(25 days)
Alexandrite 755nm laser source:
Temporary hair reduction.
Stable long-term or permanent hair reduction through selective targeting of
melanin in hair follicles. Permanent hair reduction is defined as the long-term,
stable reduction in the number of hairs regrowing when measured at 6,9, and 12 months after the completion of a
treatment regime, on all skin types (Fitzpatrick I - VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Nd:YAG 1064nm laser source:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB . The lasers are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.
Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
The laser is indicated for benign pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
Motus AZ is a medical device equipped with Alexandrite 755nm laser and Nd: YAG 1064nm laser.
The laser sources deliver the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition.
The modifications to the device consist on a restyling of the device (chassis, cover plastics and GUI) and on modifications to Moveo handpiece (new spot sizes available and new optional spacer). The spot size and the fluences are within the range of the already cleared device (K181486). The optional spacer is made of a biocompatible material (Anticorodal 6082), already used in previously cleared devices for the same type of contact (K192539, K172362, K172362, K133895).
The intended use of the modified devices, as described in the labelling, has not changed as a result of the modifications. Labelling itself has been updated also to include general improvements that have been implemented since predicate device clearance and considered as minor changes.
This document is a 510(k) summary for the DEKA Motus AZ device, a laser surgical instrument. It primarily focuses on demonstrating substantial equivalence to a predicate device (DEKA Motus AY, K181486) rather than providing extensive details about a specific clinical study for performance acceptance criteria.
The acceptance criteria presented are essentially that the proposed device (DEKA Motus AZ) maintains the same or equivalent specifications and performance characteristics as the predicate device (DEKA Motus AY). The submission asserts that the modifications are minor and do not affect safety or effectiveness.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for clinical efficacy or specific performance metrics in the way one might expect from a clinical trial summary. Instead, the acceptance criteria are implicitly met by demonstrating that the DEKA Motus AZ's specifications and performance are identical to or within acceptable variations of the predicate device (DEKA Motus AY).
| Characteristic | Acceptance Criterion (Predicate Device DEKA MOTUS AY, K181486) | Reported Device Performance (Proposed Device DEKA Motus AZ) | Comment |
|---|---|---|---|
| General Specifications | |||
| Weight | Approx. 90 kg | Approx. 100 kg | The variation to the weight does not affect safety and effectiveness of the device. |
| Dimensions (cm) | 95x51x83 (HxWxD) | 114x45x94 (HxWxD) | The variation to the dimensions does not affect safety and effectiveness of the device. |
| Mains voltage | 230 V~single phase, 50-60 Hz | 230 V~single phase, 50-60 Hz | Identical |
| Breaker | 16 A | 16 A | Identical |
| Operating environmental conditions | 15-35 °C; 30%-75% rel. humidity, 700-1060 hPa | 15-35 °C; 30%-75% rel. humidity, 700-1060 hPa | Identical |
| Transport and storage conditions | 5-50 °C; 10-90% humidity, 700-1060 hPa | 5-50 °C; 10-90% humidity, 700-1060 hPa | Identical |
| Indications for Use (Alexandrite 755nm) | Temporary hair reduction; Stable long-term or permanent hair reduction on all skin types (Fitzpatrick I - VI) including tanned skin; Treatment of benign pigmented lesions; Treatment of wrinkles; Photocoagulation of benign dermatological vascular lesions. | Identical | Identical |
| Indications for Use (Nd:YAG 1064nm) | Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB on all Skin Types Fitzpatrick I-VI including tanned skin; Photocoagulation and hemostasis of benign pigmented and benign vascular lesions; Coagulation and hemostasis of soft tissue; Benign pigmented lesions (various types); Reduction of red pigmentation in hypertrophic and keloid scars; Treatment of wrinkles. | Identical | Identical |
| Regulation number | 21 CFR 878.4810: Laser surgical instrument for use in general and plastic surgery and in dermatology | Identical | Identical |
| Product Code | GEX | Identical | Identical |
| Alexandrite 755nm Laser Source | |||
| Laser Type | Alexandrite | Alexandrite | Identical |
| Wavelength (nm) | 755 nm | 755 nm | Identical |
| Fluence (J/cm²) | 2-200 J/cm² | 2-200 J/cm² | Identical |
| Handpiece Spot Sizes (diameter mm) | 2.5, 5, 7, 10, 12, 14, 15, 16, 18, 20 mm (Moveo: 14 mm) | 2.5, 5, 7, 10, 12, 14, 15, 16, 18, 20 mm (Moveo: 7, 14 mm) | Identical overall spot size range (note: new Moveo spot size available, but within range) |
| Pulse Duration (milliseconds) | 2 to 50 ms | 2 to 50 ms | Identical |
| Pulse Repetition Rate (Hz) | up to 10 Hz | up to 10 Hz | Identical |
| Skin Cooling System | Yes (handpiece integrated and external) | Yes (handpiece integrated and external) | Identical |
| Skin Cooling Temperature | 15°C | 15°C | Identical |
| Nd:YAG 1064nm Laser Source | |||
| Laser Type | Nd:YAG | Nd:YAG | Identical |
| Wavelength (nm) | 1064 nm | 1064 nm | Identical |
| Fluence (J/cm²) | 2-600 J/cm² | 2-600 J/cm² | Identical |
| Handpiece Spot Sizes (diameter mm) | 2.5, 5, 7, 10, 12, 14, 15, 16, 18, 20 mm (Moveo: 14 mm) | 2.5, 5, 7, 10, 12, 14, 15, 16, 18, 20 mm (Moveo: 5, 14 mm) | Identical overall spot size range (note: new Moveo spot size available, but within range) |
| Pulse Duration (milliseconds) | 0.2 to 50 ms | 0.2 to 50 ms | Identical |
| Pulse Repetition Rate (Hz) | up to 10 Hz | up to 10 Hz | Identical |
| Skin Cooling System | Yes (handpiece integrated and external) | Yes (handpiece integrated and external) | Identical |
| Skin Cooling Temperature | 15°C | 15°C | Identical |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily relies on demonstrating substantial equivalence to a predicate device through engineering and performance comparisons, not on a prospective clinical trial with a "test set" as one might find for a novel device or AI algorithm. It's a "Special 510(k)" which generally indicates modifications to an already cleared device.
Therefore, there is no mention of a specific clinical "test set" sample size or data provenance in the context of efficacy for the modified DEKA Motus AZ device. The "data" refers to engineering and non-clinical performance data.
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. This submission is for a laser surgical instrument, and the performance testing mentioned (electrical safety, EMC, software validation) does not involve establishing ground truth by medical experts for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See #3.
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 is a laser surgical instrument, not an AI-based diagnostic tool that would typically involve MRMC studies or human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. See #5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of clinical efficacy ground truth for a test set. The "ground truth" for this submission are the established safety and performance standards for laser medical devices and the characteristics of the predicate device.
8. The sample size for the training set
Not applicable. This document does not describe the development or testing of an AI algorithm with a training set.
9. How the ground truth for the training set was established
Not applicable. See #8.
Summary of the Study Proving Acceptance Criteria:
The "study" proving the device meets its acceptance criteria, in this context, is the demonstration of substantial equivalence to the predicate device (DEKA Motus AY, K181486) through a combination of:
- Non-clinical performance testing:
- Electrical safety and electromagnetic compatibility (EMC): Conducted according to ANSI AAMI ES60601-1 and IEC 60601-1-2 standards.
- Software Validation and Verification Testing: Conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Additional non-clinical testing: Conducted according to IEC 60601-2-22 (particular requirements for laser equipment) and IEC 60825-1 (safety of laser products).
- Comparison of technological characteristics: A detailed side-by-side comparison (as shown in the provided table) confirming that the proposed device (DEKA Motus AZ) shares the same intended use, fundamental technology (Alexandrite 755nm and Nd:YAG 1064nm lasers, wavelengths, fluences, pulse durations, repetition rates, skin cooling systems), and similar or identical essential design parameters within acceptable ranges as the predicate device. The changes (restyling, new Moveo handpiece spot sizes and optional spacer) were evaluated to ensure they do not introduce new questions of safety or effectiveness.
The conclusion states: "Based on the comparison of indications for use and the technological characteristics, we can conclude that DEKA Motus AZ is as safe, as effective, and performs as well as the legally marketed predicate device (K181486)." This statement serves as the proof that the device meets the implicit acceptance criteria of being substantially equivalent to the cleared predicate.
§ 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.