(70 days)
No
The device description and intended use are for a hydrocolloid wound dressing, which is a passive material and does not involve any computational or analytical processes. There is no mention of AI, ML, or any related technologies.
Yes
The device is intended to treat and enhance the healing of various wounds, including ulcers and burns, which aligns with the definition of a therapeutic device.
No
The device is a wound dressing designed to maintain a moist wound environment for healing, not to diagnose medical conditions.
No
The device description clearly indicates it is a physical wound dressing made of hydrocolloid adhesive and an outer film, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a wound dressing for various types of wounds. It is applied externally to the body to manage wound healing.
- Device Description: The description details the physical composition and function of the dressing in interacting with wound fluid to create a moist environment for healing.
- Lack of IVD Characteristics: An IVD is a medical device that is used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests on bodily samples.
The device is a wound care product, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
3M Tegasorb™ Hydrocolloid Dressings are intended for use as a dressing for partial and full thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first- and second-degree burns, and donor sites.
The following conditions are considered appropriate for OTC use by the lay person: Superficial wounds such as cuts, lacerations, or abrasions First-degree burns
The following conditions are considered appropriate for OTC use under the supervision of a health care professional: Partial or full 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
See K940624 which provided biocompatibility test results to support 3M Tegasorb™ Hydrocolloid Dressing as acceptable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image contains a sequence of handwritten characters and numbers. The sequence appears to be 'K982893'. The characters are written in a dark ink, and the image has a slightly grainy texture.
OCT 2 6 1998
510(k) Summary of Safety and Effectiveness
- Manufacturer: 3M Medical Products 3M Center St. Paul, Minnesota 55144-1000 Anna E. McRight Regulatory Affairs Contact: Regulatory Affairs Specialist 3M Medical Products Resource Division 3M Center, Building 275-3E-08 St. Paul, Minnesota 55144-1000 Telephone: (651) 733-7948 Date Summarv Prepared: August 13, 1998 3M Tegasorb™ Hydrocolloid Dressing Product Trade Name: Wound Dressing Common Name: Wound Dressing Classification: Predicate Devices: 3M Tegasorb™ Ulcer Dressing (see also, K940624, May 4, 1994, for competitive comparable products). 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. (continued)
1
K982893
| Intended Use: | 3M Tegasorb™ Hydrocolloid Dressings
are intended for use as a dressing for
partial and full thickness dermal ulcers,
leg ulcers, superficial wounds, abrasions,
first- and second-degree burns, and
donor sites. |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence: | This premarket notification was
submitted for package insert changes
only. The comparative products remain
identical to those submitted in the
premarket notification, K940624, cleared
for marketing by FDA on May 4, 1994. |
| Summary of Testing: | See K940624 which provided
biocompatibility test results to support
3M Tegasorb™ Hydrocolloid Dressing as
acceptable for its intended use. |
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.
OCT 2 6 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 2. wound healing or epithelization.
- These devices may not be labeled as a long-term, permanent, or no-change dressing, 3. 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 your 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,
Salie McWitter, 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
Enclosure
4
NO. 1883 P. 3
K9182893
3M Tegasorb™ Hydrocolloid Dressing 510(k) for Labeling Changes
. ***
.
,
・
ﺮ ﺳ ﯿ
K9P2873
510(k) Number (if known): K940624, May 4, 1994
Device name: 3M Tegasorb™ Hydrocolloid Dressing, Product Number series 90001-90005.
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
The following conditions are considered appropriate for OTC use under the supervision of a health care professional:
Partial or full 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 ✓ |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K982893 |
(Optional Format 1-2-96)