(113 days)
Not Found
No
The device description focuses on laser technology and hardware components, with no mention of AI or ML capabilities.
Yes
The device is intended for the treatment of various ocular pathologies, which is a therapeutic purpose.
No
The PASCAL® Streamline 577 (with Accessories) is described as being "intended for use in the treatment of ocular pathology," which indicates a therapeutic purpose rather than a diagnostic one. Its function involves delivering laser light for photocoagulation and iridotomy/trabeculoplasty, which are treatments.
No
The device description clearly outlines numerous hardware components, including a laser system, slit lamp, control panel, footswitch, and various physical accessories. It is a physical medical device that incorporates software for control and operation, but it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The PASCAL® Streamline 577 is a laser system used for treating ocular pathology by delivering laser light directly to the eye. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states "treatment of ocular pathology."
- Device Description: The description details a laser system for delivering light to the eye, not for analyzing biological samples.
Therefore, the PASCAL® Streamline 577 is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 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
Product codes
HQF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior segment; Retinal, choroid, anterior segment
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Section 5 - 510(k) Summary
I. General Information
Submitter:
Topcon Medical Laser Systems, Inc. 3130 Coronado Drive Santa Clara, CA 95054, USA
Contact Person:
John Jossy Director of Quality Assurance and Regulatory Affairs 408-235-8202
Summary Preparation Date: June 7, 2011
II. Names
Device Name(s):
PASCAL® Streamline 577 (with Accessories)
Primary Classification Name(s): Ophthalmic laser; Laser powered surgical device
III. Predicate Devices
- PASCAL Streamline Photocoagulator, now owned/manufactured by Topcon Medical . Laser Systems (TMLS; previously owned by OptiMedica) (K100019)
- SUPRA 577.Y Photocoagulator, manufactured by Quantel Medical (K091581) .
- IO 577 Photocoagulator, manufactured by IRIDEX Corp. (K071687) .
IV. Product Description
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;
-
1
-
Footswitch;
- 公 Door Interlock Plug;
- Power cable [4.6 m (15 ft.) long] A
- Connector Ports for the table lift power connector, the table lift up/down control 公 connector, the door interlock connector, the footswitch connector, and a USB connector for an optional printer.
- a Rolling base with lockable wheels.
- Printer (optional). a
- 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. .
Intended Use & Indications for Use V.
The 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 .
2
VI. Summary of Technological Characteristics
The technological characteristics of the PASCAL® Streamline 577 (with Accessories) are substantially equivalent to those of the predicate devices.
| K 1 1 | K100019 | K091581 | K071687 | |
|---|---|---|---|---|
| PASCAL Streamline 577 | PASCAL Streamline | SUPRA 577.Y | IQ 577 | |
| (with Accessories): Topcon | Photocoagulator; OptiMedica | Photocoagulator; | Photocoagulator; | |
| Medical Laser Systems | (now Topcon Medical Laser | Quantel Medical | IRIDEX Corp | |
| Characteristics | Systems) | |||
| Treatment Laser | ||||
| Treatment 2 | 577 nm | 532 nm | 577 nm | 577 nm |
| Laser Type | OPSL - Optically Pumped | OPSL - Optically Pumped | Diode Pumped; Solid | Diode Pumped; Solid |
| Semiconductor Laser | Semiconductor Laser | State | 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, | Off. 1.0, 1.5, 2.0, 3.0, 4.0. | Not reported |