(61 days)
Not Found
No
The device description focuses on the physical characteristics and materials of a surgical prosthesis, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
This device is a prosthesis designed to reconstruct absent or defective stapes and incus, which directly treats a medical condition.
No
The device is a prosthesis intended for reconstruction, not for diagnosis. It replaces absent or defective anatomical structures rather than identifying or characterizing a medical condition.
No
The device description clearly describes a physical prosthesis made of Teflon with specific dimensions, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reconstruct an absent or defective stapes and incus." This describes a surgical implant used within the body to replace or repair anatomical structures.
- Device Description: The description details a physical prosthesis designed for surgical implantation in the ear.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly intended for in vivo (within the body) use as a surgical implant.
N/A
Intended Use / Indications for Use
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.
Product codes
77 ETB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stapes and the incus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
a. Causse Tef-Piston - Xomed Treace, b. Cause Tef-Piston Large Loop - Xomed Treace, c. Shea Malleus Teflon Piston - Richards, d. Causse Modified Teflon Piston - Richards
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAY 2 0 1998
ﺴﺘﺎﻧﻴﺎ ﺍﻟ
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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 |
| b. Cause Tef-Piston Large Loop - Xomed Treace | |
| c. Shea Malleus Teflon Piston - Richards | |
| d. Causse Modified Teflon Piston - Richards | |
| Description of Device: | 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. | |
| Intended Use: | This prosthesis can be used to reconstruct defects |
| of the stapes and the incus. | |
| Comparison with Predicate | |
| Devices: | The Exmoor Teflon Loop is made of exactly the |
| same material as all four of the predicate devices | |
| and is intended to perform exactly the same | |
| function. |
1
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
2
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)