KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM

K042503 · Heinz Kurz GmbH Medizintechnik · ETA · Oct 1, 2004 · Ear, Nose, Throat

Device Facts

• Record ID: K042503
• Device Name: KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM
• Applicant: Heinz Kurz GmbH Medizintechnik
• Product Code: ETA · Ear, Nose, Throat
• Decision Date: Oct 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3495
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bridging the stapes and the incus in cases of otosclerosis, specifically for malleovestibulopexy

Device Story

The CliP® Piston MVP is an all-titanium ossicular prosthesis used in ear surgery to restore sound transmission. It consists of a standard KURZ piston shaft connected to a modified àWengen clip via a ball joint. The device is used by surgeons in clinical settings to bridge the stapes and incus. The ball joint allows the surgeon to adjust the shaft angle without manual bending, reducing intraoperative trauma. The clip mechanism enables a 'click-on' attachment to the malleus handle, replacing traditional crimping methods. This design aims to improve vascular circulation, reduce tissue necrosis, standardize the surgical procedure, and enhance postoperative hearing outcomes. The device is provided sterile and is for single use.

Clinical Evidence

No clinical trial data provided. Safety and effectiveness are supported by design validation, bench testing, and comparison to predicate devices. MRI testing in a 3.0 Tesla environment demonstrated no implant movement or adverse tissue effects from heating.

Technological Characteristics

Material: Titanium (ASTM F67). Design: Two-limbed undulated clip laser-welded to a rectangular shaft, connected to a piston shaft via a ball joint. Energy: Passive mechanical implant. Connectivity: None. Sterilization: Sterile. Form factor: 6 sizes, 0.4mm or 0.6mm diameter, 5.75-6.25mm length.

Indications for Use

Indicated for patients with otosclerosis or ossicular chain defects requiring malleovestibulopexy to bridge the stapes and incus (manubrium mallei to vestibulum).

Regulatory Classification

Identification

A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.

Predicate Devices

• K-Piston Titanium Stapedial Prosthesis (K002221)
• CliP® àWengen Stapedial Piston (K021479)

Submission Summary (Full Text)

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K042503

Special 510(k): CLiP® Piston MVP

OCT 1 - 2004

## 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 Tel. [phone] Amstel 320-1 Fax [phone] AP Amsterdam eMail The Netherlands [e-mail]

- 2.3 Date Summary Prepared: [807.92 (a)(1)] September 8, 2004
- 2.4 Device Names: [807.92 (a)(2)] CliP® Piston MVP Proprietary
- MVP Piston Common
- Classification Replacement, Ossicular Prosthesis, Total Product Code 77 ETA Regulation # CFR 874.3495

#### 2.5 Reason for Submission:

Change in design and combination of design features of previously cleared devices

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#### Intended Use: 1807.92 (a)(5)] 2.6 Bridging the stapes and the incus in cases of otosclerosis, specifically for malleovestibulopexy

#### Modification and Combination of Existing Device 2.7

Components: [807.92 (a)(3)]

| K 002221 | K-Piston Titanium Stapedial Prosthesis<br>(Partial and Total)<br>Cleared 08/09/2000 + |
|----------|---------------------------------------------------------------------------------------|
| K 021479 | CliP® àWengen Stapedial Piston<br>Cleared 05/21/2002 |

#### Device Description: [807.92(a)(4)+(6)] 2.8

The all-titanium prosthesis consists of an undulated, selfretaining, two-limbed clip1 that is laser-welded to a rectangular shaft which is connected with a conventional KURZ piston shaft by means of a unique ball joint.2

#### Reasons for Device Modification: [807.92 (d)] 2.9

To facilitate and standardize intraoperative handling, reduce risks of patient trauma, and improve post-operative sound transmission in the affected ear.

Traditionally, common loop pistons had to be bent to an almost right angle to permit crimping to the malleus handle. With the piston articulation, no implant manipulation is required. The surgeon can bend the shaft to precisely match the patient's physiological condition.

By replacing the titanium band loop with a modified àWengen clip4 for fastening the prosthesis to the malleus handle, the clinically proven advantages of this method of attachment are added to the new device:

- (1) reduction of tissue necrosis by improving vascular circulation;
- (2) standardization and significant shortening of surgical procedure by means of 'click-on' mechanism for attachment to the malleus handle;
- (3) elimination of need for instruments and crimping to reduce the potential risks connected therewith;
- (4) improvement of audiological results as a result of gentle clip-on attachment to malleus handle.

l A modification of the CliP® àWengen

See magnified illustration and engineering drawing, pp. 4-8 to 4-9 ମ

³ K 002221

⁴ K 021479

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#### 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: 1807.92 (d)]

Testing in a 3.0 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 some lengths of the K-Piston Titanium Stapedial Prosthesis, the CliP® Piston MVP is used for bridging the stapes and incus in cases of otosclerosis in malleovestibulopexy procedures. The ball joint eliminates implant bending. The click-on mechanism and the self-retaining clip design of the modified KURZ CliP® àWengen shorten the attachment procedure to the malleus handle, minimize the risks connected with instrument manipulation and, by improving vascular circulation, reduce the risk of tissue necrosis. The gentle attachment to the malleus handle along the axis of mechanical sound transmission is expected to result in equal if not better audiological postoperative 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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| Device | CliP® Piston MVP | Titanium K-Piston<br>K 002221 | CliP àWengen<br>K 021479<br>(Only for Comparison of<br>CliP) |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 1006 711-13    0.4 mm<br>1006 761-63    0.6 mm | 1006 103 – 1006 170 | 1006 805 – 1006 861 |
| Intended Use | Bridging the stapes and incus in cases of<br>otosclerosis, specifically defects of the<br>ossicular chain between manubrium mallei<br>and vestibulum (malleovestibulopexy) | 1. Bridging the stapes in cases of<br>otosclerosis<br>2. Bridging the stapes and incus in<br>cases of otosclerosis, specifically<br>defects of the ossicular chain<br>between manubrium mallei and<br>vestibulum (malleovesti-bulopexy) | |
| Design | Standard KURZ Piston connected to<br>modified àWengen Clip w/ball joint<br>articulation<br>Image: [Piston MVP Design] | Standard KURZ Piston gradually<br>tapering towards band loop<br>Image: [Titanium K-Piston Design] | Standard KURZ Piston<br>with áWengen Clip<br>Image: [CliP aWengen Design] |
| # of Sizes | 6 (3 for each Ø) | 28 (14 for each Ø) | |
| Device<br>Lengths | 5.75 – 6.25 mm<br>(0.25 mm intervals) | 3.50 – 6.00 mm<br>(0.25 mm intervals)<br>6.00 – 10.00 mm<br>(1.00 mm intervals) | |
| Piston Ø | 0.4 + 0.6 mm | 0.4 + 0.6 mm | |
| Attachment to<br>Malleus Handle | Modified àWengen Clip | (Titanium band loop) | àWengen Clip |
| Implant<br>Manipulation | None: Articulation permits precise piston<br>bending to accommodate surgical site | Surgeon bends piston to almost 90°<br>for attachment to malleus handle | |
| Material | Titanium ASTM F67 | Titanium ASTM F67 | Titanium ASTM F67 |
| Single Use | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes |
| Design<br>Comparison<br>- Implant | An open clip ( modified àWengen) is<br>attached to a 0.2 mm rectangular shaft. A<br>novel ball joint connection to the standard<br>KURZ piston (0.4 + 0.6 mm) permits<br>precise intra-operative 'bending' without<br>implant manipulation to exactly accom-<br>modate patient's physiological require-<br>ments. | A laterally displaced band loop is<br>attached to a 0.2 mm shaft that is<br>seamlessly laserwelded to the piston<br>(0.4 + 0.6 mm). Piston requires<br>almost 90° bending for attachment<br>to malleus handle. | An open clip (àWengen) is<br>attached to a 0.2 mm shaft<br>that is seamlessly<br>laserwelded to the piston<br>stem (0.4 + 0.6 mm) |
| Design<br>Comparision<br>- CliP® | - The protuberance for grasping CliP has<br>been moved to end<br>- Limb undulation has been changed to<br>conform to more oval circumference of<br>malleus handle<br>- CliP limb opening and length was slightly<br>adjusted to assure precise fit around<br>malleus handle | | - The protuberance for<br>grasping CliP is located on<br>top of upper limb<br>- Limb undulation has been<br>designed for exact fit<br>around long incudal<br>process |
| Custom<br>Accessories | KURZ Meter<br>Cat. # 8000 106 | Identical | |
| Safety &<br>Effectiveness<br>of Design<br>Changes<br>[807.92<br>(b)(1)] | The novel ball joint piston articulation<br>eliminates implant bending.<br>Attachment to the malleus handle with<br>the previously cleared tensile clip-on<br>mechanism5 shortens surgical<br>procedure, reduces risk of tissue<br>necrosis by improving vascular<br>circulation, reduces risk of implant<br>dislocation with high degree of<br>certainty, potentially improves long-<br>term hearing gain with appropriate<br>physiological conditions, and<br>significantly reduces risks of patient<br>trauma. Clinical test results confirm<br>the safety and effectiveness of this<br>design.<br><br>There are no known characteristics<br>that would introduce adverse effects. | | |

# 2.13 COMPARISON of DESIGN + SAFETY and EFFECTIVENESS

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### Heinz Kurz GmbH Medizintechnik

9/9/2004 11:37 AM

KURZ

Date 09/09/04 Signature

Heinz Kurz Gmar
Medizintechni.
Tübinger Stras
72144 Dusslingen, G
Phone [phone]
Telefax +49 (0) 70 72/173
mip.twww.kulzmed.com

Uwe Steinhardt
Technical Director

CliP® Piston à Wengen K 021479 ર

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

OCT 1 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

HEINZ KURZ GMBH MEDIZINTECHNIK c/o Business Support International Amstel 320-I Amsterdam, Netherlands 1017AP Attn: Dagmar Mäser

Re: K042503

Trade/Device Name: KURZ CLIP® Piston MVP Regulation Number: 21 CFR 874.3495 Regulation Name: Total Ossicular Replacement Prosthesis Regulatory Class: Class II Product Code: ETA Dated: September 14, 2004 Received: September 15, 2004

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 (OS) 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 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Mace facturers, 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 halyi 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

Enclosure

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# Indications for Use

Koyaso3 510(k) Number (if known):

Device Name: CLiP® Piston MVP

Indications for Use: Bridging the stapes and incus in cases of otosclerosis and defects of the ossicular chain between manubrium mallei and vestibulum (malleovestibulopexy)

9/9/2004 1:57 PM

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kasun L. Bake

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

510(k) Number K042503

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