(117 days)
No
The document does not mention AI, ML, or related terms, and the description focuses on established laser and imaging technologies.
Yes
The device is an ophthalmic surgical laser system used in cataract surgery for procedures like anterior capsulotomy, phacofragmentation, and creation of corneal incisions, all of which are therapeutic interventions.
No
The device is described as an ophthalmic surgical laser system used for treatment procedures like anterior capsulotomy, phacofragmentation, and creation of corneal incisions, rather than for diagnosis. While it uses OCT for imaging to guide treatment, its primary function is therapeutic.
No
The device description explicitly states it is an "ophthalmic surgical laser system" that employs "femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT")" and a "Liquid Optics "[patient] Interface". These are hardware components, not solely software. While software controls and monitors these components, the device itself is a physical system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The OptiMedica 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 biological specimens taken from the patient. Its function is to perform surgical actions on the eye itself.
Therefore, based on the provided information, the OptiMedica Catalys Precision Laser System is a surgical device, not an In Vitro Diagnostic device.
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" 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).
Per 21 CFR 1040.10 and 1040.11, the Catalys Precision Laser System is classified as a Class 4 laser.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 K141079) 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 resident in the software.
Animal testing of the predicate device (resident in K141079) with regards to the assessment of the safety of the Catalys Precision Laser System, with respect to corneal incisions 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.
Clinical testing of the Catalys System predicate device (resident in K141079) 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 bench, animal and clinical performance testing provided in K141079, when coupled with the software verification and validation testing presented for the subject device, provides 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 20, 2016
Optimedica Corporation Mr. Ankur Kaushal Manager. Regulatory Affairs 1310 Moffet Park Drive Sunnyvale, CA 94089
Re: K161455
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 19, 2016 Received: August 22, 2016
Dear Mr. Kaushal:
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling; medical device reporting (reporting of medical device-related adverse
1
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 vou desire specific advice for your device on our labeling regulation . 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 yours,
Kesia Alexander
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): K161455
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
The following 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92:
5.1.1. Applicant
OptiMedica Corporation (A subsidiary of Abbott Medical Optics Inc.) 1310 Moffett Park Drive Sunnyvale, CA 94089 Phone: 408.792.8207 Fax: 408.850.8595
5.1.2. Contact Person
Ankur Kaushal Manager, Regulatory Affairs OptiMedica Corporation (A subsidiary of Abbott Medical Optics Inc.) 1310 Moffett Park Drive Sunnyvale, CA 94089 Phone: 408.792.8207 Fax: 408.850.8595 Email: ankur.kaushal(@abbott.com
5.1.3. Date Prepared
19 August 2016
5.1.4. Classification
Class II Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Classification Product Code: OOE Classification Product Code Name: Ophthalmic Femtosecond Laser
5.1.5. Trade Name
Catalys Precision Laser System
5.1.6. Predicate Devices
Catalys Precision Laser System; K141079, cleared 11 Sept 2014
5.1.7. 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 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.
4 CATALYS®, OPTIMEDICA, LIQUID OPTICS and INTEGRAL GUIDANCE are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates.
4
5.1.8. Device Description
The Catalys Precision Laser System ("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).
Per 21 CFR 1040.10 and 1040.11, the Catalys Precision Laser System is classified as a Class 4 laser.
5.1.9. Substantial Equivalence
The Catalys Precision Laser System is substantially equivalent to the predicate device (as cleared via K141079) 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 upgraded system software version cOS 3.90. Software version cOS 3.90 now provides additional software based surveillance of the vacuum pressure applied to the Liquid Optics Interface (LOI), as well as other indicators of LOI suction during docking and monitoring of the video image for fluid loss during treatment.
5.1.10. Summary of Bench and Animal Performance 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 K141079) with regards to the ability to deliver a variety of laser patterns intended for capsulotomy, phacofragmentation and corneal incisions with corresponding accuracy and
2 CATALYS®, OPTIMEDICA, LIQUID OPTICS and INTEGRAL GUIDANCE are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates.
5
ABBOTT MEDICAL OPTICS INC.
precision 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.
Animal testing of the predicate device (resident in K141079) with regards to the assessment of the safety of the Catalys Precision Laser System, with respect to corneal incisions 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.
Clinical testing of the Catalys System predicate device (resident in K141079) 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 bench, animal and clinical performance testing provided in K141079, when coupled with the software verification and validation testing presented for the subject device, provides 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.