The CATALYS™ Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/ incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Device Description

Catalys™ Precision Laser System ophthalmic surgical laser system Device Description: used in healthcare facilities such as hospitals. Ambulatory Surgerv Centers (ASCs) and surgeon office settings. The System is an electromedical device which contains software. System components include a single-use Liquid Optics™ Interface and optional Mobile Patient Bed. The Catalys™ Precision Laser System (also referred to as the Catalys™ System or System) is an ophthalmic surgical laser system indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect lens fragmentation, thus facilitating efficient lens removal. The System also creates single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. The System employs femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics. The System utilizes a common optical path for the OCT and femtosecond treatment laser (including the threedimensional scanner and Liquid Optics™ [patient] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. Ocular surfaces recognized by the system software include anatomy within the anterior chamber, such as the anterior and posterior corneal surfaces and the anterior and posterior surfaces of the crystalline lens. Detailed axial or sagittal cross-sectional views are available via OCT, to demarcate proposed incisions versus adjacent ocular structures (for example, iris, pupil and limbus). The Catalys™ Precision Laser System laser classification per 21 CFR 1040.10 and 1040.11 is Class 4.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the CATALYS™ Precision Laser System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list quantitative acceptance criteria for the device's performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through technical characteristics and software changes.

The "reported device performance" is described qualitatively as "the System's ability to meet all intended design specifications related to the software design changes" and that "the System remains safe and effective for its intended use".

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

Sample Size for Test Set: Not explicitly stated. The document refers to "hardware and software bench tests" and "simulated use testing", but does not provide details on the number of tests or specific data samples used for these tests.
Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. The testing involved "bench testing" and "simulated use testing", suggesting a controlled environment rather than real-world patient data.

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

This information is not provided in the document. The testing described primarily focuses on technical and software verification, not clinical performance based on expert review of outcomes.

4. Adjudication Method for the Test Set

This information is not provided as the type of testing described (bench and simulated use) does not typically involve expert adjudication in the way clinical studies or image-based AI studies do.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Data was deemed not necessary for the Catalys™ Precision Laser System."

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

The device itself is a laser system with integrated software, not purely an algorithm that provides a diagnostic output. The "standalone" performance in this context would refer to the laser system's ability to execute its functions (capsulotomy, phacofragmentation, corneal cuts) according to its design specifications.

The document states, "Software verification and validation testing in addition to bench testing was performed to verify the ability of the software to meet its intended use and to ensure that no adverse effects have been introduced due to the software change." This implies standalone testing of the software's functionality within the system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance data appears to be based on engineering and design specifications. The software's ability to meet its "intended design specifications" was verified. For the laser's physical actions, the ground truth would be precise measurements of the cuts/fragmentation against pre-defined parameters.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is a laser system, not an AI model trained on a large dataset in the conventional sense (e.g., for image analysis). The software updates are for workflow efficiency, astigmatism management, and iris registration, which are likely based on engineering development and calibration rather than machine learning training sets.

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

This information is not applicable/not provided for the same reasons as point 8.

Summary

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April 12, 2023

AMO Manufacturing USA, LLC Laarni Ricafort Manager, Regulatory Affairs 510 Cottonwood Drive Milpitas, CA 95035

Re: K223838

Trade/Device Name: Catalys™ Precision Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE Dated: March 10, 2023 Received: March 14, 2023

Dear Laarni Ricafort:

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.

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

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(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/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

J Angelo Green -S

Image /page/1/Picture/6 description: The image contains the letters '-S' on the left side of the image. To the right of the letters is the acronym 'FDA' in a light blue color. The letters are large and take up a significant portion of the image.

for Tieuvi Nguyen, Ph.D. Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223838

Device Name CATALYSTM Precision Laser System

Indications for Use (Describe)

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)

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510(k) SUMMARY

The following 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92

510(k) Summary:	K223838
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[807.92(a)(1)] Submitter Information

Sponsor/Submitter:	AMO Manufacturing USA, LLC510 Cottonwood DriveMilpitas, CA 95035 USAPhone 408-273-5166Fax:408 273-5966
Contact Person:	Laarni RicafortManager, Regulatory AffairsEmail: lricafor@its.jnj.comPhone: 408-273-4016Fax: :408 273-5966
Date Summary Prepared:	April 10, 2023

[807.92(a)(2)] Name of Device

Device Trade Name:	CATALYST™ Precision Laser System
Common Name:	Opthalmic laser
Device Classification:	Class II
Regulation Number:	21 CFR 886.4390
Classification Name:	Opthalmic Femtosecond Laser
Product Code:	OOE

[807.92(a)(3)] Legally Marketed Devices

Predicate Device:	CATALYST™ Precision Laser SystemK200056; cleared May 18, 2020
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[807.92(a)(4)] Device Description

[807.92(a)(5)] Intended Use

The Catalys™ Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Indications for Use:

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The Catalys™ Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior Difference in capsulotomy, phacofragmentation, and the creation of single Indications from plane and multi-plane arc cuts/incisions in the cornea, each of Predicate Device which may be performed either individually or consecutively during the same procedure. The subject device and the predicate device have the same indications for use. [807.92(a)(6)] Technical Characteristics The subject Catalys Precision Laser System is unchanged in regard to its technological characteristics, indications for use, and intended uses. The software revisions for the subject device include updates to the graphical user interface and host to improve the efficiency of the workflow as well as the addition of software modules to support the import of patient exams and iris registration. The revisions in the modified device are constrained to only software changes, of which most are related to advanced astigmatism management and additional updates to currently implemented features. Technological Software verification and validation testing in addition to bench Characteristics: testing was performed to verify the ability of the software to meet its intended use and to ensure that no adverse effects have been introduced due to the software change. This testing included subsystem level verification and regression testing as well as system validation using the latest software, Mobile Patient Bed, and Liquid Optics Interface. The following table provides a comparison of the predicate device and subject device for the purpose of demonstrating substantial equivalence to the predicate device for its indication for use, intended use, technological characteristics and added new features.

Similarities and Differences Between Cleared Predicate Device and Subject Device

Attribute	Predicate DeviceCatalys Precision LaserSystem	Subject DeviceCatalys Precision LaserSystem
510(k) Number	K200056	TBD
Regulation Number	886.4390	Same
Attribute	Predicate DeviceCatalys Precision LaserSystem	Subject DeviceCatalys Precision LaserSystem
Regulation Name	Ophthalmic Laser	Same
Regulatory Class	Class II	Same
Product Code	OOE	Same
Indications for Use	The Catalys™ Precision LaserSystem is indicated for use inpatients undergoing cataractsurgery for removal of thecrystalline lens. Intended uses incataract surgery include anteriorcapsulotomy,phacofragmentation, and thecreation of single plane andmulti-plane arc cuts/incisions inthe cornea, each of which maybe performed either individuallyor consecutively during thesame procedure.	Same
System Type	Ophthalmic Femtosecond Laserwith Spectral Domain OCT	Same
Laser Mechanism of Action	Plasma, Cavitation	Same
Treatment Laser Wavelength(nm)	$1030 \pm 5$	Same
Output Power, Max	Per ISO 15004-2:2007 limits	Same
Maximum Pulse Energy (µJ)	10	Same
Repetition Rate (kHz)	9-120	Same
Pulse Duration (fs)	< 600	Same
Spot Size; diameter (µm)	5	Same
System controls	Microprocessor with GraphicalUser Interface	Same
Patient Contact Interface	Suction-ring type interfacedevices (marketed as LiquidOptics™ Interface) Sterile andSingle-use	Same
Attribute	Predicate DeviceCatalys Precision LaserSystem	Subject DeviceCatalys Precision LaserSystem
LOI Suction Ring SealDiameters (mm)	LOIExternal (mm): 21.6Internal (mm): 14.1	Same
	LOI-12External (mm):19Internal (mm):12	Same
	0180-1401External (mm): 21.6Internal (mm): 14.1	Same
	0180-1201External (mm): 19Internal (mm): 12	Same
OCT Axial Resolution (µm)	30	Same
OCT transverse Resolution(µm)	15	Same
Scan speed (A-scans/sec)	1000	Same
A-scan depth (nm)	2	Same
Optical Source	820-930	Same
Optical Power	ANSI Class 1 < 3.48mW atcornea	Same
Iris Imaging	Live iris view	Same
Trajectory TimingSynchronization	FPGA coordinates from onenon-reentrant VI	Same
Communication Method forWatchdog for Host PC withthe Mobile Patient BedPairing	Direct FPGA Interface	Same
Attribute	Predicate DeviceCatalys Precision LaserSystem	Subject DeviceCatalys Precision LaserSystem
Software Features	Built-in Nomogram	Addition of Stevens nomogram
	Toric Alignment Marks	Toric Mark Axis Calculator
	Lens Fragmentation Alignment	Additional Nomogramcustomizations
	Pre-op Manual Entry
	Pre-op Import (from Cassinipre-op device)	Pre-op Import (from IOLMaster700 pre-op device)
	Iris Registration (built byCassini Technologies)	Iris Registration (built byJohnson and Johnson)

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[807.92(b)(1)] Determination of Substantial Equivalence

	The cOS 7.0 software within the subject device was subjected tohardware and software bench tests, in conjunction with simulateduse testing.
	Software-specific bench testing of the CatalysTM System wasconducted to demonstrate the System's ability to meet allintended design specifications related to the software design
Non-ClinicalPerformance Data:	changes.
	Bench testing of the predicate device is directly applicable to thesubject device as there are no significant changes to the subjectdevice other than the design changes resident in the software.
	Bench testing, when coupled with software regression testing,verification and validation testing presented for the subjectdevice, including regression testing provides reasonableassurance that the System remains safe and effective for itsintended use and furthermore, that it is substantially equivalent tothe identified predicate device

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Clinical PerformanceData:	Clinical Data was deemed not necessary for the Catalys™Precision Laser System. The performance data demonstrated thatthe device performs as intended.The subject device does not include any changes to theindications for use or intended use of the predicate device. It doesnot introduce any new harms or unacceptable risks, and thereforedoes not require clinical testing to assess safety and performanceor to demonstrate equivalence.
[807.92(b)(3)] Conclusion
Conclusions from Non-Clinical and ClinicalTests:	The subject Catalys Precision Laser System is substantiallyequivalent to the currently cleared Catalys Precision LaserSystem. The subject Catalys Precision Laser System issubstantially equivalent to the predicate in terms of indicationsfor use, technological characteristics and fundamental scientifictechnology. The mechanism of laser cutting is the same for bothsystems, in that the ultra-short laser pulses create a highlylocalized plasma and subsequent cavitation event that, whencontrolled by a computerized scanning system, direct the laserbeam through a three-dimensional pattern to produce a precisecapsulotomy, fragment the crystalline lens and create arccuts/incisions in the cornea.

Clinical PerformanceData:

Clinical Data was deemed not necessary for the Catalys™Precision Laser System. The performance data demonstrated thatthe device performs as intended.The subject device does not include any changes to theindications for use or intended use of the predicate device. It doesnot introduce any new harms or unacceptable risks, and thereforedoes not require clinical testing to assess safety and performanceor to demonstrate equivalence.

[807.92(b)(3)] Conclusion

Conclusions from Non-Clinical and ClinicalTests:

The subject Catalys Precision Laser System is substantiallyequivalent to the currently cleared Catalys Precision LaserSystem. The subject Catalys Precision Laser System issubstantially equivalent to the predicate in terms of indicationsfor use, technological characteristics and fundamental scientifictechnology. The mechanism of laser cutting is the same for bothsystems, in that the ultra-short laser pulses create a highlylocalized plasma and subsequent cavitation event that, whencontrolled by a computerized scanning system, direct the laserbeam through a three-dimensional pattern to produce a precisecapsulotomy, fragment the crystalline lens and create arccuts/incisions in the cornea.

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.