NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
Device Facts
| Record ID | K130512 |
|---|---|
| Device Name | NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS |
| Applicant | Heinz Kurz GmbH Medizintechnik |
| Product Code | ETB · Ear, Nose, Throat |
| Decision Date | Dec 2, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3450 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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 2. Otosclerosis (stapedial fixation) / congenital stapedial fixation 3. Traumatic injury to the ossicular chain 4. Malformation of the middle ear 5. Revision surgery to correct inadequate hearing improvement, e.g. through dislocation of a prosthesis
Device Story
Stapes prostheses (NiTiFLEX, Detroit Piston, Skarzynski Piston, Roberson Stapes Prosthesis) designed for partial ossicular chain replacement; restore sound transfer from tympanic membrane to oval window. NiTiFLEX features superelastic Nitinol clip for non-crimping attachment to incus; Detroit and Skarzynski pistons utilize manual crimping; Roberson uses bucket design. All shafts made of pure titanium (ASTM F67). Used by surgeons in clinical/OR settings. Devices provide mechanical bridge to improve hearing; benefit patients with conductive hearing loss. MR conditional (1.5, 3, 7 Tesla).
Clinical Evidence
No clinical data. Substantial equivalence demonstrated via bench testing, including attachment force, MRI compatibility (ASTM F2119, F2052, F2182), biocompatibility (EN ISO 10993), shelf life, and sterilization validation (EN ISO 11137).
Technological Characteristics
Materials: Pure titanium (ASTM F67), superelastic Nitinol. Design: Piston-style ossicular prostheses with varying loop/bucket configurations. Energy: Passive mechanical device. Connectivity: None. Sterilization: Gamma radiation (EN ISO 11137). MR Conditional (1.5, 3, 7 Tesla).
Indications for Use
Indicated for patients requiring partial or total ossicular chain replacement due to chronic middle ear inflammation, otosclerosis, congenital stapedial fixation, traumatic injury, middle ear malformation, or revision surgery for hearing improvement.
Regulatory Classification
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.
Predicate Devices
- K-Piston, Heinz Kurz GmbH Medizintechnik (K002221)
- CliP® Piston àWengen, Heinz Kurz GmbH Medizintechnik (K021479)
- NiTiBOND Stapes Prosthesis, Heinz Kurz GmbH Medizintechnik (K112616)
- Big Easy, Medtronic (unknown)
- Roberson Stapes Prosthesis, Medtronic (K002897)
Related Devices
- K063374 — NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE · Grace Medical, Inc. · Dec 6, 2006
- K112616 — NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS · Heinz Kurz GmbH Medizintechnik · Feb 8, 2013
- K033554 — SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS · Gyrus Ent LLC · Nov 24, 2003
- K080070 — K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES · Grace Medical, Inc. · Apr 17, 2008
- K043375 — FISCH TITANIUM MIDDLE EAR PROSTHESES · Karl Storz Endoscopy · Jan 24, 2005
Submission Summary (Full Text)
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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 |
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# 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.
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# 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.
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# 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
- 2. 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.
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| HEINZ KURZ GmbH MEDIZINTECHNIK<br>Tuebinger Str. 3, D-72144 Dusslingen, Germany | Traditional 510(k) K130512<br>Stapes Prostheses | |
|---------------------------------------------------------------------------------|-------------------------------------------------|-------------|
| 510(k) Summary | Date: 17-May-2013 | Page 5 of 8 |
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| Device | NITIFLEX<br>Stapes Prosthesis<br>Heinz Kurz GmbH | PREDICATE DEVICE<br>CliP® Piston<br>áWengen<br>Heinz Kurz GmbH<br>K021479 | PREDICATE DEVICE<br>NITIBOND<br>Heinz Kurz GmbH<br>K112616 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------|
| Design Comparison | | | a |
| Intended Use | The prosthesis is<br>intended for ossicular<br>replacement to restore<br>functionality to the middle<br>ear in cases of<br>pathological changes of<br>the sound transmission<br>system. | Identical | Identical |
| Method of Attachment | Manually, without<br>crimping | 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<br>[mm] | 3.5 - 5.5<br>(up to 5.0 in 0.25 mm<br>intervals<br>+ 5.5 mm ) | 3.5 - 5.5<br>(up to 5.0 in 0.25 mm<br>intervals<br>+ 5.5 mm ) | 3.5 - 5.5<br>(up to 5.0 in 0.25 mm<br>intervals<br>+ 5.5 mm ) |
| Piston Ø<br>[mm] | 0.4 / 0.6 | 0.4 / 0.6 | 0.4 / 0.6 |
| Width of Loop Band<br>[mm] | 0.25 | 0.25 | 0.25 |
| Materials<br>Loop<br>Piston | Nitinol<br>Titanium (ASTM F67) | Titanium (ASTM F67) | Nitinol<br>Titanium (ASTM F67) |
| Single Use | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes |
| MRI | MR Conditional<br>1.5, 3 + 7 Tesla | MR Conditional<br>1.5, 3 + 7 Tesla | MR Conditional<br>1.5, 3 + 7 Tesla |
| Biocompatible | Yes | Yes | Yes |
{5}------------------------------------------------
| HEINZ KURZ GmbH MEDIZINTECHNIK<br>Tuebinger Str. 3, D-72144 Dusslingen, Germany | Traditional 510(k) K130512<br>Stapes Prostheses | |
|---------------------------------------------------------------------------------|-------------------------------------------------|-------------|
| 510(k) Summary | Date: 17-May-2013 | Page 6 of 8 |
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| Device | Detroit Piston<br>Heinz Kurz GmbH | Skarzynski Piston<br>Heinz Kurz GmbH | PREDICATE DEVICE<br>K-Piston<br>Heinz Kurz GmbH<br>K002221 | PREDICATE DEVICE<br>Big Easy<br>Medtronic<br>510(k) number<br>unknown |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Design<br>Comparison | Image: Detroit Piston | Image: Skarzynski Piston | Image: K-Piston | Image: Big Easy |
| Intended Use | The prosthesis is<br>intended for partial<br>ossicular replacement<br>to restore functionality<br>to the middle ear in<br>cases of pathological<br>changes of the sound<br>transmission system. | Identical | Identical | Identical |
| Method of<br>Attachment | Manually, with<br>crimping | Manually, with<br>crimping | Manually, with<br>crimping | Manually, with<br>crimping |
| # of Sizes | 24<br>(8 for each shaft Ø) | 16<br>(8 for each shaft Ø) | 28<br>(14 for each shaft Ø) | 10 (4 straight, 3 each<br>left ear offset / right<br>ear offset) |
| Dimensions<br>Length<br>[mm] | 3.5 - 5.5<br>(up to 5.0 mm in 0.25<br>mm intervals + 5.5<br>mm) | 3.5 - 5.5<br>(up to 5.0 mm in 0.25<br>mm intervals + 5.5<br>mm) | 3.5 - 10.0<br>(up to 5.50 in 0.25<br>mm intervals; than<br>1.0 mm intervals) | 4.00 - 5.00<br>(0.25 mm intervals) |
| Piston Ø<br>[mm] | 0.4 / 0.5 / 0.6 | 0.4 / 0.6 | 0.4 / 0.6 | 0.5 |
| Width of Loop<br>Band<br>[mm] | 0.5 | 0.25 | 0.3 | 0.4 |
| Materials<br>Loop<br>Piston | Titanium (ASTM F67) | Titanium (ASTM F67) | Titanium (ASTM F67) | Platinum<br>Titanium |
| Single Use | Yes | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes | Yes |
| MRI | MR Conditional<br>1.5, 3 + 7 Tesla | MR Conditional<br>1.5, 3 + 7 Tesla | MR Conditional<br>1.5, 3 + 7 Tesla | MR Conditional |
| Biocompatible | Yes | Yes | Yes | Yes |
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# 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 Prosthesis<br>Heinz Kurz GmbH | PREDICATE DEVICE<br>Roberson Stapes Prosthesis<br>Medtronic<br>510(k) number unknown |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Design<br>Comparison | Image: Roberson Stapes Prosthesis | Image: PREDICATE DEVICE |
| Intended Use | The prosthesis is intended for ossicular<br>replacement to restore functionality to the<br>middle ear in cases of pathological<br>changes of the sound transmission system. | Identical |
| Method of<br>Attachment | Manually, without crimping | Manually, without crimping |
| # of Sizes | 6 (3 for each bucket Ø) | 6 (3 for each bucket Ø) |
| Dimensions<br>Length<br>[mm] | 4.0 - 4.5<br>(0.25 mm intervals) | 4.0 - 4.5<br>(0.25 mm intervals) |
| Piston Ø<br>[mm] | 0.6 | 0.6 |
| Bucket Ø<br>[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 Conditional<br>1.5, 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
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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
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# 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
- 1. Chronic middle ear inflammation (also following removal of a tumor, e.g. cholesteatoma) with functional impairment of the ossicular chain
- 2. Otosclerosis (stapedial fixation) / congenital stapedial fixation
- 3. Traumatic injury to the ossicular chain
- 4. Malformation of the middle ear
- 5. 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'
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