(70 days)
No
The device description and intended use are for a hydrocolloid wound dressing, and there is no mention of AI or ML in the provided text.
Yes
The device is described as interacting with wound fluid to create an absorbent mass and maintaining a moist wound environment, which "has been shown to enhance wound healing." This demonstrates a functional role in promoting healing, making it a therapeutic device.
No.
The device is a wound dressing designed to cover and protect wounds, absorb fluid, and maintain a moist wound environment to enhance healing. It does not perform any diagnostic function.
No
The device description clearly states it is a sterile wound dressing consisting of physical components (hydrocolloid adhesive, outer clear adhesive cover film). It is a physical medical 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 dressing and protecting wounds on the skin. This is a topical application for wound management.
- Device Description: The device is a sterile wound dressing that interacts with wound fluid to create a moist environment for healing. It does not perform any diagnostic testing on biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health by examining specimens from the human body.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens like blood, urine, or tissue to provide information for diagnosis, monitoring, or screening. This device is applied in vivo (on the body) for wound care.
N/A
Intended Use / Indications for Use
3M Tegasorb™ THIN Hydrocolloid Dressing is intended for use as a dressing for partial thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first- and second-degree burns, and donor sites. It may also be used as a protective dressing on at-risk, undamaged skin or on skin beginning to show signs of damage from friction or shear.
The following conditions are considered appropriate for OTC use by the lay person:
- Superficial wounds such as cuts, lacerations, or abrasions
- First-degree burns
- Skin needing protection from friction or sheer
The following conditions are considered appropriate for OTC use under the supervision of a health care professional:
- Partial thickness dermal ulcers
- Leg ulcers
- Second-degree burns
- Donor sites
Product codes
KMF
Device Description
[3M Tegasorb™ and] 3M Tegasorb™ Thin Hydrocolloid Dressings are sterile wound dressings which consist of a hypoallergenic hydrocolloid adhesive with an outer clear adhesive cover film. The film is moisture vapor permeable and water and bacteria impermeable. The products are not designed, sold or intended for use except as indicated. Over the wound site, [3M Tegasorb and] 3M Tegasorb THIN Hydrocolloid dressings interact with wound fluid to create a soft, semi-transparent absorbent mass. The dressings maintain a moist wound environment, which has been shown to enhance wound healing.
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
See K924280 which provided Summary of Testing: biocompatibility test results to support 3M Tegasorb™ THIN Hydrocolloid Dressing as acceptable for its intended use.
Key Metrics
Not Found
Predicate Device(s)
3M Tegasorb™ Ulcer Dressing (see also, K924280, May 12, 1993, for competitive comparable products).
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
| OCT 26 | 510(k) Summary of Safety and Effectiveness |
|---|---|
| -------- | -------------------------------------------- |
- 3M Medical Products Manufacturer: 3M Center St. Paul, Minnesota 55144-1000
- Requlatory Affairs Anna E. McRight Contact: Requlatory Affairs Specialist 3M Medical Products Resource Division 3M Center, Building 275-3E-08 St. Paul, Minnesota 55144-1000
- Telephone: (651) 733-7948
Date Summary Prepared:
- 3M Tegasorb™ THIN Hydrocolloid Product Trade Name: Dressing
- Wound Dressing Common Name:
- Classification: Wound Dressing
- Predicate Devices: 3M Tegasorb™ Ulcer Dressing (see also, K924280, May 12, 1993, for competitive comparable products).
August 13, 1998
- [3M Tegasorb™ and] 3M Tegasorb™ Thin Description: Hydrocolloid Dressings are sterile wound dressings which consist of a hypoallergenic hydrocolloid adhesive with an outer clear adhesive cover film. The film is moisture vapor permeable and water and bacteria impermeable. The products are not designed, sold or intended for use except as indicated. Over the wound site, [3M Tegasorb and] 3M Tegasorb THIN Hydrocolloid dressings interact with wound fluid to create a soft, semi-transparent absorbent mass. The dressings maintain a moist wound environment, which has been shown to enhance wound healing. (continued)
1
| Intended Use: | 3M Tegasorb™ THIN Hydrocolloid Dressing is intended for use as a dressing for partial thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first- and second-degree burns, and donor sites. It may also be used as a protective dressing on at-risk, undamaged skin or on skin beginning to show signs of damage from friction or shear. |
|---|---|
| Substantial Equivalence: | This premarket notification was submitted for package insert changes only. The comparative products remain identical to those submitted in the premarket notification, K924280, cleared for marketing by FDA on May 12, 1993. |
See K924280 which provided Summary of Testing: biocompatibility test results to support 3M Tegasorb™ THIN Hydrocolloid Dressing as acceptable for its intended use.
2
Image /page/2/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features an abstract image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle.
OCT 26 1998
Anna E. McRight. 3M Medical Products Division Building 275 - 3E- 08 St. Paul, Minnesota 55144
Re: K982892 Trade Name: 3M Tegasorb™ Thin Hydrocolloid Dressing K982893 Trade Name: 3M Tegasorb™ Hydrocolloid Dressing Regulatory Class: Unclassifed Product Code: KMF Dated: August 13 and 14. 1998 Received: August 17, 1998
Dear Ms. McRight:
We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined the devices are 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 devices subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
- These devices may not be labeled for use on third degree burns. 1 .
-
- These devices may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
- These devices may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- These devices 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 devices 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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3
Page 2 - Ms. Anna McRight
If vour devices are 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 devices 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 devices 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 devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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
4
22892
3M Tegasorb™ THIN Hydrocolloid Dressin 510(k) for Labeling Changes
982892
510(k) Number (if known): K924280; May 12, 1993
Device name: 3M Tegasorb™ THIN Hydrocolloid Dressing, Product Number series 90021-90025.
Indications for Use:
The following conditions are considered appropriate for OTC use by the lay person:
Superficial wounds such as cuts, lacerations, or abrasions
- First-degree burns
- Skin needing protection from friction or sheer
The following conditions are considered appropriate for OTC use under the supervision of a health care professional:
- Partial thickness dermal ulcers
- Leg ulcers
・・
Second-degree burns
- Donor sites
[PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED]
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| OR Over the Counter Use |
(Optional Format 1-2-96)
(Division Sign-Off)
of General Restorative Devices
| 510(k) Number |