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K Number
K992094
Device Name
GILTECH PLUS HYDROGEL SKIN DRESSING
Manufacturer
GILTECH PLUS, INC.
Date Cleared
1999-09-17

(88 days)

Product Code
NAE,MGQ
Regulation Number
878.4022
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Giltech Plus Hydrogel Wound Dressing is intended to be used in the management of.

  1. Minor burns
  2. Decubitus ulcers
  3. Superficial lacerations, cuts and abrasions
  4. Postoperative incisions
  5. Sunburn
Device Description

This hydrogel retains cold temperature. Its' high specific heat, due to high water content, allows it to have a cooling effect.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "Hydrogel Wound Dressing". This type of document does not contain the detailed study information requested in the prompt.

Here's why and what information can be extracted:

  • 510(k) Clearance: This is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It does not typically require extensive clinical trials with detailed acceptance criteria and performance data like a PMA (Premarket Approval) submission would.
  • "Substantially Equivalent": The core of a 510(k) is to show substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise different questions of safety and effectiveness. The studies conducted are often limited and comparative, not necessarily focused on meeting specific quantitative performance metrics against a hard acceptance criterion in the way an AI algorithm study would.

Therefore, most of the requested information cannot be found in this document:

  1. Table of acceptance criteria and reported device performance: Not present. This document only states that the device is "substantially equivalent" to predicate devices.
  2. Sample size, data provenance: Not mentioned.
  3. Number of experts and qualifications: Not mentioned.
  4. Adjudication method: Not mentioned.
  5. MRMC comparative effectiveness study: Not applicable or mentioned. This is a physical wound dressing, not an AI algorithm.
  6. Standalone performance: Not applicable or mentioned for an AI device. The document is about a hydrogel dressing.
  7. Type of ground truth: Not applicable or mentioned.
  8. Sample size for training set: Not applicable or mentioned.
  9. Ground truth for training set: Not applicable or mentioned.

Information that can be extracted:

  • Device Name: Hydrogel Wound Dressing (Trade Name: Giltech Plus Hydrogel Wound Dressing)
  • Indications for Use:
    1. Minor burns
    2. Decubitus ulcers
    3. Superficial lacerations, cuts and abrasions
    4. Postoperative incisions
    5. Sunburn
  • Regulatory Class: Unclassified
  • Product Code: MGQ
  • Applicant: Giltech Plus, Inc.

To get the type of detailed study information requested, you would typically need to consult a Premarket Approval (PMA) document, a clinical study report linked to an IDE (Investigational Device Exemption), or a scientific publication detailing the device's development and testing, rather than a 510(k) clearance letter.

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Image /page/0/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 a staff with two snakes entwined around it. The symbol is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. The text is written in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 1999

Mr. William J. Giliam President Giltech Plus, Inc. P.O. Box 728 Milford, Pennsylvania 18337

Re: K992094

Trade Name: Hydrogel Wound Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: June 17, 1999 Received: June 21, 1999

Dear Mr. Giliam:

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 (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.

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Page 2 - Mr. William J. Giliam

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,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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"INDICATIONS FOR USE"

Page 1 of 1

510(k) Number (if known): K992094

Device Name: Giltech Plus Hydrogel Wound Dressing

Indications For Use:

Giltech Plus Hydrogel Wound Dressing is intended to be used in the management of.

  1. Minor burns
  • Decubitus ulcers 2.
    1. Superficial lacerations, cuts and abrasions
    1. Postoperative incisions
  • પં Sunburn

This hydrogel retains cold temperature. Its' high specific heat, due to high water content, allows it to have a cooling effect.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dcollepe

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

§ 878.4022 Hydrogel wound dressing and burn dressing.

(a)
Identification. A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.