(88 days)
The purchaser shall sufficiently inform themselves regarding the use of silicone materials in any surgical procedure to insure its proper use. Sil-Tec Medical Grade Oval Shape is a soft, radiopaque silicon elastomer shape intended for reconstruction and surgical repair procedures. Some uses have been: As temporary stents for the formation of new tendon sheaths. Other surgical repair procedures demanding a highly inert and flexible oval shaped material.
Sil-Tec Medical Grade Oval Shape is a soft, radiopaque silicon elastomer shape intended for reconstruction and surgical repair procedures.
I am sorry, but based on the limited information provided in the given text, I cannot answer the questions about acceptance criteria and study details. The document is an FDA 510(k) clearance letter for a medical device called "SilTec™ Oval Shapes," issued in 1997.
This type of letter indicates that the FDA has found the device to be substantially equivalent to a legally marketed predicate device, meaning it doesn't require a new premarket approval. However, it does not contain the detailed acceptance criteria or the specific study results. It mentions the device's intended use and regulatory classification but doesn't elaborate on performance metrics or the studies used to establish substantial equivalence.
To answer your questions, I would need access to the actual 510(k) submission (which often includes performance data and acceptance criteria) or a separate study report for the SilTec™ Oval Shapes.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 5 1997
Mr. Norbert D. Thompson President Technical Products, Incorporated 2416 Park Central Boulevard Decatur, Georgia 30035
Re: K973385 Trade Name: SilTec™ Oval Shapes Regulatory Class: II Product Code: HXA Dated: August 20, 1997 Received: September 8, 1997
Dear Mr. Thompson:
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
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Page 2 - Mr. Thompson
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 vour 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 (301) 594-4595. Additionally, for questions 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/cdrh/dsmamain.html".
Sincerely yours,
fo coole
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Oval Shapes Device Name:
Indications For Use:
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The purchaser shall sufficiently inform themselves regarding the use of silicone materials in any surgical procedure to insure its proper use.
Sil-Tec Medical Grade Oval Shape is a soft, radiopaque silicon elastomer shape intended for reconstruction and surgical repair procedures. Some uses have been:
- As temporary stents for the formation of new tendon sheaths 1.
- Other surgical repair procedures demanding a highly inert 2. and flexible oval shaped material
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K973385 |
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 888.3025 Passive tendon prosthesis.
(a)
Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a polyester reinforced medical grade silicone elastomer intended for use in the surgical reconstruction of a flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for the ligament or tendon nor to function as a scaffold for soft tissue ingrowth.(b)
Classification. Class II.