(375 days)
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.
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.
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 ) | 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:
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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.
- Test Set:
-
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 'ground truth' for this device's performance is established by:
-
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.
§ 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.