(99 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 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) is a femtosecond laser system intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, 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] Interface1). 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). In addition to the laser classifications per 21 CFR 1040.10 and 1040.11, the Catalys® Precision Laser System complies with the requirements for Class I lasers per ANSI Z136.1-2007.
The provided document is a 510(k) summary for the AMO Manufacturing USA, LLC's Catalys® Precision Laser System. This submission is for software revisions to an already cleared device (predicate device K172002). The core of the summary focuses on demonstrating substantial equivalence to the predicate device, especially considering the software changes.
Based on the provided text, we can extract the following information regarding acceptance criteria and study data:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with quantitative performance metrics for the software changes. Instead, it outlines the scope of the software revisions and states that verification and validation testing was performed to ensure the software meets its intended use and introduces no adverse effects.
The "acceptance criteria" for this 510(k) are implicitly focused on demonstrating that the modified device's performance is maintained and that the software changes do not negatively impact its safety or effectiveness compared to the predicate. The performance aspects mentioned relate to maintaining the ability to deliver laser patterns for capsulotomy, phacofragmentation, and corneal incisions with corresponding accuracy and precision.
Here's how we can interpret and present the information given:
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary of Study Findings) |
|---|---|
| Software revisions do not introduce adverse effects and meet intended use. | Software verification and validation testing, in addition to bench testing, was performed. This included subsystem level verification and regression testing, as well as system validation using the latest software, Mobile Patient Bed, and Liquid Optics Interface. The testing aimed to address: - Updates to hardware communication timing to reduce false positive alarms. - Graphical user interface changes to support use of the Mobile Patient Bed in environments with multiple Catalys systems. - A revision associated with trajectory timing offsets seen most evidently in the alignment verification function of the System. The modifications are stated to "employ additional tests to verify the performance of the laser's ability to execute the intended trajectory." |
| Continued ability to deliver various laser patterns (capsulotomy, phacofragmentation, corneal incisions) with accuracy and precision. | Bench testing of the predicate device (K172002) regarding the ability to deliver these patterns with accuracy and precision is directly applicable to the subject device because "there are no significant changes to the subject device other than the design changes resident in the software." The modified device reportedly "employs additional tests to verify the performance of the laser's ability to execute the intended trajectory." |
| System remains safe and effective for its intended use and is substantially equivalent to the predicate device. | Bench testing, coupled with software regression testing, verification, and validation, 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 predicate device." The changes in software are stated not to "raise new questions of safety and efficacy." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing, software regression testing, verification, and validation testing. It does not mention a 'test set' in terms of patient data or clinical samples. The testing is hardware and software focused.
- Sample Size: Not applicable in the context of patient data. The "sample" would be the software builds and system configurations tested. No specific number of test cases or test runs is provided, only the types of testing.
- Data Provenance: Not applicable in the context of patient data. The testing appears to be internal engineering and software validation. No country of origin for data is stated as it's not a clinical study on patients.
- Retrospective/Prospective: Not applicable for this type of software/bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The "ground truth" for this submission revolves around the correct functioning of the software and hardware according to design specifications, rather than expert interpretation of medical images or patient outcomes. The testing involves engineers and quality assurance personnel validating system performance against requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this submission. Adjudication methods are typically employed in clinical studies involving multiple expert readers assessing medical data. This submission focuses on software and bench testing, where the "ground truth" is defined by the technical specifications and expected system behavior.
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
No MRMC comparative effectiveness study was done or mentioned. This device is a laser system for cataract surgery, not an AI diagnostic or assistance tool for human readers of medical images. The submission pertains to software updates for the laser system's operational functionality.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical laser system with integrated software. Its performance is inherently "standalone" in the sense that the laser performs the surgical actions. However, it's a human-operated device. The software changes are about the internal operation and control of the laser system, not an external algorithm processing data for human interpretation. The testing described is of the full device system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the software revisions and the device's continued substantial equivalence is based on design specifications, pre-defined operational parameters, and expected system behavior for the laser's functions (capsulotomy, phacofragmentation, corneal incisions). This is primarily established through engineering validation, verification, and bench testing. There is no mention of expert clinical consensus, pathology, or outcomes data used as ground truth for these software changes. The original predicate device (K172002) would have had its own validation studies to support its initial clearance, but this submission specifically addresses the impact of software revisions.
8. The sample size for the training set
Not applicable. This submission is for software revisions to an existing medical device, not for an AI/machine learning algorithm that requires a "training set" of data. The software updates are described as modifying hardware communication timing, GUI, and trajectory timing offsets, which points to traditional software engineering rather than an AI model that learns from large datasets.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set or AI/machine learning in this 510(k) summary.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."
November 9, 2018
AMO Manufacturing USA, LLC James Garvey II Associate Director, Regulatory Affairs 510 Cottonwood Drive Milpitas. CA 95035
Re: K182083
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: August 29, 2018 Received: August 30, 2018
Dear James Garvey II:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely vours.
Bradley S. Cunningham -A
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182083
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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| Traditional 510(k) Premarket Notification | |||
|---|---|---|---|
| -- | -- | -- | ------------------------------------------- |
510(k) Summary
| [807.92(a)(1)] Submitter Information | |
|---|---|
| Sponsor/Submitter: | AMO Manufacturing USA, LLC510 Cottonwood DriveMilpitas, CA 95035, USAPhone: 408-723-5166Fax: 408-273-5966 |
| Contact Person: | Patrick GarveyAssociate Director, Regulatory Affairs Email:pgarvey@its.jnj.comPhone: 408-723-5166Fax: 408-273-5966 |
| Date Summary Prepared | October 29, 2018 |
| [807.92(a)(2)] Name of Device | |
| Device Trade Name: | Catalys® Precision Laser System1 |
| 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(K172002, August 25, 2017) |
| [807.92(a)(4)] Device Description | |
| Device Description: | Catalys® Precision Laser System ophthalmic surgical laser system used inhealthcare facilities such as hospitals, Ambulatory Surgery Centers (ASCs)and surgeon office settings. The System is an electromedical device whichcontains 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 |
¹ CATAL YS®, OPTIMEDICA, LIQUID OPTICS and INTEGRAL GUIDANCE are trademarks owned by or licensed to AMO Manufacturing USA LLC, its subsidiaries, or affiliates.
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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] Interface1). 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). In addition to the laser classifications per 21 CFR 1040.10 and 1040.11, the Catalys® Precision Laser System complies with the requirements for Class I lasers per ANSI Z136.1-2007. [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 There are no differences in the Indications for Use from the predicate Indications from device. Table 1 of this summary provides a summary of the changes Predicate Device from the predicate device. [807.92(a)(6)] Technical Characteristics The modified Catalys® Precision Laser System is unchanged in Technological Characteristics regards to its technological characteristics, indications for use, and intended uses. The software revisions in the modified device include updates to hardware communication timing to reduce false positive alarms, graphical user interface changes to support use of the Mobile Patient Bed in environments with multiple Catalys systems, and a revision associated with trajectory timing offsets seen most evidently in the alignment verification function of the System. 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 have been introduced due to the software change. This testing included subsystem level verification and regression testing as well as system validation using the latest software, Mobile Patient Bed,
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and Liquid Optics Interface
A substantial equivalence summary is provided in the Table 1 immediately below:
| Attribute | Predicate Device | Subject Device |
|---|---|---|
| 510(k) Number | K172002 | TBD |
| Regulation Number | 886.4390 | Same |
| Regulation Name | Ophthalmic Laser | Same |
| Regulatory Class | Class II | Same |
| Product Code | OOE | Same |
| Indications for Use | The OptiMedica® Catalys® PrecisionLaser System is indicated for use inpatients undergoing cataract surgery forremoval of the crystalline lens. Intendeduses in cataract surgery include anteriorcapsulotomy, phacofragmentation, andthe creation of single plane and multi-plane arc cuts/incisions in the cornea,each of which may be performed eitherindividually or consecutively during thesame procedure." | Same |
| System Type | Ophthalmic Femtosecond Laser withSpectral Domain OCT | Same |
| Laser Mechanismof Action | Plasma, Cavitation | Same |
| Laser BeamPositioning | Computer-controlled3-dimensional scanning system | Same |
| Treatment LaserWavelength (nm) | 1030±5 | Same |
| Output Power, Max | Per ISO 15004-2:2007 limits | Same |
| Maximum PulseEnergy(μJ) | 10 | Same |
| RepetitionRate (kHz) | 9-120 | Same |
| Pulse Duration(fs) | < 600 | Same |
| Spot Size;diameter (um) | 5 | Same |
Table 1: Substantial Equivalence Summary
(continued next page)
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| System controls | Microprocessor withGraphical User Interface | Same | |
|---|---|---|---|
| Patient ContactInterface | Suction ring-type interface devices(marketed as Liquid Optics™ Interface)Sterile and Single-useCleared on K141079 & K170322 | Same | |
| LOI Suction RingSeal Diameters(mm) | LOIExternal (mm): 21.6Internal (mm): 14.50180-1401External (mm): 21.6Internal (mm): 14.5 | LOI-12External (mm): 19Internal (mm): 120180-1201External (mm): 19Internal (mm): 12 | Same |
| OCT AxialResolution (µm) | 30 | Same | |
| OCT transverseResolution (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 < 3.48mW at cornea | Same | |
| Iris Imaging | Live iris view | Same | |
| Trajectory TimingSynchronization | FPGA coordinates from one of twocopies of the reentrant VI | FPGA coordinates from onenon--reentrant VI | |
| CommunicationMethod forWatchdog for HostPC with the MobilePatient Bed Pairing | USB Interface | Direct FPGA Interface | |
| Software Features | Changes to provide compatibility withGeneration 2 Liquid Optics Interface andMobile Patient Bed | Watchdog improvements to reduce potential for false alarmsImproved handling of multiple MPBs in use environmentChanges to address a cut trajectory shift issue |
| Table 1: Substantial Equivalence Summary - continued. |
|---|
| ------------------------------------------------------- |
[807.92(b) (1)] Determination of Substantial Equivalence
Non-Clinical Performance Data The 5.00.33 and 5.00.34 software configurations of the subject device we subjected to hardware and software bench tests, in conjunction with simulated use testing. Software-specific bench testing of the Catalys System was conducted to demonstrate the System's ability to meet all intended design specifications related to the software design changes. Bench testing of the predicate device (resident in K172002) with regards to the ability to deliver a variety
of laser patterns intended for capsulotomy,
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| phacofragmentation and corneal incisions withcorresponding accuracy and precision is directlyapplicable to the subject device as there are no significantchanges to the subject device other than the designchanges resident in the software. The modified deviceemploys additional tests to verify the performance of thelaser's ability to execute the intended trajectory. | |
|---|---|
| Bench testing, when coupled with software regressiontesting, verification and validation testing presented forthe subject device, including regression testing providesreasonable assurance that the System remains safe andeffective for its intended use and furthermore, that it issubstantially equivalent to the identified predicate device. | |
| Clinical Performance Data | Clinical data was not necessary for the Catalys® PrecisionLaser System. The performance data demonstrated that thedevice performs as intended. |
| [807.92(b) (3)] Conclusion | |
| Conclusion from Non-Clinical andClinical Tests | The modified Catalys® Precision Laser System issubstantially equivalent to the currently clearedCatalys® Precision Laser System. The changes in softwarebetween the predicate device and modified device do notraise new questions of safety and efficacy of the modifieddevice. The Catalys® Precision Laser System is substantiallyequivalent to the predicate device (as cleared via K172002)in terms of indications for use, technological characteristicsand fundamental scientific technology. The mechanism oflaser cutting is the same for both systems, in that the ultra-short laser pulses create a highly localized plasma andsubsequent cavitation event that, when controlled by acomputerized scanning system, direct the laser beam througha three-dimensional pattern to produce a precisecapsulotomy, fragment the crystalline lens and create arccuts/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.