CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257

K013573 · Heinz Kurz GmbH Medizintechnik · ETB · Nov 9, 2001 · Ear, Nose, Throat

Device Facts

• Record ID: K013573
• Device Name: CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257
• Applicant: Heinz Kurz GmbH Medizintechnik
• Product Code: ETB · Ear, Nose, Throat
• Decision Date: Nov 9, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ossicle replacement in case of interrupted sound conducting chain in patients with intact, mobile stapes

Device Story

The Clip Partial Prosthesis-Titanium "Dresden" is a middle ear implant used to restore sound conduction. It consists of a head plate, a shaft, and a clip with seven resilient prongs. The device is implanted by a surgeon in a clinical setting; the clip is pushed over the stapes head, where the prongs provide a secure, tension-based grip without requiring in situ manipulation or wire crimping. The head plate is typically covered with cartilage and placed under the manubrium mallei or tympanic membrane. By replacing the ossicle, the device restores the sound conducting chain, potentially improving hearing gain. Titanium is used for its biocompatibility, low weight, and sound conduction properties. The device is MRI compatible at 0.5 Tesla.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by design validation, material biocompatibility (ASTM F67), and bench testing, including MRI compatibility testing at 0.5 Tesla which showed no implant movement or adverse heating effects.

Technological Characteristics

Material: ASTM F67 Titanium. Design: Clip with seven resilient prongs, shaft, and head plate. Dimensions: Length 1.75-3.5 mm, head plate 2.6 mm, shaft 0.2 mm. Energy: Passive implant. Sterilization: Sterile, single-use. Connectivity: None.

Indications for Use

Indicated for patients with an interrupted sound conducting chain who possess an intact, mobile stapes.

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

• Bell Prosthesis (Partial) (K972492)

Submission Summary (Full Text)

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NOV 0 9 2001

2.1

1

K 013573

Heinz Kurz GmbH · Medizintechnik · Postfach 39 · D-72142 Dusslingen

Heinz Kurz GmbH Medizintechnik

Tübinger Straße 3 D-72144 Dussling

Telefon (0 70 72) 9 Telefax (0 70 72) 9

Internet: http://www.kurzme

E-Mail: info@kurzn

# 2. 510(k) SUMMARY of Safety and Effectiveness

As required by Section 807.92(c)

| Submitter: [807.92 (a)(1)] | | |
|--------------------------------|-------|-------------------|
| Heinz Kurz GmbH Medizintechnik | | |
| Tübinger Str. 3 | Tel. | [phone] |
| D-72144 Dusslingen | Fax | [phone] |
| Germany | eMail | [e-mail] |

| 2.2 | Contact Person: [807.92 (a)(1)] | | |
|-----|---------------------------------|-------|------------------|
| | Dagmar S. Mäser | | |
| | Business Support International | | |
| | Amstel 320-I | Tel. | [phone] |
| | 1017 AP Amsterdam | Fax | [phone] |
| | The Netherlands | eMail | [e-mail] |

- Date Summary Prepared: [807.92 (a)(1)] 2.3 October 10, 2001
- 2.4 Device Names: [807.92 (a)(2)] Proprietary Clip Partial Prosthesis - Titanium "Dresden"
- Common Partial Ossicular Replacement Prosthesis Classification Middle Ear Prosthesis, Partial Ossicular Replacement Product Code 77 ETB Regulation # CFR 874.3450

#### 2.5 Reason for Submission:

Change in material and design when compared to previously cleared device

> Geschäftsführer: Heinz Kurz Traute Kurz-Butzki USt.-Id. Nr. DE 8115701

Volksbank Steinlach-Wiesaz eG (BLZ 640 618 54) Konto-Nr. 70 150 001 SWIFT: GENODES1STW IBAN DE386406 18540070 150001

2-1

BW Bank AG Tübingen (BLZ 641 200 30) Konto-Nr. 1 201 402 300 SWIFT: BWBKDE6S641 IBAN DF186417 0020 1701 1072 00

Amtsgericht Tübingen

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Image /page/1/Picture/0 description: The image shows a logo with the word "KURZ" inside of a circle. The letters are in a simple, sans-serif font and appear to be slightly distressed or textured. The circle is not fully closed at the top, leaving a small gap above the letter "K". The logo has a vintage or worn appearance, possibly due to the texture and style of the letters and circle.

Heinz Kurz GmbH Medizintechnik

#### Modification to Existing Device: [807.92 (a)(3)] 2.6

Bell Prosthesis (Partial) K 972492

Heinz Kurz GmbH · Medizintechnik · Postfach 39 · D-72142 Dussfieleared 08/04/97

1.

1

#### Device Description: [807.92(a)(4)+(6)] 2.7

Tübinger Straße 3 The all-titanium prosthesis consists of a clip with seven (7-72144 Dussinge resilient prongs, a shaft, and a head plate. Telefon [phone]

#### Reasons for Device Modification: [807.92 (d)] 2.8 Material:

Internet:

- http://www.kurzme Titanium provides excellent sound conduction even E-Mail: info@kurzm at higher frequencies
- Due to the lower specific weight of titanium, the 2. device is substantially lighter than the gold KURZ Bell "Dresden" prosthesis

### Design:

By pushing the elastic clip over the stapes head and upper part of the stapes, a more secure connection is established that not only eliminates the need for device manipulation in situ but also the chance of implant dislocation with a high degree of certainty.

#### 2.9 Intended Use: [807.92 (a)(5)]

Ossicle replacement in case of interrupted sound conducting chain in patients with intact, mobile stapes

#### Industry Standards: [807.92 (d)] 2.10

KURZ certifies compliance with all appropriate industry standards and the validation of methods and processes covered by these standards.

#### 2.11 MRI Environment: [807.92 (d)]

Testing in a 0.5 Tesla nuclear magnetic resonance (NMR) tomograph has revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating.

#### Information Bearing on the Safety and Effectiveness: 2.12

[807.92 (b)(3)]

The KURZ Clip Partial Prosthesis -- Titanium "Dresden" has the same intended use as the previously cleared device made of pure gold. With the exception of the described material and design changes, there are no additional characteristics known that should adversely affect the safety and effectiveness of these implants.

## The results of design validation raise no new issues of safety and effectiveness.

Geschäftsführer: Heinz Kurz Traute Kurz-Butzki USt .- Id. Nr. DE 8115.

2-2

BW Bank AG Tübingen (BLZ 641 200 30) Konto-Nr. 1 201 402 300 SWIFT: BWBKDE6S641

Telefax (07072) 91 Internet:

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Image /page/2/Picture/0 description: The image is a black and white logo. The logo consists of the word "KURZ" in a stylized font, with the letters arranged in a slightly curved manner. The word is enclosed within a circle that is not fully complete, with gaps at the top and bottom. Below the circle, the letters "ESS" are visible.

# 2.13 COMPARISON of DESIGN + SAFETY and EFFECTIVENESS

| | Heinz Kurz GmbH · Medizintechnik · Postfach 39 · D-721 | | Gold<br>Heinz Kurz GmbH<br>Medizintechnik |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Clip Partial Prosthesis<br>"Dresden" | | Dresden Bell Prosthesis<br>Tübinger Straße<br>D-72144 Dusslingen |
| Catalog # | 1002 250 - 257 | | 1001 023 - 030 |
| Intended Use | Ossicle replacement in case of<br>interrupted sound conducting<br>chain in patients with intact,<br>mobile stapes | | Telefon (0 70 72)<br>Identical<br>Telefax (0 70 72) |
| # of Sizes | 8 | | Identical |
| Dimensions | | | |
| Length | 1.75 - 3.5 mm (0.25 mm intervals) | | Identical |
| Head Plate Ø | 2.6 mm | | |
| Shaft Ø | 0.2 mm | | |
| Material | ASTM F67 Titanium | | Pure Gold |
| Weight | 4-5 mg | | 10-12 mg |
| Single Use | Yes | | Identical |
| Sterile | Yes | | Identical |
| Design<br>Comparison | Clip with seven (7) resilient<br>prongs securely clips around<br>stapes head and upper part of<br>stapes. No manipulation and/or<br>adjustment in situ. | | The four (4) gold strips of Bell<br>prosthesis are gently pushed<br>against stapes with wire crimper<br>to achieve mechanically close fit. |
| Custom<br>Accessories | KURZ Sizer Cat.# 8000 121<br>KURZ Precise Cat # 8000 101 | | Identical |
| Safety &<br>Effectiveness of<br>Material and<br>Design<br>Changes<br>[807.92 (b)(1)] | Titanium is a clinically well-<br>established implant material with<br>excellent biocompatibility. The<br>much lighter weight appears to<br>be better suited for implantation<br>in the middle ear. Clinical<br>evidence suggests that titanium<br>has excellent sound conduction<br>properties resulting in improved<br>hearing gain.<br><br>The tensile clip mechanism<br>significantly reduces the risk of<br>implant implant dislocation while<br>the secure but vibrant connection<br>to the stapes head is expected to<br>improve long-term hearing gains<br>with appropriate physiological<br>conditions.<br><br>Careful attention must be paid to<br>KURZ operating guidelines | | |

Signature

A. Mihaes M

Uwe Steinhardt Technical Director

Date

October 22, 2001

Geschäftsführer: Heinz Kurz Traute Kurz-Butzki USt.-Id. Nr. DE 81157

A ﺳﻪ ۵۰ -- ۱۰: ۱۰ -- ۳ : ۱ : ۱ --

Volksbank Steinlach-Wiesaz eG
(BLZ 640618 54) Konto-Nr. 70 150001 SWIFT. CENIONES 1 STAI

BW Bank AG Tübingen (BLZ 641 200 30) Konto-Nr. 1 201 402 300
รังกรรม ค.ศ. 1 201 402 300
ราคมีความคร ทรรรคร

2-3

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Image /page/3/Picture/1 description: The image contains the text "Public Health Service" in a bold, sans-serif font. The text is arranged vertically, with "Public Health" on the first line and "Service" on the second line. The text is black against a white background.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2001

Heinz Kurz GmbH Medizintechnik c/o Dagmar S. Mäser Business Support International Amstel 320-I 1017 AP Amsterdan The Netherlands

Re: K013573

Trade/Device Name: Clip Partial Prosthesis-Titanium Dresden, Model 1002 Regulation Number: 21 CFR 874.3450 Regulation Name: Partial Ossicular Replacement Prosthesis Regulatory Class: Class II Product Code: ETB Dated: October 24, 2001 Received: October 29, 2001

Dear Ms. Mäser:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotes with and my of the FDA finding of substantial equivalence of your device to a legally premailed notification of the sification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number

Device Name

Clip Partial Prosthesis – Titanium "Dresden"

NOV 0 9 2001

# INDICATION FOR USE

Ossicle replacement in case of interrupted sound conducting chain in patients with intact, mobile stapes.

Kolz573

## Description of Implant and Intended Situs

The prosthesis consists of a clip consisting of seven (7) resilient prongs, a shaft, and a head plate.

Holding the device vertically to the stapes axis, the clip is gently pushed over the stapes head so that the titanium prongs with their built-in tension securely grasp the stapes head and upper part of the stapes and the two somewhat shorter rear prongs are positioned on either side of the stapedial tendon. The head plate is covered with a thinned cartilage slice and placed under the manubrium mallei or under the tympanic membrane.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use

(Per CFR 801 109)

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K0/3573

()ver-The-Counter Use

(Optiona) Format 1-2-96)

V