VISULAS green is intended for use in photocoagulation of tissues in the posterior and anterior segments of the eye including trabeculoplasty and iridotomy.

Device Description

VISULAS green is an ophthalmic laser with a 532 nm wavelength used for standard photocoagulation treatments of ocular tissue. VISULAS green is operated in single-spot mode or in multi-spot mode.

VISULAS green consists of a laser console, touch control panel, optional laser light applicators such as laser slit lamp or laser indirect ophthalmoscope, foot switch and instrument table. The device can also be used with various accessories, such as laser endoprobes, or the SL cam 5.0.

AI/ML Overview

The provided document is a 510(k) premarket notification for the VISULAS green ophthalmic laser system. It describes the device, its intended use, and a comparison to a predicate device (VISULAS 532s Laser System).

It is crucial to understand that this document does not describe a study involving an AI/machine learning device or a comparative effectiveness study with human readers assisting AI. This 510(k) submission is for a conventional medical device (a laser system) and focuses on demonstrating substantial equivalence to a legally marketed predicate device based on technological characteristics, safety standards, and intended use.

Therefore, many of the requested points regarding acceptance criteria and studies for AI/ML performance, such as sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, and training set details, are not applicable to this document as it does not concern an AI/ML device.

However, I can extract information related to the acceptance criteria and performance data for this specific medical device as presented in the document:

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

Based on the document, the "acceptance criteria" are not framed as quantitative performance metrics for a diagnostic or AI device. Instead, they are compliance with established safety and performance standards for a laser system and demonstration of substantial equivalence to a predicate device.

Acceptance Criterion (Compliance with Standards/Equivalence to Predicate)	Reported Device Performance/Compliance
Biocompatibility	Materials and manufacturing are identical to the predicate device and currently marketed devices. No new biocompatibility testing needed.
Laser Safety	Complies with: - IEC 60825-1:2007 - IEC 60601-2-22:2012
Electrical Safety	Complies with: - ANSI/AAMI ES60601-1:2005/(R)2012 - IEC 60601-1-2:2014 - IEC 62133: 2012
Electromagnetic Compatibility (EMC)	Complies with: - IEC 60601-1-2:2014
Software Verification & Validation	Software is considered "Major" level of concern. Verification and validation testing conducted as per FDA guidance. Documentation provided. Device works as designed.
Technological Equivalence to Predicate (VISULAS 532s)	Same laser type (solid state, frequency-doubled), wavelength (532 nm), power range (50-1500 mW), pulse length (10-2500 ms and cw), repeat mode, laser spot size settings (50-1000 µm), aiming beam (620-650 nm), types of laser applicators, and multi-spot treatment mode.
Indications for Use Equivalence to Predicate	VISULAS green is intended for use in photocoagulation of tissues in the posterior and anterior segments of the eye, including trabeculoplasty and iridotomy. This is within the same intended use as the predicate and does not raise different questions of safety and effectiveness.
Principle of Operation Equivalence to Predicate	Both devices operate on the principle of photocoagulation (continuous wave operation where thermal energy from laser absorption causes coagulation).

2. Sample size used for the test set and the data provenance

Not applicable. This submission is for a conventional laser device, not an AI/ML diagnostic. Performance was demonstrated through compliance with recognized standards and comparison to a predicate, not through a clinical test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No test set requiring expert ground truth for an AI/ML diagnostic was performed or described.

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

Not applicable. No test set requiring adjudication was performed or described.

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

No. An MRMC study was not done because this is not an AI-assisted device.

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

No. This is not an algorithm-only device. It is a physical laser system.

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

Not applicable. As a conventional laser device, the "ground truth" related to its performance is established by its compliance with industry safety standards (e.g., laser power output accuracy, electrical safety, EMC) and demonstration that its operating principles and technological characteristics are equivalent to a well-established predicate device. There is no diagnostic "ground truth" for patient data in this context.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML device.

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

Not applicable. This device does not involve a training set.

In summary, the provided document is a 510(k) premarket notification for a Class II ophthalmic laser device. The "acceptance criteria" and "study" described pertain to demonstrating safety, functional performance, and substantial equivalence to a predicate device, primarily through compliance with established industry standards (e.g., IEC, ANSI) and direct comparison of technical specifications. It does not involve AI/ML technology, and therefore, many of the questions related to AI device performance evaluation are not relevant to this submission.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 6, 2019

Carl Zeiss Meditec AG % Lisa Granev Senior Consultant Biologics Consulting Group, Inc. 1555 King Street. Suite 300 Alexandria, VA 22314

Re: K181682

Trade/Device Name: VISULAS green Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HOF Dated: January 31, 2019 Received: January 31, 2019

Dear Lisa Graney:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours, Alexander Beylin -S 2019.03.06 10:50:35 -05'00' for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K181682

Device Name VISULAS green

Indications for Use (Describe)

VISULAS green is intended for use in photocoagulation of tissues in the posterior and anterior segments of the eye including trabeculoplasty and iridotomy.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92), the 510(k) Summary for VISULAS green is provided below.

1. SUBMITTER

Applicant:	Carl Zeiss Meditec AGGoeschwitzer Strasse 51-52D-07745 JenaGermanyPhone: +49 3641 2200
Contact:	Dr. Christian MünsterDirector Regulatory and Clinical AffairsPhone: +49 7364 20 6985christian.muenster@zeiss.com
Submission Correspondent:	Lisa GraneySenior ConsultantBiologics Consulting Group1555 King Street, Suite 300Alexandria, VA 22314lgraney@biologicsconsulting.com)Phone: (571) 777-9518Fax: (703) 548-7457
Date Prepared:	June 25 2018

2. DEVICE

Device Trade Name:	VISULAS green
Device Common Name:	Laser, Ophthalmic
Classification Name	21 CFR 886.4390, Ophthalmic Laser
Regulatory Class:	Class II
Product Code:	HQF

3. PREDICATE DEVICE

Predicate Device:

VISULAS 532s Laser System with the VITE option (K100035)

{4}------------------------------------------------

DEVICE DESCRIPTION 4.

VISULAS green is an ophthalmic laser with a 532 nm wavelength used for standard photocoagulation treatments of ocular tissue. VISULAS green is operated in single-spot mode or in multi-spot mode.

ડ. INTENDED USE/INDICATIONS FOR USE

VISULAS green is intended for use in photocoagulation of tissues in the posterior and anterior segments of the eye, including trabeculoplasty and iridotomy.

TECHNOLOGICAL COMPARISON 6.

A technological comparison between the subject and predicate devices is shown in Table 1. The cited predicate device is VISULAS 532s Laser System with the VITE option (herein after called VISULAS 532s), cleared under K100035.

{5}------------------------------------------------

	VISULAS green	VISULAS 532s
K number	Subject Device	K100035
Legal manufacturer	Carl Zeiss Meditec AG	Carl Zeiss Meditec AG
Indications for Use Statement	VISULAS green is intended for use in photocoagulating oculartissues in the treatment of diseases of the eye, includingtrabeculoplasty and iridotomy.	The VISULAS 532s Laser System with the VITE option isintended for use in retinal, pan-retinal, focal and gridphotocoagulation of ocular tissues in the treatment of diseases ofthe eye including:-Proliferative and non-proliferative diabetic retinopathy-Macular edema-Branch and central retinal vein occlusion-Lattice degeneration-Retinal tears and detachments
	General Laser Specifications
Laser type	solid state laser, frequency-doubled	solid state laser, frequency-doubled
Wavelength	532 nm	532 nm
Power (cw laser)	50 to 1500 mW	50 to 1500 mW
Length of pulse	10 - 2500 ms and cw	10 - 2500 ms and -cw
Repeat Mode	Yes	Yes
Laser spot size settings	50 μm to 1000 μm	50 μm to 1000 μm
Aiming beam	620-650 nm	620-650 nm
Types of laser applicators	LSL, VISULINK 532/U, Endoprobes, LIO	LSL, VISULINK 532/U, Endoprobes, LIO
Multi spot treatment mode	Yes	Yes
Conditions of Use
Site in the body	Eye	Eye
Principle of operation	Photocoagulation of ocular tissue	Photocoagulation of ocular tissue

Table 1. Technological characteristics comparison table of VISULAS green and VISULAS 532s

{6}------------------------------------------------

VISULAS green and the predicate device are intended as ophthalmic lasers for photocoagulation. The indications for use are within the same intended use as the predicate device and do not raise different questions of safety and effectiveness.

VISULAS green and the predicate laser system have minor parameter differences but share the same fundamental principle of operation:

Photocoagulation: Continuous wave operation in which thermal energy created by the absorption of the laser energy by ocular tissue causes coagulation.

VISULAS green is substantially equivalent to the predicate laser system presented in the 510(k) premarket notification with respect to indications for use and technological characteristics. Differences between the subject device and the predicate device do not raise any new issues of safety or effectiveness.

7. PERFORMANCE DATA

Biocompatibility Testing

The materials and manufacturing of the subject device is identical to the predicate device and currently marketed devices. Therefore, no new biocompatibility testing is needed for this device.

Laser safety, electrical safety and electromagnetic compatibility (EMC)

VISULAS green was evaluated against the following requirements and was found to comply with:

ANSI/AAMI ES60601-1:2005/(R) 2012 ●
IEC 60601-1-2:2014 ●
ANSI Z80.36:2016 ●
. IEC 60825-1:2007
IEC 60601-2-22:2012
IEC 62133: 2012 ●

Software Verification and Validation Testing

The software of this device is considered as a "Major" level of concern. Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Verification and validation of VISULAS green demonstrated that the product works as designed.

Bench Testing

Not Applicable. Bench testing was not necessary to establish the substantial equivalence of this device.

{7}------------------------------------------------

Animal Testing

Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.

Clinical Data

Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.

CONCLUSION 8.

The VISULAS green is substantially equivalent to the predicate device, VISULAS 532s (K100035).

The VISULAS green is similar in technological characteristics, performance, principles of operation (photocoagulation) and has similar indications for use as the predicate device. Any differences between the proposed device and the predicate device do not raise any new issues of safety or effectiveness. Thus VISULAS green is substantially equivalent to the predicate device.

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.