(28 days)
Not Found
No
The description focuses on femtosecond laser technology, integrated OCT, and dedicated electronics for control and monitoring. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
Yes
The device is indicated for anterior capsulotomy and laser phacofragmentation during cataract surgery, which are medical procedures to treat a health condition.
No
The device is described as an ophthalmic surgical laser system indicated for performing anterior capsulotomy and laser phacofragmentation during cataract surgery, which are therapeutic procedures, not diagnostic ones. While it uses OCT for integrated imaging, this is for guiding treatment, not for diagnosing a condition.
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 "common optical path for the OCT and femtosecond treatment laser". This indicates significant hardware components beyond just software.
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 device is intended for performing surgical procedures (anterior capsulotomy and laser phacofragmentation) on the patient's eye during cataract surgery. IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states it's an "ophthalmic surgical laser system" used to "create a precise anterior capsulotomy and/or to effect phacofragmentation." This is a therapeutic/surgical function, not a diagnostic one performed on a sample.
- Anatomical Site: The device operates directly on the anterior segment of the eye, which is part of the living patient. IVD devices work with samples taken from the patient.
The device is a surgical tool used to perform a procedure, not a device used to analyze a biological sample for diagnostic purposes.
N/A
Intended Use / Indications for Use
The OptiMedica Catalys™ Precision Laser System is indicated for anterior capsulotomy and laser phacofragmentation during cataract surgery. The anterior capsulotomy and phacofragmentation procedures may be performed either individually or consecutively during the same surgery.
Product codes (comma separated list FDA assigned to the subject device)
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 phacofragmentation, thus facilitating efficient lens removal. 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 coregistered and provide for precise overlap between imaging and treatment beams. 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 I lasers per ANSI Z136.1-2007.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography ("OCT")
Anatomical Site
Not Found
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)
Bench testing of the Catalys™ System was conducted to demonstrate the OCT subsystem's ability to measure depth, surface profiles and iris diameters with accuracy and precision. Various test article substrates of known dimensions were measured multiple times by the System's OCT sub-system. All OCT-measured values met the test protocol acceptance criteria of ±40μm for all thicknesses and diameters, and ± 1% for all surface radii. This testing verifies that the OCT subsystem of the Catalys™ System can measure depth, surface profiles and diameters accurately and precisely.
Bench testing of the Catalys™ System was also conducted to demonstrate the System's ability to deliver a variety of laser patterns intended for capsulotomy or phacofragmentation with corresponding accuracy and precision. In this test, all laser parameters such as spot spacing, depth spacing, and pulse energy were bracketed to assess the full capability of the System. Additionally, the System's entire suite of capsulotomy and phacofragmentation patterns was similarly bracketed to test the full spectrum of physician-selectable pattern variations. Multiple samples for a given test pattern were created in a test substrate that was subsequently cross-sectioned and measured using a NIST-traceable reticule, under magnified digital image analysis. All measured values met the test protocol acceptance criteria of ±100μm relative to the intended cut dimensions. The spectrum of pattern testing validated the System capability to cut a variety of capsulotomy and phacofragmentation patterns within specified limits for accuracy and precision.
Animal testing was performed to demonstrate retinal and corneal safety, and to establish the strength of the lens post-capsulotomy.
The OptiMedica Catalys™ Precision Laser System was clinically evaluated in a prospective, randomized non-inferiority trial in which one eye was randomly assigned to receive treatment with the Catalys™ System, including capsulotomy and laser phacofragmentation, followed by standard ultrasound phacoemulsification as necessary. The subject's contralateral eye, serving as the study Control eye, was assigned treatment with the current "gold standard" surgical technique of continuous curvilinear capsulorrhexis (CCC) and standard ultrasound phacoemulsification. Catalys™ System treatment times for the combined capsulotomy and laser phacofragmentation were found to be less than one minute in all subjects. Total procedure time (defined as the total time the subject was under suction and docked to the System) averaged just over 5 minutes with a maximum of 14 minutes.
Capsulotomy effectiveness was determined by evaluating the accuracy of the laser capsulotomy compared to CCC surgical Control.
Laser phacofragmentation effectiveness was determined by comparison of the Catalys™ System (all subjects) and surgical Control cohort's Cumulative Dissipated Energy (CDE) values reported at the conclusion of the cataract surgery.
Safety of the Catalys™ System was evaluated by tallying all subject complications and adverse events and comparing these findings to those of the surgical Control cohort. Non-device-related complications and adverse events were found to be comparable between the two cohorts. Device-related complications ascribed to the Catalys™ System were limited to petechiae (72% of eyes) and subconjunctival hemorrhage (5% of eyes). All device-related complications were determined to be mild and transitory in nature, as all resolved in less than 30 days without the need for additional medical intervention.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Difference from Intended Diameter (Mean, Standard Deviation, Minimum, Maximum)
Catalys™ System: Mean (µm) 29, Standard Deviation (µm) 26, Minimum (µm) 1, Maximum (µm) 132
Control: Mean (µm) 339, Standard Deviation (µm) 248, Minimum (µm) 23, Maximum (µm) 1013
Cumulative Dissipated Energy (CDE) Values (Mean, Standard Deviation, Minimum, Maximum)
Catalys™ System: Mean 10.39, Standard Deviation 6.61, Minimum 0.91, Maximum 27.65
Control: Mean 18.54, Standard Deviation 12.07, Minimum 5.23, Maximum 47.86
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.
Not Found
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
510(k) Summary 5.1.
The following 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92:
5.1.1. Applicant
OptiMedica Corporation 3100 Coronado Drive Santa Clara, CA 95054 Phone: 408.850.8600 Fax: 408.583.4380
5.1.2. Contact Person
Alan Marquardt Vice President of Regulatory, Clinical and Quality OptiMedica Corporation 3100 Coronado Drive Santa Clara, CA 95054 Phone: 408.792.8173 Fax: 408.583.4380 Email: amarquardt@optimedica.com
5.1.3. Date Prepared
July 1, 2011
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
OptiMedica Catalys™ Precision Laser System
5.1.6. Predicate Devices
LenSx 550 Laser System (LenSx Lasers Inc. Aliso Viejo CA); K094052
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5.1.7. Intended Use
The OptiMedica Catalys™ Precision Laser System is indicated for anterior capsulotomy and laser phacofragmentation during cataract surgery. The anterior capsulotomy and phacofragmentation procedures may be performed either individually or consecutively during the same surgery.
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 phacofragmentation, thus facilitating efficient lens removal. 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 coregistered and provide for precise overlap between imaging and treatment beams. 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 I lasers per ANSI Z136.1-2007.
5.1.9. Substantial Equivalence
The OptiMedica Catalys™ Precision Laser System is substantially equivalent to the LenSx 550 Laser System in terms of indications for use, technological characteristics and performance specifications. 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 and effectively fragment the crystalline lens. Furthermore, the Catalys™ System incorporates an integrated spectral domain optical coherence tomography (OCT) sub-system to guide the laser treatment effectively.
5.1.10. Summary of Bench, Animal and Clinical Performance Testing
Bench testing of the Catalys™ System was conducted to demonstrate the OCT subsystem's ability to measure depth, surface profiles and iris diameters with accuracy and precision. Various test article substrates of known dimensions were measured multiple times by the System's OCT sub-system. All OCT-measured values met the test protocol acceptance criteria of ±40μm for all thicknesses and diameters, and ± 1% for all surface radii. This testing verifies that the OCT subsystem of the Catalys™ System can measure depth, surface profiles and diameters accurately and precisely.
Bench testing of the Catalys™ System was also conducted to demonstrate the System's ability to deliver a variety of laser patterns intended for capsulotomy or phacofragmentation with corresponding accuracy and precision. In this test, all laser parameters such as spot spacing, depth spacing, and pulse energy were bracketed to
2
assess the full capability of the System. Additionally, the System's entire suite of capsulotomy and phacofragmentation patterns was similarly bracketed to test the full spectrum of physician-selectable pattern variations. Multiple samples for a given test pattern were created in a test substrate that was subsequently cross-sectioned and measured using a NIST-traceable reticule, under magnified digital image analysis. All measured values met the test protocol acceptance criteria of ±100μm relative to the intended cut dimensions. The spectrum of pattern testing validated the System capability to cut a variety of capsulotomy and phacofragmentation patterns within specified limits for accuracy and precision.
Animal testing was performed to demonstrate retinal and corneal safety, and to establish the strength of the iens post-capsulotomy.
The OptiMedica Catalys™ Precision Laser System was clinically evaluated in a prospective, randomized non-inferiority trial in which one eye was randomly assigned to receive treatment with the Catalys™ System, including capsulotomy and laser phacofragmentation, followed by standard ultrasound phacoemulsification as necessary. The subject's contralateral eye, serving as the study Control eye, was assigned treatment with the current "gold standard" surgical technique of continuous curvilinear capsulorrhexis (CCC) and standard ultrasound phacoemulsification. Catalys™ System treatment times for the combined capsulotomy and laser phacofragmentation were found to be less than one minute in all subjects. Total procedure time (defined as the total time the subject was under suction and docked to the System) averaged just over 5 minutes with a maximum of 14 minutes.
Capsulotomy effectiveness was determined by evaluating the accuracy of the laser capsulotomy compared to CCC surgical Control. Table 1 shows the difference between the intended and the actual diameter of the capsulotomy (all subjects treated with the Catalys™ System) versus capsulorhexis (Control).
| Difference from Intended Diameter | Catalys™ System | Control |
|---|---|---|
| Mean (µm) | 29 | 339 |
| Standard Deviation(µm) | 26 | 248 |
| Minimum(µm) | 1 | 23 |
| Maximum (µm) | 132 | 1013 |
Table 1 - Difference Between Actual and Intended Diameter
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Laser phacofragmentation effectiveness was determined by comparison of the Catalys™ System (all subjects) and surgical Control cohort's Cumulative Dissipated Energy (CDE) values reported at the conclusion of the cataract surgery. The CDE values represent the total ultrasound energy delivered during the phacoemulsification and are detailed in Table 2:
| CDE | Catalys™ System | Control |
|---|---|---|
| Mean | 10.39 | 18.54 |
| Standard Deviation | 6.61 | 12.07 |
| Minimum | 0.91 | 5.23 |
| Maximum | 27.65 | 47.86 |
Table 2 - Cumulative Dissipated Energy (CDE) Values
Safety of the Catalys™ System was evaluated by tallying all subject complications and adverse events and comparing these findings to those of the surgical Control cohort. Non-device-related complications and adverse events were found to be comparable between the two cohorts. Device-related complications ascribed to the Catalys™ System were limited to petechiae (72% of eyes) and subconjunctival hemorrhage (5% of eyes). All device-related complications were determined to be mild and transitory in nature, as all resolved in less than 30 days without the need for additional medical intervention.
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OptiMedica Corporation c/o Mr. Alan Marquardt Vice President of Regulatory, Clinical and Quality 3100 Coronado Drive Santa Clara, CA 95054
DEC 2 1 2011
Re: K113479
Trade/Device Name: OptiMedica Catalys™ Precision Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE Dated: November 22, 2011 Received: November 23, 2011
Dear Mr. Marquardt:
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.
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Page 2 - Mr. Alan Marquardt
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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Debra Falls
Malvina B. Eydelmañ, M.D. Director Division of Ophthalmic, Neurological. 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):
Device Name:
Indications For Use:
OptiMedica Catalys™ Precision Laser System
The OptiMedica Catalys™ Precision Laser System is indicated for anterior capsulotomy and laser phacofragmentation during cataraot surgery. The anterior capsulotomy and phacofragmentation procedures may be performed either individually or consecutively during the same surgery.
Image /page/6/Picture/7 description: The image shows a checkmark inside a box next to the words "Prescription Use (Part 21 CFR 801 Subpart D)". The checkmark indicates that the prescription use option has been selected. The text in parentheses refers to a specific part of the Code of Federal Regulations.
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)
Tang Kaufman us
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K113479
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