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.

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.

Device Description

The implant consists of a golden wire rectangle with a structured outer surface and a stem which is available in various lengths. It ends in a 'bell' with two slits.

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.

The implant consists of a titanium mesh plate that is textured on the surface that makes contact with the tympanum and a shaft that is available in various lengths.

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.

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

AI/ML Overview

The provided 510(k) summary for the Heinz Kurz GmbH Aerial Prosthesis (K972585) does not contain the information requested regarding acceptance criteria and a study to prove the device meets those criteria.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices. In the context of 510(k) submissions, manufacturers typically compare their new device to legally marketed predicate devices to show that it is as safe and effective. This process generally does not involve establishing new acceptance criteria or conducting extensive effectiveness studies in the same way a Premarket Approval (PMA) application would.

Here's what can be inferred from the document regarding the device's assessment:

Acceptance Criteria and Reported Device Performance: This information is not present. The document states, "There are no additional characteristics known that should adversely affect the safety and effectiveness of these implants," implying that their safety and effectiveness are considered comparable to the predicate devices.
Study Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): None of these details are provided as there is no description of a specific study to establish acceptance criteria or device performance metrics. The submission is based on the premise that the device's technological characteristics and intended use are similar enough to predicate devices that new, extensive clinical studies are not required to demonstrate safety and effectiveness.
Training Set Information: Not applicable, as there's no machine learning or AI component described or evaluated.

Explanation of the 510(k) Process as it relates to this document:

The 510(k) pathway is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). This is often achieved by demonstrating "substantial equivalence," meaning that the new device has the same intended use and the same technological characteristics as the predicate device, or, if there are differences, that those differences do not raise new questions of safety or effectiveness.

In this specific 510(k) summary, the manufacturer asserts:

Identification of Predicate Devices: The KURZ Aerial total ossicular implants are substantially equivalent to total ossicular devices of Smith & Nephew Richards and Xomed (with Ionos).
Description of Device: Details on the materials (gold, titanium) and design (wire rectangle, mesh plate, shaft, bell, piston) for different models (Standard, Dresden, Düsseldorf, Tübingen).
Intended Use: Reconstruction of the ossicular chain to facilitate sound energy conduction.
Technological Characteristics: Implants can be bent and shaped but hold their shape after placement.
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."

Conclusion:

The provided K972585 document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and a study proving those criteria are met for a novel device. Therefore, the specific information requested in your prompt (acceptance criteria table, study details, sample sizes, ground truth, expert qualifications, etc.) is not contained within this submission.

Summary

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K972585

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Image /page/0/Picture/4 description: The image shows a solid black circle. The circle is slightly irregular in shape, with some minor imperfections along its edges. The background is white, providing a stark contrast to the black circle. The circle appears to be a simple, isolated shape without any additional elements or context.

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 (0 70 72) 91 79-0 Telefax (0 70 72) 91 79-75

Tel. 011 31 20 428 9591 -428 9429 Fax e-mail bsi@xs4all.nl
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 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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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH HUMAN" are arranged in a circular pattern around the eagle.

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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)

	(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K972585

Prescription Use (Per CFR 801 109)
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Over-The-Counter Use
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KRZ-USE IND

(Optional Formal 1-2-96)

Regulation Number and Section

§ 874.3495 Total ossicular replacement prosthesis.

(a)
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.(b)
Classification. Class II.