and the day and year written numerically.
Image /page/0/Picture/9 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
MED-EL Elektromedizinische Geräte GmbH Inés Román Santiago Senior Regulatory Affairs Fürstenweg 77a Innsbruck, Tirol 6020 Austria
Re: K241261
Trade/Device Name: mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit Regulation Number: 21 CFR 874.3450 Regulation Name: Partial Ossicular Replacement Prosthesis Regulatory Class: Class II Product Code: ETB Dated: December 18, 2024 Received: December 18, 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 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 820.30 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-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 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-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) K241261
Device Name
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
Indications for Use (Describe)
INTENDED USE:
The passive middle ear implant - tympanoplasty partial 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 tympanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles partially. 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 partial ossicular replacement prosthesis is indicated, if at least the stapes footplate are present and functional.
Tympanosplasty Sizers for partial prosthesis
(Note that the tympanosplasty Sizers are packaged together with the mXACT PRO Partial Prosthesis conforming the mXACT PRO Partial Prosthesis Kit).
INTENDED USE
The tympanoplasty Sizers are intended to be used during a partial 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 partial prosthesis are intended to intraoperatively determine the head 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 partial prostheses apply.
4
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
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 name is a stylized graphic of a cochlea, which is the part of the inner ear that is responsible for hearing. The logo is simple and modern, and it effectively communicates the company's focus on hearing solutions.
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 Partial Prostheses
| Device/Trade
Name | Generic category
& Medical Specialty | Classification | Product
code | Regulation
(CFR) |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------|-----------------|---------------------|
| mCLIP Partial
Prosthesis | Middle ear, Prosthesis,
Partial Ossicular
Replacement Prostheses
(Ear, Nose & Throat) | Class II | ETB | 874.3450 |
| mCLIP ARC
Partial
Prosthesis | | | | |
| mXACT Partial
Prosthesis | | | | |
| mXACT PRO
Partial
Prosthesis Kit | Middle ear, Prosthesis,
Length -Adjustable and
Partial 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.
Predicate Devices [807.92(a)(3)] 3.0
| Table 2 Predicate devices manufactured by Heinz Kurz GmbH | |||
|---|---|---|---|
| MED-EL device | Primary Predicate Device A | Predicate Device B |
|---|---|---|
| mXACT Partial Prosthesis | N/A | |
| mXACT PRO Partial | ||
| Prosthesis Kit | TTP- | |
| Tuebingen | ||
| Type BELL | ||
| Partial | ||
| Prosthesis | TTP- VARIAC | |
| System Partial | ||
| K990923 | ||
| mCLIP Partial Prosthesis | K972492 | CLIP Partial |
| Prosthesis | ||
| Dresden Type | ||
| K013573 | ||
| mCLIP ARC Partial | ||
| Prosthesis | CliP Partial | |
| FlexiBAL | ||
| K013573 |
Description of the Devices [807.92(a)(4)] 4.0
The MED-EL "Passive Middle Ear Implants" (PMEI) Tympanoplasty Partial Prostheses are partial 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.
Table 3 Description of the MED-EL PMEI Tympanoplasty Partial Prostheses
| Device/Trade Name | mXACT
Partial Prosthesis | mXACT PRO
Partial Prosthesis Kit | mCLIP
Partial Prosthesis | mCLIP ARC
Partial Prosthesis |
|-------------------|---------------------------------|-----------------------------------------|---------------------------------|-------------------------------------|
| Design | Image: mXACT Partial Prosthesis | Image: mXACT PRO Partial Prosthesis Kit | Image: mCLIP Partial Prosthesis | Image: mCLIP ARC Partial Prosthesis |
7
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, sans-serif font. A stylized graphic of an ear is placed between the "D" and "E" in MED-EL.
| System/Kit
Components
and
Accessories | N/A | System/Kit content:
1 mXACT PRO Partial
Prosthesis + 5 Sizers for
partial prostheses | N/A |
|------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Coupling
structure | Round & "bell-shaped" for optimized stability
on the stapes head | Universal clip for standardized
coupling on the stapes head | |
| Headplate | Oval 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. | Round with a
ball-joint
connection to the
shaft.
The additional
ball-joint allows
the prosthesis to
adapt itself to
postoperative
tympanic
membrane
movements (for
example: caused
by the healing
process). |
| Headplate | | Round with
optional bending
possibility | |
| Material | Medical grade
titanium | mXACT PRO Partial
Prosthesis:
Medical grade titanium
Sizer for partial
prosthesis: Polypropylene | Medical grade titanium |
| 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 Partial 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 Partial Prostheses
Intended Use
The passive middle ear implant - tympanoplasty partial 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 partial 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 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. 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 curved lines, also in red.
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 partial ossicular replacement prosthesis is indicated, if at least the stapes head and its stapes footplate are present and functional.
Tympanoplasty Sizers for partial prosthesis4
Intended Use
The tympanoplasty Sizers are intended to be used during a partial 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 partial prosthesis are intended to intraoperatively determine the distance between the head 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 partial prostheses apply.
1 Note that the "italic text" in this section shall be used if the tympanoplasty Sizers are packaged together with the mXACT PRO Partial Prosthesis conforming the mXACT PRO Partial Prosthesis Kit. Traditional 510(k) PMEI TYM Partial
9
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 letters. To the right of the name is a stylized graphic that resembles an ear.
6.0 Comparison on Technological Characteristics with predicate devices [807.92(a)(6)]
The MED-EL PMEls have the same technological characteristics (i.e. design, material composition, etc.) as the predicate devices identified in paragraph |a||3). Hence, no difference in safety and effectiveness of the MED-EL PMET Tympanoplasty Partial Prostheses as compared to the predicate devices from Heinz CmbH is expected. A summary of the technological characteristics is provided in the following table.
6.1 PMEI Tympanoplasty PARTIAL Prostheses - Comparison with predicate devices
| MED-EL
Device /
Predicate
Device | "mXACT Partial
Prosthesis" | Predicate
Device [A]
"TTP-
Tuebingen
Type BELL
Partial
Prosthesis"
(K972492) | "mXACT PRO
Partial
Prosthesis Kit" | Predicate Device
[B]
"TTP-VARIAC
System Partial"
(K990923) | "mCLIP Partial
Prosthesis" | Predicate
Device [B]
"CLIP Partial
Prosthesis
Dresden Type"
(K013573) | "mCLIP ARC
Partial
Prosthesis" | Predicate Device
[B]
"Clip Partial
FlexiBAL"
(K013573) | |
|-------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------|--|
| Design | Image: mXACT Partial Prosthesis | Image: TTP-Tuebingen Type BELL Partial Prosthesis | Image: mXACT PRO Partial Prosthesis Kit | Image: TTP-VARIAC System Partial | Image: mCLIP Partial Prosthesis | Image: CLIP Partial Prosthesis Dresden Type | Image: mCLIP ARC Partial Prosthesis | Image: Clip Partial FlexiBAL | |
| | mXACT features a slit-headplate
design for optional bending
possibility | System/Kit content:
1x Partial ossicular replacement
prosthesis
5 Sizers
1 Sizer Disc
(including 6 | | mCLIP features a slit-headplate
design for optional bending
possibility and a clip with 8
"legs" instead of 7 | | Both devices have a ball-joint in the
headplate.
mCLIP ARC has a round and centric
headplate | | | |
| | | | | Sizers) | | | | | |
| | | | Design: | | | | | | |
| | | | The mXACT
headplate
works with a
snap-closing
mechanism | TTP-VARIAC
headplate with
plastic
deformation | | | | | |
| Attachment | | Bell-shaped coupling structure for the placement onto the stapes head | | | Clip-shaped coupling structure for the placement onto the stapes head | | | | |
| | | | | 1 length adjustable partial
prosthesis | | | | | |
| # of sizes | 10 | 8 | | 5 Sizers
1 Sizer Disc
containing 6
Sizers | 10 | 8 | 10 | 8 | |
| Functional
lengths [mm] | 0.75, 1.00,
1.25, 1.50,
1.75, 2.00,
2.25, 2.50,
3.00, 3.50 | 0.75, 1.00,
1.25, 1.50,
1.75, 2.00,
2.25, 2.50 () | | length adjustable partial
prosthesis can be adjusted to a
functional length from 0.75 to
3.50
Sizers functional length:
1.0, 1.5, 2.0,
2.5, 3.5
1.0, 1.5, 2.0,
2.5, 3.0, 3.5 | 0.75, 1.00,
1.25, 1.50,
1.75, 2.00,
2.25, 2.50,
3.00, 3.50 | 0.75, 1.00,
1.25, 1.50,
1.75, 2.00,
2.25, 2.50
() | 0.75, 1.00, 1.25,
1.50, 1.75, 2.00,
2.25, 2.50, 3.00,
3.50 | 0.75, 1.00, 1.25,
1.50, 1.75, 2.00,
2.25, 2.50 (*) | |
| Shaft Ø [mm] | 0.20 | | | | | | | | |
| Headplate
dimensions
[mm] | | | Ø2.60 x 3.60 (oval and off-centric) | | | Ø2.60 (round and centric) | Ø2.60 (round
and centric) | Ø2.60 x 3.60
(oval and off-
centric) | |
| Materials | Medical grade titanium ASTM F67 | Medical grade
titanium ASTM
F67 (bell and
shaft) &
ASTMF136
(headplate); | | Medical grade titanium ASTM F67 | | Medical grade
titanium ASTM
F67, except the
micro-ball which
can be out of
ASTMF67 or ISO
5832-2; | Medical grade
titanium ASTM
F67 | | |
| Biocompatible | | | | Yes (EN ISO 10993) | | | | | |
| Surgical Tools | N/A | | | Titanium Micro | N/A | | | | |
| (mandatory) | | | | Closing Forceps
&
Cutting Forceps | | | | | |
| Surgical Tools
(optional) | Tympanoplasty
Sizers for
partial
prostheses | ACSizer Disc
Partial.
Malleus
Handle. Cavity
Bending pliers. | Tympanoplasty
Sizers for
partial
prostheses
(included in
the Kit) | ACSizer Disc Partial
(included in the
sales package).
KURZ Titanium
Tweezers.
Micro Scissors | Tympanoplasty
Sizers for
partial
prostheses | ACSizer Disc
Partial | Tympanoplasty
Sizers for partial
prostheses | ACSizer Disc Partial | |
| Packaging | One length variant per package;
Single-Use; Sterile | | | One length variable partial
ossicular replacement prosthesis +
5 Sizers for partial prostheses.
Single-Use; Sterile | | One length variant per package; Single-Use; Sterile | | | |
| MRI | MRI Conditional at 1.5, 3.0 and 7.0 T | | | | | | | | |
Table 4: PMEI Tympanoplasty Partial Prostheses - Comparison of Technical Characteristics
10
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 a bold, sans-serif font. The "O" in MED-EL is stylized with a circular design, adding a unique touch to the logo.
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. To the right of the "D" in MED, there is a stylized graphic of a cochlea, which is the part of the inner ear responsible for hearing. The logo is simple and modern, and it effectively communicates the company's focus on hearing solutions.
- The predicate device uses a different type of lent in the finctional length of the device (functional length is the distance between stages head and the tympanic nembrane), whereas for the overal length is specified as part of the mentioned 510k. According to the predicate device (see https://www.kurzmed.com/), the overall length of each variant is the functional length plus 1mm.
Comparing the MED-EL PMEI Tympanoplasty Prostheses and their identified predicate devices manufactured by Heinz Kurz GmbH, the, 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 determine the required length 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 Partial Proshess conforming the mXACT PRO Partial Prosthess, for the predicate devices, also additional optional tools (Malleus Handle Cavity Bending pliers, KURZ Titanium Tweezers, and Micro Scissors) are prosthesis length, the TTP-VARIAC System Partial (Heinz Kurz GmbH) requires the surgeon to use special tools for closing the headplate of the MED-EL mXACT PRO Partial 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 Partial Prosthesis headplate was confirmed in non-clinical testing.
12
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 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 dB HL: 6/186 patients = 3.2 % (range 11.3- O 23.5 dB HL)
- . Adverse events:
O
- Number of analyzed patients: 202 (98 female, 104 male) o
13
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 a bold, sans-serif font. To the right of the name is a circular graphic with curved lines, possibly representing sound waves or the inner ear. The logo is simple, modern, and easily recognizable.
- Age: mean 44.5 ± 18.7 vears (range 5-84) o
- Implanted ear: 107 right, 95 left o
- Follow-up: median 275.0 days (mean 284.0 ± 176.9; range 0-666 days) o
- Prosthesis type: 52 mXACT Partial, 16 mXACT PRO Partial, 72 mCLIP o Partial, 62 mCLIP ARC Partial
- Number of (recommended) revision surgeries: 5 O
- Number of (potential) device dislocations/extrusions: 3 o
- o Total 34 AEs in 21 patients: 7 Device unrelated AEs, 4 Medical related AEs, 15 Clinical/surgical related AEs, 8 AEs "unknown", 2 Follow-up AE
In the above mentioned PMCF investigation the safety and effectiveness of the PMEI Tympanoplasty Partial 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 Partial 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 Partial 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 Partial 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.