K-PISTON WITH BAND HOOK /ANGULAR PISTON

K973356 · Heinz Kurz · ETB · Nov 21, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K973356
• Device Name: K-PISTON WITH BAND HOOK /ANGULAR PISTON
• Applicant: Heinz Kurz
• Product Code: ETB · Ear, Nose, Throat
• Decision Date: Nov 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

K-Piston For bridging the stapes in case of otosclerosis, also for bridging defects of the ossicular chain between manubrium mallei and vestibulum (malleovestibulopexy). ANGULAR Piston (Gold with Titanium Bands) For bridging the stapes of otosclerosis, specifically for surgical revisions in patients with shortenend incudal process and for primary procedures when this anatomical condition is present.

Device Story

K-Piston and ANGULAR Piston are partial ossicular replacement prostheses used in middle ear surgery. K-Piston features a bishop's crosier shape with a laterally displaced gold band for secure fastening around the long process of the incus. ANGULAR Piston consists of an angled gold wire with two titanium bands designed for cases of extreme erosion of the long incudal process. Both devices are implanted by surgeons during middle ear procedures to restore ossicular chain continuity. Implants are malleable, allowing for manual adjustment of the loop or clamps and the preset 90-degree angle to fit patient anatomy. The devices are MRI compatible at 0.5 Tesla. They benefit patients by restoring hearing function compromised by otosclerosis or ossicular chain defects.

Clinical Evidence

Bench testing only. MRI compatibility testing performed at 0.5 Tesla showed no implant movement or adverse tissue effects from heating.

Technological Characteristics

Materials: 99.99% pure gold; ANGULAR Piston includes 99.99% pure titanium bands. Form factor: Malleable wire-based prostheses. Mechanical adjustment: Parts can be bent up to three times for intraoperative fitting. MRI compatibility: Tested at 0.5 Tesla.

Indications for Use

Indicated for patients with otosclerosis requiring stapes bridging or ossicular chain defect repair (malleovestibulopexy), and for surgical revisions or primary procedures in patients with shortened incudal process.

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

• Smith & Nephew Richards
• XOMED

Submission Summary (Full Text)

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# K973356

Image /page/0/Picture/1 description: The image shows a logo with the word "KURZ" inside of a circle. The text and the circle appear to be made of small dots, giving it a textured or grainy appearance. The circle is not perfectly closed, with a gap at the top right. The overall impression is that of a stamp or an imprint.

Kurz GmbH technik

schrift: r Straße 3 4 Dußlingen

(0 70 72) 91 79 (0 70 72) 91 79

| | Kurz GmbH · Medizintechnik · Postfach 39 · D-72142 Dußlingen | | Heinz K |
|-----|-------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------|
| 6. | <b>510(k) SUMMARY</b><br>As required by Section 807.92(c) | NOV 21 1997 | Medizin |
| (1) | Submitter [807.92(a)(1)]<br>Dagmar S. Mäser<br>Business Support International | | Hausan<br>Tübingen<br>D-7214 |
| | Amstel 320-I<br>Amsterdam, 1017AP<br>The Netherlands | Tel. 011 - 31 - 20 - 428 9591<br>Fax -428 9429<br>e-mail [e-mail] | Telefon<br>Telefax |
| (2) | Identification of Devices [807.92(a)(2)]<br>Proprietary Names | K-Piston; Angular Piston | |
| | Common Name | Middle Ear Pistons | |
| | Classification Name | Prosthesis, Partial Ossicular Replacement | |
| | Product Code | 77 ETB | |
| | Class | II | |
| | Regulatory Number | 874.3450 | |

#### (3) Identification of Predicate Devices [807.92(a)(3)]

KURZ pistons are substantially equivalent in size and design to FDAapproved devices manufactured by Smith & Nephew Richards, Bartlett, TN, and XOMED, Jacksonville, FL, (which also markets TREACE devices). These devices have been found substantially equivalent through the 510(k) premarket notification process.

#### (4) Description of Device 1807.92(a)(4)]

Heinz

- K-Piston Like many of the SE devices, the K-Piston is shaped like a. a bishop's crosier. Its outstanding feature is the slightly laterally displaced, wide golden band. The bent end allows overclosure and, thus, extremely secure fastening, around long process of incus.
### b. ANGULAR Piston

An angled gold wire with two titanium bands, which are connected to the shorter leg. Specifically designed in cases of extreme arrosion of long incudal process.

Both devices are manufactured of fine gold (99.99%).

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## Heinz Kurz GmbH Medizintechnik

510(k) Summary (Cont'd)

- Intended Use of Device | 807.92(a)(5)| (ર)
- (Fine Gold) a. K-Piston For bridging the stapes in case of otosclerosis, also for bridging defects of the ossicular chain between manubrium mallei and vestibulum (malleovestibulopexy).
- ANGULAR Piston (Gold with Titanium Bands) b. For bridging the stapes of otosclerosis, specifically for surgical revisions in patients with shortenend incudal process and for primary procedures when this anatomical condition is present.
- Technological Characteristics and Adjustments (6) The implants are manufactured of one piece of pure gold; the two bands on the short leg of the ANGULAR Piston of pure titanium (99.99%).

Within the range necessary for implantation, any part of the prosthesis can be bent back and forth up to three times.

Placement of the K-Piston requires bending of the loop to attach it to the long incudal process. Placement of the ANGULAR Piston requires bending of the titanium clamps for attachment to the incudal process stump. In addition, the preset 90° angle will have to be adjusted in many cases.

#### (7) MRI Environment

1

. (

Testing in a 0.5 Tesla nuclear magnetic resonance tomograph has revealed no implant movement and no adverse tissue effects attributable to MRIgenerated heating. The image quality may be impeded or blurred in direct vicinity of the implant. To date, no report of hearing loss or other adverse effect has come to the attention of the manufacturer.

#### (8) Information Bearing on the Safety and Effectiveness

The KURZ K-Piston and ANGULAR Piston partial ossicular replacement prostheses have the same intended use as predicate devices. There are no additional characteristics known that should adversely affect the safety and effectiveness of these implants.

Signature

Dagmar S. Maeser

10/20/97
Date

KRZ-PIST.SUM

6-2

Update 10/20/97

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH &" are written vertically along the left side of the logo. The words "HUMAN SERVICES" are written vertically along the right side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 | 1997

Ms. Dagmar S. Maeser Business Support International Amstel 320-I 1017 AP Amsterdam The Netherlands

Re: K973356

Heinz Kurz GmbH Medisintechnik Partial Ossicular Replacement Prosthesis Dated: October 20, 1997 Received: October 22, 1997 Regulatory Class: II 21 CFR 874.3450/Procode: 77 ETB

Dear Ms. Maeser:

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 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 misbranion.

If your device is classified (see above) into either class II (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 requirement, 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 Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

h.J.Liau Yu

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure