Innomed NPWT Silicone Foam Dressing

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December 15, 2021 Zhejiang Longterm Medical Technology Co., LTD Claudia Zsang Director of Regualtory Affair No. 493 North Huancheng Road, Mogan Mountain National High-Tech District Deqing, Zhejiang 313200 China Re: K202823 Trade/Device Name: Innomed NPWT Silicone Foam Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: November 17, 2021 Received: November 17, 2021 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. {1}------------------------------------------------ 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 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. Julie Morabito, PhD, RAC For Assistant Director DHT4B: Division of of Infection Control and Plastic 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) K202823 Device Name Innomed NPWT Silicone Foam Dressing ### Indications for Use (Describe) Innomed NPWT Silicone Foam Dressing 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. When used along with VCare 1000-300S pump, Innomed NPWT Silicone Foam Dressing is intended for patients with the following wound types: - Chronic - Acute - · Traumatic - Subacute and dehisced wounds - · Partial-thickness burns, - · Ulcers (such as diabetic or pressure) - · Flaps and grafts The device is for use in professional healthcare facilities only. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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: | December 10, 2021 | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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>claudia.zang@gmail.com | | Phone Number: | 416-276-9555 | | Device Name: | Innomed NPWT Silicone Foam Dressing | | Common Name: | NPWT System Accessories | | FDA Panel: | General & Plastic surgery | | Product Code: | OMP | | Regulation Number: | 21 CFR 878.4780 | | Regulation Name: | Powered Suction Pump | | Class: | II | | Predicate Devices: | Primary Predicate Device:<br>VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam<br>Dressing (K162159)<br>Secondary Predicate Device:<br>PICO Single Use Negative Pressure Wound Therapy System<br>(K151436) | #### 2 Device Description: Innomed NPWT Silicone foam dressing is a single-use device, as an accessory to VCare-1000-300S pump, manufactured by VR Medical Technology Co., Ltd. The NPWT Silicone foam dressing consists of silicone adhesive coated foam dressing attached with a suction bell and fixation film strips. The silicone foam dressing is comprised of PU film, absorbent pad consisting of polyurethane (PU) foam, absorbent fibre and polyester fabric, a layer silicone adhesive is coated onto the entire surface. The suction bell is comprised of a polyvinyl chloride drainage tubing with a polypropylene pinch clamp, a polypropylene luer taper, a bell shape dome made of polyvinyl chloride, a {4}------------------------------------------------ transparent poly urethane film coated with acrylic adhesive. The suction bell is attached on the silicone foam dressing surface. Fixations film strips is composed of PU film coated with acrylic adhesive. Machnism of Action: The silicone adhesive coated foam dressing is used to pack the wound bed and cover periwound area, and the fixation film strips are applied over the outside edges of the dressing to facilitate hold the silicone foam dressing in place and seal the wound bed area. The other end of the attached suction bell is connected to a canister attached to the negative pressure pump, VCare 1000-300S pump, and served as a conduit to transfer the wound exudate to the canister under negative pressure when the pump is turned on. Innomed NPWT Silicone Foam Dressing is available in 10 sizes: SNPWT-1010 ( 10cm X 10cm ), SNPWT-1020 (10cm X 20cm ), SNPWT-1030 (10cm X 30cm ), SNPWT-1040( 10cm X 40cm ), SNPWT-1515(15cm X 15cm ), SNPWT-1520 (15cm X 20cm ), SNPWT-1530 (15cm X 30cm ), SNPWT-2020 (20cm X 20cm ), SNPWT-2025(20cm X 25cm ), SNPWT-2525(25cm X 25cm ) #### Indications for Use: 3 Innomed NPWT Silicone Foam Dressing 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. When used along with VCare 1000-300S pump, Innomed NPWT Silicone Foam Dressing is intended for patients with the following wound types: - Chronic - Acute - · Traumatic - · Subacute and dehisced wounds - · Partial-thickness burns, - · Ulcers (such as diabetic or pressure) - · Flaps and grafts The device is for use in professional healthcare facilities only. {5}------------------------------------------------ #### 4 Substantial Equivalence Comparison | Characteristics | Subject Device | Primary Predicate Device | Secondary Predicate Device | Comment | |----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------| | 510(k)# | K202823 | K162159 | K151436 | | | Device name | Innomed NPWT Silicone Foam Dressing | VCare 1000-300S Pump, Vcare 1000-300S System, | PICO Single Use Negative Pressure Wound<br>Therapy System(K151436) | | | Note | Accessory to Vcare pump (510 (k)<br>K162159) | Only the foam dressing is used as the predicate | Only silicone foam dressing is used as<br>the predicate | | | Class | Class II | Class II | Class II | Same | | Classification<br>Regulation | 21CFR 878.4780 | 21CFR 878.4780 | 21CFR 878.4780 | Same | | Product Code | OMP | OMP | OMP | Same | | Skin Contact<br>Materials | - Silicone foam dressing<br>- PU film strips coated with acrylic<br>adhesive | - Foam dressing | - Silicone foam dressing<br>- PU film strips with acrylic adhesive | Similar to<br>secondary<br>predicate | | Non-Skin<br>Contact<br>Materials | Suction Bell system | Suction Bell system | Suction bell system | Similar to<br>primary<br>/secondary<br>predicates | | Mechanism of<br>Action | The silicone foam dressing is used to pack<br>the wound bed and provide a sealed<br>environment. The wound fluid is removed<br>from the wound bed to a canister through<br>the attached suction bell tube under a<br>negative pressure. | The foam dressing is used to pack the wound bed<br>and provide a sealed environment. The wound fluid<br>is removed from the wound bed to a canister<br>through the attached suction bell tube under a<br>negative pressure. | The silicone foam dressing is used to pack<br>the wound bed and provide a sealed<br>environment. The wound fluid is removed<br>from the wound bed to a canister through the<br>attached suction bell tube under a negative<br>pressure. | Similar to<br>primary/<br>secondary<br>predicates | | Indications<br>for Use | Innomed NPWT Silicone Foam Dressing<br>is intended to be used along with VCare<br>1000- 300S pump for wound management<br>via the application of negative pressure to<br>the wound, in order for the removal of<br>fluids, including wound exudates,<br>irrigation fluids, body fluids and infectious<br>materials.<br>When used along with VCare 1000-300S<br>pump, Innomed NPWT Silicone Foam | The VR Medical VCare 1000-300S Negative<br>Pressure Wound Therapy System is an integrated<br>wound management system, indicated for wound<br>management via the application of negative<br>pressure to the wound, in order for the removal of<br>fluids, including wound exudates, irrigation fluids,<br>body fluids and infectious materials. The system is<br>intended for patients with chronic, acute, traumatic,<br>subacute and dehisced wounds, partial-thickness<br>burns, ulcers (such as diabetic or pressure), flaps<br>and grafts. | PICO is intended for the patients who<br>may benefit from a suction device (Negative<br>Pressure Wound Therapy) as it may promote<br>wound healing via removal of low to<br>moderate levels of exudate and infectious<br>materials.<br>Appropriate wound types include:<br>- Chronic<br>- Acute<br>- Traumatic<br>- Subacute and dehisced wounds | A subset of<br>the primary /<br>secondary<br>predicates | | Characteristics | Subject Device | Primary Predicate Device | Secondary Predicate Device | Comment | | 510(k)# | K202823 | K162159 | K151436 | | | | Dressing is intended for patients with the<br>following wound types:<br>• Chronic<br>• Acute<br>• Traumatic<br>• Subacute and dehisced wounds<br>• Partial-thickness burns,<br>• Ulcers (such as diabetic or pressure)<br>• Flaps and grafts<br>The device is for use in professional<br>healthcare facilities only. | The device is for use in professional healthcare<br>facilities only. | • Partial-thickness burns<br>• Ulcers(such as diabetic or pressure)<br>• Flaps and grafts<br>• Closed surgical incisions<br>PICO single use negative pressure wound<br>therapy system is suitable for use both in a<br>hospital and homecare setting. | | | Use<br>environment | The device is for use in professional<br>healthcare facilities only. | The device is for use in professional healthcare<br>facilities only. | The device is suitable for use both in a<br>hospital and homecare setting. | Same to<br>primary<br>predicate | | Biocompatibil<br>ity<br>(silicone foam<br>dressing,<br>(breached<br>skin,<br>prolonged,<br>>24hr to<br>30days) | Non-cytotoxic, non-irritating, non-<br>sensitizing, non-toxic, non-pyrogenic | Non cytotoxic, non-irritant, non-sensitizing, non-<br>toxic, none- pyrogenic | Non cytotoxic, Negligible irritant, non-<br>sensitizing | Same to<br>primary/secon<br>dary<br>predicates | | Sterilization | Ethylene Oxide | Gamma Irradiation | Ethylene Oxide | Same to<br>secondary<br>predicate | | Sterility<br>Assurance<br>Level | SAL of 10-6 | SAL of 10-6 | SAL of 10-6 | Same to<br>primary/secon<br>dary<br>predicates | | Single Use | Yes | Yes | Yes | Same to<br>primary/secon<br>dary<br>predicates | | Characteristics | Subject Device | Primary Predicate Device | Secondary Predicate Device | Comment | | 510(k)# | K202823 | K162159 | K151436 | | | Prescription | Yes | Yes | Yes | Same to | | | | | | primary | | | | | | predicate | | Shelf-life | 3 years | 3 years | 2 years | Same to | | | | | | primary | | | | | | predicate | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ #### 5 Non-clinical Testing Summary: The following tests were performed to support the safety and effectiveness of the subject device: ## Biocompatibility Testing: - Cytotoxicity ISO 10993-5:2009 . - Irritation ISO 10993-10:2010 ● - Sensitization ISO 10093-10:2010 ● - Acute and subacute systemic toxicity- ISO 10993-11:2017 - Material mediated pyrogenicity ISO 10993-11:2017/USP<151> ● - Implantation ISO 10993-6:2016 . ## Bench testing: Innomed NPWT Silicone Foam Dressing was evaluated under of bench tests, along with the predicate, to ensure the dressing can be used along with VCare 1000-300S pump regarding performance and functionality requirements and performs similarly as the predicates. | Test Parameters | Subject<br>Device<br>(K202823) | Secondary<br>predicate<br>(K151436) | Comment | |----------------------------------------------------------------------------------------------------------------------|--------------------------------|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Silicone adhesive peel<br>strength (N/25cm) | 0.51 | 0.60 | Similar | | Water absorption | 7 | 9 | Similar | | Moisture vapor<br>transmission rate<br>(MVTR) | 699 | 1112 | The secondary predicate does not<br>work with a canister, therefore the<br>wound exudate removal is<br>dependent on the MVTR and the<br>ability to retain the wound exudate<br>in the dressing (Fluid Handling<br>Capacity). | | Fluid handling<br>capacity | 4.7 | 11 | The secondary predicate does not<br>work with a canister, therefore the<br>wound exudate removal is<br>dependent on the MVTR and the<br>ability to retain the wound exudate<br>in the dressing (Fluid Handling<br>Capacity). | | Pressure distribution<br>underneath the<br>dressings in 72 hours<br>under various<br>negative pressure<br>conditions | Meet the<br>requirements | Meet the<br>requirements | Similar | | Alarming functions | Meet the<br>requirements | Meet the<br>requirements | Similar | | Liquid pooling | No | No | Similar | {9}------------------------------------------------ #### Clinical Testing: 6 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.