With an endocular probe – for intraocular retinal photocoagulation as an adjunct to vitrectomy surgery (and not the sole indication for vitrectomy) in the management of complicated rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy.

With a slit Lamp - for the treatment of proliferative diabetic retinopathy, choroidal neovascularization secondary to age-related macular degeneration, and retinal detachments.

Device Description

The Quantel Vitra Ophthalmic Laser Photocoagulator is a Nd:YAG frequency doubled laser with a KTP crystal which emits a beam of coherent light at 532 nm. The energy is delivered to the treatment site(s) via delivery systems/devices.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, focusing on acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not applicable.	Not applicable.

Explanation: This 510(k) submission (K043236) is for a modified indication for use for an existing device, the Quantel Vitra Ophthalmic Laser Photocoagulator, and is based on substantial equivalence to predicate devices. For this type of submission for a laser device, quantitative performance criteria (like accuracy, sensitivity, specificity, etc., typically seen with diagnostic or AI-powered devices) are not required or provided. Instead, the acceptance criteria are implicitly that the modified indications are safe and effective, and that the device operates fundamentally similarly to its predicates for these expanded uses. The "Performance Data: None required" statement explicitly confirms this.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable.
Data Provenance: Not applicable.

Explanation: No clinical study involving a test set of patient data was conducted or required for this 510(k) submission. The submission relies on a comparison to legally marketed predicate devices to establish substantial equivalence for the expanded indications.

3. 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)

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

Explanation: As no test set data was used, no ground truth establishment by experts was necessary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable.

Explanation: No test set data was used to require adjudication.

5. 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

MRMC Study: No.
Effect Size: Not applicable.

Explanation: This device is an ophthalmic laser, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant to this submission.

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

Standalone Study: Not applicable.

Explanation: This device is a treatment device (laser photocoagulator), not an algorithm. Furthermore, it operates with a human operator (ophthalmologist) in the loop, directly controlling the energy delivery.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not applicable.

Explanation: No clinical data or test sets requiring ground truth were used in this submission. The "ground truth" for proving safety and effectiveness relies on the established safety and effectiveness of the predicate devices for similar applications, demonstrating that the Vitra laser operates within similar parameters and delivers similar therapeutic effects.

8. The sample size for the training set

Sample Size for Training Set: Not applicable.

Explanation: This is a hardware device (laser) and not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Ground Truth Establishment for Training Set: Not applicable.

Explanation: No training set was used.

Summary

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FEB - 7 2005

510(k) SUMMAR Y

KO 43236

This 510(k) summary of safety and effectiveness for the modification in the Indications for Use for the Vitra Ophthalmic Laser Photocoagulator is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

Applicant:	Quantel Medical
Address:	QUANTEL MEDICAL21 rue NewtonZ.I. du Br 'zet63039 Clermont-FerrandCedex 2FRANCE+33 (0)473 745 745+33 (0)473 745 700 (Fax)
Contact Person:	Mr. Jean AbascalRegulatory Affairs Manager(+33) 169 29 17 25(+33) 169 29 17 29

Preparation Date: November 2004 (of the Summary)

Device Name: Quantel Vitra Ophthalmic Laser Photocoagulator

Common Name: Ophthalmic Laser, frequency doubled Nd: YAG (532 nm) laser Laser Surgical Instrument, frequency doubled Nd: Y AG (532 nm) laser
Ophthalmic laser (see 21 CFR 886.4390) Classification

Product Code: HQF; Panel: 86

Name:

Predicate devices: B.V.I. Viridis Laser (K960867); Novus Verdi Laser and Delivery Systems (K991258), Carl Zeiss Visulas 532s (K013402), and the 532 nm laser of the Quantel Viridis Twin Laser (K023464).
Device description: The Quantel Vitra Ophthalmic Laser Photocoagulator is a Nd:YAG frequency doubled laser with a KTP crystal which emits a beam of coherent light at 532 nm. The energy is delivered to the treatment site(s) via delivery systems/devices.

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Indications: The Vitra Ophthalmic Laser Photocoagulator is indicated for retinal photocoagulation in the following conditions:
With an indirect ophthalmoscope - for peripheral photocoagulation for the treatment of proliferative diabetic retinopathy and retinal detachments.

With a slit Lamp - for the treatment of proliferative diabetic retinopathy, choroidal neovascularization secondary to age-related macular degeneration, and retinal detachments.

Performance Data: None required.

CONCLUSION: Based on the information in this notification Quantel Medical concludes that the Vitra Ophthalmic Laser Photocoagulator is substantially equivalent to the cited legally marketed predicates. 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.

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 7 2005

Quantel Medical c/o Mr Roger Barnes 342 Sunset Bay Road Hot Springs, Arkansas 71913

Re: K043236

Ko+5230
Trade/Device Name: Quantel Vitra Ophthalmic Laser Photocoagulator Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: II Product Code: HQF Dated: November 19, 2004 Received: November 22, 2004

Dear Mr. Barnes:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regary the enactment date of the Medical Device Amendments, or to comments provided in accordance with the provisions of the Federal Food. Drug. devices may been receissined in assee approval of a premarket approval application (PMA). alla Cosment Act (Act) that do not require approvisions of the general controls provisions of the Act. The I ou may, dicierore, market the act include requirements for annual registration, listing of general controls provisions of tax tice, 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 If your device is elassinod (600 as controls. Existing major regulations affecting your device can may oc subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be fourther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I Dr o locan that your device complies with other requirements of the Act that I DA has made a determissions administered by other Federal agencies. You must of any I cacal statutes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr Roger Barnes

This letter will allow you to begin marketing your device as described in your Section 510(k)
10 1legal This letter will allow you to begin maketing your active of your device of your device to a legally premarket notification. The FDA midnig of substantal equive 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
rs the results of the may of 10, 276 0115. All as a loca note the requilati If you desire specific advice for your ac vice on our nooming the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please note the regulation o contact the Office of Colliphalice at (240) 270 - 131 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). "Misbranding by reference to premarket nonfication" (1733 Act from the Division of Small
other general information on your responsibilities under the Act from the (800) 638-2 other general information on your responsionner Assistance at is toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at is toll-free which Manufacturers, Internet address http://www.fda.cov/cdrb/industry/support/index.html.

Sincerely yours,

Mark A. Milliken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological 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): _ K043236

Device Name: Quantel Vitra Ophthalmic Laser Photocoagulator

Indications for Use Statement:

The Vitra Ophthalmic Laser Photocoagulator is indicated for retinal photocoagulation in the following conditions:

With an indirect ophthalmoscope -- for peripheral photocoagulation for the treatment of proliferative diabetic retinopathy and retinal detachments.

With a slit Lamp - for the treatment of proliferative diabetic retinopathy, choroidal neovascularization secondary to age-related macular degeneration, and retinal detachments.

(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 General, Restorative,
and Necrological Devices

036

510(k) Number K04

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.