(128 days)
The following indications for use are for Over The Counter Use: Superficial Abrasions, Scrapes, Cuts, and Lacerations Minor Burns and scalds
Spyrogel Hydrogel Wound and Burn Dressings are sterile individually packaged hydrogel dressings.
The provided 510(k) summary for the Spyrogel® Hydrogel Wound and Burn Dressing does not contain information on acceptance criteria or a study proving that the device meets such criteria. This document is a premarket notification for a Class I device seeking substantial equivalence to existing products, rather than demonstrating performance against specific metrics through clinical trials.
The summary primarily focuses on:
- Description of the Device: Spyrogel® Hydrogel Wound and Burn Dressings are sterile, individually packaged hydrogel dressings.
- Intended Use: Over-the-counter use for superficial abrasions, scrapes, cuts, lacerations, minor burns, and scalds.
- Substantial Equivalence Claim: The device is claimed to be substantially equivalent to Spenco's 2nd Skin Moist Burn Pads and Johnson and Johnson's Nu-Gel, which are self-adhesive wound dressings for a wide variety of wounds.
- Safety Tests: Laboratory tests showed the device to be nontoxic, nonirritating, and nonsensitizing.
- FDA Response: The FDA letter confirms the substantial equivalence and outlines labeling limitations (e.g., not for third-degree burns, not to claim accelerated healing, not as a long-term dressing or artificial skin, not a treatment/cure).
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment as these details are not present in the provided text. The document indicates a regulatory pathway based on substantial equivalence, which often relies on demonstrating similarity to a predicate device rather than presenting detailed performance metrics from new clinical studies against predefined acceptance criteria.
{0}------------------------------------------------
UEC 16
510(k) Spyrogel® Hydrogel Wound and Burn Dressing Innovative Technologies (US) Inc.
510(k) Summary
| Proprietary Name: | Spyrogel® Hydrogel Wound and Burn Dressing |
|---|---|
| Common Name: | Dressing, Wound and Burn Hydrogel |
| Classification: | 79 MGQ, Class I |
| Submitter's Details: | Innovative Technologies (US), Inc.581 Conference PlaceGolden, CO 80401Tel: (303)271-0340FAX: (303)271-0397Contact: Julie Chaffee |
Description:
Spyrogel Hydrogel Wound and Burn Dressings are sterile individually packaged hydrogel dressings.
Over the Counter usages include superficial abrasions, scrapes, cuts, and lacerations, as well as minor burns and scalds.
Spyrogel Hydrogel Wound and Burn Dressings are substantially equivalent to Spenco's 2nd Skin Moist Burn Pads and Johnson and Johnson's Nu-Gel. These devices are self-adhesive wound dressings which provide a degree of absorption. They are all intended for use in the management of a wide variety of wounds.
Spyrogel Hydrogel Wound and Burn Dressings have been shown in laboratory tests to be nontoxic, nonirritating, and nonsensitizing.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's role in promoting health and well-being in the United States.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 1998
Ms. Julie Chaffee Manager, Quality Control and Regulatory Affairs Innovative Technologies, Incorporated 581 Conference Place Golden, Colorado 80401
Re: K982804
Trade Name:Spyrogel® Hydrogel Wound and Burn Dressing Regulatory Class: Unclassifed Product Code: MGQ Dated: November 12, 1998 Received: November 12, 1998
Dear Ms. Chaffee:
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.
- 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, or as an artificial (synthetic) skin.
-
- 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).
{2}------------------------------------------------
Page 2 - Ms. Julie Chaffee
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.
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 toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
Colin M. Witt, Ph.D., M.D.
~ Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
{3}------------------------------------------------
510(k) Spyrogel® Hydrogel Wound and Burn Dressing Innovative Technologies (US) Inc.
Page 1 of 1
PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
510(k) Number:
982804
Innovative Technologies (US), Inc.
Device Name:
Spyrogel® Hydrogel Wound and Burn Dressing
Indications for Use:
The following indications for use are for Over The Counter Use: Superficial Abrasions, Scrapes, Cuts, and Lacerations Minor Burns and scalds
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Pioleda
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K982804
Prescription Use_ (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Fornat 1-2-
N/A