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

iridotomv .
trabeculoplasty .

Device 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.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device called the PASCAL® Laser Indirect Ophthalmoscope. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies in the typical sense for AI/software devices.

Therefore, many of the requested sections regarding acceptance criteria and performance against those criteria, especially those pertaining to AI/software performance assessment like MRMC studies, standalone performance, and ground truth establishment, are not applicable to this type of submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" in this 510(k) is framed around substantial equivalence to predicate devices rather than quantitative performance metrics for a novel functionality. The primary acceptance criteria for a 510(k) submission are that the new device has the same intended use and technological characteristics as a legally marketed device (predicate device) and does not raise new questions of safety and effectiveness.

Acceptance Criteria Category	Specific Criteria (from text)	PASCAL® Laser Indirect Ophthalmoscope Performance (from text)
Intended Use	Same as predicate devices	"The PASCAL® Laser Indirect Ophthalmoscope shares the same indications for use..." (Section VII)
Technological	Similar design features and functional capabilities as predicate devices	"The technological characteristics of the PASCAL® Laser Indirect Ophthalmoscope are substantially equivalent to those of the predicate devices." (Section VI)
Characteristics	Treatment Wavelength: 577 ±2 nm or 532 ±2 nm Aiming Wavelength: 635 +10 nm Eye Filter OD: > 5 @ 532 nm or > 5 @ 577 nm Working Distance: 280 mm Fiber Length: 5 meters Aerial Spot Size: 1060 µm Illumination Source: LED and DC Battery Cooling System: Convection Cooled Air Weight: < 7 lbs.	Treatment Wavelength: 577 ±2 nm or 532 ±2 nm (Matches K111108 for 577nm, and K062336 for 532nm) Aiming Wavelength: 635 +10 nm (Matches both predicates) Eye Filter OD: > 5 @ 532 mm or > 5 @ 577 nm (Matches both predicates) Working Distance: 280 mm (Matches both predicates) Fiber Length: 5 meters (Matches both predicates) Aerial Spot Size: 1060 µm (Matches both predicates) Illumination Source: LED and DC Battery (Different from predicates, but considered "similar" functionality) Cooling System: Convection Cooled Air (Matches both predicates) Weight: < 7 lbs. (Matches both predicates)
Safety and Effectiveness	Does not raise new questions of safety and effectiveness compared to predicates	"The review of the indications for use and technical characteristics demonstrates that the PASCAL® Laser Indirect Ophthalmoscope is substantially equivalent to the predicate devices." (Section VIII)

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

Not applicable. This is a hardware device submission demonstrating substantial equivalence, not a performance study on a test set of data. There is no "test set" of patient data in the context of evaluating an algorithm.

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

Not applicable. There is no test set or ground truth established by experts for algorithmic performance in this submission.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or adjudication method described for an algorithm.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (a laser indirect ophthalmoscope), not an AI/software algorithm intended to aid human readers in diagnostic tasks.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is a delivery system for laser treatment, used by a physician (human-in-the-loop is inherent in its intended use), and does not involve AI or algorithms running independently.

7. The Type of Ground Truth Used

Not applicable. "Ground truth" in the context of expert consensus, pathology, or outcomes data is relevant for evaluating diagnostic or predictive algorithms. This submission is for a laser delivery device, where the "ground truth" relates to its physical and functional specifications meeting pre-defined engineering and safety standards, and its equivalence to devices already on the market.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an algorithm for this device.

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

Not applicable. There is no training set or ground truth for algorithmic development in this submission.

Summary

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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
	pmbuckman@gmail.com

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 PlasticSurgery and Dermatology

III. Predicate Devices

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

IV. Product Description

V. Intended Use & Indications for Use

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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 @ 577nm	> 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 (800) 638-2041 or (301) 796-7100 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:

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

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

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

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.