(168 days)
The CO2 Laser Equipment is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
The subject device CO2 Laser Equipment is a carbon dioxide laser used in medical and aesthetic industry. The device emits laser energy at 10.6 um wavelength to induce human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. The CO2 Laser Equipment includes two models US800/US800N, the two models have same mechanism of action, structure, material, motherboard, software, principle and specification. The difference is appearance and size.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the CO2 Laser Equipment (K212611):
1. Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device (K192528) through performance and safety comparisons, rather than explicitly stating quantitative "acceptance criteria" for a novel device performance claim. The "acceptance criteria" are implied by the "Remark" column being "SAME" or "SE" (Substantially Equivalent) between the proposed and predicate devices.
| Item | Acceptance Criteria (Implied by Predicate) | Reported Device Performance |
|---|---|---|
| Product Code | GEX | GEX |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Class | 2 | 2 |
| Where used | hospital | hospital |
| Intended Use | Human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. | Human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. |
| Maximum Power | 30W | 30W |
| Work mode | Single Pulse, Continuous, Muti-Pulse | Single Pulse Mode, Continuous Pulse Mode, Multi Pulse Mode |
| Wavelength | 10.6 um | 10.6 um |
| Beam delivery | 7 knucklearmkey joints light arm | 7 joint Light guide arm |
| Light arm | 1.36m | 1.36m |
| Aiming Beam | 630-650nm red diode laser (≤5 mW) | 650nm/0.5mW |
| Spot size | 0.5 mm | 0.5 mm |
| Pulse Setting | Single Pulse / 0.1ms-1000ms. Multi Pulse. Continuous 1-30W | Single Pulse / 0.1ms-1000ms. Multi Pulse. Continuous 1-30W |
| Power calibration | Period of 1 year | Period of 1 year |
| Control System | Touch screen, footswitch | Touch screen, footswitch |
| Laser operation | Footswitch | Footswitch |
| Laser medium/ energy source | CO2 | CO2 |
| Cooling System | Air cooling | Air cooling |
| Clean Method | 70% medical alcohol | 70% medical alcohol |
| Patient Contacted Part | Skin | Skin |
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 |
| Patient Contact Materials | (Predicate did not specify, implied no significant patient contact for material concerns) | No patient contacting components/materials claimed |
For dimensions and weight, the proposed device differs but is deemed acceptable by complying with IEC 60601-1, indicating that this difference is not expected to adversely affect safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
This document describes a premarket notification for a Class II medical device (CO2 Laser Equipment). The submission is based on demonstrating substantial equivalence to a previously cleared predicate device.
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. There is no specific "test set" of patient data in the way one would conduct a clinical trial for a novel device performance claim. The key assessment is against technical specifications and safety standards.
- Data Provenance: Not applicable for a typical clinical test set. The data provenance relates to the technical specifications, design documents, and results of non-clinical bench testing. The predicate device's prior clearance provides the established safety and effectiveness benchmark. The manufacturer is Beijing Globalipl Development Co., Ltd. (China).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This submission relies on demonstrating adherence to recognized consensus standards and equivalence to a predicate device, not on expert consensus to establish a "ground truth" for a diagnostic or predictive performance.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is needed or included in this submission."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a CO2 Laser Equipment, a physical surgical instrument, not an AI algorithm or software-only device. There is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness of the predicate device (K192528), along with compliance to recognized international safety and performance standards for medical electrical equipment and laser products (e.g., AAMI ES60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2). The submission argues that since the proposed device is technologically similar and meets the same or comparable performance standards, it is as safe and effective as the predicate.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that would have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device.
§ 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.