PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01

K043486 · Topcon Medical Laser Systems, Inc. · GEX · Mar 3, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043486
• Device Name: PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01
• Applicant: Topcon Medical Laser Systems, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• 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 Photocoagulator is an integrated ophthalmic laser system; comprises solid-state aiming/treatment lasers, control electronics, GUI, slit-lamp, and table. Used by ophthalmologists in clinical settings for retinal and anterior segment photocoagulation. Device delivers laser energy to ocular tissue to treat vascular/structural abnormalities. Features semi-automatic repeat mode for treatment delivery. Physician operates system via slit-lamp delivery and foot switch; visualizes target tissue through slit-lamp optics. Output is controlled laser energy; facilitates precise tissue coagulation; benefits patients by addressing sight-threatening retinal conditions and glaucoma.

Clinical Evidence

Bench testing only. Performance test results, system/software hazard analysis, and verification/validation information were submitted to support substantial equivalence.

Technological Characteristics

Integrated system with solid-state laser, control electronics, GUI, slit-lamp, and table. Features include semi-automatic repeat mode, foot switch energy delivery, and adjustable treatment parameters (wavelength, power, duration, spot size).

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

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Lumenis Novus Varia (K022181)
• Laserex LP1 532 (K972514)
• Iridex Oculight SL/SLx (K020374)
• Iridex Medical Oculight GL (K960971)
• Infinitech Slit Lamp Laser Adapter (K971950)

Submission Summary (Full Text)

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MAR 3 - 2005

SUMMARY OF SAFETY AND EFFECTIVENESS

# SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## Submitter's name, address, telephone number, contact person, and date 1. summary prepared:

- a. Applicant:
SECTION 11

OptiMedica Corporation 1793 Lafayette Street Suite 105 Santa Clara, Ca. 95051

- b. Contact Person:
Judy F. Gordon, D.V.M. ClinReg Consulting Services, Inc.

Rudy Dordon

Date Summary Prepared: c.

December 10, 2004

### 2. Name of device, including trade name and classification name:

Trade/Proprietary Name:

Classification:

Pascal™ Photocoagulator

GEX 21 CFR 878.4810 Laser instrument, surgical, powered

HOF 21 CFR 886.4390 Laser, ophthalmic

- 3. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

| 510(K) | Company | Device Name |
|---------|--------------------|------------------------------------|
| K022181 | Lumenis, Inc. | Lumenis Novus Varia |
| K972514 | Laserex Systems | Laserex LP1 532 |
| K020374 | Iridex Corporation | Iridex Oculight SL/SLx |
| K960971 | Iridex Corporation | Iridex Medical Oculight GL |
| K971950 | Infinitech, Inc. | Infinitech Slit Lamp Laser Adapter |

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## 4. A description of the device that is the subject of the 510(k):

The Pascal laser photocoagulator is an integrated system comprising 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.

## 5. Statement of intended use:

The Pascal 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
- macular edema
- 트 choroidal neovascularization
- . branch and central retinal vein occlusion
- age-related macular degeneration
- . lattice degeneration
- 이 retinal tears and detachments
- 에 Iridotomy, iridectomy and trabeculoplasty in angle closure and open angle glaucoma.

## 6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.

The Pascal™ Retinal Photocoagulator system shares the same intended use, indications for use and the same or similar technological characteristics (including treatment wavelengths, laser active medium, pumping system, aiming beam, mode of operation, exposure duration, power, treatment intervals, spot size, semi-automatic repeat mode, controls and displays, laser energy delivery control (foot switch), and slit lamp delivery, and therefore is substantially equivalent to the predicate devices referenced in Item 3.

### 7. Brief summary of nonclinical tests and results:

Performance test results, as well as system and software hazard analysis information and system and software verification and validation information, have been submitted in conjunction with this Premarket Notification submission. The determination of substantial equivalence was based on the comparison of the technical characteristics between the Pascal Retimal Photocoagulator and the predicate laser systems.

### 8. Conclusion

The Pascal Retinal Photocoagulator is substantially equivalent to similar predicate laser devices and slit lamp delivery systems. The Pascal Retinal Photocoagulator shares the same intended use, indications for use, and technological characteristics as the predicate ophthalmic laser systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 - 2005

OptiMedica Corporation c/o Judy F. Gordon, D.V.M. ClinReg Consulting Services, Inc. 2 Delphinus Irvine, California 92612

Re: K043486

Trade/Device Name: Pascal™ Photocoagulator Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 14, 2004 Received: December 17, 2004

Dear Dr. Gordon:

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, listing 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 such 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, I'DA 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 complics 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); 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.

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Page 2 - Judy F. Gordon, D.V.M.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to ocgin manistang , .
premarket notification. The FDA finding of substantial equivalence of your device to a legally prematicated predicated on: "The classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spoonly and 101-10-10115. Also, please note the regulation entitled, Connact the Oriece of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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.

Sincerely yours,

uriam C. Parret

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## KO43486 510(k) Number (if known):

Pascal™ Photocoagulator Device Name:

Indications for Use:

The Pascal 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
- 포 macular edema
- 해 choroidal neovascularization
- branch and central retinal vein occlusion 트
- 트 age-related macular degeneration
- 이 lattice degeneration
- 트 retinal tears and detachments
- Iridotomy, iridectomy and trabeculoplasty in angle closure and open angle glaucoma. I

Muriam C. Provost

(Division Sign-Off Division of General, Restorative, and Neurological Devices

**510(k) Number** K043456

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Perscription Use X

OR

Over-The-Counter Use (Optional Format 1-2-96)

OptiMedica TMCorporation Pascall M Photocogoulator

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