Catalys Precision Laser System

K182083 · Amo Manufacturing USA, LLC · OOE · Nov 9, 2018 · Ophthalmic

Device Facts

• Record ID: K182083
• Device Name: Catalys Precision Laser System
• Applicant: Amo Manufacturing USA, LLC
• Product Code: OOE · Ophthalmic
• Decision Date: Nov 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Catalys Precision Laser System is an ophthalmic surgical laser used in hospitals and ambulatory surgery centers. It utilizes femtosecond laser technology and integrated Optical Coherence Tomography (OCT) to perform cataract surgery procedures. The system captures OCT images of anterior chamber anatomy, including corneal and lens surfaces, to guide the laser. A computer-controlled 3D scanner directs the laser beam to create precise incisions and fragment the lens via plasma and cavitation. The system uses a single-use Liquid Optics Interface for patient contact. Surgeons operate the system via a graphical user interface, using OCT cross-sectional views to demarcate incisions relative to ocular structures. The device automates the delivery of laser patterns, facilitating efficient lens removal and corneal incisions, which can improve surgical precision and patient outcomes.

Clinical Evidence

Bench testing only. No clinical data was necessary to demonstrate substantial equivalence. Performance was verified through software regression testing, subsystem verification, and simulated use testing.

Technological Characteristics

Ophthalmic femtosecond laser (1030±5 nm). Integrated Spectral Domain OCT (820-930 nm). 3D computer-controlled scanner. Max pulse energy 10 µJ; pulse duration < 600 fs; repetition rate 9-120 kHz. Single-use Liquid Optics Interface. Complies with ANSI Z136.1-2007 (Class I laser). Software-controlled via microprocessor.

Indications for Use

Indicated for patients undergoing cataract surgery for removal of the crystalline lens. Includes anterior capsulotomy, phacofragmentation, and corneal arc cuts/incisions.

Regulatory Classification

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.

Predicate Devices

• Catalys Precision Laser System (K172002)

Submission Summary (Full Text)

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November 9, 2018

AMO Manufacturing USA, LLC James Garvey II Associate Director, Regulatory Affairs 510 Cottonwood Drive Milpitas. CA 95035

Re: K182083

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: August 29, 2018 Received: August 30, 2018

Dear James Garvey II:

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.

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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 (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely vours.

# Bradley S. Cunningham -A

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

Enclosure

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## Indications for Use

510(k) Number (if known) K182083

Device Name Catalys 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) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <div><span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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| | | | Traditional 510(k) Premarket Notification |
|--|--|--|-------------------------------------------|
|--|--|--|-------------------------------------------|

## 510(k) Summary

| [807.92(a)(1)] Submitter Information | |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor/Submitter: | AMO Manufacturing USA, LLC<br>510 Cottonwood Drive<br>Milpitas, CA 95035, USA<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Patrick Garvey<br>Associate Director, Regulatory Affairs Email:<br>[e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared | October 29, 2018 |
| [807.92(a)(2)] Name of Device | |
| Device Trade Name: | Catalys® Precision Laser System1 |
| Common Name: | Ophthalmic Laser |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 886.4390 |
| Classification Name: | Ophthalmic Femtosecond Laser |
| Product Code: | OOE |
| [807.92(a)(3)] Legally Marketed Devices | |
| Predicate Device: | Catalys® Precision Laser System<br>(K172002, August 25, 2017) |
| [807.92(a)(4)] Device Description | |
| Device Description: | Catalys® Precision Laser System ophthalmic surgical laser system used in<br>healthcare facilities such as hospitals, Ambulatory Surgery Centers (ASCs)<br>and surgeon office settings. The System is an electromedical device which<br>contains software. System components include a single-use Liquid Optics™<br>Interface and optional Mobile Patient Bed.<br>The Catalys® Precision Laser System (also referred to as the Catalys® System |

¹ CATAL YS®, OPTIMEDICA, LIQUID OPTICS and INTEGRAL GUIDANCE are trademarks owned by or licensed to AMO Manufacturing USA LLC, its subsidiaries, or affiliates.

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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] Interface1). 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). 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 I lasers per ANSI Z136.1-2007. [807.92(a)(5)] 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. Difference in There are no differences in the Indications for Use from the predicate Indications from device. Table 1 of this summary provides a summary of the changes Predicate Device from the predicate device. [807.92(a)(6)] Technical Characteristics The modified Catalys® Precision Laser System is unchanged in Technological Characteristics regards to its technological characteristics, indications for use, and intended uses. The software revisions in the modified device include updates to hardware communication timing to reduce false positive alarms, graphical user interface changes to support use of the Mobile Patient Bed in environments with multiple Catalys systems, and a revision associated with trajectory timing offsets seen most evidently in the alignment verification function of the System. 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,

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### and Liquid Optics Interface

A substantial equivalence summary is provided in the Table 1 immediately below:

| Attribute | Predicate Device | Subject Device |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| 510(k) Number | K172002 | TBD |
| Regulation Number | 886.4390 | Same |
| Regulation Name | Ophthalmic Laser | Same |
| Regulatory Class | Class II | Same |
| Product Code | OOE | Same |
| Indications for Use | The OptiMedica® Catalys® Precision<br>Laser System is indicated for use in<br>patients undergoing cataract surgery for<br>removal of the crystalline lens. Intended<br>uses in cataract surgery include anterior<br>capsulotomy, phacofragmentation, and<br>the creation of single plane and multi-<br>plane arc cuts/incisions in the cornea,<br>each of which may be performed either<br>individually or consecutively during the<br>same procedure." | Same |
| System Type | Ophthalmic Femtosecond Laser with<br>Spectral Domain OCT | Same |
| Laser Mechanism<br>of Action | Plasma, Cavitation | Same |
| Laser Beam<br>Positioning | Computer-controlled<br>3-dimensional scanning system | Same |
| Treatment Laser<br>Wavelength (nm) | 1030±5 | Same |
| Output Power, Max | Per ISO 15004-2:2007 limits | Same |
| Maximum Pulse<br>Energy<br>(μJ) | 10 | Same |
| Repetition<br>Rate (kHz) | 9-120 | Same |
| Pulse Duration<br>(fs) | < 600 | Same |
| Spot Size;<br>diameter (um) | 5 | Same |

## Table 1: Substantial Equivalence Summary

(continued next page)

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| System controls | Microprocessor with<br>Graphical User Interface | | Same |
|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Contact<br>Interface | Suction ring-type interface devices<br>(marketed as Liquid Optics™ Interface)<br>Sterile and Single-use<br>Cleared on K141079 & K170322 | | Same |
| LOI Suction Ring<br>Seal Diameters<br>(mm) | LOI<br>External (mm): 21.6<br>Internal (mm): 14.5<br>0180-1401<br>External (mm): 21.6<br>Internal (mm): 14.5 | LOI-12<br>External (mm): 19<br>Internal (mm): 12<br>0180-1201<br>External (mm): 19<br>Internal (mm): 12 | Same |
| OCT Axial<br>Resolution (µm) | 30 | | Same |
| OCT transverse<br>Resolution (µm) | 15 | | Same |
| Scan speed<br>(A-scans/sec) | 1000 | | Same |
| A-scan depth<br>(mm) | 2 | | Same |
| Optical Source | 820-930 | | Same |
| Optical Power | ANSI Class 1 < 3.48mW at cornea | | Same |
| Iris Imaging | Live iris view | | Same |
| Trajectory Timing<br>Synchronization | FPGA coordinates from one of two<br>copies of the reentrant VI | | FPGA coordinates from one<br>non--reentrant VI |
| Communication<br>Method for<br>Watchdog for Host<br>PC with the Mobile<br>Patient Bed Pairing | USB Interface | | Direct FPGA Interface |
| Software Features | Changes to provide compatibility with<br>Generation 2 Liquid Optics Interface and<br>Mobile Patient Bed | | Watchdog improvements to reduce potential for false alarmsImproved handling of multiple MPBs in use environmentChanges to address a cut trajectory shift issue |

| Table 1: Substantial Equivalence Summary - continued. |
|-------------------------------------------------------|
|-------------------------------------------------------|

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

Non-Clinical Performance Data The 5.00.33 and 5.00.34 software configurations of the subject device we subjected to hardware and software bench tests, in conjunction with simulated use testing. Software-specific bench testing of the Catalys 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 (resident in K172002) with regards to the ability to deliver a variety

of laser patterns intended for capsulotomy,

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| | phacofragmentation and corneal incisions with<br>corresponding accuracy and precision is directly<br>applicable to the subject device as there are no significant<br>changes to the subject device other than the design<br>changes resident in the software. The modified device<br>employs additional tests to verify the performance of the<br>laser's ability to execute the intended trajectory. |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Bench testing, when coupled with software regression<br>testing, verification and validation testing presented for<br>the subject device, including regression testing provides<br>reasonable assurance that the System remains safe and<br>effective for its intended use and furthermore, that it is<br>substantially equivalent to the identified predicate device. |
| Clinical Performance Data | Clinical data was not necessary for the Catalys® Precision<br>Laser System. The performance data demonstrated that the<br>device performs as intended. |
| [807.92(b) (3)] Conclusion | |
| Conclusion from Non-Clinical and<br>Clinical Tests | The modified Catalys® Precision Laser System is<br>substantially equivalent to the currently cleared<br>Catalys® Precision Laser System. The changes in software<br>between the predicate device and modified device do not<br>raise new questions of safety and efficacy of the modified<br>device. The Catalys® Precision Laser System is substantially<br>equivalent to the predicate device (as cleared via K172002)<br>in terms of indications for use, technological characteristics<br>and fundamental scientific technology. The mechanism of<br>laser cutting is the same for both systems, in that the ultra-<br>short laser pulses create a highly localized plasma and<br>subsequent cavitation event that, when controlled by a<br>computerized scanning system, direct the laser beam through<br>a three-dimensional pattern to produce a precise<br>capsulotomy, fragment the crystalline lens and create arc<br>cuts/incisions in the cornea. |