(293 days)
3M™ Tegaderm™ Matrix dressing is intended for use on chronic, partial thickness wounds and full thickness wounds including: pressure ulcers, venous stasis ulcers and diabetic ulcers. It can also be used on skin irritations, cuts and abrasions.
Description of Device. with a low pH ointment containing 1.93% w/w potassium citrate, 0.008% w/w rubidium with a low pri onlinent consuming 1727, and 0.0002% w/w zinc chloride to constitute a saline chional, 0.000970 m w v valendin omorison and moist environment is known to be conducive to wound healing. This dressing is permeable to both air and wound exudates. Dressings are gamma irradiated for sterility.
The provided text describes a 510(k) premarket notification for the 3M™ Tegaderm™ Matrix Dressing. This document does not contain information about acceptance criteria, device performance tables, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The submission is for a wound dressing, which is a medical device, not an AI/ML-driven diagnostic or image analysis tool. Consequently, standard acceptance criteria and study methodologies relevant to AI/ML or image processing devices (which often involve sensitivity, specificity, reader studies, etc.) are not applicable here.
The document states:
- Non-Clinical Performance Data: "Tegaderm™ Matrix dressing has been tested per ISO 10993-1 and determined to be safe for the intended use." ISO 10993-1 relates to biocompatibility testing, not performance metrics in the context of diagnostic accuracy.
- Clinical Performance Data: "N/A" (Not Applicable). This indicates no clinical performance data was presented in this 510(k) summary for measuring device effectiveness in a clinical setting against a specific ground truth, as would be expected for a diagnostic device.
- Conclusion: "Tegaderm™ Matrix dressing is safe for human use and acceptable for its intended use." This conclusion is based on the non-clinical (biocompatibility) data and similarity to the predicate device.
Therefore, none of the requested information regarding acceptance criteria and studies proving the device meets those criteria (in the context of AI/ML or diagnostic performance) can be extracted from this document. The device is a physical wound dressing and its equivalence was established based on its intended use, indications for use, composition, physical properties, and technological characteristics comparing it to a predicate device, along with non-clinical safety data.
{0}------------------------------------------------
DEC - 7 2011
510(K) SUMMARY
Sponsor Information:
| Applicant Name: | 3M Health Care3M Center, Bldg 275-5W-0St. Paul, MN 55144-1000 |
|---|---|
| Contact Person: | Maria Ruiz |
| Regulatory Affairs | |
| Phone Number: | 651-736-2733 |
| Fax Number: | 651-737-5320 |
| Date Prepared: | February 16, 2011 |
Device Name and Classification:
| Common or Usual Name: | Impregnated Wound Dressing |
|---|---|
| Trade Name: | Tegaderm™ Matrix Dressing |
| Classification Name: | Unclassified |
| Product Code: | FRO |
| Performance Standards: | Not applicable. |
| Predicate Device: | Epi-Max® Wound Dressing, K041059 |
Description of Device:
Description of Device. with a low pH ointment containing 1.93% w/w potassium citrate, 0.008% w/w rubidium with a low pri onlinent consuming 1727, and 0.0002% w/w zinc chloride to constitute a saline chional, 0.000970 m w v valendin omorison and moist environment is known to be conducive to wound healing. This dressing is permeable to both air and wound exudates.
Dressings are gamma irradiated for sterility.
Indications for Use:
Tegaderm™ Matrix dressing is intended for use on chronic, partial thickness wounds including: I egademi - Manix drossing is intensed diabetic ulcers. It can also be used on skin irritations, cuts and abrasions.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image contains a handwritten text string. The string appears to be "RI10457". The characters are written in a cursive style with varying stroke thicknesses. The text is oriented horizontally and is the primary focus of the image.
page 2/2
Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:
Tegaderm™ Matrix dressing is substantially equivalent to the predicate device, Epi-Max® Wound Dressing, cleared under K041059, May 17, 2005.
Tegaderm™ Matrix dressing is similar in intended use, indications for use, composition, physical properties and technological characteristics as the predicate device, Epi-Max® Wound Dressing.
Non-Clinical Performance Data
Tegaderm™ Matrix dressing has been tested per ISO 10993-1 and determined to be safe for the intended use.
Clinical Performance Data N/A
Non-Clinical and Clinical Conclusion Tegaderm™ Matrix dressing is safe for human use and acceptable for its intended use.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, oriented diagonally from the upper right to the lower left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MI) 20993-0002
3M Company % Ms. Maria Ruiz Regulatory Affairs Specialist 3M Center, Building 275-5W-06 Saint Paul, Minnesota 54144-1000
JAN - 4 2012
Re: K110457
Trade/Device Name: 3MTM Tegaderm™ Matrix Dressing Regulation Name: Unclassified Product Code: FRO Dated: December 7, 2011 Received: December 7, 2011
Dear Ms. Ruiz:
This letter corrects our substantially equivalent letter of December 7, 2011.
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 (for the indications for use stated in the enclosure) 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 include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
{3}------------------------------------------------
Page 2 - Ms. Maria Ruiz
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2111'J Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Fn Nth Vm Dsn Ccin
Mark N. Melkerson
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Attachment 3.
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K110457
3M TM Tegaderm™ Matrix Dressing Device Name:
Indications for Use:
3M™ Tegaderm™ Matrix dressing is intended for use on chronic, partial thickness wounds and full thickness wounds including: pressure ulcers, venous stasis ulcers and diabetic ulcers. It can also be used on skin irritations, cuts and abrasions.
Prescription Use X Use
AND/OR Over-The-Counter
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Knaepen Mxim
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110457
N/A