(269 days)
Not Found
No
The document describes a standard negative pressure wound therapy system with a pump and dressing kit. There is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies. The software is described as "Moderate" concern, which is typical for device control and safety features, not complex AI/ML algorithms.
Yes
The device is described as an "integrated wound management system, indicated for wound management via the application of negative pressure to the wound" for removing fluids and infectious materials, which directly addresses medical conditions and provides treatment.
No
The device is described as an integrated wound management system that applies negative pressure for the removal of fluids from wounds; it treats rather than diagnoses.
No
The device description clearly states it is an "AC-Powered portable suction device, with battery backup" and includes a "powered suction pump device" and a "foam dressing kit," indicating it is a hardware device with software components, not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "wound management via the application of negative pressure to the wound, in order for the removal of fluids...". This describes a therapeutic intervention applied directly to the patient's body, not a test performed on samples taken from the body.
- Device Description: The description details a suction pump, foam dressing, and collection canister. These are components of a system designed to physically remove fluids from a wound, not to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, sample analysis, or diagnostic results.
- Performance Studies: The performance studies focus on the device's ability to deliver negative pressure, system performance with dressings, alarms, battery performance, electrical safety, software validation, and biocompatibility. These are all relevant to a therapeutic device, not an IVD.
In summary, the VR Medical VCare 1000-300S Negative Pressure Wound Therapy System is a therapeutic device used for wound management, not a diagnostic device used to test samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OMP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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.
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 Pump
VCare 1000-300S System
Perme-foam Dressing |
|-------------------------|--------------------------------------------------------------------------------|
| Common Names: | Negative Pressure Wound Therapy Pump
Negative 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
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
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)
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.
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
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.