(61 days)
This prosthesis can be used to reconstruct defects of the stapes and the incus.
This prosthesis can be used to reconstruct an absent or defective stapes and incus.
The Exmoor Teflon Loop will be offered in two sizes. Each comprises one element, the shaft of which is 6.0mm long and is either 0.4mm or 0.6mm in diameter. The loop has an internal dimension of 0.7mm to fit the malleus for the replacement of the stapes and the incus. Secure closure is provided by "plastic memory". The outside diameter of the loop is either 1.5mm or 1.9mm.
The provided document is a 510(k) premarket notification for a medical device (Exmoor Teflon Loop Replacement Prosthesis) and does not contain the information required to answer the prompt.
Specifically, the document focuses on establishing substantial equivalence to predicate devices and receiving clearance from the FDA. It does not include:
- Acceptance criteria and reported device performance: This document only describes the device and its intended use, with no data on its performance against specific metrics.
- Sample size and data provenance for a test set: No study data is presented.
- Number and qualifications of experts for ground truth: Not applicable as no study data is presented.
- Adjudication method for the test set: Not applicable.
- MRMC comparative effectiveness study: Not mentioned or conducted.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
The document primarily states that the device is "made of exactly the same material as all four of the predicate devices and is intended to perform exactly the same function," which is the basis for its substantial equivalence claim, rather than presenting a detailed performance study.
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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 Treaceb. Cause Tef-Piston Large Loop - Xomed Treacec. Shea Malleus Teflon Piston - Richardsd. Causse Modified Teflon Piston - Richards |
| Description of Device: | The Exmoor Teflon Loop will be offered in twosizes. Each comprises one element, the shaft ofwhich is 6.0mm long and is either 0.4mm or 0.6mmin diameter. The loop has an internal dimension of0.7mm to fit the malleus for the replacement of thestapes and the incus. Secure closure is providedby "plastic memory". The outside diameter of theloop is either 1.5mm or 1.9mm. |
| Intended Use: | This prosthesis can be used to reconstruct defectsof the stapes and the incus. |
| Comparison with PredicateDevices: | The Exmoor Teflon Loop is made of exactly thesame material as all four of the predicate devicesand is intended to perform exactly the samefunction. |
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Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
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:
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 (301) 594-4613. Additionally, for question on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)
§ 874.3450 Partial ossicular replacement prosthesis.
(a)
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.(b)
Classification. Class II.