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 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 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.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Longterm NPWT Foam Dressing Kit, which is an accessory to a Negative Pressure Wound Therapy (NPWT) pump. The FDA has determined the device to be substantially equivalent to legally marketed predicate devices.

Acceptance Criteria and Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for an AI/ML device. This 510(k) is for a medical device (wound dressing kit) and not an AI/ML product. Therefore, the "acceptance criteria" discussed are related to the performance characteristics of the physical device as tested in a bench and animal study, demonstrating substantial equivalence to a predicate device.

However, based on the non-clinical testing summary, we can infer the tested parameters and their implied acceptance criteria (meeting expectations for safe and effective wound management when used with the pump).

Inferred Performance and Acceptance Criteria (from Non-Clinical Testing Summary):

Acceptance Criteria (Implied)	Reported Device Performance (Summary of results)
Biocompatibility:	The device components (foam, film, suction bell materials) were evaluated and found to be:
- Non-cytotoxic (ISO 10993-5:2009)	Met
- Non-irritating (ISO 10993-10:2010)	Met
- Non-sensitizing (ISO 10993-10:2010)	Met
- Non-pyrogenic (ISO 10993-11:2006/USP39-NF34 <151>)	Met
- Acute toxicity (ISO 10993-11:2017)	Met
- Subacute toxicity (ISO 10993-11:2017/ ISO 10993-6:2016)	Met
- Subchronic toxicity (ISO 10993-11: 2017 / ISO 10993-2016)	Met
- Muscle implantation (ISO 10993-6:2016)	Met
Bench Testing (Functionality/Performance with pump):	The dressing kit demonstrated the ability to be used along with the VCare 1000-300S pump and meet performance and functionality requirements. Specific findings include:
- Foam dressing dimension stability under various negative pressure (continuous/intermittent, 72 hours)	"The foam dressing dimension test... under various negative pressure after 72 hours at both continuous and intermittent modes;" - Implied: Stable/Maintained sufficient dimensions for proper function.
- Fluid removal rate	"The fluid removal rate under various negative pressure at 72 hours at both continuous and intermittent modes;" - Implied: Effective fluid removal comparable to predicate, demonstrating proper function.
- Pressure distribution under foam	"The pressure distribution under the foam dressing in 72 hours at both continuous and intermittent modes;" - Implied: Maintained uniform and effective pressure distribution under the foam.
- Pressure difference under foam	"The pressure difference under the foam dressing in 72 hours at both continuous and intermittent modes." - Implied: Maintained appropriate pressure differences to facilitate NPWT.
- Mechanical properties (tensile strength, elongation)	"Mechanical properties (tensile strength and elongation, ASTM D3574)" - Implied: Met specified strength and elasticity requirements for the foam.
Sterilization:	Each kit component was individually sterilized. Sterility Assurance Level (SAL) of 10-6 was achieved.

Regarding the other requested information, which typically applies to AI/ML devices, it's important to clarify that this 510(k) is for a physical medical device (NPWT Foam Dressing Kit), not an AI/ML product. Therefore, many of the requested points are not applicable to this submission.

Here's a breakdown of the requested points in the context of this device:

Sample size used for the test set and the data provenance:
- Test Set:
  - Biocompatibility: The sample sizes would be specific to each ISO standard for material testing (e.g., number of test specimens, number of animals in acute/subacute toxicity studies). The document does not specify these numbers, but implies compliance with the referenced ISO standards.
  - Bench Testing: The document lists the types of tests performed (e.g., foam dimension, fluid removal rate, pressure distribution). The sample size for these tests (e.g., number of foam dressing kits tested) is not specified.
  - Animal Testing: A "Porcine wound healing study" was conducted. The number of animals used is not specified in this summary.
- Data Provenance: Not explicitly stated, but the testing would typically be conducted at certified labs either within the manufacturer's facility or at contract research organizations.
- Retrospective or Prospective: These terms are generally more relevant to clinical studies. Biocompatibility and bench testing are typically prospective experiments designed to evaluate specific device properties. The porcine study would be a prospective animal study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as there is no "ground truth" in the AI/ML sense (e.g., image annotation for disease detection). The "truth" is established by the physical and functional properties of the device meeting pre-defined engineering and safety standards.
- The "experts" involved would be the engineers, scientists, and veterinarians conducting and overseeing the biocompatibility, bench, and animal studies. Their qualifications would be in their respective fields (e.g., toxicologists for biocompatibility, mechanical engineers for bench testing, veterinarians for animal studies).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies or expert labeling tasks for AI/ML validation. Device testing results are typically objectively measured against defined criteria.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is not an AI/ML product and does not involve human readers interpreting data or assisting with diagnosis.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm. Bench testing evaluates the standalone performance of the physical device components and their functionality when integrated with the pump.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The 'ground truth' for this device's performance is established by:
  - Standardized material and performance tests (bench testing): Adherence to ISO standards for biocompatibility and specific engineering specifications for foam dimensions, fluid removal rate, pressure distribution, and mechanical properties.
  - Animal study outcomes: For the porcine wound healing study, the outcomes would be assessed based on observed wound healing parameters (e.g., wound size reduction, tissue granulation, infection status), which serve as a proxy for clinical performance.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K211571

Device Name Longterm NPWT Foam Dressing Kit

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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., LTDNo. 493 North Huancheng Road, Mogan Mountain National High-Tech District, Deqing Zhejiang, CHINA 313200
Official Correspondent:	Claudia ZsangClaudia.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:

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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.

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

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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 1000-300SSystem, 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
ClassificationRegulation	878.4780	Same	Same
Product Code	OMP	Same	Same
Skin ContactMaterials	- Polyurethane ester foam with 0.1% carbonblack colorant- Polyurethane film with acrylic adhesive	- Polyurethane ester foam;- Polyurethane drape	- Black, reticulated, polyurethane foam
Non-SkinContactMaterials	Suction Bell comprised of a polypropylenedrainage tubing with a polypropylene pinchclamp, a bell shape dome made of polyvinylchloride, a transparent poly urethane filmcoated with acrylic adhesive.	Suction Bell with connecting (drainage) tubeand clamp	Non-specific
Mechanism ofAction	The foam dressing is used to pack the woundbed, the PU film drape is used to cover thepacked wound bed and peri-wound area tocreate and maintain a sealed environment, thesuction bell is served as a conduit between thewound bed and the negative pressure pump totransfer the wound fluid to the canisterattached to the pump.	Same	Same
Intended Use	The dressing kit is intended to be used alongwith VCare 1000-300S pump for woundmanagement via the application of negativepressure to the wound, in order for the removalof fluids, including wound exudates, irrigationfluids, body fluids and infectious materials.The system is intended for patients withchronic, acute, traumatic, subacute anddehisced wounds, partial-thickness burns,ulcers (such as diabetic or pressure), flaps andgrafts.	The VR Medical VCare 1000-300S NegativePressure Wound Therapy System is anintegrated wound management system,indicated for wound management via theapplication of negative pressure to the wound,in order for the removal of fluids, includingwound exudates, irrigation fluids, body fluidsand infectious materials. The system is intendedfor patients with chronic, acute, traumatic,subacute and dehisced wounds, partial-thickness	The V.A.C. family of devices are feedback-controlled negative pressure devices usedto help promote wound healing, through meansincluding vacuum assisted drainage andremoval of infectious material or other fluids, underthe influence of continuous and orintermittent suction pressures, particularly forpatients with chronic, acute, traumatic,subacute and dehisced wounds, partial-thicknessburns, 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), flapsand grafts.	grafts. Feedback control is achieved by measuring thelevel of negative pressure at the wound site.
Use environment	The foam dressing kit is for use in professionalhealthcare facilities only.	The device is for use in professionalhealthcare 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 sterilizedby Ethylene Oxide or Gamma Irradiation	Gamma Irradiation	Gamma Irradiation
SterilityAssurance Level	SAL of 10-6	SAL of 10-6	SAL of 10-6

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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.

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
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.(b)
Classification. Class II.