(23 days)
No
The device description and intended use clearly describe a passive wound dressing made from alginate, with no mention of any computational or analytical capabilities that would involve AI/ML.
Yes
The device is intended for use on various types of wounds to promote healing, control bleeding, and provide a moist healing environment, which are all therapeutic functions.
No
Explanation: The document describes wound dressings intended for use on various types of wounds to absorb exudate, provide a moist healing environment, and help control minor bleeding. It does not mention any function for diagnosing conditions or diseases.
No
The device description clearly states it is a nonwoven dressing made from calcium alginate, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a wound dressing for various types of wounds. This is a topical application for wound management, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details the physical properties and composition of the dressing, which is applied directly to the wound. This aligns with a medical device for wound care, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, the Tegagen HI & HG alginate dressings are classified as a medical device for wound care, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
QSY, FRO
Device Description
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.
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)
Biocompatibility test results are as those presented in both K953781 and K980989 and therefore are not re submitted.
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
N/A
0
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
1
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.
2
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.
3
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)
5
AUG 21 1998
Summary of Safety and Effectiveness for 3M™ Tegagen™ HI Alginate Dressing and 3M™ Tegagen™ HG Alginate Dressing
| Manufacturer: | Innovative Technologies, Limited
Road Three, Winsford Industrial Estate
Cheshire 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 , Product
Number 901XX Series and
3M™ Tegagen™ HG Alginate Dressing, Product
Number 902XX Series. |
| Common or Usual Name: | Alginate Wound Dressings |
| Classification: | Wound Dressings, currently unclassified by
FDA. |
| Description: | 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. |
| Intended Use: | Tegagen HI and Tegagen HG alginate
dressings are intended for use on partial and
full thickness wounds with moderate to heavy
exudate. They may be used for pressure
ulcers, arterial ulcers, venous ulcers, diabetic
ulcers, donor sites, trauma wounds, and other
dermal lesions. They also are intended to help
control minor bleeding. This product is not
designed, sold, or intended for use except as
indicated. |
| 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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