(126 days)
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.
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 information provided is about the CATALYS® Precision Laser System for cataract surgery, specifically a software update (K200056), and does not describe a device that uses AI or machine learning. Therefore, many of the requested categories related to AI performance, such as sample size for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable.
The document indicates that the device itself is a laser system used in ophthalmic surgery. The update discussed in this document relates to software revisions to improve workflow efficiency, advanced astigmatism management, and additional improvements to existing features, including the addition of software modules to support patient exam import and iris registration.
Here's an analysis of the provided text based on the questions, with "N/A" for criteria not applicable to this type of device and submission:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a table format with corresponding reported performance metrics for the software updates. Instead, it states that "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." and "The modified device employs additional tests to verify the performance of the laser’s ability to execute the intended trajectory."
The non-clinical performance data section effectively serves as the "study" that proves the device meets (implied) acceptance criteria, by demonstrating that the software changes do not negatively impact safety and efficacy.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software ability to meet all intended design specifications | Software-specific bench testing conducted to demonstrate the System's ability to meet all intended design specifications related to the software design changes. |
| No adverse effects introduced due to software changes | Software verification and validation testing, in conjunction with bench tests and simulated use testing, was performed to ensure no adverse effects were introduced. |
| Performance of the laser’s ability to execute the intended trajectory | The modified device employs additional tests to verify the performance of the laser's ability to execute the intended trajectory. |
| Overall safety and efficacy for intended use remains | Bench testing, coupled with software regression testing, verification, and validation testing, provides reasonable assurance that the System remains safe and effective for its intended use and is substantially equivalent to the primary predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided document. The testing involved "hardware and software bench tests, in conjunction with simulated use testing."
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing described as "bench testing" and "simulated use testing" implies a controlled, laboratory-type environment rather than patient data. The submission is from AMO Manufacturing USA, LLC, suggesting the testing was likely conducted in the US. The term "retrospective or prospective" is not applicable as this was bench and simulated use testing, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of expert consensus is typically relevant for interpretative devices (like AI for image analysis). This document describes a surgical laser system with software updates, and the testing focuses on functional performance and adherence to design specifications through bench and simulated use testing, not on expert interpretation of output.
4. Adjudication method for the test set
Not applicable, as expert adjudication of results is not relevant for this type of technical device performance testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a laser system for surgery, not an AI-powered diagnostic or interpretive tool where human readers would be assessing cases with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The software changes are part of a surgical laser system, which inherently involves a human operator (surgeon). The testing described focuses on the software's ability to control the laser and execute its functions as designed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically defined for AI/diagnostic devices (e.g., pathology, clinical outcomes) is not directly applicable. For this device, the "ground truth" would be established by engineering specifications, validated measurements, and successful execution of intended laser trajectories and software functions during bench and simulated use testing. For example, "the performance of the laser's ability to execute the intended trajectory" would be verified against its programmed design.
8. The sample size for the training set
Not applicable. This document describes software updates for an existing medical device, not a machine learning model that requires a training set. The changes involve workflow improvements, astigmatism management, and patient data import/iris registration functionalities.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device requiring a training set.
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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.
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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/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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
[807.92(a)(1)] Submitter Information
| Sponsor/Submitter: | AMO Manufacturing USA, LLC510 Cottonwood DriveMilpitas, CA 95035 USAPhone 408-273-5166Fax:408 273-5966 |
|---|---|
| Contact Person: | Laarni RicafortProject Manager, Regulatory AffairsEmail: lricafor@its.jnj.comPhone: 408-273-4016Fax: :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(K182083, November 9, 2018) |
|---|---|
| Reference Predicate Device: | LENSAR Laser System (LLS-fs 3D)(K182795, December 21, 2018) |
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[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 patientsundergoing 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-planearc cuts/incisions in the cornea, each of which may be performed eitherindividually or consecutively during the same procedure. |
|---|---|
| Difference inIndications from | The Catalys® Precision Laser System is indicated for use in patientsundergoing cataract surgery for removal of the crystalline lens. |
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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.
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| Subject Device | Primary Predicate Device | Reference PredicateDevice | |
|---|---|---|---|
| Attribute | Catalys Precision LaserSystem | Catalys Precision LaserSystem | LENSAR LaserSystemLLS-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® PrecisionLaser System is indicatedfor use in patientsundergoing cataractsurgery for removal of thecrystalline lens. Intendeduses in cataract surgeryinclude anteriorcapsulotomy,phacofragmentation, andthe creation of single planeand multi-plane arccuts/incisions in thecornea, each of which maybe performed eitherindividually orconsecutively during thesame procedure. | The Catalys® PrecisionLaser System is indicatedfor use in patientsundergoing cataractsurgery for removal of thecrystalline lens. Intendeduses in cataract surgeryinclude anteriorcapsulotomy,phacofragmentation, andthe creation of single planeand multi-plane arccuts/incisions in thecornea, each of which maybe performed eitherindividually orconsecutively during thesame procedure. | The LENSAR LaserSystem - fs 3D (LLS-fs 3D)with Streamline™ isan ophthalmic surgicallaser indicated for use:• in the creation of ananterior capsulotomy;• in patients undergoingsurgery requiringlaser-assistedfragmentation of thecataractous lens;• in the creation of fulland partial thicknesssingle-plane and multiplanearc cuts/incisions in thecornea;• in patients undergoingophthalmic surgery orother treatmentsrequiring pocketcuts/incisions in thecornea;• in the creation of acorneal flap in patientsundergoing treatmentrequiring initiallamellar resection ofthe cornea; |
| System Type | Opthalmic FemtosecondLaser with SpectralDomain OCT | Opthalmic FemtosecondLaser with SpectralDomain OCT | Not applicable |
| Laser Mechanism ofAction | Plasma, Cavitation | Plasma, Cavitation | Not applicable |
| Treatment LaserWavelength (nm) | 1030 ±5 | 1030 ±5 | Not applicable |
| Output Power, Max | Per ISO 15004-2:2007limits | Per ISO 15004-2:2007limits | Not applicable |
| Maximum PulseEnergy (µJ) | 10 | 10 | Not applicable |
| Repetition Rate(kHz) | 9-120 | 9-120 | Not applicable |
| Subject Device | Primary Predicate Device | Reference Predicate Device | |
| Attribute | |||
| Catalys Precision LaserSystem | Catalys Precision LaserSystem | LENSAR LaserSystemLLS-fs 3D Laser System | |
| Pulse Duration (fs) | < 600 | < 600 | Not applicable |
| Spot Size; diameter(μm) | 5 | 5 | Not applicable |
| System controls | Microprocessor withGraphical User Interface | Microprocessor withGraphical User Interface | Not applicable |
| Patient ContactInterface | Suction-ring type interfacedevices (marketed asLiquid Optics™ Interface)Sterile and Single-useCleared on K141079 &K170322 | Suction-ring type interfacedevices (marketed asLiquid Optics™ Interface)Sterile and Single-useCleared on K141079 &K170322 | Not applicable |
| LOIExternal (mm): 21.6Internal (mm): 14.1 | LOIExternal (mm): 21.6Internal (mm): 14.1 | ||
| LOI Suction RingSeal Diameters(mm) | LOI-12External (mm):19Internal (mm):12 | LOI-12External (mm):19Internal (mm):12 | Not applicable |
| 0180-1401External (mm): 21.6Internal (mm): 14.1 | 0180-1401External (mm): 21.6Internal (mm): 14.1 | ||
| 0180-1201External (mm): 19Internal (mm): 12 | 0180-1201External (mm): 19Internal (mm): 12 | ||
| OCT AxialResolution (µm) | 30 | ||
| OCT transverseResolution (µm) | 15 | 15 | Not applicable |
| Scan speed (A-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 atcornea | ANSI Class 1 < 3.48mW atcornea | Not applicable |
| Iris Imaging | Live iris view | Live iris view | Not applicable |
| Trajectory TimingSynchronization | FPGA coordinates fromonenon--reentrant VI | FPGA coordinates fromonenon--reentrant VI | Not applicable |
| CommunicationMethod forWatchdog for HostPC with the MobilePatient Bed Pairing | Direct FPGA Interface | Direct FPGA Interface | Not applicable |
| Software Features | Built-in Nomogram:Inclusion of nomogramformula calculator forarcuate incisions | The items listed under the"subject device" columnare new features. Allother software features not | Not applicable |
| Attribute | Subject Device | Primary Predicate Device | Reference PredicateDevice |
| Catalys Precision LaserSystem | Catalys Precision LaserSystem | LENSAR LaserSystemLLS-fs 3D Laser System | |
| Toric Alignment Marks:New geometry ofintrastromal cornealincisions in a radial line | listed remain unchangedfrom the primary predicatedevice | Not applicable | |
| Lens FragmentationAlignment: Ability torotate the orientation of thefragmentation pattern todeliver into cataractouslens | Not applicable | ||
| Pre-op Manual Entry: Newdata fields to allow theoperator to input patientcorneal measurementsrelated to astigmatism | Not applicable | ||
| Pre-op Import: Ability toimport patient cornealmeasurements and eyeimage from a Cassinicorneal topographer viaencrypted data transfer | Not applicable | Pre-op Import: Integrationwith pre-op analysisdevices. | |
| Iris Registration: Accountfor cyclorotation betweenupright and supine positionusing imported eye image | Not applicable | Iris Registration: Automatediris registration withautomatic cyclorotationadjustment |
Similarities and Differences Between Cleared Predicate Devices and Subject Device
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[807.92(b)(1)] Determination of Substantial Equivalence
| Non-ClinicalPerformance Data: | The 6.0 software within the subject device was subjected tohardware and software bench tests, in conjunction with simulateduse testing.Software-specific bench testing of the Catalys® System wasconducted to demonstrate the System's ability to meet all intendeddesign specifications related to the software design changes.Bench testing of the primary predicate device is directlyapplicable to the subject device as there are no significant changesto the subject device other than the design changes resident in thesoftware. The modified device employs additional tests to verifythe performance of the laser's ability to execute the intendedtrajectory. |
|---|---|
| ----------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Bench testing, when coupled with software regression testing, verification and validation testing presented for the subject device, including regression testing provides reasonable assurance that the System remains safe and effective for its intended use and furthermore, that it is substantially equivalent to the identified primary predicate device | |
|---|---|
| Clinical Performance Data: | Clinical Data was deemed not necessary for the Catalys® Precision Laser System. The performance data demonstrated that the device performs as intended. |
| 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. |
[807.92(b)(3)] Conclusion
| Conclusions from Non-Clinical and ClinicalTests: | The modified Catalys Precision Laser System issubstantially equivalent to the currently cleared Catalys PrecisionLaser System. The changes in software between the primarypredicate and the modified device do not raise new questions ofsafety and efficacy of the new device. The Catalys PrecisionLaser System is substantially equivalent to the primary predicatein terms of indications for use, technological characteristics andfundamental scientific technology. The mechanism of lasercutting is the same for both systems, in that the ultra-short laserpulses create a highly localized plasma and subsequent cavitationevent that, when controlled by a computerized scanning system,direct the laser beam through a three-dimensional pattern toproduce a precise capsulotomy, fragment the crystalline lens andcreate arc cuts/incisions in the cornea. |
|---|---|
| ---------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 886.4390 Ophthalmic laser.
(a)
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.(b)
Classification. Class II.