Who is the manufacturer of Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

Zhejiang Longterm Medical Technology Co., Ltd. filed the 510(k) submission for Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit (K211571).

What is the FDA product code for Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

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 Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

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

What are the predicate devices for Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing (K162159); KCI USA Inc-V.A.C.® ATS, mini VAC, VAC Freedom (K032310).

Who can help prepare an FDA 510(k) submission like Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

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.

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit

K211571 · Zhejiang Longterm Medical Technology Co., Ltd. · OMP · May 31, 2022 · General, Plastic Surgery

Device Facts

Record ID	K211571
Device Name	Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit
Applicant	Zhejiang Longterm Medical Technology Co., Ltd.
Product Code	OMP · General, Plastic Surgery
Decision Date	May 31, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Longterm NPWT Foam 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. Longterm NPWT foam dressing kit is for use in professional healthcare facilities only.

Device Story

Accessory kit for VCare 1000-300S negative pressure wound therapy (NPWT) pump; used in professional healthcare facilities. Components include hydrophobic reticulated polyurethane foam dressing, polyurethane film drape, and suction bell. Foam packs wound bed; drape creates sealed environment; suction bell acts as conduit for fluid transfer to pump canister. System applies negative pressure to remove wound exudates, irrigation fluids, and infectious materials. Clinician applies dressing and monitors wound; output is fluid removal and wound environment management. Benefits include promotion of wound healing via vacuum-assisted drainage.

Clinical Evidence

Bench testing only. Evaluated foam dimensions, fluid removal rates, pressure distribution, and pressure differentials under continuous/intermittent modes over 72 hours. Mechanical properties tested per ASTM D3574. Biocompatibility testing performed per ISO 10993 standards (cytotoxicity, irritation, sensitization, pyrogenicity, acute/subacute/subchronic toxicity, muscle implantation). Porcine wound healing study conducted. No clinical testing required.

Technological Characteristics

Materials: Hydrophobic reticulated polyurethane ester foam (with 0.1% carbon black), polyurethane film drape with acrylic adhesive, PVC suction bell, polypropylene pinch clamp. Dimensions: Foam (4 sizes), Drape (2 sizes). Energy: Passive accessory to powered suction pump. Sterilization: Ethylene Oxide or Gamma Irradiation (SAL 10^-6). Mechanical testing per ASTM D3574.

Indications for Use

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

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)
KCI USA Inc-V.A.C.® ATS, mini VAC, VAC Freedom (K032310)

Related Devices

K182458 — Longterm NPWT Foam Dressing Kit · Zhejiang Longterm Medical Technology Co., Ltd. · May 23, 2019
K202823 — Innomed NPWT Silicone Foam Dressing · Zhejiang Longterm Medical Technology Co., Ltd. · Dec 15, 2021
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. May 31, 2022 Zhejiang Longterm Medical Technology Co., LTD Claudia Zsang Director of Regulatory Affairs No. 493 North Huancheng Road Mogan Mountain National High-Tech District Deging, Zhejiang 313200 China Re: K211571 Trade/Device Name: Small Foam Kit. Large Foam Kit. Extra Large Foam Kit. Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: November 29, 2021 Received: December 7, 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 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. Julie Morabito, Ph.D. Assistant Director DHT4B: Division 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) K211571 Device Name Longterm NPWT Foam Dressing Kit ### Indications for Use (Describe) Longterm NPWT Foam 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. Longterm NPWT foam dressing kit is for use in professional healthcare facilities only. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | 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}------------------------------------------------ K211571 ## 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 03, 2022 | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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.zsang@gmail.com | | Phone Number: | 1-416-276-9555 | | 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- foam Dressing (K162159) (Primary) KCI USA Inc-V.A.C.® ATS, mini VAC, VAC Freedom (K032310) | #### 2 Device Description: Longterm NPWT Foam dressing kit is an accessory to VCare 1000-300S pump, manufactured by VR Medical Technology Co., Ltd. The dressing kit is composed of black foam dressing, polyurethane (PU) film drape and suction bell. The foam dressing is used to pack the wound bed, the PU 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 negative pressure pump to transfer the wound fluid to the canister attached to the pump. Longterm NPWT Foam 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 {4}------------------------------------------------ ## K211571 adhesive. Each component is individually packaged and sterilized. The foam dressing should be changed every 2-3 days depending on the wound condition or according to the local protocol. 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 (18cmx12.5cmx2.5cm), large (26cmx15cmx2.5cm) and extra large (45cmx30cmx2.5cm). PU film drape is available in 2 sizes; 30cmx30cm and 45cmx30cm. #### 3 Indications for Use: Longterm NPWT Foam 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. Longterm NPWT foam dressing kit is for use in professional healthcare facilities only {5}------------------------------------------------ #### 4 Substantial Equivalence | Parameter | Subject Device | Predicate Device #1 (Primary) | Predicate Device #2 | |-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k)# | K211571 | K162159 | K032310 | | Device name | Longterm NPWT Foam Dressing Kit | VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing (K162159) | KCI-V.A.C. ATS, mini VAC, VAC Freedom | | Note | Accessory to VCare pump (510 (k) K162159) | - | Only foam dressing is used as the predicate | | Classification Regulation | 878.4780 | Same | Same | | Product Code | OMP | Same | Same | | Skin Contact Materials | - Polyurethane ester foam with 0.1% carbon black colorant - Polyurethane film with acrylic adhesive | - Polyurethane ester foam; - Polyurethane drape | - Black, reticulated, polyurethane foam | | Non-Skin Contact Materials | Suction Bell comprised of a polypropylene drainage tubing with a polypropylene pinch clamp, a bell shape dome made of polyvinyl chloride, a transparent poly urethane film coated with acrylic adhesive. | Suction Bell with connecting (drainage) tube and clamp | Non-specific | | Mechanism of Action | The foam dressing is used to pack the wound bed, the PU 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 negative pressure pump to transfer the wound fluid to the canister attached to the pump. | Same | Same | | Intended 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 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 | The V.A.C. family of devices are feedback- controlled negative pressure devices used to help promote wound healing, through means including vacuum assisted drainage and removal of infectious material or other fluids, under the influence of continuous and or intermittent suction pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and | | Parameter | Subject Device | Predicate Device #1 (Primary) | Predicate Device #2 | | 510(k)# | K211571 | K162159 | K032310 | | | | burns, ulcers (such as diabetic or pressure), flaps and grafts. | grafts. Feedback control is achieved by measuring the level of negative pressure at the wound site. | | Use environment | The foam dressing kit is for use in professional healthcare facilities only. | The device is for use in professional healthcare facilities only. | Non-specific | | Biocompatibility (breached skin, prolonged, >24hr to 30days) | Non cytotoxic, non-irritant, non-sensitizing, non-toxic, none- pyrogenic | Non cytotoxic, non-irritant, non-sensitizing, non-toxic, none- pyrogenic | Biocompatible | | Sterilization | Each kit components individually sterilized by Ethylene Oxide or Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | | Sterility Assurance Level | SAL of 10-6 | SAL of 10-6 | SAL of 10-6 | {6}------------------------------------------------ {7}------------------------------------------------ #### ਟ Non-clinical Testing Summary: The following tests were performed to support the substantial equivalence of the subject ## device: Biocompatibility Testing: - Cytotoxicity - ISO 10993-5:2009 - Irritation ISO 10993-10:2010 ● - Sensitization ISO 10093-10:2010 ● - . Pyrogenicity -ISO 10993-11:2006/USP39-NF34 <151> - Acute toxicity ISO 10993-11:2017 ● - Subacute toxicity ISO 10993-11:2017/ ISO 10993-6:2016 ● - Subchronic toxicity ISO 10993-11: 2017 / ISO 10993-2016 ● - Muscle implantation ISO 10993-6:2016 . ## 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 various negative pressure after 72 hours at both continuous and intermittent modes; - The fluid removal rate under various negative pressure at 72 hours at both continuous and intermittent modes; - The pressure distribution under the foam dressing in 72 hours at both continuous and ● intermittent modes; - The pressure difference under the foam dressing in 72 hours at both continuous and ● intermittent modes. - Mechanical properties (tensile strength and elongation, ASTM D3574) ## Animal testing: Porcine wound healing study #### 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 device.