(107 days)
Not Found
No
The description focuses on laser and OCT technology with dedicated electronics and software for control and monitoring, without mentioning AI or ML.
Yes
The device is used to perform surgical procedures (anterior capsulotomy, phacofragmentation, and creation of corneal cuts/incisions) to facilitate the removal of the crystalline lens during cataract surgery, which directly addresses a medical condition.
No.
The device is described as an ophthalmic surgical laser system used for procedures in cataract surgery such as capsulotomy, phacofragmentation, and creating corneal incisions, rather than for diagnosing conditions. While it uses OCT for imaging to guide treatment, its primary function is surgical intervention.
No
The device description explicitly details hardware components such as a femtosecond laser, integrated Optical Coherence Tomography (OCT), dedicated electronics, and a patient interface. The performance studies also include bench testing related to hardware components.
Based on the provided information, the OptiMedica Catalys Precision Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for surgical procedures performed on a patient (cataract surgery, anterior capsulotomy, phacofragmentation, corneal incisions). IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a surgical laser system that interacts directly with the patient's eye. It uses OCT for imaging in vivo (within the living body) to guide the laser treatment.
- Anatomical Site: The anatomical sites listed are parts of the human eye, which are treated directly by the device.
In summary, the Catalys Precision Laser System is a surgical device used for treatment, not a device used to analyze samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The OptiMedica 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
The Catalys Precision Laser System ("Catalys 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 2[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
Anterior chamber, anterior and posterior corneal surfaces, anterior and posterior surfaces of the crystalline lens, iris, pupil and limbus.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
Bench testing related to the patient interface component (LOI) of the Catalys Laser System was conducted:
- Functional Verification bench testing was performed by installing the LOI onto a Catalys system to verify the functional requirements for the subject device as a complete assembly with the system.
- Sub-assembly testing was performed to verify that the subject device functional requirements were successfully met on a sub-assembly level which included the disposable lens, suction ring and the fluid reservoir subassemblies.
- Design validation was performed to validate the subject device requirements and its functionality with the Catalys System with cOS 3.90 software.
- Subject device functionality testing was also performed with a cadaver eye model to demonstrate that the product continues to perform as intended with regards to the eye fit, intraocular pressure rise at the eye and the suction ring's ability to maintain vacuum and seal when attached to the eye.
In addition, packaging validation was conducted to verify the integrity and product functionality of the subject device packaging configuration. Shelf-life testing was successfully performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2017
Abbott Medical Optics Inc. Audrev Munnerlyn Senior Director, Regulatory Affairs 510 Cottonwood Drive Milpitas, CA 95035
Re: K170322
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 7, 2017 Received: April 10, 2017
Dear Audrey Munnerlyn:
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. 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.
1
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Denise L. Hampton -S
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: | K170322 |
|---|---|
| Device Name: | Catalys Precision Laser System |
| Indications for Use: | The OptiMedica 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. |
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary - K170322
The following 510(k) summary for K170322 is submitted in accordance with the requirements of 21 CFR 807.92:
Applicant
OptiMedica Corporation (A subsidiary of Abbott Medical Optics Inc.) 510 Cottonwood Drive Milpitas, CA 95035 Phone: 408.733.2020
Contact Person
Audrey Munnerlyn Senior Director, Regulatory Affairs Abbott Medical Optics Inc., 510 Cottonwood Drive Milpitas, CA 95035 Phone: +1 408.273.4106 Fax: +1 408.273.5966 Email: audrey.munnerlyn@abbott.com
Date Prepared
30 Jan 2017
Classification
Class II Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Classification Product Code: OOE Classification Product Code Name: Ophthalmic Femtosecond Laser
Trade Name
Catalys 2 Precision Laser System
Predicate Devices
Catalys Precision Laser System; K161455, cleared 20 Sep 2016
Intended Use
The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in
1 CATALYS, OPTIMEDICA and LIQUID OPTICS are trademarks owned by or licensed to Abbott Medical Optics Inc., its subsidiaries or affiliates.
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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.
Device Description
The Catalys Precision Laser System ("Catalys 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 2[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).
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 4 lasers per ANSI Z136.1-2007.
Substantial Equivalence
The Catalys Precision Laser System is substantially equivalent to the predicate device (as cleared via K161455) in terms of indications for use, technological characteristics and fundamental scientific technology. The mechanism of laser cutting is the same for both systems, in that the ultra-short laser pulses create a highly localized plasma and subsequent cavitation event that, when controlled by a computerized scanning system, direct the laser beam through a three-dimensional pattern to produce a precise capsulotomy, fragment the crystalline lens and create arc cuts/incisions in the cornea.
As compared to the predicate device, the subject device has an updated version of the Liquid Optics Interface (LOI). The subject device now consists of an additional vacuum line specifically reserved for the purpose of vacuum sensing, thereby providing a faster means of detecting suction loss between the patient's eye and the System. Additionally, the profile of the Suction ring component of the suction ring has been slimmed. Finally, the volume of the fluid reservoir component of the subject device has been increased.
2 CATALYS, OPTIMEDICA and LIQUID OPTICS are trademarks owned by or licensed to Abbott Medical Optics Inc., its subsidiaries or affiliates.
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Summary of Bench and Animal Performance Testing
Bench testing related to the patient interface component (LOI) of the Catalys Laser System was conducted to demonstrate the LOI and the System's ability to meet all intended design specifications related to the subject device design changes. The following testing was performed to verify the requirements related to the subject device design changes:
- . Functional Verification bench testing was performed by installing the LOI onto a Catalys system to verify the functional requirements for the subject device as a complete assembly with the system
- Sub-assembly testing was performed to verify that the subject device functional requirements were successfully met on a sub-assembly level which included the disposable lens, suction ring and the fluid reservoir subassemblies
- Design validation was performed to validate the subject device requirements and it's functionality with the Catalys System with cOS 3.90 software
- Subject device functionality testing was also performed with a cadaver eye model to demonstrate that the product continues to perform as intended with regards to the eye fit, intraocular pressure rise at the eye and the suction ring's ability to maintain vacuum and seal when attached to the eye
In addition, packaging validation was conducted to verify the integrity and product functionality of the subject device packaging configuration. Testing demonstrated that the packaging meets the requirements for maintaining sterile barrier integrity, product functionality and labeling. Also, shelf-life testing was successfully performed to verify and validate the shelf life of the subject device and its associated packaging system. Overall, bench testing demonstrated that subject device with the Catalys system continues to deliver incisions as intended. Bench testing of the predicate device (resident in K161455) with regards to the ability to deliver a variety of laser patterns intended for capsulotomy, phacofragmentation and corneal incisions with corresponding accuracy and precision is directly applicable to the subject device as there are no significant changes to the subject device other than the design changes made to the LOI.
The bench testing provided in K161455, when coupled with the bench and cadaver testing presented for the subject device provided in this submission, provide reasonable assurance that the system is safe and effective for its intended use and furthermore, that it is substantially equivalent to the identified predicate device.