K Number
K110457
Device Name
3M TEGADERM MATRIX DRESSING
Manufacturer
Date Cleared
2011-12-07

(293 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
Device Description
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.
More Information

No
The document describes a wound dressing with a specific chemical composition and physical properties, with no mention of AI or ML technology.

Yes
The "Intended Use / Indications for Use" section states that the device 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," which describes a therapeutic purpose.

No
The document describes a wound dressing intended for healing wounds. There is no mention of it being used to diagnose conditions or diseases.

No

The device description clearly describes a physical wound dressing with a specific chemical composition and manufacturing process (gamma irradiation), indicating it is a hardware medical device, not software.

Based on the provided information, the 3M™ Tegaderm™ Matrix dressing is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states it's for use on wounds (pressure ulcers, venous stasis ulcers, diabetic ulcers, skin irritations, cuts, and abrasions). This is a topical application for wound care, not a test performed on samples taken from the body to diagnose a condition.
  • Device Description: The description details a dressing with an ointment and its properties related to wound healing (moist environment, permeability). It doesn't describe a device that analyzes biological samples.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Providing diagnostic information
    • Using reagents or assays

The device is a wound dressing, which falls under a different regulatory category than IVDs.

N/A

Intended Use / 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.

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.

Product codes

FRO

Device Description

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.

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)

Non-Clinical Performance Data

Tegaderm™ Matrix dressing has been tested per ISO 10993-1 and determined to be safe for the intended use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K041059

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

N/A

0

K110457

DEC - 7 2011

510(K) SUMMARY

Sponsor Information:

| Applicant Name: | 3M Health Care
3M Center, Bldg 275-5W-0
St. 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.

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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