3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing are intended to be used to cover and protect catheter sites and to secure devices to the skin. Common applications include covering and securing IV catheters, other intravascular catheters and percutaneous devices.

Device Description

3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3MTM Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing are similar dressings with one provided as a film dressing and the latter provided as a film dressing with a soft cloth border. Performance data supports both product configurations.

3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3MTM Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing consists of a polyurethane film coated with a transparent chlorhexidine gluconate (CHG) acrylic adhesive. CHG, a broad spectrum antimicrobial/antifungal agent known to inhibit microbial growth has been formulated into the acrylic adhesive.

The transparent film is breathable, allowing oxygen and moisture vapor exchange, yet is impermeable to external contaminants. including fluids (waterproof), bacteria, viruses* and yeast. The dressing must remain intact to protect the IV site from external contaminants.

3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing is bordered, notched and reinforced with soft cloth tape and is designed to provide securement around catheters and other devices.

In vitro testing (time kill) demonstrates that the 3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing has an antimicrobial effect against a variety of gram-positive bacteria, gramnegative bacteria, yeast and mold in the dressing.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device, specifically the 3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing. The purpose of this document is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to set and meet new performance criteria. Therefore, the "acceptance criteria" discussed here are implicitly related to the concept of substantial equivalence, meaning the new device performs similarly and is as safe and effective as the predicate device.

It's important to note that this is a medical dressing, not an AI or imaging device. The questions provided in the prompt (e.g., "Number of experts used to establish the ground truth," "MRMC comparative effectiveness study," "standalone algorithm performance") are highly relevant to AI/ML medical devices, but not applicable to this type of traditional medical device submission.

However, I can extract the relevant "performance data" that serves as the "proof" the device meets the criteria for substantial equivalence, as requested.

Here's an analysis based on the provided document, adapting the prompt's framework where possible:

Device: 3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing

Study Proving Substantial Equivalence (Implicit Acceptance Criteria)

The proof focuses on demonstrating that the new devices are substantially equivalent to a legally marketed predicate device (BD ChloraShield™ I.V. Dressing with CHG Antimicrobial). This means they perform similarly, and do not raise new questions of safety or effectiveness. The "acceptance criteria" are therefore aligned with demonstrating this equivalence in terms of biocompatibility, physical properties, antimicrobial activity, and wear performance.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

Implied Acceptance Criterion (from predicate comparison & testing)	Reported Device Performance (vs. Predicate)
Biocompatibility: Safe for skin contact (prolonged duration, <30 days, breached/compromised skin).	Met: Evaluated in accordance with ISO 10993 and FDA guidance. Battery of tests included: Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Acute System Toxicity and Subacute/Subchronic Toxicity, Implantation. (Specific results are not detailed in this summary, but the completion of these tests meeting established safety profiles is the criterion.)
Physical Properties:	Met: Bench testing showed comparable performance to the predicate device in:
- Tensile and Elongation	- Performed. (Specific values not provided in summary, but implied to be within acceptable range or comparable to predicate.)
- Moisture Vapor Transmission Rate (MVTR)	- Performed. (Specific values not provided in summary, but implied to be within acceptable range or comparable to predicate.)
- Waterproof	- Performed. (Confirmed as waterproof with film being impermeable to fluids.)
Antimicrobial Activity: Effective against target microbes (due to CHG in adhesive).	Met: In vitro (time kill) testing demonstrated an antimicrobial effect against a variety of gram-positive bacteria, gram-negative bacteria, yeast, and mold in the dressing for both configurations. (Specific log reduction or kill rates not provided in summary, but implied to be effective and comparable to predicate.)
Virus Barrier: Provides a barrier to viruses.	Met: In vitro testing shows the film provides a barrier to viruses ≥27 nm in diameter (while intact). Note: No clinical study on prevention of viral infection was conducted.
Wear Performance/Securement: Ability to remain on skin and secure devices for specified duration (e.g., up to 7 days).	Met: Clinical Study Results: A randomized, controlled, open-label study assessed wear performance at 3 and 7 days. At 72 hours (3 days), all dressings (subject and predicate) remained on the arms. At 168 hours (7 days), the subject device remained on the arms. Three of the predicate devices had been removed due to excess lift before 168 hours. The lift of the subject device was substantially equivalent to the predicate device at both 72 and 168 hours. The study demonstrated the subject device secured catheters for seven days.
Adhesive CHG Release: Maintains CHG release throughout use life.	Met: Amount of CHG within the device through release kinetics was studied and implied to be sufficient over the use life. (Specific release profile not provided in summary, but implied to meet requirements.)

2. Sample Size Used for the Test Set and Data Provenance

Clinical Study (Wear Performance):
- Sample Size: 24 healthy subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be a prospective clinical study given the description of a "randomized, controlled, open-label study."
Bench Testing & In vitro Testing:
- Sample Size: Not specified for individual bench tests or in vitro antimicrobial tests. These typically involve a defined number of samples according to standards (e.g., for tensile strength, MVTR, etc.) or bacterial cultures for time-kill assays.
- Data Provenance: These are laboratory tests, provenance is the testing facility/lab.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This is a physical medical device (dressing) and not an AI/imaging device requiring expert interpretation for ground truth.
For the clinical study, "ground truth" would be the observed wear performance and device integrity on subjects.

4. Adjudication Method for the Test Set

Not Applicable. As above, not an AI/imaging study requiring expert adjudication.
For the clinical study, the "adjudication" was the quantitative measurement of dressing lift/removal.

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

Not Applicable. This is not an AI-assisted device or an imaging study.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is not an algorithm-based device. "Standalone performance" would refer to the dressing's intrinsic properties and direct interaction with the body/catheter, which are assessed through the biocompatibility, bench, and clinical wear studies.

7. The Type of Ground Truth Used

Biocompatibility: Established toxicological and biological response standards (e.g., ISO 10993).
Bench Testing: Engineering and material science standards (e.g., for tensile properties, moisture vapor transmission, waterproofing, CHG release).
Antimicrobial Activity: Microbiological time-kill assays (comparing to established efficacy standards, or benchmarked against predicate).
Clinical Study (Wear Performance): Direct clinical observation and quantitative measurement of dressing adhesion and removal on human subjects. The "ground truth" here is the objective adhesion/lift measurement, comparing the subject device directly to the predicate.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not Applicable. (As above)

In summary, the "acceptance criteria" for this device are implicitly tied to demonstrating its substantial equivalence to a predicate device across various safety and performance attributes (biocompatibility, physical integrity, antimicrobial function, and wear performance), as evidenced by standard laboratory and a small clinical study. The framework of AI/ML device evaluation does not directly apply here.

Summary

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November 20, 2017

3M Company, 3M Health Care Maria Ruiz Regulatory Affairs Specialist 3M Center, 2510 Conway Ave., Bldg. 275-5W-06 St. Paul, Minnesota 55144

Re: K170754

Trade/Device Name: 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing Regulatory Class: Unclassified Product Code: FRO Dated: October 25, 2017 Received: October 26, 2017

Dear Maria Ruiz:

We have reviewed vour 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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.

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 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.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170754

Device Name

3M™ Tegadern™ Antimicrobial Transparent Dressing, 3M™ Tegadem™ Antimicrobial I.V. Advanced Securement Dressing

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510K SUMMARY

I. SUBMITTER

3M Company 3M Health Care 3M Center 2510 Conway Ave., Bldg 275-5W-06 St. Paul, MN 55144

Phone:	651-736-2733
Fax:	651-737-5320
E-Mail:	meruiz@mmm.com
Contact Person:	Maria RuizRegulatory Affairs Specialist

Date Prepared: March 10, 2017

II. DEVICE

Name of Device:	3M™ Tegaderm™ Antimicrobial Transparent Dressingand 3M™ Tegaderm™ Antimicrobial I.V. AdvancedSecurement Dressing
Common or Usual Name:	Dressing, Wound, Drug
Regulatory Class:	Unclassified
Product Code:	FRO

III. PREDICATE DEVICE

BD ChloraShield™ I.V. Dressing with CHG Antimicrobial (K113836, originally cleared September 24, 2012 under the device name Benehold CHG Transparent Film Dressing)

DEVICE DESCRIPTION IV.

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spectrum antimicrobial/antifungal agent known to inhibit microbial growth has been formulated into the acrylic adhesive.

3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing is bordered, notched and reinforced with soft cloth tape and is designed to provide securement around catheters and other devices.

In vitro testing shows that the film of the dressing provides a barrier to viruses 27 nm in diameter or larger while the dressing remains intact without leakage. These results have not been studied with regard to prevention of viral infection. No clinical study has been conducted regarding the ability of the dressing to prevent viral infections.

INDICATIONS FOR USE V.

3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing is intended to be used to cover and protect catheter sites and to secure devices to the skin. Common applications include covering and securing IV catheters, other intravascular catheters and percutaneous devices.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The technological principle for the subject device and the predicate device, BD ChloraShield™ I.V. Dressing with CHG Antimicrobial, are that they are both transparent dressings containing chlorhexidine gluconate (CHG) in the adhesive. They are both intended to cover and protect catheter sites and secure devices to the skin.

The subject device and predicate device have similar technological elements which include:

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Operational principle .
Device is transparent ●
Device is provided with an adhesive containing Chlorhexidine Gluconate (CHG) ●
Device is breathable .
Device is conformable ●
Device is waterproof ●
. Device is a barrier to viruses

The minor differences do not raise different questions of safety and effectiveness. The following technological differences exist between the subject device and the predicate device:

. Sterilization method
. Concentration of CHG
. Absorption

PERFORMANCE DATA VII.

The following performance data is provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for 3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing was conducted in accordance with International Organization for Standardization ISO-10993, Biological Evaluation of Medical Devices and FDA's guidance. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued June 16, 2016. 3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing are characterized as a surface contacting device for use on breached or compromised skin for prolonged duration (less than 30 days). The battery of testing included the following tests:

Cytotoxicity .
. Sensitization
Irritation ●
Pyrogenicity ●

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Acute System Toxicity and Subacute/Subchronic Toxicity .
Implantation ●

Bench Testing

Bench testing for 3M™ Tegaderm™ Antimicrobial Transparent Dressing was conducted in support of substantial equivalence to the predicate devices. The bench testing included the following tests:

. Tensile and Elongation*
Moisture Vapor Transmission Rate* .
Waterproof* ●
Amount of CHG within the device throughout the use life through Release Kinetics* ●
Barrier Performance .
Antimicrobial activity spectrum (Time kill)* ● *Studies conducted in comparison with the predicate device.

Clinical Study

A randomized, controlled, open-label study on 24 healthy subjects was conducted to assess wear performance at three (3) and seven (7) days with the subject device and the predicate device, BD ChloraShield™ I.V. Dressing with CHG Antimicrobial. A Mixed Model ANOVA was used to analyze wear/lift of the dressing. At 72 hours (3 days), all dressings remained on the arms for both the subject and predicate device. At 168 hours (7 days), the subject device remained on the arms and three of the predicate devices had been removed due to excess lift <168 hours. The lift of the subject device was substantially equivalent to the predicate device at both the 72 and 168 hour time points. The study demonstrated that the subject device secured catheters for seven days.

VIII. CONCLUSIONS

The Indications for Use statement for the subject device, 3MTM Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing, is the identical to the predicate device, BD ChloraShield™ I.V. Dressing with CHG Antimicrobial (K113836). Both the subject device and predicate device have the same intended use to cover and protect catheter sites and to secure devices to the skin.

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3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3MTM Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing is composed of similar components and the differences in technology do not raise new questions of safety and effectiveness.

Performance data provided demonstrates performance and safety of the subject device is substantially equivalent to the predicate device, BD ChloraShield™ I.V. Dressing with CHG Antimicrobial (K113836).

Regulation Number and Section

N/A