(545 days)
The Vectra Family of Laser Systems and Accessories are indicated for ablation, vaporization, coagulation, incision/excision of soft tissue in contact or non-contact mode including open surgery and via endoscopes, introducers, trocars, or catheters. The Vectra Family of Laser Systems and Accessories are indicated for use in surgical procedures on skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands in surgical specialties including but not limited to genitourinary surgery, urology (including BPH), gynecology (GYN), gastroenterology, general surgery (including specific treatment of varicose veins, varicosities associated with superficial reflux of the greater saphenous vein, removal of pigmented lesions, photothermolysis of hair follicles), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, podiatry, pulmonary/ thoracic surgery, dentistry and oral surgery (intra/extra oral soft tissue, e.g., removal of diseased soft tissue in the periodontal pocket, and for light activation of bleaching materials for teeth whitening.)
The device is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes. The device is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, genecology, neurosurgery (peripheral nervous system), pulmonary and cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.
The Vectra Family of Laser Systems emitting 980nm and 1470 nm wavelengths are substantially equivalent to the Xintec Corporation Vectra Laser Systems (Xintec Corporation, dba, Convergent Laser Technologies, Alameda, CA) and Ceralas D 980nm and 1470nm Diode Laser Systems (East Longmeadow, MA) which have been previously cleared for marketing under applicable 510(k) pre-market notification regulations.
This document is a 510(k) premarket notification for the Vectra™ Family of Laser Systems and Accessories. It describes the device's intended use and claims substantial equivalence to previously cleared predicate devices. Crucially, this document does not contain an acceptance criteria table, reported device performance metrics, or details of a study demonstrating the device meets performance criteria.
The 510(k) submission process for this type of device (surgical laser) typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical performance studies with specific acceptance criteria in the same way that novel diagnostic AI/ML devices might.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices, not on meeting new, specific algorithmic performance metrics.
- Sample size used for the test set and the data provenance: Not applicable as a standalone performance study with a test set for acceptance criteria is not described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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. This device is a surgical laser, not an AI diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of what the document does provide regarding "acceptance criteria" and "study":
- Acceptance Criteria (Implied by Substantial Equivalence): The implicit "acceptance criteria" for a 510(k) for a device like this is demonstrating substantial equivalence to existing predicate devices. This means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate(s).
- "Study" (Demonstration of Substantial Equivalence): The document states:
- "There should be no significant differences in laser delivery performance for each of 980nm and 1470nm wavelengths for the Vectra Family of Laser Systems compared to the cleared predicate devices."
- This "performance data" statement, in the context of a 510(k), typically refers to non-clinical testing (e.g., bench testing, engineering comparisons) to confirm that the laser itself performs comparably to the predicate devices in terms of power output, wavelength stability, beam characteristics, safety features, etc. It does not refer to a clinical study with patients to evaluate diagnostic accuracy or a specific clinical outcome with acceptance criteria.
The 510(k) process for this device is centered on the comparison to predicate devices: Biolitec Ceralas 980nm and 1470nm Diode Laser, Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories, and Cynosure Smart Lipo Multiwavelength Laser. The "study" here is the assessment that the new device's technological characteristics and intended uses are similar enough to these predicates that it doesn't require a new, full-scale clinical trial to prove safety and effectiveness.
§ 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.