BOJRAB MICRO-TORP, MODEL 7014-5845

K990601 · Gyrus Ent LLC · ETA · Mar 31, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K990601
• Device Name: BOJRAB MICRO-TORP, MODEL 7014-5845
• Applicant: Gyrus Ent LLC
• Product Code: ETA · Ear, Nose, Throat
• Decision Date: Mar 31, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3495
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Otosclerosis . Congenital fixation of the stapes . When previous remedial surgery has been unsuccessful for the treatment of hearing loss . due to otosclerosis, and a significant conductive loss remains with good cochlear reserve. Chronic middle ear disease . Trauma .

Device Story

Bojrab Micro-TORP Prosthesis is a total ossicular replacement prosthesis used in middle ear surgery. It functions to reconstruct the ossicular chain following loss of function due to disease, trauma, or congenital defects. The device features a Hydroxylapatite head and a trimmable HAPEX shaft. It is implanted by an otolaryngologist during middle ear reconstructive surgery. The prosthesis serves as a mechanical bridge to restore sound conduction to the inner ear, potentially improving patient hearing.

Technological Characteristics

Total ossicular replacement prosthesis. Materials: Hydroxylapatite (head), HAPEX (shaft). Design features a trimmable shaft for surgical customization. Non-electronic, mechanical implant.

Indications for Use

Indicated for patients with hearing loss due to otosclerosis, congenital stapes fixation, chronic middle ear disease, trauma, or failed prior remedial surgery, provided there is good cochlear reserve.

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

• Black Oval-Top TORP (Smith & Nephew, Inc.)
• Schwaber Total implant (Xomed)

Submission Summary (Full Text)

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Food and Drug Administration 510(k) Notification - Boirab Micro-TORP Prosthesis February 22, 1999

KG90601

## 510(k) Summary of Safety and Effectiveness

| Trade Name: | Bojrab Micro-TORP Prosthesis |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Total Ossicular Replacement Prosthesis |
| Classification Name: | Total Ossicular Replacement Prosthesis (§ 874.3495) |
| Official Contact: | Alicia E. Farage<br>Senior Regulatory Affairs Specialist<br>Smith & Nephew, Inc.<br>ENT Division<br>2925 Appling Road<br>Bartlett, TN 38133 |
| Telephone: | [phone] |
| Telefax: | [phone] |
| Date Prepared: | February 22, 1999 |

The Bojrab Micro-TORP Prosthesis is substantially equivalent to the Black Oval-Top TORP marketed by Smith & Nephew, Inc., ENT Division, and the Schwaber Total implant marketed These devices have the same indications for use, total reconstruction of the by Xomed. ossicular chain that has lost its function due to disease, trauma, or congenital defect. The head of the Bojrab Micro-TORP Prosthesis is made from Hydroxylapatite, a widely accepted material for middle ear reconstruction, as are the heads of the two predicate devices. The Bojrab Micro-TORP Prosthesis and the predicate devices all have trimmable shafts. The Bojrab and Black implant shafts are made from HAPEX and the Schwaber implant shaft is manufactured from FLEX H/A.

Differences between the Bojrab Micro-TORP Prosthesis and the predicate devices should not affect the safety or effectiveness.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three flowing lines representing the body and head. The figure is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 1999

Ms. Alicia E. Farage Sr. Regulatory Affairs Specialist Smith & Nephew, Inc. 2925 Appling Road Bartlett, TN 38133

Re: K990601 Trade Name: Bojrab Micro-TORP Prosthesis Regulatory Class: II Product Code: 87 ETA Dated: March 4, 1999 Received: March 5, 1999

Dear Ms. Farage:

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 - Ms. Alicia E. Farage, Sr. Regulatory Affairs Specialist

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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Food and Drug Administration 510(k) Notification - Bojrab Micro-TORP Prosthesis February 22, 1999

510(k) Number: Device Name:

* 946601 Bojrab Micro-TORP®

## Indications For Use:

- Otosclerosis .
- Congenital fixation of the stapes .
- When previous remedial surgery has been unsuccessful for the treatment of hearing loss . due to otosclerosis, and a significant conductive loss remains with good cochlear reserve.
- Chronic middle ear disease .
- Trauma .

(Division Sign-Off) Division of Ophthalmic Devices K99060 510(k) Number ـ

Karen Bohm (for HRS)

**Prescription Use**
(Per 21 CFR 801.109)