(14 days)
The Cynosure Smartlipo Multiwavelength Laser is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Cynosure Smartlipo Multiwavelength Laser is futher indicated for laser assisted lipolysis.
The Cynosure Smartlipo Multiwavelength laser is a Nd:YAG laser, having a ND: YAG crystal rod as a lasing medium. It is a laser with a wavelength of 1064 nm and 1320 nm. Laser activation is by footswitch. Overall weight of the laser is 285lbs, and the size is 41"x18"x32" (HxWxD). Electrical requirement is 220 VAC, 20A, 50-60 Hz, single phase.
Here's an analysis of the provided information regarding the Cynosure Smartlipo Multiwavelength Laser, focusing on acceptance criteria and supporting studies:
Based on the provided K080121 510(k) summary, there are no explicit performance acceptance criteria or a study detailed that proves the device meets specific performance criteria.
The submission relies entirely on substantial equivalence to a predicate device, the Cynosure YAG Family laser. This means the FDA has determined the new device is as safe and effective as a legally marketed device, primarily because it shares the same intended use, principle of operation, and laser parameters.
Here's a breakdown of the requested information, reflecting the content of the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| None explicitly stated. The submission relies on substantial equivalence to a predicate device. | Not applicable. No specific performance metrics or data against acceptance criteria are reported. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No test set or clinical study data is reported.
- Data Provenance: Not applicable. No clinical data was used for the submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. No test set requiring ground truth establishment was used.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No.
- Effect Size of Human Readers with vs. without AI Assistance: Not applicable, as no AI component is mentioned, and no such study was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance Study: No. The device is a physical laser system, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable. No clinical or performance data requiring ground truth was presented. The basis for clearance is substantial equivalence to a predicate device with a history of safe and effective use.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. No training set was used, as this is not a machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. No training set was used.
Conclusion from the document:
The 510(k) summary explicitly states:
- "Nonclinical Performance Data: none"
- "Clinical Performance Data: none"
The conclusion for this submission is: "The Cynosure Smartlipo Mutliwavelength Laser is a safe and effective device for the 'indications for use' specified." This conclusion is drawn based on its substantial equivalence to the predicate device, the Cynosure YAG Family laser, meaning it has the same indications for use, principle of operation, and laser parameters, and therefore does not require new performance data to be demonstrated.
§ 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.