Catalys Precision Laser System

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May 18, 2020 AMO Manufacturing USA, LLC Laarni Ricafort Project Manager, Regulatory Affairs 510 Cottonwood Drive Milpitas, CA 95035 Re: K200056 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: April 16, 2020 Received: April 20, 2020 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. {1}------------------------------------------------ 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/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 medical devices and radiation-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. 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) K200056 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) | | |------------------------------------------------------------|---------------------------------------------| | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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 ## [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>Project Manager, Regulatory Affairs<br>Email: lricafor@its.jnj.com<br>Phone: 408-273-4016<br>Fax: :408 273-5966 | Date Summary Prepared: May 7, 2020 ## [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 | Primary Predicate Device: | CATALYS® Precision Laser System<br>(K182083, November 9, 2018) | |-----------------------------|-----------------------------------------------------------------| | Reference Predicate Device: | LENSAR Laser System (LLS-fs 3D)<br>(K182795, December 21, 2018) | {4}------------------------------------------------ ### [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 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. ### [807.92(a)(5)] Intended Use | Indications for Use: | The Catalys® Precision Laser System is indicated for use in patients<br>undergoing cataract surgery for removal of the crystalline lens.<br>Intended uses in cataract surgery include anterior capsulotomy,<br>phacofragmentation, and the creation of single plane and multi-plane<br>arc cuts/incisions in the cornea, each of which may be performed either<br>individually or consecutively during the same procedure. | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Difference in<br>Indications from | The Catalys® Precision Laser System is indicated for use in patients<br>undergoing cataract surgery for removal of the crystalline lens. | {5}------------------------------------------------ Intended uses in cataract surgery include anterior capsulotomy. Primary Predicate phacofragmentation, and the creation of single plane and multiplane arc cuts/incisions in the cornea, each of which may be Device performed either individually or consecutively during the same procedure. The subject device and primary predicate device have the same indications for use. ### [807.92(a)(6)] Technical Characteristics Technological The modified Catalys Precision Laser System is unchanged with regard to its technological characteristics, indications for use, and Characteristics: intended uses. The software revisions in the modified 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 improvements to currently implemented features. > 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 were introduced due to the software changes. 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 primary predicate device, reference predicate device, and subject device for the purpose of demonstrating substantial equivalence to the predicate devices for its indication for use, intended use, technological characteristics and added new features. {6}------------------------------------------------ | | Subject Device | Primary Predicate Device | Reference Predicate<br>Device | |-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Attribute | Catalys Precision Laser<br>System | Catalys Precision Laser<br>System | LENSAR Laser<br>System<br>LLS-fs 3D Laser System | | 510(k) Number | K200056 | K182083 | K182795 | | Regulation Number | 886.4390 | 886.4390 | 886.4390 | | Regulation Name | Ophthalmic Laser | Ophthalmic Laser | Ophthalmic Laser | | Regulatory Class | Class II | Class II | Class II | | Product Code | OOE | OOE | OOE | | Indications for Use | The Catalys® Precision<br>Laser System is indicated<br>for use in patients<br>undergoing cataract<br>surgery for removal of the<br>crystalline lens. Intended<br>uses in cataract surgery<br>include anterior<br>capsulotomy,<br>phacofragmentation, and<br>the creation of single plane<br>and multi-plane arc<br>cuts/incisions in the<br>cornea, each of which may<br>be performed either<br>individually or<br>consecutively during the<br>same procedure. | The Catalys® Precision<br>Laser System is indicated<br>for use in patients<br>undergoing cataract<br>surgery for removal of the<br>crystalline lens. Intended<br>uses in cataract surgery<br>include anterior<br>capsulotomy,<br>phacofragmentation, and<br>the creation of single plane<br>and multi-plane arc<br>cuts/incisions in the<br>cornea, each of which may<br>be performed either<br>individually or<br>consecutively during the<br>same procedure. | The LENSAR Laser<br>System - fs 3D (LLS-fs 3D)<br>with Streamline™ is<br>an ophthalmic surgical<br>laser indicated for use:<br>• in the creation of an<br>anterior capsulotomy;<br>• in patients undergoing<br>surgery requiring<br>laser-assisted<br>fragmentation of the<br>cataractous lens;<br>• in the creation of full<br>and partial thickness<br>single-plane and multiplane<br>arc cuts/<br>incisions in the<br>cornea;<br>• in patients undergoing<br>ophthalmic surgery or<br>other treatments<br>requiring pocket<br>cuts/incisions in the<br>cornea;<br>• in the creation of a<br>corneal flap in patients<br>undergoing treatment<br>requiring initial<br>lamellar resection of<br>the cornea; | | System Type | Opthalmic Femtosecond<br>Laser with Spectral<br>Domain OCT | Opthalmic Femtosecond<br>Laser with Spectral<br>Domain OCT | Not applicable | | Laser Mechanism of<br>Action | Plasma, Cavitation | Plasma, Cavitation | Not applicable | | Treatment Laser<br>Wavelength (nm) | 1030 ±5 | 1030 ±5 | Not applicable | | Output Power, Max | Per ISO 15004-2:2007<br>limits | Per ISO 15004-2:2007<br>limits | Not applicable | | Maximum Pulse<br>Energy (µJ) | 10 | 10 | Not applicable | | Repetition Rate<br>(kHz) | 9-120 | 9-120 | Not applicable | | | Subject Device | Primary Predicate Device | Reference Predicate Device | | | | | | | Attribute | | | | | | Catalys Precision Laser<br>System | Catalys Precision Laser<br>System | LENSAR Laser<br>System<br>LLS-fs 3D Laser System | | Pulse Duration (fs) | < 600 | < 600 | Not applicable | | Spot Size; diameter<br>(μm) | 5 | 5 | Not applicable | | System controls | Microprocessor with<br>Graphical User Interface | Microprocessor with<br>Graphical User Interface | Not applicable | | Patient Contact<br>Interface | Suction-ring type interface<br>devices (marketed as<br>Liquid Optics™ Interface)<br>Sterile and Single-use<br>Cleared on K141079 &<br>K170322 | Suction-ring type interface<br>devices (marketed as<br>Liquid Optics™ Interface)<br>Sterile and Single-use<br>Cleared on K141079 &<br>K170322 | Not applicable | | | LOI<br>External (mm): 21.6<br>Internal (mm): 14.1 | LOI<br>External (mm): 21.6<br>Internal (mm): 14.1 | | | LOI Suction Ring<br>Seal Diameters<br>(mm) | LOI-12<br>External (mm):19<br>Internal (mm):12 | LOI-12<br>External (mm):19<br>Internal (mm):12 | Not applicable | | | 0180-1401<br>External (mm): 21.6<br>Internal (mm): 14.1 | 0180-1401<br>External (mm): 21.6<br>Internal (mm): 14.1 | | | | 0180-1201<br>External (mm): 19<br>Internal (mm): 12 | 0180-1201<br>External (mm): 19<br>Internal (mm): 12 | | | | OCT Axial<br>Resolution (µm) | 30 | | | OCT transverse<br>Resolution (µm) | 15 | 15 | Not applicable | | Scan speed (A-<br>scans/sec) | 1000 | 1000 | Not applicable | | A-scan depth (nm) | 2 | 2 | Not applicable | | Optical Source | 820-930 | 820-930 | Not applicable | | Optical Power | ANSI Class 1 < 3.48mW at<br>cornea | ANSI Class 1 < 3.48mW at<br>cornea | Not applicable | | Iris Imaging | Live iris view | Live iris view | Not applicable | | Trajectory Timing<br>Synchronization | FPGA coordinates from<br>one<br>non--reentrant VI | FPGA coordinates from<br>one<br>non--reentrant VI | Not applicable | | Communication<br>Method for<br>Watchdog for Host<br>PC with the Mobile<br>Patient Bed Pairing | Direct FPGA Interface | Direct FPGA Interface | Not applicable | | Software Features | Built-in Nomogram:<br>Inclusion of nomogram<br>formula calculator for<br>arcuate incisions | The items listed under the<br>"subject device" column<br>are new features. All<br>other software features not | Not applicable | | Attribute | Subject Device | Primary Predicate Device | Reference Predicate<br>Device | | | Catalys Precision Laser<br>System…