PASCAL STREAMLINE 577 (WITH ACCESSORIES)

K111108 · Topcon Medical Laser Systems, Inc. · HQF · Aug 11, 2011 · Ophthalmic

Device Facts

• Record ID: K111108
• Device Name: PASCAL STREAMLINE 577 (WITH ACCESSORIES)
• Applicant: Topcon Medical Laser Systems, Inc.
• Product Code: HQF · Ophthalmic
• Decision Date: Aug 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

PASCAL Streamline 577 is an Optically Pumped Semiconductor Laser (OPSL) system for ophthalmic photocoagulation. Input: 577 nm yellow laser light; 635 nm diode aiming beam. Operation: Physician uses integrated slit lamp or optional Laser Indirect Ophthalmoscope (LIO) to deliver laser energy to ocular tissue; energy delivery controlled via footswitch; system includes scanning pattern generator for precise application. Output: Laser pulses (100-2000 mW; 5-1000 ms duration) for thermal treatment of retinal/choroidal vascular/structural abnormalities or anterior segment procedures. Used in clinical settings by ophthalmologists. Output allows physician to perform targeted photocoagulation, potentially stabilizing vision or preventing further retinal damage in patients with specified ocular pathologies.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

OPSL (Optically Pumped Semiconductor Laser) system; 577 nm treatment wavelength; 635 nm aiming beam. Integrated slit lamp with scanning pattern generator. Power output 0-2000 mW; pulse duration 5-1000 ms. Connectivity includes USB for printer. System includes control electronics, LCD touchscreen, footswitch, and emergency stop. Class II device.

Indications for Use

Indicated for patients requiring retinal or anterior segment photocoagulation for conditions including diabetic retinopathy, macular edema, choroidal neovascularization, retinal vein occlusions, wet age-related macular degeneration, lattice degeneration, retinal tears/detachments, retinopathy of prematurity, iridotomy, and trabeculoplasty.

Regulatory Classification

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.

Predicate Devices

• PASCAL Streamline Photocoagulator (K100019)
• SUPRA 577.Y Photocoagulator (K091581)
• IQ 577 Photocoagulator (K071687)

Submission Summary (Full Text)

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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

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;

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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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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 [phone] or [phone] 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:

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 .

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)