PASCAL LASER INDIRECT OPHTHALMOSCOPE

K123056 · Topcon Medical Laser Systems, Inc. (Tmls) · HQF · Nov 13, 2012 · Ophthalmic

Device Facts

• Record ID: K123056
• Device Name: PASCAL LASER INDIRECT OPHTHALMOSCOPE
• Applicant: Topcon Medical Laser Systems, Inc. (Tmls)
• Product Code: HQF · Ophthalmic
• Decision Date: Nov 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PASCAL® Laser Indirect Ophthalmoscope is intended for use with the PASCAL Streamline 577 laser or the PASCAL Streamline 532 laser when either of those lasers is used 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: 532nm - macular edema - age-related macular degeneration - lattice degeneration - retinal tears and detachments 577nm - 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 - retinopathy of prematurity Intended for use in the treatment of ocular pathology in the anterior segment including: 577nm - iridotomy - trabeculoplasty

Device Story

PASCAL Laser Indirect Ophthalmoscope (LIO) is a head-worn delivery device used with a hand-held ophthalmoscopic lens to view and treat the retina. It connects to PASCAL Streamline 577 or 532 laser systems. Used by physicians to treat patients in supine positions or those unsuitable for slit-lamp delivery. The device delivers laser energy to the posterior or anterior segment of the eye to perform photocoagulation, iridotomy, or trabeculoplasty. It features an integrated eye safety filter to protect the operator. The device utilizes LED illumination and convection air cooling. It provides a non-invasive method for retinal and anterior segment therapy, enabling treatment of structural and vascular abnormalities.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design comparisons to predicate devices.

Technological Characteristics

Head-worn ophthalmoscope; 577nm or 532nm laser delivery; 635nm aiming beam; LED illumination; convection air cooling; 5-meter fiber optic cable; 280mm working distance; 1060 µm aerial spot size; eye safety filter OD > 5 at 532/577nm; weight < 7 lbs.

Indications for Use

Indicated for patients requiring retinal or anterior segment photocoagulation treatment for ocular pathologies including macular edema, age-related macular degeneration, lattice degeneration, retinal tears/detachments, diabetic retinopathy, choroidal neovascularization, retinal vein occlusions, 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

• Optimedica Laser Indirect Ophthalmoscope (K062336)
• Topcon Laser Indirect Ophthalmoscope (K111108)

Submission Summary (Full Text)

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### 510(K) SUMMARY

#### I. General Information

# NOV 1 3 2012

| Submitter: | Topcon Medical Laser Systems, Inc. |
|------------|------------------------------------|
| | 3130 Coronado Drive |
| | Santa Clara, CA 95054, USA |

| Contact Person: | Pamela M. Buckman |
|-----------------|-----------------------|
| | Regulatory Consultant |
| | T 925 980 7007 |
| | F 925 705 7381 |
| | [e-mail] |

October 22, 2012 Summary Preparation Date:

### II. Names

| Device Name(s): | PASCAL® Laser Indirect Ophthalmoscope |
|-------------------------|-------------------------------------------------------------------------------------|
| Classification Name(s): | Laser Surgical Instrument for use in General and Plastic<br>Surgery and Dermatology |

### III. Predicate Devices

- Optimedica Laser Indirect Ophthalmoscope (K062336) .
- . Topcon Laser Indirect Ophthalmoscope (K111108)

#### IV. Product Description

The PASCAL Laser Indirect Ophthalmoscope (LIO) with eye safety filter is a non-sterile, multiple use, delivery device that is worn on the physician's head and is used in conjunction with a compatible hand held ophthalmoscopic examination lens to view and treat the patient's retina. LIOs are used to treat patients in a supine position or who could not otherwise be treated using a slit lamp delivery system.

#### V. Intended Use & Indications for Use

The PASCAL® Laser Indirect Ophthalmoscope is intended for use with the PASCAL Streamline 577 laser or the PASCAL Streamline 532 laser when either of those lasers is used 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:

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### 532nm

- . macular edema
- age-related macular degeneration .
- lattice degeneration .
- . retinal tears and detachments

### 577nm

- 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 .
- retinopathy of prematurity .

Intended for use in the treatment of ocular pathology in the anterior segment including:

577nm

- iridotomv .
- trabeculoplasty .

### Summary of Technological Characteristics VI.

The technological characteristics of the PASCAL® Laser Indirect Ophthalmoscope are substantially equivalent to those of the predicate devices.

| | | K062336 | K111108 |
|------------------|---------------------------------|---------------------------|----------------------------|
| | The PASCAL® Laser Indirect | Topcon LIO | LIO |
| | Ophthalmoscope Topcon | (formerly Optimedica; now | Accessory to Topcon PASCAL |
| | Medical Laser Systems | Topcon Medical Laser | Streamline Laser System |
| Characteristics | | Systems | |
| Treatment Length | 577 ±2 nm or 532 ±2 nm | 532 ±2 nm | 577 ±2 nm |
| Aiming | 635 +10 nm | 635 +10 nm | 635 +10 nm |
| Wavelength | | | |
| Eye Filter OD | > 5 @ 532 mm or > 5 @ 577<br>nm | > 5 @ 532 nm | > 5 @ 577 nm |
| Working Distance | 280 mm | 280 mm | 280 mm |
| Fiber Length | 5 meters | 5 meters | 5 meters |
| Aerial Spot Size | 1060 µm | 1060 µm | 1060 µm |
| Illumination | LED and DC Battery | Halogen Cabled to DC Base | Halogen Cabled to DC Base |
| Source | | Station | Station |
| Cooling System | Convection Cooled Air | Convection Cooled Air | Convection Cooled Air |
| Weight | < 7 lbs. | < 7 lbs. | < 7 lbs. |

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### VII. Rationale for Substantial Equivalence

The PASCAL® Laser Indirect Ophthalmoscope shares the same 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® Laser Indirect Ophthalmoscope is substantially equivalent to the predicate devices.

#### IX. Conclusion

The PASCAL® Laser Indirect Ophthalmoscope was found to be substantially equivalent to the predicate devices. The PASCAL® Laser Indirect Ophthalmoscope shares the same indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

November 13, 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Topcon Medical Laser System, Inc. (TMLS) % Buckman Company, Inc. Ms. Pamela M. Buckman 2800 Pleasant Hill Road, Suite 175 Pleasant Hill, California 94523

Re: K123056

Trade/Device Name: PASCAL® Laser Indirect Ophthalmoscope Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF Dated: October 22, 2012 Received: October 24, 2012

Dear Ms. Buckman:

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. 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.

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

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Page 2 - Ms. Pamela M. Buckman

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.

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/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.

# Peter D. Rumm -S

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

Enclosure

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## Intended/Indications for Use

K123056 510(k) Number:

Topcon PASCAL® Laser Indirect Ophthalmoscope Device Name:

The PASCAL® Laser Indirect Ophthalmoscope is intended for use with the PASCAL Streamline 577 laser or the PASCAL Streamline 532 laser when either of those lasers is used 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:

532nm

- . macular edema
- age-related macular degeneration ●
- . lattice degeneration
- . retinal tears and detachments

577nm

- 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 ●
- retinopathy of prematurity

Intended for use in the treatment of ocular pathology in the anterior segment including:

577nm

- iridotomy .
- trabeculoplasty

X

OR

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

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| NEEDED | Neil R.D. goven for mxm |

Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K123056