3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is indicated for use as an incise drape with continuous antibacterial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only.

Device Description

3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is a sterile adhesive film that is applied pre-operatively to skin. It adheres and conforms to body contours, providing a sterile surface on top of the skin prior to surgery. The surgeon incises through the adhesive film and skin, ensuring a sterile film barrier all the way to the edge of the incision. The Chlorhexidine Gluconate (CHG) contained in the adhesive provides antibacterial activity to help reduce the risk of bacterial contamination in the surgical wound.

The drape consists of a transparent, conformable, barrier film coated with an acrylic adhesive containing 2% w/w CHG. The adhesive drape is delivered on a release liner that is discarded after application.

AI/ML Overview

The provided text describes the acceptance criteria and the results from non-clinical testing performed for the 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Barrier Performance	Level 4	PASS
Force at 25% Elongation	< 425 g/in	PASS
Assessment of Tear Resistance	Rationalization Provided	PASS
Flammability	Class I (Normal)	PASS
Moisture Vapor Transmission Rate	> 400 g/m²/24 hours	PASS
in vitro Direct Time Kill and Minimum Effective Concentration	> 4 log reduction at 90 minutes	PASS
CHG Release Kinetics	> 0.0% after 90 minute extraction	PASS
Ethylene Oxide Residuals	Per ISO 10993-7: 2008; Amd 1: 2019	PASS
Biocompatibility (Chemical Characterization, Hemolysis, Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity)	Not cytotoxic, slight irritant, not a potential skin sensitizer, not pyrogenic, not acutely systemically toxic, non-hemolytic (for predicate, but additional endpoints tested for submission device)	All tests PASS (e.g., Not cytotoxic, slight irritant, not a potential skin sensitizer, not pyrogenic, not acutely systemically toxic, non-hemolytic)

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

The document primarily details non-clinical bench testing and biocompatibility testing. It does not specify sample sizes for each individual test. The data provenance is not explicitly stated beyond being "bench testing" and "biocompatibility testing," implying laboratory-based data rather than patient data from a specific geographical location. The nature of these tests suggests they are prospective, as they were conducted specifically to evaluate the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the document discusses non-clinical bench and biocompatibility testing. These types of tests typically rely on standardized methods and laboratory analysis rather than expert human interpretation for ground truth.

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

This information is not applicable as the document discusses non-clinical bench and biocompatibility testing. Adjudication methods are typically used in clinical studies or studies involving subjective human interpretation of outputs, which is not the case here.

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

This information is not applicable. The device is an incise drape with antibacterial properties, not an AI-assisted diagnostic or interpretive device that would involve human readers.

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

This information is not applicable. The device is a physical medical device (incise drape), not a software algorithm.

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

The ground truth for the non-clinical tests is established by objective measurements against predefined scientific and regulatory standards/methods. For example:

Barrier Performance: Measured against AAMI PB70:2012 using ASTM F1670.
Antibacterial Activity: Measured by in vitro direct time kill based on ASTM E2315, aiming for a >4 log reduction.
Biocompatibility: Evaluated against ISO 10993-1 and FDA Guidance for biological evaluation.

8. The sample size for the training set

This information is not applicable. The document describes the testing of a physical medical device, not a machine learning model that would require a training set.

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

This information is not applicable for the same reason as point 8.

Summary

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

Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 18, 2023

3M Company Hilary Hovde Regulatory Affairs Specialist 2510 Conway Ave. Building 275-5W-06 St. Paul, Minnesota 55144

Re: K222578

Trade/Device Name: 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape And Drape Accessories Regulatory Class: Class II Product Code: KKX Dated: April 14, 2023 Received: April 14, 2023

Dear Hilary Hovde:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Bifeng Qian -S

Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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

Indications for Use

510(k) Number (if known) K222578

Device Name

3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)

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}------------------------------------------------

510(k) Summary for 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)

K222578

3M Company 3M Health Care 2510 Conway Ave. 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000

Contact: Hilary B. Hovde Regulatory Affairs Specialist hbhovde(@mmm.com

Submission Date: May 18, 2023

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

Device Name and Classification

Trade Name:	3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape(contains 2% w/w CHG)
Common/Usual Name:	Surgical drape
Device Classification:	Class II
Classification Name:	Surgical drape and drape accessories[21 CFR § 878.4370, KKX]

Predicate Device

3MTM Steri-Drape™ CHG Antimicrobial Incise Drape, K140250

Indications for Use

Description of Device

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

TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)

	Submission Device:	Predicate Device(K140250):
Feature	3MTM IobanTMCHG ChlorhexidineGluconate Incise Drape(contains 2% w/w CHG)	3MTM Steri-DrapeTMCHG AntimicrobialIncise Drape	Comparison
ClassificationName	Surgical drape and drapeaccessories	Surgical drape anddrape accessories	Identical
Regulation	21 CFR 878.4370	21 CFR 878.4370	Identical
Product Code	KKX	KKX	Identical
Classification	Class II	Class II	Identical
Committee	General Hospital	General Hospital	Similar
Indications for use	3MTM IobanTM CHGChlorhexidine GluconateIncise Drape (contains 2%w/w CHG) is indicated foruse as an incise drape withcontinuous antibacterialactivity based on in vitro timekill data out to 90 minutes. Itis intended for external useonly.	3MTM Steri-DrapeTMCHG AntimicrobialIncise Drape isindicated for use asan incise drape withcontinuousantimicrobial activitybased on in vitro timekill data out to 90minutes. It isintended for externaluse only.	Both thesubmission andpredicate devicesare intended to beused as an incisedrape. The testingof the submissiondevice supportsthat the drape isantibacterial ratherthan antimicrobial.Similar
Design/Materials	Antibacterial impregnatedadhesive coated on breathablefilm with silicone-coatedrelease liner.	Antimicrobialimpregnated adhesivecoated on breathablefilm with silicone-coated release liner.	SimilarSome minormodificationswere made to theadhesiveformulation,adhesive coatweight, and filmof the submissiondevice ascompared to thepredicate device.
Active Ingredient	Chlorhexidine Gluconate(2% w/w CHG)	ChlorhexidineGluconate(2% w/w CHG)	Identical
Sterilization	Modality: Ethylene OxideSAI : 10-6	Modality: EthyleneOxide	Identical
	Submission Device:	Predicate Device(K140250):
Feature	3MTM IobanTMCHG ChlorhexidineGluconate Incise Drape(contains 2% w/w CHG)	3MTM Steri-DrapeTMCHG AntimicrobialIncise Drape	Comparison
Packaging	Film/Tyvek pouch	Film/Tyvek pouch	Identical
Principles ofOperation	The 3MTM IobanTM CHGChlorhexidine GluconateIncise Drape (contains 2%w/w CHG) is considered anon-invasive devicecontaining anantimicrobial/antibacterialagent (chlorhexidinegluconate) in the adhesive.The primary mode of actionof this device is to provide asterile barrier during surgicalprocedures. The secondarymode of action, based on theCHG containing adhesive, isto provide continuousantibacterial activity and toreduce the risk of surgical sitecontamination due to skinflora. Surgical incisions canbe made directly through theIoban incise film whichcreates a sterile surface all theway to the wound edge.	The 3MTM Steri-DrapeTM CHGAntimicrobial Drapeis a sterile adhesivefilm that is appliedpre-operatively toskin. The filmadheres and conformsto the body contours,providing a sterilesurface on top of theskin prior to surgery.The surgeon incisesthrough the adhesivefilm and skin,ensuring a sterile filmbarrier all the way tothe edge of theincision. The CHGcontained in theadhesive providesadditionalantimicrobial activityto reduce the risk ofmicrobialcontamination of thesurgical wound.	Identical
PerformanceCharacteristics	• Barrier performance perAAMI PB70:2012 usingASTM 1670 Resistance toSynthetic Blood Penetration• Force at 25% Elongation• Assessment of TearResistance	SAL: 10-6• Barrierperformance perAAMI PB70:2012using ASTM 1670Resistance toSynthetic BloodPenetration	The same testingwas completed toassess the barrier,mechanical andantimicrobialproperties of thesubject device in
	Submission Device:	Predicate Device(K140250):
Feature	3MTM IobanTMCHG ChlorhexidineGluconate Incise Drape(contains 2% w/w CHG)	3MTM Steri-DrapeTMCHG AntimicrobialIncise Drape	Comparison
	• Flammability testing per 16CFR 1610• Moisture VaporTransmission Rate• In vitro Direct Time Kill• Minimum EffectiveConcentration• CHG Release Kinetics	• Tensile andElongation• Flammabilitytesting per 16 CFR1610• Moisture VaporTransmission Rate• In vitro Direct TimeKill• Minimum EffectiveConcentration• CHG ReleaseKinetics	addition to anassessment of tearresistance.
Biocompatibility	Not cytotoxic, slight irritant,not a potential skin sensitizer,not pyrogenic, not acutelysystemically toxic, non-hemolytic	Non cytotoxic, slightirritant, not apotential skinsensitizer	Duration and typeof contact areidentical.Additionalendpoints testedare in alignmentwith updates toISO 10993.
Clinical Testing	None provided	Adhesion to skinstudy	No clinical testingwas provided tosupport substantialequivalence sincethis was a minorchange. Adhesionwas assessedthrough benchtesting.

Comparison of Technological Characteristics with the Predicate Device

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

TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)

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

TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)

{8}------------------------------------------------

Summary of Non-Clinical Testing

Bench Testing and biocompatibility testing were completed to demonstrate substantial equivalence of the submission device, the 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG), to the predicate device.

Test	Test MethodDescription	Acceptance Criteria	Results
BarrierPerformance	AAMI PB70:2012 usingASTM F1670 Resistanceto Synthetic BloodPenetration	Level 4	PASS
Force at 25%Elongation	Based on PSTC-131,ASTM D882,ASTM D3759	< 425 g/in	PASS
Assessment ofTear Resistance	N/A	Rationalization Provided	PASS
Flammability	16 CFR 1610	Class I (Normal)	PASS
Moisture VaporTransmissionRate	Based on ASTM E96	> 400 g/m²/24 hours	PASS
in vitro DirectTime Kill andMinimumEffectiveConcentration	Based on ASTM E2315	> 4 log reduction at 90 minutes	PASS
CHG ReleaseKinetics	3M CHG Kinetic ReleaseTest Method	> 0.0% after 90 minute extraction	PASS
Ethylene OxideResiduals	ISO 10993-7: 2008;Amd 1: 2019	Per ISO 10993-7: 2008;Amd 1: 2019	PASS

The device performance was verified through the following tests:

{9}------------------------------------------------

TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)

Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1. Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process as recognized by FDA. The 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is categorized as a surface contacting device, with breached or compromised skin contact of limited duration in accordance with ISO 10993-1 and FDA Guidance, Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process." The battery of tests included the following:

Chemical Characterization and Toxicology Risk Assessment of Extractables ●
. Hemolysis
Cytotoxicity
Sensitization ●
Irritation ●
Acute Systemic Toxicity ●
. Material-Mediated Pvrogenicity

Summary of Clinical Testing

Clinical testing was not provided to support substantial equivalence.

Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K140250.

Regulation Number and Section

§ 878.4370 Surgical drape and drape accessories.

(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.