(29 days)
CATALYS® Precision Laser System (K200056)
No
The summary describes a laser system with integrated OCT and software control, but there is no mention of AI or ML capabilities in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
Explanation: The device is indicated for use in cataract surgery for the removal of the crystalline lens and performs procedures like anterior capsulotomy and phacofragmentation, which are therapeutic interventions.
No
The device is described as an ophthalmic surgical laser system used for procedures like anterior capsulotomy, phacofragmentation, and creating corneal incisions. While it uses OCT for imaging and monitoring, its primary function is surgical treatment, not diagnosis of a condition.
No
The device description explicitly states that the Catalys® Precision Laser System is an "electromedical device" and includes hardware components such as a femtosecond laser, integrated Optical Coherence Tomography (OCT), dedicated electronics, a single-use Liquid OpticsTM Interface, and an optional Mobile Patient Bed. While it contains software, it is not solely software.
Based on the provided information, the CATALYS® Precision Laser System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- CATALYS® System Function: The CATALYS® System is a surgical laser system used during cataract surgery to perform procedures directly on the patient's eye (anterior capsulotomy, phacofragmentation, corneal incisions). It uses OCT for imaging and guidance in vivo (within the living body).
- Lack of Specimen Examination: The system does not examine specimens (like blood, tissue, urine, etc.) derived from the human body outside of the body. Its function is to perform a surgical procedure directly on the patient.
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 (comma separated list FDA assigned to the subject device)
OOE
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 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.
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.
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)
Non-Clinical Performance Data: 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. This testing included subsystem level verification and regression testing, as well as system validation using the latest Catalys System software, and Liquid Optics Interface. The testing conducted and presented for the subject device, provides reasonable assurance that the System remains substantially equivalent for its intended use and furthermore, that it is substantially equivalent to the identified 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
CATALYS® Precision Laser System (K200056)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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, LLC
510 Cottonwood Drive
Milpitas, CA 95035 USA
Phone 408-273-5166
Fax: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
4
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
| Technological
Characteristics: | Both the subject and the predicate Catalys® System utilize
the same spectral-domain OCT technology. The OCT
acquires and analyzes cross-sectional tomograms of the
anterior eye segment, including the iris and the anterior and
posterior surfaces of both the cornea and lens capsule. The
OCT three-dimensional volumes of the eye are then used to
guide the Catalys laser system effectively, to deliver precise
and accurate laser pulses for capsulotomy,
phacofragmentation of the crystalline lens and single plane
and multi-plane arc cuts/incisions in the cornea. The
integrated OCT component of the System provides not only
for anatomical relationships, but also provides essential
information regarding the orientation of these anterior
segment areas of interest relative to the System, to ensure
safe 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 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 |
| 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) |