(30 days)
SideLaze800™ is an accessory to deliver optical energy for Cynosure 1440nm wavelength lasers and intended to be used with Cynosure 1440nm wavelength lasers' cleared indications for use, such as the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue (including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands) and laser assisted lipolysis. SideLaze800™ may be used in combination with a Cynosure SMA-compatible laser system for the same indications.
SideLaze800™ is an optional side-firing fiber optic accessory to the currently cleared Cynosure Lasers with 1440nm wavelength. The addition of the Cynosure SideLaze800™ option to the cleared laser devices is intended to offer physicians a convenient accessory within cleared indications for use.
The provided 510(k) summary for the SideLaze800™ device does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in a clinical context.
This submission is a "Special 510(k)" for the addition of an accessory (SideLaze800™) to existing, cleared 1440nm wavelength lasers. The core argument for clearance is based on substantial equivalence to predicate devices, asserting that the accessory does not change the fundamental scientific technology or indications for use, and therefore does not raise new questions of safety and effectiveness.
Here's why the requested information is largely absent:
- Type of Device: The SideLaze800™ is a "laser beam delivery accessory." Its function is to deliver optical energy, not to interpret or diagnose.
- Regulatory Pathway (Special 510(k)): For accessories or minor modifications to cleared devices, the FDA often accepts a Special 510(k) if the changes do not affect the fundamental technology, indications for use, or safety/effectiveness. This pathway generally relies more heavily on bench testing and comparison to existing predicate devices rather than extensive new clinical studies with detailed acceptance criteria for diagnostic performance.
- Nature of the Therapy: This device is a laser for surgical procedures (incision, excision, vaporization, ablation, coagulation, laser-assisted lipolysis). It's a therapeutic device, not a diagnostic or AI-powered one. Therefore, "acceptance criteria" and "device performance" as typically understood for AI/diagnostic devices (e.g., sensitivity, specificity, AUC) are not applicable here.
However, I can extract the following information based on the request, even if it's not directly related to AI or diagnostic performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness equivalent to predicate devices | Substantially Equivalent to predicate devices. Bench testing summaries included in submission for performance. |
| Conforms to Laser Performance Standard (21 CFR 1040) | Device conforms to this standard. |
| No fundamental changes in technology nor changes in indicated use | Stated that the accessory does not represent any fundamental changes in technology or any changes in indicated use. |
| Does not raise additional questions of safety and effectiveness | Stated that the accessory does not raise any additional questions of safety and effectiveness. |
Explanation: The "acceptance criteria" here are broad regulatory benchmarks for safety and effectiveness, primarily demonstrated through substantial equivalence to already cleared devices. The "performance data" mentioned is "bench testing summaries" related to the accessory itself, not clinical outcomes from a study measuring device performance against specific targets for diagnostic accuracy or efficacy improvement.
Due to the nature of the device (a laser accessory) and the regulatory submission type (Special 510(k) for an accessory), the following points are not applicable or not provided in the given document:
- Sample size used for the test set and the data provenance: Not applicable for this type of device and submission. No clinical "test set" for diagnostic performance is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method 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 is not an AI-powered diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- 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.
In summary, this 510(k) is for a laser accessory that delivers existing laser energy. The focus is on demonstrating that the accessory maintains the safety and effectiveness profile of the currently cleared laser systems, rather than demonstrating new clinical performance metrics or AI capabilities.
§ 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.