(398 days)
Dermatology, Plastic & General Surgery
The CO2 laser, model MedArt 610, is intended to be used by physicians in the performatice of the following specialities:
The ablation and coagulation of soft tissue in dermatology, plastic and general surgery in the performance of:
- Skin Resurfacing .
- . Treatment of wrinkles and rhytids
- Treatment of furrows .
- Soft tissuc ablation .
The MedArt 610 system comprises the following major parts:
- A laser console containing a CO2 laser module capable of providing a laser beam having a wave-. length of 10,600 nm.
- A scanner that is intended to manipulate and place a pulsed beam received from the laser console in . a pre-specified pattern on the skin being treated.
- An optical fiber providing a beam path from the laser to the scanner. .
The MedArt 610 Laser system is identified as substantially equivalent to the Uni-Laser 450P (K991297) manufactured by ASAH Medico A/S. The submission demonstrates substantial equivalence through a side-by-side comparison of device specifications and indications for use, rather than a primary clinical study with predefined acceptance criteria. Therefore, the information provided focuses on the comparative data rather than a direct performance study against specific acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device, Uni-Laser 450P. This implies that the MedArt 610 is expected to perform at least as safely and effectively as the predicate device for its stated indications. The document does not provide explicit numerical acceptance criteria, but rather a direct comparison of features and performance parameters.
| Acceptance Criteria (Implied by Predicate Equivalence) | MedArt 610 Performance (Reported Device Performance) | Predicate Device (Uni-Laser 450P) Performance |
|---|---|---|
| Indications for Use: | ||
| Skin Resurfacing | Yes (Identical application) | Yes |
| Treatment of wrinkles and rhytids | Yes (Identical application) | Yes |
| Treatment of furrows | Yes (Identical application) | Yes |
| Soft tissue ablation | Yes (Identical application) | Yes |
| Technology: | ||
| CO2 laser module | Yes | Yes |
| Scanner for pattern production | Yes | Yes |
| Beam delivering system (fiber) | Yes | Yes |
| Physical Parameters: | ||
| Length of beam delivering system | 165cm | 165cm |
| Type of beam delivering system | Fiber providing full freedom of movement | Fiber providing full freedom of movement |
| Wavelength | 10,600nm | 10,600nm |
| Max power | 0.1 - 12W | 0.1 - 12W |
| Minimum scanner spot size | Ø400µm | Ø400µm |
| Max power density | 17 kW/cm2 (Computed from 12W/Ø300µm) | 17 kW/cm2 (Computed from 12W/Ø300µm) |
| Aiming beam | 635nm, max 5mW | 635nm, max. 2mW |
| Scanning speed | 0.3-100 Hz | Not specified, but "In the range of 1 sec. Actual time is depending on scan pattern chosen" for full scan time. |
| Time for a full scan | In the range of 1 sec. Actual time is depending on scan pattern chosen | In the range of 1 sec. Actual time is depending on scan pattern chosen |
| Beam activation | Foot switch | Foot switch |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical data is provided for the MedArt 610 within this 510(k) summary. The submission relies on a comparison to a legally marketed predicate device (Uni-Laser 450P) to demonstrate substantial equivalence. Therefore, there is no sample size for a test set or data provenance from a new study provided for the MedArt 610.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The submission does not involve a test set requiring expert ground truth establishment for the MedArt 610. The equivalence is based on engineering specifications and comparison to the predicate device's cleared indications and performance characteristics.
4. Adjudication Method for the Test Set
Not applicable. There was no test set or clinical study requiring an adjudication method presented in this 510(k) summary.
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 laser system for surgical and dermatological procedures, not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC study and
effect size related to AI assistance for human readers is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical laser system operated by physicians, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the MedArt 610's substantial equivalence determination is the previously cleared performance and indications for use of the predicate device, the Uni-Laser 450P. This is based on the regulatory clearance of a similar device with known safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This submission does not involve training data for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This submission does not involve a training set or ground truth establishment for an algorithm.
§ 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.