(260 days)
Intended Use: Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.
Indications for Use:
1064 nm wavelength
- Tattoo Removal (dark ink: blue and black) .
- Nevus of Ota ●
- Removal or lightening of hair with or without adjuvant preparation. .
- Skin Resurfacing for Acne Scars and Wrinkles ●
- Benign cutaneous lesions, such as, but not limited to: striae and scars
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an . integral part of the scar
532 nm wavelength
- Tattoo removal (light ink: red, sky blue, green) .
- Vascular lesions including but not limited to: port wine birthmarks, telangjectasias,
- spider angioma, cherry angioma, spider nevi .
- Epidermal Piamented lesions including but not limited to: cafe-au-lait birthmarks, . solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus
- Skin Resurfacing for Acne Scars and Wrinkles .
- Benign cutaneous lesions, such as, but not limited to: striae and scars .
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an . integral part of the scar
The Cutera QSwitch Laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Laser energy produced within the device is delivered to the tissue by means of an articulated arm and a specially designed Multiple Spot Handpiece (532 nm and 1064 nm). The user activates laser emission by means of a footswitch.
The Cutera QSwitch Laser is designed to provide laser energy for use in a variety of dermatological procedures. The 532 nm and 1064 nm wavelengths are absorbed by pigment and other chromophores within the skin to create the desired clinical effect.
The laser incorporates very narrow laser pulses (5-20 ns) designed to apply higher peak power over a very short period to minimize the time to absorb heat into the tissue.
The Cutera QSwitch Laser System is a laser device intended for various dermatological procedures. No specific acceptance criteria or a study proving that the device meets acceptance criteria is provided in the document. Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device (RevLite Q-Switched Nd:YAG Laser System, K083899).
Here's an analysis of the provided information, addressing your questions to the extent possible given the document's content:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance in the traditional sense of a clinical trial demonstrating efficacy against pre-defined endpoints. Instead, it presents a comparison of technological characteristics between the Cutera QSwitch Laser System and its predicate device to argue for substantial equivalence.
| Characteristic | Cutera, Inc. Q-Switched Laser | Predicate: RevLite Q-Switched Nd:YAG Laser |
|---|---|---|
| 532nm Wavelength | ||
| Max delivered Energy @ end of articulate arm with no handpiece | 500mJ | 500mJ |
| Spot Size | 2mm - 6mm | 2mm - 6mm |
| Maximum Fluence @ 2mm spot | 5J/cm² | 5J/cm² |
| Maximum Fluence @ 6mm spot | 1.5J/cm² | Unknown |
| Pulse Width | 5-20ns | 5-20ns |
| Rep Rate | Single shot, 1, 2, 5, 10 Hz | Single shot, 1, 2, 5, 10 Hz |
| 1064nm Wavelength | ||
| Max delivered Energy @ end of articulate arm with no handpiece | 1.6J | 1.6J |
| Spot Size | 3mm - 8mm | 3mm - 8mm |
| Maximum Fluence @ 3mm spot | 12J/cm² | 12J/cm² |
| Maximum Fluence @ 8mm spot | 3.5J/cm² | Unknown |
| Pulse Width | 5-20ns | 5-20ns |
| Rep Rate | Single shot, 1, 2, 5, 10 Hz | Single shot, 1, 2, 5, 10 Hz |
The "unknown" values for maximum fluence at certain spot sizes in the predicate device table do not serve as a performance metric for the new device but rather indicate incomplete information about the predicate in the provided summary. The implication is that the Cutera QSwitch Laser System's performance for known parameters is equivalent or within expected ranges of the predicate.
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 explicitly states "Performance Data: None" and "Results of Clinical Study: None". Therefore, there was no test set in the context of a clinical performance study. The data provenance is not applicable as no such data was presented.
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, as no test set or clinical study was conducted for this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no test set or clinical study was conducted for this submission.
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 system, not an AI-powered diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser system and does not involve an algorithm for standalone performance evaluation in the context of diagnostic or interpretive tasks.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical study with a ground truth was conducted. The ground for this submission is substantial equivalence based on technological characteristics and intended use.
8. The sample size for the training set
Not applicable, as no training set was used for an algorithm in this submission.
9. How the ground truth for the training set was established
Not applicable, as no training set was used for an algorithm in this submission.
§ 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.