← Product Code [OOE](/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE) · K220516 # CATALYS Precision Laser system (K220516) _Amo Manufacturing USA, LLC · OOE · May 17, 2022 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K220516 ## Device Facts - **Applicant:** Amo Manufacturing USA, LLC - **Product Code:** [OOE](/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE.md) - **Decision Date:** May 17, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.4390 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic - **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. Inputs: ocular surface anatomy (anterior/posterior cornea, crystalline lens) via integrated OCT. Operation: femtosecond laser pulses create localized plasma and cavitation; 3D scanner directs laser beam in programmed patterns. Output: precise anterior capsulotomy, lens fragmentation, and corneal incisions. Physician-operated; OCT provides cross-sectional views to demarcate incisions relative to iris, pupil, and limbus. Benefits: facilitates efficient lens removal through precise, computer-controlled incisions. ## Clinical Evidence No clinical data. Bench testing only. Testing included sterilization cycle validation (ISO 11135, AAMI TIR28), sub-system level verification, system validation, shelf-life (T=0 and T=24 months), and biocompatibility testing for the modified LOI component. ## Technological Characteristics Class II ophthalmic femtosecond laser (1030±5 nm). Features integrated Spectral Domain OCT (820-930 nm) for imaging. System uses 3D scanner, microprocessor control, and sterile single-use Liquid Optics Interface (LOI). Laser mechanism: plasma/cavitation. Pulse duration <600 fs, max pulse energy 10 µJ, repetition rate 9-120 kHz. Sterilization: 100% Ethylene Oxide (EO) to 10^-6 SAL. Connectivity: FPGA-based watchdog for host PC/patient bed pairing. ## Regulatory 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 ([K210701](/device/K210701.md)) ## Reference Devices - CATALYS® Precision Laser System ([K170322](/device/K170322.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. May 17, 2022 AMO Manufacturing USA, LLC Alex Etlin Senior Specialist, Regulatory Affairs 510 Cottonwood Drive Milpitas, California 95035 Re: K220516 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: February 23, 2022 Received: February 25, 2022 Dear Alex Etlin: 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. 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 {1}------------------------------------------------ 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) 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 (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-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Anjana Jain, PhD 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K220516 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) > 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 The following 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92 ### [807.92(a)(1)] Submitter Information | Sponsor/Submitter: | AMO Manufacturing USA, LLC | |--------------------|----------------------------| | | 510 Cottonwood Drive | | | Milpitas, CA 95035 USA | | | Phone 408-273-5166 | | | Fax: 408 273-5966 | - Contact Person: Alex Etlin, PhD Sr. Specialist, Regulatory Affairs Email: aetlin@its.jnj.com Phone: 415 797-9879 Fax: 408 273-5966 May 13, 2022 Date Summary Prepared: ### [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
(K210701, cleared on April 7, 2021) | | Reference Device: | CATALYS® Precision Laser System
(K170322, cleared on May 19, 2017) | {4}------------------------------------------------ ### [807.92(a)(4)] Device Description Catalys® Precision Laser System is an ophthalmic surgical laser system used Device Description: in healthcare facilities such as hospitals, Ambulatory Surgery Centers (ASCs) and surgeon office settings. The Catalys® Precision Laser 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 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 21 CFR 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. Difference in Indications from Predicate Device: The subject device and the predicate device have the same indications for use. {5}------------------------------------------------ ### [807.92(a)(6)] Technical Characteristics Technological Characteristics: The modified System is unchanged in regard to its technological characteristics, indications for use, and intended uses. The scope of change for this submission is constrained to only the sterile, single-use patient-user interface (known as Liquid Optics Interface or LOI) that will be manufactured by an alternate third-party-manufacturer (TPM) Flextronics Medical (Tijuana, Mexico also known as Flex). The project name given to establishing Flex as an alternate manufacturer is Gen3 LOI, and therefore hereon the subject device will be referred to as Gen3 LOI (it does not indicate a new version of the device). The Gen2 LOI manufactured by current TPM, Juno Pacific (Soquel, CA, USA), remains unchanged. The only modifications made to Gen3 LOI are: 1) a minor modification of sterilization cycle parameters (without change of modality or the sterility assurance level), 2) the use of alternate colorant in the Suction Seal Ring sub assembly and 3) removal of unnecessary feature in the form of tabs originally intended to hold the lens cone when not in use. These changes are minor and are intended to improve manufacturing capacity and reduce production costs. These changes do not introduce new risks, do not impact the safety, efficacy, nor substantial equivalence of the device. Bench testing was performed to confirm the ability of the Gen3 LOI to meet the intended use with the System and to ensure that no new risks or adverse effects have been introduced, due to the proposed changes. Testing included sterilization cycle validation, sub-system level verification as well as system validation, shelf-life and biocompatibility testing. {6}------------------------------------------------ | Characteristic | Predicate Device | Subject Device | |--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------| | 510(K) Number | K210701, cleared April 07, 2021 (predicate)
K170322, cleared May 19, 2017 (reference) | This submission | | 21 CFR Number | 886.4390 | Same | | Regulation Name | Ophthalmic Laser | Same | | Regulatory Class | Class II | Same | | Product Code | OOE | Same | | Indication 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. | Same | | System Type | Ophthalmic Femtosecond Laser with Spectral
Domain OCT | Same | | Laser Mechanism of Action | Plasma, Cavitation | Same | | Laser Beam Positioning | Computer-controlled 3-dimensional scanning
system | Same | | Treatment Laser
Wavelength (nm) | 1030±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) | 5.0 | Same | | System Controls | Microprocessor with Graphical User Interface | Same | | Patient Contact Interface | Suction ring-type interface (Liquid Optics
Interface); sterile and single-use | Same | | LOI Suction Ring Seal
Diameters (mm) | 0180-1401
External (mm): 21.6
Internal (mm): 14.1
0180-1201
External (mm): 19 | Same | | Characteristic | Predicate Device | Subject Device | | | Internal (mm): 12 | | | OCT axial resolution (µm) | 30 | Same | | OCT transverse resolution
(µm) | 15 | Same | | Scan speed (A-scans/sec) | 1000 | Same | | A-scan depth (mm) | 2 | Same | | Optical source | 820 - 930 | Same | | Optical power | ANSI Class 1 < 3.48 mW at cornea | Same | | Iris Imaging | Live iris view | Same | | Trajectory Timing
Synchronization | FPGA coordinates from one non--reentrant VI | Same | | Communication Method for
Watchdog for Host PC with
the Mobile Patient Bed
Pairing | Direct FPGA Interface | Same | | Software Features | Built-in Nomogram | Same | | | Toric Alignment Marks | Same | | | Lens Fragmentation Alignment | Same | | | Pre-op Manual Entry | Same | | | Pre-op Import | Same | | | Iris Registration | Same | ## Substantial Equivalence Summary {7}------------------------------------------------ # [807.92(b)(1)] Determination of Substantial Equivalence | Non-Clinical
Performance Data: | Bench testing of the System (K210701, cleared on April 7, 2021) in regard to the delivering a variety of laser patterns intended for capsulotomy, phacofragmentation and corneal incisions with corresponding accuracy and precision is directly applicable to the subject device since there are no changes to the Catalys System's hardware nor software. | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Also, all bench testing, previously performed for the Gen2 Liquid Optic interface manufactured by Juno Pacific, Soquel, CA (reference device resident in K170322, cleared May 19, 2017) is directly applicable and unchanged. All testing subject to this submission is limited to the Gen3 LOI. | | | Sterilization cycle validation for the Gen3 LOI was carried out using the conservative overkill approach and as defined by ISO 11135 and AAMI TIR28 (as applicable). Like the sterilization cycle of the reference device, the subject | {8}------------------------------------------------ ### [807.92(b)(1)] Determination of Substantial Equivalence sterilization cycle utilizes a 100% Ethylene Oxide (EO) sterilization modality resulting in a minimum 10-6 SAL. All acceptance criteria were met. | | Performance testing conducted for the Gen3 LOI has been carried out
according to the same principles and included the same tests as for the
reference Gen2 LOI. Tests were performed at baseline time point T=0 (before
aging) and at T=24 (after accelerated aging equivalent to 24 months). The
acceptance criteria remain unchanged between Gen2 and Gen3 LOI. All
acceptance criteria have been met. | |-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Biocompatibility testing was performed to demonstrate that the colorant used
in the processing of the Suction Seal Ring sub assembly of the Gen3 LOI is
biocompatible for the finished sterile product configuration. Testing
confirmed no leaching and no cytotoxicity for this minor colorant addition. | | | Bench testing presented for the subject device provides reasonable assurance
that the System with the LOI remains safe and effective for its intended use
and furthermore, that it is substantially equivalent to the identified reference
device. | | Clinical Performance
Data: | The proposed device does not include any changes to the indications for use
or intended use of the primary predicate device. It does not introduce any new
harms or unacceptable risks, and therefore does not require clinical testing to
assess safety and performance or to demonstrate equivalence.
The performance data demonstrated that the device performs as intended. | ### [807.92(b)(3)] Conclusion Conclusions from Non-The modified Catalys Precision Laser System is substantially equivalent to the Clinical and Clinical currently cleared Catalys Precision Laser System. The changes in the LOI do Tests: not raise new questions of safety and efficacy of the device. The Catalys Precision Laser System is substantially equivalent to the predicate 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. --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K220516](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K220516) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com