PASCAL STREAMLINE PHOTOCOAGULATOR

K092621 · Topcon Medical Laser Systems, Inc. · HQF · Sep 25, 2009 · Ophthalmic

Device Facts

• Record ID: K092621
• Device Name: PASCAL STREAMLINE PHOTOCOAGULATOR
• Applicant: Topcon Medical Laser Systems, Inc.
• Product Code: HQF · Ophthalmic
• Decision Date: Sep 25, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for use in the treatment of ocular pathology in both the posterior and anterior segments. 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 . age-related macular degeneration . lattice degeneration . retinal tears and detachments . iridotomy, iridectomy and trabeculoplasty in angle closure and open angle . glaucoma.

Device Story

PASCAL Streamline Photocoagulator is an integrated ophthalmic laser system; includes solid-state aiming and treatment lasers, control electronics, graphical user interface (GUI), slit lamp, and table. Used by clinicians to perform retinal and anterior segment photocoagulation. System delivers laser energy to ocular tissues to treat vascular and structural abnormalities. Clinician operates system via GUI to control treatment parameters; output is laser energy directed at target tissue. Benefits include precise, controlled photocoagulation for various retinal and glaucoma conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Integrated system comprising solid-state aiming and treatment lasers, control electronics, GUI, slit lamp, and table. Class II device per 21 CFR 878.4810 and 886.4390.

Indications for Use

Indicated for patients requiring treatment of ocular pathology in posterior and anterior segments, including diabetic retinopathy, macular edema, choroidal neovascularization, retinal vein occlusions, age-related macular degeneration, lattice degeneration, retinal tears/detachments, and glaucoma (iridotomy, iridectomy, 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 Photocoagulator (K091666)

Submission Summary (Full Text)

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OPTIMEDICA CORPORATION

#### PASCAL® STREAMLINE™ PHOTOCOAGULATOR SPECIAL 510(k) PREMARKET NOTIFICATION

# SECTION 6 510(k) SUMMARY (CONT.)

| | 510(k) Notification K_09262 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|--|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

#### GENERAL INFORMATION

## Applicant:

OptiMedica Corporation 3130 Coronado Drive Santa Clara, CA 95054 U.S.A. Pone: 408-850-8600 FAX: [phone]

## Contact Person:

Darlene Crockett-Billig President Experien Group 155-A Moffett Park Drive, Suite 210 Sunnyvale, CA 94089-1330 U.S.A. Phone: [phone] ext. 105 FAX: [phone] Email: dcb(@experiengroup.com

Date Prepared: August 25, 2009

## Classification:

21 CFR§878.4810, Class II 21 CFR§886.4390, Class II

Product Code: GEX, HQF

Trade Name: PASCAL® Streamline™ Photocoagulator

## Generic/Common Name: Laser instrument, surgical, powered

Laser, ophthalmic

## Predicate Device

PASCAL Photocoagulator (K091666)

# SEP 2 5 2009

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#### OPTIMEDICA CORPORATION

## SECTION 6 510(k) SUMMARY (CONT.)

#### Intended Use

Intended for use in the treatment of ocular pathology in both the posterior and anterior segments.

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 .
- age-related macular degeneration .
- lattice degeneration .
- retinal tears and detachments .
- iridotomy, iridectomy and trabeculoplasty in angle closure and open angle . glaucoma.

#### Product Description

The PASCAL Streamline Photocoagulator is an integrated system comprising of solid state aiming and treatment lasers, control electronics, graphical user interface, slit lamp and table. It is intended for use in the treatment of ocular pathology in both the posterior and anterior segments.

#### Substantial Equivalence

The PASCAL Streamline Photocoagulator is substantially equivalent to the predicate device with regard to function, intended use and performance. Any differences in the technological characteristics between the two devices do not raise any new issues of safety or efficacy. Thus, the proposed PASCAL Streamline Photocoagulator is substantially equivalent to the predicate device.

# Testing in Support of Substantial Equivalence Determination

All necessary bench testing was conducted on the proposed PASCAL Streamline Photocoagulator to support a determination of substantial equivalence to the predicate device.

#### Summary

The PASCAL Streamline Photocoagulator is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three overlapping, curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

# SEP 2 5 2009

OptiMedica Corporation % Experien Group, LLC Ms. Darlene Crocket-Billig 155-A Moffett Park Drive, Suite 210 Sunnyvale, California 94089-1330

Re: K092621

Trade/Device Name: PASCAL Streamline Photocoagulator Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF Dated: August 25, 2009 Received: August 26, 2009

Dear Ms. Crocket-Bilig:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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.

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

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Page 2 - Ms. Darlene Crocket-Billig

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.

If 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 Part 803), please go to http://www.fda.gov/cdrh/mdr/ 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/cdrh/industry/support/index.html.

- ok

Sincerely yours,

Williain A. Gray.

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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#### OPTIMEDICA CORPORATION

#### PASCAL® STREAMLINE™ PHOTOCOAGULATOR SPECIAL 510(k) PREMARKET NOTIFICATION

## SECTION 5 INDICATIONS FOR USE STATEMENT

# 510(k) Number (if known): K 0 92621

Device Name: PASCAL Streamline Photocoagulator

#### Indications for Use:

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The PASCAL Streamline Photocoagulator indications for use are the following:

Intended for use in the treatment of ocular pathology in both the posterior and anterior segments.

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
- 트 macular edema
- 트 choroidal neovascularization
- I branch and central retinal vein occlusion
- K age-related macular degeneration
- 트 lattice degeneration
- retinal tears and detachments 트
- iridotomy, iridectomy and trabeculoplasty in angle closure and open angle E glaucoma.

Prescription Use X (21 CFR Part 801 Subpart D) and/Or

Over the Counter Use · (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil K Ogden for men

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092621