(90 days)
The Ceralas G Frequency Doubled Nd:YAG Laser System and Accessories is intended as a surgical instrument for use in the photocoagulation of: ocular tissue, and vascular and pigmented skin lesions.
The Ceralas G3 is a complete, self-contained, compact surgical laser system that utilizes a diode pumped neodymium-doped yttrium aluminum garnet (Nd:YAG) laser whose output is frequency doubled to produce radiation in the green visible spectrum at 532 nm. Frequency doubling is achieved by the use of an intercavity Potassium Titanyl Phosphate ("KTP") crystal. KTP is a crystalline material that has nonlinear optical properties which allows the input of light of one color and output of a different light color. Specifically, it allows infrared light in and emits green light. The laser employs a modular design which includes: 1) laser crystal; 2) cooling module; 3) built in power meter with automatic calibration; 4) continuous or pulsed operating modes; and 5) front controls with a display panel. The laser system delivers up to 3 Watts of optical power. The exposure mode for the laser is selectable from 0.10 Watts to 3 Watts at 532 nm. The delivery systems for the Ceralas G Frequency Doubled Nd: Y AG Laser Systems consist of an optical fiber in a coaxially mounted protective sheath which is fitted with an SMA connector at the proximal end. The fiber is a bare, polished quartz fiber provided in a 200 micron to 1400 micron diameter range. The delivery systems are hand-held, designed to fit the Ceralas G3, and deliver the laser energy via the SMA connector which couples it to the laser. The Ceralas the delivery systems are supplied sterile.
This 510(k) premarket notification describes the Ceralas G Frequency Doubled Nd:YAG Laser System (Ceralas G3) and its substantial equivalence to previously cleared devices. The submission primarily focuses on adding a new indication for use: "photocoagulation of vascular and pigmented skin lesions."
Here's an analysis based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" or present a study comparing the device's numerical performance against such criteria. Instead, it argues for substantial equivalence based on technological characteristics and intended use matching predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (vs. Predicate) |
|---|---|
| Intended Use | Identical intended use (photocoagulation) |
| Principle of Operation | Similar (solid-state, diode-pumped frequency-doubled Nd:YAG) |
| Technological Characteristics | Similar (532nm wavelength, continuous/pulsed modes, 0.1-3 Watts power, air-cooled, fiber optic delivery) |
| Safety and Effectiveness | No new questions of safety or effectiveness raised by differences in dimensions/weight. Anticipated "same" laser tissue interaction and surgical performance. |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical study with a defined sample size is mentioned for the new indication. The submission relies on establishing substantial equivalence to existing cleared devices rather than providing new clinical data for this specific product. Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This submission does not describe a study involving the establishment of ground truth by experts for a test set. The claim of equivalence is based on technical specifications and prior regulatory approvals of predicate devices.
4. Adjudication Method
Not applicable. There is no adjudicated test set described in the submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission does not discuss human readers or AI assistance.
6. Standalone Performance Study
No standalone performance study for the algorithm (device) is described in the provided text. The submission focuses on device characteristics and substantial equivalence, not on a new performance evaluation for the device itself.
7. Type of Ground Truth Used
Not applicable. Since no new clinical study or test set is presented for the Ceralas G3 for this new indication, there is no 'ground truth' defined for such a study. The "ground truth" implicitly relies on the FDA's prior clearance of predicate devices and the established safety and effectiveness of those technologies for similar indications.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML product, and therefore no training set or associated sample size is mentioned.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML device and does not involve a training set.
§ 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.