(216 days)
The CO2 Laser (10600nm) is indicated for use in dermatological procedures requiring ablation, resurfacing and coagulation of soft tissue.
The CO2 Laser consists of semiconductor solid-state lasers, switching power supply, laser power, treatment handle, key switch, cooling system and accessories. The CO2 Laser produces a beam of coherent infrared light with 10600nm wavelength. The CO2 laser comprises five models: YILIYA-10600AH, YILIYA-10600AL, YILIYA-10600CH, Aeslight-10600EH, Aeslight-Ultra peel; their technical parameters and functions are the same, the only difference is their appearances and sizes.
The provided 510(k) Premarket Notification Submission (K131837) for the HONKON CO2 Laser focuses on establishing substantial equivalence to a predicate device (K080496). This type of submission generally relies on demonstrating that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device, and that any differences do not raise new questions of safety or effectiveness.
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are primarily related to demonstrating substantial equivalence through technical comparison with the predicate device and adherence to relevant safety standards, rather than a clinical performance study with specific metrics like sensitivity, specificity, or reader improvement.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on predicate equivalence and safety standards) | Reported Device Performance (Proposed CO2 Laser) |
|---|---|
| Intended Use: For dermatological procedures requiring ablation, resurfacing, and coagulation of soft tissue. | Met: "The CO2 Laser is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue." (Identical to predicate) |
| Energy Output: Comparable to predicate (2-240mj) | Met: 2-200mj (Within acceptable range or minor difference not raising new safety/effectiveness questions) |
| Laser Transfer Method: Articulated Arm with Handpiece | Met: Articulated Arm with Handpiece (Identical to predicate) |
| CO₂ RF Module Maximum Power: Maximum 30w at continuous wave | Met: Maximum 30w at continuous wave (Identical to predicate) |
| Wavelength (nm): 10600 | Met: 10600 (Identical to predicate) |
| Pulse Duration (ms): Comparable to predicate (5-100) | Met: 5-100 (Identical to predicate) |
| Frequency (Hz): Comparable to predicate (10-200Hz) | Met: 10-200Hz (Identical to predicate) |
| Patient Contacting Materials: Aluminum | Met: Aluminum (Identical to predicate) |
| Compatibility with environment and other devices: Comply with IEC 60601-1-2 | Met: Comply with the IEC 60601-1-2 |
| Electrical Safety: Comply with IEC 60601-1 | Met: Comply with the IEC 60601-1 |
| Radiation Safety: Comply with IEC 60825-1; IEC 60601-2-22 | Met: Comply with the IEC 60825-1; IEC 60601-2-22 |
| Biocompatibility: Comply with ISO 10993-5; ISO 10993-10 | Met: Comply with the ISO 10993-5; ISO 10993-10 |
| Other Device Specific Guidance Requirements: Adherence to "Guidance on the Content and Organization of a Premarket Notification for a Medical Laser; 21 CFR 1040.10" | Met: The submission states: "The CO2 Laser and its application comply with standards as detailed in section 9, 11 and 17 of this premarket notification. Therefore, Beijing Honkon states that the non-clinical tests determined that the CO2 Laser to be as safe, as effective and performance is substantially equivalent to the predicate device(s)." |
2. Sample size used for the test set and the data provenance
This is a 510(k) submission for a medical laser device, not an AI or diagnostic device that typically uses "test sets" of data for performance evaluation in the way you might describe for software.
- Sample Size for Test Set: Not applicable in the context of clinical data. The "test set" here refers to the physical device being tested against engineering standards and compared to the predicate device's specifications. The document does not specify a "sample size" of devices tested, but rather refers to conformance of "the CO2 Laser" (implying a representative unit/design) with established standards.
- Data Provenance: The data provenance is primarily from non-clinical testing (bench testing, engineering verification, and compliance with recognized standards) conducted by the manufacturer (Beijing Honkon Technologies Co., Ltd.) to demonstrate safety and performance according to the cited IEC and ISO standards. The country of origin for the manufacturing and testing would be China. This is a prospective evaluation in the sense that the device was manufactured and then tested to meet these criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a laser device like this, "ground truth" is not established by medical experts for diagnostic accuracy. Instead, safety and performance are assessed against predefined engineering specifications, international safety standards (IEC, ISO), and the performance characteristics of the predicate device. The "experts" involved would be engineers, quality control specialists, and regulatory affairs personnel who conducted and reviewed the technical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy to resolve discrepancies between human readers or between human readers and AI. This submission is based on technical specifications and compliance with standards.
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. An MRMC study is relevant for diagnostic devices (often AI-powered) where human readers evaluate cases. This document describes a medical laser, not a diagnostic imaging or AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's acceptance is based on:
- Engineering Specifications: Conformance to the stated technical parameters (e.g., wavelength, energy output, pulse duration, frequency).
- International Safety and Performance Standards: Compliance with recognized standards like IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, ISO 10993-5, and ISO 10993-10. These standards define the acceptable limits and test methods for safety and performance of such devices.
- Predicate Device Equivalence: The key "ground truth" is showing that the device's technical characteristics and intended use are substantially equivalent to a legally marketed predicate device, implying it is as safe and effective.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI model, there is no ground truth established for it in this context.
§ 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.