3M™ Tegaderm™ CHG Dressings (Chlorhexidine Gluconate I.V. Securement Dressing), can be used to cover and protect catheter sites and to secure devices to skin. Common applications include IV catheters, other intravascular catheter and percutaneous devices.

Device Description

3M™ Tegaderm™ CHG Dressing, Chlorhexidine Gluconate I.V. Securement Dressing, is used to cover and protect catheter sites and to secure devices to skin. Available in a variety of shapes and sizes to meet the needs of the caregiver.

Tegaderm™ CHG Dressing consists of a transparent adhesive dressing and an integrated pad containing Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad-spectrum antimicrobial and antifungal activity. The dressing is a barrier to liquid (waterproof), bacteria and viruses* and yeast, and protects the IV site from outside contamination. The pad absorbs up to eight times its weight in fluid. In vitro testing (log reduction, barrier, and zone of inhibition) demonstrates that the Tegaderm™ CHG dressing has an antimicrobial effect against, and is a barrier to, the passage of a variety of gram-positive and gram-negative bacteria and yeast in the dressing. Tegaderm™ CHG Dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.

In vitro testing has proven that Tegaderm CHG provides a viral barrier from viruses 27 nm in diameter, (e.g. HCV) or larger (e.g. HBV and HIV) while the dressing remains intact without leakage.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device (3M™ Tegaderm™ CHG Dressing) and primarily focuses on regulatory clearance by demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the way you've described for an AI/device performance evaluation.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided text. The document describes the device's function and properties, and mentions "in vitro testing" as proof of certain antimicrobial effects, but it does not detail those tests with acceptance criteria or performance metrics in a structured format as typically found in clinical performance studies.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a specific study. The document focuses on demonstrating substantial equivalence to predicate devices and inherent properties.
Reported Device Performance:
- "In vitro testing (log reduction, barrier, and zone of inhibition) demonstrates that the Tegaderm™ CHG dressing has an antimicrobial effect against, and is a barrier to, the passage of a variety of gram-positive and gram-negative bacteria and yeast in the dressing."
- "In vitro testing has proven that Tegaderm CHG provides a viral barrier from viruses 27 nm in diameter, (e.g. HCV) or larger (e.g. HBV and HIV) while the dressing remains intact without leakage."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The descriptions refer to "in vitro testing" which typically involves laboratory experiments with microbial cultures, not patient-derived "test sets" in the context of clinical studies.
Data Provenance: The testing is described as "in vitro testing," meaning laboratory-based. No country of origin for the data is mentioned, nor is it classified as retrospective or prospective study design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as this document describes in vitro (laboratory) tests, not human- expert-interpreted data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The "test set" refers to microbial cultures in a lab, not data requiring expert adjudication.

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 a medical dressing, not an AI diagnostic device. No human reader or AI component is involved.

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

Not applicable. This is a medical dressing, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Ground Truth: For the "in vitro testing," the ground truth would be established by standard microbiological methods (e.g., direct measurement of log reduction, observation of zone of inhibition, successful barrier against organisms). This is empirical, objective lab data rather than expert consensus or pathology.

8. The sample size for the training set

Not applicable. As a medical dressing, there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable.

Summary

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K080620

Premarket Notification (510(k)) Summary

1. Sponsor Information:

MAY 1 9 2008

3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000

Contact Person:	Maria RuizSenior Regulatory Affairs Associate
Phone Number:	(651) 736-2733
FAX Number:	(651) 737-5320
Date of Summary:	April 18, 2008

April 18, 2008

2. Device Name and Classification:

	Common or Usual Name:	Antimicrobial I.V. Securement Dressing
Proprietary Name:	3M™ Tegaderm™ CHG Dressing(Chlorhexidine Gluconate I.V. Securement Dressing)
Classification Name:	Antimicrobial Dressing, Unclassified
Performance Standards:	None

Predicate Devices: 3.

3M™ Tegaderm™ CHG Dressings (K063458, cleared April 5, 2007) .
Bioclusive Transparent Film Dressing (K895207, cleared September 28, 1989) .
Opsite IV 3000 (K895353, cleared December 14, 1989) .
Tegaderm™ Transparent Film Dressings (K973036, cleared November 12, 1997) .
SorbaView® Ultimate Window Dressing .
SorbaView® 2000 .

4. Description of Device:

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protects the IV site from outside contamination. The pad absorbs up to eight times its weight in fluid. In vitro testing (log reduction, barrier, and zone of inhibition) demonstrates that the Tegaderm™ CHG dressing has an antimicrobial effect against, and is a barrier to, the passage of a variety of gram-positive and gram-negative bacteria and yeast in the dressing. Tegaderm™ CHG Dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.

In vitro testing has proven that Tegaderm CHG provides a viral barrier from viruses 27 nm in diameter, (e.g. HCV) or larger (e.g. HBV and HIV) while the dressing remains intact without leakage.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 19 2008

3M Health Care % Ms. Maria Ruiz Senior Regulatory Affairs Associate 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144-1000

Re: K080620

Trade/Device Name: 3M™ Tegaderm™ CHG Dressing, (Chlorhexidine Gluconate I.V. Securement Dressing) Regulatory Class: Unclassified Product Code: FRO Dated: April 18, 2008 Received: April 22, 2008

Dear Ms. Ruiz:

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 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 (OS) 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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Page 2 - Ms. Maria Ruiz

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to I legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Petmanect Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/industry/support/index.html.

Sincerely yours,

Mark M. Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

Device Name:

3MTM Tegaderm™ CHG Dressing, (Chlorhexidine Gluconate I.V. Securement Dressing)

080620

Indications for Use:

Prescription Use_ X (Per 21 CFR 801 109)

Over-The-Counter-Use

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Ogle for myn
(Division Sign-Off)

Division of General, Restorative, and Neurological Dexicest 2 - 2

510(k) Number K070620

Regulation Number and Section

N/A