(137 days)
The CO2 Laser Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
The CO2 Laser Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
The CO2 laser machine has two modes, continuous mode and multi-pulse mode. It utilizes CO2 laser to vaporize and heat tissue.
During the treatment, the water in skin tissues absorbs laser energy and then vaporizes.
Laser parameters and other system features are controlled from the control panel on the console, which provides an interface to the system's micro-controller through a LCD touch-screen.
The provided text does not describe acceptance criteria for a medical device's performance, nor does it detail a study proving its performance against such criteria.
Instead, this document is a 510(k) summary for a CO2 Laser Machine, Model: BW-203B, seeking market clearance from the FDA. The purpose of a 510(k) submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective as the predicate and does not raise different questions of safety and effectiveness.
The document focuses on comparing the proposed device to a predicate device (K200042) in terms of general characteristics, performance specifications, and safety standards.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them from the given text.
However, I can extract information related to the comparison with the predicate device and the non-clinical tests performed:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present "acceptance criteria" in the traditional sense of performance metrics that the device's output is measured against. Instead, it compares the proposed device's specifications and compliance with safety standards against a predicate device. The "Remark" column indicates if the characteristic is "SAME" or "SIMILAR."
| ITEM | Proposed Device (K211735) | Predicate Device (K200042) | Remark |
|---|---|---|---|
| General Comparison | |||
| Product Code | GEX | GEX | SAME |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Class | 2 | 2 | SAME |
| Where used | Hospital | Hospital | SAME |
| Intended Use | The CO2 Laser Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. | The CO2 Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. | SAME |
| Performance Comparison | |||
| Maximum Power | 30W | 30W | SAME |
| Work mode | Continuous, Muti-Pulse | Single Pulse, Continuous, Muti-Pulse | SAME |
| Wavelength | 10.6 um | 10.6 um | SAME |
| Mode Structure | TEM00 | TEM00 | SAME |
| Beam delivery | 7 knucklearmkey joints light arm | 7 knucklearmkey joints light arm | SAME |
| Light arm | 1.36m | 1.36m | SAME |
| Handpiece Type | Be part of light arm | Be part of light arm | SAME |
| Aiming Beam | 630-650nm red diode laser (≤5 mW) | 650nm red diode laser(≤ 5 mW) | SAME |
| Spot size | 0.5 mm | 0.5mm | SAME |
| Output Power | 1-30W | 1-30W | SAME |
| Pulse Duration | 1-1000 ms | 1-1000 ms | SAME |
| Control System | Touch screen, footswitch | Touch screen, footswitch | SAME |
| Laser operation | Footswitch | Footswitch | SAME |
| Laser medium/energy source | CO2 | CO2 | SAME |
| Cooling System | Water + Air cooling | Air cooling | SIMILAR |
| Clean Method | 70% isopropanol | 70% isopropyl alcohol | SAME |
| Dimension | 61 cm x 32 cm x 22 cm | 37.5 cm x 29 cm x 113 cm | Analysis (Difference noted, but stated "will not affect safety and effectiveness") |
| Weight | 35 kg | 40 kg | Analysis (Difference noted, but stated "will not affect safety and effectiveness") |
| Power input | AC100V/60Hz | 110V 60Hz or 230V 50Hz | SAME |
| Safety Comparison | |||
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | SAME |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SAME |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 | SAME |
| Patient Contact Materials | handpiece | handpiece | SAME |
| Cytotoxicity | No Cytotoxicity (Comply with ISO 10993-10 and ISO 10993-5) | Comply with ISO 10993-10 and ISO 10993-5 | SAME |
| Sensitization | No evidence of sensitization | (Not explicitly stated for predicate, but overall SAME implies compliance) | |
| Irritation | No evidence of irritation | (Not explicitly stated for predicate, but overall SAME implies compliance) |
2. Sample size used for the test set and the data provenance:
The document explicitly states: "No clinical study is included in this submission." This implies there was no "test set" in the context of clinical performance evaluation. The evaluation for substantial equivalence was based on non-clinical tests (bench testing, standards compliance) and comparison to the predicate device's specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical study or test set requiring expert ground truth was conducted.
4. Adjudication method for the test set:
Not applicable, as no clinical study or test set was conducted.
5. 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 device is a CO2 Laser Machine for surgical use, not an AI-assisted diagnostic or imaging device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is hardware for surgical procedures, not an algorithm.
7. The type of ground truth used:
Not applicable. The "ground truth", in this context, is the compliance with established electrical, laser, and biocompatibility safety standards (IEC, ISO) and the functional specifications demonstrated through non-clinical testing.
8. The sample size for the training set:
Not applicable, as no AI/algorithm training was performed or reported.
9. How the ground truth for the training set was established:
Not applicable, as no AI/algorithm training was performed or reported.
Summary of what the document does provide:
The document focuses on demonstrating substantial equivalence to a predicate device (K200042) through:
- Comparison of technical specifications: Maximum power, work mode, wavelength, beam delivery, control system, cooling system, etc.
- Compliance with recognized standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10.
- Non-clinical testing: This involved verifying that the proposed device met design specifications and complied with the listed safety standards. It also mentions "Software Validation & Verification Test."
- Conclusion: Based on the comparison and non-clinical tests, the proposed device is determined to be Substantially Equivalent (SE) to the predicate 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.