(88 days)
Specialty Surgical Products Silicone Sheeting is intended for a variety of medical purposes both in short term and long term applications. For short term applications for use are: for nasal splinting, wound dressings, managment of hypertrophic or keloid scarring, to prevent soft tissue fibrosis or bony ankylosis following surgical correction of trismus, temporary joint spacers and laboratory uses. For longterm application the indications for use are: for nasal septal repair, orbital floor reconstruction, tympanic membrane repair, dialysis shunt anchoring, duramater repair of omphalocele, for lengthening extraocular muscles in select cases of strabismus, as a protective sheathing to help facilitate neural regeneration and tendon anastomosis, as a protective sheathing to help facilitate osteogenesis, guided tissue regeneration between teeth and gingival margin, or external ear canal for example
Silicone Elastomer Sheeting
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes for testing or training, data provenance, expert participation, adjudication methods, or comparative effectiveness studies.
The document is a 510(k) clearance letter from the FDA for a device called "Silicone Elastomer Sheeting." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines its approved indications for use.
Such a clearance letter generally does not contain the detailed study results and acceptance criteria that would be submitted to the FDA during the 510(k) application process. This document is the FDA's decision, not the applicant's submission.
Therefore, I cannot populate the table or answer the specific questions you've posed about the study and acceptance criteria based solely on the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 13 1998
Mr. T. Jan Varner · President & C.E.O. Specialty Surgical Products, Inc. P.O. Box 218 59840 Hamilton, Montana
K974653 Re: Silicone Elastomer Sheeting Trade Name: Regulatory Class: Unclassified Product Code: MIB November 17, 1997 Dated: December 15, 1997 Received:
Dear Mr. Varner:
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 The general controls provisions of the Act 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. ਬੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set… … forth in the Quality System Requlation (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 In addition, FDA may publish further announcements action. 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.
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Page 2 - Mr. Varner
This letter will allow you to beqin 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 requlation (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.qov/cdrh/dsmamain.html".
Sincerely yours,
a 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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1974653 510(k) Number (if known): _
Device Name: Silicone Elastomer Sheeting
Indications For Use:
Specialty Surgical Products Silicone Sheeting is intended for a variety of medical purposes both in short term and long term applications. For short term applications for use are: for nasal splinting, wound dressings, managment of hypertrophic or keloid scarring, to prevent soft tissue fibrosis or bony ankylosis following surgical correction of trismus, temporary joint spacers and laboratory uses. For longterm application the indications for use are: for nasal septal repair, orbital floor reconstruction, tympanic membrane repair, dialysis shunt anchoring, duramater repair of omphalocele, for lengthening extraocular muscles in select cases of strabismus, as a protective sheathing to help facilitate neural regeneration and tendon anastomosis, as a protective sheathing to help facilitate osteogenesis, guided tissue regeneration between teeth and gingival margin, or external ear canal for example
Warning: Not for permanent use in Temporo Mandibular Joint applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
eneral Restorative De
$
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.