(88 days)
The Nidek Green Laser Photocoagulator Model GYC-1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
The Nidek Green Laser Photocoagulator Model GYC-1000 is a frequency doubled diode pumped solid state (DPSS) laser ophthalmic photocoagulation system that produces a 532 nm (green) wavelength light as the treatment beam. The Model GYC-1000 uses a diode laser (red) with a wavelength of 635 nm as the aiming beam. The green laser beam is aligned with the red aiming laser beam in the optical system inside the unit and gathers them in a fiber-optic cable. The laser beam is led to the delivery unit via the fiber-optic cable, shaped into the specified spot size in the optical system, and emitted to the affected area (the emission areas of both the therapeutic laser beam and the aiming beam are the same).
The Model GYC-1000 can be used to coagulate the target tissue efficiently and safely, and the system can be applied to transpupillary photocoagulation procedures using a slit-lamp or indirect ophthalmoscope and intraocular photocoagulation procedures using an endophotocoagulation probe. The Model GYC-1000 is a smaller, modified version of the Models GYC-1500 and GYC-2000, which were the subject of premarket notification number K980547.
A protective filter may be attached to each delivery unit in the observation optical path so that the operator's eye can be protected from the laser beam if it is reflected from a patient's eve or contact lens during laser emission. The Model G Y C-1000 has a number of delivery units available for use in a variety of ophthalmic procedures:
- Endophotocoagulation Delivery Unit .
- NIDEK Slit-Lamp Delivery Unit
- ZEISS Slit-Lamp Attachable Delivery Unit ●
- HAAG Attachable Slit-Lamp Delivery Unit .
- Binocular Indirect Ophthalmoscope Delivery Unit .
- Combination Delivery Unit for Nidek Nd: YAG laser .
The Nidek Green Laser Photocoagulator Model GYC-1000 acceptance criteria and the study that proves the device meets them are described below based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is primarily assessed through its adherence to specified safety and performance standards for medical electrical equipment and laser products. The acceptance criteria are implicit in meeting the requirements of these standards.
| Acceptance Criteria (Implied by Standards Compliance) | Reported Device Performance |
|---|---|
| Conformance to Electrical Safety Standard (EN 60601-1) | The Nidek Green Laser Photocoagulator Model GYC-1000 was tested in accordance with EN 60601-1 and was found to meet all requirements. |
| Conformance to Electromagnetic Compatibility (EN 60601-1-2) | The Nidek Green Laser Photocoagulator Model GYC-1000 was tested in accordance with EN 60601-1-2 and was found to meet all requirements. |
| Conformance to Programmable Electrical Medical Systems (EN 60601-1-4) | The Nidek Green Laser Photocoagulator Model GYC-1000 was tested in accordance with EN 60601-1-4 and was found to meet all requirements. |
| Conformance to Safety of Diagnostic and Therapeutic Laser Equipment (IEC 60601-2-22, JIS T1204, JIS C6802) | The Nidek Green Laser Photocoagulator Model GYC-1000 was tested in accordance with IEC 60601-2-22, JIS T1204, and JIS C6802, and was found to meet all requirements of the standards. |
| Substantial Equivalence to Predicate Device | A comparison of technological characteristics was performed. The device was concluded to have the same basic technological characteristics as the predicate device (Nidek GYC-1500/2000, K980547) and to be equivalent. Differences were deemed insignificant and not affecting safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text only mentions "System and component testing" without specifying a sample size in terms of the number of devices tested. It also does not specify the provenance of any data (e.g., country of origin, retrospective/prospective clinical data). The testing appears to be primarily laboratory/bench testing against engineering specifications and international standards, rather than clinical trials with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The study described is primarily technical testing against established engineering and safety standards, not a study requiring expert-established ground truth for medical diagnoses or outcomes.
4. Adjudication Method for the Test Set
Not applicable. The study described involves compliance testing against technical standards, not a process of adjudicating medical interpretations.
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 photocoagulator, not an AI software intended for image interpretation or diagnostic assistance. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical instrument (laser photocoagulator), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is compliance with established international and Japanese electro-medical and laser safety standards (EN 60601-1, EN 60601-1-2, EN 60601-1-4, IEC 60601-2-22, JIS T1204, and JIS C6802) and product specifications derived from a risk analysis. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" in this context.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical instrument and does not involve AI or machine learning algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.