The SUPRA SCAN™ Delivery System when connected to a compatible laser system is indicated for use in the treatment of ocular pathology of anterior segments including, retinal photocoagulation, pan retinal photocoagulation for vascular and structural abnormalities of the retina and choroids including:

· Proliferative and nonproliferative diabetic retinopathy;
· Choroidal neovascularization;
· Branch retinal vein occlusion;
· Age-related macular degeneration;
· Retinal tears and detachments
· Macular edema
· Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.

Device Description

SUPRA SCAN™ Delivery System is a scanning laser delivery system that enables the use of proprietary pattern scanning technology when coupling with laser platforms. This offers existing commercially available laser platform the ability to deliver a full spectrum of pattern scanning options.
The Quantel Medical SUPRA SCAN™ Delivery System consists of the following system components:

1. Scanning Laser Delivery System adapter with scanner controls that may be coupled to a slit lamp type Haag Streit or similar models, and connected to a currently cleared Quantel Medical 532nm retinal photocoagulator (SUPRA 532).
1. Scanner control module with LCD/Touch screen, power supply, electronics and electrical connections.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SUPRA SCAN™ Delivery System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the SUPRA SCAN™ Delivery System's equivalence to a predicate device rather than setting specific numerical acceptance criteria for performance in a clinical study. The "acceptance criteria" here are implicitly whether the device meets the specifications and safety standards of the predicate device, or relevant international and US standards. The "reported device performance" is essentially a comparison of its technical specifications to those of the predicate.

Given the nature of the submission (510(k) for substantial equivalence), the acceptance criteria are primarily that the device's technical characteristics, safety profile, and intended use are sufficiently similar to the predicate device.

Characteristic / Acceptance Criteria (Implicit)	SUPRA SCAN™ Delivery System Performance	Predicate Device (PASCAL Synthesis™) Performance	Comparison / Outcome
Intended Use	Photocoagulation of anterior and posterior segments of the eye for various ocular pathologies.	Photocoagulation of anterior and posterior segments of the eye for various ocular pathologies.	Equivalent
Laser Energy Source	Frequency doubled Nd:YAG	Frequency doubled Nd:YAG	Equivalent
Laser Energy Delivery	Single spot & Multi spot	Single spot & Multi spot	Equivalent
Spot Placement	Centered on Guide Beam	Centered on Guide Beam	Equivalent
Laser energy Intensity	Selected by Physician	Selected by Physician	Equivalent
Pulsing System	Continuous	Continuous	Equivalent
Output Wavelength	532 nm	532 nm	Equivalent
Average Power (AP)	2W (with SUPRA Scan)	2 W	Equivalent
Laser Safety Class	4/IV	4/IV	Equivalent
Exposure Selections (t)	0.007s to continuous	0.01s to continuous	Slightly broader range for SUPRA SCAN, but considered equivalent/safe.
Cooling Method	Solid State Cooling with thermoelectric (Peltier) heat pump	Air cooled	Different, but considered safe and effective to meet performance.
Aiming Beam Type	Red diode	Red diode	Equivalent
Aiming Beam Wavelength	635 nm	635 nm	Equivalent
Aiming laser power	< 1mW	< 1mW	Equivalent
Laser Safety Class (Aiming Beam)	2/II	2/II	Equivalent
Power calibration	YES	YES	Equivalent
Mini focal spot size diameter (Multi-Spot)	100μm	100μm	Equivalent
Exposure Selections (Multi-Spot)	0.01s to continuous	0.01s to continuous	Equivalent
Mini focal spot size diameter (Multi-Spot)	500 µm	400 μm	Different (SUPRA SCAN has larger max). Stated as "not clinically significant" as SUPRA SCAN can treat at 400µm.
Mini focal spot size diameter (Single-Spot)	50μm	60 μm	Different, but within acceptable range for treatment.
Exposure Selections (Single-Spot)	0.007s to continuous	0.01s to continuous	Slightly broader range for SUPRA SCAN, but considered equivalent/safe.
Repetition rate between two spots	8ms	8ms	Equivalent
Type of scanning system	Scanners	Scanners	Equivalent
Filter protection integrated	YES	YES	Equivalent
Compliance to Standards	IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, EU Directive 93/42/EEC, US Federal Performance Standards 21 CFR 1002.10, Part 820, ISO 9001, 13485	IEC 60601-2-22, IEC 60825-1	Equivalent safety and performance standards compliance.

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

The document explicitly states: "Clinical Conclusion: No Clinical information is required." This indicates that no clinical test set (i.e., human patient data) was used for this 510(k) submission. Therefore, there is no sample size for a test set, nor data provenance (country of origin, retrospective/prospective).

The evaluation was based on non-clinical performance data, which involved laboratory testing to validate and verify that the device met all design specifications and was substantially equivalent to the predicate device. The provenance of this non-clinical testing data would be from the manufacturer's (Quantel Medical, France) internal labs.

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

As no clinical data or test set involving human patients was used, no experts were used to establish ground truth for a clinical test set. The evaluation relied on technical specification comparisons and adherence to established engineering and safety standards.

4. Adjudication Method for the Test Set

Since no clinical test set was utilized requiring expert interpretation, no adjudication method was employed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Status and Effect Size

No MRMC comparative effectiveness study was done. The submission solely focuses on demonstrating substantial equivalence to a predicate device through technical and safety performance comparisons, not on evaluating human reader improvement with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Status

This device is a laser delivery system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context. The device is intended for use by a trained ophthalmologist (human-in-the-loop product).

7. Type of Ground Truth Used

For this 510(k) submission, the "ground truth" was established by engineering specifications, international and US safety standards, and the technical characteristics of the predicate device. The primary ground truth was compliance with these established benchmarks rather than clinical outcomes or expert consensus on clinical findings.

8. Sample Size for the Training Set

No training set data is mentioned or relevant, as this is a physical medical device, not an AI/machine learning algorithm that requires training data.

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

Not applicable, as there is no training set for this type of device.

Summary

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K100678

JUL 2-1 2010

Executive Summary 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).

I. General information

Applicant:	Quantel Medical
------------	-----------------

Address:

QUANTEL MEDICAL 21 rue Newton Z.I. du Brezet 63039 Clermont-Ferrand Cedex 2 FRANCE +33 (0)473 745 745 +33 (0)473 745 700 (Fax)

Contact Person:	Mr. Patrick QUERO
	Quality Director & Regulatory Affair
	(+33) 473 74 57 45
	(+33) 473 74 57 00
Summary Preparation Date:	July 2009

II. Name

Name:

SUPRA SCANTM Delivery System Device Name:

Common Name: SUPRA SCANTM Delivery System

Classification Laser instrument, surgical, powered (see 21CFR 878.4810)

Product Code: GEX ; Panel: 79

III. Predicate Device

OptiMedica PASCAL Synthesis™ Delivery System (K081744)

IV. Product Description

The SUPRA SCAN™ Delivery System is intended for use by trained ophthalmologist for diagnosis and treatment of ocular pathology.

The Quantel Medical SUPRA SCAN™ Delivery System consists of the following system components:

1. Scanning Laser Delivery System adapter with scanner controls that may be coupled to a slit lamp type Haag Streit or similar models, and connected to a currently cleared Quantel Medical 532nm retinal photocoagulator (SUPRA 532).
1. Scanner control module with LCD/Touch screen, power supply, electronics and electrical connections.

Image /page/0/Picture/23 description: The image shows the number 052 in a bold, slightly distorted font. The numbers are black against a white background. The digits are closely spaced, giving the impression of a single unit.

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V. Indications for Use

· Proliferative and nonproliferative diabetic retinopathy;
· Choroidal neovascularization;
· Branch retinal vein occlusion;
· Age-related macular degeneration;
· Retinal tears and detachments
· Macular edema
· Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.

VI. Device Technological Characteristics and comparison to Predicate Device

Predicate Product Comparison Table:

Manufacturer	QUANTEL MEDICAL	OPTIMEDICA Corporation
Model	SUPRA SCAN™ Delivery System	PASCAL Synthesis™ Delivery System
510 (K) Number		K081744
Intended Use	Photocoagulation of both anterior and posteriorsegments of the eye by generation of patterns oflaser spots.	Photocoagulation of both anterior and posteriorsegments of the eye by generation of patterns oflaser spots.
Type of Delivery System	Slit lamp adaptor with optical fiber connected to alaser	Slit lamp with laser integrated
Laser Energy source	Frequency doubled Nd : YAG	Frequency doubled Nd : YAG
Laser Energy Delivery	Single spot & Multi spot	Single spot & Multi spot
Spot placement	Centered on Guide Beam	Centered on Guide Beam
Laser energy Intensity	Selected by Physician	Selected by Physician
Pulsing System	Continuous	Continuous
Power requirements : Current	1 A	---
Computer control	Yes	Yes
Can user change computerprogram ?	No	No

VI - 1 - GENERAL SPECIFICATIONS COMPARISON TABLE -

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Manufacturer	QUANTEL MEDICAL	OPTIMEDICA Corporation
Model	SUPRA 532	Pascal ™ Photocoagulator
510 (K) Number	K070776	K043486
Lasing Medium	Frequency doubled Nd : YAG	Frequency doubled Nd : YAG
Pulsing System	Continuous	Continuous
Output Wavelength	532 nm	532 nm
Average Power (AP)	2W with SUPRA Scan	2 W
Laser Safety Class	4/IV	4/IV
Exposure Selections (t)	0.007s to continuous	0.01s to continuous
Cooling Method	Solid State Cooling withthermoelectric(Peltier) heat pump	Air cooled
Aiming Beam :	Coaxial with treatment beam
Aiming Beam : Type	Red diode	Red diode
Aiming Beam : Wavelength	635 nm	635 nm
Aiming laser power	< 1mW	< 1mW
Laser Safety Class	2/II	2/II
Power requirements :Voltage	100 to 240 Vac	100 to 240 Vac
Power requirements : Current		5 A
Computer control	Yes	Yes
Can user change computerprogram ?	No	No
Safety measures	Conform to standard 60601-2-22and 60825-1	Conform to standard 60601-2-22 and60825-1

. .

and the comments of the comments of the comments of

VI -2 - LASER ENERGY SOURCE COMPARISON TABLE

. . . . .

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Manufacturer	QUANTEL MEDICAL	OPTIMEDICA Corporation
Model	SUPRA SCAN™ DeliverySystem connected toSUPRA 532	PASCAL Synthesis™ DeliverySystem
510 (K) Number		K081744
User interface	Touchscreen	Touchscreen
Dimensions	5,8in H x 13in W x 12,1in D	---
Power calibration	YES	YES
Laser Energy Delivery	Multi-Spot Mode	Multi-Spot Mode
Mini focal spot size diameter	100μm	100μm
Exposure Selections (Multi spot mode)	0.01s to continuous	0.01s to continuous
Mini focal spot size : (area)	$7.8539 x 10^{-5} cm^2$	$7.8539 x 10^{-5} cm^2$
Average Power Density (APD=AP/area)	$0.2546 x10^{5} W/cm^2$	$0.2546 x10^{5} W/cm^2$
Energy max at minimum exposure(APx t)	20mJ	20mJ
Max energy density at min exposure(APxt/area)	$0.254 x10^{3} J/cm^2$	$0.254 x10^{3} J/cm^2$
Mini focal spot size diameter	500 µm	400 μm
Mini focal spot size : (area)	$1,9635 x 10^{-3} cm^2$	$1,256 x 10^{-3} cm^2$
Average Power Density (APD=AP/area)	$1,02 x10^{3} W/cm^2$	$1,59 x10^{3} W/cm^2$
Energy max at minimum exposure(APx t)	20mJ	20mJ
Max energy density at min exposure(APxt/area)	102 mJ/cm²	159 mJ/cm²
Laser Energy Delivery	Single spot Mode	Single spot Mode
Mini focal spot size diameter	50μm	60 μm
Exposure Selections (Single spot mode)	0.007s to continuous	0.01s to continuous
Mini focal spot size : (area)	$1,9635 x 10^{-5} cm^2$	$2,8274 x 10^{-5} cm^2$
Average Power Density (APD=AP/area)	$1,02 x10^{5} W/cm^2$	$0,7073 x10^{5} W/cm^2$
Energy max at minimum exposure (APx t)	14mJ	20mJ
Max energy density at minexposure(APxt/area)	71 mJ/cm²	71 mJ/cm²

VI - 3 - LASER CHARACTERISTICS COMPARISON TABLE

・・・・・・

055

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Manufacturer	QUANTEL MEDICAL	OPTIMEDICA Corporation
Model	SUPRA SCAN™ Delivery System	PASCAL Synthesis™ Delivery System
510 (K) Number	---	K081744
User interface	Touch screen + manual zoom	Touch screen
Dimensions	Screen : 20cm H x 12cm W x 4cm DAdaptor : 25cm H x 20cm W x 13cm D	122cm H x 76cm W x 122cm D
Weight	2 kg	137 kg
Focal spot size diameters available	Continuously adjustable with parafocalzoom from 50μm to 500μm	4 sizes available : 60μm - 100μm – 200μm -400μm
Spot size adjustment	Manually on the zoom	From touch screen
Type of patterns available	Square - Triple arc - Circle - Macular grid	Square - Triple arc - Circle - Macular grid -Octant
Repetition rate between two spots	8ms	8ms
Type of scanning system	scanners	scanners
Filter protection integrated	YES	YES

VI-4-SYSTEM CHARACTERISTICS COMPARISON TABLE

VII. Performance Standard

SUPRA SCAN™ Delivery System is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including:

IEC 60825-1:2007, Safety of laser products Part 1 : Equipment classification, requirements and . user's guide.
. IEC 60601-2-22: Ed 1995, Medical electrical Equipment - Part 2 : Particular requirements for the safety of diagnostic and therapeutic laser equipment.
. IEC 60601-1: 1988 + A1:1991 + A2:1995, Medical Electrical equipment - Part 1 : gencral requirement for safety.
. IEC 60601-1-2: 2001, Medical Electrical equipment - Part 1 : General requirements for safety-2. Collateral Standard : electromagnetic compatibility - requirements and tests.
. IEC 60601-1-4: 2000, Medical electrical equipment - Part 1 : General requirements for safety -4 -Collateral standard : Programmable electrical medical systems, edition 1.1

The device also complies with European Medical Directive 93/42/EEC + Amendment 2007/47/EEC and the US Federal Performance Standards 21 CFR 1002.10 Requirements (21 CFR 1040.10 and

21CFR 1040.11 for Class IV Laser Products with permissible deviations defined in Laser Notice 50, dated July 26, 2001.), Part 1010.2 and 1010.3, Part 820 - Quality System Regulation, and have passed ISO 9001 and 13485 System Certification.

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VIII. Discussion of similarities and Differences with the Predicate Product

SUPRA SCANT" Delivery System share the same indications for use and safety compliance, similar design features, functional features, and therefore are substantially equivalent to the predicate device , the PASCAL Synthesis™ Delivery System (K081744). In addition a review of the predicate device demonstrate that the SUPRA SCAN™ Delivery System is safe and effective as the predicate device as they share equivalent specifications / characteristics and are used to perform the same indicated surgical procedures.

The only differences in the specifications/characteristics of the SUPRA SCAN ™ Delivery System and its predicate PASCAL Synthesis™ Delivery System (K081744) is that :

1. The SUPRA SCAN™ Delivery System has a maximum spot size of 500 microns instead of 400 microns for PASCAL Synthesis™ Delivery System. This difference is not viewed as being clinically significant. SUPRA SCAN 100 Delivery System offers to treat at 400 microns with equivalent energy output performance.

Conclusion:

SUPRA SCAN™ Delivery System use the same fundamental technology features as the PASCAL Synthesis The Delivery System (K081744) and delivers the same level of effectiveness. Therefore, it is concluded that there is no significant difference in the basic function, safety and effectiveness between the PASCAL Synthesis" Delivery System (Predicate Device) and the SUPRA SCAN 100 Delivery System.

IX. Non-clinical performance data and conclusions from non-clinical tests

Laboratory testing was conducted to validate and verify that the proposed device, SUPRA SCAN™ Delivery System met all design specifications and was substantially equivalent to the predicate device. Clinical Conclusion: No Clinical information is required.

X. Conclusion

Based on the information in this notification Quantel Medical concludes that the SUPRA SCAN™ Delivery System is substantially equivalent (SE) to the cited legally marketed predicate.

The potential hazards. e.g. are controlled by a risk management plan including :

A hazard identification (Section 9) t
-A Risk evaluation (Section 9)
A software Development and Validation Process (Section 10). l

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted in a simple, abstract style, with three curved lines representing the snakes and a horizontal line representing the staff. The text is in uppercase letters and is evenly spaced around the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JUL 21 2010

Quantel Medical % TUV Rheinland of North America, Inc. Mr. Tamas Borsai 12 Commerce Road Newton, Connecticut 06470

Re: K100678

Trade/Device Name: Supra Scan™ Delivery System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II

Product Code: GEX Dated: July 19, 2010 Received: July 19, 2010

Dear Mr. Borsai:

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.

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Page 2 - Mr. Tamas Borsai

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.

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/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Melkerson

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): _ K

Device Name: SUPRA SCAN™ Delivery System

Indications for Use Statement:

The SUPRA SCAN™ Delivery System when connected to a compatible laser system is indicated for use in the treatment of ocular pathology of anterior and posterior segments including, retinal photocoagulation, pan retinal photocoagulation for vascular and structural abnormalities of the retina and choroids including:

· Proliferative and nonproliferative diabetic retinopathy;
· Choroidal neovascularization;
· Branch retinal vein occlusion;
· Age-related macular degeneration;
· Retinal tears and detachments
· Macular edema
· Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use X (Per 21 CFR 801.109) OR

Over-The Counter Use

Mark A. Millerson

(Division Sigr. Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number _

020

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.