The VITRA MULTISPOT Laser photocoagulator is indicated for use in the treatment of ocular pathology of anterior and posterior segments including, retinal photocoagulation and pan retinal photocoagulation of 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

VITRA MULTISPOT is a laser photocoagulator emitting a treatment beam of green (532nm) laser radiation. The treatment beam is delivered through a delivery system and is aimed using a Red Laser diode (635-650nm).

The Quantel Medical VITRA MULTISPOT Laser can be connected with the following delivery systems:

1. Scanning Laser Delivery System adaptor
1. Slit Lamp adaptor
1. Indirect ophthalmoscope adaptor

Output power from all these delivery systems are calibrated to deliver a maximum of 1.5 watts. The control box is a tactile LCD screen which is part of the main housing.

AI/ML Overview

The provided text describes a 510(k) summary for the Quantel Medical VITRA MULTISPOT, a laser photocoagulator. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth are not present in the provided document. The document states that "Laboratory testing was conducted to validate and verify that the VITRA MULTISPOT Laser met all design specifications and was substantially equivalent to the predicate devices." This implies that the acceptance criteria are likely related to meeting design specifications and achieving comparable performance to the predicate devices, as assessed through laboratory testing.

Here's a breakdown of what information can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Met all design specifications (Implied)	Laboratory testing was conducted to validate and verify that the VITRA MULTISPOT Laser met all design specifications.
Substantially equivalent to predicate devices (Implied)	Laboratory testing was conducted to validate and verify that the VITRA MULTISPOT Laser was substantially equivalent to the predicate devices. The device shares the same intended use, safety compliance, similar design features, functional features, and equivalent specifications/characteristics to the predicate devices (PASCAL Photocoagulator (K043486) and Synthesis Delivery System (K081744), VITRA (K043236), and Quantel Medical SUPRA SCAN™ Delivery System coupled to the SUPRA 532 (K100678)).

Acceptance Criteria

Reported Device Performance

Met all design specifications (Implied)

Laboratory testing was conducted to validate and verify that the VITRA MULTISPOT Laser met all design specifications.

Substantially equivalent to predicate devices (Implied)

Laboratory testing was conducted to validate and verify that the VITRA MULTISPOT Laser was substantially equivalent to the predicate devices. The device shares the same intended use, safety compliance, similar design features, functional features, and equivalent specifications/characteristics to the predicate devices (PASCAL Photocoagulator (K043486) and Synthesis Delivery System (K081744), VITRA (K043236), and Quantel Medical SUPRA SCAN™ Delivery System coupled to the SUPRA 532 (K100678)).

Missing Information: Specific quantitative design specifications (e.g., laser power accuracy, spot size consistency, pulse duration accuracy, beam quality, safety interlock performance) and the precise metrics/results obtained from the laboratory testing that demonstrate these specifications were met.

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

Missing Information: The document does not describe a "test set" in the context of patient data or clinical performance evaluation. The "testing" mentioned is laboratory-based. Therefore, there is no information on sample size for a test set or data provenance (country of origin, retrospective/prospective).

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

Missing Information: No clinical test set or ground truth establishment by experts is described in the provided document. The evaluation focuses on laboratory performance and substantial equivalence to existing devices.

4. Adjudication Method for the Test Set

Missing Information: As no clinical test set with human assessment is described, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Missing Information: An MRMC comparative effectiveness study is not mentioned. This device is a laser photocoagulator, a treatment device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this type of study is not applicable to the information provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Missing Information: This is not an algorithm-only device. It is a physical medical device (laser photocoagulator) operated by a human. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Missing Information: If by "ground truth" we refer to the standard against which the device's technical specifications were measured in the lab, it would likely be established engineering standards, regulatory requirements, or the performance specifications of the predicate devices. No clinical "ground truth" (expert consensus, pathology, outcomes data) is mentioned as part of the evaluation for this 510(k).

8. The Sample Size for the Training Set

Missing Information: The device (VITRA MULTISPOT) is a laser photocoagulator, not an AI/machine learning model that requires a "training set" in the conventional sense. The regulatory submission primarily relies on demonstrating that its design and performance are substantially equivalent to already cleared predicate devices through laboratory testing and engineering analysis.

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

Missing Information: See point 8. No training set is described for this type of device.

Summary

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K 122.251

JAN 2 4 2013

510(k) Summary for the Quantel Medical VITRA MULTISPOT

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:

January 23, 2013

1. Names
  Device Name:

VITRA MULTISPOT

Classification Name:

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

3. Predicate Device

Quantel Medical SUPRA SCAN™ Delivery System coupled to a SUPRA 532 . -(K100678)
Quantel Medical VITRA (K043236) -
OPTIMEDICA CORPORATION PASCAL Photocoagulator (K043486) -
OPTIMEDICA CORPORATION PASCAL Synthesis Delivery System -(K081744)

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4. Device Description

The Quantel Medical VITRA MULTISPOT Laser can be connected with the following delivery systems:

1. Scanning Laser Delivery System adaptor
1. Slit Lamp adaptor
1. Indirect ophthalmoscope adaptor

Output power from all these delivery systems are calibrated to deliver a maximum of 1.5 watts. The control box is a tactile LCD screen which is part of the main housing.

5. Indications for Use

The VITRA MULTISPOT Laser is indicated for use in the treatment of ocular pathology of anterior and posterior segments including, retinal photocoagulation and 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.

6. Substantial Equivalence

The VITRA MULTISPOT Laser shares the same intended use and safety compliance, similar design features, functional features, and therefore is substantially equivalent to the predicate devices, the PASCAL Photocoagulator (K043486) and Synthesis Delivery System (K081744), VITRA (K043236) and the Quantel Medical SUPRA SCAN™ Delivery System coupled to the SUPRA 532 (K100678). In addition, a review of the predicate devices demonstrates that the VITRA MULTISPOT Laser is substantially equivalent to the predicate

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devices as they share equivalent specifications / characteristics and are used to perform the same indicated surgical procedures.

7. Performance Data

Laboratory testing was conducted to validate and verify that the VITRA MULTISPOT Laser met all design specifications and was substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

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

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

January 24. 2013

Re: K122251

Trade/Device Name: VITRA MULTISPOT Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 12, 2012

Received: December 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Ms. Maureen O'Connell

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

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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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K122251

Device Name: YITRA MULTISPOT

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

Neil R Ogden 2013.01.23 14:36:51 -05'00'

mkm (Division Sign-Off) tor Division of Surgical Devices 510(k) Number K122251

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.