(146 days)
Carilex VT·One/VT·One 60days is indicated for patients who benefit from removal of fluids and excess exudates, infectious material, and tissue debris, which may promote wound healing. The VT-One/VT-One 60days suction therapy unit is indicated on use with patients with the following wounds: Traumatic, Dehisced wounds, Partial thickness burns, Chronic wounds including pressure ulcers, diabetic foot ulcers, and venous leg ulcers, Acute wounds, Flaps and grafts.
Carilex VT One and VT One 60days are suction pumps with collection canisters for negative pressure wound therapy. Carilex VT.One 60days are modified from its precursor VOLTERA Powered Suction Pump, S1001-3 Series (K112853), and they are smaller, portable and lighter in weight. The pump is connected to the wound dressing via a tube connected to a disposable canister. The device provides negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The device can operate either by a mains power supply or internal battery. The intended use, performance, and technology for Carilex VT·One and VT·One 60days are mostly identical. However, the VT·One 60days is programmed to stop working after 60 days of use and will not re-start after this time. This feature makes VT One 60days a single patient use NPWT pump that has a lifetime of 60 days; while VT-One is a durable medical device with a minimum lifetime of 3 years.
This document describes the FDA's 510(k) summary for the Carilex VT.One/VT.One 60days powered suction pump. The device is a negative pressure wound therapy (NPWT) system.
Here's an analysis based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The pumps met all pre-determined acceptance criteria and passed the tests." However, it does not provide a specific table of acceptance criteria or detailed reported device performance values for the non-clinical tests beyond confirming they passed. It only lists the tests performed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC60601-1:2005+COR1(2006)+COR2(2007)+AMD1(2012) Basic Safety and Essential Performance | Met (passed the tests) |
| Compliance with IEC60601-1-2:2007 Electromagnetic Compatibility | Met (passed the tests) |
| Performance/Comparison Testing with predicate device | Met (passed the tests) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set in the non-clinical performance/comparison testing. It only states that "Performance/Comparison Testing of VT.One 60days with the predicate" was conducted. This implies a comparison between the proposed device and the predicate. The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective), but given it's non-clinical testing of a medical device, it would have been conducted in a lab environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This question is not applicable. The study described is non-clinical performance and safety testing of a medical device against established standards and a predicate device. It does not involve establishing ground truth from expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
This question is not applicable as the study involved non-clinical performance testing against technical standards and a predicate, not human adjudication of medical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical tests were not performed."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a powered suction pump, not an AI algorithm. Its performance is mechanical and electrical, not algorithmic. The term "standalone" in this context typically refers to the performance of an AI model without human intervention.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" was compliance with established international standards (IEC60601-1, IEC60601-1-2) for medical electrical equipment safety and essential performance, and comparability to the predicate device's performance specifications. This is a technical, rather than medical, ground truth.
8. The Sample Size for the Training Set
This question is not applicable. The device is a mechanical/electrical pump, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above (not an AI/ML 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.