Who is the manufacturer of Innomed NPWT Silicone Foam Dressing?

Zhejiang Longterm Medical Technology Co., Ltd. filed the 510(k) submission for Innomed NPWT Silicone Foam Dressing (K202823).

What is the FDA product code for Innomed NPWT Silicone Foam Dressing?

OMP. It is classified under 21 CFR 878.4780 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Innomed NPWT Silicone Foam Dressing?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Innomed NPWT Silicone Foam Dressing?

VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing (K162159); PICO Single Use Negative Pressure Wound Therapy System (K151436).

Who can help prepare an FDA 510(k) submission like Innomed NPWT Silicone Foam Dressing?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Innomed NPWT Silicone Foam Dressing

K202823 · Zhejiang Longterm Medical Technology Co., Ltd. · OMP · Dec 15, 2021 · General, Plastic Surgery

Device Facts

Record ID	K202823
Device Name	Innomed NPWT Silicone Foam Dressing
Applicant	Zhejiang Longterm Medical Technology Co., Ltd.
Product Code	OMP · General, Plastic Surgery
Decision Date	Dec 15, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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.

Device Story

Single-use accessory for VCare 1000-300S negative pressure wound therapy (NPWT) pump; consists of silicone adhesive-coated polyurethane foam dressing, suction bell, and fixation film strips. Dressing packs wound bed; suction bell connects to pump canister via PVC tubing. System applies negative pressure to remove wound exudates, irrigation fluids, and infectious materials. Used in professional healthcare facilities by clinicians. Output is a sealed wound environment with active fluid drainage. Benefits include wound management and exudate removal. Device materials include PU film, PU foam, absorbent fiber, polyester fabric, and silicone adhesive.

Clinical Evidence

No clinical testing was required to support substantial equivalence. Safety and effectiveness supported by bench testing and biocompatibility testing (ISO 10993-5, -6, -10, -11).

Technological Characteristics

Materials: PU film, PU foam, absorbent fiber, polyester fabric, silicone adhesive, PVC tubing, polypropylene clamp/luer. Sterilization: Ethylene Oxide (SAL 10^-6). Form factor: 10 sizes (10x10cm to 25x25cm). Connectivity: Accessory to external pump. Shelf-life: 3 years.

Indications for Use

Indicated for patients with chronic, acute, traumatic, subacute, dehisced wounds, partial-thickness burns, ulcers (diabetic or pressure), flaps, and grafts requiring negative pressure wound therapy for fluid removal. For use in professional healthcare facilities only.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing (K162159)
PICO Single Use Negative Pressure Wound Therapy System (K151436)

Related Devices

K182458 — Longterm NPWT Foam Dressing Kit · Zhejiang Longterm Medical Technology Co., Ltd. · May 23, 2019
K211571 — Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit · Zhejiang Longterm Medical Technology Co., Ltd. · May 31, 2022
K133333 — UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT · Blue Ocean Medical Product, LLC · Dec 31, 2014
K082211 — RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS · Smith & Nephew, Inc. · Nov 14, 2008
K161570 — Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large · Lc Medical Concepts, Inc. · Aug 29, 2016

Submission Summary (Full Text)

{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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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. 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: | December 10, 2021 | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant: | Zhejiang Longterm Medical Technology Co., LTD No. 493 North Huancheng Road, Mogan Mountain National High- Tech District, Deqing Zhejiang, CHINA 313200 | | Official Correspondent: | Claudia Zsang 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: VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing (K162159) Secondary Predicate Device: PICO Single Use Negative Pressure Wound Therapy System (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 Therapy System(K151436) | | | Note | Accessory to Vcare pump (510 (k) K162159) | Only the foam dressing is used as the predicate | Only silicone foam dressing is used as the predicate | | | Class | Class II | Class II | Class II | Same | | Classification Regulation | 21CFR 878.4780 | 21CFR 878.4780 | 21CFR 878.4780 | Same | | Product Code | OMP | OMP | OMP | Same | | Skin Contact Materials | - Silicone foam dressing - PU film strips coated with acrylic adhesive | - Foam dressing | - Silicone foam dressing - PU film strips with acrylic adhesive | Similar to secondary predicate | | Non-Skin Contact Materials | Suction Bell system | Suction Bell system | Suction bell system | Similar to primary /secondary predicates | | Mechanism of Action | The silicone foam dressing is used to pack the wound bed and provide a sealed environment. The wound fluid is removed from the wound bed to a canister through the attached suction bell tube under a negative pressure. | The foam dressing is used to pack the wound bed and provide a sealed environment. The wound fluid is removed from the wound bed to a canister through the attached suction bell tube under a negative pressure. | The silicone foam dressing is used to pack the wound bed and provide a sealed environment. The wound fluid is removed from the wound bed to a canister through the attached suction bell tube under a negative pressure. | Similar to primary/ secondary predicates | | Indications for Use | 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 | The VR Medical VCare 1000-300S Negative Pressure Wound Therapy System is an integrated wound management system, indicated 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. | PICO is intended for the patients who may benefit from a suction device (Negative Pressure Wound Therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. Appropriate wound types include: - Chronic - Acute - Traumatic - Subacute and dehisced wounds | A subset of the primary / secondary predicates | | Characteristics | Subject Device | Primary Predicate Device | Secondary Predicate Device | Comment | | 510(k)# | K202823 | K162159 | K151436 | | | | 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. | The device is for use in professional healthcare facilities only. | • Partial-thickness burns • Ulcers(such as diabetic or pressure) • Flaps and grafts • Closed surgical incisions PICO single use negative pressure wound therapy system is suitable for use both in a hospital and homecare setting. | | | Use environment | The device is for use in professional healthcare facilities only. | The device is for use in professional healthcare facilities only. | The device is suitable for use both in a hospital and homecare setting. | Same to primary predicate | | Biocompatibil ity (silicone foam dressing, (breached skin, prolonged, >24hr to 30days) | Non-cytotoxic, non-irritating, non- sensitizing, non-toxic, non-pyrogenic | Non cytotoxic, non-irritant, non-sensitizing, non- toxic, none- pyrogenic | Non cytotoxic, Negligible irritant, non- sensitizing | Same to primary/secon dary predicates | | Sterilization | Ethylene Oxide | Gamma Irradiation | Ethylene Oxide | Same to secondary predicate | | Sterility Assurance Level | SAL of 10-6 | SAL of 10-6 | SAL of 10-6 | Same to primary/secon dary predicates | | Single Use | Yes | Yes | Yes | Same to primary/secon dary 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 Device (K202823) | Secondary predicate (K151436) | Comment | |----------------------------------------------------------------------------------------------------------------------|--------------------------------|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Silicone adhesive peel strength (N/25cm) | 0.51 | 0.60 | Similar | | Water absorption | 7 | 9 | Similar | | Moisture vapor transmission rate (MVTR) | 699 | 1112 | The secondary predicate does not work with a canister, therefore the wound exudate removal is dependent on the MVTR and the ability to retain the wound exudate in the dressing (Fluid Handling Capacity). | | Fluid handling capacity | 4.7 | 11 | The secondary predicate does not work with a canister, therefore the wound exudate removal is dependent on the MVTR and the ability to retain the wound exudate in the dressing (Fluid Handling Capacity). | | Pressure distribution underneath the dressings in 72 hours under various negative pressure conditions | Meet the requirements | Meet the requirements | Similar | | Alarming functions | Meet the requirements | Meet the 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.