(295 days)
Not Found
K/DEN:
No
The summary describes a standard wound dressing and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is intended for the management of wounds by absorbing exudate and maintaining a moist wound environment to support autolytic debridement, and is indicated for various types of wounds such as ulcers, surgical incision sites, and minor burns, which are therapeutic functions.
No
The device is a Hydrocolloid Dressing intended for wound management, not for diagnosing conditions. Its function is to absorb exudate, maintain a moist wound environment, and support healing, rather than to identify or classify diseases or conditions.
No
The device description clearly identifies the device as a "Hydrocolloid Wound Dressing," which is a physical, material-based product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a wound dressing applied externally to the skin for managing wounds. This is a topical application, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description confirms it's a "Wound Dressing."
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing information about a patient's health status, disease, or condition based on the analysis of samples.
- Using reagents or instruments to perform diagnostic tests.
Therefore, the Hydrocolloid Dressing described is a medical device for wound care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hydrocolloid Dressing is intended for applications where gentle adhesion to the skin is desirable. Also, the dressing is intended for the management of lightly to heavily exudating wounds by absorbing exudate and by maintaining a moist wound environment. The moist wound environment supports autolytic debridement. The dressing backing allows for gas exchange. The dressing is indicated for use in the following types of wounds: Venous stasis ulcers, pressure ulcers, surgical incision sites, and minor burns.
Product codes
MGP
Device Description
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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 depiction of an eagle or bird with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1 1998
Mr. Greg Holland Director of Regulatory Affairs Acutek Adhesive Specialties, Inc. 540 North Oak St. Inglewood, California 90302
Re: K974891
Trade Name: Acutek Hydrocolloid Wound Dressing, TIB 197013 Regulatory Class: Unclassifed Product Code: MGP Dated: July 30, 1998 Received: July 31, 1998
Dear Mr. Holland:
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, or 3. 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
1
Page 2 - Mr. Greg Holland
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,
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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Page 1
510(k) Number (if known):_K 974891
Device Name: Acutek Hydrocolloid Wound Dressing, TIB 197013
Indications For Use:
The Hydrocolloid Dressing is intended for applications where gentle adhesion to the skin is desirable. Also, the dressing is intended for the management of lightly to heavily exudating wounds by absorbing exudate and by maintaining a moist wound environment. The moist wound environment supports autolytic debridement. The dressing backing allows for gas exchange. The dressing is indicated for use in the following types of wounds: Venous stasis ulcers, pressure ulcers, surgical incision sites, and minor burns.
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AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General Restorative Devices 510(k) Number _ OR Prescription Use_ Over-The-Counter Use (Optional Format 1-2-96) (Per 21 CFR 801.109)