PREVANTICS DEVICE SWAB

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "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. The profiles are rendered in a dark color, contrasting with the white background of the seal. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 27, 2014 Professional Disposables International, Inc. Ms. Elizabeth Ernst Senior Director, Regulatory & Medical Affairs Two Nice-Pak Park Orangeburg, NY 10962 Re: K132380 Trade/Device Name: Prevantics® Device Swab Regulation Number: Unclassified Regulation Name: Pad, Alcohol, Device Disinfectant Regulatory Class: Unclassified Product Code: LKB Dated: July 31, 2014 Received: August 1, 2014 Dear Ms. Ernst: 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. {1}------------------------------------------------ Page 2 - Ms. Ernst 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. 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/Resourcesfor You/Industry/default.htm. 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 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 vours. # Erin |. Keith -S Erin I. Keith, M.S. 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) K132380 Device Name Prevantics® Device Swab Indications for Use (Describe) Prevantics® Device swab contains a 3.15% Chlorhexidine Gluconate and 70% (v/v) Isopropyl Alcohol swab is intended for use to disinfect needleless access sites prior to use. 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) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Saiiad H. Digitally signed by Sajjad H. Syed -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Sajjad H. Syed -S, 0.9.2342.19200300.100.1.1=2000601742 Date: 2014.08.27 09:51:06 -04'00' 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}------------------------------------------------ ## Section 5: 510(K) Summary Statement 21(CFR 807.92) | 510 K Summary | | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer Name | Professional Disposables International, Inc. | | Contact Name | Elizabeth Ernst | | Title | Senior Director, Regulatory & Medical Affairs | | Postal Address: | 100 Phillips Parkway, Montvale, NJ 07645 | | Fax: | 845-398-5347 | | Date: | 7/29/2014 | | Device Proprietary<br>Names | Prevantics® Device swab | | Device Common or<br>Usual Name | Chlorhexidine Gluconate (3.15%)* and Isopropyl Alcohol (70%) Swab | | Classification Code | LKB | | Classification Panel | General Hospital | | Regulation Number | N/A | | Predicate Device | Substantial equivalence is claimed to the following devices as related to<br>intended use and design characteristics:<br>Curos® Port Protector, Ivera Medical Corp. (K080466)<br>BD Alcohol Swab, BD Medical – Medical Surgical Systems (K121655) | | Description of the Device | The Prevantics® Device swab is available as a 2 in. x 2 in. swab which<br>contains a 1mL solution (3.15% Chlorhexidine Gluconate and 70% (v/v)<br>Isopropyl Alcohol). The product is intended for single, non-sterile use and<br>is not made with natural rubber latex. The subject device is not intended<br>to treat existing infections. The device is not intended to have any effect<br>on contaminated infusion solutions. The subject device is composed of<br>materials that have been successfully and safely used in medical devices<br>including the predicate devises. | | Intended Use of the<br>Device: | Prevantics® Device swab is intended for needleless access site<br>disinfection. | | Technological<br>Characteristics | The Prevantics® Device Swab has a similar intended use as its predicate<br>device for disinfecting needleless access sites with the home or healthcare<br>facility. It is provided non-sterile and is constructed with 3.15%<br>chlorhexidine gluconate and the same 70% isopropyl alcohol as its<br>predicate devices. It varies in technological characteristics as compared to<br>two (2) of the predicate devices as the subject device is a nonwoven pad<br>saturated with chlorhexidine gluconate (3.15%) and isopropyl alcohol<br>(70%) and the predicate devices are either an alcohol pad (BD Alcohol<br>Pad) or contain an alcohol pad-like sponge within a rigid cap design like<br>Ivera's Curos® Port Protector. | {4}------------------------------------------------ #### Prevantics® Device swab Section 5: 510(K) Summary Statement 21(CFR 807.92) Professional Disposables International, Inc. | 510K Number | | K121655 | K080466 | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | LKB | LKB | LKB | | Device Name | Prevantics® Device Swab | BD Alcohol Swab | Curos® Port | | Manufacturer | Professional Disposable<br>International Inc | BD Medical - Medical Surgical<br>Systems | Ivera Medical Corporation | | Intended Use | When used for scrubbing for 5<br>seconds and drying for 5<br>seconds, Prevantics® Device<br>Swab (a single use device) will<br>disinfect needleless access sites<br>prior to access. | Is a single use, sterile device containing<br>70% Isopropyl alcohol. When used for<br>scrubbing for 5 seconds and allowing<br>drying for 5 seconds, the device will<br>disinfect needleless access sites prior to<br>use. | Is a device containing 70%<br>alcohol, intended for use on<br>swabbable luer access valves as a<br>disinfecting cleaner prior to line<br>access and to act as a physical<br>barrier to contamination between<br>line accesses. The device will<br>disinfect the valve three (3)<br>minutes after application and act<br>as a physical barrier to<br>contamination for up to seven (7)<br>days (168 hours) if not removed. | | Additional<br>Claims | Not made with natural rubber<br>latex | | | | Antimicrobial<br>Agent | Chlorhexidine Gluconate<br>(3.15%) and Isopropyl Alcohol<br>(70%) | 70% Isopropyl Alcohol | 70% Isopropyl Alcohol | | User<br>Population | It may be used in the home or<br>healthcare facility. | It may be used in the home or<br>healthcare facility. | The Curos® Disinfecting Port<br>Protector may be used in the home<br>or healthcare facility. | | Sterilization | Non-sterile | Terminally Sterile (Unknown Method) | Gamma Irradiated | | Packaging | Individually wrapped | Individually wrapped | Individually wrapped | {5}------------------------------------------------ PDI performed multiple non-clinical tests in support of this 510k submission. Testing included the following: a time kill study involving (two gram positive, two gram negative and 2 fungi) evaluated at multiple time points (15 and 30 sec), a minimum effective concentration (MEC) study (tested at 15 and 30 seconds) and a simulated use study. #### Time-Kill Study A time-kill study was performed (based on ASTM E2315 - 03(2008) Standard Guide for Assessment of Microbial Activity Using a Time-Kill Procedure) to determine how rapidly and effectively Prevantics® Device Swab kills a variety of microorganisms. Three (3) lots Prevantics® Device Swab nearing end of shelf life were tested. (Three lots of the devices were labeled as Chlorascrub. This was the device name prior to rebranding. The devices will be referred to as Prevantics® Device Swabs throughout this document.) Sterile Water for Injection was used as a control. Six microorganisms were tested: two (2) Gram positive, two (2) Gram negative and 2 fungi (Staphylococcus aureus (ATCC #6538). Enterococcus faecalis (ATCC #29212). Escherichia coli (ATCC #11229), Pseudomonas aeruginosa (ATCC #15442), Candida albicans (ATCC #10231), and Candida glabrata (ATCC #2001). At both 15 and 30 seconds, application of the Prevantics Device Swab solution to the microbial cultures resulted in a >5.00 log10 reduction in CFU/mL for each of the six (6) microorganism listed above. | | | Mean Log10 Reduction | | |---------------------------------------|--------------------------------------|----------------------|--------| | Microorganism | Test Substance | 15 sec | 30 sec | | Escherichia coli<br>(ATCC #11229) | Chlorascrub Swab<br>Lot No. 11200159 | 6.07 | 6.07 | | | Chlorascrub Swab<br>Lot No. 11200247 | 6.07 | 6.07 | | | Chlorascrub Swab<br>Lot No. 11200251 | 6.07 | 6.07 | | | Sterile Water<br>Lot No. 25065031 | 0.01 | 0.02 | | Staphylococcus aureus<br>(ATCC #6538) | Chlorascrub Swab<br>Lot No. 11200159 | 6.00 | 6.00 | | | Chlorascrub Swab<br>Lot No. 11200247 | 6.00 | 6.00 | | | Chlorascrub Swab<br>Lot No. 11200251 | 6.00 | 6.00 | | | Sterile Water<br>Lot No. 25065031 | -0.01 | 0.06 | | Candida albicans<br>(ATCC #10231) | Chlorascrub Swab<br>Lot No. 11200159 | 5.88 | 5.88 | | | Chlorascrub Swab<br>Lot No. 11200247 | 5.88 | 5.88 | | | Chlorascrub Swab<br>Lot No. 11200251 | 5.88 | 5.88 | | | Sterile Water<br>Lot No. 25065031 | 0.07 | -0.01 | {6}------------------------------------------------ #### Prevantics® Device swab Section 5: 510(K) Summary Statement 21(CFR 807.92) Professional Disposables International, Inc. | Microorganism | Test Substance | Mean Log10 Reduction | | |------------------------------------------|--------------------------------------|----------------------|--------| | | | 15 sec | 30 sec | | Enterococcus faecalis<br>(ATCC #29212) | Chlorascrub Swab<br>Lot No. 11200159 | 5.76 | 5.76 | | | Chlorascrub Swab<br>Lot No. 11200247 | 5.76 | 5.76 | | | Chlorascrub Swab<br>Lot No. 11200251 | 5.76 | 5.76 | | | Sterile Water<br>Lot No. 25065031 | 0.07 | 0.14 | | Pseudomonas aeruginosa<br>(ATCC # 15442) | Chlorascrub Swab<br>Lot No. 11200159 | 6.46 | 6.46 | | | Chlorascrub Swab<br>Lot No. 11200247 | 6.46 | 6.46 | | | Chlorascrub Swab<br>Lot No. 11200251 | 6.46 | 6.46 | | | Sterile Water<br>Lot No. 25065031 | 0.20 | 0.23 | | Candida glabrata<br>(ATCC #2001) | Chlorascrub Swab<br>Lot No. 11200159 | 6.07 | 6.07 | | | Chlorascrub Swab<br>Lot No. 11200247 | 6.07 | 6.07 | | | Chlorascrub Swab<br>Lot No. 11200251 | 6.07 | 6.07 | | | Sterile Water<br>Lot No. 25065031 | 0.16 | 0.19 | ## Minimal Effective Concentration (MEC) Study The minimal effective concentration was examined using a range of dilutions of the Prevantics® Device Swab solution (50 - 90% of nominal). The testing was performed using the same techniques outlined in the Time-Kill Study section above. The microorganisms were limited to one each of Gram positive, Gram negative and fungus (Staphylococcus aureus (ATCC #6538), Escherichia coli (ATCC #11229), and Candida albicans (ATCC #10231)). At both 15 and 30 seconds, application of the Prevantics® Device Swab solution to the microbial cultures resulted in a >4.00 log10 reduction in CFU/mL for each of the three (3) microorganism listed above. The results indicate that even when diluted to 50% of the nominal concentration, Prevantics Device Swab contains an effective antimicrobial combination. {7}------------------------------------------------ #### Simulated Use Study Additionally, in-vitro data from a Simulated Use Study is also submitted to substantiate performance that the subject device is substantially equivalent to the predicate devices. | | | Mean Log10 Reduction (CFU/mL) of Needless Access<br>Site After 5 Second Application | | | | | |--------------------------------------------------|------|-------------------------------------------------------------------------------------|---------------|---------------|-------------------------------|---------------| | Microorganism | Soil | Mean<br>Lot 1 | Mean<br>Lot 2 | Mean<br>Lot 3 | Overall<br>Mean<br>Prevantics | Mean<br>Curos | | Candida albicans<br>(ATCC #10231) | No | 6.5 | 6.5 | 4.9 | 6.0 | 6.5 | | | Yes | 6.2 | 6.2 | 6.2 | 6.2 | 5.3 | | Candida parapsilosis<br>(ATCC #7330) | No | 7.2 | 5.2 | 7.2 | 6.5 | 2.1 | | | Yes | 4.8 | 5.4 | 3.5 | 4.6 | 2.5 | | Escherichia coli<br>(ATCC #25922) | No | 5.7 | 4.9 | 4.4 | 5.0 | 6.3 | | | Yes | 4.8 | 6.2 | 3.1 | 4.7 | 6.2 | | Pseudomonas aeruginosa<br>(ATCC #27853) | No | 3.3 | 4.4 | 4.6 | 4.1 | 5.5 | | | Yes | 5.3 | 4.3 | 3.1 | 4.2 | 5.4 | | Staphylococcus aureus MRSA<br>(ATCC #33591) | No | 5.1 | 3.6 | 3.4 | 4.1 | 6.5 | | | Yes | 6.6 | 4.9 | 4.9 | 5.5 | 4.3 | | Staphylococcus epidermidis MRSE<br>(ATCC #51625) | No | 2.3 | 2.8 | 2.3 | 2.4 | 2.7 | | | Yes | 4.6 | 3.0 | 1.3 | 2.9 | 2.2 | | Staphylococcus aureus<br>(ATCC #6538)* | No | 5.8 | 5.5 | 6.2 | 5.8 | 5.5 | | | Yes | 4.7 | 6.1 | 5.4 | 5.4 | 6.2 | | Staphylococcus epidermidis<br>(ATCC #12228)* | No | 5.5 | 5.4 | 5.3 | 5.4 | 5.7 | | | Yes | 6.4 | 5.7 | 5.5 | 5.9 | 5.0 | * The testing of both Staphylococcus aureus and Staphylococcus epidermidis were repeated after the initial results for Staphylococcus epidermidis demonstrated a <3 logio reduction for both predicate and test devices. The results demonstrate that Prevantics® Device Swab produces a >4.0 log10 reduction in microbial CFU/mL for seven (7) of eight (8) tested microorganisms, regardless of soil conditions. In comparison, the predicate device (Curos® Port Protector) achieved similar >4.0 log10 reduction on six (6) of eight (8) microorganisms. The Curos® Port Protector failed to achieve a >4.0 log10 reduction for Candida parapsilosis (ATCC #7330) and Staphylococcus epidermidis MRSE (ATCC 51625). The results of the simulated use testing indicate that Prevantics® Device Swab provides substantially equivalent results to the predicate device (Curos® Port Protector). {8}------------------------------------------------ | Determination of Substantial<br>Equivalence: | Summary of Non-Clinical Tests | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | A variety of non-clinical tests were conducted to show the safety<br>and effectiveness of the subject device including comparisons<br>against the predicate devices. Standardized test methods from ISO-<br>10993 were used in this testing and the methods and results are<br>described in the submission. | | | Summary of Clinical Tests<br>No new clinical tests were required to support the change.<br><br>The review of the indications for use, the technical characteristics<br>and the results provided from the non-clinical tests performed to<br>satisfy International Standard ISO-10993, Biological Evaluation of<br>Medical Devices Part 1: Evaluation and Testing (Cytotoxicity,<br>Closed Patch Test, Dermal Irritation, Systemic Toxicity)<br>demonstrate that Prevantics® Device Swabs are substantially<br>equivalent to the predicate devices. | - Conclusion Prevantics® Device Swab shares the same indications for use, similar design and functional features and was found to be substantially equivalent to the predicate devices. Prevantics® Device Swab has the same intended use as the predicate; and while it has different technological characteristics, the information submitted to FDA does not raise new questions of safety and effectiveness and demonstrates that the device is at least as safe and effective as the legally marketed devices. This summary includes all information necessary and Professional Disposable International Inc will provide any additional information requested by FDA during review of the 510(k). Professional Disposable International Inc verifies that the following criteria have been met. - The summary includes only information that is also covered in the body of the 510(k). . - The summary does not contain any puffery or unsubstantiated labeling claims. . - The summary does not contain any raw data, i.e., contains only summary data. ● - The summary does not contain any trade secret or confidential commercial information. . - The summary does not contain any patient identification information. .