PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT

K972815 · Grace Medical, Inc. · ETB · Oct 8, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K972815
• Device Name: PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
• Applicant: Grace Medical, Inc.
• Product Code: ETB · Ear, Nose, Throat
• Decision Date: Oct 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ossicular replacement prostheses are indicated for the function of the ossicular chain when a conductive hearing loss is present. Indications include - Chronic middle ear disease ● - . Otosclerosis - Congenital fixation of the stapes - Secondary surgical intervention to correct for a significant and persistent conductive . hearing loss from prior otologic surgery - Surgically correctible injury to the middle ear from trauma .

Device Story

Partial and Total Ossicular Replacement Prostheses (PORP/TORP) designed to restore ossicular chain function in middle ear. Used by otolaryngologists during reconstructive ear surgery. Prostheses bridge gap between tympanic membrane and inner ear (oval window/stapes footplate) to facilitate sound conduction. Benefit: restoration of hearing in patients with conductive hearing loss. Device is implanted surgically.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Porous polyethylene material. Form factor: partial and total ossicular replacement prostheses. Intended for surgical implantation in the middle ear.

Indications for Use

Indicated for patients with conductive hearing loss due to chronic middle ear disease, otosclerosis, congenital stapes fixation, prior otologic surgery failure, or middle ear trauma.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Anthony D. Prescott President Grace Medical, Inc. 7715 Highway 70 Suite 109 Bartlett, TN 38133

Re:

OCT - 8 1997 K972815 Partial Ossicular Replacement Proshesis Total Ossicular Replacement Prostheses Porous Polyethylene Ossicular Replacement Dated: July 11, 1997 Received: July 18, 1997 Regulatory class: II 21 CFR 874.3450/Procode: 77 ETB 21 CFR 874.3495/Procode: 77 ETA

Dear Mr. Prescott:

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 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 question 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 vours.

h.D.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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510(k) Number (if known):

Device Name Partial & Total Ossicular Replacement Prosthesis

## Indications For Use

Ossicular replacement prostheses are indicated for the function of the ossicular chain when a conductive hearing loss is present. Indications include

- Chronic middle ear disease ●
- . Otosclerosis
- Congenital fixation of the stapes
- Secondary surgical intervention to correct for a significant and persistent conductive . hearing loss from prior otologic surgery
- Surgically correctible injury to the middle ear from trauma .

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801 109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

Daniel L. Syverson

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