CATALYS Precision Laser System

K210701 · Amo Manufacturing USA, LLC · OOE · Apr 7, 2021 · Ophthalmic

Device Facts

• Record ID: K210701
• Device Name: CATALYS Precision Laser System
• Applicant: Amo Manufacturing USA, LLC
• Product Code: OOE · Ophthalmic
• Decision Date: Apr 7, 2021
• Decision: SESE
• Submission Type: Special
• 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

Ophthalmic surgical laser system for cataract surgery; used in hospitals, ASCs, and surgeon offices. Employs femtosecond laser and integrated spectral-domain OCT; uses common optical path for imaging and treatment. System scans laser pulses in 3D patterns to perform anterior capsulotomy, lens phacofragmentation, and corneal incisions. Surgeon operates system via GUI; OCT provides cross-sectional views of anterior chamber (cornea, lens, iris, pupil, limbus) to guide laser delivery. Laser creates localized plasma and cavitation for tissue disruption. Includes single-use Liquid Optics Interface and Mobile Patient Bed. Benefits include precise, automated lens removal and corneal incisions.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical performance data, including subsystem verification, regression testing, and system-level validation.

Technological Characteristics

Class 4 femtosecond laser (1030nm); spectral-domain OCT (820-930nm). Features 3D scanner, Liquid Optics Interface, and Mobile Patient Bed. OCT resolution: 30µm axial, 15µm transverse. Laser pulse duration <600fs, spot size 5µm. System controlled by microprocessor with GUI. Software-controlled laser delivery via pre-defined patterns.

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 (K200056)

Reference Devices

• K141079
• K170322

Submission Summary (Full Text)

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April 7, 2021

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

Re: K210701

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 7. 2021 Received: March 9, 2021

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/cdrl/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 (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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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-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Charles Chiang -S

LT Charles Chiang Assistant 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) K210701

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> <b> X </b> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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#### 510(k) Summary: K210701

### [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: | Laarni Ricafort |

- Project Manager, Regulatory Affairs Email: [e-mail] Phone: [phone] Fax: [phone]
Date Summary Prepared: March 5, 2021

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

| Device Trade Name: | CATALYS® Precision Laser System |
|------------------------|---------------------------------|
| 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 |
|-------------------|---------------------------------|
| | (K200056, May 18, 2020) |

#### [807.92(a)(4)] Device Description

Device Description: Catalys® Precision Laser System ophthalmic surgical laser system used in healthcare facilities such as hospitals, Ambulatory Surgery Centers (ASCs) and surgeon office settings. The System is an electromedical device that

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contains software. System components include a single-use Liquid OpticsTM 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 arccuts/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 OpticsTM [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

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.

The subject device and predicate device have the same Difference in Indications from indications for use. Primary Predicate Device

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#### [807.92(a)(6)] Technical Characteristics

| Technological<br>Characteristics: | Both the subject and the predicate Catalys® System utilize<br>the same spectral-domain OCT technology. The OCT<br>acquires and analyzes cross-sectional tomograms of the<br>anterior eye segment, including the iris and the anterior and<br>posterior surfaces of both the cornea and lens capsule. The<br>OCT three-dimensional volumes of the eye are then used to<br>guide the Catalys laser system effectively, to deliver precise<br>and accurate laser pulses for capsulotomy,<br>phacofragmentation of the crystalline lens and single plane<br>and multi-plane arc cuts/incisions in the cornea. The<br>integrated OCT component of the System provides not only<br>for anatomical relationships, but also provides essential<br>information regarding the orientation of these anterior<br>segment areas of interest relative to the System, to ensure<br>safe and accurate delivery of the laser energy. |
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The predicate and subject devices both use the same type of treatment laser to create an anterior femtosecond capsulotomy, to perform phacofragmentation of the crystalline lens, and to create single plan and multi-plane arc cuts/incisions in the cornea by scanning individual pulses of laser energy in a pre-defined pattern. The mechanism of laser cutting is the same in that the ultra-short laser pulses create a highly localized plasma and subsequent cavitation event that disrupts only microns of tissue. The location of the tissue photo-disruption is controlled in both systems by moving the focus of the laser beam to the beam through a threedimensional pattern to produce the intended cut/incision.

#### Similarities and Differences:

The Catalys Precision Laser System is unchanged with regard to its technological characteristics, indications for use, and intended use. The modifications to the Mobile Patient Bed are limited to:

- 1. Electronics/Circuits Changes;
- 2. Battery/Charging Changes;
- 3. Firmware/FPGA Changes;
- 4. Mechanical Changes; and
- 5. Minor Packaging Changes

These changes do not impact the safety and efficacy of the proposed Mobile Patient Bed and raise no new questions of safety and efficacy as a result of these differences.

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The following table provides a comparison of the predicate device versus the proposed device for the purpose of demonstrating substantial equivalence to the predicate devices for its indication for use, intended use and technological characteristics

# Similarities and Differences Between Cleared Predicate Devices and Subject Device

| Attribute | Predicate Device | Proposed Device |
|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K200056 | This application |
| Regulation Number | 886.4390 | Same |
| Regulation Name | Ophthalmic Laser | Same |
| Regulatory Class | Class II | Same |
| Product Code | OOE | Same |
| Indications for Use | The Catalys® Precision Laser<br>System is indicated for use in<br>patients undergoing cataract<br>surgery for removal of the<br>crystalline lens. Intended uses in<br>cataract surgery include anterior<br>capsulotomy, phacofragmentation,<br>and the creation of single plane<br>and multi-plane arc cuts/incisions<br>in the cornea, each of which may<br>be performed either individually<br>or consecutively during the same<br>procedure. | Same |
| System Type | Ophthalmic Femtosecond Laser<br>with Spectral Domain OCT | Same |
| Laser Mechanism of<br>Action | Plasma, Cavitation | Same |
| Treatment Laser<br>Wavelength (nm) | 1030 ±5 | Same |
| Output Power, Max | Per ISO 15004-2:2007 limits | Same |
| Maximum Pulse<br>Energy (µJ) | 10 | Same |
| Repetition Rate<br>(kHz) | 9-120 | Same |
| Pulse Duration (fs) | < 600 | Same |
| Spot Size; diameter<br>(μm) | 5 | Same |
| System controls | Microprocessor with Graphical<br>User Interface | Same |
| Patient Contact<br>Interface | Suction-ring type interface<br>devices (marketed as Liquid<br>Optics™ Interface) Sterile and | Same |
| Attribute | Predicate Device | Proposed Device |
| LOI Suction Ring<br>Seal Diameters<br>(mm) | Single-use Cleared on K141079 &<br>K170322 | Same |
| | LOI<br>External (mm): 21.6<br>Internal (mm): 14.1 | |
| | LOI-12<br>External (mm):19<br>Internal (mm):12 | |
| | 0180-1401<br>External (mm): 21.6<br>Internal (mm): 14.1 | |
| | 0180-1201<br>External (mm): 19<br>Internal (mm): 12 | |
| Patient Interfaces | Patient Chair<br>or<br>Mobile Patient Bed | Same |
| | | |
| Patient Interfaces<br>communication<br>interface | Patient Chair<br>Wired connection to Catalys<br>System | Same |
| | | |
| | Mobile Patient Bed<br>Wireless (Bluetooth) connection<br>to Catalys System | |
| Attribute | Predicate Device | Proposed Device |
| | Electronics/Circuits<br>• Z-Motors<br>Inconsistent motor output<br>between MPB's when<br>lifting maximum weight<br>• Battery/Charging<br>Internally designed<br>charging and battery<br>circuit | Electronics/Circuits<br>• Z-Motors<br>Consistent motor output<br>between MPB's when<br>lifting maximum weight<br>• Battery/Charging<br>Vendor provided battery<br>management module |
| Mobile Patient Bed<br>Key Design<br>Characteristics | Firmware/FPGA<br>• No data logging capability | Firmware/FPGA<br>• Diagnostic data logging<br>(only field service<br>accessible) |
| | Mechanical<br>• Capacitive touch buttons<br>on pendant<br>• Armrest attached to center<br>of seat<br>• Complex headrest<br>assembly with multiple<br>articulation points | Mechanical<br>• Tactile membrane<br>switches on pendant<br>• Armrest attached to seat<br>near backrest<br>• Simpler headrest<br>assembly with only one<br>articulation points |
| OCT Axial<br>Resolution (µm) | 30 | Same |
| OCT transverse<br>Resolution (µm) | 15 | Same |
| Scan speed (A-<br>scans/sec) | 1000 | Same |
| A-scan depth (nm) | 2 | Same |
| Optical Source (nm) | 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 non-<br>reentrant VI | Same |
| Communication<br>Method for<br>Watchdog for Host<br>PC with the Mobile<br>Patient Bed Pairing | Direct FPGA Interface | Same |

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| Non-Clinical<br>Performance Data: | Design verification and validation testing was performed to<br>verify the ability of the modified Mobile Patient Bed to meet<br>its intended use with the Catalys System and to ensure that<br>no adverse effects have been introduced due to the changes.<br>This testing included subsystem level verification and<br>regression testing, as well as system validation using the<br>latest Catalys System software, and Liquid Optics<br>Interface.<br>The testing conducted and presented for the subject device,<br>provides reasonable assurance that the System remains<br>substantially equivalent for its intended use and<br>furthermore, that it is substantially equivalent to the<br>identified predicate device |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Performance<br>Data: | Clinical Data was deemed not necessary for the Catalys®<br>Precision Laser System. The performance data<br>demonstrated that the device performs as intended.<br>The proposed device does not include any changes to the<br>indications for use or intended use of the primary predicate<br>device. It does not introduce any new harms or unacceptable<br>risks, and therefore does not require clinical testing to assess<br>safety and performance or to demonstrate equivalence. |

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

# [807.92(b)(3)] Conclusion

| Conclusions from Non-Clinical and Clinical Tests: | The Catalys Precision Laser System with the proposed modifications to the Mobile Patient Bed and labeling changes have the same intended use, indications for use and the same fundamental and scientific technology as the predicate device. Therefore, the Catalys Precision Laser System with the proposed modifications to the Mobile Patient Bed and labeling is substantially equivalent to the predicate device. |
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