The VISULAS 532s Laser System with the VITE option is intended for use in retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including:

Proliferative and non-proliferative diabetic retinopathy .
Macular edema ◆
Branch and central retinal vein occlusion .
Lattice degeneration .
Retinal tears and detachments .

Device Description

The VISULAS 532s Laser System with the VITE option is an ophthalmic surgical laser intended for use in photocoagulating ocular tissues in treatment of diseases of the eye. As with the predicate device, laser energy for the proposed device is delivered via transpupillary delivery or intraocular endoprobe delivery. The VISULAS 532s Laser System with the VITE option includes an optional new laser slit lamp (the LSL 532s VITE) that features a multispot treatment cascade delivery option.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (VISULAS 532s Laser System with the VITE option). It establishes substantial equivalence by demonstrating that the new device has "the same intended use and technological characteristics as a predicate device," rather than by comparing it with specific acceptance criteria that must be met in a clinical study. Therefore, the requested information (performance table, sample sizes, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth types, and training set details) is largely not applicable in the context of this 510(k) summary.

The document states:

"The determination of substantial equivalence is based on the comparison between the results of performance data conducted using the VISULAS 532s with the VITE option and the predicate device. These results demonstrate the ability of the proposed device to produce photocoagulation of ocular tissues that is comparable to the photocoagulation produced by the predicate device."
"The VISULAS 532s Laser System with the VITE option is substantially equivalent to the predicate device, the VISULAS 532s Laser System (K013402)."

This indicates that the study performed was a nonclinical performance study comparing the new device against a predicate device, focusing on producing comparable photocoagulation, rather than meeting specific quantifiable performance metrics.

Here is a summary of what can be extracted from the provided text, while noting the limitations due to the nature of a 510(k) submission based on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is that the VISULAS 532s Laser System with the VITE option is substantially equivalent to the predicate device (VISULAS 532s Laser System, K013402) in terms of its ability to perform photocoagulation of ocular tissues. Specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are not provided or required for this type of submission.
Reported Device Performance: "These results demonstrate the ability of the proposed device to produce photocoagulation of ocular tissues that is comparable to the photocoagulation produced by the predicate device." No specific numerical performance values are given.

Acceptance Criterion	Reported Device Performance
Substantial Equivalence to predicate device (VISULAS 532s Laser System, K013402) based on comparable photocoagulation of ocular tissues.	The device demonstrates the ability to "produce photocoagulation of ocular tissues that is comparable to the photocoagulation produced by the predicate device." It is deemed "substantially equivalent."

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

Sample Size (Test Set): Not specified.
Data Provenance: Not specified, but given the nonclinical nature, it would likely involve experimental setups rather than human patient data from a specific country. The study was a "Brief Summary of Nonclinical Tests & Results."

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

Number of Experts/Qualifications: Not applicable for a nonclinical study comparing device output.

4. Adjudication method for the test set

Adjudication Method: Not applicable. The "study" refers to nonclinical performance data comparing the device's output to a predicate, not to an assessment of diagnostic or clinical accuracy requiring expert 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. This is a nonclinical submission for a laser surgical system, not an AI-assisted diagnostic or therapeutic device. No human readers or AI assistance are mentioned.

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

Standalone Performance: Not applicable. The device is a surgical laser system, not an algorithm. Its performance is inherent to its physical operation, with a human surgeon always in the loop.

7. The type of ground truth used

Type of Ground Truth: For the nonclinical performance data, the "ground truth" would implicitly be the established performance characteristics and outputs of the predicate device. The new device's output was compared for comparability.

8. The sample size for the training set

Sample Size (Training Set): Not applicable. This device is not an AI/ML model that requires a training set.

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

Ground Truth (Training Set) Establishment: Not applicable.

Summary

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510(K) SUMMARY

MAR 1 7 2010

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92(a).

SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE PREPARED

Carl Zeiss Meditec AG Applicant: a. Goeschwitzer Strasse 51-52 7740 Jena Germany
Judith A. Brimacombe Contact Person: b. Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 USA j.brimacombe(@meditec.zeiss.com Tel: (925) 557-4616 Fax: (925) 557-4259
November 20, 2009 c. Date Prepared:

NAME OF DEVICE, INCLUDING TRADE NAME & CLASSIFICATION NAME

VISULAS 532s Laser System with the VITE option Trade/Proprietary Name:
Common/Usual Name: Ophthalmic surgical laser
- Laser Instrument, Surgical, Powered
Classification Code: d.

Classification Name:

21 CFR §878.4810; 79 GEX

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100035

PREDICATE DEVICES

PREDICATE DEVICE	MANUFACTURER	510(K)CLEARANCENUMBER	CLEARANCE DATE
VISULAS 532s	Carl Zeiss Meditec AG	K013402	November 14, 2001
PASCALPhotocoagulator	OptiMedica Corporation	K043486	March 3, 2005
PASCAL SynthesisDelivery System	OptiMedica Corporation	K081744	September 9, 2008
PASCALPhotocoagulator	OptiMedica Corporation	K091966	July 15, 2009
PASCAL StreamlinePhotocoagulator	OptiMedica Corporation	K092621	September 25, 2009

DEVICE DESCRIPTION

STATEMENT OF INTENDED USE

The VISULAS 532s Laser System with the VITE option is intended for use in retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including:

Proliferative and non-proliferative diabetic retinopathy .
Macular edema ◆
Branch and central retinal vein occlusion .
Lattice degeneration .
Retinal tears and detachments .

TECHNOLOGICAL CHARACTERISTICS COMPARISON

The VISULAS 532s Laser System with the VITE option has the same operating characteristics and is substantially equivalent to the predicate VISULAS 532s Laser System, also by Carl Zeiss Meditec (K013402). Both the predicate and proposed devices deliver laser energy via the Laser Slit Lamp (LSL), the Laser Indirect Ophthalmoscope LIO 532 (for transpupillary delivery) or the endoprobe (for intraocular delivery). The primary

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106035

modification incorporated in the VISULAS 532s Laser System is the addition of an alternative laser slit lamp that is equipped with the VITE functionality, which allows the option of delivering a multi-spot treatment.

BRIEF SUMMARY OF NONCLINICAL TESTS & RESULTS

The VISULAS 532s Laser System with the VITE option has been designed and tested to applicable safety standards. The determination of substantial equivalence is based on the comparison between the results of performance data conducted using the VISULAS 532s with the VITE option and the predicate device. These results demonstrate the ability of the proposed device to produce photocoagulation of ocular tissues that is comparable to the photocoagulation produced by the predicate device.

CONCLUSION

The VISULAS 532s Laser System with the VITE option is substantially equivalent to the predicate device, the VISULAS 532s Laser System (K013402).

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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 image of an eagle or bird with its wings spread, rendered in a simple, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAR 1 7 2010

Carl Zeiss Meditec, Inc. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K100035

Trade/Device Name: VISULAS 532s Laser System with the VITE option Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology. Regulatory Class: Class II Product Code: GEX Dated: March 08, 2010 Received: March 09, 2010

Dear Mr. Job:

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 - Mr. Mark Job

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.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdaggv/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/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcestorYou/Industry/default.htm

Sincerely yours,

cerely yours,
for Peter Thum

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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510(k) Number (if known): _ | < | 066 > |

Device Name(s): VISULAS 532s Laser System with the VITE option

Indications for Use:

The VISULAS 532s Laser System with the VITE option is intended for use in retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including:

Proliferative and nonproliferative diabetic retinopathy .
. Macular edema
. Branch and central retinal vein occlusion
Lattice degeneration .
Retinal tears and detachments .

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

Over-The-Counter Use (21 CFR§ 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

l of 1 Page

Neil Rodda for mkm

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

510(k) Number K100035

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.