MediClear PreOp

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, wave-like appearance. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 14, 2017 Covalon Technologies, Inc. Kim Crooks VP Of Operations 1660 Tech Avenue Unit 5 Mississsauga, L4W 5S7 CA Re: K163556 Trade/Device Name: Mediclear PreOp Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: August 17, 2017 Received: August 18, 2017 Dear Kim Crooks: 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 mav 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 {1}------------------------------------------------ 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 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. 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. # Tara A. Ryan -S Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K163556 Device Name MediClear™ PreOp Indications for Use (Describe) MediClear™ PreOp is indicated for use as a pre-operative (incision/insertion) drape that provides continuous antimicrobial activity to reduce the risk of contamination of the skin site by acting as an external barrier to microbial and other contamination. MediClear™ PreOp can be left on the preoperative incision site for up to 7 days. MediClear™ PreOp is intended to be used on intact skin and for external use only. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| Prescription Use (Part 21 CFR 801 Subpart D) |X | 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}------------------------------------------------ K163556 # 510(k) Summary In accordance with 21 CFR 807.92, the following information is provided for Covalon's MediClear PreOp antimicrobial self-adherent silicone film drape for pre-operative skin with chlorhexidine and silver 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued August 12, 2005. #### l. Sponsor Information | Contact Address: | Covalon Technologies, Inc.<br>1660 Tech Avenue, Unit 5<br>Mississauga, Ontario, Canada L4W 5S7 | |---------------------------|------------------------------------------------------------------------------------------------| | Contact Person:<br>Title: | Kim Crooks<br>VP of Operations | | Phone Number: | 905-568-8400 x265 | | Fax Number: | 905-568-5200 | | Date of Summary: | September 07, 2017 | #### II. Device Name and Classification | Device Name: | MediClear™ PreOp | |---------------|--------------------------------------| | Common Name: | Surgical Drape and Drape Accessories | | FDA Panel: | General & Plastic surgery | | Product Code: | KKX | | Class: | II | | Model No(s).: | 7000404; 7000630; 7001012 | #### lll. Predicate Devices | Manufacturer: | 3M Healthcare Company | 3M Healthcare Company | |---------------|----------------------------------------------------|--------------------------------------------| | Device: | 3M™ Steri-Drape™ CHG<br>Antimicrobial Incise Drape | 3M™ loban™ 2 Antimicrobial<br>Incise Drape | | 510(k): | K140250 | K801550 | {4}------------------------------------------------ #### IV. Reference Devices | Manufacturer: | Covalon Technologies, Inc. | Covalon Technologies, Inc. | |---------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| | Device: | SurgiClear™ Antimicrobial<br>Clear Silicone Adhesive<br>Dressing with Chlorhexidine<br>and Silver | IV Clear™ Antimicrobial Clear<br>Silicone Adhesive Dressing with<br>Chlorhexidine and Silver | | 510(k): | K121819 | K112549 | #### V. Device Description MediClear™ PreOp consists of a clear polyurethane film coated with an antimicrobial silicone adhesive containing 3% w/w chlorhexidine and 0.5% w/w silver salts and is intended to cover and protect skin from the risk of contamination prior to an invasive procedure (i.e. incision or insertion). The chlorhexidine and silver contained in the adhesive provides continuous antimicrobial activity while the polyurethane barrier film acts as a protective patient covering to isolate a procedural site from microbial and other contamination. MediClear™ PreOp provides an effective physical barrier against external contamination including fluids, bacteria, and yeast. In vitro testing* demonstrates that the chlorhexidine and silver incorporated within the silicone adhesive provides a rapid bactericidal and fungicidal effect against microorganisms including Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Enterococcus faecalis (VRE), Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterobacter cloacae, Candida albicans, and Candida tropicalis averaging a 99.9% reduction at 10 minutes and a 99.99% reduction at 30 minutes, and prevents their re-growth for up to 7 days during wear. * In vitro effectiveness does not predict clinical performance. MediClear™ PreOp is a breathable, transparent, self-adhesive silicone film that conforms to the contours of the body. #### VI. Indications for Use MediClear™ PreOp is indicated for use as a pre-operative (incision/insertion) drape providing continuous antimicrobial activity to reduce the risk of contamination of the skin site by acting as an external barrier to microbial and other contamination. MediClear™ PreOp may be left on the pre-operative incision site for up to 7 days. MediClear™ PreOp is intended to be used on intact skin and for external use only. {5}------------------------------------------------ #### VII. Performance Testing The following tests were conducted to evaluate performance of the subject device*: -In vitro microbial log reduction; -Real time aging and stability; -Distribution simulation (journey hazards); -Biocompatibility including cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogen, and subacute toxicity; -Operational qualification including visual, functional, and additional criteria; -Microbial strikethrough: - Liquid barrier ASTM F1670. * In vitro effectiveness does not predict clinical performance. #### VIII. Substantial Equivalence Performance testing, including bench, biocompatibility, shelf life, log-reduction, and human clinical studies, confirms that MediClear™ PreOp is substantially equivalent in that it has similar technological characteristics as its predicate devices, 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape and 3M™ Ioban™ 2 Antimicrobial Incise Drape pursuant to section 510(k). MediClear™ PreOp has an intended use equivalent to its predicates, 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape and 3M™ Ioban™ 2 Antimicrobial Incise Drape and aligns with the drape and drape accessory definition per FDA requlation 878.4370 which states that this device is intended to be used as a protective patient covering such as to isolate a site of surgical incision from microbial and other contamination. MediClear™ PreOp is indicated for use as a pre-operative (incision/insertion) drape providing continuous antimicrobial activity to reduce the risk of contamination of the skin site by acting as an external barrier to microbial and other contamination. MediClear™ PreOp and its predicates, 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape and 3MTM Ioban™ 2 Antimicrobial Incise Drape are all intended for use as drapes with continuous antimicrobial activity. Both MediClear™ PreOp and its predicates 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape and 3M™ loban™ 2 Antimicrobial Incise Drape are intended for external use only. The use of MediClear™ PreOp, a device similar in all technological characteristics to its predicates 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape and 3M™ Ioban™ 2 Antimicrobial Incise Drape raises no new or different issue(s) of safety and effectiveness. Please refer to Table VIII-1 for the comparison between the subject device and the predicate devices. | Table VIII-1 Predicate device comparison table | | | | |------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------| | Device name | MediClear™ PreOp<br>antimicrobial self-<br>adherent silicone film for<br>preoperative skin with<br>chlorhexidine and silver | 3M™ Steri-Drape™<br>CHG Antimicrobial<br>Incise Drape (Predicate<br>#1) | 3M™ Ioban™ 2<br>Antimicrobial Incise<br>Drape (Predicate #2) | | Manufacturer | Covalon Technologies, | 3M Company | 3M Company | | | Inc. | | | | 510(k) | Subject device | K140250 | K801550 | | Class | Class II | Class II | Class II | | Product code | KKX | KKX | KKX | | Classification | General and plastic | General and plastic | General and plastic | | panel | surgery | surgery | surgery | | Common | Surgical Drape and Drape | Surgical Drape and Drape | Surgical Drape and Drape | | name | Accessories | Accessories | Accessories | | Intended Use | MediClear™ PreOp is | 3M™ Steri-Drape™ is | 3M™ loban™ is indicated | | | indicated for use as a pre- | indicated for use as an | for use as an incise drape | | | operative | incise drape with | with continuous | | | (incision/insertion) drape | continuous antimicrobial | antimicrobial activity. | | | providing continuous | activity. | | | | antimicrobial activity to | It is intended for external | It is intended for external | | | reduce the risk of | use only. | use only. | | | contamination of the skin | | | | | site by acting as an<br>external barrier to | | | | | microbial and other | | | | | contamination. | | | | | | | | | | MediClear™ PreOp may | | | | | be left on the pre-operative | | | | | incision site for up to 7 | | | | | days. | | | | | MediClear™ PreOp is | | | | | intended to be used on | | | | | intact skin and for external | | | | | use only. | | | | Used on intact | Used on intact skin | Used on incision site | Used on incision site | | skin or | | | | | incision site | | | | | General | MediClear™ PreOp is a | 3M™ Steri-Drape™ is an | 3M™ loban™ is an | | design | clear polyurethane film | antimicrobial impregnated | antimicrobial impregnated | | | coated with an | adhesive coated on a | adhesive coated on a | | | antimicrobial silicone | breathable film with | breathable film with | | | adhesive. | silicone-coated release | silicone-coated release | | | | liner. | liner. | | Active | Chlorhexidine diacetate | Chlorhexidine gluconate | Iodine | | antimicrobial | and silver sulfate | (CHG) | | | agents | | | | | Packaging<br>ASTM F1670 | Tyvek Pouch | Film/Tyvek Pouch | Foil Pouch | | Liquid Barrier | Level 4 | Level 4 | Level 4 | | Performance | | | | | Biocompatible | Under the conditions of the | Not cytotoxic, slight | Not cytotoxic, slight | | per | studies employed, the | irritant, not a potential skin | irritant, not a potential skin | | ISO 10993 | device is non-cytotoxic, | sensitizer | sensitizer | | | non-irritating, does not | | | | | induce acute or subacute | | | | | toxicity and is non- | | | | | pyrogenic as per the rabbit | | | | | pyrogen test. | | | | Sold Sterile | Yes | Yes | Yes | | Sterilization | Ethylene Oxide (ETO)<br>sterilized, 10-6 SAL per ISO<br>11135 | ETO sterilized, 10-6 SAL<br>per ISO 11135 | Gamma sterilized, 10-6<br>SAL per ISO 11137 | | Single use | Yes | Yes | Yes | | Over the<br>Counter | Yes | Yes | Yes | | | | | | ## Table VIII-1 Predicate device comparison table {6}------------------------------------------------ {7}------------------------------------------------ In addition, MediClear™ PreOp, is a device similar in all technological characteristics and performance specifications to the previously FDA cleared reference devices SurgiClear™ (K121819) and IV Clear™ (K112549) with exception of silver salt identity and other minor variations. Please refer to Table VIII-2 for the comparison between the subject device and the reference devices. | Device name | MediClear™ PreOp<br>antimicrobial self-<br>adherent silicone film<br>drape for preoperative<br>skin with chlorhexidine<br>and silver | SurgiClear™<br>antimicrobial clear<br>silicone adhesive<br>dressing with<br>chlorhexidine and silver | IV Clear™ antimicrobial<br>clear silicone adhesive<br>dressing with<br>chlorhexidine and silver | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Covalon Technologies,<br>Inc. | Covalon Technologies,<br>Inc. | Covalon Technologies,<br>Inc. | | 510(k) | Subject device | K121819 | K112549 | | Class | Class II | Unclassified | Unclassified | | Product code | KKX | FRO | FRO | | Classification | General and plastic | General and plastic | General and plastic | | panel | surgery | surgery | surgery | | Common | Surgical Drape and Drape<br>Accessories | Dressing, wound, drug | Dressing, wound, drug | | name | | | | | Indications for | MediClear™ PreOp is | SurgiClear™ is intended | IV Clear™ is intended to | | Use statement | indicated for use as a pre-<br>operative<br>(incision/insertion) drape<br>providing continuous<br>antimicrobial activity to<br>reduce the risk of<br>contamination of the skin<br>site by acting as an<br>external barrier to<br>microbial and other<br>contamination.<br>MediClear™ PreOp may<br>be left on the pre-<br>operative incision site for<br>up to 7 days.<br>MediClear™ PreOp is<br>intended to be used on<br>intact skin and for external<br>use only. | to cover and protect a<br>wound caused by<br>percutaneous medical<br>devices such as drains,<br>chest tubes, orthopedic<br>pins, fixtures, and wires.<br>SurgiClear™ may also be<br>used to cover and secure<br>primary dressings.<br>SurgiClear™ inhibits<br>microbial growth within the<br>dressing and prevents<br>external contamination. | cover and protect insertion<br>sites, and secure devices<br>to skin. Common<br>applications include IV<br>catheters, central venous<br>lines, PICCs, suction<br>catheters, epidural<br>catheters, hemodialysis<br>catheters, orthopedic pins,<br>other intravascular<br>catheters and<br>percutaneous devices. IV<br>Clear™ inhibits microbial<br>growth within the dressing<br>and prevents external<br>contamination. | | Used on intact<br>or breached<br>skin | Used on intact skin | Used on breached skin | Used on insertion site | | General | MediClear™ PreOp is a | SurgiClear™ is a clear film | The clear film allows | | design | clear polyurethane film<br>coated with an<br>antimicrobial silicone<br>adhesive. | which allows the site or<br>the wound to be<br>constantly monitored and<br>assessed. The dressing is<br>self-adhesive and<br>breathable, allowing for<br>good moisture vapor<br>exchange. | continual site observation,<br>and is breathable, allowing<br>moisture vapor exchange. | # Table VIII-2 Reference device comparison table {8}------------------------------------------------ | Active<br>antimicrobial<br>agents | Chlorhexidine diacetate<br>and silver sulfate | Chlorhexidine diacetate<br>and silver acetate | Chlorhexidine diacetate<br>and silver acetate | |---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | Dressing<br>construct | MediClear™ PreOp is a<br>clear polyurethane film<br>coated with an<br>antimicrobial silicone<br>adhesive containing 3%<br>w/w chlorhexidine and<br>0.5% w/w silver salts. | SurgiClear™ is a clear<br>polyurethane film coated<br>with an antimicrobial<br>silicone adhesive<br>containing 3% w/w<br>chlorhexidine and 0.5%<br>w/w silver salts. | The dressing consists of a<br>clear polyurethane film<br>coated with a silicone<br>adhesive containing 3%<br>w/w chlorhexidine and<br>0.5% w/w silver salts. | | Wear time | Up to 7 days | Up to 7 days | Up to 7 days | | Transparent | Yes | Yes | Yes | | ASTM F1670<br>Liquid Barrier<br>Performance | Level 4 | N/A | N/A | | Microbial<br>barrier | Yes | Yes | Yes | | Biocompatible<br>per<br>ISO 10993 | Under the conditions of<br>the studies employed, the<br>device is non-cytotoxic,<br>non-irritating, does not<br>induce acute or subacute<br>toxicity and is non-<br>pyrogenic as per the rabbit<br>pyrogen test. | Cytotoxic, not a dermal<br>sensitizer, not a dermal<br>sensitizer, no systemic<br>toxicity, no subacute<br>toxicity, | Cytotoxic, not a dermal<br>sensitizer, not a dermal<br>sensitizer, no systemic<br>toxicity, no subacute<br>toxicity, | | Sterilization | Ethylene Oxide (ETO) | ETO | ETO | | Single use | Yes | Yes | Yes | #### IX. Non-clinical testing summary The following non-clinical tests have been conducted to support the safety and efficacy of the subject device: | Test item | Refence standard/test method | |-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------| | 7-day Antimicrobial<br>activity | ISO 22196:2010-Plastic-Measurement of Antimicrobial Activity on<br>Plastic Surface | | Minimum Effective<br>Concentration (MEC)<br>of antimicrobial activity | ISO 22196:2010-Plastic-Measurement of Antimicrobial Activity on<br>Plastic Surface | | Cytotoxicity | ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5:<br>Tests for in vitro Cytotoxicity | | Skin Irritation | ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part<br>10: Tests for irritation and skin sensitization | | Guinea Pig<br>Maximization<br>Sensitization | ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part<br>10: Tests for irritation and skin sensitization | | Acute Systemic<br>Toxicity | ISO 10993-11:2006 Biological Evaluation of Medical Devices- Part<br>11: Tests for systemic toxicity | | Subacute Toxicity Test<br>- 4-week | ISO 10993-6: 2007 Biological Evaluation of Medical Devices Part 6<br>Tests for local effects after implantation | | Subcutaneous<br>implantation | ISO 10993-11:2006 Biological Evaluation of Medical Devices- Part<br>11: Tests for systemic toxicity | | Implantation | ISO 10993-6: 2007 Biological Evaluation of Medical Devices Part 6<br>Tests for local effects after implantation | | Material-mediated | ISO 10993-11:2006 Biological Evaluation of Medical Devices- Part | {9}------------------------------------------------ | pyrogencity | 11: Tests for systemic toxicity<br>USP 30 <151> Pyrogenicity Test | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Liquid barrier | AAMI PB-70-2012 Liquid barrier performance and classification of<br>protective apparel and drapes intended for use in health care<br>facilities & ASTM F1670/F1670M-08(Reapproved 2014) Standard<br>test method for resistance of material used in protective clothing to<br>penetration by synthetic blood | | MVTR | E96/E96M-05 Standard Test Methods for Moisture Transmission of<br>Materials<br>EN 13726-2-2002 Test methods for primary wound dressings. Part<br>2: Moisture Vapour Transmission Rate of Permeable Film<br>Dressings | | Real time aging | ICH Q1A Stability Testing of New Drug Substances and Products | | EO sterilization | ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products<br>- Ethylene oxide – Part 1: Requirements for development,<br>validation, and routine control of a sterilization process for medical<br>devices<br>ANSI/AAMI/ISO 10993-7:2008 Biological Evaluation of Medical<br>Devices Part 7: Ethylene oxide sterilization residuals | | Distribution simulation<br>(journey hazards) | ISTA Project 2A (2008); Performance Test for Individual Packaged-<br>Products 150 lb. or Less.<br>ASTM D 4169-09; Performance Testing of Shipping Containers and<br>Systems | #### X. Clinical Testing Clinical testing was not needed for this device. #### XI. Conclusion The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.