(255 days)
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.
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.
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 ) | 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.
§ 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.