(29 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 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.
This document is a 510(k) premarket notification for the CATALYS® Precision Laser System. It is a submission for a modified device, comparing it to a previously cleared predicate device (K200056). The core of this submission is to demonstrate that the modified device remains substantially equivalent to its predicate.
Based on the provided information, the focus is on non-clinical performance data because clinical data was deemed not necessary for this submission. The device modifications are related to the Mobile Patient Bed, not the primary laser system itself.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable format for this specific submission. Instead, it relies on demonstrating that the modified device's performance is maintained and that the changes do not introduce new safety or efficacy concerns compared to the predicate device. The "acceptance criteria" in this context are implicitly that the modified Mobile Patient Bed performs its intended function safely and effectively within the CATALYS® System, consistent with the original cleared device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mobile Patient Bed Functionality:- Maintain consistent motor output for Z-motors when lifting maximum weight.- Proper battery and charging management.- Diagnostic data logging capability (field service accessible).- Functional and tactile mechanical interface (pendant buttons, armrest, headrest). | Electronics/Circuits:- Z-Motors: "Consistent motor output between MPB's when lifting maximum weight."- Battery/Charging: "Vendor provided battery management module" (implies proper functionality).Firmware/FPGA:- "Diagnostic data logging (only field service accessible)."Mechanical:- "Tactile membrane switches on pendant."- "Armrest attached to seat near backrest."- "Simpler headrest assembly with only one articulation points." |
| System Integration and Safety:- No adverse effects introduced by the changes to the Mobile Patient Bed.- Maintains same intended use, indications for use, and fundamental/scientific technology as the predicate device.- No new harms or unacceptable risks. | "Design verification and validation testing was performed to verify the ability of the modified Mobile Patient Bed to meet its intended use with the Catalys System and to ensure that no adverse effects have been introduced due to the changes.""The testings conducted and presented for the subject device, provides reasonable assurance that the System remains substantially equivalent for its intended use...""It does not introduce any new harms or unacceptable risks..." |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a numerical sample size for the test set used in the design verification and validation testing. The testing refers to "subsystem level verification and regression testing, as well as system validation."
- Data Provenance: The data is internally generated by AMO Manufacturing USA, LLC, as part of their design verification and validation process for the device modifications. The geographic origin of the data is not specified, but it would typically be internal testing data from the manufacturer's facilities. It is retrospective in the sense that it's performed on the modified device before submission for clearance, but it's prospective in terms of testing the changes being proposed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the study described is a non-clinical device verification and validation study, not a study involving expert-derived ground truth (e.g., image interpretation). The "ground truth" here is the expected functional and safety performance of the device components, which is defined by engineering specifications and regulatory standards.
4. Adjudication method for the test set
This section is not applicable for the same reasons as above. There isn't a need for adjudication in the context of verification and validation testing of device components.
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
An MRMC comparative effectiveness study was not done. This device is an ophthalmic laser system for cataract surgery, not an AI-powered diagnostic or assistive tool for human readers. The clinical performance data was deemed "not necessary."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable in the context of an "algorithm only" performance. The device is a physical laser system with integrated software, not a standalone AI algorithm. The performance evaluation focuses on the entire system's functionality and safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As this is a non-clinical validation of device modifications, the "ground truth" for the tests performed (subsystem verification, regression testing, system validation) would be based on:
- Engineering specifications and design requirements: The modified components (electronics, battery, firmware, mechanical parts of the Mobile Patient Bed) must meet pre-defined engineering and performance criteria.
- Regulatory standards: Compliance with relevant medical device safety and performance criteria (e.g., ISO 15004-2:2007 mentioned for output power) is an implicit ground truth.
- Equivalence to predicate: The ultimate "ground truth" for this submission is demonstrating that the changes do not negatively impact the substantial equivalence to the already cleared predicate device.
8. The sample size for the training set
This section is not applicable as there is no mention of machine learning or an "AI algorithm" requiring a training set in the context of this 510(k) submission. The changes are hardware and associated firmware modifications to a component of an existing laser system.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
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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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- 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary: K210701
[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 Ricafort |
- Project Manager, Regulatory Affairs Email: lricafor@its.jnj.com Phone: 408-273-4016 Fax: 408 273-5966
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
| TechnologicalCharacteristics: | Both the subject and the predicate Catalys® System utilizethe same spectral-domain OCT technology. The OCTacquires and analyzes cross-sectional tomograms of theanterior eye segment, including the iris and the anterior andposterior surfaces of both the cornea and lens capsule. TheOCT three-dimensional volumes of the eye are then used toguide the Catalys laser system effectively, to deliver preciseand accurate laser pulses for capsulotomy,phacofragmentation of the crystalline lens and single planeand multi-plane arc cuts/incisions in the cornea. Theintegrated OCT component of the System provides not onlyfor anatomical relationships, but also provides essentialinformation regarding the orientation of these anteriorsegment areas of interest relative to the System, to ensuresafe and accurate delivery of the laser energy. |
|---|---|
| ----------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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:
-
- Electronics/Circuits Changes;
-
- Battery/Charging Changes;
-
- Firmware/FPGA Changes;
-
- Mechanical Changes; and
-
- 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 LaserSystem is indicated for use inpatients undergoing cataractsurgery for removal of thecrystalline lens. Intended uses incataract surgery include anteriorcapsulotomy, phacofragmentation,and the creation of single planeand multi-plane arc cuts/incisionsin the cornea, each of which maybe performed either individuallyor consecutively during the sameprocedure. | Same |
| System Type | Ophthalmic Femtosecond Laserwith Spectral Domain OCT | Same |
| Laser Mechanism ofAction | Plasma, Cavitation | Same |
| Treatment LaserWavelength (nm) | 1030 ±5 | Same |
| Output Power, Max | Per ISO 15004-2:2007 limits | Same |
| Maximum PulseEnergy (µJ) | 10 | Same |
| Repetition Rate(kHz) | 9-120 | Same |
| Pulse Duration (fs) | < 600 | Same |
| Spot Size; diameter(μm) | 5 | Same |
| System controls | Microprocessor with GraphicalUser Interface | Same |
| Patient ContactInterface | Suction-ring type interfacedevices (marketed as LiquidOptics™ Interface) Sterile and | Same |
| Attribute | Predicate Device | Proposed Device |
| LOI Suction RingSeal Diameters(mm) | Single-use Cleared on K141079 &K170322 | Same |
| LOIExternal (mm): 21.6Internal (mm): 14.1 | ||
| LOI-12External (mm):19Internal (mm):12 | ||
| 0180-1401External (mm): 21.6Internal (mm): 14.1 | ||
| 0180-1201External (mm): 19Internal (mm): 12 | ||
| Patient Interfaces | Patient ChairorMobile Patient Bed | Same |
| Patient Interfacescommunicationinterface | Patient ChairWired connection to CatalysSystem | Same |
| Mobile Patient BedWireless (Bluetooth) connectionto Catalys System | ||
| Attribute | Predicate Device | Proposed Device |
| Electronics/Circuits• Z-MotorsInconsistent motor outputbetween MPB's whenlifting maximum weight• Battery/ChargingInternally designedcharging and batterycircuit | Electronics/Circuits• Z-MotorsConsistent motor outputbetween MPB's whenlifting maximum weight• Battery/ChargingVendor provided batterymanagement module | |
| Mobile Patient BedKey DesignCharacteristics | Firmware/FPGA• No data logging capability | Firmware/FPGA• Diagnostic data logging(only field serviceaccessible) |
| Mechanical• Capacitive touch buttonson pendant• Armrest attached to centerof seat• Complex headrestassembly with multiplearticulation points | Mechanical• Tactile membraneswitches on pendant• Armrest attached to seatnear backrest• Simpler headrestassembly with only onearticulation points | |
| OCT AxialResolution (µm) | 30 | Same |
| OCT transverseResolution (µm) | 15 | Same |
| Scan speed (A-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 TimingSynchronization | FPGA coordinates from one non-reentrant VI | Same |
| CommunicationMethod forWatchdog for HostPC with the MobilePatient Bed Pairing | Direct FPGA Interface | Same |
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| Non-ClinicalPerformance Data: | Design verification and validation testing was performed toverify the ability of the modified Mobile Patient Bed to meetits intended use with the Catalys System and to ensure thatno adverse effects have been introduced due to the changes.This testing included subsystem level verification andregression testing, as well as system validation using thelatest Catalys System software, and Liquid OpticsInterface.The testing conducted and presented for the subject device,provides reasonable assurance that the System remainssubstantially equivalent for its intended use andfurthermore, that it is substantially equivalent to theidentified predicate device |
|---|---|
| Clinical PerformanceData: | Clinical Data was deemed not necessary for the Catalys®Precision Laser System. The performance datademonstrated that the device performs as intended.The proposed device does not include any changes to theindications for use or intended use of the primary predicatedevice. It does not introduce any new harms or unacceptablerisks, and therefore does not require clinical testing to assesssafety 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. |
|---|---|
| --------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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.