(70 days)
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
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.
The provided text is related to the 510(k) premarket notification for the 3M Tegasorb™ Hydrocolloid Dressing (K982893). This submission is for package insert changes only, and explicitly states that the comparative products remain identical to those submitted in the premarket notification K940624. Therefore, the acceptance criteria and the study proving the device meets those criteria are not detailed in this document. Instead, it refers back to K940624 and highlights biocompatibility test results from that earlier submission.
Based on the provided text, I can infer the following:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the given document for K982893 as this submission is for labeling changes only and refers to K940624 for performance data. The document for K982893 primarily focuses on the device's intended use and substantial equivalence to previously cleared devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the given document. The document refers to K940624 for "biocompatibility test results."
3. 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 information is not provided in the given document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the given document.
5. 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 is not applicable. The device is a wound dressing, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not explicitly stated for K982893, as it defers to K940624 for testing. However, given that it's a hydrocolloid dressing, the relevant "ground truth" for biocompatibility would typically be established through standardized in vitro and in vivo toxicology and irritation tests, often comparing results against established safety benchmarks and historical controls rather than expert consensus on diagnostic images or pathology.
8. The sample size for the training set:
This is not applicable as the device is a medical product (wound dressing), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable as the device is a medical product (wound dressing), not an AI algorithm that requires a training set.
In summary:
The provided document for K982893 is a 510(k) summary for labeling changes only. It explicitly states that the premarket notification for performance and substantial equivalence refers to K940624, which "provided biocompatibility test results to support 3M Tegasorb™ Hydrocolloid Dressing as acceptable for its intended use." Therefore, the detailed information regarding acceptance criteria and the study that proves the device meets them would be found in the K940624 submission, not in the provided K982893 document.
{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 Dressingsare intended for use as a dressing forpartial and full thickness dermal ulcers,leg ulcers, superficial wounds, abrasions,first- and second-degree burns, anddonor sites. |
|---|---|
| SubstantialEquivalence: | This premarket notification wassubmitted for package insert changesonly. The comparative products remainidentical to those submitted in thepremarket notification, K940624, clearedfor marketing by FDA on May 4, 1994. |
| Summary of Testing: | See K940624 which providedbiocompatibility test results to support3M Tegasorb™ Hydrocolloid Dressing asacceptable 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)
§ 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.