(76 days)
No
The summary describes a hydrogel wound dressing and its sterilization process, with no mention of AI or ML technology.
Yes
The device is intended for the treatment of superficial wounds and minor burns, which constitutes a therapeutic use.
No
This device is a wound and burn dressing used for treatment, not for diagnosing conditions.
No
The device description clearly describes a physical wound dressing made of hydrogel, supplied in pouches, and sterilized by gamma irradiation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating superficial wounds and burns. This is a direct therapeutic application to the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a wound dressing, its materials, sterilization process, and biocompatibility testing. This aligns with a medical device intended for external application.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls under the category of a wound dressing, which is a therapeutic medical device.
N/A
Intended Use / Indications for Use
Advanced Medical Solutions Group plc Spyrogel Hydrogel Wound and Burn Dressing SA is intended for OTC use on: Superficial wounds such as, minor cuts, lacerations and minor burns and scalds
Product codes
MGP, MGQ
Device Description
Advanced Medical Sulutions Group plc Spyrogel® Hydrogel Wound and Rurn Dressing SA are supplied individually packaged in medical graum fuil pouches suitable for gamma irradiation. They are supplied to the market place as sterile dreasings.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
10-Jun-99 17:41;
Page 3/3
K991287
JUN 29 1999
Attachmont 2
Summary of Safety and Efficacy Summary of Advanced Medical Solutions Group plc Spyrogel® Hydrogel Wound and Burn Dressing SA
Manufacturer:
Telephone:
Classification:
Description:
Regulatory Affairs Contact:
Date Summary Presared:
Common or Usual Name:
Device Trade Name:
Advanced Medical Solutions ple Road Three, Winsford Industrial Estato Cheshire CW7 3PD, United Kingdom
Christopher Oakes, Mariayor
44 1606 863 500
April 13, 1999
Spyrogel® Hydrogel Wound and Burn Dressing SA.
Dressing, Wound and Burn, Hydrogel
Wound Dressings, currently unclassified by FDA.
Advanced Medical Sulutions Group plc Spyrogel® Hydrogel Wound and Rurn Dressing SA are supplied individually packaged in medical graum fuil pouches suitable for gamma irradiation. They are supplied to the market place as sterile dreasings.
The intelligent film is as comercially distrubuted in the USA under 510(k) (K981753) June 30, 1998.
The dressings are sterilized by gamma Irradiation. Isotron Laboratories provided Dose Mapping per ISO 11137, validation was undertaken in accordance with ISO 11137 Mothod 1. The verification dose required for a Sterllity Assurance Level (SAL) of 10-6 is 23.4 kGy. Starilization velidation data is on file at Isotron Laboratories.
Biooompatability tosting has boon performed in accordance with ISO10983-1 Biological Evaluation of Medical Devices -- Part 1 Guidance on Selection of Tests First Edition. Data and Safety evaluation is as that submitted with aiready sporoved 510(k)'s K881753 and K982804. No components or raw materials have changed therefore no resubmission of loxicily data its required.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 29 1999
Mr. Christopher Oakes Regulatory Affairs Manager Advanced Medical Solutions plc Road Three. Winsford Industrial Estate Cheshire CW7 3PD United Kingdom
K991287 Re:
Trade Name: Spyrogel Hydrogel Wound and Burn Dressing Regulatory Class: Unclassified Product Code: MGP and MGQ Dated: April 13, 1999 Received: April 14, 1999
Dear Mr. Oakes:
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 (QS) 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.
2
Page 2 - Mr. Christopher Oakes
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,
tocafo
-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
3
Page 1 of 1
K991287 510(k) Number (if known):
Device name: Advanced Medical Solutions Group plc, Spyrogel Hydrogel Wound and Burn Dressing SA
Indications For Use:
Advanced Medical Solutions Group plc Spyrogel Hydrogel Wound and Burn Dressing SA is intended for OTC use on:
Superficial wounds such as, minor cuts, lacerations and 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)
Prescription Use (Per 21 CFR 801.109)
OR Over The Counter Use
(Optional Format 1-2-96)
Põllufto
Division Siyn-O Division of General Restorative Devi 510(k) Number -