(87 days)
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
The Candela GentleLASE Family of Lasers utilizes an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near infrared region. Energy from the laser is directed to the target area via optical fiber handpiece delivery system. The Dynamic Cooling Device provides a short burst of cryogen spray prior to firing the laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 6, 8, 10, 12, 15, 18 millimeters on the skin. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece. The GentleLASE Family of Laser Systems are designed with six major components:
- High voltage power supply and modulator system
- Optical laser head
- Circulator system
- Optical delivery system
- Software control system
- Dynamic cooling device
The Candela GentleLASE Family of Laser Systems are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.
The provided text is a 510(k) summary for the Candela GentleLASE Family of Laser Systems, seeking clearance based on substantial equivalence to predicate devices. It does not contain information about a study that establishes acceptance criteria and then proves the device meets those criteria in the way described in the prompt's request.
Instead, this document focuses on demonstrating substantial equivalence to existing, legally marketed devices, rather than establishing and meeting novel performance acceptance criteria through clinical studies designed for that purpose.
Therefore, most of the requested information cannot be extracted from the provided text. Here's a breakdown of what can be inferred or directly stated, and what information is missing:
1. A table of acceptance criteria and the reported device performance
Not applicable. The submission focuses on demonstrating substantial equivalence to predicate devices based on shared intended uses, operating principles, and key design aspects (spot size, wavelength, maximum delivered fluence). No specific performance metrics for novel "acceptance criteria" are provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No "test set" in the context of a performance study is described. The submission relies on comparisons to predicate devices.
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. No "ground truth" establishment for a performance study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "test set" or adjudication method for a performance study is described.
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. The device is a laser system for dermatological use, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not relevant as the device is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth for a performance study is described. The "ground truth" in this context is the safety and effectiveness of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device requiring a training set.
Summary of Device Acceptance/Equivalence from the Provided Text:
The acceptance of the device is based on its substantial equivalence to previously cleared predicate devices. The study, in this case, is a comparison against these predicates, highlighting similarities in design and principle.
Key Information from the Document regarding "Acceptance":
-
Acceptance Criteria (Implicit for 510(k) submission): The device must be "substantially equivalent" to predicate devices. This is demonstrated by showing:
- Same intended uses (photocoagulation of dermatological vascular lesions).
- Similar operating principles (Alexandrite rod, 755nm pulsed energy, optical fiber handpiece delivery, Dynamic Cooling Device).
- Matches key design aspects (similar spot size, same wavelength, same maximum delivered fluence as predicate devices).
- Conforms to relevant safety standards (Laser Performance Standard (21 CFR 1040), IEC (EN) 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-22).
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Reported Device Performance (as demonstrated for equivalence):
The Candela GentleLASE Family of Laser Systems has the same intended uses, utilizes similar operating principles, and matches key design aspects (including similar spot size, the same wavelength, and the same maximum delivered fluence) as the predicate devices (GentleLASE Family of Laser Systems K024371, K024335, K024260, and previous models K994260, K981351, K974381, K972767). The device also conforms to various laser and medical electrical equipment safety standards.
The FDA's letter (K11144) ultimately states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... You may, therefore, market the device." This constitutes the "acceptance" based on the provided evidence of equivalence.
§ 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.