(70 days)
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
[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.
This document, K982892, is a 510(k) summary for labeling changes to the 3M Tegasorb™ THIN Hydrocolloid Dressing. It states that the premarket notification refers to package insert changes only and that the comparative products remain identical to those submitted in the previous premarket notification, K924280, which was cleared on May 12, 1993.
Therefore, this specific submission (K982892) does not contain new acceptance criteria or new study data proving the device meets acceptance criteria. Instead, it references the original submission, K924280, for such information.
The relevant section states:
"See K924280 which provided Summary of Testing: biocompatibility test results to support 3M Tegasorb™ THIN Hydrocolloid Dressing as acceptable for its intended use."
To answer your request comprehensively, one would need to review the K924280 submission. However, based solely on the provided K982892 document, I can only provide information about the lack of new studies and the reference to a previous submission.
Based on the provided document (K982892):
-
Table of acceptance criteria and the reported device performance:
- This document does not contain a table of acceptance criteria or new reported device performance. It refers to the previous submission, K924280, for "biocompatibility test results to support 3M Tegasorb™ THIN Hydrocolloid Dressing as acceptable for its intended use."
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document does not provide this information. It refers to the previous submission, K924280.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This document does not provide this information. It refers to the previous submission, K924280.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This document does not provide this information. It refers to the previous submission, K924280.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This device is a wound dressing, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be applicable. This document does not mention any such study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is a wound dressing, not an algorithm. Therefore, a standalone algorithm performance study would not be applicable. This document does not mention any such study.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- This document does not provide this information. It refers to the previous submission, K924280, which mentions "biocompatibility test results." For a wound dressing, ground truth would typically relate to clinical outcomes (healing rates, infection rates, adverse reactions) or established biocompatibility standards.
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The sample size for the training set:
- This document refers to biocompatibility testing, not an AI algorithm requiring a training set. No such information is provided.
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How the ground truth for the training set was established:
- This document refers to biocompatibility testing, not an AI algorithm requiring a training set. No such information is provided.
In summary: K982892 is a 510(k) for labeling changes only and explicitly states that the substantial equivalence relies on the previous K924280 submission for all testing and performance data.
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| 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)
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| 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.
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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.
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- 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
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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
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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 | <982892 |
|---|---|
| --------------- | --------- |
§ 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.