NU-GEL * WOUND DRESSING

K983362 · Johnson & Johnson Medical, Inc. · MGQ · Dec 16, 1998 · SU

Device Facts

• Record ID: K983362
• Device Name: NU-GEL * WOUND DRESSING
• Applicant: Johnson & Johnson Medical, Inc.
• Product Code: MGQ · SU
• Decision Date: Dec 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

NU-GEL* Wound Dressing is a sterile hydrogel formulation of preserved polyvinyt pyrrolidone in water. The gel is supported by a fusible fiber fabric scrim and protected on both sides by polyethylene film. NU-GEL* Wound Dressing maintains a moist wound environment. A moist wound environment supports the wound healing process by encouraging autolytic debridement thus enabling granulation to proceed under optimum conditions. It protects against dehydration, bacterial contamination and absorbs exudate from the wound. NU-GEL Wound Dressing is indicated for dry, light and moderately exuding partial and full thickness wounds such as: - First and second degree burns . - Severe sunburns ◆ - Superficial injuries, superficial lacerations, cuts, abrasions, incisions/surgical . wounds, and skin tears NU-GEL* Wound Dressing should be used under health care professional direction for the following indications: - Burns caused by radiation oncology procedures . - Pressure ulcers Stage I-IV . - Lower extremity ulcers . - . Venous ulcers - Arterial ulcers . - Ulcers of mixed etiology ● - Diabetic ulcers ● - Donor sites and skin grafts . Precautions: NU-GEL* Wound Dressing is not indicated for use on the following: - · Third degree bums - · Lesions with active vasculitis as this type of ulcer needs more frequent observation by a healthcare professional. NU-GEL Wound Dressing may be used when visible signs of infection are present in the wound area only when proper medical treatment addresses the underlying cause. NU-GEL* Wound Dressing may be used under compression therapy with healthcare profession supervision.

Device Story

Sterile hydrogel wound dressing; composed of preserved polyvinyl pyrrolidone in water; supported by fusible fiber fabric scrim; protected by polyethylene film. Maintains moist wound environment; facilitates autolytic debridement; absorbs exudate; protects against dehydration and bacterial contamination. Applied topically to wound site; used by healthcare professionals or patients (OTC). Provides physical barrier; supports natural healing process. Does not treat or cure wounds; not for long-term/permanent use or artificial skin.

Clinical Evidence

Bench testing only. Biocompatibility testing conducted per ISO 10993-1: Cytotoxicity (non-toxic), Primary Skin Irritation (non-irritating), Guinea Pig Excision (no adverse effects), Mice Burn Healing (reduced inflammation), Porcine Partial Thickness/Burn Wound Healing (no adverse effects), and Kligman Chamber Scarification (low irritation potential).

Technological Characteristics

Sterile hydrogel (polyvinyl pyrrolidone in water); fusible fiber fabric scrim support; polyethylene film protective layers. Biocompatibility tested per ISO 10993. Non-active, passive dressing.

Indications for Use

Indicated for dry, light, and moderately exuding partial and full-thickness wounds, including 1st/2nd-degree burns, severe sunburns, superficial injuries/lacerations, cuts, abrasions, surgical wounds, skin tears, radiation burns, pressure ulcers (Stage I-IV), venous/arterial/mixed/diabetic ulcers, and donor sites/skin grafts. Contraindicated for 3rd-degree burns and lesions with active vasculitis.

Predicate Devices

• DuoDERM CGF Control Gel Formula Border Dressing (K973688)

Submission Summary (Full Text)

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K983362

DEC 16 1998

510 (k) NU-GEL* Wound Dressing Full Thickness Wound Submission

# APPENDIX F

## 510(k) SUMMARY

#### 1. DATE PREPARED

December 1, 1998

#### SUBMITTER 2.

Johnson & Johnson Medical Division of Ethicon Inc. 2500 Arbrook Blvd. P.O. Box 90130 Arlington, TX 76004-3130

### CONTACT PERSON 3.

Terry James Dagnon Regulatory Affairs Project Manager Phone: [phone] Fax:

#### NAME OF THE MEDICAL DEVICE 4.

Classification Name: Common/Usual Name: Proprietary Name:

Dressing, Wound Topical wound dressing NU-GEL* Wound Dressing

#### રું. DEVICE CLASSIFICATION

Product Code/Classification Number: Unclassified Requiatory Class: Unclassified

### STATEMENT OF SUBSTANTIAL EQUIVALENCE હ્. NU-GEL* Wound Dressing is substantially equivalent and identical in function to

DuoDERM" CGF Control Gel Formula Border Dressing (K973688) manufactured by ConvaTec - A Division of E.R. Squibb & Sons. Inc.

### 7. INDICATIONS FOR USE

NU-GEL* Wound Dressing is a sterile hydrogel formulation of preserved polyvinyt pyrrolidone in water. The gel is supported by a fusible fiber fabric scrim and protected on both sides by polyethylene film. NU-GEL* Wound Dressing maintains a moist wound environment. A moist wound environment supports the wound healing process by encouraging autolytic debridement thus enabling granulation to proceed under optimum conditions. It protects against dehydration, bacterial contamination and absorbs exudate from the wound.

NU-GEL Wound Dressing is indicated for dry, light and moderately exuding partial and full thickness wounds such as:

- First and second degree burns .
- Severe sunburns ◆
- Superficial injuries, superficial lacerations, cuts, abrasions, incisions/surgical . wounds, and skin tears

Trademark *

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K983362

# 510 (k) NU-GEL* Wound Dressing Full Thickness Wound Submission

NU-GEL* Wound Dressing should be used under health care professional direction for the following indications:

- Burns caused by radiation oncology procedures .
- Pressure ulcers Stage I-IV .
- Lower extremity ulcers .
- . Venous ulcers
- Arterial ulcers .
- Ulcers of mixed etiology ●
- Diabetic ulcers ●
- Donor sites and skin grafts .

# Precautions:

NU-GEL* Wound Dressing is not indicated for use on the following:

- · Third degree bums
- · Lesions with active vasculitis as this type of ulcer needs more frequent observation by a healthcare professional.

NU-GEL Wound Dressing may be used when visible signs of infection are present in the wound area only when proper medical treatment addresses the underlying cause. NU-GEL* Wound Dressing may be used under compression therapy with healthcare profession supervision.

### PHYSICAL DESCRIPTION 8.

NU-GEL* Wound Dressing is a sterile hydrogel formulation of preserved polyviny pyrrolidone in water. The gel is supported by a fusible fiber fabric scrim and protected on both sides by polyethylene film. NU-GEL* Wound Dressing maintains a moist wound environment. A moist wound environment supports the wound healing process by encouraging autolytic debridement thus enabling granulation to proceed under optimum conditions. It protects against dehydration, bacterial contamination and absorbs exudate from the wound.

### BIOCOMPATIBILITY റി

The following safety testing was conducted in accordance with ISO 10993 Part 1 Biological Evaluation of Medical Devices to support the Biocompatibility of this product.

| SAFETY TESTING | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------|
| TEST | RESULTS |
| Cytotoxicity | Non-toxic |
| Primary Skin Irritation | Non-irritating |
| Wound Healing (Guinea Pig Excision) | No Adverse Effects |
| Burn Healing Study (Mice) | Reduced Inflammation-equivalent to<br>immediately immersing the burn in ice water<br>for 3 minutes |
| Porcine Partial Thickness Wound Healing | No Adverse Effects |
| Porcine Burn Wound Healing | No Adverse Effects |
| Kligman Chamber Scarification | Irritation Potential - Low |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 1998

Terry J. Dagnon Johnson & Johnson Medical, Inc. 2500 Arbrook Blvd P.O. Box 90130 Arlington, Texas 76004

Re: K983362 Trade Name: Nu-Gel Wound Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: September 23, 1998 Received: September 24, 1998

Dear Mr. Dagnon:

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:

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

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 registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Mr. Terry J. Dagnon

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 tollfree number [phone] or 301-443-6597 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

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### 510(k) NU-GEL* Wound Dressing Full Thickness Wound Submission

### K983362 510(k) Number : Johnson & Johnson Medical Applicant: A Division of Ethicon Inc. 2500 Arbrook Blvd. Arlington, TX 76004-3130

# Device Name: NU-GEL * Wound Dressing

### Indications for Use:

NU-GEL" Wound Dressing is a sterile hydrogel formulation of preserved polyvinyl pyrrolidone in water. The gel is supported by a fusible fiber fabric scrim and protected on both sides by polyethylene film. NU-GEL" Wound Dressing maintains a moist wound environment. A moist wound environment supports the wound healing process by encouraging autolytic debridement thus enabling granulation to proceed under optimum conditions.

It protects against dehydration, bacterial cortamination and absorbs exudate from the wound.

NU-GEL Wound Dressing is indicated for dry, light and moderately exuding partial and full thickness wounds such as:

- First and second degree burns
- Severe sunbums .
- Superficial injuries, superficial lacerations, cuts, abrasions/surgical wounds, and skin . tears

NU-GEL* Wound Dressing should be used under health care professional direction for the following indications:

- Burns caused by radiation oncology procedures ●
- Pressure ulcers Stage I-IV
- . Lower extremity ulcers
- . Venous ulcers
- Arterial ulcers .
- Ulcers of mixed etiology .
- Diabetic ulcers �
- Donor sites and skin grafts .

Precaulions:

NU-GEL* Wound Dressing is not indicated for use on the following:

- · Third degree burns
- · Lesions with active vasculitis as this type of ulcer needs more frequent observation by a healthcare professional.

NU-GEL " Wound Dressing may be used when visible signs of infection are present in the wound area only when proper medical treatment addresses the underlying cause.

NU-GEL " Wound Dressing may be used under compression therapy with healthcare profession supervision..

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) |
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Division of General Restorative Devices

| 510(k) Number | 1983362 |
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| Prescription Use<br>(Per 21 CFR 801.109) | Or Over-The-Counter Use | X |
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