(200 days)
The Orion Series Surgical Laser System (Q-switched Nd:YAG configuration) is intended for removal of dark tattoo ink, including blue and black
The Orion Series Surgical Laser System consists of a movable containing power supplies, a treatment laser on a solid optical deck, and a cooling system to dissipate the heat generated by the system. A keypad control panel with CRT enables the user to control the laser system operating parameters. Surgical power is controlled via a footswitch. Laser power is emitted only when the footswitch is depressed. The delivery system is through fiber optics. Five configurations are currently available: 12W KTP only, 208 VAC 12W KTP/30W Nd:YAG, 208 VAC 20W KTP only, 208 VAC 20W KTP/50W Nd:YAG,208 VAC 50W Nd:YAG only, 208 VAC
This document is a 510(k) summary for the Laserscope Orion Series Surgical Laser System. It is a premarket notification for a medical device, not a study report. Therefore, it does not contain the detailed information about acceptance criteria and a study proving the device meets them as requested.
The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory clearance. It states that the device "conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems" and that "Safety and effectiveness are reasonably assured." However, it does not provide specific acceptance criteria values or the results of a study to demonstrate performance against those criteria.
Here's why the requested information cannot be extracted from this document:
- Acceptance Criteria and Reported Device Performance: This document states the device conforms to standards, but it doesn't list specific performance metrics (e.g., energy output tolerance, pulse duration accuracy, spot size consistency) as acceptance criteria, nor does it provide detailed test results showing the device achieved those criteria.
- Sample Size and Data Provenance: There is no mention of a test set, sample size, or data provenance because no specific clinical or performance study details are included.
- Number of Experts and Qualifications: This applies to studies involving human reading or interpretation, which is not relevant for this laser system's performance evaluation as presented here.
- Adjudication Method: Not applicable for this type of device submission.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This device is a surgical laser, not an imaging or diagnostic device requiring human interpretation of results.
- Standalone (Algorithm Only) Performance: Not applicable as it's a hardware device, not an algorithm.
- Type of Ground Truth: Not applicable in the context of this device and submission.
- Sample Size for Training Set: Not applicable as there's no mention of a training set or machine learning components.
- How Ground Truth for Training Set was Established: Not applicable.
Instead, the document highlights:
- Regulatory Compliance: Conformance with 21 CFR 1040.10 and 1040.11 for medical laser systems. These are general performance standards for laser products.
- Substantial Equivalence: The primary strategy for clearance is demonstrating that the Orion Series Surgical Laser System (Q-switched Nd:YAG configuration) is substantially equivalent to the Medlite™ Q-switched Nd:YAG Laser System. This means it is considered as safe and effective as a legally marketed predicate device without the need for new clinical studies to prove efficacy.
- Indications for Use: Removal of dark tattoo ink (blue and black).
To find the specific acceptance criteria and performance data, one would typically need to refer to:
- Internal design specifications and verification/validation reports from the manufacturer.
- Detailed test protocols and results submitted to the FDA during the 510(k) process, which are not usually publicly available in this summary format.
- Relevant ISO or ANSI standards that apply to medical laser systems, as 21 CFR 1040.10 and 1040.11 are general regulations, and specific performance details would come from recognized consensus standards.
This 510(k) summary provides a high-level overview for regulatory clearance, not a detailed technical performance study report.
§ 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.