(23 days)
Tegagen HI & HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate, eg:
- Pressure ulcers Arterial Ulcers Venous ulcers Diabetic ulcers Superficial wounds; such as cuts and abrasions Donor wounds Post-operative wounds Trauma wounds Dermal lesions
Tegagen HI & HG alginate dressings are also intended to help control minor bleeding.
These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterile, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist healing environment. Use of any dressing, including Tegagen HG and HI alginate dressings, should be part of a well defined protocol for dermal wound management.
This document is a 510(k) summary for the 3M™ Tegagen™ HI Alginate Dressing and 3M™ Tegagen™ HG Alginate Dressing. It states that substantial equivalence was provided in previous 510(k) applications (K953781 and K980989) and that biocompatibility test results were also presented in those previous applications. Therefore, there is no new study or acceptance criteria information in the provided text to describe.
The letter explicitly states: "The 510(k) submission was not re-reviewed." (Page 0, K982638, Jun 11, 2023 letter) and "This letter corrects our substantially equivalent letter of August 21, 1998." (Page 1, K982638, Mar 1 9 2007 letter). This indicates that the current document is an administrative update and a correction to previous approvals, not a new submission with new performance studies.
Hence, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth details. This information would have been contained in the original 510(k) submissions (K953781 and K980989) which are not provided here.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 11, 2023
Innovative Technologies Plc c/o 3M (Minnesota Mining & Manufacturing) Anna E. McRight Regulatory Affairs Specialist 3M Center, Building 275-3E-08 St. Paul Minnesota 55144
Re: K982638
Trade/Device Name: 3M™ Tegagen™ HI Alginate Dressing & 3M™ Tegagen™ HG Alginate Dressings Regulatory Class: Unclassified Product Code: QSY
Dear Anna E. McRight:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 21, 1998 and correction letter dated March 19, 2007. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely, Julie A. Morabito -S Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/1 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 three human profiles facing right, arranged in a way that they appear to be connected or overlapping. The profiles are depicted with simple, curved lines. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2007
Innovative Technologies, Plc c/o 3M (Minnesota Mining & Manufacturing) Ms. Anna E. McRight Regulatory Affairs Specialist 3M Center, Building 275-3E-08 St. Paul, Minnesota 55144
- K982638 Re:
Trade Name: 3M Tegagen Hi Alginate Dressing & 3M Tegagen HG Alginate Regulatory Class: Unclassified Product Code: FRO Dated: July 21, 1998 Received: July 29, 1998
Dear Mr. Dagnon:
This letter corrects our substantially equivalent letter of August 21, 1998.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent to legally marketed predicate 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 (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act including requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration and the following limitations:
-
This device may not be labeled for use on third degree burns.
-
This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
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Page 2 - Ms. Anna E. McRight
- This device may not be labeled as a treatment or a cure for any type of wound.
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).
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 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.
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Page 3 - Ms. Anna E. McRight
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark N. McWeir
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1
510(k) Number (if known): K982638
Device name: 3M Tegagen HI & 3M Tegagen HG Alginate Dressings
Indications For Use:
Tegagen HI & HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate, eg:
- Pressure ulcers Arterial Ulcers Venous ulcers Diabetic ulcers Superficial wounds; such as cuts and abrasions Donor wounds Post-operative wounds Trauma wounds Dermal lesions
Tegagen HI & HG alginate dressings are also intended to help control minor bleeding.
Nussell Payne fuizl)
General Res Xk) Number
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over The Counter Use
(Optional Format 1-2-96)
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AUG 21 1998
Summary of Safety and Effectiveness for 3M™ Tegagen™ HI Alginate Dressing and 3M™ Tegagen™ HG Alginate Dressing
| Manufacturer: | Innovative Technologies, LimitedRoad Three, Winsford Industrial EstateCheshire CW7 3PD, United Kingdom |
|---|---|
| Regulatory Affairs Contact: | Christopher James Oakes, Manager |
| Telephone: | 44 1606 863 500 |
| Date Summary Prepared: | July 21, 1998 |
| Device Trade Name: | 3M™ Tegagen™ HI Alginate Dressing , ProductNumber 901XX Series and3M™ Tegagen™ HG Alginate Dressing, ProductNumber 902XX Series. |
| Common or Usual Name: | Alginate Wound Dressings |
| Classification: | Wound Dressings, currently unclassified byFDA. |
| Description: | These are nonwoven dressings made from100% pharmaceutical grade calcium alginateharvested from seaweed. The nonwovenalginate fiber dressings are highly conformable,soft, absorbent, sterile, primary wounddressings that become "gels" when they comeinto contact with wound exudate to form agelatinous mass which provides a moist healingenvironment. Use of any dressing, includingTegagen HG and HI alginate dressings, shouldbe part of a well defined protocol for dermalwound management. |
| Intended Use: | Tegagen HI and Tegagen HG alginatedressings are intended for use on partial andfull thickness wounds with moderate to heavyexudate. They may be used for pressureulcers, arterial ulcers, venous ulcers, diabeticulcers, donor sites, trauma wounds, and otherdermal lesions. They also are intended to helpcontrol minor bleeding. This product is notdesigned, sold, or intended for use except asindicated. |
| Substantial Equivalence: | Substantial equivalence was provided in 510(k)K953781 and K980989. |
| Testing Summary: | Biocompatibility test results are as those |
presented in both K953781 and K980989 and therefore are not re submitted.
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