(269 days)
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.
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.
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. |
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.
§ 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.