The VISULAS Trion is a diode-pumped, solid state, three-color laser system for green, yellow and red wavelengths, based upon the predicate VISULAS 532s (K013402). The VISULAS Trion laser system consists of the following components: Laser console as the source of laser radiation with detachable operating control panel, two fiber ports for application devices and a foot switch. Application devices for laser radiation delivery are offered via either transpupillary or intraocular delivery, laser slit lamp, laser indirect ophthalmoscope and endoprobes.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and a study demonstrating the device meets those criteria. Medical device 510(k) summaries typically focus on establishing substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the manner requested.

However, based on the information provided, here's what can be gathered or inferred about the device's intended use and the nature of the evaluation for substantial equivalence:

Device Information (VISULAS Trion)

Intended Use: Photocoagulation of ocular tissues for the treatment of diseases of the eye, including:
- Photocoagulation of the retina
- Trabeculoplasty for treatment of glaucoma
- Iridotomy for treatment of glaucoma
Operating Principle: Diode-pumped, solid-state, three-color laser system (green, yellow, red wavelengths).
Predicate Device: VISULAS 532s (K013402) by Carl Zeiss Meditec AG, among others.

Inferred Acceptance Criteria and Study Information (Based on 510(k) Process)

Since direct acceptance criteria and detailed study results are not presented in this 510(k) summary, the following sections will be largely speculative or based on the common practices for establishing substantial equivalence for devices like the VISULAS Trion.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred): For a laser photocoagulator, acceptance criteria would typically revolve around meeting established safety standards (e.g., IEC 60601-2-22 for medical laser equipment) and demonstrating equivalent performance characteristics to the predicate devices. These characteristics would likely include:
- Wavelength accuracy and stability
- Output power accuracy and stability
- Spot size accuracy and consistency
- Pulse duration accuracy and consistency
- Beam quality (e.g., divergence)
- Safety features (e.g., interlocks, emergency stop)
- biocompatibility of patient-contacting parts
- Electrical safety and electromagnetic compatibility (EMC)
- Reliability and durability
- Clinical effectiveness equivalent to predicate devices for the stated indications.
Reported Device Performance: The summary states: "Evaluation performed on the VISULAS Trion supports the indications for use statement and demonstrates the device is substantially equivalent to the predicate devices and does not raise new questions regarding safety and effectiveness." This indicates that the device's performance, as evaluated against the predicate devices and relevant standards, met the criteria for substantial equivalence. No specific quantitative performance metrics are provided in this summary.

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

Sample Size: Not explicitly stated. For substantial equivalence of a physical medical device like a laser, the "test set" would typically refer to the number of devices or components tested. This could involve bench testing, engineering verification, and potentially limited clinical data if necessary to address specific equivalence questions. However, the summary doesn't detail these numbers.
Data Provenance: The device manufacturer, Carl Zeiss Meditec AG, is based in Jena, Germany. Testing would likely have been conducted by the manufacturer, possibly at their facilities or through authorized testing houses. The nature of the submission (510(k)) and the device type (laser system) suggests that a significant portion of the data would be from bench testing and engineering verification/validation, rather than large-scale clinical trials in the way one might expect for a diagnostic AI device. Clinical data, if any, would likely be limited to demonstrate consistency with the predicate. It's not specified if data was retrospective or prospective beyond the internal testing.

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

This question is more applicable to diagnostic devices where human expert interpretation is crucial for ground truth. For a therapeutic laser device like the VISULAS Trion, "ground truth" would be established through objective physical measurements (e.g., power meters, beam profilers, spectrometers) and engineering validation against established specifications and predicate device performance. Clinical ground truth, if involved, would be based on established medical success criteria for the procedures (e.g., successful photocoagulation, IOP reduction post-trabeculoplasty), but the role of "experts establishing ground truth for a test set" in the context of substantial equivalence of the device's performance directly is not typically structured in this way.

4. Adjudication Method for the Test Set

Not applicable in the typical sense for a therapeutic device's performance validation for substantial equivalence. Adjudication methods (like 2+1, 3+1) are common in clinical trials or studies for diagnostic accuracy involving human readers. For the VISULAS Trion, performance is determined by objective physical measurements and engineering validation, not subjective expert agreement on a diagnosis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was NOT done. MRMC studies are specifically designed to evaluate the diagnostic accuracy of a new method/device (often AI) compared to human readers, and how human performance changes when aided by the device, usually with imaging data. The VISULAS Trion is a therapeutic laser, not a diagnostic imaging AI device. Its effectiveness is based on its ability to deliver precise laser energy for photocoagulation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The VISULAS Trion is a therapeutic laser system operated by a human clinician. It does not consist of a standalone "algorithm" in the way an AI diagnostic device would. Its performance is inherent in its engineering and physical output, which is then used by a human operator.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the VISULAS Trion's performance would primarily be objective physical measurements and engineering standards. This would include:
- Metrology: Using calibrated instruments to measure laser power, wavelength, spot size, pulse duration, and beam quality.
- Safety Standards: Compliance with international and national safety standards for medical electrical equipment and laser products (e.g., IEC 60601 series, IEC 60825 series).
- Predicate Device Performance Data: Direct comparison of critical performance parameters against those of the legally marketed predicate devices.
- Biocompatibility Testing: For patient-contacting components.
- Functional Testing: To ensure all operational modes and safety features work as designed.
"Pathology" or "outcomes data" might be part of post-market surveillance or larger clinical trials, but for a 510(k) of this nature, the primary ground truth for device performance is technical and engineering-based.

8. The Sample Size for the Training Set

Not applicable. The VISULAS Trion is a hardware-based medical device, not an AI or machine learning algorithm that requires a "training set" of data. Its design and development would involve engineering prototypes, design iterations, and testing, but not a data training set.

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

Not applicable for the same reason as point 8.

Summary

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510(K) SUMMARY

5. 510 (K) SUMMARY

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510 (k) SUMMARY (per 21 CFR §807.92)

VISULAS Trion

GENERAL INFORMATION

Name and Address of theApplicant:	Carl Zeiss Meditec AGGoeschwitzer Strasse 51-5207745 Jena, GermanyEst. Reg. No. 9615030
Official Correspondent:	Kent W. JonesVice President, RA/CA/QA/ComplianceCarl Zeiss Meditec Inc.5160 Hacienda DriveDublin, California 94568(925) 557-4353 (phone)(925) 557-4481 (fax)
Classification name:	Laser Instrument, Surgical, Powered
Classification:	Class II (acc. 21 CFR 878.4810)
Product Code:	GEX
Trade/Proprietary name:	VISULAS Trion
PREDICATE DEVICE
Company:Device:	Carl Zeiss Meditec AGVISULAS 532s (K013402)
Company:Device:	LumenisNovus® Varia™ Ophthalmic Laser and Delivery Devices(K022181)
Company:Device:	NidekMulti Color Laser Photocoagulator Model MC-300(K042785)

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INTENDED USE

The VISULAS Trion is intended for use in photocoagulating ocular tissues for the treatment of diseases of the eye, such as:

Photocoagulation of the retina .
Trabeculoplasty for treatment of glaucoma .
. Iridotomy for treatment of glaucoma.

The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.

DEVICE DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The VISULAS Trion is substantially equivalent to the predicate devices identified previously. The VISULAS Trion is substantially equivalent to the predicate devices with regard to intended use, operating principle, function, and materials.

Evaluation performed on the VISULAS Trion supports the indications for use statement and demonstrates the device is substantially equivalent to the predicate devices and does not raise new questions regarding safety and effectiveness.

SUMMARY

As described in this 510(k) Summary, all testing deemed necessary was conducted on the VISULAS Trion to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 2007

Carl Zeiss Meditec AG % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street Buffalo, MN 55313

Re: K072514 Trade/Device Name: VISULAS Trion 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: September 6, 2007 Received: September 7, 2007

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.

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 - Mr. Mark Job

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

PdOL
Mark N. Melkerson

Dr.
12-11-2

Mark N. Melkers Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: VISULAS Trion

The VISULAS Trion is intended for use in photocoagulating Indications for Use: ocular tissues for the treatment of diseases of the eye, such as:

Photocoagulation of the retina .
Trabeculoplasty for treatment of glaucoma .
Iridotomy for treatment of glaucoma. .

The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) المستقل التي تعاون القرار المستوى التي تعاون المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number	L072514

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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.