EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS

K981045 · Exmoor Plastics , Ltd. · ETB · May 20, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K981045
• Device Name: EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
• Applicant: Exmoor Plastics , Ltd.
• Product Code: ETB · Ear, Nose, Throat
• Decision Date: May 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This prosthesis can be used to reconstruct defects of the stapes and the incus.

Device Story

Exmoor Teflon Loop is an ear prosthesis designed for middle ear reconstruction. It consists of a single-element shaft (6.0mm length; 0.4mm or 0.6mm diameter) and a loop (0.7mm internal dimension) to fit the malleus. The device utilizes 'plastic memory' for secure closure around the malleus. It is intended for use by surgeons to replace the stapes and incus, restoring ossicular chain continuity. The device is a passive implant; it does not involve electronic components, software, or active sensing.

Clinical Evidence

No clinical data provided; substantial equivalence is based on material and functional similarity to legally marketed predicate devices.

Technological Characteristics

Material: Teflon. Dimensions: 6.0mm shaft length; 0.4mm or 0.6mm shaft diameter; 1.5mm or 1.9mm outside loop diameter. Mechanism: Passive mechanical reconstruction using plastic memory for malleus attachment. No energy source, software, or connectivity.

Indications for Use

Indicated for the reconstruction of an absent or defective stapes and incus.

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.

Predicate Devices

• Causse Tef-Piston - Xomed Treace
• Cause Tef-Piston Large Loop - Xomed Treace
• Shea Malleus Teflon Piston - Richards
• Causse Modified Teflon Piston - Richards

Submission Summary (Full Text)

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K981045

MAY 2 0 1998

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Attachm

011073007102

Contact: Margaret Blackmore

10 March 1998

## SUMMARY OF SAFETY AND EFFECTIVENESS

| Trade Name: | Exmoor Teflon Loop Replacement Prosthesis |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Teflon Loop |
| Classification Name: | Prosthesis, Ear, Internal |
| Predicate Devices: | a. Causse Tef-Piston - Xomed Treace<br>b. Cause Tef-Piston Large Loop - Xomed Treace<br>c. Shea Malleus Teflon Piston - Richards<br>d. Causse Modified Teflon Piston - Richards |
| Description of Device: | The Exmoor Teflon Loop will be offered in two<br>sizes. Each comprises one element, the shaft of<br>which is 6.0mm long and is either 0.4mm or 0.6mm<br>in diameter. The loop has an internal dimension of<br>0.7mm to fit the malleus for the replacement of the<br>stapes and the incus. Secure closure is provided<br>by "plastic memory". The outside diameter of the<br>loop is either 1.5mm or 1.9mm. |
| Intended Use: | This prosthesis can be used to reconstruct defects<br>of the stapes and the incus. |
| Comparison with Predicate<br>Devices: | The Exmoor Teflon Loop is made of exactly the<br>same material as all four of the predicate devices<br>and is intended to perform exactly the same<br>function. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 1998

Margaret Blackmore Regulatory Affairs Exmoor Plastics, Inc. Lisieux Way Taunton, TA1 2LB United Kingdom

Re:

K981045

Teflon Loop Replacement Prosthesis Dated: March 12, 1998 Received: March 20, 1998 Regulatory Class: II 21 CFR 874.3450/Procode: 77 ETB

Dear Ms. Blackmore:

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 (OS) 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 vitto diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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/cdrb/dsmaldsmam.html".

Sincerely yours,

Lillian Yi, Ph.D.

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): KAX | UYS

EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

This prosthesis can be used to reconstruct an absent or defective stapes and incus.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel h. Skjerm

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic

Prescription Use (Per 21 CFR 801.109)

OR

510(k) Number .

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)