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

{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) 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### 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<br>(contains 2% w/w CHG) | |------------------------|------------------------------------------------------------------------------| | Common/Usual Name: | Surgical drape | | Device Classification: | Class II | | Classification Name: | Surgical drape and drape accessories<br>[21 CFR § 878.4370, KKX] | ## Predicate Device 3MTM Steri-Drape™ CHG Antimicrobial Incise Drape, K140250 ## Indications for Use 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. ## Description of Device 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. {5}------------------------------------------------ #### TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | | Submission Device: | Predicate Device<br>(K140250): | | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | 3MTM IobanTM<br>CHG Chlorhexidine<br>Gluconate Incise Drape<br>(contains 2% w/w CHG) | 3MTM Steri-DrapeTM<br>CHG Antimicrobial<br>Incise Drape | Comparison | | Classification<br>Name | Surgical drape and drape<br>accessories | Surgical drape and<br>drape 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 CHG<br>Chlorhexidine Gluconate<br>Incise Drape (contains 2%<br>w/w CHG) is indicated for<br>use as an incise drape with<br>continuous antibacterial<br>activity based on in vitro time<br>kill data out to 90 minutes. It<br>is intended for external use<br>only. | 3MTM Steri-DrapeTM<br>CHG Antimicrobial<br>Incise Drape is<br>indicated for use as<br>an incise drape with<br>continuous<br>antimicrobial activity<br>based on in vitro time<br>kill data out to 90<br>minutes. It is<br>intended for external<br>use only. | Both the<br>submission and<br>predicate devices<br>are intended to be<br>used as an incise<br>drape. The testing<br>of the submission<br>device supports<br>that the drape is<br>antibacterial rather<br>than antimicrobial.<br>Similar | | Design/Materials | Antibacterial impregnated<br>adhesive coated on breathable<br>film with silicone-coated<br>release liner. | Antimicrobial<br>impregnated adhesive<br>coated on breathable<br>film with silicone-<br>coated release liner. | Similar<br>Some minor<br>modifications<br>were made to the<br>adhesive<br>formulation,<br>adhesive coat<br>weight, and film<br>of the submission<br>device as<br>compared to the<br>predicate device. | | Active Ingredient | Chlorhexidine Gluconate<br>(2% w/w CHG) | Chlorhexidine<br>Gluconate<br>(2% w/w CHG) | Identical | | Sterilization | Modality: Ethylene Oxide<br>SAI : 10-6 | Modality: Ethylene<br>Oxide | Identical | | | Submission Device: | Predicate Device<br>(K140250): | | | Feature | 3MTM IobanTM<br>CHG Chlorhexidine<br>Gluconate Incise Drape<br>(contains 2% w/w CHG) | 3MTM Steri-DrapeTM<br>CHG Antimicrobial<br>Incise Drape | Comparison | | Packaging | Film/Tyvek pouch | Film/Tyvek pouch | Identical | | Principles of<br>Operation | The 3MTM IobanTM CHG<br>Chlorhexidine Gluconate<br>Incise Drape (contains 2%<br>w/w CHG) is considered a<br>non-invasive device<br>containing an<br>antimicrobial/antibacterial<br>agent (chlorhexidine<br>gluconate) in the adhesive.<br>The primary mode of action<br>of this device is to provide a<br>sterile barrier during surgical<br>procedures. The secondary<br>mode of action, based on the<br>CHG containing adhesive, is<br>to provide continuous<br>antibacterial activity and to<br>reduce the risk of surgical site<br>contamination due to skin<br>flora. Surgical incisions can<br>be made directly through the<br>Ioban incise film which<br>creates a sterile surface all the<br>way to the wound edge. | The 3MTM Steri-<br>DrapeTM CHG<br>Antimicrobial Drape<br>is a sterile adhesive<br>film that is applied<br>pre-operatively to<br>skin. The film<br>adheres and conforms<br>to the body contours,<br>providing a sterile<br>surface on top of the<br>skin prior to surgery.<br>The surgeon incises<br>through the adhesive<br>film and skin,<br>ensuring a sterile film<br>barrier all the way to<br>the edge of the<br>incision. The CHG<br>contained in the<br>adhesive provides<br>additional<br>antimicrobial activity<br>to reduce the risk of<br>microbial<br>contamination of the<br>surgical wound. | Identical | | Performance<br>Characteristics | • Barrier performance per<br>AAMI PB70:2012 using<br>ASTM 1670 Resistance to<br>Synthetic Blood Penetration<br>• Force at 25% Elongation<br>• Assessment of Tear<br>Resistance | SAL: 10-6<br>• Barrier<br>performance per<br>AAMI PB70:2012<br>using ASTM 1670<br>Resistance to<br>Synthetic Blood<br>Penetration | The same testing<br>was completed to<br>assess the barrier,<br>mechanical and<br>antimicrobial<br>properties of the<br>subject device in | | | Submission Device: | Predicate Device<br>(K140250): | | | Feature | 3MTM IobanTM<br>CHG Chlorhexidine<br>Gluconate Incise Drape<br>(contains 2% w/w CHG) | 3MTM Steri-DrapeTM<br>CHG Antimicrobial<br>Incise Drape | Comparison | | | • Flammability testing per 16<br>CFR 1610<br>• Moisture Vapor<br>Transmission Rate<br>• <i>In vitro</i> Direct Time Kill<br>• Minimum Effective<br>Concentration<br>• CHG Release Kinetics | • Tensile and<br>Elongation<br>• Flammability<br>testing per 16 CFR<br>1610<br>• Moisture Vapor<br>Transmission Rate<br>• <i>In vitro</i> Direct Time<br>Kill<br>• Minimum Effective<br>Concentration<br>• CHG Release<br>Kinetics | addition to an<br>assessment of tear<br>resistance. | | Biocompatibility | Not cytotoxic, slight irritant,<br>not a potential skin sensitizer,<br>not pyrogenic, not acutely<br>systemically toxic, non-<br>hemolytic | Non cytotoxic, slight<br>irritant, not a<br>potential skin<br>sensitizer | Duration and type<br>of contact are<br>identical.<br>Additional<br>endpoints tested<br>are in alignment<br>with updates to<br>ISO 10993. | | Clinical Testing | None provided | Adhesion to skin<br>study | No clinical testing<br>was provided to<br>support substantial<br>equivalence since<br>this was a minor<br>change. Adhesion<br>was assessed<br>through bench<br>testing. | ## 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 Method<br>Description | Acceptance Criteria | Results | |----------------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------|---------| | Barrier<br>Performance | AAMI PB70:2012 using<br>ASTM F1670 Resistance<br>to Synthetic Blood<br>Penetration | Level 4 | PASS | | Force at 25%<br>Elongation | Based on PSTC-131,<br>ASTM D882,<br>ASTM D3759 | < 425 g/in | PASS | | Assessment of<br>Tear Resistance | N/A | Rationalization Provided | PASS | | Flammability | 16 CFR 1610 | Class I (Normal) | PASS | | Moisture Vapor<br>Transmission<br>Rate | Based on ASTM E96 | > 400 g/m²/24 hours | PASS | | <i>in vitro</i> Direct<br>Time Kill and<br>Minimum<br>Effective<br>Concentration | Based on ASTM E2315 | > 4 log reduction at 90 minutes | PASS | | CHG Release<br>Kinetics | 3M CHG Kinetic Release<br>Test Method | > 0.0% after 90 minute extraction | PASS | | Ethylene Oxide<br>Residuals | ISO 10993-7: 2008;<br>Amd 1: 2019 | Per ISO 10993-7: 2008;<br>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.