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

Tegaderm™ CHG I.V. Securement Dressing is intended to reduce vascular catheter colonization and catheter-related bloodstream infections (CRBSI) in patients with central venous or arterial catheters.

Device Description

3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing is used to cover and protect catheter sites and to secure devices to skin. It is available in a variety of shapes and sizes.

Tegaderm™ CHG I.V. Securement Dressing consists of a transparent adhesive dressing and an integrated gel pad containing 2% w/w Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad spectrum antimicrobial and antifungal activity. The transparent film provides an effective barrier against external contamination including fluids (waterproof), bacteria. viruses* and yeast, and protects the IV site.

In vitro testing (log reduction and barrier testing) demonstrates that the Tegaderm™ CHG gel pad in the Tegaderm™ CHG I.V. Securement Dressing has an antimicrobial effect against, and is a barrier to, a variety of gram-positive and gram-negative bacteria, and yeast in the dressing. The gel pad absorbs fluid.

*In vitro testing shows that the transparent film of the Tegaderm™ CHG dressing provides a viral barrier from viruses 27 nm in diameter or larger while the dressing remains intact without leakage.

Tegaderm™ CHG dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.

AI/ML Overview

The provided text is a 510(k) summary for the 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing. This document does not include information about acceptance criteria and a study proving the device meets those criteria in the way specifically requested in your prompt (e.g., performance metrics like sensitivity/specificity for a diagnostic device, or detailed clinical study results with effect sizes for comparative effectiveness).

Instead, this submission is a Special 510(k) for a device modification, which means it focuses on demonstrating that the modified device remains substantially equivalent to its own predicate device.

Here's a breakdown based on the information provided in the document, and what is missing based on your prompt:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Non-clinical testing of the subject device for viral barrier performance at the end of shelf-life was performed. The device's performance is substantially equivalent to the predicate device."

It doesn't provide specific numerical acceptance criteria (e.g., "X% viral barrier efficacy") or reported numerical performance for this test. It only states that the performance is "substantially equivalent" to the predicate. The predicate device's performance is described as: "In vitro testing shows that the transparent film of the Tegaderm™ CHG dressing provides a viral barrier from viruses 27 nm in diameter or larger while the dressing remains intact without leakage."

Therefore, for the specific viral barrier performance, a table cannot be constructed with numerical values from this document. The "acceptance criterion" seems to be "substantially equivalent viral barrier performance to the predicate," and the "reported device performance" is that it met this criterion.

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

The document does not specify the sample size for the viral barrier performance test. It only mentions "Non-clinical testing." The data provenance is also not specified (e.g., country of origin). It is an in vitro test, not human data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable and not provided. The viral barrier test is an in vitro (laboratory) performance test, not a subjective interpretation requiring expert consensus.

4. Adjudication Method:

This is not applicable and not provided for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was done or reported. This submission is for a dressing, not a diagnostic imaging device where MRMC studies are common.

6. Standalone (Algorithm Only) Performance:

This is not applicable as the device is a physical medical dressing, not an algorithm.

7. Type of Ground Truth Used:

For the viral barrier test, the "ground truth" would be established by the laboratory testing methodology itself (e.g., direct measurement of viral pass-through). This is not explicitly detailed but is inherent to in vitro performance testing.

8. Sample Size for the Training Set:

This is not applicable. The device is a physical dressing, not an AI/ML algorithm that requires a training set.

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

This is not applicable.

Summary based on information provided for K171908:

The provided document is a 510(k) Pre-Market Notification for a modification to a medical device (3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing). The primary goal of this submission is to demonstrate substantial equivalence to existing predicate devices (itself, specifically K063458, K080620, K153410).

The main "study" mentioned is non-clinical testing for viral barrier performance at the end of shelf-life. The conclusion is that the modified device's performance is "substantially equivalent" to the predicate device. The predicate device's performance regarding viral barrier is described as providing a barrier from viruses 27 nm or larger. No specific numerical acceptance criteria or performance metrics for this test are provided in this regulatory document.

No clinical studies, expert consensus, or AI/ML-related studies (like MRMC or standalone algorithm performance) are part of this particular submission for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/2 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 image of three human profiles facing to the right, stacked on top of each other.

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

July 11, 2017

3M Company Melissa Forth Regulatory Affairs Specialist 3M Center. 2510 Conwav Ave. Bldg 275-5W-06 St. Paul, Minnesota 55144

Re: K171908

Trade/Device Name: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 22, 2017 Received: June 26, 2017

Dear Melissa Forth:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K171908

Device Name

3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/3 description: The image shows the 3M logo. The logo consists of the number "3" and the letter "M" in a bold, sans-serif font. The color of the text is red, and the background is white.

510(k) Summary

This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.92.

I. SUBMITTER

Applicant Name:	3M Health Care3M Center2510 Conway Ave, Bldg. 275-5W-06St. Paul, MN 55144-1000
Contact Person:	Melissa J. ForthRegulatory Affairs Specialist
Phone:Fax:Email:	(651) 737-5016(651) 737-5320mjforth@mmm.com
Date Prepared:	June 22, 2017
II. DEVICE
Trade Name:	3MTM TegadermTM CHG Chlorhexidine GluconateI.V. Securement Dressing
Common or UsualName:	Antimicrobial I.V. Securement Dressing
Classification:	Unclassified
Product Code:	FRO
ClassificationName:	Dressing, wound, drug

{4}------------------------------------------------

3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing 510(k) Premarket Notification - Special 510(k): Device Modification

III. PREDICATE DEVICE

3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing (K063458, K080620, K153410)

No reference devices are used in this submission.

IV. DEVICE DESCRIPTION

3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing is used to cover and protect catheter sites and to secure devices to skin. It is available in a variety of shapes and sizes.

*In vitro testing shows that the transparent film of the Tegaderm™ CHG dressing provides a viral barrier from viruses 27 nm in diameter or larger while the dressing remains intact without leakage.

Tegaderm™ CHG dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.

CatalogNumber	Device Name	Dressing Size	Average Amount ofCHG per Dressing(mg based on gel pad size)
1657	3M™ Tegaderm™ CHGChlorhexidine Gluconate I.V.Securement Dressing	8.5 cm x 11.5 cm(3-1/2 X 4-1/2 in)	45 mg
1658	3M™ Tegaderm™ CHGChlorhexidine Gluconate I.V.Securement Dressing	10 cm X 12 cm(4 X 4-3/4 in)	45 mg
1659	3M™ Tegaderm™ CHGChlorhexidine Gluconate I.V.Securement Dressing	10 cm x 15.5 cm(4 X 6-1/8 in)	78 mg

The device is single-use, provided sterile and the sterilization method is ethylene oxide. There are no associated accessories.

{5}------------------------------------------------

3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing 510(k) Premarket Notification - Special 510(k): Device Modification

CatalogNumber	Device Name	Dressing Size	Average Amount ofCHG per Dressing(mg based on gel pad size)
1660	3M™ Tegaderm™ CHGChlorhexidine Gluconate I.V.Securement Dressing	7 cm x 8.5 cm(2 3/4 in. x 3 3/8 in.)	15 mg
1877*	3M™ PICC / CVC SecurementDevice + Tegaderm™ CHGChlorhexidine Gluconate I.V.Securement Dressing	8.5 cm x 11.5 cm(3 1/2 x 4 1/2 in)	45 mg
1879*	3M™ PICC / CVC SecurementDevice + Tegaderm™ CHGChlorhexidine Gluconate I.V.Securement Dressing	10 cm x 15.5 cm(4 x 6 1/8 in)	78 mg

Note: Catalog numbers 1877 and 1879 are convenience kits. The 3M™ PICC / CVC Securement Device portion of the kit is a US Class I device.

V. INDICATIONS FOR USE

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

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Characteristic	3M™ Tegaderm™ CHGI.V. Securement Dressing(Submission Subject)	3M™ Tegaderm™ CHGI.V. Securement Dressing(K063458, K080620, K153410)
Intended Use	No changes.Same intended use as predicatedevice.	3M™ Tegaderm™ CHG ChlorhexidineGluconate I.V. Securement Dressing can be usedto cover and protect catheter sites and to securedevices to skin.
Indications forUse	No changes.Same Indications for Use aspredicate device.	3M™ Tegaderm™ CHG ChlorhexidineGluconate I.V. Securement Dressing can be usedto cover and protect catheter sites and to securedevices to skin. Common applications includesecuring and covering I.V. catheters, otherintravascular catheters and percutaneous devices.
Characteristic	3MTM TegadermTM CHGI.V. Securement Dressing	3MTM TegadermTM CHGI.V. Securement Dressing
	(Submission Subject)	(K063458, K080620, K153410)
		TegadermTM CHG I.V. Securement Dressing isintended to reduce vascular catheter colonizationand catheter-related bloodstream infections(CRBSI) in patients with central venous orarterial catheters.
OperatingPrinciple	No change.Same operating principle aspredicate.	Catheter securement device.
Antimicrobialagent	No change.Same as predicate device.	CHG Chlorhexidine Gluconate (CHG)Gel pad contains 2% w/w chlorhexidinegluconate (CHG) or 15-78 mg CHG per pad(depending on dressing size).
Technologydescription	No change.Same as predicate device.	The Chlorhexidine Gluconate I.V. SecurementDressing consists of a transparent adhesivedressing and an integrated hydrophilic gel padcontaining 2% w/w Chlorhexidine Gluconate(CHG). The gel pad absorbs fluid.
Absorbent	No change.Same as predicate device.	Yes
Transparent	No change.Same as predicate device.	Yes
Breathable	No change.Same as predicate device.	Yes
Secures	No change.Same as predicate device.	Yes
Broad spectrum,continuous,antimicrobial /Broad spectrumantifungal	No change.Same as predicate device.	In vitro testing (log reduction and barrier testing)demonstrates that the TegadermTM CHG gel padin the TegadermTM CHG I.V. SecurementDressing has an antimicrobial effect against, andis a barrier to, a variety of gram-positive andgram-negative bacteria, and yeast in the dressing.
Suppressesre-growth ofmicroorganisms	No change.Same as predicate device.	Yes
Reduces vascularcathetercolonization	No change.Same as predicate device.	Yes
Reduces catheter-relatedbloodstreaminfection (CRBSI)	No change.Same as predicate device.	Yes

{6}------------------------------------------------

3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing 510(k) Premarket Notification – Special 510(k): Device Modification

{7}------------------------------------------------

VII. SUMMARY OF PERFORMANCE (NON-CLINICAL TESTING) DATA

Non-clinical testing of the subject device for viral barrier performance at the end of shelf-life was performed. The device's performance is substantially equivalent to the predicate device. No biocompatibility, animal studies or clinical studies were needed to support this change.

Regulation Number and Section

N/A