N-TERFACE

K973538 · Winfield Laboratories, Inc. · MGP · Dec 16, 1997 · SU

Device Facts

• Record ID: K973538
• Device Name: N-TERFACE
• Applicant: Winfield Laboratories, Inc.
• Product Code: MGP · SU
• Decision Date: Dec 16, 1997
• Decision: SN
• Submission Type: Traditional
• Device Class: Class U

Intended Use

N-TERFACE® Interpositional Surfacing Material is intended for use as the primary wound contact layer after laser skin resurfacing.

Device Story

N-TERFACE® is an extruded, non-woven, high-density polyethylene sheeting material. It functions as a primary wound contact layer applied by clinicians following laser skin resurfacing procedures. The material acts as a physical interface between the wound bed and secondary dressings. It is not intended for use on third-degree burns, nor is it labeled as a treatment, cure, or artificial skin. The device provides a protective barrier to manage the wound environment post-procedure.

Clinical Evidence

No clinical data provided; substantial equivalence is based on physical identity to the predicate device.

Technological Characteristics

Material: Extruded, non-woven, high-density polyethylene sheeting. Physical properties: Weight 0.36-0.8 oz/yd2; Thickness 4.0-5.0 mils; Tensile strength (roll direction) 14-77 lbs/in, (cross direction) 1.5-4.5 lbs/in; Air permeability 545-1144 ft3/min/ft2.

Indications for Use

Indicated for use as a wound contact layer for partial thickness burns and wounds resulting from laser skin resurfacing.

Predicate Devices

• N-TERFACE® Interpositional Surfacing Material (K820198)

Submission Summary (Full Text)

{0}------------------------------------------------

# 473538

DEC 1997

### 510 (k) Summary as required by 807.92(c) for N-TERFACE® Interpositional Surfacing Material Prepared July 10, 1997

| Submitted by: | Winfield Laboratories, Inc.<br>10488 Brockwood Road<br>Dallas, Texas 75238<br>214/553-8072 |
|-----------------|--------------------------------------------------------------------------------------------|
| Contact Person: | Gary W. Cummings<br>Executive Vice President |

Device Trade Name: N-TERFACE® Interpositional Surfacing Material.

Wound contact layers have not been classified. Classification:

- N-TERFACE® Interpositional Surfacing Material Predicate Device: manufactured by Winfield Laboratories, Inc., 10488 Brockwood Road, Dallas, TX 75238. (K820198).
Description of Device:

N-TERFACE® Interpositional Surfacing Material is an extruded, non-woven, high density polyethylene sheeting material with the following physical properties: Weight, oz/yd2: 0.36 to 0.8, Thickness, Mils: 4.0 to 5.0, Tensile, Ibs/in .: roll direction 14 to 77, cross direction 1.5 to 4.5, Air Permeability ft3/min/ft2: 545 to 1144.

Intended Use of Device:

N-TERFACE® Interpositional Surfacing Material is intended for use as the primary wound contact layer after laser skin resurfacing.

{1}------------------------------------------------

K473338

Substantial Equivalence to Predicate Device:

N-TERFACE Interpositional Surfacing Material indicated for use in laser skin resurfacing is physically identical to N-TERFACE® Interpositional Surfacing Material (K820198) indicated for use in the treatment of partial thickness burns. The wounds created in laser skin resurfacing are partial thickness burns. The material with this new explicit indication for a subset of the previously cleared use is therefore substantially equivalent to the device described in K820198.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 6 1997

Mr. Gary W. Cummings Executive Vice President Winfield Laboratories, Inc. 10488 Brockwood Road Dallas, Texas 75238

Re: K973538

N-TERFACE™ Interpositional Surfacing Material Regulatory Class: Unclassified Product Code: MGP Dated: September 18, 1997 Received: September 18, 1997

Dear Mr. Cummings:

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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food. Drug, and Cosmetic Act (Act) and the following limitations:

- 1. This device may not be labeled for use on third degree burns.
- 2. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
- 3. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- 4. This device may not be labeled as a treatment or a cure for any type of wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).The general controls provisions of the Act include requirements for annual

{3}------------------------------------------------

#### Page 2 - Mr. Gary W. Cummings

registration, listing of devices, good manufacturing practices, 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 (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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 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 301-443-6597 or at its internet address http://www.fda.gov/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

{4}------------------------------------------------

| SIAK) Number (if known): | K973538 |
|--------------------------|---------|
|--------------------------|---------|

N-TERFACE Interpositional Surfacing MaterialDevice Name:

### Indications For Usc:

· ·· . . ・・ ・・・

N-TERFACH interpositional Surfacing Matcrial is indicated for use as a wound contact layer for partial thickness burns
and and confection worselves of laser skin resurfacing. indicated for use as a wound concace in ......................................................................................................................................

(I'LEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IT NEEDED)

# Coucurrence of CDRH, Office of Device Evaluation (ODE)

**(Division Sign-Off)**

Division of General Restorative Devices 12973534 510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)

ીર

Over-The-Counter Use

(Optional Formal 1-2-96)