(281 days)
Carilex VT • 100/VT • 200 is indicated for patients who would benefit from wound management via the application of negative pressure for removal of fluids and excess exudate, infectious material, and tissue debris which may promote wound healing. The VT · 100/VT · 200 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 • 100 and VT • 200 are suction pumps with collection canisters for negative pressure wound therapy. The VT · 100 and VT · 200 are modified from their precursor VOLTERA Powered Suction Pump, S1001-3 Series (K112853). The pump is connected to the wound dressing via a tube connected to a disposable canister. The devices provide 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 devices can operate either by a mains power supply or internal battery. The VT • 200 is developed with technology and components that are almost identical to VT • 100, but for marketing differentiation it is designed with a new outer case which contains extra room to allow incorporation with different types of air compressors in the future.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Carilex VT-100 and VT-200 devices:
Acceptance Criteria and Study for Carilex VT-100 and VT-200 (K173407)
Based on the provided FDA 510(k) summary, the Carilex VT-100 and VT-200 are powered suction pumps for negative pressure wound therapy. The substantial equivalence was primarily determined through non-clinical testing and comparison to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Safety: Device meets general requirements for basic safety and essential performance (based on AAMI/ANSI ES60601-1:2005/(R)2012+A1:2012, C1:2009/(R)2012+A2:2010/(R)2012) | Passed |
| Electromagnetic Compatibility (EMC): Device meets requirements for EMC (based on IEC 60601-1-2:2007) | Passed |
| Performance - Suction Pressure: The VT-100/VT-200 maintains suction characteristics within acceptable limits. | Met all pre-determined acceptance criteria |
| Performance - Fluid Removal Rate: The VT-100/VT-200 achieves a fluid removal rate within acceptable limits. | Met all pre-determined acceptance criteria |
| Performance - Alarm Functionality: All alarms on the VT-100/VT-200 operate correctly. | Met all pre-determined acceptance criteria |
| Shelf-Life: Device maintains specified performance over its intended lifespan (3 years). | Shelf-life test reports were analyzed, implying successful demonstration of shelf-life. (Specific performance parameters for shelf-life not detailed, but implied by analysis of reports.) |
| Software Functionality: Software operates as intended and meets safety and performance requirements. | Software documents were analyzed, implying software functionality was found acceptable. (Specific criteria not detailed.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical tests (bench tests). It does not specify a "test set" in the context of patient data or clinical samples. The testing involved multiple devices (VT-100 and VT-200 models) in a laboratory setting. No information on the number of individual devices tested or their origin (provenance) is provided beyond the company being based in Taoyuan City, Taiwan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This was a non-clinical, bench testing study. There was no "ground truth" derived from expert consensus on patient data. The "ground truth" for the bench tests would be the established performance specifications of the predicate device and relevant international standards.
4. Adjudication Method for the Test Set:
Not applicable. As this was non-clinical bench testing, an adjudication method for a test set (e.g., 2+1, 3+1) is not relevant. Pass/fail criteria were based on predetermined engineering specifications and conformity to standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. A MRMC study was not conducted as this was a non-clinical evaluation to demonstrate substantial equivalence to a predicate device, focusing on engineering and performance criteria rather than human reader interpretation of medical images or data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. The VT-100 and VT-200 are physical powered suction pumps, not AI algorithms. Their performance is tested directly, not as an algorithm's output.
7. Type of Ground Truth Used:
The "ground truth" for this substantial equivalence determination was based on:
- Predicate Device Specifications: The performance characteristics (suction pressure, fluid removal rate, etc.) and safety profile of the legally marketed predicate device (VOLTERA Powered Suction Pump, S1001-3 Series, K112853).
- International Standards: Conformity to recognized standards such as AAMI/ANSI ES60601-1 and IEC 60601-1-2 for safety and electromagnetic compatibility.
- Engineering Specifications: Pre-determined performance specifications for the VT-100 and VT-200 devices themselves.
8. Sample Size for the Training Set:
Not applicable. There is no concept of a "training set" in the context of this device and study type, as it does not involve machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no training set.
§ 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.