(278 days)
KURZ middle ear prostheses are intended for the partial or total surgical replacement of the ossicular chain of the human middle ear. The objective is the restoration of the mechanical transfer of sound from the tympanic membrane to the oval window of the cochlear with the least impairment of hearing.
Specifically, the devices are designed for the treatment of
- Chronic middle ear inflammation (also following removal of a tumour, e.g. cholesteatoma) with functional impairment of the ossicular chain
- Otosclerosis (stapedial fixation) / congenital stapedial fixation
- Traumatic injury to the ossicular chain
- Malformation of the middle ear
- Revision surgery to correct inadequate hearing improvement, e.g. through dislocation of a prosthesis
Due to different preferences and different techniques of the surgeons various designs of stapes prosthesis are available. The objective of all stapedial prostheses is the restoration of the mechanical transfer of sound from the tympanic membrane to the oval window of the cochlear with the least impairment of hearing.
NiTiFLEX Stapes Prosthesis:
The NiTiFLEX is a stapes prosthesis for partial replacement of the ossicular chain. It consists of a Nitinol clip and the standard KURZ shaft (piston) made of pure titanium with a diameter of 0.4 and 0.6 mm (ASTM F67). The Nitinol clip is made of superelastic Nitinol. Due to the CliP Design, already available with the predicate device CliP® Piston àWengen, the NiTiFLEX can be fixed on the long process of the incus without manual crimping. With the superelastic characteristics of the loop the easier handling of the application of the CliP can be achieved.
Detroit Piston:
The Detroit Piston is a stapes prosthesis for partial replacement of the ossicular chain. It is made of pure titanium (ASTM F67). As shaft the standard KURZ piston is used with a diameter of 0.4 / 0.5 / 0.6 mm. The loop has got a width of 0.5 mm and is twisted (like the loop of the predicate device K-Piston) for easier application on the long process of the incus especially in cases were the incus diameter is very small. The attachment to the incus is done by manual crimping of the prosthesis loop.
Roberson Stapes Prosthesis:
The Roberson Stapes Prosthesis is a stapes prosthesis for partial replacement of the ossicular chain. It is made of pure titanium (ASTM F67). The long process of the incus is placed within the bucket. Two different diameters of the bucket are available - 0.9 and 1.0 mm - for different incus diameters. A piston diameter of 0.6 mm is used. Additional stability is provided by the wire that is placed over the incus. This design is comparable to the Roberson Stapes Prosthesis by Metronic (predicate device).
Skarzynski Piston:
The Skarzynski Piston is a stapes prosthesis for partial replacement of the ossicular chain. It is made of pure titanium (ASTM F67). As shaft the standard KURZ piston is used with a diameter of 0.4 and 0.6 mm. The loop has got a width of 0.25 mm and is twisted (like the loop of the predicate device K-Piston) for easier application on the long process of the incus especially in cases were the incus diameter is very small. The attachment to the incus is done by manual crimping of the prosthesis loop.
The provided document describes the 510(k) summary for several stapes prostheses manufactured by Heinz Kurz GmbH Medizintechnik. This is a premarket notification for medical devices, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data to prove efficacy. Therefore, much of the requested information regarding "acceptance criteria" for performance metrics like sensitivity/specificity, or detailed clinical study designs with ground truth established by experts, will not be present in this type of submission. The "acceptance criteria" here refer more broadly to the regulatory requirements for showing safety and effectiveness through substantial equivalence and meeting specified non-clinical performance benchmarks.
Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance | Comments |
|---|---|---|---|
| Intended Use | Restoring mechanical transfer of sound from tympanic membrane to oval window; treating specific ear conditions (chronic inflammation, otosclerosis, trauma, malformation, revision surgery). | Declared identical to predicate devices. | This is a key criterion for demonstrating substantial equivalence. |
| Design & Dimensions | Specific lengths, piston diameters, loop band widths, and bucket diameters as outlined in tables (Pages 4-6). | Adheres to specified dimensions and sizes for each device type. | Directly compared to predicate devices; design considered sufficiently similar. |
| Materials | NiTiFLEX: Nitinol clip, Titanium (ASTM F67) shaft. Detroit Piston, Skarzynski Piston, Roberson Piston: Titanium (ASTM F67). | Materials used as specified and are common in predicate devices. | ASTM F67 is a standard for unalloyed titanium. |
| Method of Attachment | NiTiFLEX: Manually, without crimping. Detroit Piston, Skarzynski Piston: Manually, with crimping. Roberson Stapes Prosthesis: Manually, without crimping. | Specific to each device type, consistent with predicate devices. | Important for surgical technique and device function. |
| Single Use & Sterility | Single Use, Sterile (SAL < 10^-6) | All devices are declared single-use and sterile. | Confirmed by Sterilization validation according to EN ISO 11137-1, 11137-2, Gamma Sterilization. |
| Biocompatibility | Biocompatible | All devices declared biocompatible. | Confirmed by Biocompatibility testing according to EN ISO 10993. |
| MRI Safety | MR Conditional (1.5, 3 + 7 Tesla) | All devices declared MR Conditional. | Confirmed by MRI environment testing according to ASTM F2119, F2052, F2182. |
| Shelf Life | Validated shelf life | Not explicitly stated duration, but "Shelf life testing according EN ISO 11607" was conducted. | Ensures device remains functional and sterile over time. |
| Packaging | Validated packaging | Not explicitly stated details, but "Packaging validation according EN ISO 11607" was conducted. | Ensures integrity and sterility until use. |
| Attachment Forces | Specific to NiTiFLEX | "Attachment Forces" test was conducted for NiTiFLEX. (Details on exact acceptance criteria or results not provided in summary, but assumed to be acceptable). | Essential for the functional integrity of the non-crimping NiTiFLEX. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document primarily details a non-clinical (bench) testing and regulatory submission process for substantial equivalence, not a clinical study with human subjects.
- Test Set Sample Size: No information on a "test set" in the context of clinical data (e.g., patient cases) is provided. The performance testing refers to bench testing, for which sample sizes for each specific test (e.g., MRI testing, biocompatibility, attachment forces) are not detailed in this summary.
- Data Provenance: The document does not refer to clinical data (e.g., country of origin, retrospective/prospective). All referenced testing appears to be laboratory-based ("Bench testing") conducted by the manufacturer, Heinz Kurz GmbH Medizintechnik, based in Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable or available in this document. The submission focuses on substantial equivalence based on material, design, and non-clinical performance characteristics, not on clinical effectiveness studies requiring expert-adjudicated ground truth.
4. Adjudication Method for the Test Set
This type of information is not applicable or available in this document, as there is no mention of a human-adjudicated test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This information is not applicable. This document describes a medical device (stapes prostheses), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related comparative effectiveness is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This document describes a medical device, not an algorithm, and therefore human-in-the-loop performance or standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
For the non-clinical performance testing, the "ground truth" would be established by:
- Industry standards and regulatory requirements: e.g., ASTM F2119, F2052, F2182 for MRI safety; EN ISO 10993 for biocompatibility; EN ISO 11607 for shelf life and packaging; EN ISO 11137 for sterilization.
- Engineering specifications and measurements: For design parameters like dimensions, attachment forces, and material properties.
For the purpose of the 510(k) submission, the ultimate "truth" is the demonstration of substantial equivalence to predicate devices in terms of intended use, technology, and safety/effectiveness performance, rather than an independently established "ground truth" of a disease state.
8. The Sample Size for the Training Set
This information is not applicable or available. No "training set" in the context of machine learning or clinical data is mentioned in this document.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or available, as there is no mention of a "training set" or corresponding ground truth establishment.
Summary of the Study Proving Acceptance Criteria:
The "study" proving the device meets acceptance criteria, in the context of this 510(k) submission, is a comprehensive set of non-clinical bench tests and comparisons to predicate devices.
The manufacturer, Heinz Kurz GmbH Medizintechnik, conducted the following tests to demonstrate safety and effectiveness and substantiate equivalence:
- NiTiFLEX Specific Test: Attachment Forces (details on criteria/results not in summary).
- All Products:
- MRI Environment Testing: Conducted according to ASTM F2119, F2052, F2182, demonstrating MR Conditional status at 1.5, 3, and 7 Tesla.
- Biocompatibility Testing: Conducted according to EN ISO 10993.
- Shelf Life Testing: Conducted according to EN ISO 11607.
- Sterilization Validation: Conducted according to EN ISO 11137-1, 11137-2 (Gamma Sterilization), achieving a sterility assurance level (SAL) of < 10^-6.
- Packaging Validation: Conducted according to EN ISO 11607.
The document states that these tests, along with detailed comparisons of the new devices to legally marketed predicate devices (K002221, K021479, K112616, etc.) in terms of intended use, design, materials, and other specifications, demonstrated that the Kurz Stapes Prostheses are "as safe and effective as the predicate devices." The conclusion is that "Nonclinical and clinical testing demonstrated that the Kurz Stapes Prostheses are as safe and effective as the predicate devices. The results of non-clinical design performance validations raise no new issues of safety and effectiveness." (Note: The "clinical testing" mentioned here is likely a boilerplate reference or refers to existing clinical knowledge about predicate devices, as no new clinical study data is presented for these specific devices in the summary).
{0}------------------------------------------------
Date: 17-May-2013
Page 1 o' 8
1. Submitter
Heinz Kurz GmbH Medizintechnik Tübinger Str. 3 D-72144 Dusslingen Germany Tel. +49-7072-91 79 0 Fax +49-7072 -91 79 79
DEC 02 2013
Contact Person: Kristina Bitzer
Manager Regulatory Affairs, Heinz Kurz GmbH Medizintechnik Email: kbitzer@kurzmed.de
Date Summary Prepared: May 17, 2013
2. Device Name
| Trade | NiTiFLEX Stapes Prosthesis |
|---|---|
| Detroit Piston | |
| Skarzynski Piston | |
| Roberson Stapes Prosthesis | |
| Common | Stapes Prosthesis, Stapes Piston |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Product Code | 77 ETB |
| Regulation # | CFR 874.3450 |
3. Predicate Devices
| K002221 | K-Piston, Heinz Kurz GmbH Medizintechnik |
|---|---|
| K021479 | CliP® Piston àWengen, Heinz Kurz GmbH Medizintechnik |
| K112616 | NiTiBOND Stapes Prosthesis, Heinz Kurz GmbH Medizintechnik |
| unknown | Big Easy, Medtronic |
| K002897 | Roberson Stapes Prosthesis, Medtronic |
{1}------------------------------------------------
510(k) Summary
Date: 17-May-2013
ge 2 of 8
4. Device Description
Due to different preferences and different techniques of the surgeons various designs of stapes prosthesis are available. The objective of all stapedial prostheses is the restoration of the mechanical transfer of sound from the tympanic membrane to the oval window of the cochlear with the least impairment of hearing.
NiTiFLEX Stapes Prosthesis:
Image /page/1/Picture/8 description: The image shows a drawing of a tool. The tool has a long handle with a bulbous end. The top of the tool has a curved shape with two hooks. The drawing is in black and white and has a vintage look.
The NiTiFLEX is a stapes prosthesis for partial replacement of the ossicular chain.
It consists of a Nitinol clip and the standard KURZ shaft (piston) made of pure titanium with a diameter of 0.4 and 0.6 mm (ASTM F67).
The Nitinol clip is made of superelastic Nitinol. Due to the CliP Design, already available with the predicate device CliP® Piston àWengen, the NiTiFLEX can be fixed on the long process of the incus without manual crimping. With the
superelastic characteristics of the loop the easier handling of the application of the CliP can be achieved.
Detroit Piston:
Image /page/1/Picture/14 description: The image shows a tool with a cylindrical handle and a curved, hook-like head. The handle appears to be made of metal and has a smooth, polished surface. The head of the tool is also metal and has a series of openings or slots along its curved surface. The tool is likely used for gripping or manipulating objects, possibly in an agricultural or industrial setting.
The Detroit Piston is a stapes prosthesis for partial replacement of the ossicular chain.
It is made of pure titanium (ASTM F67). As shaft the standard KURZ piston is used with a diameter of 0.4 / 0.5 / 0.6 mm. The loop has got a width of 0.5 mm and is twisted (like the loop of the predicate device K-Piston) for easier application on the long process of the incus especially in cases were the incus diameter is very small. The attachment to the incus is done by manual crimping of the prosthesis loop.
{2}------------------------------------------------
510(k) Summary
Date: 17-May-2013
Page 3 of 8
Roberson Stapes Prosthesis
The Roberson Stapes Prosthesis is a stapes prosthesis for partial replacement of the ossicular chain. It is made of pure titanium (ASTM F67). The long process of the incus is placed within the bucket. Two different diameters of the bucket are available - 0.9 and 1.0 mm - for different incus diameters. A piston diameter of 0.6 mm is used. Additional stability is provided by the wire that is placed over the incus. This design is comparable to the Roberson Stapes Prosthesis by Metronic (predicate device).
Skarzynski Piston
Image /page/2/Figure/8 description: The image shows a tool with a curved blade at the top and a long handle. The blade is shaped like a crescent moon, with the sharp edge facing inward. The handle is straight and cylindrical, providing a grip for the user. The tool appears to be made of metal, with a light gray color.
The Skarzynski Piston is a stapes prosthesis for partial replacement of the ossicular chain.
It is made of pure titanium (ASTM F67). As shaft the standard KURZ piston is used with a diameter of 0.4 and 0.6 mm. The loop has got a width of 0.25 mm and is twisted (like the loop of the predicate device K-Piston) for easier application on the long process of the incus especially in cases were the incus diameter is very small. The attachment to the incus is done by manual crimping of the prosthesis loop.
{3}------------------------------------------------
510(k) Summary
Date: 17-May-2013
Page 4 of 8
5. Statement of Intended Use
KURZ middle ear prostheses are intended for the partial or total surgical replacement of the ossicular chain of the human middle ear. The objective is the restoration of the mechanical transfer of sound from the tympanic membrane to the oval window of the cochlear with the least impairment of hearing.
Specifically, the devices are designed for the treatment of
- 1 . Chronic middle ear inflammation (also following removal of a tumour, e.g. cholesteatoma) with functional impairment of the ossicular chain
-
- Otosclerosis (stapedial fixation) / congenital stapedial fixation
- Traumatic injury to the ossicular chain 3.
- ব -Malformation of the middle ear
- ട്. Revision surgery to correct inadequate hearing improvement, e.g. through dislocation of a prosthesis
The indications are identical to the predicate devices and therefore do not affect safety and effectiveness.
6. Comparison with Predicate Devices
Due to different preferences and different techniques of the surgeons various designs of stapes prosthesis are available. The objective of all stapedial prostheses, including the predicate devices, is the restoration of the mechanical transfer of sound from the tympanic membrane to the oval window of the cochlear with the least impairment of hearing.
{4}------------------------------------------------
| HEINZ KURZ GmbH MEDIZINTECHNIKTuebinger Str. 3, D-72144 Dusslingen, Germany | Traditional 510(k) K130512Stapes Prostheses | |
|---|---|---|
| 510(k) Summary | Date: 17-May-2013 | Page 5 of 8 |
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| Device | NITIFLEXStapes ProsthesisHeinz Kurz GmbH | PREDICATE DEVICECliP® PistonáWengenHeinz Kurz GmbHK021479 | PREDICATE DEVICENITIBONDHeinz Kurz GmbHK112616 |
|---|---|---|---|
| Design Comparison | a | ||
| Intended Use | The prosthesis isintended for ossicularreplacement to restorefunctionality to the middleear in cases ofpathological changes ofthe sound transmissionsystem. | Identical | Identical |
| Method of Attachment | Manually, withoutcrimping | Manually, without crimping | Heat activated |
| # of Sizes | 16 (8 for each shaft Ø) | 16 (8 for each shaft Ø) | 16 (8 for each shaft Ø) |
| Dimensions Length[mm] | 3.5 - 5.5(up to 5.0 in 0.25 mmintervals+ 5.5 mm ) | 3.5 - 5.5(up to 5.0 in 0.25 mmintervals+ 5.5 mm ) | 3.5 - 5.5(up to 5.0 in 0.25 mmintervals+ 5.5 mm ) |
| Piston Ø[mm] | 0.4 / 0.6 | 0.4 / 0.6 | 0.4 / 0.6 |
| Width of Loop Band[mm] | 0.25 | 0.25 | 0.25 |
| MaterialsLoopPiston | NitinolTitanium (ASTM F67) | Titanium (ASTM F67) | NitinolTitanium (ASTM F67) |
| Single Use | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes |
| MRI | MR Conditional1.5, 3 + 7 Tesla | MR Conditional1.5, 3 + 7 Tesla | MR Conditional1.5, 3 + 7 Tesla |
| Biocompatible | Yes | Yes | Yes |
{5}------------------------------------------------
| HEINZ KURZ GmbH MEDIZINTECHNIKTuebinger Str. 3, D-72144 Dusslingen, Germany | Traditional 510(k) K130512Stapes Prostheses | |
|---|---|---|
| 510(k) Summary | Date: 17-May-2013 | Page 6 of 8 |
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| Device | Detroit PistonHeinz Kurz GmbH | Skarzynski PistonHeinz Kurz GmbH | PREDICATE DEVICEK-PistonHeinz Kurz GmbHK002221 | PREDICATE DEVICEBig EasyMedtronic510(k) numberunknown |
|---|---|---|---|---|
| DesignComparison | Image: Detroit Piston | Image: Skarzynski Piston | Image: K-Piston | Image: Big Easy |
| Intended Use | The prosthesis isintended for partialossicular replacementto restore functionalityto the middle ear incases of pathologicalchanges of the soundtransmission system. | Identical | Identical | Identical |
| Method ofAttachment | Manually, withcrimping | Manually, withcrimping | Manually, withcrimping | Manually, withcrimping |
| # of Sizes | 24(8 for each shaft Ø) | 16(8 for each shaft Ø) | 28(14 for each shaft Ø) | 10 (4 straight, 3 eachleft ear offset / rightear offset) |
| DimensionsLength[mm] | 3.5 - 5.5(up to 5.0 mm in 0.25mm intervals + 5.5mm) | 3.5 - 5.5(up to 5.0 mm in 0.25mm intervals + 5.5mm) | 3.5 - 10.0(up to 5.50 in 0.25mm intervals; than1.0 mm intervals) | 4.00 - 5.00(0.25 mm intervals) |
| Piston Ø[mm] | 0.4 / 0.5 / 0.6 | 0.4 / 0.6 | 0.4 / 0.6 | 0.5 |
| Width of LoopBand[mm] | 0.5 | 0.25 | 0.3 | 0.4 |
| MaterialsLoopPiston | Titanium (ASTM F67) | Titanium (ASTM F67) | Titanium (ASTM F67) | PlatinumTitanium |
| Single Use | Yes | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes | Yes |
| MRI | MR Conditional1.5, 3 + 7 Tesla | MR Conditional1.5, 3 + 7 Tesla | MR Conditional1.5, 3 + 7 Tesla | MR Conditional |
| Biocompatible | Yes | Yes | Yes | Yes |
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{6}------------------------------------------------
HEINZ KURZ GmbH MEDIZINTECHNIK
Tuebinger Str. 3, D-72144 Dusslingen, Germany
Traditional 510(k) K130512 Stapes Prostheses
510(k) Summary
Date: 17-May-2013
| Device | Roberson Stapes ProsthesisHeinz Kurz GmbH | PREDICATE DEVICERoberson Stapes ProsthesisMedtronic510(k) number unknown |
|---|---|---|
| DesignComparison | Image: Roberson Stapes Prosthesis | Image: PREDICATE DEVICE |
| Intended Use | The prosthesis is intended for ossicularreplacement to restore functionality to themiddle ear in cases of pathologicalchanges of the sound transmission system. | Identical |
| Method ofAttachment | Manually, without crimping | Manually, without crimping |
| # of Sizes | 6 (3 for each bucket Ø) | 6 (3 for each bucket Ø) |
| DimensionsLength[mm] | 4.0 - 4.5(0.25 mm intervals) | 4.0 - 4.5(0.25 mm intervals) |
| Piston Ø[mm] | 0.6 | 0.6 |
| Bucket Ø[mm] | 0.9 / 1.0 | 0.9 / 1.0 |
| Materials | Titanium (ASTM F67) | Titanium (ASTM F67) |
| Single Use | Yes | Yes |
| Sterile | Yes | Yes |
| MRI | MR Conditional1.5, 3 + 7 Tesla | MR Conditional |
| Biocompatible | Yes | Yes |
{7}------------------------------------------------
7. Performance Testing
Safety and effectiveness has been demonstration within the Bench testing and performance specifications are met.
The following tests were conducted:
-
· NiTiFLEX: Attachment Forces
All products: -
· MRI environment according ASTM F2119, F2052, F2182
-
· Biocompatibility according EN ISO 10993
-
· Shelf life testing according EN ISO 11607
-
· Sterilization validation according EN ISO 11137-1, 11137-2, Gamma Sterilization with a confirmed sterility assurance level of < 10°6
-
· Packaging validation according EN ISO 11607
8. Conclusion
Nonclinical and clinical testing demonstrated that the Kurz Stapes Prostheses are as safe and effective as the predicate devices. The results of non-clinical design performance validations raise no new issues of safety and effectiveness.
Differences between the Kurz Stapes Prostheses and the predicate devices should not affect the safety or effectiveness.
Date: 17-May-2013
Signature:
Hote
Kristina Bitzer Manager Regulatory Affairs
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gots Silver Spring. MI) 2009-0002
December 2, 2013
Heinz Kurz GmbH Medizintechnik c/o Ms. Kristina Bitzer Manager Regulatory Alfairs Tübinger Strasse 3 72144 Dusslingen Germany
Re: K130512
Trade/Device Name: NitFLEX Stapes Prosthesis. Detroit Piston, Skarzynski Piston, Roberson Stapes Prosthesis Regulation Number: 21 CFR 874.3450 Regulation Name: Partial Ossicular Replacement Prosthesis Regulatory Class: Class II Product Code: ETB Dated: October 28, 2013 Received: October 31, 2013
Dear Ms. Bitzer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 vou, 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 vour device in the Federal Register.
{9}------------------------------------------------
Page 2 - Ms. Kristina Bitzer
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDR/10ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{10}------------------------------------------------
Indications for Use
510(k) Number (if known): K130512
Device Name: NiTiFLEX Stapes Prosthesis Detroit Piston Skarzynski Piston Roberson Stapes Prosthesis
Indications For Use:
KURZ middle ear prostheses are intended for the partial or total surgical replacement of the ossicular chain of the human middle ear. The objective is the restoration of the mechanical transfer of sound from the tympanic membrane to the oval window of the cochlear with the least impairment of hearing.
Specifically, the devices are designed for the treatment of
-
- Chronic middle ear inflammation (also following removal of a tumor, e.g. cholesteatoma) with functional impairment of the ossicular chain
-
- Otosclerosis (stapedial fixation) / congenital stapedial fixation
-
- Traumatic injury to the ossicular chain
-
- Malformation of the middle ear
-
- Revision surgery to correct inadequate hearing improvement, e.g. through dislocation of a prosthesis
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Sunny Park 2013.11.27 14:51:54 -05'00'
Page 1 of 1 -
§ 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.