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.

Device Description

The VR Medical VCare 1000-300S System is an AC-Powered portable suction device, with battery backup, that provides localized negative pressure when used with the VR Medical Perme-Foam Dressing to remove fluid, irrigation solutions and infectious materials from the wound. The systems consist of a powered suction pump device with a built-in placement holder for the disposable fluid collection canister, and a foam dressing kit. The kit consists of polyurethane foam, suction bell with connecting (drainage) tube and clamp, and polyurethane drape. The single-use foam dressing kit is packaged in a PE/PET peel pouch bag, which is gamma sterilized.

The Foam Dressing Kit (VR Medical Perme-Foam Dressing) can be sold alone or as a part of the VCare 1000-300S System in two sizes:

Large foam dressing kit
Medium foam dressing kit
The Foam Dressing can be used for up to 72 hours of continuous use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the VR Medical VCare 1000-300S System, a negative pressure wound therapy device. This document details the device's technical specifications and the testing conducted to demonstrate its substantial equivalence to predicate devices, rather than a study proving the device meets an acceptance criterion for diagnostic or screening performance.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" related to diagnostic performance (like sample size for test set, ground truth, experts, MRMC study, standalone performance) are not applicable or cannot be extracted from this document as it pertains to a medical device's physical and functional performance, safety, and equivalence, not its diagnostic or clinical efficacy in the traditional sense of an AI/imaging device.

However, I can extract information regarding the performance data (non-clinical tests) used to demonstrate substantial equivalence to predicate devices. While not "acceptance criteria" in the sense of a clinical trial's endpoint for AI performance, they serve as the "criteria" the device had to meet to be considered substantially equivalent.

Here's the information extracted and adapted to the best fit given the document's content:

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

Acceptance Criteria (Demonstrated)	Reported Device Performance (as demonstrated by testing)
Device Functionality
Deliver negative pressure wound therapy in continuous and intermittent operating modes (variable & pulse) identical to predicate devices using simulated exudate.	Verified that the device delivers negative pressure wound therapy in continuous and intermittent (variable & pulse) operating modes identical to the predicate devices using simulated exudate.
System performance with foam dressing kits and accessories identical to predicate devices.	Verified system performance with foam dressing kits and accessories identical to predicate devices.
System alarms functionality.	Verified system alarms.
Battery performance.	Verified battery performance.
Electrical Safety and Electromagnetic Compatibility (EMC)
Compliance with IEC 60601-1 and IEC 60601-1-11 standards for safety.	The system complies with the IEC 60601-1 and IEC 60601-1-11 standards for safety.
Compliance with IEC 60601-1-2 standard for EMC.	The system complies with the IEC 60601-1-2 standard for EMC.
Software Verification and Validation
Software verified and validated as per FDA Guidance for industry. Considered "Moderate" level of concern.	Software verification and validation testing were conducted and documentation was provided as recommended by the FDA's Guidance. The software was considered a "Moderate" level of concern, implying a failure could result in minor injury to the patient or operator. (No specific performance metrics like error rates are provided, only that testing was done and documentation provided.)
Biocompatibility (for Perme-Foam Dressing)
Compliance with ISO 10993-5 (Cytotoxicity).	Successfully passed In Vitro Cytotoxicity Test per ISO 10993-5:2009.
Compliance with ISO 10993-10 (Skin Sensitization).	Successfully passed Skin Sensitization Test per ISO 10993-10:2010.
Compliance with ISO 10993-10 (Intracutaneous Reactivity).	Successfully passed Intracutaneous Reactivity Test per ISO 10993-10:2010.
Compliance with ISO 10993-11 (Acute Systemic Toxicity).	Successfully passed Acute Systemic Toxicity Test per ISO 10993-11:2006.
Compliance with ISO 10993-3 (In Vitro Mammalian Cell Gene Mutation).	Successfully passed In Vitro Mammalian Cell Gene Mutation test per ISO 10993-3:2009.
Compliance with ISO 10993-3 (Ames Test).	Successfully passed Ames Test per ISO 10993-3:2014.
Compliance with ISO 10993-3 (In Vitro Mammalian Chromosome Aberration).	Successfully passed In Vitro Mammalian Chromosome Aberration Test per ISO 10993-3:2014.
Compliance with ISO 10993-6 (Muscle Implantation).	Successfully passed Muscle Implantation Test per ISO 10993-6:2007.
Compliance with ISO 10993-4 (In Vitro Hemolytic Test).	Successfully passed In Vitro Hemolytic Test per ISO 10993-4:2002/Amd.1:2006.
Compliance with ISO 10993-11 (Subchronic Systemic Toxicity).	Successfully passed Subchronic Systemic Toxicity Test per ISO 10993-11:2006.
Compliance with ISO 10993-11 and USP39-NF34 (Pyrogen Test).	Successfully passed Pyrogen Test per ISO 10993-11:2006 and USP39-NF34<151>.

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

The document does not specify sample sizes for "test sets" in the context of diagnostic accuracy. The testing described is bench testing for device functionality, safety, and biocompatibility. For biocompatibility, it states "Perme-Foam Dressing samples were tested," but does not explicitly state the number of samples.
Data provenance is not provided, other than the manufacturer being in China. The testing appears to be non-clinical (bench testing) rather than clinical data from patients or a specific country.

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)

Not applicable. This is not a diagnostic device for which expert ground truth would be established. The "ground truth" for these tests are the standards themselves (e.g., IEC, ISO, functional specifications).

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

Not applicable. Adjudication methods are typically for clinical case interpretation in diagnostic studies.

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 is a negative pressure wound therapy device, not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is a physical medical device, not an algorithm, and the testing focuses on its physical and functional performance, not diagnostic accuracy.

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

For the non-clinical tests, the "ground truth" refers to the established engineering and safety standards (e.g., IEC 60601-1, ISO 10993 series) and the device's functional specifications (e.g., delivering specific negative pressure, battery life). For biocompatibility, the ground truth is the successful passing of the specified ISO standard tests.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of an AI algorithm.

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

Not applicable. This device does not involve a "training set" in the context of an AI algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three heads, representing the department's focus on health, human services, and the well-being of the population. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 28, 2017

VR Medical Technology Company, Ltd. Lee Pan CEO 90 Gaoxin Rd. Kunshan, CN 215325 Jiangsu

Re: K162159

Trade/Device Name: VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: March 27, 2017 Received: March 28, 2017

Dear Lee Pan:

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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K162159

Device Name

VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing

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)

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

I. Submitter Information

VR Medical Technology Co., Ltd. 90 Gaoxin Rd., Zhouzhuang Kunshan, Jiangsu, CHINA 215325

Contact Person: Lee Pan, Ph.D. lpan@vrmedical.net +86 512 5720 0500
Date Prepared: April 22, 2017

II. Device Information

Name of Device:	VCare 1000-300S PumpVCare 1000-300S SystemPerme-foam Dressing
Common Names:	Negative Pressure Wound Therapy PumpNegative Pressure Wound Therapy System
Classification Name(s):	Powered Suction Pump (21 CFR 878.4780)
Regulatory Class:	II
Product Code:	OMP

III. Predicated Device

Primary: K140634 Devon Medical Products Inc., ExtriCare 2400 NPWT System with ExtriCare 2400 Pump and ExtriCare NPWT Foam Dressing Kit This predicate has not been subject to a design-related recall
K112458 Medica-Rents Co., Prospera Pro-II This predicate has not been subject to a design-related recall

K132252 Devon Medical Inc., ExtriCare Negative Pressure Wound Therapy 100cc, 250cc, and 300cc canisters This predicate has not been subject to a design-related recall

IV. Device Description

{4}------------------------------------------------

polyurethane drape. The single-use foam dressing kit is packaged in a PE/PET peel pouch bag, which is gamma sterilized.

The Foam Dressing Kit (VR Medical Perme-Foam Dressing) can be sold alone or as a part of the VCare 1000-300S System in two sizes:

. Large foam dressing kit
Medium foam dressing kit
. The Foam Dressing can be used for up to 72 hours of continuous use.

V. Intended Use(s)

VI. Technological Characteristics

The manufacturer believes that the technological characteristics of the VCare 1000-300S System are substantially similar to those of the predicate devices. The subject and predicate devices are based on the following same technical elements:

Continuous and Intermitted negative pressure treatment modes -
-Selectable Pressure Settings from -20 mmHg to -200 mmHg
-AC and rechargeable battery with 48 hour battery life

VII. Performance Data

Non-Clinical Tests (Bench)

Testing has been conducted to verify that the VR Medical VCare 1000-300S System demonstrates substantial equivalence to the predicate devices. The list below summarizes the testing conducted for the VR Medical VCare 1000-300S device.

. Verification that the device delivers negative pressure wound therapy in continuous and intermittent (variable & pulse) operating modes identical to the predicate devices using simulated exudate
. Verification of system performance with foam dressing kits and accessories identical to predicate devices
Verification of system alarms
Verification of battery performance

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the VR Medical VCare 1000-300S System. The system complies with the IEC 60601-1 and IEC 60601-1-11 standards for safety and the IEC 60601-1-2 standard for EMC.

{5}------------------------------------------------

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the patient or operator.

Biocompatibility

The VCare 1000-300S System consists of both the VCare 1000-300S Pump and the VR Medical Perme-Foam Dressing. While the pump has no direct body contact when used as indicated, the Perme-Foam Dressing does have direct body contact. Per ISO-10993 B-prolonged contact (24h-30days) requirements, the Perme-Foam Dressing samples were tested for the following items and all tests were successfully passed.

In Vitro Cytotoxicity Test per ISO 10993-5:2009
Skin Sensitization Test per ISO 10993-10:2010
. Intracutaneous Reactivity Test per ISO 10993-10:2010
Acute Systemic Toxicity Test per ISO 10993-11:2006 ●
In Vitro Mammalian Cell Gene Mutation test per ISO 10993-3:2009
Ames Test per ISO 10993-3:2014
In Vitro Mammalian Chromosome Aberration Test per ISO 10993-3:2014
Muscle Implantation Test per ISO 10993-6:2007
In Vitro Hemolytic Test per ISO 10993-4:2002/Amd.1: 2006 ●
Subchronic Systemic Toxicity Test per ISO 10993-11:2006
Pyrogen Test per ISO 10993-11:2006 and USP39-NF34<151>

VIII. Conclusion

The non-clinical tests, electrical safety and EMC, software verification & validation, and biocompatibility, demonstrate that the VR Medical VCare 1000-300S System is equivalent to the predicate device for the intended use.

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.