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.

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 (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.

AI/ML Overview

The provided document describes a 510(k) Premarket Notification for the Longterm NPWT Foam Dressing Kit, which is an accessory to the VCare 1000-300S pump. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness de novo through extensive clinical trials. Therefore, the information provided focuses on comparative performance and compliance with relevant standards.

Here's an analysis of the requested information based on the document:

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission, "acceptance criteria" and "reported device performance" are often framed in terms of meeting established standards and demonstrating equivalence to predicate devices, rather than achieving specific numerical thresholds for effectiveness (like sensitivity/specificity). The document details several non-clinical tests performed to support substantial equivalence.

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance
Biocompatibility	Cytotoxicity (ISO 10993-5:2009)	Non-cytotoxic (for Foam, Drape, Suction bell)
	Irritation (ISO 10993-10:2010)	Non-irritant (for Foam, Drape, Suction bell)
	Sensitization (ISO 10093-10:2010)	Non-sensitizing (for Foam, Drape, Suction bell)
	Pyrogenicity (ISO 10993-11:2006/USP39-NF34 <151>)	Non-pyrogenic (for Foam, Drape)
	Acute systemic toxicity (ISO 10993-11:2017)	Non-toxic (for Foam, Drape)
Sterility	Sterility Assurance Level (SAL)	Achieved SAL of 10^-6
Bench Testing	Foam dressing dimension test under various negative pressure mode after 72 hours	Evaluated to ensure the dressing kit can be used with the VCare 1000-300S pump regarding performance and functionality requirements. (Specific numerical results not provided in this summary, but the implication is "met requirements").
	Fluid removal rate under various negative pressure in 72 hours	Evaluated to ensure the dressing kit can be used with the VCare 1000-300S pump regarding performance and functionality requirements. (Specific numerical results not provided in this summary, but the implication is "met requirements").
	Pressure distribution under the foam in 72 hours (continuous negative pressure)	Evaluated to ensure the dressing kit can be used with the VCare 1000-300S pump regarding performance and functionality requirements. (Specific numerical results not provided in this summary, but the implication is "met requirements").
	Pressure difference under the foam in 72 hours (intermittent negative pressure)	Evaluated to ensure the dressing kit can be used with the VCare 1000-300S pump regarding performance and functionality requirements. (Specific numerical results not provided in this summary, but the implication is "met requirements").
	Mechanical properties (tensile strength and elongation, ASTM D3574)	Evaluated to ensure the dressing kit can be used with the VCare 1000-300S pump regarding performance and functionality requirements. (Specific numerical results not provided in this summary, but the implication is "met requirements" and comparable to predicate, if compared).

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document lists "non-clinical testing" including biocompatibility and bench testing. These tests typically involve material samples or simulated environments, not patient data in the sense of a clinical test set.

Sample Size for Test Set: Not applicable in the context of clinical patient data. The tests involved material samples (foam, drape, suction bell components) and possibly multiple units for bench testing, but specific quantities are not provided in this summary.
Data Provenance: The manufacturer is "Zhejiang Longterm Medical Technology Co., LTD" located in Deqing, Zhejiang, CHINA. The testing would have been conducted to support a US FDA submission, implying adherence to relevant international standards (e.g., ISO) which might be carried out by various certified labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as no clinical test set involving human experts to establish ground truth was conducted for this 510(k) submission. The document explicitly states: "No clinical testing was required to support substantial equivalence."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as there was no clinical test set requiring expert adjudication.

5. 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 a medical dressing and accessory; it does not involve AI or human readers for diagnostic interpretation. No MRMC study was conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable, as this device does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests:

Biocompatibility: Ground truth is established by adherence to recognized international standards (e.g., ISO 10993 series) and specific test methodologies that define what constitutes "non-cytotoxic," "non-irritant," etc.
Bench Testing: Ground truth is established by engineering specifications, performance requirements for negative pressure wound therapy systems, and comparison to the performance characteristics of the predicate device (VCare 1000-300S pump, which this dressing kit is an accessory to). The "Conclusion" states "The non-clinical tests demonstrate that the subject device is as safe, as effective and performs as well as the legally marked predicate devices," implying a comparison to the predicate's established performance.

8. The sample size for the training set

Not applicable, as this device does not involve AI or machine learning that would require a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.

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

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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

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Indications for Use

510(k) Number (if known) K182458

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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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., LTDNo. 493 North Huancheng Road, Mogan Mountain National High-Tech District, Deqing Zhejiang, CHINA 313200
Official Correspondent:	Claudia Zsangclaudiaz@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-foam Dressing (K162159)Cork Medical Products- Cork Medical Products NPWT Wound DressingKit (K132004)V.A.C.® ATS, mini VAC, VAC Freedom (K032310)

2 Device Description:

Foam dressing is available in 4 sizes; small (10cmx7.5cmx2.5cm), medium

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(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 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 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	Predicate Device #2	Predicate Device #3
510(k)#	K182458	K162159	K132004	K032310
Device name	Longterm NPWT FoamDressing Kit	VCare 1000-300S Pump,VCare 1000-300S System,Perme-foam Dressing(K162159)	Cork NPWT WoundDressing Kit	KCI-V.A.C. ATS, miniVAC, VAC Freedom
Note	Accessory to VCare pump (510(k) K162159)	-	-	Only foam dressing isused as the predicate
ClassificationRegulation	878.4780	Same	Same	Same
Product Code	OMP	Same	Same	Same
Skin ContactMaterials	- Polyurethane ester foam with0.1% carbon black colorant- Polyurethane film with acrylicadhesive	- Polyurethane ester foam;- Polyurethane drape	- Reticulated polyether basedpolyurethane foam (30pores per inch);- Transparent polyurethanefilm drape with adhesivebacking	- Black, reticulated,polyurethane foam
Non-SkinContactMaterials	Suction Bell comprised of apolypropylene drainage tubingwith a polypropylene pinchclamp, a bell shape dome madeof polyvinyl chloride, atransparent poly urethane filmcoated with acrylic adhesive.	Suction Bell with connecting(drainage) tube and clamp	port pad comprised of portpad, drainage tubing, luerconnector, pinch clamp,transparent film drape withadhesive backing.	Suction bell with drainagetube
Intended Use	The dressing kit is intended to beused along with VCare 1000-300S pump for woundmanagement via the applicationof negative pressure to thewound, in order for the removalof fluids, including woundexudates, irrigation fluids, body	The VR Medical VCare 1000-300S Negative Pressure WoundTherapy System is anintegrated wound managementsystem, indicated for woundmanagement via the applicationof negative pressure to thewound, in order for the removal	Cork Medical ProductsNPWT Wound Dressing Kitis intended to be used inconjunction with theGenadyne XLRS Pump todeliver negative pressurewound therapy to the wound.When used in conjunction	The V.A.C. family ofdevices are feedback-controlled negativepressure devices usedto help promote woundhealing, through meansincluding vacuum assisteddrainage and

	fluids and infectious materials.The system is intended forpatients with chronic, acute,traumatic, subacute and dehiscedwounds, partial-thickness burns,ulcers (such as diabetic orpressure), flaps and grafts.	of fluids, including woundexudates, irrigation fluids, bodyfluids and infectious materials.The system is intended forpatients with chronic, acute,traumatic, subacute anddehisced wounds, partial-thickness burns, ulcers (such asdiabetic or pressure), flaps andgrafts.	with a NPWT pump system,Cork Medical ProductsNPWT Wound Dressing Kitis indicated for patients whowould benefit from a suctiondevice particularly as thedevice may promote woundhealing by the removal ofexcess exudates, infectiousmaterial, and tissue debris.	removal of infectiousmaterial or other fluids,under the influence ofcontinuous and orintermittent suctionpressures, particularly forpatients with chronic,acute, traumatic,subacute and dehiscedwounds, partial-thicknessburns, ulcers (such asdiabetic orpressure), flaps and grafts.Feedback control isachieved by measuring thelevel ofnegative pressure at thewound site.
Use environment	The foam dressing kit is for usein professional healthcarefacilities only.	The subject device is for use inprofessional healthcarefacilities only.	The subject device is for usein professional healthcarefacilities only.	The subject device is foruse in professionalhealthcare facilities only.
Biocompatibility(Foam)	Non-cytotoxic, non-irritant, non-sensitizing, non- pyrogenic	Non-cytotoxic, non-irritant,non-sensitizing, non-toxic, non-pyrogenic	Non-cytotoxic, non-irritant,non-sensitizing	Biocompatible
Biocompatibility(Drape)	Non-cytotoxic, non-irritant, non-sensitizing, non-toxic, non-pyrogenic	Non-cytotoxic, non-irritant,non-sensitizing, non-toxic, non-pyrogenic	Non-cytotoxic, non-irritant,non-sensitizing	Biocompatible
Biocompatibility(Suction bell)	Non cytotoxic, non-irritant, non-sensitizing	Biocompatible	Biocompatible	Biocompatible
Sterilization	Each kit componentsindividually sterilized byEthylene Oxide or GammaIrradiation	Gamma Irradiation	Individual kit componentsindividually sterilized byEthylene Oxide or GammaIrradiation	Gamma irradiation
Sterility	SAL of 10-6	SAL of 10-6	SAL of 10-6	SAL of 10-6
Assurance Level

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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.

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.