AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN

K972585 · Heinz Kurz GmbH Medizintechnik · ETA · Aug 4, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K972585
• Device Name: AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN
• Applicant: Heinz Kurz GmbH Medizintechnik
• Product Code: ETA · Ear, Nose, Throat
• Decision Date: Aug 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3495
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The KURZ Aerial implants are intended for the elective reconstruction of the ossicular chain to facilitate conduction of sound energy from the ear drum to the inner ear. The prosthesis is implanted into the middle ear during a tympanoplasty procedure and is retained in the middle ear by the design configuration of the device and the favorable biocompatible characteristics of gold and titanium. The device can be used on adults and children.

Device Story

KURZ Aerial total ossicular replacement prostheses (TORP) are passive implants used during tympanoplasty to reconstruct the middle ear ossicular chain. The device bridges the gap between the stapes footplate and the tympanic membrane or manubrium mallei to restore sound conduction. Available in multiple configurations (Standard, Dresden, Düsseldorf, Tübingen), the implants are constructed from gold or titanium mesh and wire. The surgeon selects the appropriate length and shape, manually bending the implant to fit the patient's specific middle ear anatomy. Once placed, the device maintains its shape to provide structural support. The implants are provided sterile for single-patient use.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material characteristics.

Technological Characteristics

Materials: Gold and titanium. Form factor: Mesh plates, wires, and shafts of varying lengths. Features: Structured surfaces, split pistons, and hollow pistons. Connectivity: None. Sterilization: Sterile. Software: None.

Indications for Use

Indicated for ossicle replacement in patients with interrupted sound conducting chain and intact, mobile stapes footplate. Intended for bridging complete auditory ossicle defects in adults and children.

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

• Smith & Nephew Richards total ossicular devices
• Xomed (with Ionos) total ossicular devices

Submission Summary (Full Text)

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K972585

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510(k) SUMMARY

Heinz Kurz GmbH · Medizintechnik · Postfach 39 · D-72142 Dußlingen As required by Section 807.92(c)

- (1) Submitter Dagmar S. Mäser Business Support International Amstel 320-I Amsterdam, 1017AP The Netherlands
(2)

AUG - 4 1997

Heinz Kurz GmbH Medizintechnik

Hausanschrift: Tübinger Straße 3 D-72144 Dußlingen

Telefon [phone] Telefax (0 70 72) 91 79-75

- Tel. [phone] Fax e-mail [e-mail]
Identification of Device 1807.92(a)(2)] Trade Name Aerial Prosthesis Total Ossicular Replacement Prosthesis (TORP) Common Name Middle-Ear, Replacement, Ossicular Prosthesis, Total Classification Name Product Code 77 ETA

Class II 874.3495 Regulatory Number

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

The KURZ Aerial total ossicular implants are substantially equivalent to total ossicular devices of Smith & Nephew Richards and Xomed (with Ionos). These devices have been found substantially equivalent through the 510(k) premarket notification process.

### (4) Description of Device [807.92(a)(4)]

- Standard The implant consists of a golden wire rectangle Gold a. with a structured outer surface and a stem which is available in various lengths. It ends in a 'bell' with two slits.
Dresden The implant consists of an extremely thin mesh plate made of gold and a thin shaft, which is available in different lengths. It has a split piston at the end.

- Titanium Düsseldorf The implant consists of a titanium mesh plate b. that is textured on the surface that makes contact with the tympanum and a shaft that is available in various lengths.
Tübingen The prosthesis consists of a titanium mesh plate that is connected eccentrically with a shaft available in various lengths. A hollow piston, open at the bottom, the inside of which is also textured, is located at the end of the shaft.

6-1

Geschäftsführer: Heinz Kurz Traute Kurz-Butzki USt .- Id. Nr. DE 811570328

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510(k) Summary (Cont'd)

The device is a single patient use only implant. It comes in an individual sterile package in a sealed carton.

## Intended Use of Device {{807.92(a)(5)] (5)

The KURZ Aerial implants are intended for the elective reconstruction of the ossicular chain to facilitate conduction of sound energy from the ear drum to the inner ear. The prosthesis is implanted into the middle ear during a tympanoplasty procedure and is retained in the middle ear by the design configuration of the device and the favorable biocompatible characteristics of gold and titanium.

The device can be used on adults and children.

#### (6) Technological Characteristics [807.92(a)(6)]

The implants can be bent and easily shaped to the individual conditions in the middle ear, yet hold their shape after placement.

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

The KURZ Aerial total ossicular replacements 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

KRZ-ETA.SUM

【划赚钱最佳影视】【

is /has

Date July 7, 1997

Dagmar S. Mäser

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 1997

Dagmar S. Maser Business Support International Amstel 320-1 1017 AP Amsterdam The Netherlands

Re: K972585 Heinz Kurz GmbH Medizintechnik Dated: July 7 . 1997 ... . . Received: July 10, 1997 Regulatory class: II 21 CFR 874.3495/Procode: 77 ETA

Dear Mr. Maser:

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, 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 III (Premarket Approval), it may be subject * 1 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.7liau 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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# Heinz Kurz GmbH Medizintechnik

510(k) - 77 ETA

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Device Name

Device Name ________________________________________________________________________________________________________________________________________________________________

INDICATIONS FOR USE:

Ossicle replacement in case of interrupted sound conducting chain and intact, mobile stapes footplate.

The Aerial Total Prosthesis is intended for bridging a complete auditory ossicle defect.

The prosthesis is placed on the basis of the stapedis and the defect is bridged as far as the ear drum or up to the manubrium mallei.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <img alt="Signature" src="signature.png"/> <div>(Division Sign-Off)</div> |
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| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K972585 |

| Prescription Use (Per CFR 801 109) | <div></div> |
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| Over-The-Counter Use | |
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KRZ-USE IND

(Optional Formal 1-2-96)