(85 days)
The device is intended for endovascular coagulation of blood vessels. The device is indicated for endovascular coagulation of the Greater Saphenous vein of the thigh in patients with superficial vein reflux.
The ELVeS kit with Radial Fibers contain the following components: (1) radial fiber; (2) access needle; (3) introducer sheath/ dilator; and (4) a guidewire and is identical to that cleared under K101712.
This 510(k) summary does not contain any performance data or a study describing acceptance criteria for the Endo Laser Vein System Kit with Radial Fiber.
Instead, the document states:
- Technological Characteristics: The device is "identical to that cleared under K101712."
- Performance Data: "The device complies with the following voluntary consensus standards: 21 C.F.R. §$ 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 601-1; IEC 601-2-22; EN 60825 ANSI/AAMI/ISO 10993-7." These are general safety and performance standards for medical electrical equipment and laser products, not specific clinical performance criteria.
- Substantial Equivalence: The primary argument for clearance is based on the device being "identical to that cleared under K101712 and uses previously cleared radial fiber technology (K924258) and has the same intended use and indications for use as the cleared Ceralas 1470, 980 and 810nm ELVeS kits."
Therefore, I cannot provide the requested table and study details because the provided text does not include information about acceptance criteria or a study proving the device meets them, in the typical sense of clinical or diagnostic performance.
The FDA cleared this device based on its substantial equivalence to previously cleared devices and compliance with relevant safety standards, rather than new clinical performance data in this specific submission.
§ 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.