(92 days)
The Candela Cbeam Pulse Dye Laser is indicated for the following uses in:
General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions.
Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesion, such as facial and leg telangiectasia, rosacea, port wine stains, hemangioma, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and psoriasis. and the treatment of wrinkles.
New indication : Treatment of Inflammatory Acne Vulgaris
Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology.
Podiatry: Treatment of benign cutaneous lesion, such as warts.
The Cbeam is a 585 nm flash-lamp excited pulse dye medical laser, controlled by an embedded microprocessor., to be used for the treatment of benign cutaneous vascular lesions, such as facial and leg telangicctasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of CivatTe and benign cutaneous lesions, such as warts, scars, striea and psoriasis. Photocoagulation of benign cutaneous lesion and benign vascular lesion in Gynecology. Treatment of wrinkles and the treatment of inflammatory acne vulgaris. The Cbeam laser may be used with the Candela Dynamic Cooling Device, which provides a short burst of cryogen spray prior to firing the laser pulse. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 5, 7 or 10 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 Candela Cbeam Pulse Dye Laser is 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.
This 510(k) summary describes a device that is substantially equivalent to a predicate device, and thus does not include a study to prove meeting acceptance criteria in the sense of a novel device performance study. Instead, the "acceptance criteria" are the demonstration of substantial equivalence to a legally marketed predicate device, primarily through matching various design and operating characteristics.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Substantial Equivalence) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Intended Use | The device has the same intended use: photocoagulation of benign cutaneous vascular lesions (facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte), benign cutaneous lesions (warts, scars, striae, psoriasis), benign cutaneous and vascular lesions in gynecology, treatment of wrinkles, and treatment of inflammatory acne vulgaris (new indication). |
| Operating Principles | Utilizes similar operating principles (585 nm flash-lamp excited pulse dye medical laser, microprocessor controlled, optical fiber to handpiece, optional Dynamic Cooling Device). |
| Key Design Aspects | Matches key design aspects, including similar spot size (5, 7, 10 mm), the same wavelength (585 nm), and/or the same maximum delivered power. |
| Methods of Assembly | Similar methods of assembly to the predicate device. |
| Method of Operation | Similar methods of operation to the predicate device. |
| Safety Standards Conformance | Conforms to the Laser Performance Standard (21 CFR 1040), UL 2601 Electrical Safety Standard, and harmonized standard EN 60601-1-2. |
Study Proving Acceptance Criteria:
The "study" proving the device meets the acceptance criteria is the 510(k) Premarket Notification itself, which aims to demonstrate substantial equivalence to identified predicate devices (Candela Cbeam Pulse Dye Laser (K020958) and ICN Photonics NLite (K024189)).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This device's submission is for substantial equivalence, not a clinical trial. Therefore, there is no "test set" in the context of clinical data or patient samples used for demonstrating performance in this 510(k) summary. The testing mentioned refers to engineering and safety standards conformance, not clinical performance data from a patient cohort.
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 there is no clinical "test set" in the context of patient data, no experts were used to establish ground truth for such a set within this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical "test set" requiring adjudication.
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 device is a laser system, not an AI or diagnostic imaging device that would typically involve a multi-reader multi-case comparative effectiveness study with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of a clinical performance study. The "ground truth" for this submission is the established performance and safety of the predicate devices. The new indication for Inflammatory Acne Vulgaris would typically require clinical data, but this summary doesn't detail it. The FDA's letter states the device is substantially equivalent "for the indications for use stated in the enclosure," which includes the new indication, implying that sufficient data (if required for new indication) was provided elsewhere or relied on existing literature/predicate's data.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for a laser device in this type of submission.
9. How the ground truth for the training set was established
Not applicable.
§ 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.