CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861

K021479 · Heinz Kurz GmbH Medizintechnik · ETB · May 21, 2002 · Ear, Nose, Throat

Device Facts

• Record ID: K021479
• Device Name: CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861
• Applicant: Heinz Kurz GmbH Medizintechnik
• Product Code: ETB · Ear, Nose, Throat
• Decision Date: May 21, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bridging the stapes in cases of otosclerosis

Device Story

The CliP Piston àWengen is a middle ear prosthesis used by surgeons to treat otosclerosis. It consists of a titanium piston shaft laser-welded to an undulated, self-retaining two-limbed clip. Unlike conventional prostheses requiring manual crimping, this device features a 'click-on' mechanism; the surgeon positions the clip on the long incudal process and secures it with a microhook. This design eliminates the need for crimping instruments, reduces surgical time, and improves vascular circulation to the incudal process, thereby lowering the risk of tissue necrosis. The device is MRI-compatible (0.5 Tesla). By providing a stable, gentle attachment along the axis of mechanical sound transmission, it aims to achieve optimal post-operative hearing gain.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by design validation and bench testing, including MRI compatibility testing in a 0.5 Tesla field showing no implant movement or adverse heating effects.

Technological Characteristics

Material: ASTM F67 Titanium. Design: Two-limbed undulated clip laser-welded to a piston shaft. Dimensions: Lengths 4.00-5.50 mm; Piston diameters 0.4-0.6 mm. Mechanism: Self-retaining 'click-on' attachment. Energy: Passive implant. Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients with otosclerosis requiring stapedial bridging.

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 Titanium Stapedial Prosthesis (K002221)

Submission Summary (Full Text)

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K021479

MAY 2 1 2002

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

As required by Section 807.92(c)

| 2.1 | 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 [phone] Tel. Amstel 320-l Fax [phone] AP Amsterdam eMail [e-mail] The Netherlands
- 2.3 Date Summary Prepared: [807.92 (a)(1)] April 30, 2001
- 2.4 Device Names: [807.92 (a)(2)] CIIP Piston àWengen Proprietary
- Stapedial Piston Common
- Middle Ear Prosthesis, Partial Ossicular Classification Replacement

77 ETB Product Code

CFR 874.3450 Regulation #

- 2.5 Reason for Submission:
Change in design when compared to previously cleared device

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

- K-Piston Titanium Stapedial Prosthesis (Partial) Cleared 08/09/2000
#### 2.7 Device Description: [807.92(a)(4)+(6)]

K 002221

The all-titanium prosthesis consists of an undulated, selfretaining, two-limbed clip that is laser-welded to a conventional KURZ piston shaft.

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

- To reduce risk of tissue necrosis by improving 1. vascular circulation;
- To standardize and significantly shorten surgical 2. procedure by 'click-on' mechanism for attachment to long incudal process;
- To eliminate need for instruments and crimping and 3. to reduce potential risks connected therewith;
- To improve audiological results by the unique 4. attachment to incudal process

#### 2.9 Intended Use: 1807.92 (a)(5)]

Bridging the stapes in cases of otosclerosis

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

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.

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

[807.92 (b)(3)]

Like the K-Piston Titanium Stapedial Prosthesis, the KURZ CliP àWengen is used for bridging the stapes in cases of otosclerosis. The click-on mechanism and the self-retaining design shorten the procedure, minimize the risks connected with instrument manipulation and, by improving vascular circulation, reduce the risk of tissue necrosis. The gentle attachment to the incudal process along the axis of mechanical sound transmission is expected to result in equal if not better audiological post-operative hearing gain. 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.

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# 2.13 COMPARISON of DESIGN ・SAFETY and EFFECTIVENESS

.

| | CliP àWengen | Titanium K-Piston<br>K 002221 |
|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Catalog # | 1006 805 - 1006 861 | 1006 103 - 1006 170 |
| Intended Use | Bridging the stapes in cases of<br>otosclerosis | 1. Bridging the stapes in cases of<br>otosclerosis<br>2. Bridging defects of the ossicular<br>chain between manubrium<br>mallei and vestibulum<br>(malleovestibulopexy) |
| # of Sizes | 12 (6 for each Ø) | 28 (14 for each Ø) |
| Device Lengths | 4.00 - 5.00 mm (0.25 mm intervals)<br>5.00 - 5.50 mm (0.50 mm interval) | 3.50 - 6.00 mm (0.25 mm intervals)<br>6.00 - 10.00 mm (1.00 mm intervals |
| Piston Ø | 0.4 + 0.6 mm | Identical |
| Material | ASTM F67 Titanium | Identical |
| Single Use | Yes | Identical |
| Sterile | Yes | Identical |
| Design<br>Comparison | An open clip is attached to a 0.2 mm<br>shaft that is seamlessly laserwelded<br>to the piston stem (0.4 + 0.6 mm) | A laterally displaced band loop is<br>attached to a 0.2 mm shaft that is<br>seamlessly laserwelded to the piston<br>stem (0.4 + 0.6 mm) |
| Custom<br>Accessories | KURZ Measuring Rod<br>Cat. # 8000 106<br>(to determine proper device length) | Identical |
| Safety &<br>Effectiveness of<br>Material and<br>Design<br>Changes<br>[807.92 (b)(1)] | The tensile clip-on mechanism<br>shortens surgical procedure,<br>reduces risk of tissue necrosis on<br>incudal process by improving<br>vascular circulation, reduces risk<br>of implant dislocation with high<br>degree of certainty, and<br>potentially improves long-term<br>hearing gain with appropriate<br>physiological conditions. Clinical<br>test results to date confirm the<br>safety and effectiveness of the<br>new design.<br>There are no known<br>characteristics that would<br>introduce adverse effects | |

. . . . . . . .

:

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 2002

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

Re: K021479

Trade/Device Name: CliP Piston à Wengen Regulation Number: 21 CFR 874.3450 Regulation Name: Middle Ear Prosthesis, Partial Ossicular Replacement Regulatory Class: Class II Product Code: ETB Dated: May 6, 2002 Received: May 8, 2002

Dear Ms. Mäser:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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); 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.

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Page 2 - Dagmar S. Mäser

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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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Heinz Kurz GmbH Medizintechnik

Special 510(k): Device Modification - 77 ETB

510(k) Number

KO21479

Device Name

CliP Piston à Wengen

# INDICATIONS FOR USE

For bridging the stapes in case of otosclerosis;

## Description of Implant and Intended Situs

The titanium prosthesis consists of a piston with an open undulated clip at its end. Contrary to convential prostheses, the CliP requires no crimping. After positioning it on the long incudal process, slightly above the incudostapedial joint, it is permanently attached with a slight push of a microhook instrument. The CliP is self-retaining and stays securely in place due to the elasticity of material and design

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

✓

| Prescription Use | |
|--------------------|--|
| (Per CFR) 801 109) | |

OR

Over-The-Counter Use

Optional Format 1-2-

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K02179