(97 days)
The equipment is used for human tissue vaporization in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing.
The subject device, CO2 Laser System (Model: GP900F) mainly consist of console, articulated arm and a foot switch. CO2 laser wavelength is 10600nm, which is used to gasify the skin tissue based on the principle of the theory selective photothermolysis. The water in skin absorbs laser energy and evaporates. By setting up the suitable energy and other parameters on skin tissue, the device can be used for human tissue vaporization and coagulation as well as for the treatment of wrinkles and skin resurfacing.
This document describes the CO2 Laser System (Model: GP900F) and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria, device performance metrics (e.g., accuracy, sensitivity, specificity), or a study designed to prove the device meets such criteria in terms of clinical effectiveness.
The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through comparisons of technological characteristics, safety standards, and non-clinical testing. This type of submission (510(k)) generally does not require clinical effectiveness studies in the same way a PMA (Premarket Approval) would.
Therefore, many of the requested details cannot be extracted from the provided text. I will answer the questions based on the information that is available.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity) and corresponding device performance metrics are not detailed. The acceptance criteria are implicit in the demonstration of substantial equivalence to predicate devices and compliance with safety and performance standards.
The "performance" described relates to adherence to safety standards and the ability to deliver set laser energy parameters within specifications, not clinical outcomes or diagnostic accuracy.
| Category | Acceptance Criteria (Implied by equivalence to predicates and standards) | Reported Device Performance (as demonstrated for SE) |
|---|---|---|
| Functional Equivalence | Similar Indications for Use to Predicate Devices | Equipment used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. Classical scanner for wrinkles and skin resurfacing. (Same as predicate) |
| Safety | Compliance with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2 | Passed tests for these standards. |
| Biocompatibility | Compliance with ISO 10993-5, ISO 10993-10 | Passed tests for In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity. |
| Software Validation | Compliance with FDA guidance for "moderate" level of concern software | Software functions as specified in requirement specifications. |
| Bench Performance | Deliver set laser energy parameters within specifications | Device delivers set laser energy parameters within specifications. |
| Technological Characteristics | Similar key specifications (Output Power, Laser Wavelength, etc.) to Predicate Devices | Device matches or is similar in key specifications to predicate devices (e.g., 30W output, 10600nm wavelength, |
§ 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.