SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA

K971472 · Technical Products, Inc. · FTL · Jul 1, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971472
• Device Name: SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA
• Applicant: Technical Products, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jul 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Sil Tec Medical Grade Silicone Sheeting is suitable for external use or short-term mplantanon (30 days or less). Sil-Tec sheeting is intended for modification with a scalpel or scissors, by the surgeon or medical practical practions patientspecific applicanons. Patient selection and suitability is up to the surgeon/medical practioner user The surgeon/medical practitioner user must rely on his or her own best medical judgment and training as to the use of this device. The following are some indications where silicone sheeting bas been successfully employed Surgical repairs, anchoring device for hemodialysis shunts; temporary covering for a presentally ruptured omphalocele during staged repair of wethral strictures; protective to help facilitate neural regeneration and tendon healing, surgical repair of fractured orbital floors; to prevent soft tissue fibrosis or bony michlosis following surgical correction of trismus (Waming Note: Not for permanent use in the presence of degenerative bone changes, chronic bruxism, or temporomandibular 1011 applications); other surgical procedures; and as insulating material for recoveramulation. It is the surgeon/medical practitioner users responsibility to thoroughly test any products made in part or otherwise incorporating Sil-Tec medical grade sheeting to determine the acceptability of the products performance in a specific application.

Device Story

Sil-Tec Sheeting consists of medical-grade silicone material provided in sheet form. Intended for use by surgeons or medical practitioners; device is manually modified using a scalpel or scissors to create patient-specific shapes or components for various surgical applications. Functions as a protective barrier, anchoring aid, or insulating material. Clinical utility includes facilitating neural/tendon healing, supporting orbital floor repairs, and preventing fibrosis. Device is not for permanent implantation; limited to short-term use (30 days or less). Practitioner relies on professional judgment for patient selection and application suitability.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Medical-grade silicone sheeting. Form factor: sheet material for manual cutting/shaping. Intended for external use or short-term implantation (≤30 days).

Indications for Use

Indicated for surgical repairs, hemodialysis shunt anchoring, temporary omphalocele covering, urethral stricture repair, neural regeneration/tendon healing protection, orbital floor fracture repair, and prevention of soft tissue fibrosis or bony ankylosis following trismus correction. Suitable for external use or short-term implantation (≤30 days). Contraindicated for permanent use in cases of degenerative bone changes, chronic bruxism, or temporomandibular applications.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Norbert D. Thompson President Technical Products, Inc. ...... 2416 Park Central Boulevard Decatur, Georgia 30035

JUL = 1 1997

Re: K971472 Trade Name: Sil-Tec Sheeting Regulatory Class: II Product Code: FTL Dated: April 18, 1997 Received: April 23, 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 our

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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 vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions 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/cdrh/dsmamain.html".

Sincerely yours,

elia 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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K-971472 510(k) Number (if known): __

Device Name: Sil-Tec Sheeting

Indications For Use:

Sil Tec Medical Grade Silicone Sheeting is suitable for external use or short-term mplantanon (30 days or less). Sil-Tec sheeting is intended for modification with a scalpel or scissors, by the surgeon or medical practical practions patientspecific applicanons. Patient selection and suitability is up to the surgeon/medical practioner user The surgeon/medical practitioner user must rely on his or her own best medical judgment and training as to the use of this device.

The following are some indications where silicone sheeting bas been successfully employed Surgical repairs, anchoring device for hemodialysis shunts; temporary covering for a presentally ruptured omphalocele during staged repair of wethral strictures; protective to help facilitate neural regeneration and tendon healing, surgical repair of fractured orbital floors; to prevent soft tissue fibrosis or bony michlosis following surgical correction of trismus (Waming Note: Not for permanent use in the presence of degenerative bone changes, chronic bruxism, or temporomandibular 1011 applications); other surgical procedures; and as insulating material for recoveramulation.

It is the surgeon/medical practitioner users responsibility to thoroughly test any products made in part or otherwise incorporating Sil-Tec medical grade sheeting to determine the acceptability of the products performance in a specific application.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lelen wille

(Division Sign-Off)

Prescription Use √
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)