3 M Th Tegaderm™ CHG Chlorhexidine Gluconate I. V. Port Dressing can be used to cover and protect catheter sites and to secure devices to skin. Common applications include securing and covering intravascular catheters and percutaneous devices.

Device Description

3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing is used to cover and protect vascular access sites and to secure devices to the skin. The Chlorhexidine Gluconate I.V. Port Dressing is a two part system consisting of a bordered, transparent film cover dressing with an adhesive free window and an antimicrobial CHG Gel Device. The Chlorhexidine Gluconate I.V. Port Dressing is breathable and transparent, allowing continuous site observation. The cover dressing provides an effective barrier against external contamination including fluids (waterproof), hacteria, and yeast. The CHG gel pad device consists of an integrated gel pad containing 2% w/w Chlorhexidine Gluconate (CHG), an antiseptic agent with broad spectrum antimicrobial and antifungal activity. The gel absorbs fluid.

AI/ML Overview

The 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing is a medical device used to cover and protect vascular access sites and secure devices to the skin. This submission is a 510(k) premarket notification, which means the manufacturer seeks to demonstrate the device is substantially equivalent to a predicate device already legally marketed. Therefore, the "acceptance criteria" are typically related to proving this substantial equivalence, rather than setting specific performance targets against a disease state or clinical endpoint.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" generally refer to demonstrating that the new device is as safe and effective as a predicate device. This is primarily done through comparative data, including non-clinical (bench) testing. The text does not provide a table with quantitative acceptance criteria for specific performance metrics (e.g., a specific log reduction in bacteria counts, or a certain peel strength). Instead, the acceptance criteria are implicitly met by demonstrating sameness or similarity to the predicate device in key characteristics.

Acceptance Criteria (Implied)	Reported Device Performance
Same or similar components	"composed of the same or similar components" as the predicate device.
Same or similar performance	"has same or similar performance" as the predicate device. Bench testing was conducted to demonstrate this.
Same or similar intended use	"same or similar... intended use" as the predicate device.
Same or similar indications for use	"same or similar... indications for use" as the predicate device. Indications are "to cover and protect catheter sites and to secure devices to skin. Common applications include securing and covering intravascular catheters and percutaneous devices."
Effective barrier against external contamination	Cover dressing "provides an effective barrier against external contamination including fluids (waterproof), bacteria, and yeast." (Attributed to the cover dressing component).
Antimicrobial effect	CHG gel pad demonstrates "an antimicrobial effect against a variety gram-positive and gram-negative bacteria and yeast" (based on in vitro testing).
Breathable and transparent	Device is "breathable and transparent, allowing continuous site observation."
Gel absorbs fluid	The CHG gel pad device is noted to absorb fluid.

Study Proving Acceptance Criteria:

The study proving the device meets the (implied) acceptance criteria is a non-clinical (bench) testing study. The text explicitly states: "Bench testing was collected to demonstrate substantial equivalence for this submission."

The document also mentions "In vitro testing (time kill and zone of inhibition) demonstrates that the gel pad in the device has an antimicrobial effect against a variety gram-positive and gram-negative bacteria and yeast." This in vitro testing is a component of the non-clinical performance data.

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

Sample Size: The document does not specify the sample size for the bench testing or in vitro tests.
Data Provenance: The data is "non-clinical performance data" and "in vitro testing." It is not clinical data from human subjects. Therefore, concerns about country of origin or retrospective/prospective nature are not directly applicable in the same way as clinical trials. It's safe to assume these were laboratory tests conducted by the manufacturer (3M Company).

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

Not applicable. For a 510(k) based on non-clinical data, the "ground truth" is typically established by the results of the bench and in vitro tests themselves, often adhering to recognized standards or established testing methodologies. There would not be "experts" in the sense of clinical reviewers establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical trials or studies where human interpretation of data is crucial. For bench testing, the results are typically determined by laboratory measurements and experimental procedures, not by a panel of adjudicators.

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 device is an I.V. port dressing, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for demonstrating substantial equivalence and device performance was derived from:

Bench testing: Measuring physical properties, barrier effectiveness, and other relevant characteristics.
In vitro testing: Demonstrating antimicrobial and antifungal activity against specific microorganisms using laboratory assays (time kill and zone of inhibition).

These tests act as the "ground truth" to show the device functions as intended and is comparable to the predicate.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, not for physical product development and testing in this context.

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

Not applicable, as there is no "training set" in the context of this device.

Summary

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3M Company

3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing 5.10(k) Premarket Notification - Traditional

008 510k SUMMARY

Sponsor Information:

Applicant Name:

3M Company 3M Health Care Skin and Wound Care Division 3M Center 2510 Conway Ave., Bldg. 275-5W-06 St. Paul, Minnesota 55144

Contact Person:

Phone Number: Fax Number: Email:

Joann Huehn Regulatory Affairs 651-733-9209 651-737-5320 jlhuehn1 @mmm.com

Date Prepared:

November 29, 2012

Device Name and Classification:

Trade Name:	3M™ Tegaderm™ CHGChlorhexidine Gluconate I.V. Port Dressing
Common or Usual Name:	I.V. Dressing with CHG
Classification Name:	Unclassified
Product Code:	FRO
Performance Standards:	Not Applicable
Predicate Device:	3M™ Tegaderm™ CHG Dressing(Chlorhexidine Gluconate Securement Dressing)

Description of Device:

3M .

FEB 2 8 2013

K123679

p 112

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3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing 510(k) Premarket Notification - Traditional

The cover dressing provides an effective barrier against external contamination including fluids (waterproof), hacteria, and yeast.

The CHG gel pad device consists of an integrated gel pad containing 2% w/w Chlorhexidine Gluconate (CHG), an antiseptic agent with broad spectrum antimicrobial and antifungal activity. The gel absorbs fluid.

In vitro testing (time kill and zone of inhibition) demonstrates that the gel pad in the device has an antimicrobial effect against a variety gram-positive and gram-negative bacteria and yeast.

Indications for Use:

3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing can be used to cover and protect catheter sites and to secure devices to skin. Common applications include securing and covering intravascular catheters and percutaneous devices.

Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:

Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing is substantially equivalent to the predicate device, Tegaderm™ CHG Dressing (Chlorhexidine Gluconate Securement Dressing), cleared under K063458.

The Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing is composed of the same or similar components, has same or similar performance, intended use and indications for use as the predicate device.

Non-Clinical Performance Data:

Bench testing was collected to demonstrate substantial equivalence for this submission.

Clinical Performance Data:

Clinical information provided supports the subject device, therefore, no additional clinical information was determined to be needed.

Non-Clinical and Clinical Conclusion:

Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing is safe for human use and acceptable for its intended use.

1223619

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three intertwined lines representing health and well-being.

DEPARTMENT OF HEALTH & HUM AN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Letter dated: February 28, 2013

3M Company % Ms. Joann Huehn Regulatory Affairs 3M Center, 2510 Conway Avenue, Building 275-5W-06 St. Paul, Minnesota 55144

Re: K123679

Trade/Device Name: 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 29, 2012 Received: November 30, 2012

Dear Ms. Huehn:

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. 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 (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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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/ucm115809.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" (21CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3M Company

3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing 510(k) Premarket Notification - Traditional

3M Confidential

K123679

007_INDICATION FOR USE STATEMENT

510(k) Number (if known): To be Assigned

Device Name: 3M™ Tegaderm™ CHG Chlorhexidinc Gluconate I.V. Port Dressing

Indications for Use:

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (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)

Mark N. Melkerson , S 2013.02.28 13:26:08 =05 00'

(Division Sign-Off) Division of Surgical Devices 510(k) Number

Page 007-1

Regulation Number and Section

N/A