(39 days)
The DEPILASE TWIN YAG Laser System is intended for the coagulation and haemostasis of vascular lesions( 1064 and 532 nm wavelengths) and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types (1064 nm wavelength).
The DEPILASE TWIN YAG Laser System is based on Nd: YAG laser technology. Within the system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of a flashlamp, with the option of frequency doubling the fundamental laser wavelength, from 1064 nm to 532 nm. The frequency doubling wavelength is obtained by warelonging with the laser radiation through a special crystal called Second Harmonic Crystal (SHC). After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using (SHO). The combined therapeutic and aiming beams are guided down an optical fibre delivery system to a focusing handpiece. The laser is used in a non-contact mode.
The DEPILASE TWIN YAG Laser System is designed with 5 major sub-systems:
- a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
- b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
- c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 3 Hz
- d) An optical delivery system, interfacing the energy from the laser to the patient via an optical fibre and focusing handpiece.
- e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.
Here's an analysis of the provided text regarding the Depilase Twin YAG Laser System, focusing on the acceptance criteria and study information.
It's important to note that the provided 510(k) summary is for a laser system, not an AI/ML powered device. Therefore, many of the requested elements pertaining to AI/ML device studies (such as sample sizes for test and training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) are not applicable and will be marked as such. The "acceptance criteria" for this type of device typically revolve around demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness.
Acceptance Criteria and Study Information for Depilase Twin YAG Laser System (K020697)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | The device's indications for use must be substantially equivalent to those of legally marketed predicate devices. | Met: The DEPILASE TWIN YAG Laser System is indicated for: |
- Coagulation and haemostasis of vascular lesions (1064 nm and 532 nm wavelengths).
- Removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types (1064 nm wavelength).
These indications are stated to be the same as those of the predicate devices: Laserscope Lyra (K990718) and Altus Medical Aesthetic CoolGlide (K991798) for hair removal/vascular lesions (Nd:YAG), and Fotona Dualis KTP (K011939) for vascular lesions (532 nm). |
| Technological Equivalence | The device's technological characteristics must be identical or very similar to those of legally marketed predicate devices, and any differences should not raise new questions of safety or effectiveness. | Met: The DEPILASE TWIN YAG Laser System, like the predicate devices, comprises:
- Flashlamp-pumped Nd:YAG laser rod generating light at 1064nm (with optional 532nm via SHC).
- Optical fiber delivery system and focusing handpiece.
- Microprocessor controlled.
- Class I aiming beams.
- Internal closed-loop water-air heat exchange for thermal control.
The output characteristics are reported as "very similar" to predicate devices. |
| Safety and Effectiveness | The risks and benefits of the device, when used for its intended applications, must be comparable to those of the predicate devices, and the device should not raise new questions of safety or effectiveness. | Met: The submission asserts that "The risk and benefits of the DEPILASE TWIN YAG Laser System are comparable to the predicate devices when used for similar clinical applications." Concludes: "It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device." This is indirectly evidenced by the FDA's clearance of the device based on substantial equivalence. |
2. Sample Size for the Test Set and Data Provenance
- Not Applicable (N/A) for AI/ML device: This is a laser system, not an AI/ML device. Therefore, there isn't a "test set" in the context of evaluating algorithm performance on a dataset of images or other data types. The submission relies on demonstrating engineering and clinical equivalence to existing predicate devices.
3. Number of Experts and Qualifications for Ground Truth
- N/A for AI/ML device: Ground truth for AI/ML performance evaluation is not relevant for this type of laser system submission. The "ground truth" implicitly assessed here is the established safety and effectiveness of the predicate devices.
4. Adjudication Method for the Test Set
- N/A for AI/ML device: No test set or adjudication method as would be used for AI/ML algorithm performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study performed: As this is a laser system, an MRMC study comparing human readers with and without AI assistance is not applicable. The device's effectiveness is established through clinical equivalence to predicate devices, not by assisting human interpretation of data.
6. Standalone (Algorithm Only) Performance Study
- No Standalone Study Performed: Not an AI/ML device. The "standalone" performance for this laser system would refer to its physical output and functional specifications, which were likely tested during development and manufacturing, but not in a formal "standalone performance study" akin to an AI algorithm.
7. Type of Ground Truth Used
- Clinical Equivalence/Predicate Devices' Established Safety and Effectiveness: For this type of device, the "ground truth" essentially comes from the established safety and effectiveness records and clinical use history of the identified predicate devices (Laserscope Lyra, Altus Medical Aesthetic CoolGlide, Fotona Dualis KTP). The applicant is arguing that their device operates similarly and achieves comparable outcomes, thus leveraging the "ground truth" already established for the predicates.
8. Sample Size for the Training Set
- N/A for AI/ML device: There is no "training set" as would be used for an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
- N/A for AI/ML device: No training set, therefore no associated ground truth establishment method.
Summary of the Study (Substantial Equivalence Argument):
The "study" presented in this 510(k) is a demonstration of substantial equivalence (not a randomized controlled trial or an AI performance study). The applicant, Depilase Group Ltd., systematically compares their DEPILASE TWIN YAG Laser System against three predicate devices already cleared by the FDA:
The core of their argument is that their device shares identical intended use (coagulation/haemostasis of vascular lesions, permanent hair reduction) and substantially similar technological characteristics (Nd:YAG laser with optional 532nm, fiber optic delivery, microprocessor control, aiming beam, cooling system) with these predicates. They also assert that the device's output characteristics are "very similar" to the predicates. By demonstrating these similarities, the applicant aims to convince the FDA that their device raises no new questions of safety or effectiveness beyond what has already been established for the predicate devices. The FDA's clearance indicates their concurrence with this argument.
§ 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.