(86 days)
The Laserscope EL Laser System and Accessories is indicated for use in procedures involving cutting (incision/excision), vaporizing, ablation and coagulation of soft tissue. All soft tissue is included such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
The Laserscope EL Laser System and Accessories consists of a moveable console containing power supplies, aiming and treatment lasers on a solid optical deck, and a cooling mechanism to dissipate the heat generated by the svstem. The entire laser unit and controls are contained in a single console. This console is electrically connected to the facility's power source. Emission of the laser beam is through an anodized aluminum articulated arm. The articulated arm is positioned at the left, upper part of the device and is not removable by the customer. Handpieces with removable, sterilizable tips, are available in 1, 3, 5 and 7 mm spotsizes. The user interface consists of an LCD which displays laser parameters, data on connected devices and information on messages and prompts. Located on the front panel are four knobs enabling the user to select laser settings, and a READY/STANDBY button for selecting READY or STANDBY mode. An on/off keyswitch turns the laser system on and off. An emergency shut off button disables the laser and places the laser system in a holding status.
The provided text is a 510(k) summary for the Laserscope EL Laser System and Accessories. It outlines the device's description, classification, indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document states that the device "conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems," implying that these regulations set the performance standards that need to be met. However, the specific acceptance criteria (e.g., in terms of power output, beam quality, safety features) and the details of any study performed to demonstrate compliance with these criteria are not included in this summary.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such study is described.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a laser system, not an AI algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices based on indications for use, materials, method of operation, and physical construction, implying that if it matches these aspects of already approved devices, then its safety and effectiveness are reasonably assured.
§ 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.