Catalys™ Precision Laser System

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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. 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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). 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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 {2}------------------------------------------------ ## 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) | | |-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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<br>510 Cottonwood Drive<br>Milpitas, CA 95035 USA<br>Phone 408-273-5166<br>Fax:408 273-5966 | |------------------------|----------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Laarni Ricafort<br>Manager, Regulatory Affairs<br>Email: lricafor@its.jnj.com<br>Phone: 408-273-4016<br>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<br>K200056; cleared May 18, 2020 | |-------------------|-------------------------------------------------------------------| |-------------------|-------------------------------------------------------------------| {4}------------------------------------------------ ### [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 | Predicate Device<br>Catalys Precision Laser<br>System | Subject Device<br>Catalys Precision Laser<br>System | |--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------| | 510(k) Number | K200056 | TBD | | Regulation Number | 886.4390 | Same | | Attribute | Predicate Device<br>Catalys Precision Laser<br>System | Subject Device<br>Catalys Precision Laser<br>System | | 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,<br>phacofragmentation, and the<br>creation of single plane and<br>multi-plane arc cuts/incisions in<br>the cornea, each of which may<br>be performed either individually<br>or consecutively during the<br>same procedure. | Same | | System Type | Ophthalmic Femtosecond Laser<br>with Spectral Domain OCT | Same | | Laser Mechanism of Action | Plasma, Cavitation | Same | | Treatment Laser Wavelength<br>(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 Graphical<br>User Interface | Same | | Patient Contact Interface | Suction-ring type interface<br>devices (marketed as Liquid<br>Optics™ Interface) Sterile and<br>Single-use | Same | | Attribute | Predicate Device<br>Catalys Precision Laser<br>System | Subject Device<br>Catalys Precision Laser<br>System | | LOI Suction Ring Seal<br>Diameters (mm) | LOI<br>External (mm): 21.6<br>Internal (mm): 14.1 | Same | | | LOI-12<br>External (mm):19<br>Internal (mm):12 | Same | | | 0180-1401<br>External (mm): 21.6<br>Internal (mm): 14.1 | Same | | | 0180-1201<br>External (mm): 19<br>Internal (mm): 12 | Same | | OCT Axial Resolution (µm) | 30 | Same | | OCT transverse Resolution<br>(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 at<br>cornea | Same | | Iris Imaging | Live iris view | Same | | Trajectory Timing<br>Synchronization | FPGA coordinates from one<br>non-reentrant VI | Same | | Communication Method for<br>Watchdog for Host PC with<br>the Mobile Patient Bed<br>Pairing | Direct FPGA Interface | Same | | Attribute | Predicate Device<br>Catalys Precision Laser<br>System | Subject Device<br>Catalys Precision Laser<br>System | | Software Features | Built-in Nomogram | Addition of Stevens nomogram | | | Toric Alignment Marks | Toric Mark Axis Calculator | | | Lens Fragmentation Alignment | Additional Nomogram<br>customizations | | | Pre-op Manual Entry | | | | Pre-op Import (from Cassini<br>pre-op device) | Pre-op Import (from IOLMaster<br>700 pre-op device) | | | Iris Registration (built by<br>Cassini Technologies) | Iris Registration (built by<br>Johnson and Johnson) | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ # [807.92(b)(1)] Determination of Substantial Equivalence | | The cOS 7.0 software within the subject device was subjected to<br>hardware and software bench tests, in conjunction with simulated<br>use testing. | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Software-specific bench testing of the CatalysTM System was<br>conducted to demonstrate the System's ability to meet all<br>intended design specifications related to the software design | | Non-Clinical<br>Performance Data: | changes. | | | Bench testing of the predicate device is directly applicable to the<br>subject device as there are no significant changes to the subject<br>device other than the design changes resident in the software. | | | Bench testing, when coupled with software regression testing,<br>verification and validation testing presented for the subject<br>device, including regression testing provides reasonable<br>assurance that the System remains safe and effective for its<br>intended use and furthermore, that it is substantially equivalent to<br>the identified predicate device | {9}------------------------------------------------ | Clinical Performance<br>Data: | Clinical Data was deemed not necessary for the Catalys™<br>Precision Laser System. The performance data demonstrated that<br>the device performs as intended.<br>The subject device does not include any changes to the<br>indications for use or intended use of the predicate device. It does<br>not introduce any new harms or unacceptable risks, and therefore<br>does not require clinical testing to assess safety and performance<br>or to demonstrate equivalence. | |----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | [807.92(b)(3)] Conclusion | | | Conclusions from Non-<br>Clinical and Clinical<br>Tests: | The subject Catalys Precision Laser System is substantially<br>equivalent to the currently cleared Catalys Precision Laser<br>System. The subject Catalys Precision Laser System is<br>substantially equivalent to the predicate in terms of indications<br>for use, technological characteristics and fundamental scientific<br>technology. The mechanism of laser cutting is the same for both<br>systems, in that the ultra-short laser pulses create a highly<br>localized plasma and subsequent cavitation event that, when<br>controlled by a computerized scanning system, direct the laser<br>beam through a three-dimensional pattern to produce a precise<br>capsulotomy, fragment the crystalline lens and create arc<br>cuts/incisions in the cornea. |