(83 days)
No
The summary does not mention AI, ML, or related terms, and the description focuses on established technologies like femtosecond lasers and OCT.
Yes
The device is described as an "ophthalmic surgical laser system" that performs procedures such as anterior capsulotomy, phacofragmentation, and creation of corneal incisions to facilitate efficient lens removal during cataract surgery, which are therapeutic interventions.
No
Explanation: The device is described as an ophthalmic surgical laser system used for performing surgical procedures like anterior capsulotomy, phacofragmentation, and corneal incisions during cataract surgery. While it includes OCT for imaging and real-time monitoring to guide the surgical procedure, its primary function is therapeutic (performing surgery), not diagnostic (identifying or characterizing a disease or condition). The imaging is integrated solely for the purpose of guiding the therapeutic action.
No
The device description explicitly states it is an "electromedical device" and includes hardware components like a femtosecond laser, integrated OCT, and a single-use Liquid Optics™ Interface.
Based on the provided information, the Catalys® Precision Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Catalys® Function: The Catalys® Precision Laser System is a surgical laser system used directly on the patient's eye during cataract surgery. It performs procedures like anterior capsulotomy, phacofragmentation, and corneal incisions.
- Lack of Specimen Analysis: The device does not collect or analyze specimens from the body. Its function is to perform surgical actions on the eye itself.
Therefore, the Catalys® Precision Laser System falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
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.
Product codes
OOE
Device Description
Catalys® Precision Laser System is an ophthalmic surgical laser system used 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography ("OCT")
Anatomical Site
Anterior chamber (anterior and posterior corneal surfaces, anterior and posterior surfaces of the crystalline lens), iris, pupil, limbus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare facilities such as hospitals, Ambulatory Surgery Centers (ASCs) and surgeon office settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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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
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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)
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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) |
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[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.
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[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.
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| 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) |