(91 days)
The PhotoGenica sV laser is indicated for vascular and vascular dependent lesions of the upper airway including, but not limited to, glottal dysplasia, laryngeal papillomas and haemorrhagic telangiectasia.
The PhotoGenica sV is a pulse-dye laser, having the organic dye as the lasing medium. It is a pulsed dye laser with a wavelength of 585nm. Laser activation is by footswitch. Overall weight of the laser is 285lbs, and the size is 44"x19"x24" (HxWxD). Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single phase.
Analysis of Acceptance Criteria and Study for Cynosure PhotoGenica sV Laser (K032539)
Based on the provided 510(k) summary and FDA clearance letter, it's evident that no clinical performance data or specific acceptance criteria for device performance related to a clinical study were provided or required for the substantial equivalence determination of the PhotoGenica sV laser.
The submission focuses primarily on demonstrating substantial equivalence to predicate devices (PhotoGenica V and PhotoGenica sV - implying a prior version or a very similar model) based on shared principle of operation, wavelength, and pulse energy range, rather than performance against predetermined clinical metrics.
Therefore, the following sections will reflect the absence of such information in the provided documents.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (No specific clinical performance or acceptance criteria were defined or required for this 510(k) submission based on the provided documents.) | Not Applicable (No clinical performance data was reported or used to establish substantial equivalence.) |
Explanation: The 510(k) summary explicitly states "Clinical Performance Data: none." The FDA clearance letter makes no mention of clinical data review, but rather focuses on substantial equivalence to predicate devices based on technical specifications.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set data was provided.
- Data Provenance: Not applicable. No clinical data was provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. No clinical ground truth was established through expert review for this submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set and thus no adjudication method was employed or described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The provided documents explicitly state "Clinical Performance Data: none," indicating no such study was conducted or submitted.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: Not applicable. This device is a medical laser system, not an algorithm-driven diagnostic or therapeutic device requiring a standalone performance study.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable. No clinical ground truth was required or used for this 510(k) submission. Substantial equivalence was based on comparison to existing predicate devices' technical specifications and intended use.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The device is a physical laser system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable. As the device is a laser system and not an AI/ML model, the concept of a "training set" and associated ground truth is not relevant.
§ 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.