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;
Treatment of choroidal neovascularization associated with wet age-related macular degeneration;
Retinal tears and detachments
Macular edema
Retinopathy of prematurity
Iridotomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.

Device Description

SUPRA SCANTM 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 SCANTM Delivery System consists of the following system components:
l ) Scanning Laser Delivery System adaptor 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 577nm retinal photocoagulator (SUPRA 5577.Y-K091581).
2) Scanner control module with LCD/Touch screen, power supply, electronics and clectrical connections.

AI/ML Overview

Acceptance Criteria and Study for Quantel Medical SUPRA SCAN™ Delivery System

This response outlines the acceptance criteria and the study conducted for the Quantel Medical SUPRA SCAN™ Delivery System, as detailed in the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results. Instead, the basis for clearance is substantial equivalence to predicate devices. The primary "performance" demonstrated is that the device met all design specifications and exhibited substantial equivalence to the predicates.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Design Specifications	Met all design specifications	Laboratory testing confirmed the device met all design specifications.
Substantial Equivalence	Equivalent indications for use, safety compliance, similar design features, and functional features to predicate devices.	The SUPRA SCAN™ Delivery System shares the same indications for use and safety compliance, similar design and functional features with the predicate devices (PASCAL Streamline 577 (K111108), IQ 577 (K071687), and Quantel Medical SUPRA SCAN™ Delivery System coupled to a SUPRA 532 (K100678)).
Key Performance Feature	Similar energy output performance at 400 microns spot size compared to predicate devices.	The SUPRA SCAN™ Delivery System offers to treat at 400 microns with equivalent energy output performance.
Clinical Significance of Differences	Any differences from predicate devices should not be clinically significant.	The only difference (maximum spot size of 500 microns vs. 400 microns for PASCAL Streamline 577) was deemed not clinically significant, as the SUPRA SCAN™ Delivery System also supports a 400-micron spot size with equivalent performance.

2. Sample Size for Test Set and Data Provenance

The document does not describe a clinical study with a "test set" in the traditional sense of patient data. The performance claims are based on laboratory testing to verify design specifications and substantial equivalence. Therefore:

Sample Size for Test Set: Not applicable, as no human subject test set was used for performance evaluation in the provided summary.
Data Provenance: Not applicable. The "study" was laboratory testing, implying in-house validation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. Given the nature of the study (laboratory testing for design specifications and substantial equivalence), no external experts were used to establish ground truth from a clinical perspective.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as there was no clinical test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. The provided information does not mention an MRMC comparative effectiveness study involving human readers. The device is a delivery system for a laser, not an diagnostic imaging tool that would typically be evaluated with MRMC studies.
Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no MRMC study was conducted and the device is a laser delivery system, not an AI diagnostic tool.

6. Standalone Performance Study

Standalone Performance Study Done: Yes, in the sense that laboratory testing was conducted to validate and verify that the SUPRA SCAN™ Delivery System met all design specifications. This laboratory testing evaluated the device's intrinsic characteristics and functions without direct human intervention as an evaluator of diagnostic output.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for this device's performance evaluation was defined by engineering and design specifications and the characteristics of the predicate devices. The goal was to prove that the device performs according to its intended design and is comparable to legally marketed devices.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The device is not an AI algorithm that requires a training set of data. Its development would likely involve engineering iterations and testing against specifications, not a data-driven training process.

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

How Ground Truth for Training Set Was Established: Not applicable, as there was no training set for an AI algorithm.

Summary

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SEP 14 2012

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510(k) Summary for the Quantel Medical SUPRA SCAN™ Delivery System

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

1. General Information

Submitter:

Quantel Medical 11 Rue du Bois Joli - CS 40015 63808 Cournon D'Auvergne Cedex FRANCE 33-473 745 745 33-473 745 700 (Fax)

Contact Person:

Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Telephone: 978-207-1245 Fax: 978-824-2541

Summary Preparation Date:

March 27, 2012

1. Names
  Device Name:

SUPRA SCAN™ Delivery System

Classification Name:

Laser Instrument, Surgical, Powered Product Code: GEX Panel: General & Plastic Surgery

Predicate Device 3.

Quantel Medical SUPRA SCAN™ Delivery System coupled to a SUPRA 532 ﮯ (K100678)
Topcon Medical Laser Systems PASCAL Streamline 577 (K111108)
IRIDEX Corp, IQ 577 (K071687)

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4. Device Description

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

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

l ) Scanning Laser Delivery System adaptor 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 577nm retinal photocoagulator (SUPRA 5577.Y-K091581).

Scanner control module with LCD/Touch screen, power supply, electronics and clectrical connections.

5. Indications for Use

Proliferative and nonproliferative diabetic retinopathy;
Choroidal neovascularization;
Branch retinal vein occlusion;
Treatment of choroidal neovascularization associated with wet age-related macular degeneration;
Retinal tears and detachments
Macular edema
· Retinopathy of prematurity
· Iridotomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.

6. Substantial Equivalence

The SUPRA SCAN™ Delivery System shares the same indications for use and safety compliance, similar design features, functional features, and therefore are substantially equivalent to the predicate devices, the PASCAL Streamline 577

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(K111108), the IQ 577 (K071687) and the Quantel Medical SUPRA SCANTM Delivery System coupled to a SUPRA 532 (K100678). In addition a review of the predicate devices demonstrates that the SUPRA SCAN™ Delivery System is substantially equivalent to the predicate devices 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 Streamline 577 (K111108) is that the SUPRA SCAN™ Delivery System has a maximum spot size of 500 microns instcad of 400 microns for PASCAL Streamline 577 (K111108). This difference is not viewed as being clinically significant. The SUPRA SCAN™ Delivery System offers to treat at 400 microns with equivalent energy output performance. Additionally, the SUPRA SCAN™ Delivery System for use with a 532 nm laser uses a 500 micron spot size for similar indications for use.

The SUPRA SCAN™ Delivery System uses the same fundamental technology features as the PASCAL Streamline 577 (K111108). Therefore, it is concluded that SUPRA SCAN"M Delivery System is substantially equivalent to the identified predicate devices.

7. Performance Data

Laboratory testing was conducted to validate and verify that the SUPRA SCAN™ Delivery System met all design specifications and was substantially equivalent to the predicate device.

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Image /page/3/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. The logo is presented in black and white.

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

Quantel Medical % O'Connell Regulatory Consultants, Incorporated Ms. Maureen O'Connell Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864

SEP 14 2012

Re: K120825

Trade/Device Name: SUPRA SCAN™ Delivery System Regulation Number: 21 CFR 886.4390 Regulation Name: Opthalmic laser Regulatory Class: Class II Product Code: HQF Dated: August 09, 2012 Received: August 13, 2012

Dear Ms. O'Connell:

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

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Page 2 - Ms. Maureen O'Connell

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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

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

510(k) Number (if known): _

Device Name: SUPRA SCAN™ Delivery System

Indications for Use:

· Proliferative and nonproliferative diabetic retinopathy;
· Choroidal neovascularization;
· Branch retinal vein occlusion;
Treatment of choroidal neovascularization associated with wet age-related macular degeneration;
· Retinal tears and detachments
· Macular edema
· Retinopathy of Prematurity
· Iridotomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over The Counter Use _ (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

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(Division Sign Off)

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

510(k) Number K120825

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.