Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 6, 2023 Cork Medical Antonio Williams Quality/Regulatory Engineer 8000 Castleway Drive Indianapolis. Indiana 46112 Re: K230677 Trade/Device Name: Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: November 1, 2023 Received: November 6, 2023 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Yu-chieh Chiu -S Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230677 Device Name VERSA Negative Pressure Wound Therapy System 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). The VERSA Negative Pressure Wound Therapy System is not intended for home use environments. Type of Use (Select one or both, as applicable) | <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |-----------------------------------------------------------------------| | <input type="checkbox"/> 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 | | Company Address: | 8000 Castleway Drive<br>Indianapolis, IN 46250 | | Telephone: | 317-361-4387 | | Fax: | 866-271-2580 | | Contact Person: | Antonio Williams | | Date Prepared: | 11/01/2023 | | DEVICE NAME | 807.92(a)(2) | | Trade Name: | VERSA Negative Pressure Wound<br>Therapy System | | Common / Usual Name: | VERSA NPWT System | | Classification Name: | Negative Pressure Wound Therapy<br>Powered Suction Pump | | Regulation Number: | 21 CFR 878.4780 | | Product Code: | OMP | | Device Class: | Class II | | Panel: | General & Plastic Surgery | # PREDICATE DEVICE 807.92(a)(3) | Company | Trade Name | 510(k) Number | |--------------|-----------------------------------------------------------------------|---------------| | Cork Medical | Cork Medical Products Nisus Negative Pressure<br>Wound Therapy System | K140022 | # DEVICE DESCRIPTION ### 807.92(a)(4) Cork Medical has developed a negative pressure wound therapy pump with the same intended {4}------------------------------------------------ use as its predicate device, Cork Medical Products Nisus Negative Pressure Wound Therapy System (K140022) but with a compacted footprint compared to the predict device. The VERSA Negative Pressure Wound Therapy 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 (K140022) which uses multiple buttons and menus to adjust settings. #### INDICATIONS FOR USE #### 807.92(a)(5) 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). The VERSA Negative Pressure Wound Therapy System is not intended for home use environments. ### PHYSICIAN ORDERS Caution: Federal Law (USA) restricts this device to sale by or on the order of a licensed physician. Use of the VERSA NPWT System must be prescribed by a physician per the stated indications for use. As a condition of use, the VERSA NPWT System should only be used by qualified and authorized personnel. The user must have the necessary knowledge of the specific medical application for which negative pressure wound therapy is being used. Prior to placement of the VERSA NPWT System, the medical professional treating the wound must assess how to best use the system for an individual wound. It Is important to carefully assess the wound and patient to ensure clinical indications for negative pressure wound therapy are met. #### USER The VERSA Negative Pressure Wound Therapy System is a prescribed device to be used under the guidance of licensed healthcare professionals. The VERSA NPWT System Instructions for use provide information regarding safe and effective operation of the VERSA Negative Pressure Wound Therapy System. {5}------------------------------------------------ ### USE ENVIRONMENT VERSA NPWT System is designed for the following environmental conditions: Operating Temperature: 18ºC to 34ºC (65ºF to 94ºF) Operating Relative Humidity: 10% - 95% Operating Pressure: 700-hPA – 1060-hPA (10.15-atm – 15.37-atm) atmospheric pressure ## PREDICATE PRODUCT COMPARISON TABLE #### 807.92(a)(6) | | Subject Device | Predicate Device | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | Cork Medical | Cork Medical | | Device Name | VERSA Negative Pressure<br>Wound Therapy System | Cork Medical Products Nisus<br>Negative Pressure Wound<br>Therapy System | | 510(k) Number | K230677 | K140022 | | Regulation Number / Product Code | 21 CFR 878.4780 / OMP | 21 CFR 878.4780 / OMP | | Indications for Use | The VERSA Negative Pressure<br>Wound Therapy System is<br>indicated for use in patients who<br>would benefit from negative<br>pressure wound therapy<br>particularly as the device may<br>promote wound healing by the<br>removal of excess exudates,<br>infectious material, and tissue<br>debris. | The Cork Medical Products<br>Nisus Negative Pressure<br>Wound Therapy System is<br>indicated for use in patients<br>who would benefit from<br>negative pressure wound<br>therapy particularly as the<br>device may promote wound<br>healing by the removal of<br>excess exudates, infectious<br>material, and tissue debris. | | Features | · Compact size<br>· 2 continuous pressure<br>settings of 75mm/Hg and 125<br>mm/Hg<br>• Disposable batteries<br>· Variable intermittent mode | · Multiple keys for navigation<br>including power, menu/select,<br>exit, up arrow, down arrow,<br>left arrow, right arrow<br>· Continuous Setting<br>· Variable Intermittent | | Suction Capacity | 2 liters / minute | 4 liters / minute | | Maximum Vacuum<br>Pressure | 170 mm/Hg | 220-mmHg | | Power Requirements | 3 x 1.5 V (3 AA battery) | 18 VDC, 2A | | Battery Type | Li-ion | Li-ion | | Dimensions | 4.6" (H) x 2.4" (W) x 2.0" (D)<br>Device<br>4.6" (H) x 2.4" (W) x 3.0" (D)<br>with Canister | 151 x 108 x 71-mm (~6<br>x 4.3 x 2.8-inches) | | Weight | 0.6 lb | 0.575-kg (~1.27-lb) | | Reusable | Yes | Yes | | Sterile | Non-sterile | Non-sterile | | Compliance | IEC 60601-1-2 ed 4.0 (2014-02)<br>IEC 60601-1:2005, AMD1:2012<br>CSA C22.2#60601-1:2014 Ed.3<br>AAMI ES60601-1:2005+C1;A2:2010<br>IEC 60601-1-8:2006, AMD1:2012 for use in<br>conjunction with IEC 60601-1:2005, AMD1:2012<br>IEC 60601-1-6:2010, AMD1:2013 for use in<br>conjunction with IEC 62366:2007, AMD1:2014 and<br>IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012<br>IEC 60601-1-11:2015 for use in<br>conjunction with IEC 60601-1:2005, AMD1:2012 | IEC 60601-1, 3rd Edition (AAMI<br>IES 60601-1, CAN/CSA C22.2<br>No. 60601-1-08, EN 60601-1)<br>IEC 60601-1-2<br>IEC 60601-1-6/IEC 62366<br>IEC 60601-1-11 | | Storage & Shipping Conditions | -30°C (-22°F) without relative<br>humidity control to 60°C (140°F)<br>up to 90% relative humidity<br>(non-condensing) | -25°C (-13°F) without relative<br>humidity control to 44°C (111°F)<br>up to 93% relative humidity<br>(noncondensing) | | Environmental Conditions | Operating Temperature: 18°C to<br>34°C (65°F to 94°F)<br>Operating Relative Humidity:<br>10% - 95%<br>Operating Pressure: 700-hPA –<br>1060-hPA (10.15-atm – 15.37-<br>atm) atmospheric pressure | Operating Temperature: 18°C to<br>34°C (65°F to 94°F)<br>Operating Relative Humidity:<br>10% - 95%<br>Operating Pressure: 700-hPA –<br>1060-hPA (10.15-atm – 15.37-<br>atm) atmospheric pressure | | Accessories | Canisters:<br>One canister size 100 ml<br>Features: hydrophobic<br>membrane filter, liquid<br>solidifier<br>Bench Testing completed<br>utilized accessories previously<br>cleared under (K132004) | Canisters:<br>One canister size 250mL<br>Features: hydrophobic<br>membrane filter, liquid<br>solidifier (cleared with<br>application)<br>Wound Dressing Kit: Cork<br>NPWT Wound Dressing Kit<br>(K132004)<br>Bench Testing utilized canisters<br>in application, and accessories<br>cleared on separate application. | {6}------------------------------------------------ {7}------------------------------------------------ #### NONCLINICAL TESTS #### 807.92(b)(1) The VERSA Negative Pressure Wound Therapy System underwent bench performance testing to establish basic functionality. The bench performance tests conducted are: - . Continuous Mode Typical Pressure (75-mmHg) Test - . Continuous Mode Typical Pressure (125-mmHg) Test - . Intermittent Mode Test - Low Battery Test . - Leak Alarm . - Block Alarm . - Canister full . - Flow Rate Testing . - One-Year Aged Canister Testing . - Post-Storage Conditional Testing . - Battery Run-Time Testing . The testing results show the VERSA NPWT System functioned as expected. Performance tests used simulated wound exudate. Pressure measurements were taken using a wound test bed fixture. ## Software Verification and Validation Testing Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern. The corresponding software documentation required for a 510(k) submission is included per "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" as published by the FDA. ### Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing were conducted on the VERSA Negative Pressure Wound Therapy System. The system complies with the IEC 60601-1: 2005, IEC 60601-1-6: 2010, and IEC 60601-1-11: 2010 standards for safety and the IEC 60601-1-2: ed 4.0 (2014-02) standard for EMC. {8}------------------------------------------------ ### CLINICAL TESTS No clinical testing is required to support these 510(k) submissions. No clinical testing has been performed. ### CONCLUSIONS Cork Medical concludes, based on nonclinical testing, that the VERSA Negative Pressure Wound Therapy System is as safe, as effective, and performs as well as the predicate device, Cork Medical Products Nisus Negative Pressure Wound Therapy System (K140022). ## 807.92(b)(2) ### 807.92(b)(3)