(58 days)
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No
The description focuses on the physical components and materials of a laser fiber for treating varicose veins and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the "treatment of varicose veins and varicosities" and "treatment of incompetence and reflux of superficial veins," which are therapeutic applications.
No
The device is indicated for treatment of varicose veins and varicosities, not for diagnosis. It is a laser fiber used for therapeutic purposes.
No
The device description clearly outlines physical components like a laser fiber, silica core, outer nylon buffer, strain relief, SMA connector, platinum/iridium sleeve, and stainless steel/nitinol wire, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Vari-Lase WireFiber is a laser fiber used for the treatment of varicose veins and superficial venous reflux. It is a therapeutic device that directly interacts with the patient's anatomy (veins) using laser energy.
- Lack of Diagnostic Activity: The description does not mention any analysis of biological samples or the provision of diagnostic information. Its purpose is to deliver laser energy for therapeutic effect.
Therefore, the Vari-Lase WireFiber falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vari-Lase WireFiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux in the Great Saphenous Vein and for the treatment of incompetence and reflux of superficial veins in the lower extremity.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The WireFiber is a laser fiber that is compatible with a solid state diode laser console operating at a maximum power of 14 watts and wavelengths of 810 nm and 980 mm. The laser fiber is comprised of a 600 um silica core with a dual clad of silica hard clad and polymer, an outer nylon buffer, a strain relief, and an SMA connector. The distal tip of the laser fiber consists of a platinum/iridium sleeve that terminates with a stainless steel/nitinol wire. The laser fiber lengths are between 2.4 meters and 3.6 meters, as measured from the proximal end of the SMA connector to the distal tip, with a maximum diameter of 0.038". The laser fiber is provided with positioning marks.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Great Saphenous Vein, superficial veins in the lower extremity.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Technological and performance differences in design and materials have been qualified through the following tests:
- Simulated use blood burn .
- Simulated anatomy ●
- Ultrasound visualization .
- . Corrosion resistance
- . Tensile strength
- Compressive force .
- Biocompatibility .
The results of the verification and biomaterial assessments did not raise any new safety or performance questions and confirm that the Vari-Lase WireFiber is substantially equivalent to the predicate Vari-Lase laser fibers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K072332 - Vari-Lase WireFiber (Vascular Solutions, Inc.), K091551 - Vari-Lase Platinum Bright Tip (Vascular Solutions, Inc.)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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