(60 days)
Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 mm) Tattoo Removal: Dark ink (blue and black) (1064 nm) Tattoo Removal: light ink (red, sky blue, green) (532 nm) telangiectasias (532 nm) spider nevi (532 nm) solar lentiginos, senile lentiginos, becker's nevi, freckles (532 nm) nevus of ota (1064 nm)
The ACTIVO is based on the Nd:YAG(1064nm) and KTP Nd: YAG(532nm) laser technology. It is indicated for the incision, ablation, vaporization of soft tissues for general dermatology. Three basic elements of operations are as follows: 1) A Nd:YAG crystal is used as a gain medium which produces a laser beam. 2) A resonator then amplifies the beam. 3) A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy(1064nm). This converted light energy pumps the Nd: YAG crystal - a gain medium - and the light exhausted from the crystal is amplified into a specific wavelength light(532nm). As it passes between the resonant gases, laser beam radiates to an output unit. The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.
This FDA 510(k) summary is for the ACTIVO laser surgical instrument. It relies on non-clinical testing for substantial equivalence, as no clinical testing was performed or required. Therefore, the device does not have acceptance criteria defined by an effectiveness study that proves its performance against clinical endpoints. Instead, its acceptance criteria are based on meeting design specifications and demonstrating substantial equivalence to a predicate device through non-clinical performance and safety standards.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
Since this filing is based on substantial equivalence through non-clinical testing, the "acceptance criteria" are the standards and design specifications met by the device, and the "reported device performance" is that it successfully met these standards.
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1: Evaluation and testing within a risk management process | Met (cytotoxicity, sensitization, irritation tests passed) |
| ISO 10993-5:2009 Tests for in vitro cytotoxicity | Passed | |
| ISO 10993-10:2021 Tests for skin sensitization (Guinea pig maximization test) | Passed | |
| ISO 10993-23:2021 Tests for irritation (Animal irritation test by skin exposure) | Passed | |
| Electrical Safety | IEC 60601-1: 2005+A2:2020 Medical electrical equipment - General requirements for basic safety and essential performance | Compliant |
| EMC | IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Electromagnetic disturbances - Requirements and tests | Compliant |
| Laser Safety | IEC 60825-1:2014 Safety of laser products - Equipment classification and requirements | Compliant |
| Particular Performance | IEC 60601-2-22:2019 Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | Compliant |
| Software V&V | FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate level of concern) | Successfully conducted and documentation provided |
| Accuracy Testing | Max. energy, stability of energy, spot size, wavelength, and pulse duration do not deviate from tolerance of setting/fixed value | Verified |
| Substantial Equivalence | Similar indications, design, technology, functions, and principle of operation to predicate device. Differences do not affect safety or effectiveness. | Determined to be Substantially Equivalent (SE) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. No clinical test set involving human or animal subjects was used as the submission relies solely on non-clinical testing and comparison to a predicate device.
- Data Provenance: Not applicable for clinical data. For non-clinical testing, the tests were conducted at facilities presumably in the country of manufacture or a certified testing laboratory, but this specific detail is not provided. The device manufacturer is DAEJU MEDITECH ENGINEERING CO., LTD. in Seoul, Republic of Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. There was no clinical test set requiring expert ground truth establishment. The document refers to compliance with international standards and internal verification for non-clinical aspects.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication was used.
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. No MRMC study was conducted. This device is a laser surgical instrument, not an AI-assisted diagnostic or treatment planning system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (laser surgical instrument), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" equivalent would be the established specifications and parameter tolerances of the device, and the established limits and requirements of the referenced international standards (e.g., IEC 60601-1, ISO 10993).
8. The sample size for the training set
- Not applicable. This device is a physical laser instrument, not an AI/ML-based device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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.