Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a laser system controlled by dedicated electronics and software, utilizing OCT for imaging and guidance. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The software testing described is standard verification and validation, not indicative of AI/ML development or evaluation.

Therapeutic

Yes
The device is described as an "ophthalmic surgical laser system" that assists in cataract surgery by performing anterior capsulotomy, phacofragmentation, and creating corneal incisions, all of which are medical procedures aimed at treating a health condition (cataracts).

Diagnostic

No

The device is an ophthalmic surgical laser system used for treatment (cataract surgery procedures), not for diagnosing conditions. While it uses OCT for imaging, the imaging is for guiding the surgical procedure, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "electromedical device" and lists hardware components like a laser system, OCT, and a Liquid Optics™ Interface. While it contains software, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Device Function: The CATALYS™ Precision Laser System is a surgical laser system used directly on the patient's eye during cataract surgery. It performs procedures like capsulotomy, phacofragmentation, and corneal incisions.
Lack of Specimen Analysis: The device does not collect, prepare, or analyze any specimens taken from the patient's body. Its function is to perform a surgical procedure on the patient's body.

Therefore, the CATALYS™ Precision Laser System falls under the category of a surgical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

OOE

Device Description

Catalys™ Precision Laser System ophthalmic surgical laser system 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 three-dimensional 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Optical Coherence Tomography ("OCT")
Iris Imaging: Live iris view

Anatomical Site

Anterior chamber, anterior and posterior corneal surfaces, anterior and posterior surfaces of the crystalline lens, iris, pupil and limbus.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare facilities such as hospitals. Ambulatory Surgerv Centers (ASCs) and surgeon office settings.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 testing included subsystem level verification and regression testing as well as system validation using the latest software, Mobile Patient Bed, and Liquid Optics Interface.

Non-Clinical Performance Data: The cOS 7.0 software within the subject device was subjected to hardware and software bench tests, in conjunction with simulated use testing. Software-specific bench testing of the CatalysTM System was conducted to demonstrate the System's ability to meet all intended design specifications related to the software design changes. Bench testing of the predicate device is directly applicable to the subject device as there are no significant changes to the subject device other than the design changes resident in the software. Bench testing, when coupled with software regression testing, verification and validation testing presented for the subject device, including regression testing provides reasonable assurance that the System remains safe and effective for its intended use and furthermore, that it is substantially equivalent to the identified predicate device.

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K200056

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

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

1

(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)

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.

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
-----------------	---------

[807.92(a)(1)] Submitter Information

| Sponsor/Submitter: | AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035 USA
Phone 408-273-5166
Fax:408 273-5966 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Laarni Ricafort
Manager, Regulatory Affairs
Email: lricafor@its.jnj.com
Phone: 408-273-4016
Fax: :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 System
K200056; cleared May 18, 2020 |

-------------------	-------------------------------------------------------------------

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[807.92(a)(4)] 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.

[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:

5

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 Catalys Precision Laser
System Catalys Precision Laser
System |
|---------------------- | 510(k) Number | Regulation Number | Attribute Catalys Precision Laser
System Catalys Precision Laser
System |
| Regulation Name | Regulatory Class | Product Code | Indications for Use 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. | Same | System Type with Spectral Domain OCT | Laser Mechanism of Action | Treatment Laser Wavelength
(nm) | Output Power, Max | Maximum Pulse Energy (µJ) | Repetition Rate (kHz) | Pulse Duration (fs) | Predicate Device
| Subject Device
----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| K200056 | TBD |
| 886.4390 | Same |
| Predicate Device
| Subject Device
| Ophthalmic Laser | Same |
| Class II | Same |
| OOE | Same |
| The Catalys™ Precision Laser
|
| Ophthalmic Femtosecond Laser
| Same |
| Plasma, Cavitation | Same |
| $1030 \pm 5$ | Same |
| Per ISO 15004-2:2007 limits | Same |
| 10 | Same |
| 9-120 | Same |
|