VERSA Negative Pressure Wound Therapy System (VCMPP-100)

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August 21, 2024 Cork Medical Antonio Williams Quality/Regulatory Engineer 8000 Castleway Drive Indianapolis, Idaho 46250 Re: K241061 Trade/Device Name: VERSA Negative Pressure Wound Therapy System (VCMPP-100) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: May 13, 2024 Received: May 24, 2024 Dear Antonio Williams: 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. 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 {1}------------------------------------------------ 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 medical devices and radiation-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, Yu-chieh Chiu -S Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K241061 Device Name VERSA Negative Pressure Wound Therapy System (VCMPP-100) Indications for Use (Describe) The VERSA Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris. The VERSA Negative Pressure Wound Therapy System is only intended to be used with the Cork NPWT Wound Dressing Kit (K132004) and the VERSA NPWT 100ml Canister. The VERSA Negative Pressure Wound Therapy System is suitable for use in both a professional healthcare facility and home use environment. | 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 807.92(c) ## SPONSOR 807.92(a)(1) | Company Name: | Cork Medical, LLC | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company Address: | 8000 Castleway Drive<br>Indianapolis, IN 46250 | | Telephone: | 317-361-4387 | | Fax: | 866-271-2580 | | Establishment Registration<br>Number | 3010588638 | | Contact Person: | Antonio Williams<br>Regulatory Engineer<br>awilliams@corkmedical.com | | Date Prepared: | 04/17/2024 | | DEVICE NAME | 807.92(a)(2) | | Trade Name | VERSA Negative Pressure Wound Therapy System (VCMPP-100) | | Common/Usual Name: | VERSA NPWT System | | Model Number | VCMPP-100 | | Classification Name: | Powered Suction Pump | | Regulation Number: | 21 CFR 878.4780 | | Product Code: | OMP | | Device Class: | Class II | | Panel: | General & Plastic Surgery | | Reason for 510(k) Traditional | Change the environment of use identified under K230677 for the VERSA NPWT System from a professional healthcare facility only to both professional healthcare facility and home use environment Update Firmware - Firmware update will add a troubleshooting display that will cycle on the LCD 1 of 5 | {4}------------------------------------------------ screen after the alarm condition occurs. - Adding visual inspection instructions in both the . Instruction for Use (IFU) and Quick Refence Guide (QRG) according to FDA Guidance: - Added Illustrations to the IFU . #### PREDICATE DEVICE #### 807.92(a)(3) 807.92(a)(4) 807.92(a)(5) | Company | Trade Name | 510(k)<br>Number | |--------------|--------------------------------------------------------------|------------------| | Cork Medical | Cork Medical VERSA Negative Pressure Wound<br>Therapy System | K230677 | #### DEVICE DESCRIPTION #### The Cork Medical VERSA Negative Pressure Wound Therapy System is designed to provide gentle powered suction to treat and promote wound healing by aiding in the removal of excess exudates, infectious material, and tissue debris. The single button design makes applying negative pressure wound therapy for patients and physicians without compromising the power and performance demanded for wound management. The VERSA NPWT System interface utilizes a single membrane switch keypad to power the device and switch between continuous and intermittent therapy modes. One button power on and off the pump and the other button switches pressure settings from 75 mm/Hg and 125 mm/Hg continuous and a 10 second hold on this button switches the pump to a variable intermittent mode, unlike its predecessor Cork NPWT System which uses multiple buttons and menus to adjust settings. The VERSA NPWT System includes a therapy pump, 100 ml collection disposable canister, and carrying bag. The VERSA NPWT System is only intended to be used with the Cork NPWT Wound Dressing Kit. #### INDICATIONS FOR USE The VERSA Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris. The VERSA Negative Wound Therapy System is only intended to be used with the Cork NPWT Wound Dressing Kit (K132004) and the VERSA 100 ml Canister. The VERSA Negative Wound Therapy System is suitable for use in both a professional healthcare facility and home use environment. {5}------------------------------------------------ # PREDICATE PRODUCT COMPARSION TABLE # 807.92(a)(6) | | Subject Device | Predicate Device | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | Cork Medical | Cork Medical | | Device Name | VERSA Negative Pressure<br>Wound Therapy System | VERSA Negative Pressure<br>Wound Therapy System | | 510(k) Number | K241061 | K230677 | | Regulation Number /<br>Product Code | 21 CFR 878.4780 / OMP | 21 CFR 878.4780 / OMP | | Indications for Use | The VERSA Negative<br>Pressure Wound Therapy<br>System is indicated for use in<br>patients who would benefit<br>from negative pressure<br>wound therapy particularly as<br>the device may promote<br>wound healing by the<br>removal of excess exudates,<br>infectious material, and tissue<br>debris.<br>The VERSA Negative<br>Wound Therapy System is<br>only intended to be used with<br>the Cork NPWT Wound<br>Dressing Kit (K132004) and<br>the VERSA 100 ml Canister.<br>The VERSA Negative<br>Wound Therapy System is | The VERSA Negative<br>Pressure Wound Therapy<br>System is indicated for use<br>in patients who would<br>benefit from negative<br>pressure wound therapy<br>particularly as the device<br>may promote wound healing<br>by the removal of excess<br>exudates, infectious<br>material, and tissue debris.<br>The VERSA Negative<br>Wound Therapy System is<br>only intended to be used<br>with the Cork NPWT<br>Wound Dressing Kit<br>(K132004) and the VERSA<br>100 ml Canister. | | | suitable for use in both a<br>professional healthcare<br>facility and home use<br>environment. | | | Features | No change | · Compact size<br>· 2 continuous pressure<br>settings of 75mm/Hg<br>and 125 mm/Hg<br>· Disposable batteries<br>· Variable intermittent mode | | Suction Capacity | No change | 2 liters / minute | | Maximum Vacuum<br>Pressure | No Change | 170 mm/Hg | | Power Requirements | No Change | 3 x 1.5 V (3 AA battery) | | Battery Type | No Change | Li-ion | | Dimensions | No Change | 4.6" (H) x 2.4" (W) x 2.0"<br>(D) - Device<br>4.6" (H) x 2.4" (W) x 3.0"<br>(D) with Canister | | Weight | No change | 0.6 lb. | | Reusable | No Change | Yes | | Sterile | No Change | Non-sterile | | Compliance | No Change | IEC 60601-1-2 ed 4.0 (2014-<br>02)<br>IEC 60601-1:2005,<br>AMD1:2012 CSA<br>C22.2#60601-1:2014 Ed.3<br>AAMI ES60601-<br>1:2005+C1;A2:2010<br>IEC 60601-1-8:2006,<br>AMD1:2012<br>for use in conjunction with<br>IEC 60601-1:2005,<br>AMD1:2012<br>IEC 60601-1-6:2010,<br>AMD1:2013<br>for use in conjunction with<br>IEC 62366:2007,<br>AMD1:2014 and IEC<br>60601-1:2005, COR1:2006,<br>COR2:2007, AMD1:2012<br>IEC 60601-1-11:2015 for<br>use in conjunction with IEC<br>60601-1:2005, AMD1:2012 | | Storage & Shipping<br>Conditions | No Change | -30°C (-22°F) without<br>relative humidity control<br>to 60°C (140°F)<br>up to 90% relative<br>humidity (non-<br>condensing) | | Environmental<br>Conditions | No Change | Operating Temperature:<br>18°C to 34°C (65°F to 94°F)<br>Operating Relative<br>Humidity: 10% - 95%<br>Operating Pressure: 700-<br>hPA - 1060-hPA (10.15-atm<br>- 15.37-atm)<br>atmospheric pressure | | Accessories | No Change | Canisters:<br>One canister size 100 ml<br>Features: hydrophobic<br>membrane filter, liquid<br>solidifier<br>Wound Dressing Kit: Cork<br>NPWT Wound Dressing Kit<br>(K132004)<br><br>Bench Testing completed<br>utilized accessories<br>previously cleared on<br>separate 510k applications<br>to mimic the predicate<br>device setting. | {6}------------------------------------------------ {7}------------------------------------------------ ## NONCLINICAL TESTS #### 807.92(b)(1) The VERSA Negative Pressure Wound Therapy System underwent bench performance testing and usability testing to demonstrate substantial equivalence to the predicate device. The bench performance tests conducted are: - . Block Alarm Testing - Canister Full Alarm Testing . - Leak Alarm Testing . - Low Battery Alarm Testing . The testing results show the VERSA NPWT System functioned as safe and effective as the predicate device. The software modifications were developed, tested and assessed according to FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and FDA-recognized standard: IEC 62304 Ed. 1.1 b:2015 The usability testing was conducted in accordance with the applicable guidelines listed in FDA Guidance Document: Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016) and in FDA-recognized standards: IEC 62366-1:2015+AMD1:2020 and ANSI/AAMI HE75:2009 # CLINICAL TESTS No clinical testing required to support these 510(k) submissions. No clinical testing has been performed. # CONCLUSIONS The subject devices indications for use, fundamental technology and principles of operation are unchanged when compared to the predicate devices as cleared under K230677. Minor changes between the subject and predicate device as cleared under K230677: - Update Firmware . - Adding visual inspection instructions in the Instruction for Use (IFU) ● - Add illustrations Quick Refence Guide (ORG) according to FDA Guidance for Home Use . The minor technological differences between the subject VERSA NPWT System provide additional safety features to further mitigate existing risks for the home use environment, do not significantly affect the effectiveness of the device and do not represent a major change in user tasks or interactions. The subject device is as safe and effective as the predicate device. Thus, the subject VERSA NPWT System is substantially equivalent to its predicate. # 807.92(b)(3) 807.92(b)(2)