Longterm NPWT Foam Dressing Kit

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May 23, 2019 Zhejiang Longterm Medical Technology Co., LTD Claudia Zsang Director of Regulatory Affairs No. 493 North Huancheng Road Mogan Mountain National High-Tech District Deging, 313200 Cn Re: K182458 Trade/Device Name: Longterm NPWT Foam Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: April 14, 2019 Received: April 23, 2019 Dear Claudia Zsang: 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for David Krause, Ph.D. Acting Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182458 Device Name Longterm NPWT Foam Dressing Kit ### Indications for Use (Describe) The dressing kit is intended to be used along with VCare 1000-300S pump for wound management via the application of negative pressure to the wound, in order for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The NPWT foam dressing kit is for use in professional healthcare facilities only. Type of Use (Select one or both, as applicable) | <label><input checked="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 ### 1 The 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807. 92(c). | Date Prepared: | May 20, 2019 | |-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant: | Zhejiang Longterm Medical Technology Co., LTD<br>No. 493 North Huancheng Road, Mogan Mountain National High-<br>Tech District, Deqing Zhejiang, CHINA 313200 | | Official Correspondent: | Claudia Zsang<br>claudiaz@longterm-health.com | | Phone Number: | 416-276-9555 | | Device Name: | Longterm NPWT Foam Dressing Kit | | Common Name: | NPWT System Accessories | | FDA Panel: | General & Plastic surgery | | Product Code: | OMP | | Class: | II | | Predicate Devices: | VCare 1000-300S Pump, VCare 1000-300S System, Perme-<br>foam Dressing (K162159)<br>Cork Medical Products- Cork Medical Products NPWT Wound Dressing<br>Kit (K132004)<br>V.A.C.® ATS, mini VAC, VAC Freedom (K032310) | #### 2 Device Description: Longterm NPWT dressing kit is a single use device as an accessory to VCare 1000-300S pump, manufactured by VR Medical Technology Co., Ltd. The dressing kit consists of hydrophobic, reticulated Polyurethane foam, polyurethane film drape coated with acrylic adhesive, suction bell composed of a polyvinyl chloride (PVC) drainage tubing with a polypropylene pinch clamp, a bell shape dome made of polyvinyl chloride, a transparent polyurethane film coated with acrylic adhesive. Each component is individually packaged and sterilized. The suction bell is comprised of a polyvinyl chloride drainage tubing with a polypropylene pinch clamp, a bell shape dome made of polyvinyl chloride, a transparent poly urethane film coated with acrylic adhesive. Foam dressing is available in 4 sizes; small (10cmx7.5cmx2.5cm), medium {4}------------------------------------------------ (18cmx12.5cmx2.5cm), large (26cmx15cmx2.5cm) and extra large (45cmx30cmx2.5cm). PU film drape is available in 2 sizes; 30cmx30cm and 45cmx30cm. The foam dressing is used to pack the wound bed, the film drape is used to cover the packed wound bed and peri-wound area to create and maintain a sealed environment, the suction bell is served as a conduit between the wound bed and the suction pump to transfer the wound fluid to the canister attached to the suction pump. The foam dressing should not be used for more than 24 hours and should be replaced with other dressings compatible with the VCare 1000-300S pump after 24 hours. #### 3 Indications for Use: The dressing kit is intended to be used along with VCare 1000-300S pump for wound management via the application of negative pressure to the wound, in order for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The NPWT foam dressing kit is for use in professional healthcare facilities only. {5}------------------------------------------------ ### 4 Substantial Equivalence | Parameter | Subject Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k)# | K182458 | K162159 | K132004 | K032310 | | Device name | Longterm NPWT Foam<br>Dressing Kit | VCare 1000-300S Pump,<br>VCare 1000-300S System,<br>Perme-foam Dressing<br>(K162159) | Cork NPWT Wound<br>Dressing Kit | KCI-V.A.C. ATS, mini<br>VAC, VAC Freedom | | Note | Accessory to VCare pump (510<br>(k) K162159) | - | - | Only foam dressing is<br>used as the predicate | | Classification<br>Regulation | 878.4780 | Same | Same | Same | | Product Code | OMP | Same | Same | Same | | Skin Contact<br>Materials | - Polyurethane ester foam with<br>0.1% carbon black colorant<br>- Polyurethane film with acrylic<br>adhesive | - Polyurethane ester foam;<br>- Polyurethane drape | - Reticulated polyether based<br>polyurethane foam (30<br>pores per inch);<br>- Transparent polyurethane<br>film drape with adhesive<br>backing | - Black, reticulated,<br>polyurethane foam | | Non-Skin<br>Contact<br>Materials | Suction Bell comprised of a<br>polypropylene drainage tubing<br>with a polypropylene pinch<br>clamp, a bell shape dome made<br>of polyvinyl chloride, a<br>transparent poly urethane film<br>coated with acrylic adhesive. | Suction Bell with connecting<br>(drainage) tube and clamp | port pad comprised of port<br>pad, drainage tubing, luer<br>connector, pinch clamp,<br>transparent film drape with<br>adhesive backing. | Suction bell with drainage<br>tube | | Intended Use | The dressing kit is intended to be<br>used along with VCare 1000-<br>300S pump for wound<br>management via the application<br>of negative pressure to the<br>wound, in order for the removal<br>of fluids, including wound<br>exudates, irrigation fluids, body | The VR Medical VCare 1000-<br>300S Negative Pressure Wound<br>Therapy System is an<br>integrated wound management<br>system, indicated for wound<br>management via the application<br>of negative pressure to the<br>wound, in order for the removal | Cork Medical Products<br>NPWT Wound Dressing Kit<br>is intended to be used in<br>conjunction with the<br>Genadyne XLRS Pump to<br>deliver negative pressure<br>wound therapy to the wound.<br>When used in conjunction | The V.A.C. family of<br>devices are feedback-<br>controlled negative<br>pressure devices used<br>to help promote wound<br>healing, through means<br>including vacuum assisted<br>drainage and | | | | | | | | | fluids and infectious materials.<br>The system is intended for<br>patients with chronic, acute,<br>traumatic, subacute and dehisced<br>wounds, partial-thickness burns,<br>ulcers (such as diabetic or<br>pressure), flaps and grafts. | of fluids, including wound<br>exudates, irrigation fluids, body<br>fluids and infectious materials.<br>The system is intended for<br>patients with chronic, acute,<br>traumatic, subacute and<br>dehisced wounds, partial-<br>thickness burns, ulcers (such as<br>diabetic or pressure), flaps and<br>grafts. | with a NPWT pump system,<br>Cork Medical Products<br>NPWT Wound Dressing Kit<br>is indicated for patients who<br>would benefit from a suction<br>device particularly as the<br>device may promote wound<br>healing by the removal of<br>excess exudates, infectious<br>material, and tissue debris. | removal of infectious<br>material or other fluids,<br>under the influence of<br>continuous and or<br>intermittent suction<br>pressures, particularly for<br>patients with chronic,<br>acute, traumatic,<br>subacute and dehisced<br>wounds, partial-thickness<br>burns, ulcers (such as<br>diabetic or<br>pressure), flaps and grafts.<br>Feedback control is<br>achieved by measuring the<br>level of<br>negative pressure at the<br>wound site. | | Use environment | The foam dressing kit is for use<br>in professional healthcare<br>facilities only. | The subject device is for use in<br>professional healthcare<br>facilities only. | The subject device is for use<br>in professional healthcare<br>facilities only. | The subject device is for<br>use in professional<br>healthcare facilities only. | | Biocompatibility<br>(Foam) | Non-cytotoxic, non-irritant, non-<br>sensitizing, non- pyrogenic | Non-cytotoxic, non-irritant,<br>non-sensitizing, non-toxic, non-<br>pyrogenic | Non-cytotoxic, non-irritant,<br>non-sensitizing | Biocompatible | | Biocompatibility<br>(Drape) | Non-cytotoxic, non-irritant, non-<br>sensitizing, non-toxic, non-<br>pyrogenic | Non-cytotoxic, non-irritant,<br>non-sensitizing, non-toxic, non-<br>pyrogenic | Non-cytotoxic, non-irritant,<br>non-sensitizing | Biocompatible | | Biocompatibility<br>(Suction bell) | Non cytotoxic, non-irritant, non-<br>sensitizing | Biocompatible | Biocompatible | Biocompatible | | Sterilization | Each kit components<br>individually sterilized by<br>Ethylene Oxide or Gamma<br>Irradiation | Gamma Irradiation | Individual kit components<br>individually sterilized by<br>Ethylene Oxide or Gamma<br>Irradiation | Gamma irradiation | | Sterility | SAL of 10-6 | SAL of 10-6 | SAL of 10-6 | SAL of 10-6 | | Assurance Level | | | | | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ #### Non-clinical Testing Summary: 5 The following tests were performed to support the substantial equivalence of the subject device: ## Biocompatibility Testing: - Cytotoxicity ISO 10993-5:2009 (Foam, Drape, Suction bell) ● - Irritation ISO 10993-10:2010 (Foam, Drape, Suction bell) ● - Sensitization ISO 10093-10:2010 (Foam, Drape, Suction bell) ● - Pyrogenicity -ISO 10993-11:2006/USP39-NF34 <151> (Foam, Drape) - Acute systemic toxicity ISO 10993-11:2017 (Foam, Drape) ● ## Bench testing: Longterm NPWT Foam Dressing Kit was evaluated under of bench tests to ensure the dressing kit can be used along with VCare 1000-300S pump regarding performance and functionality requirements. - The foam dressing dimension test under continuous various negative pressure mode after 72 ● hours: - The fluid removal rate under various negative pressure in 72 hours; - . The pressure distribution under the foam dressing in 72 hours under continuous negative pressure mode; - The pressure difference under the foam dressing in 72 hours under intermittent negative pressure mode. - Mechanical properties (tensile strength and elongation, ASTM D3574) . #### 6 Clinical Testing: No clinical testing was required to support substantial equivalence. #### 7 Conclusion: The non-clinical tests demonstrate that the subject device is as safe, as effective and performs as well as the legally marked predicate devices.