CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)

K963899 · Exmoor Plastics , Ltd. · ETA · Aug 22, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K963899
• Device Name: CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)
• Applicant: Exmoor Plastics , Ltd.
• Product Code: ETA · Ear, Nose, Throat
• Decision Date: Aug 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3495
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This product may be used for any defect in the ossicular chain of the middle ear, whether occurring from disease, injury or congenital malformation.

Device Story

Causse Universal HA Prosthesis is an implantable device designed to reconstruct the ossicular chain in the middle ear. It serves as a bridge to restore sound conduction when the natural ossicles are damaged or missing due to disease, trauma, or congenital conditions. The device is surgically implanted by an otolaryngologist during middle ear surgery. By replacing or bypassing non-functional ossicles, the prosthesis facilitates the transmission of mechanical vibrations from the tympanic membrane to the inner ear, potentially improving hearing function for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ossicular replacement prosthesis constructed from Hydroxyapatite (HA). Designed for middle ear implantation to restore ossicular chain continuity. Mechanical device; no energy source or software components.

Indications for Use

Indicated for patients with ossicular chain defects in the middle ear resulting from disease, injury, or congenital malformation.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Margaret Blackmore
Regulatory Affairs
Exmoor Plastics Ltd.
Lisieux Way
Taunton, TA1 2LB, U.K.

Re: K963899
Causse Universal Ossicular Replacement Prosthesis
Dated: July 29, 1997
Received: August 12, 1997
Regulatory class: II
21 CFR 874.3450/Procode: 77 ETA
21 CFR 874.3495/Procode: 77 ETB

Dear Ms. Blackmore:

AUG 22 1997

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 the Electronic Product 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,


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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A895743

510(k) Number (if known) K963899

Device Name: CAUSSE UNIVERSAL HA PROSTHESIS (formerly 'Causse Universal Ossicular Replacement Prosthesis)

Indications for Use:

This product may be used for any defect in the ossicular chain of the middle ear, whether occurring from disease, injury or congenital malformation.

9PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CORH, Office of Device Evaluation (ODE)

David A. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K963899

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-the-Counter Use

Optional Format 1-2-96)