(126 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on established technologies like femtosecond lasers and OCT, controlled by dedicated electronics and software, without mentioning any AI/ML components or training/test data.
Yes
The device is used in cataract surgery for procedures like anterior capsulotomy, phacofragmentation, and corneal incisions, which are therapeutic interventions.
No
The device is described as an "ophthalmic surgical laser system" used for procedures like "anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea" during cataract surgery. While it uses Optical Coherence Tomography (OCT) for imaging, this is stated to be integrated for "precise overlap between imaging and treatment beams" and to "demarcate proposed incisions versus adjacent ocular structures," indicating its use for guiding surgical treatment rather than solely for diagnosis.
No
The device description explicitly states it is an "electromedical device" and includes hardware components such as a femtosecond laser, integrated Optical Coherence Tomography (OCT), dedicated electronics, a three-dimensional scanner, and a Liquid Optics™ Interface. While it contains software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device 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 capsulotomy, phacofragmentation, and corneal incisions.
- Lack of Specimen Analysis: The device does not analyze any specimens taken from the patient's body. Its function is to perform a surgical procedure.
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 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography ("OCT")
Anatomical Site
Crystalline lens, cornea, anterior chamber (iris, pupil and 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
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.
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. The modified device employs additional tests to verify the performance of the laser's ability to execute the intended trajectory.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: The 6.0 software within the subject device was 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 primary predicate device is directly applicable to the subject device as there are no significant changes to the subject device other than the design changes resident in the software. The modified device employs additional tests to verify the performance of the laser's ability to execute the intended trajectory. 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.
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.
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.
0
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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.
1
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
2
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, 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: 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) |
4
[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 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 | The Catalys® Precision Laser System is indicated for use in patients
undergoing cataract surgery for removal of the crystalline lens. |
5
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 Predicate
Device |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attribute | Catalys Precision Laser
System | Catalys Precision Laser
System | LENSAR Laser
System
LLS-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® 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 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 LENSAR Laser
System - fs 3D (LLS-fs 3D)
with Streamline™ is
an ophthalmic surgical
laser indicated for use:
• in the creation of an
anterior capsulotomy;
• in patients undergoing
surgery requiring
laser-assisted
fragmentation of the
cataractous lens;
• in the creation of full
and partial thickness
single-plane and multiplane
arc cuts/
incisions in the
cornea;
• in patients undergoing
ophthalmic surgery or
other treatments
requiring pocket
cuts/incisions in the
cornea;
• in the creation of a
corneal flap in patients
undergoing treatment
requiring initial
lamellar resection of
the cornea; |
| System Type | Opthalmic Femtosecond
Laser with Spectral
Domain OCT | Opthalmic Femtosecond
Laser with Spectral
Domain OCT | Not applicable |
| Laser Mechanism of
Action | Plasma, Cavitation | Plasma, Cavitation | Not applicable |
| Treatment Laser
Wavelength (nm) | 1030 ±5 | 1030 ±5 | Not applicable |
| Output Power, Max | Per ISO 15004-2:2007
limits | Per ISO 15004-2:2007
limits | Not applicable |
| Maximum Pulse
Energy (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 Laser
System | Catalys Precision Laser
System | LENSAR Laser
System
LLS-fs 3D Laser System |
| Pulse Duration (fs) |