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 .

Device Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the NU-GEL Wound Dressing, structured to address your specific requests.

Based on the provided document, the "acceptance criteria" discussed are related to the biocompatibility and wound healing performance of the NU-GEL Wound Dressing, primarily for demonstrating substantial equivalence to a predicate device. This is a 510(k) submission, which focuses on demonstrating equivalence rather than a full clinical trial for novel device approval.

It's important to note that this submission describes preclinical (animal) studies and in-vitro tests, not clinical studies involving human subjects or AI algorithms. Therefore, many of your specific questions related to human reader studies, AI assistance, and large-scale clinical data provenance are not applicable to this 1998 510(k) document.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Reported Device Performance (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 immediately immersing the burn in ice water for 3 minutes
Porcine Partial Thickness Wound Healing	No Adverse Effects
Porcine Burn Wound Healing	No Adverse Effects
Kligman Chamber Scarification	Irritation Potential - Low

Study Details (Preclinical/Benchtop)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test (e.g., number of guinea pigs, mice, or porcine subjects). The studies are described in terms of the animal model used.
- Data Provenance: Preclinical animal studies and in-vitro lab tests. The country of origin for these specific tests is not mentioned in the provided text. These are retrospective in the sense that the data was collected and then submitted, but they are prospective in their study design (i.e., experiments were designed and then conducted).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. These are preclinical tests in animal models and in-vitro studies, not clinical studies requiring expert interpretation of medical images or human patient outcomes. The "ground truth" for these tests would be objective measurements or observations by the researchers conducting the animal and lab studies.
Adjudication method for the test set:
- Not applicable. This concept typically refers to expert consensus in clinical studies, which is not relevant here. The results of the biocompatibility and animal healing studies are likely based on direct observation, histological analysis, and standardized scoring methods within the preclinical research setting.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this device (a wound dressing from 1998) does not involve AI or human readers in the context of diagnostic interpretation. Therefore, an MRMC study with AI assistance is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this device is a physical wound dressing and does not involve any algorithm or software. Therefore, a standalone algorithm performance study is not applicable.
The type of ground truth used:
- Preclinical Endpoints:
  - Cytotoxicity: Measured in-vitro, likely by assessing cell viability or metabolic activity in culture after exposure to the device material.
  - Skin Irritation/Kligman Chamber Scarification: Assessed through visual scoring of skin reactions (e.g., erythema, edema) on animal subjects (or human volunteers for Kligman, though not specified here) according to standardized protocols.
  - Wound/Burn Healing (Guinea Pig, Mice, Porcine): Assessed through gross observation of wound closure, visual assessment of inflammation, histological analysis of tissue samples, and potentially planimetry (wound area measurement) to track healing progression. "No Adverse Effects" or "Reduced Inflammation" are the reported ground truths.
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set" in the context of data used to train an algorithm. The preclinical studies themselves could be considered "training" in a broad sense for product development, but not for an algorithm.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI algorithm. The ground truth for the preclinical studies was established through the scientific methods appropriate for each test (e.g., lab assays, animal observations, histology).

Summary

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

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: 817-262-4953 817-262-4992 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 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 *

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

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.

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 toimmediately immersing the burn in ice waterfor 3 minutes
Porcine Partial Thickness Wound Healing	No Adverse Effects
Porcine Burn Wound Healing	No Adverse Effects
Kligman Chamber Scarification	Irritation Potential - Low

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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.

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

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 (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 tollfree number (800) 638-2041 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

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

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..

(Please Do Not Write Below This Line-Continue on Another Page if Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
---------------------

Division of General Restorative Devices

510(k) Number	1983362
---------------	---------

Prescription Use(Per 21 CFR 801.109)	Or Over-The-Counter Use	X
------------------------------------------	-------------------------	---

Regulation Number and Section

N/A