The OptiMedica® 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

The Catalys Precision Laser System ("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).

AI/ML Overview

This document describes a 510(k) premarket notification for the "Catalys Precision Laser System" (K172002). The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K170322). The changes primarily involve an upgraded software version (cOS 5.0) and the addition of a Mobile Patient Bed.

Based on the provided text, the following information can be extracted/inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical performance metrics for an AI/algorithm-based device. Instead, it focuses on demonstrating that the updated "Catalys Precision Laser System" with cOS 5.0 and the Mobile Patient Bed continues to meet its intended design specifications and performs as intended.

The acceptance criteria are implicitly related to the device's ability to "deliver incisions as intended" and continue to provide the functions (anterior capsulotomy, phacofragmentation, corneal incisions) with appropriate accuracy and precision, as established during the clearance of the predicate device (K170322).

Reported Device Performance:

"Bench testing demonstrated that subject device with cOS 5.0 continues to deliver incisions as intended."
"Bench testing of the predicate device with regards to the ability to deliver a variety of laser patterns intended for capsulotomy, phacofragmentation and corneal incisions with corresponding accuracy and precision is directly applicable to the subject device as there are no significant changes to the subject device other than the software change and the use of the Mobile Patient Bed with the Catalys Precision Laser System."
The system complies with laser classifications per 21 CFR 1040.10 and 1040.11, and Class 4 lasers per ANSI Z136.1-2007.
Biocompatibility testing confirmed the Mobile Patient Bed upholstery meets ISO 10993-1 requirements.
Electrical safety and EMC testing ensured compliance with electrical safety standards.

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

The document primarily describes bench testing and design validation. It does not mention clinical studies or test sets involving patient data (images, clinical records, etc.) in the context of an AI algorithm's performance on such data. The testing described is focused on the device's functional performance, hardware, and software.

No specific sample size for a "test set" of patient data is provided, as the studies are not evaluating diagnostic or prognostic AI performance on patient data.
The data provenance is from bench testing activities (e.g., software-specific bench testing, hardware-specific bench testing of the Mobile Patient Bed) rather than patient data. The country of origin of this testing is not explicitly stated, but the applicant (AMO Manufacturing USA, LLC) is based in Milpitas, CA, USA. The testing appears to be prospective in nature, conducted specifically for this submission.

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

As the studies described are bench tests of hardware and software functionality and safety, and not an evaluation of an AI algorithm on patient data, the concept of "ground truth" derived from experts' review of patient data is not applicable here. The "ground truth" for these tests would be the design specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable as there is no mention of a test set involving human interpretation of data requiring adjudication.

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

No, an MRMC comparative effectiveness study is not mentioned. This submission is for a laser surgical system, not a diagnostic or decision-support AI intended to assist human readers in interpreting medical cases.

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

The device is a "Precision Laser System" that employs "femtosecond laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics." It has "system software" (cOS 5.0) that "recognizes ocular surfaces" and uses "a computerized scanning system" to direct the laser.

While the system has automated functions and software, the description does not position it as a standalone AI algorithm in the sense of a diagnostic or prognostic tool that processes data independently to produce an output for human review in a clinical decision-making pathway. It's an automated surgical device. The "standalone" performance described is the system's ability to fulfill its intended surgical actions (capsulotomy, phacofragmentation, corneal cuts) based on its programming, without direct human intervention in each laser pulse, but still under the supervision and operation of a surgeon.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" is defined by:

Design specifications: The intended performance parameters and requirements of the device.
Regulatory standards: Compliance with standards like 21 CFR 1040.10, 1040.11, ANSI Z136.1-2007, and ISO 10993-1.
Predicate device performance: The previously cleared performance of the K170322 system serves as a baseline for "accuracy and precision" in delivering laser patterns.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning. The software (cOS 5.0) for this device is described as an "upgraded software version" to provide "compatibility" and ensure continued performance, rather than a learning algorithm trained on a dataset.

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

Not applicable, as a machine learning training set is not described. The "ground truth" for the software's functionality would be its adherence to engineering specifications and safe operation relative to the established performance of the predicate device.

Summary

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August 25, 2017

Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

AMO Manufacturing USA, LLC Anita Xavier Senior Specialist, Regulatory Affairs 510 Cottonwood Drive Milpitas, CA 95035

Re: K172002

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: July 5, 2017 Received: July 6, 2017

Dear Anita Xavier:

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.

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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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) 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. 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 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 Industry and Consumer Education (DICE) 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.

Sincerely,

Denise L. Hampton -S

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

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Indications for Use

510(k) Number:	K172002
Device Name:	Catalys Precision Laser System
Indications for Use:	The OptiMedica® 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.

510(k) Number:

K172002

Device Name:

Catalys Precision Laser System

Indications for Use:

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

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

Applicant

AMO Manufacturing USA, LLC 510 Cottonwood drive, Milpitas, CA 95035 Phone: 408.733.2020

Contact Person

Anita Xavier Senior Regulatory Affairs Specialist Abbott Medical Optics Inc., 510 Cottonwood Drive, Milpitas, CA 95035 Phone: 408.273.4025 Email: anita.xavier@abbott.com

Date Prepared

29 June 2017

Classification

Class II Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Classification Product Code: OOE Classification Product Code Name: Ophthalmic Femtosecond Laser

Trade Name

Catalys Precision Laser System

Predicate Devices

Catalys Precision Laser System; K170322, cleared 19 May 2017

Intended Use

The OptiMedica 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.

4 CATAL YS®, OPTIMEDICA, LIQUID OPTICS and INTEGRAL GUIDANCE are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates.

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Device Description

In addition to the laser classifications per 21 CFR 1040.10 and 1040.11, the Catalys Precision Laser System complies with the requirements for Class 4 lasers per ANSI Z136.1-2007.

Substantial Equivalence

The Catalys Precision Laser System is substantially equivalent to the predicate device (as cleared via K170322) in terms of indications for use, technological characteristics and fundamental scientific technology. The mechanism of laser cutting is the same for both systems, in that the ultra-short laser pulses create a highly localized plasma and subsequent cavitation event that, when controlled by a computerized scanning system, direct the laser beam through a three-dimensional pattern to produce a precise capsulotomy, fragment the crystalline lens and create arc cuts/incisions in the cornea.

As compared to the predicate device, the subject device has an upgraded software version cOS 5.0 and the Mobile Patient Bed which serves the same purpose as the current Patient Chair with the Catalys Precision Laser System. The upgraded Catalys System software cOS 5.0 is intended to provide compatibility of the Mobile Patient Bed with the Catalys Precision Laser System. The software version cOS 5.0 has also been tested to ensure backward compatibility with the current Patient Chair. The Catalys System with the upgraded software version cOS 5.0 will also continue to provide compatibility of the Liquid Optics Interface and Generation 2 Liquid Optics Interface which was most recently cleared under K170322.

2 CATALYS®, OPTIMEDICA, LIQUID OPTICS and INTEGRAL GUIDANCE are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates.

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Summary of Bench and Animal Performance Testing

Bench testing related to the performance of the Catalys Precision Laser System with the upgraded software and the use of the Mobile Patient Bed with the Catalys System was conducted to demonstrate the System's ability to meet all intended design specifications related to the subject device changes. The following testing was performed to verify the requirements related to the subject device design changes:

. Software specific bench testing of the Catalys System and the Mobile Patient Bed was conducted to ensure the use of Mobile Patient Bed with the Catalys Precision Laser System and the overall Catalys System's ability to continue to perform as intended.
Hardware specific bench testing of the Mobile Patient Bed was conducted to verify the mechanical hardware requirements and to ensure that the Mobile Patient Bed functions as a stable patient support system
. Electrical safety and EMC testing specific to the use of Mobile Patient Bed and its communication with the Catalys Precision Laser System was conducted by Intertek testing Laboratories to ensure compliance to the electrical safety standards
. Biocompatibility testing was performed to ensure that the Mobile Patient Bed upholstery meets requirements of ISO 10993-1
Design validation was performed to validate the subject device requirements . and it's functionality with the Catalys System with cOS 5.0 software

Overall, bench testing demonstrated that subject device with cOS 5.0 continues to deliver incisions as intended. Bench testing of the predicate device with regards to the ability to deliver a variety of laser patterns intended for capsulotomy, phacofragmentation and corneal incisions with corresponding accuracy and precision is directly applicable to the subject device as there are no significant changes to the subject device other than the software change and the use of the Mobile Patient Bed with the Catalys Precision Laser System.

The bench testing provided in K170322, when coupled with the verification and validation testing presented for the subject device, provides reasonable assurance that the System is safe and effective for its intended use and furthermore, that it is substantially equivalent to the identified 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.