(83 days)
Not Found
No
The device description and intended use clearly define a hydrogel wound dressing with no mention of software, algorithms, or data processing capabilities that would indicate AI/ML.
Yes
The device is a wound dressing that aids in the healing process of various wounds by maintaining a moist environment, encouraging debridement, and protecting against contamination, which are therapeutic functions.
No
The device, NU-GEL Wound Dressing, is described as a sterile hydrogel formulation used for wound care, maintaining a moist wound environment, and protecting against dehydration and bacterial contamination. Its intended use and indications are for treating various types of wounds, not for diagnosis.
No
The device is a physical wound dressing made of hydrogel, fabric, and film, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a wound dressing applied externally to wounds to maintain a moist environment, encourage healing, and protect against contamination. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details the physical composition and function of the wound dressing, which is consistent with a topical medical device.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the body (like blood, urine, or tissue) to provide diagnostic information.
- Performance Studies: The performance studies focus on the biocompatibility and wound healing properties of the dressing, not on diagnostic accuracy or performance metrics typically associated with IVDs (like sensitivity, specificity, etc.).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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
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.
Product codes (comma separated list FDA assigned to the subject device)
MGQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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 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 *
1
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 |
| 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 |
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 |
|---|---|---|
| ------------------------------------------ | ------------------------- | --- |