(84 days)
The Candela Sclero Long Pulse Laser is indicated for the following uses: General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions. DermatologyPlastic Surgery: For treatment of benign cutaneous vascular lesion, such as facial and leg telangiectasia, rosacea, port wine stains, hemangioma, spider angioma, poikiloderma of Civatte and benign cutaneous lesion, such as warts, scars, striae. Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology Podiatry: Treatment of benign cutaneous lesion, such as warts. The Candela Sclero Long Pulse Laser includes an integrated Dynamic Cooling Device, which is indicated for: 1. the reduction in pain. 2. cooling of the skin prior to laser treatment
The Sclero LP laser is a pulsed, flash lamp excited dye, medical laser, controlled by an embedded processor, to be used for the treatment of telangiectasia, port wine stains, benign cutaneous lesions and other benign cutaneous vascular lesions. The laser system has a Dynamic Cooling Device built into it which provides a short burst of cryogen spray prior to firing the laser output energy is delivered via an optical fiber to a handpiece on to the skin. The cryogen which is housed within the laser enclosure is delivered via a hose to a nozzle located in the handpiece. The Dynamic Cooling Device functions to cool the skin prior to laser treatment, minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment. The Candela Sclero Long Pulse system is comprised of the following components: - High voltage power supply (HVPS) 1. - Flashlamp laser head 2. - Circulatory System 3. - 4. Dve fluid system - న్. Optical delivery system - Software control system 6. - Dynamic Cooling Device 7. The Candela Sclero Long Pulse Lasers 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 K993671 510(k) summary for the Candela Sclero Long Pulse Laser System. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing de novo performance criteria through new clinical studies with predefined acceptance criteria.
Therefore, the document does not contain information on acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for novel devices or AI/software as a medical device (SaMD) clearances.
Instead, the substantiation for the Candela Sclero Long Pulse Laser System is based on its similarity to predicate devices.
Here's a breakdown of why the requested information cannot be provided from this document:
- Acceptance Criteria & Reported Device Performance: This device is a hardware laser system, not a diagnostic or AI-driven system with performance metrics like accuracy, sensitivity, or specificity against a ground truth. Its "performance" is implicitly tied to safety and efficacy through its intended use and similarity to predicates.
- Sample Size for Test Set & Data Provenance: No test set is described for performance evaluation in the context of diagnostic accuracy. The testing mentioned refers to conformity to laser performance standards and electrical safety.
- Number of Experts/Qualifications/Adjudication Method: These concepts are relevant to establishing ground truth for diagnostic or AI performance studies, which are not detailed here.
- MRMC Comparative Effectiveness Study: There is no mention of human readers or AI assistance, as this is a hardware laser system.
- Standalone Performance: Not applicable for this type of device.
- Type of Ground Truth: Not applicable, as performance isn't measured against a diagnostic ground truth.
- Sample Size for Training Set & Ground Truth establishment for Training Set: These are concepts for machine learning or AI algorithm development, which are not relevant to this hardware device's submission.
What the document does provide in relation to "acceptance" (of equivalence):
The primary "acceptance criteria" for this 510(k) revolve around demonstrating that the Candela Sclero Long Pulse Laser System:
- Has the same intended use as predicate devices.
- Utilizes the same operating principles as predicate devices.
- Matches key design aspects (e.g., spot size, wavelength, maximum delivered power) as predicate devices.
- Conforms to relevant safety standards (Laser Performance Standard 21 CFR 1040, UL 544 electrical safety standard, Essential Requirements of the European Union Medical Device Directives).
The "study" that proves substantial equivalence (not performance against de novo criteria) is the 510(k) submission itself and the FDA's review. The FDA determined that "the device is substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976."
In summary, the provided text describes a 510(k) submission for a medical laser system based on demonstrating substantial equivalence to predicate devices, rather than a study designed to meet specific performance acceptance criteria for a novel diagnostic or AI device.
§ 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.