(143 days)
The YELLOW LASER PHOTOCOAGULATOR SYSTEM YLC-500 is intended to be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty. The YELLOW LASER PHOTOCOAGULATOR SYSTEM YLC-500 is intended to work in conjunction with the following delivery units in ophthalmic photocoagulation procedures: NIDEK SL-1800, SL-1600, ZEISS SL 130, HAAG BQ900, HEINE OMEGA 500
The Yellow Laser Photocoagulator System YLC-500 (hereafter referred to as "YLC-500") is a laser photocoagulator for ophthalmology using the 577 nm optically-pumped semiconductor laser (yellow laser beam) as the treatment beam and 635 nm diode laser (red laser beam) as the aiming beam. Like other conventional laser photocoagulation systems, the YLC-500 can be used in ophthalmic surgical procedures including retinal and macular photocoagulation, iridotomy and trabeculoplasty. The YLC-500 is a modified version of the GYC-500 as the primary predicate device and MC-500 Vixi which were the subjects of premarket notification numbers K152603 and K111493.
The YLC-500 is mainly comprised of the main body that incorporates a laser source, the control box that controls laser emission, and a delivery unit that guides the laser beam emitted from the main body to the patient's eye.
To use the YLC-500, the operator sets laser emission conditions such as laser power output, spot size, and exposure time according to the condition of treatment site through the control box of the YLC-500 or operation part of the connected delivery unit. When using an (attachable) slit lamp delivery unit, the operator observes the treatment site with the slit lamp, and aligns the treatment beam and aiming beam to the site. Then the operator presses the foot switch to emit the treatment beam and aiming beam to the treatment site from the exit end of the YLC-500 system in a READY status while observing the operative field with the slit lamp. As the treatment beam is optically coaxial to the aiming beam, alignment is achieved when the operator aligns the aiming beam to the treatment site. When the foot switch is pressed under the condition, the treatment beam of the set spot size is irradiated at which the aiming beam is projected. The operator can also select the laser irradiation pattern from a single laser spot and multiple laser spots in a scanning manner when a scan (attachable) delivery unit is connected to the YLC-500.
Various types of the delivery units are available for the YLC-500. As the delivery units using a slit lamp, broadly speaking, two types of delivery units are available. One is called "Slit lamp delivery unit" integrating a slit lamp and a laser delivery unit. The other is called "Attachable delivery unit" that is the laser delivery unit integrative filer and so on for connection to the slit lamp owned by the user.
Furthermore, the slit lamp delivery units are classified into "Slit lamp delivery unit" that delivers a single laser spot only, and "Scan slit lamp delivery unit" that delivers multiple laser spots in a predetermined pattern while scanning the laser spots as well as the single laser spot. In a similar manner, the attachable delivery units are further classified into "Attachable slit lamp delivery unit" that delivers a single laser spot only, and "Scan attachable slit lamp delivery unit" that delivers multiple laser spots in a predetermined pattern while scanning the laser spots as well as the single laser spot. The YLC-500 connected with a scan (attachable) delivery unit is called "Yellow Scan Laser Photocoagulator YLC-500 Vixi".
Various slit lamp delivery units are available that allow for the adaptation of the YLC-500 to a slit lamp. An optical fiber cable is connected from the YLC-500 main body to the slit lamp, thereby allowing the laser beam to be sent to the delivery unit. With the delivery unit, the patient can be treated in a seated position. The following slit lamp delivery units are available: Slit lamp delivery unit (NIDEK SL-1800 type), Scan slit lamp delivery unit (NIDEK SL-1800 type), Attachable delivery unit (NIDEK SL-1800/SL-1600 type, ZEISS SL 130 type), and Scan attachable delivery unit (NIDEK SL-1800/SL-1600 type, ZEISS SL 130 type, HAAG BQ900).
Other than the (scan and/or attachable) slit lamp delivery units, a binocular indirect ophthalmoscope (B.I.O.) delivery unit is available.
The B.I.O. delivery unit enables photocoagulation using a vellow laser beam (577 mm) while observing the patient's eye with a binocular indirect ophthalmoscope. With the delivery unit, the patient can be treated in a supine position. The delivery unit (Heine Omega 500 type) connects to the YLC-500 main body via an optical fiber cable. The delivery unit consists of a binocular indirect ophthalmoscope (with headband), a 20 D condensing lens, illumination lamp, and stand. The headband fits over the operator's head and has height and circumference adjustment knobs. A working distance control sets the distance among the operator, the patient, and 20 D condensing lens, which can be varied within a range of 300 to 700 mm. The treatment and aiming beam spot size can also be selected by changing working distance (with the 20D condensing lens).
The delivery units allow transpupillary photocoagulation using a slit lamp or binocular indirect ophthalmoscope. The operator chooses the optimal delivery unit for the purpose of photocoagulation of the patient's eye.
The provided document is a 510(k) premarket notification for a medical device, the Yellow Laser Photocoagulator System YLC-500. This type of regulatory submission establishes substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study in the way an AI/ML diagnostic software might.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria for an AI/ML diagnostic. It describes:
- Device Type: A laser photocoagulator for ophthalmic surgical procedures. This is a hardware device, not an AI/ML diagnostic software.
- Purpose of Submission: To demonstrate substantial equivalence to existing predicate devices (other laser photocoagulators), not to prove performance against specific diagnostic accuracy metrics.
- Testing: The testing conducted (bench testing, safety, electrical, software verification/validation, usability) is aimed at demonstrating the device's basic functionality, safety, and effectiveness compared to the predicate, but it does not involve diagnostic performance metrics, expert adjudication, or MRMC studies as would be seen for an AI/ML diagnostic.
In summary, this document is irrelevant to the prompt asking about acceptance criteria and studies for an AI/ML diagnostic device, as it describes a hardware therapeutic device and its 510(k) submission based on substantial equivalence.
§ 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.