MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES

K992138 · Micromedics, Inc. · ETA · Aug 9, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K992138
• Device Name: MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES
• Applicant: Micromedics, Inc.
• Product Code: ETA · Ear, Nose, Throat
• Decision Date: Aug 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3495
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For surgical reconstruction of the ossicular chain between the stapes footplate and ear drum where the stapes footplate is present and mobile.

Device Story

S&T Total Ossicular Replacement Prosthesis is a surgical implant used for ossicular chain reconstruction. The device is placed by an otolaryngologist during middle ear surgery to bridge the gap between the stapes footplate and the tympanic membrane (ear drum). By restoring the mechanical linkage of the ossicular chain, the prosthesis facilitates sound conduction to the inner ear, potentially improving hearing in patients with ossicular chain discontinuity. The device is a passive implant; it does not involve electronic processing, software, or algorithms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Passive surgical implant for middle ear reconstruction. Materials and dimensions are consistent with traditional ossicular replacement prostheses. No energy source, software, or connectivity features.

Indications for Use

Indicated for patients requiring surgical reconstruction of the ossicular chain, specifically between the stapes footplate and the ear drum, provided the stapes footplate is present and mobile.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 1999

Mr. Charles Grote Manager of Quality Assurance and Regulatory Affairs Micromedics, Inc. 1285 Corporate Center Drive-#150 Eagan, MN 55121 USA

Re: K992138 Trade Name: S&T Total Ossicular Replacement Prosthesis Regulatory Class: II Product Code: ETA Dated: July 8, 1999 Received: July 9, 1999

Dear Mr. Grote:

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 Device Amendments, or to 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 misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (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 requirements, 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Mr. Charles Grote

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,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## MICROMEDICS, INC. 510(K) Premarket Notification

510(K) Number: Not known at this time

KA92138

Device Name: S&T Total Ossicular Replacement Prosthesis

## STATEMENT OF INDICATIONS FOR USE

For surgical reconstruction of the ossicular chain between the stapes footplate and ear drum where the stapes footplate is present and mobile.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use
Krea Bohr

(Division Sign-Off) (Division of Ophthalmic Devices 510(k) Number