SPENCO SILICONE GEL SHEET

K981902 · Spenco Medical Corp. · MDA · Jun 25, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981902
• Device Name: SPENCO SILICONE GEL SHEET
• Applicant: Spenco Medical Corp.
• Product Code: MDA · General, Plastic Surgery
• Decision Date: Jun 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4025
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Spenco Silicone Gel Sheet is indicated for: - Use as a scar management dressing on old and new 1. hyperthropic or keloid scars. - infected wounds Not to be used on ત્વે. - Is not indicated for use on 3rd degree burns - The device can be used by layman, safely when following the instructions-for use included with the product.

Device Story

Spenco Silicone Gel Sheet functions as a topical scar management dressing. Applied directly to skin over hypertrophic or keloid scars; provides protective barrier. Intended for use by laypeople in home or clinical settings. Device aids in scar management; no complex inputs, algorithms, or electronic outputs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Silicone gel sheet dressing. Non-electronic, passive medical device. No software or complex technological components.

Indications for Use

Indicated for management of old and new hypertrophic or keloid scars. Contraindicated for infected wounds and 3rd degree burns. Suitable for layperson use.

Regulatory Classification

Identification

Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 25 1998

Ms. Brenda Hunt ·Spenco Medical Corporation 6301 Imperial Drive Waco, Texas 76702

K981902 Re: Trade Name: Spenco Silicone Gel Sheet Regulatory Class: Unclassified Product Code: MDA Dated: May 28.1998 Received: June 1, 1998

Dear Ms. Hunt:

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 requirement, 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.

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Page 2 - Ms. Brenda Hunt

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,

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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Pagc of

510(k) Number (if known): K 981902

Device Name: Spenco Silicone Grel Sheet

Indications For Use:

Spenco Silicone Gel Sheet is indicated for:

- Use as a scar management dressing on old and new 1. hyperthropic or keloid scars.
- infected wounds Not to be used on ત્વે.
- Is not indicated for use on 3rd degree burns
- The device can be used by layman, safely when following the instructions-for use included with the product.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | <div> <img alt="signature" src="..."/> </div> |
|--------------------------------------------------------|-----------------------------------------------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K991902 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use <img alt="check" src="..."/><br>(Optional Format 1-2-96) |
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