(317 days)
The "Carilex" VT · 200-i NX 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
The device is not intended for home use. Wound irrigation/Instillation function is not intended for use in a homecare setting.
Carilex VT 200-i NX is a powered, portable suction device with battery backup that provides localized negative pressure wound therapy when used with the VT Dressing kits to remove body fluids, irrigation fluids, infectious material and tissue debris from the wound.
Carilex VT 200-i NX have shown that they may help promote the healing of several different kind of wounds via fluid removal. When in use, the vacuum air suction pump in the control unit suck the air from the wound through the connecting hose and dressing to create a negative pressure environment of the wound. The suction of the pump will help remove excess fluids from the wound. VT Dressing kits will be placed onto the wound by healthcare professional and a tube will be connected from the wound to the canister on the pump. After the dressing and tube are correctly applied and connected, turn on the VT · 200 i NX device and set to the pressure setting that is prescribed by healthcare provider. The canister will then collect the excess fluid. This device is not intended for home use.
Carilex VT-200-i NX is an updated version of Carilex VT-100/VT-200 (K173407) via engineering change, and its software and hardware modifications are made to add instill function. The instillation mode is a modified continuous mode, where wound irrigation solution is simultaneously infused during negative pressure suction to assist in wound cleaning and removal of infectious substances. There has been no change to the operating principle, mechanism of action or fundamental scientific technology of the predicate device. The Carilex VT-200-i NX is developed with technology and components that are almost identical to Carilex VT·100/ VT·200.
Carilex VT-200-i NX use the same collection canisters as predicate, VT-100, and VT-200 that are supplied non-sterile, single-use with a volume capacity of 300 ml or 1000ml. The canister is permanently sealed to minimize the potential of users coming into contact with exudates. Two tubes with two connector attached to its distal end is attached to the canister, and this connector which can be provided with or without lock feature attaches to the corresponding tubing included in the Carilex VT Dressing Kits.
The Carilex VT-200-i NX is a powered, portable suction device used for negative pressure wound therapy. The device has an instillation mode for wound irrigation.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria were demonstrated through a series of bench tests comparing the Carilex VT-200-i NX to its predicate device, Carilex VT-100/VT-200 (K173407). The aim was to show the overall system performance, including suction pressure, fluid removal rate, and alarm functions.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance (Carilex VT-200-i NX) |
|---|---|---|
| Suction Pressure | Compare suction pressure with no fluid (air) under continuous and intermittent mode. | Demonstrated to be within specification, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification") |
| Fluid Removal Rate | Compare suction pressure and fluid removal rate with plasma under continuous and intermittent mode. | Demonstrated to be within specification, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification") |
| Compare suction pressure and fluid removal rate with Simulated Body Fluid (SBF) under continuous and intermittent mode. | Demonstrated to be within specification, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification") | |
| Test suction pressure and fluid removal rate with Normal saline introduced under instill mode. | Demonstrated to be within specification, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification") | |
| Alarm Functions | Compare leakage alarm function under continuous and intermittent mode. | Functionality demonstrated, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification" and results "can be concluded that Carilex VT 200-i NX are substantially equivalent") |
| Compare canister-full alarm function under continuous and intermittent mode. | Functionality demonstrated, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification" and results "can be concluded that Carilex VT 200-i NX are substantially equivalent") | |
| Compare blockage alarm function with default time delay (1 min) under continuous and intermittent mode. | Functionality demonstrated, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification" and results "can be concluded that Carilex VT 200-i NX are substantially equivalent") | |
| Instillation Specific | Test the possibility of pooling occurring at the simulated wound site under instill mode. | Functionality demonstrated (implying no pooling or controlled pooling as intended by the instillation function), comparable to predicate's similar function. (Details not explicitly quantified, but overall conclusion states "within specification" and results "can be concluded that Carilex VT 200-i NX are substantially equivalent") |
| Test leakage indicator function under instill mode. | Functionality demonstrated, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification" and results "can be concluded that Carilex VT 200-i NX are substantially equivalent") | |
| Test canister-full indicator function under instill mode. | Functionality demonstrated, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification" and results "can be concluded that Carilex VT 200-i NX are substantially equivalent") | |
| Test blockage indicator function under instill mode. | Functionality demonstrated, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification" and results "can be concluded that Carilex VT 200-i NX are substantially equivalent") | |
| Electrical/Safety | AAMI/ANSI ES60601-1:2005/(R) 2012+A1:2012, C1:2009/(R) 2012+A2:2010/(R)2012 Medical Electrical Equipment – Part 1 : General Requirements for basic safety and essential performance | The device complies with the standard. |
| IEC 60601-1-2:2014 Medical Electrical Equipment – Part 1-2: General Requirements for basic safety and essential performance – Collateral Standard: Electromagnetic Compatibility- Requirements and Tests | The device complies with the standard. | |
| Usability | IEC 62366:2015 and FDA guidance for usability study to evaluate safety and effectiveness under intended user and conditions of use. | A usability study was conducted and evaluated the safety and effectiveness. (Details not provided within the document, but implies satisfactory results for substantial equivalence conclusion) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "head to head simulated use testing" and "the above tests" (referring to the listed methods 1-11 and the electrical/EMC tests) as being performed to demonstrate substantial equivalence. However, it does not explicitly state the specific sample sizes used for each of these performance tests (e.g., number of runs, devices tested, or duration). The data provenance is also not specified; it is implied to be internal bench testing performed by the manufacturer/sponsor for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since the tests described are bench tests involving simulated use, and not clinical studies with patient data requiring expert adjudication of ground truth, there is no mention of experts being used to establish ground truth for the test set. The "ground truth" for these tests would be the established performance specifications and expected outcomes under controlled testing conditions, as measured by standard laboratory equipment and procedures.
4. Adjudication Method for the Test Set
Not applicable, as the tests were bench tests comparing device performance to specifications and a predicate, rather than human-interpreted data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case comparative effectiveness study was mentioned. The submission focuses on the stand-alone performance and technical equivalence to predicate devices, not on human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The studies described are for the "algorithm only" in the sense that they evaluate the performance of the device itself (Carilex VT-200-i NX) without human intervention in operating the core functions during the specified tests. The tests directly assess the device's technical capabilities (suction pressure, fluid removal, alarm functions, instillation mode) against predetermined benchmarks and its predicate device.
7. Type of Ground Truth Used
The ground truth for the performance tests was based on established engineering specifications, physical measurements (e.g., pressure, fluid volume, time delays for alarms), and direct comparison to the performance of a legally marketed predicate device (Carilex VT-100/VT-200). For the electrical and EMC tests, the ground truth was compliance with recognized international standards (AAMI/ANSI ES60601-1 and IEC 60601-1-2).
8. Sample Size for the Training Set
This information is not applicable. The Carilex VT-200-i NX is a medical device for negative pressure wound therapy, not an AI/machine learning device that requires a "training set" in the context of data-driven model development. The modifications were engineering changes to hardware and software to add an instill function to an existing device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no mention of a training set for an AI/machine learning model. The device's functionality is based on electromechanical principles and control software for specific therapy modes.
§ 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.