(49 days)
The OPHTHALMIC YAG LASER SYSTEM YC-200 consists of a slit lamp and the YAG Laser and is indicated for the performance of posterior capsulotomy, posterior membranectomy, pupillary membranectomy, iridotomy (hole in the iris) and selective laser trabeculoplasty.
The OPHTHALMIC YAG LASER SYSTEM YC-200 is an ophthalmic pulsed laser system using a 1,064 nm Q-switched pulsed Nd: YAG laser as the treatment beam source. The system consists of two types, differing only in the available types of laser emission. The two types are collectively referred to as "YC-200" throughout this 510(k). The operation mode(s) available differs depending on the type.
| Type name | Model name | Emitted laser (wavelength) | Operation mode available |
|---|---|---|---|
| YC-200 | YC-200 | Nd: YAG laser (1,064 nm) | YAG mode |
| YC-200 S | |||
| Plus | YC-200 | Nd: YAG laser (1,064 nm) | |
| SLT laser (532 nm) | YAG mode | ||
| SLT mode |
As shown in the above table, the YC-200 S Plus provides the operator with two treatment modes, YAG mode and SLT mode, whereas the YC-200 type provides the operator with a single treatment mode, YAG mode.
In YAG mode, treatment using the YAG treatment beam whose wavelength is 1,064 nm is available. This mode is used mainly for posterior capsulotomy and iridotomy. The 360-degree rotating two-aiming-beam system that separates the YAG aiming beam into two beams is used. The focus position is determined according to the alignment of the beams. In YAG mode, single irradiation mode and burst mode are available. In single mode, one shot of the treatment beam is emitted each time the trigger switch is pressed, whereas in burst mode, two or three shots of the treatment beam are emitted each time the trigger switch is pressed. In YAG mode, the focus shift function to shift the focal points of the YAG treatment beam on the basis of the YAG aiming beam is available. This function allows the operator to shift the focal point of the YAG beam to the posterior chamber side compared to the aiming beam in order to prevent pitting of the intraocular lens.
In SLT mode, treatment using the YAG treatment beam whose wavelength is 532 mm is available. This mode is used for selective laser trabeculoplasty. In this mode, a parfocal optical system is used. In the parfocal optical system, the image of an object surface is formed on the target surface. The SLT aiming beam is emitted from the fiber tip (the object surface) so that it appears as a sharply-edged spot on the target surface. The focus position is determined according to the projection status of the beams. In SLT mode, SLT-NAVI assists the operator in surgery by specifying the laser emission positions and sequence before the treatment is available. The progress status of laser treatment is intuitively displayed in real time in the SLT-NAVI area of the main screen based on the premise that the treatment is proceeding as scheduled.
The system is mainly comprised of the YC-200 main body that incorporates a laser source, and a slit lamp that is similar to the previously cleared SL-2000 (K163564), a head rest, a control box that controls laser emission, and a connector box.
To use the YC-200, the operator should first adjust the focus of the evepieces to the operator's refractive error and adjusts the evepieces to the operator's pupillary distance. The operator instructs the patient to place his or her chin on the chinrest, to rest his or her forehead on the forehead rest, and to hold the grips. The operator aligns the level of the patient's eye with the eye level marker, fasten the patient's head with the head belt, and instructs the patient to look at the fixation lamp to stabilize his or her visual axis. The operator looks through the microscope to observe the treatment site. The operator sets laser emission conditions such as laser power output through the control box of the YC-200, turns on the aiming beam, and set the YC-200 to the READY mode. Alignment is achieved when the operator adjusts the joystick and contact lens to align the aiming beam focus with the target position. Finally, the operator presses the hand switch or depresses the optional foot switch to emit the treatment beam in the READY mode while observing the operative field with the slit lamp.
One of the reasons for this 510(k) submission is to add the combination delivery unit to connect the subject device to the GYC-500 previously cleared in 510(k) No. K152603.
The combination delivery unit allows the operator to perform photocoagulation using the green laser beam (532 nm) or photodisruption using the Nd: YAG laser pulse beam (1064 nm, hereafter referred to as "YAG laser beam") or SLT laser (532 nm, for YC-200 S plus only) while observing the patient's eve with the slit lamp of the YC-200. The delivery unit is connectable to the previously cleared Green Laser Photocoagulator GYC-500, and the subject YC-200. The photocoagulation unit of the combination delivery unit is mounted on the subiect YC-200's slit lamp and is connected to the GYC-500 main body using a connecting cable and a fiber-optic cable.
The operator selects the laser beam to be emitted by switching the optical path using the laser beam selector of the combination delivery unit. The optical path of the combination delivery unit for the green laser beam is completely independent from that of the subject YC-200 for the Nd: YAG laser beam. When "YC" is selected by the laser beam selector to select the laser beam to be emitted, the laser refractive mirror is stored in the photocoagulation unit of the delivery unit. When "COAG" is selected by the laser beam selector, the laser refractive mirror comes out from the photocoagulation unit.
When the combination delivery unit is attached to the YC-200 and connected to the previously cleared GYC-500 (510(k) No. K152603), the YC-200 works strictly as a diagnostic slit lamp - all photodisruptor and SLT laser functions are disabled.
The combination delivery unit is comprised of the photocoagulation unit, and protective filter. The photocoagulation unit adjusts the spot size of the treatment beam and aiming beam emitted from the GYC-500, while the protective filter protects the operator's eve from the reflected green laser beam that can be emitted only when the protective filter is inserted in the optical path.
The green laser beam from the GYC-500 requires a delivery unit to be delivered to the patient's eye. The green laser beam is delivered to the patient's eve via the combination delivery unit when it is mounted on the YC-200. The combination delivery unit is intended to save the area occupied by the slit lamp of delivery unit for the GYC-500 by using the slit lamp of the YC-200 consistently during both photocoagulation and photodisruption.
Another reason for this 510(k) submission is to add "posterior membranectomy" is to expand treatment options. With the addition of "posterior membranectomy" to the indications for use, the split mirror illumination tower for posterior membranectomy is added as an optional accessory. The split mirror illumination tower was designed to irradiate the target with slit illumination so that the slit illumination is made incident from the center while allowing the YAG treatment beam to pass between the upper and lower mirrors. The previously cleared illumination tower equipped with a tilting function for SLT mode, and illumination tower with the base fixed for YAG mode do not allow the treatment beam to be delivered to the posterior segment of the eye while the operator observes the posterior segment because these illumination towers themselves interrupt the YAG treatment beam. Thus, the previously cleared ones are inappropriate for posterior membranectomy.
The provided text is a 510(k) summary for the Nidek Ophthalmic YAG Laser System YC-200. It focuses on demonstrating substantial equivalence to a predicate device, as required for FDA clearance. Consequently, it does not contain the detailed clinical study information (such as acceptance criteria, sample sizes, expert qualifications, or MRMC study results) that would typically be found in a clinical study report or a more comprehensive regulatory submission for a novel or high-risk device requiring such evidence.
The document primarily describes:
- Device Name: Ophthalmic YAG Laser System YC-200
- Indications for Use: Posterior capsulotomy, posterior membranectomy, pupillary membranectomy, iridotomy (hole in the iris), and selective laser trabeculoplasty.
- Predicate Devices: NIDEK OPHTHALMIC YAG LASER SYSTEM YC-200 (K192045) and Ellex Medical Pty. Ltd. LUMENIS SELECTA DUET (K021550).
- Reference Device: NIDEK Green Laser Photocoagulator GYC-500 (K152603).
- Key changes from predicate: Addition of a combination delivery unit to connect to the GYC-500, and the addition of "posterior membranectomy" to the indications for use, necessitating a new split mirror illumination tower.
- Testing performed: Bench testing for safety and performance standards (ISO, ANSI, IEC).
Conclusion regarding acceptance criteria and study data:
Based on the provided text, there is no detailed information about acceptance criteria or a clinical study (specifically, a human-in-the-loop or standalone AI study) that proves the device meets specific performance criteria against a ground truth.
The submission relies on:
- Bench testing: Listed on page 9, affirming compliance with various safety and performance standards (e.g., ISO15004-1, IEC 60601-2-22). These are engineering performance metrics, not clinical performance metrics against a medical ground truth for a diagnostic or AI-driven device.
- Substantial Equivalence: The primary argument is that the device is substantially equivalent to a previously cleared predicate device, meaning it has similar indications, technological characteristics, and does not raise new questions of safety or effectiveness. This regulatory pathway typically minimizes the need for extensive new clinical performance data if the changes are minor or the device operates on well-understood principles.
Therefore, I cannot provide the requested table or answer most of the specific questions about clinical study details (sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set) because this information is not present in the provided FDA 510(k) summary. The device in question is a laser system for surgical procedures, not a diagnostic device relying on AI or image analysis that would typically involve the type of acceptance criteria and clinical validation described in your prompt.
The document states: "The collective performance testing demonstrates that the YC-200 does not raise any new questions of safety or effectiveness when compared to the primary predicate device. The results of the performance testing demonstrate that the YC-200 performs as intended and does not raise any new questions of safety or effectiveness." This statement refers to the bench testing and the argument for substantial equivalence, not a clinical trial with human subjects assessing performance against a clinical ground truth.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.