The SUPRA 577.Y Laser is indicated for use in photocoagulation of both anterior and posterior segments including: Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of 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, retinopathy of prematurity; Iridotomy, iridectorny and trabeculoplasty in angle closure glaucoma and open angle glaucoma.

Device Description

The Quantel SUPRA 577.Y Laser is a semi conductor laser which emits a beam of coherent light The Qualiter SUPRA 577.1 Lase 16 a delivery site(s) via delivery systems/devices.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Quantel SUPRA 577.Y Laser, a medical device for ophthalmic photocoagulation. The application focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo clinical study with acceptance criteria and performance data.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance are not available in the provided document. The submission relies on non-clinical data and comparison to the predicate device to establish safety and effectiveness.

Here's a breakdown of what can be extracted based on your request:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" in the sense of predefined performance targets for a clinical study are not reported. Instead, the acceptance is based on the device meeting design specifications and demonstrating safety and effectiveness equivalent to a legally marketed predicate device.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Non-Clinical Validation)
Shares "same indications for use" as predicate	Confirmed in Section V and Section VI
Shares "safety compliance" as predicate	Confirmed in Section VI
Shares "similar design features" as predicate	Confirmed in Section VI
Shares "equivalent wavelengths" with predicate	Confirmed in Section VI
Shares "equivalent power" with predicate	Confirmed in Section VI
Shares "equivalent exposure time" with predicate	Confirmed in Section VI
Performs "same indicated surgical procedures"	Confirmed in Section VI
Complies with mandatory and voluntary performance standards (e.g., IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2)	Confirmed in Section VII
Complies with European Medical Directive 93/42/EEC	Confirmed in Section VII
Complies with US Federal Performance Standards (21 CFR 1040.10, 21 CFR 1040.11, Laser Notice 50)	Confirmed in Section VII
Complies with 21 CFR Part 820 – Quality System Regulation	Confirmed in Section VII
ISO 9001 and 13485 System Certification	Confirmed in Section VII
Met all design specifications	Confirmed in "Non clinical Conclusion"

Study Details

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The submission states "No Clinical information is required" (Section VII, Clinical Conclusion). The equivalence is based on non-clinical laboratory testing and comparison of technical specifications to the predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable / Not provided. No clinical test set requiring expert ground truth was performed for this 510(k) submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No clinical test set requiring adjudication was performed.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a laser for photocoagulation, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a therapeutic laser operated by a human, not a standalone algorithm. Performance validation relates to its physical output and safety, not an algorithmic assessment.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical validation, the "ground truth" was adherence to established engineering and medical device standards (e.g., IEC standards, CFR regulations) and validation against the design specifications of the device itself and the predicate device's specifications. No biological or clinical ground truth (like pathology or outcomes data) was used or required for this submission.
The sample size for the training set:
- Not applicable / Not provided. This is not an AI/machine learning device that requires a training set. The device's design and performance are based on engineering principles and regulatory standards.
How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no training set, there is no ground truth for it.

Summary

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SECTION 11
page 1/2

510(k) SUMMARY

K09158

I. General information

Applicant:

Address:

Quantel Medical QUANTEL MEDICAL 21 rue Newton

Z.1. du Brezel 63039 Clermont-Ferrand Cedex 2 FRANCE +33 (0)473 745 745 ÷33 (0)473 745 700 (Fax)

Mr. Patrick QUERO Contact Person: Quality Manager & Regulatory Affairs (+33) 473 74 57 45 (+33) 473 74 57 00

Preparation Date: November 2008 (of the Summary)

II. Name

Device Name:	SUPRA 577.Y Laser
Common Name:	SUPRA 577.Y Laser
ClassificationName:	Ophthalmic laser (see 21CFR 886.4390)
Product Code:	HOF : Panel: 86

III. Predicate Device

IRIDEX IQ 577 Laser (K071687)

IV. Product Description

The Quantel SUPRA 577.Y Laser is a semi conductor laser which emits a beam of coherent light The Qualiter SUPRA 577.1 Lase 16 a delivery site(s) via delivery systems/devices.

V. Indications for Use

The SUPRA 577.Y Laser is indicated for use in photocoagulation of both anterior and posterior segments including:

& Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of ▼ Retinal photocouraliation, paid iss of the retina and choroids including:

030

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Page 2/2

Proliferative and nonproliferative diabetic retinopathy, 1.
choroidal neovascularization: ni
branch retinal vein occlusion: าก
age-related macular degeneration: র্ব
retinal tears and detachments: 5.
retinopathy of prematurity:

� Iridotomy, iridectorny and trabeculoplasty in angle closure glaucoma and open angle glaucoma.

KO91581

VI. Device Technological Characteristics and comparison to Predicate Device

SUPRA 577. Y share the same indications for use and safety compliance. similar design features, Son to For . I mare the une are substantially equivalent to the predicate device , the IRIDEX 1Q 577 Laser (K071687). In addition a review of the predicate device demonstrate that the SUPRA 577. Y Laser is safe and effective as the predicate device as they share equivalent wavelengths, power, exposure time and are used to perform the same indicated surgical procedures.

VII. Performance Standard

SUPRA 577.Y 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 quide.
IEC 60601-2-22: 2007, Medical electrical Equipment -- Part 2 : Particular requirements for the safety .� of diagnostic and therapeutic laser equipment.
IEC 60601-1: 1998 + A1:1991+A2:1995, Medical Electrical equipment Part 1 : general requirement . ● for safety.
IEC 60601-1-2: 2001 +A1:2004. Medical Electrical equipment -- Part 1 : General requirements for . � safety-2, Collateral Standard : electromagnetic compatibility - requirements and tests.

The device also complies with European Medical Directive 93/42/EEC and the US Federal Performance The dovide and coulphen with (2) CFR 1040.10 and 21CFR1040.10 and 21CFR1040.11 for Class IV Laser Products with permissible deviations defined in Laser Notice 50, dated July 26, 2001.), Part 820 – Quality System Regulation, and have passed ISO 9001 and 13485 System Certification.

Non clinical Conclusion:

Laboratory testing was conducted to validate and verify that the proposed device. SUPRA 577. Y met all design specifications and was substantially equivalent to the predicate device.

Clinical Conclusion: No Clinical information is required.

VIII. Conclusion

Based on the information in this notification Quantel Medical concludes that the SUPRA 577. Y Laser is substantially equivalent (SE) to the cited legally marketed predicate. Information regarding delivery systems which may be used with the laser is supplied by Quantel Medical; the individual devices or systems are marketed by their respective manufacturers who have the responsibility for complying with applicable regulations and marketing requirements.

Siège social et burnaux : 21 le Bréat - 6303 Clemont-Ferrand Ceda: 2 - Frans» - Tél. +33 (0) 73.745.70 - email : contact@gardel-médial.fr

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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 features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Quantel Medical c/o Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Rd. Newton, CT 06470

JUN 1 6 2009

Re: K091581

Trade/Device Name: SUPRA 577.Y LASER Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: II Product Code: HOF Dated: May 28, 2009 Received : June 2 2009

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.

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 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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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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Keria Alexander for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat 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_ 69 / 58 /

Device Name: Supra 577.Y

Indications for Use Statement:

The Supra 577. Y Laser system and accessories that are used with it to deliver laser energy in either CW pulse, MicroPulse or Long Pulse mode in the medical specialties of ophthalmology as follows:

Ophthalmology:

Indicated for use in photocoagulation of both anterior and posterior segments including: ◆ Retinal photocoagulation, panretinal photocoagulation and intravitreal

endophotocoagulation of vascular and structural abnormalities of the retina and choroids . including:

1. Proliferative and nonproliferative diabetic retinopathy; "
1. choroidal neovascularization;
1. branch retinal vein occlusion;
1. age-related macular degeneration;
1. retinal tears and detachments;
1. retinopathy of prematurity;

Iridotomy, iridectorny 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

(Division/Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

025

510(k) Number K091581

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.