(136 days)
Veincare is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb
The Veincare laser system consists of a Laser Diode module, a power supply and a cooling system. The laser diode module consists of an optical sensor interface, fiber connector for high power SMA fiber, protective glass holder, monitoring interface, cathode and anode. The system delivers laser energy at a wavelength of 1470mm. The output of the laser is delivered to the area of treatment through an optical fiber cable a trigger (Foot switch) controls the delivery of pulses. The user selects the desired energy density and enables or disables the laser at the touched LCD panel.
The Veincare device is intended for the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and incompetent refluxing veins in the superficial venous system in the lower limb.
Here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state "acceptance criteria" for clinical performance. Instead, it details the technical specifications of the Veincare device and compares them to predicate devices to demonstrate substantial equivalence. The non-clinical performance section verifies these technical specifications through bench testing.
| Criterion (as defined by technical specifications and non-clinical tests) | Reported Device Performance (Veincare) | Comparison to Predicate Devices & SE Decision |
|---|---|---|
| Intended Use | Treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb | Same as Predicate 1, Similar to Predicate 2 (SE: Same as 1, similar to 2) |
| Principle/Method of Operation | Laser Diode module, power supply, cooling system, optical sensor interface, fiber connector for high power SMA fiber, protective glass holder, monitoring interface, cathode and anode. Delivers 1470nm laser energy via optical fiber, controlled by foot switch/LCD. | Similar to Predicate 1 and 2 (SE: Same as 1 and 2) |
| Maximum Power Output | 0.5~15W | Same as Predicate 1 (15W), similar to Predicate 2 (1~15W) (SE: Same as 1 and 2) |
| Wavelength | 1470nm | Same as Predicate 1 (1470nm), same as Predicate 2 (1470nm) (SE: Same as 1 and 2) |
| Pulse Repetition | 1Hz~500Hz | Predicate 1: Up to 2000Hz, Predicate 2: 0.2 Hz ~ 50Hz (SE: Similar to 1 and 2, does not affect safety and efficacy) |
| Pulse Duration | 0.2ms ~ 800ms | Predicate 1: Up to 10,000ms, Predicate 2: 10ms ~ 2500ms (SE: Similar to 2, does not affect safety and efficacy) |
| Mode of Operation | CW, pulsed, Group pulsed | Predicate 1: CW, pulsed, Predicate 2: CW, single pulse, repeat pulse (SE: Same as 1 and 2) |
| Electrical Safety | Compliant with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2 | Verified through non-clinical testing. |
| Electromagnetic Compatibility (EMC) | Compliant with IEC 60601-1-2 | Verified through non-clinical testing. |
| Software Validation | Designed and developed according to a software development process, verified and validated (MODERATE level of concern software). | Verified through non-clinical testing. |
| Biocompatibility | Optical fiber component received prior 510(k) clearance (e.g., K232106), thus no additional testing was deemed necessary. | Verified through non-clinical testing. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "No clinical studies were considered necessary and performed." Therefore, there is no test set in the traditional sense of patient data. The evaluation was based on non-clinical (bench) testing of the device's technical specifications and comparison to legally marketed predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable, as no clinical test set was used and therefore no ground truth was established by experts for such a set.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used.
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. The Veincare is a laser surgical instrument, not an AI-assisted diagnostic or interpretive device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as the Veincare is a medical device for treatment, not a standalone algorithm. The "standalone" performance here refers to the device's physical and functional performance, which was evaluated through non-clinical bench tests.
7. The Type of Ground Truth Used:
For the comparisons concerning technical specifications, the "ground truth" is established by the specifications of the legally marketed predicate devices and by international standards (e.g., IEC standards for electrical safety, EMC). For the device's own performance, the "ground truth" is its measured performance per internal design specifications during bench testing.
8. The Sample Size for the Training Set:
Not applicable. This device does not have a "training set" in the context of an AI/machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.