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

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.

AI/ML Overview

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	< kHz
Pulse Counter	0 - 99.9999	0 - 99 999	Not reported (pulse counter present)	Not reported (pulse counter present)
Aiming Beam
Wavelength / Type	635 nm; Direct diode (Adjustable to <1 mW)	635 nm; Direct diode (Adjustable to <1 mW)	635 nm; diode	630 - 670 nm (diode), <1.0 mW
Other Specifications
Spot Diameter (Slit Lamp)	60 - 400 um delivered to the focal plane of the slit lamp in air.	60 - 400 um delivered to the focal plane of the slit lamp in air.	50 - 500 um	SLA/OMA Spot Size Ranges: 50 - 5000 um to the retina
Spot Diameter (LIO)	360 um (at fundus w/ 20D lens)	360 um (at fundus w/ 20D lens)	Unknown spot diameter	360 um & 1.3 mm (at retina w/ 20D lens)

Implicit Acceptance Criteria: The new device's specifications (e.g., laser wavelength, power output range, pulse duration) must be within acceptable ranges or comparable to those of the predicate devices. Deviations (like the 577nm vs. 532nm wavelength difference from one predicate) must be justified as not raising new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: None specified. This is not a study involving a "test set" of patient data for performance evaluation in the typical sense of AI/diagnostic devices. The "test" environment would be the performance of the physical device components against engineering specifications.
Data Provenance: Not applicable in the context of clinical data. The "data" here are technical specifications of medical devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Number of Experts/Qualifications: Not applicable. Ground truth for device technical specifications is established through engineering measurements and design documents, not clinical expert consensus on patient data. This section often applies to diagnostic AI.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. There is no clinical "test set" or diagnostic assessment requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No. The document describes a laser device, not a diagnostic AI or imaging interpretation tool that would typically involve an MRMC study. Therefore, there is no effect size reported for human readers with vs. without AI assistance.

6. Standalone Performance Study:

Standalone Performance Study: No, not in the sense of an algorithm operating independently on patient data to produce a diagnosis or risk score. The device is a physical laser system, and its "standalone performance" refers to its ability to meet its engineering specifications (e.g., laser power, wavelength accuracy, spot size) which are assessed through internal testing, not a clinical study detailed here.

7. Type of Ground Truth Used:

Type of Ground Truth: Not applicable in the clinical sense. For a 510(k) submission showing substantial equivalence for a physical device, the "ground truth" for the device itself would be its engineering specifications and the validated performance of its components. For the "indications for use," the ground truth is established by decades of clinical experience with similar laser photocoagulation therapies.

8. Sample Size for the Training Set:

Training Set Sample Size: Not applicable. This device is not an AI model that requires a training set of data.

9. How the Ground Truth for the Training Set was Established:

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for an AI model.

In summary:

This document is a regulatory submission for a medical laser system. The "acceptance criteria" and "study" described are focused on demonstrating that the device is substantially equivalent to already-approved predicate devices based on its intended use, design features, and functional characteristics, rather than proving performance against clinical metrics through a new clinical trial or AI performance evaluation. The "study" implicitly refers to internal engineering testing and comparison to predicate device specifications.

Summary

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Section 5 - 510(k) Summary

I. General Information

K111108

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

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;

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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 .

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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	< kHz
	5.0, 6.0, 7.0, and 8.0 Hz	5.0, 6.0, 7.0, and 8.0 Hz
	(available w/ single spot	(available w/ single spot
	pattern only)	pattern only)
Pulse counter	0 - 99.9999	0 - 99 999	Not reported	Not reported
			(pulse counter present)	(pulse counter present)
Aiming Beam
Aiming Beam 2	635 nm; Direct diode	635 nm; Direct diode	635 nm; diode	630 - 670 nm (diode),
(power output)	(Adjustable to <1 mW)	(Adjustable to <1 mW)		<1.0 mW
Other Specifications
Spot diameter	Slit Lamp Microscope	Slit Lamp Microscope	Microscope Adapter	Microscope Adapters
	(integrated)	(integrated)		- 577 nm
	· 60 - 400 um delivered to	· 60 - 400 um delivered to	· 50 - 500 um	SLA/OMA Spot Size
	the focal plane of the slit	the focal plane of the slit		Ranges: 50 - 5000 um
	lamp in air.	lamp in air.		to the retina
	LIO 577	LIO - 532	LIO - 577 nm	LIO - 577 nm
	· 360 um (at fundus w/ 20D	• 360 um (at fundus w/ 20D	Unknown spot	360 um & 1.3 mm (at
	lens)	lens)	diameter	retina w/ 20D lens)

Rationale for Substantial Equivalence VII.

The PASCAL® Streamline 577 (with Accessories) shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.

VIII. Safety and Effectiveness Information

The review of the indications for use and technical characteristics demonstrates that the PASCAL® Streamline 577 (with Accessories) is substantially equivalent to the predicate devices.

IX. Conclusion

The PASCAL® Streamline 577 (with Accessories) was found to be substantially equivalent to the predicate devices.

The PASCAL® Streamline 577 (with Accessories) shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus has a staff with two snakes winding around it, and a pair of wings at the top.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Topcon Medical Laser Systems, Inc. % Mr. John Jossy Director, Quality Assurance and Regulatory Affairs 3130 Coronado Drive Santa Clara, California 95054

AUG 1 1 2011

Re: K111108

Trade/Device Name: PASCAL Streamline 577 (with Accessories) Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF Dated: June 07, 2011 Received: June 09, 2011

Dear Mr. Jossy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Mr. John Jossy

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Pari 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Malkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K11108

Device Name: PASCAL® Streamline 577 (with Accessories)

Indications for Use:

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 .

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evalu

NeLRPOgilem for mxn,
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

. 510(k) Number K111108

Page 1 of

TMLS Premarket Notification, 510(k) Submission for: PASCAL Streamline 577 (with Accessories)

Regulation Number and Section

§ 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.