(113 days)
PASCAL® Streamline 577 (with Accessories) is intended for use in the treatment of ocular pathology in the posterior segment; Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:
- proliferative and nonproliferative diabetic retinopathy
- macular edema
- choroidal neovascularization
- branch and central retinal vein occlusion
- the treatment of choroidal neovascularization associated with wet age-related macular degeneration
- lattice degeneration
- retinal tears and detachments
- retinopathy of prematurity
Intended for use in the treatment of ocular pathology in the anterior segment including:
- iridotomy
- trabeculoplasty
The PASCAL® Streamline 577 (with Accessories) is an Optically Pumped Semiconductor Laser (OPSL: solid state) with integrated slit lamp that is intended for use in ophthalmic applications. The PASCAL® Streamline 577 system delivers 577 nm laser light (yellow) at a spot size range of 60 - 400 micrometers (um) to the focal plane of the slit lamp. The integrated slit lamp allows the physician (using a physician selected lens) to deliver the laser light to the treatment site. The treatment laser delivers single pulses or a scanned pattern of 100 to 2000 milliwatts (mW) per pulse duration of approximately 5 - 1000 milliseconds (ms) per pulse. A diode laser (635 nm) provides a visible aiming beam.
Laser light is delivered to the treatment site via the integrated slit lamp or via an optional Laser Indirect Ophthalmoscope (LIO) 577 with eye safety filter for ophthalmic indications.
The physician is able to control the delivery of laser energy using a footswitch.
The PASCAL® Streamline 577 (with Accessories) is comprised of the following functional components:
- Slit Lamp Table with integrated 577 nm laser system:
- 577 nm Laser system control electronics and power supply;
- Control Panel with LCD (liquid crystal display) Touchscreen;
- Keyswitch:
- Emergency Laser Stop Button;
- Footswitch;
- Door Interlock Plug;
- Power cable [4.6 m (15 ft.) long]
- Connector Ports for the table lift power connector, the table lift up/down control connector, the door interlock connector, the footswitch connector, and a USB connector for an optional printer.
- a Rolling base with lockable wheels.
- Printer (optional).
- Slit Lamp with integrated scanning pattern generator (and laser eye safety filter).
Accessories (Optional)
- Laser Indirect Ophthalmoscope (LIO) 577 with eye safety filter.
- Video Teaching System (VTS).
- Physician Elbow Rest.
The provided text does not contain acceptance criteria for a device, nor does it describe a study proving the device meets acceptance criteria in the way typically associated with algorithmic performance (e.g., sensitivity, specificity, AUC).
Instead, this document is a 510(k) Summary for a medical device (PASCAL® Streamline 577), which focuses on demonstrating substantial equivalence to existing predicate devices already on the market. The "study" referenced implicitly in this context is the comparison between the new device's technical characteristics and the predicate devices, rather than a clinical trial or performance evaluation against specific metrics like accuracy or error rates.
Here's how to interpret the provided information within the context of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance:
There is no table of "acceptance criteria" for performance metrics like sensitivity or specificity. Instead, the document provides a table comparing the technical characteristics of the new device (PASCAL Streamline 577) to its predicate devices. The "acceptance criteria" here are implicitly that the new device's technical specifications are similar enough to the legally marketed predicate devices to establish substantial equivalence.
| Characteristic | PASCAL Streamline 577 (K111108) Reported Performance | Predicate 1: PASCAL Streamline (K100019) | Predicate 2: SUPRA 577.Y (K091581) | Predicate 3: IQ 577 (K071687) |
|---|---|---|---|---|
| Treatment Laser | ||||
| Wavelength | 577 nm | 532 nm | 577 nm | 577 nm |
| Laser Type | OPSL - Optically Pumped Semiconductor Laser | OPSL - Optically Pumped Semiconductor Laser | Diode Pumped; Solid State | Diode Pumped; Solid State |
| Power Output | 0 - 2000 mW | 100 mW - 2000 mW | Up to 2000 mW | Up to 5000 mW |
| Duty Cycle | 100% | 100% | Not reported | Variable |
| Pulse Duration | 5 ms - 1000 ms | 10 ms - 1000 ms | 10 ms to continuous | 10 us - 60 min |
| Repetition Rate | Off, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, and 8.0 Hz (available w/ single spot pattern only) | Off, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, and 8.0 Hz (available w/ single spot pattern only) | Not reported |
§ 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.