(37 days)
Intended for use in the treatment of ocular pathology in both the posterior and anterior segments.
Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:
(532nm)
- proliferative and non-proliferative diabetic retinopathy
- macular edema
- choroidal neovascularization associated with wet age-related macular degeneration
- age-related macular degeneration
- lattice degeneration
- retinal tears and detachments
(577nm)
- proliferative and non-proliferative diabetic retinopathy
- macular edema
- choroidal neovascularization associated with wet age-related macular degeneration
- age-related macular degeneration
- lattice degeneration
- retinal tears and detachments
Intended for use in the treatment of ocular pathology in the anterior segment including:
(532 nm and 577nm)
- iridotomy
- trabeculoplasty
The Iridex PASCAL® (532 nm and 577 nm models) is an ophthalmic scanning laser system. PASCAL is an acronym for Pattern SCAn Laser. The system can perform single shot photocoagulation as is performed conventionally. In addition, the system is equipped with proprietary laser scanning technology that provides the user with the option to perform laser pattern scanning. This allows the user to place many laser treatment spots in a patient's eye rapidly by performing pattern scan laser photocoagulation. The system will scan user-selectable patterns of laser spots into a patient's eye.
The system includes a table for housing the laser module and associated electronics. A slit lamp is also integrated in the table enabling the interface to be at the base of the slit lamp, i.e., no external cabling. The table is smaller in size compared to prior versions to accommodate use in smaller rooms. In addition to single shot and pattern scanning the system also supports the use of a Laser Indirect Ophthalmoscope (LIO) with optical fiber port for connection of a LIO.
The system is available with either 532nm or 577nm laser emission.
This document is a 510(k) summary for the Iridex PASCAL® 532, Iridex PASCAL® 577, and Iridex PASCAL® (532 nm and 577 nm models) ophthalmic laser systems. It compares the subject device to a predicate device (PASCAL® Synthesis™ Ophthalmic Scanning Laser System) to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Verification/Validation Method(s) | Acceptance Criteria | Summary of Results |
|---|---|---|
| IEC 60601-1 Electrical Safety | Meet applicable clauses of IEC 60601-1 | PASS.Device meets requirements of applicable clauses of IEC 60601-1 |
| IEC 60601-1-2 EMI/EMC | Meet IEC 60601-1-2 Requirements | PASS.The unit met the requirements of applicable clauses of IEC 60601-1-2. |
| IEC 60601-1-6 Usability | Meet the requirements of the applicable clauses IEC 60601-1-6 | PASS.Device meets requirements of applicable clauses of IEC 60601-1-6 |
| IEC 60601-2-22 Laser Safety | Meet all applicable IEC 60601-2-22 test items except for EMC, Biocompatibility | PASS.Device meets requirements of applicable clauses of IEC 60601-2-22. |
| IEC 60825-1 Laser Safety | Meet applicable IEC 60825-1 requirements | PASS.Device meets IEC 60825-1 Requirements |
| IEC 62304, Medical device software, Software life-cycle processes | Software lifecycle processes and activities meet requirements of applicable clauses of IEC 62304 | PASSSoftware lifecycle processes and activities meet IEC 62304 Requirements |
| Shipping and Packaging Testing | Meet ISTA 3B Testing and Acceptance Requirements for:• Climatic Conditioning-Package• Climatic Conditioning-Product• Atmospheric Preconditioning• Shock (First Sequence)• Vertical Vibration (Random Vibration with Top Load)• Shock (Second Sequence)Meet Iridex performance specifications pre- and post-conditioning testing. | PASS.Test unit passed ISTA-3B conditioning and testing (Westpak testing)Test unit passed Iridex performance testing Pre-and Post-conditioning (Iridex testing). |
2. Sample size used for the test set and the data provenance:
The document states that "Clinical testing was not required for this product change." This indicates that the performance data summarized above is based on non-clinical testing (e.g., bench testing, engineering validation). Therefore, there isn't a "test set" in the sense of a patient cohort. The testing was conducted on samples of the device itself.
- Sample size for test set: Not applicable for a clinical test set. The number of devices or components tested for each non-clinical verification is not specified, but it would typically be a statistically appropriate engineering sample size.
- Data provenance: The testing appears to be conducted by the manufacturer (Iridex testing) and potentially third-party labs (Westpak testing for shipping and packaging). The origin is thus manufacturer's internal testing and outsourced engineering testing. It is not retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is typically relevant for studies involving human interpretation or clinical outcomes. Since this submission relies on non-clinical engineering and safety standards, the concept of "ground truth established by experts" in this context is not directly applicable. The "ground truth" is the objective compliance with the specified international standards (e.g., IEC 60601 series, IEC 60825-1, IEC 62304) and the manufacturer's performance specifications. The experts involved would be the engineers and quality assurance personnel performing and overseeing these tests, and potentially external auditors or testing facility personnel. Their specific qualifications are not detailed but are presumed to be appropriate for conducting such technical verification.
4. Adjudication method for the test set:
Not applicable, as there is no clinical test set requiring expert adjudication of results. The testing involves objective measurements and comparisons against predefined criteria in relevant standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This device is an ophthalmic laser system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (laser system), not an algorithm or AI. The tests performed are to confirm that the hardware and software components of the device meet safety and performance standards in a standalone operational capacity.
7. The type of ground truth used:
The "ground truth" used is defined by:
- International Standards: e.g., IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMI/EMC), IEC 60601-1-6 (Usability), IEC 60601-2-22 (Laser Safety), IEC 60825-1 (Laser Safety), IEC 62304 (Software life-cycle processes).
- Manufacturer Performance Specifications: For shipping and packaging testing, "Iridex performance specifications" are used.
These standards and specifications serve as the objective criteria against which the device's performance is measured.
8. The sample size for the training set:
Not applicable. This is a physical medical device submission, not an AI/machine learning model that requires a training set of data.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device submission.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 9, 2022
Iridex Corporation Bill Hyatt Director of Regulatory Affairs 1212 Terra Bella Ave. Mountain View, CA 94043
Re: K223132
Trade/Device Name: Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532 nm and 577 nm models) Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HOF Dated: September 23, 2022 Received: October 3, 2022
Dear Bill Hyatt:
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.
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
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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 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-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 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,
Anjana Jain -S
Anjana Jain, PhD 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) K223132
Device Name
Iridex PASCAL® 532. Iridex PASCAL® 577, and Iridex PASCAL® (532 nm and 577 nm models)
Indications for Use (Describe)
Intended for use in the treatment of ocular pathology in both the posterior and anterior segments.
Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:
(532nm)
- · proliferative and non-proliferative diabetic retinopathy
- macular edema
- · choroidal neovascularization associated with wet age-related macular degeneration
- · age-related macular degeneration
- lattice degeneration
- retinal tears and detachments
(577nm)
- · proliferative and non-proliferative diabetic retinopathy
- · macular edema
- choroidal neovascularization associated with wet age-related macular degeneration
- · age-related macular degeneration
- lattice degeneration
- · retinal tears and detachments
Intended for use in the treatment of ocular pathology in the anterior segment including:
(532 nm and 577nm)
- · iridotomy
- · trabeculoplasty
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle made of dots on the left and the word "IRIDEX" in purple on the right. The circle is half-filled with a solid purple color, and the other half is made of dots.
510(k) SUMMARY; K223132
Submitter Information
| Company: | Iridex Corporation1212 Terra Bella AveMountain View, CA 94043-1824Phone: (650) 940-4700Fax: (650) 355-1305Establishment Registration No.: 2939653 |
|---|---|
| Contact Person: | Bill HyattDirector, Regulatory AffairsPhone: (650) 605-8727Fax: (650) 940-4710 |
- Date Prepared: November 09, 2022
Device Name and Classification
| Common Name: | Ophthalmic Laser |
|---|---|
| Proprietary Name: | Iridex PASCAL® 532 |
| Proprietary Name: | Iridex PASCAL® 577 |
| Proprietary Name: | Iridex PASCAL® (532 nm and 577nm models) |
| Classification Name: | Laser, Ophthalmic |
|---|---|
| Product Code: | HQF |
| Regulation Number: | 21 CFR 886.4390 |
| Device Class: | II |
Predicate Device
| Laser Console | |
|---|---|
| Company: | Iridex Corporation |
| Device: | PASCAL® Synthesis™ Ophthalmic Scanning Laser System(K123542) |
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Image /page/5/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle made of dots on the left, followed by the word "IRIDEX" in a dark blue sans-serif font. The circle is only half-filled in with purple, and the dots are arranged in a semi-circular pattern.
Intended Use
A laser system console with an integrated slit lamp. The system connects to the slit lamp to enable laser energy to be delivered through the slit lamp illumination path. The system may be used for standard single shot photocoagulation and laser scanning patterns.
The system enables the physician to deliver multiple laser spots with a single footswitch depression by automating the emission of laser light. The aiming beam displays the pattern, allowing the physician to place it in the appropriate location.
Indications for Use
Intended for use in the treatment of ocular pathology in both the posterior and anterior segments.
Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:
(532nm)
- proliferative and non-proliferative diabetic retinopathy ●
- . macular edema
- . choroidal neovascularization associated with wet age-related macular degeneration
- . age-related macular degeneration
- . lattice degeneration
- . retinal tears and detachments
(577nm)
- . proliferative and non-proliferative diabetic retinopathy
- macular edema
- choroidal neovascularization associated with wet age-related macular degeneration .
- age-related macular degeneration .
- . lattice degeneration
- . retinal tears and detachments
Intended for use in the treatment of ocular pathology in the anterior segment including:
(532 nm and 577nm)
- iridotomy .
- trabeculoplasty .
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Image /page/6/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle on the left side with a dotted outline. To the right of the circle is the word "IRIDEX" in a dark purple sans-serif font. The logo is simple and modern.
Device Description
The Iridex PASCAL® (532 nm and 577 nm models) is an ophthalmic scanning laser system. PASCAL is an acronym for Pattern SCAn Laser. The system can perform single shot photocoagulation as is performed conventionally. In addition, the system is equipped with proprietary laser scanning technology that provides the user with the option to perform laser pattern scanning. This allows the user to place many laser treatment spots in a patient's eye rapidly by performing pattern scan laser photocoagulation. The system will scan user-selectable patterns of laser spots into a patient's eye.
The system includes a table for housing the laser module and associated electronics. A slit lamp is also integrated in the table enabling the interface to be at the base of the slit lamp, i.e., no external cabling. The table is smaller in size compared to prior versions to accommodate use in smaller rooms. In addition to single shot and pattern scanning the system also supports the use of a Laser Indirect Ophthalmoscope (LIO) with optical fiber port for connection of a LIO.
The system is available with either 532nm or 577nm laser emission.
Comparison of Technological Characteristics with the Predicate Device
A risk management analysis was conducted in accordance with standard EN ISO 14971.
The following table provides a comparison of Technological Characteristics of the SUBJECT device (Iridex PASCAL® 532 and Iridex PASCAL® 577) to the PREDICATE Device (PASCAL® Synthesis™ Ophthalmic Scanning Laser System).
The technological characteristics of the SUBJECT device (laser console) are substantially equivalent to those of the PREDICATE device.
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Image /page/7/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle on the left, with a series of dots forming the left half of the circle. To the right of the circle is the word "IRIDEX" in purple, with each letter capitalized.
| Characteristic | PASCAL® Synthesis™Ophthalmic Scanning Laser System(Predicate Device) | Iridex PASCAL®(532 nm and 577 nm models)(Subject Device) | Bearing onSubstantialEquivalence |
|---|---|---|---|
| Intended Use and Indications for Use | |||
| Intended Useand Indicationsfor Use | Intended Use:A laser system console with an integrated slit lamp. Thesystem connects to the slit lamp to enable laser energy to bedelivered through the slit lamp illumination path. The systemmay be used for standard single shot photocoagulation andlaser scanning patterns.The system enables the physician to deliver multiple laserspots with a single footswitch depression by automating theemission of laser light. The aiming beam displays the pattern,allowing the physician to place it in the appropriate location.Indications for Use:Intended for use in the treatment of ocular pathology in boththe posterior and anterior segments.Intended for use in the posterior segment to perform retinalphotocoagulation, panretinal photocoagulation, focalphotocoagulation and grid photocoagulation for vascular andstructural abnormalities of the retina and choroid including:(532nm)proliferative and non-proliferative diabetic retinopathy macular edema choroidal neovascularization associated with wet age-related macular degeneration age-related macular degeneration lattice degeneration retinal tears and detachments (577nm) proliferative and non-proliferative diabetic retinopathy macular edema choroidal neovascularization associated with wet age-related macular degeneration age-related macular degeneration lattice degeneration retinal tears and detachments Intended for use in the treatment of ocular pathology in theanterior segment including:(532 nm and 577nm) iridotomy trabeculoplasty | Identical (no change)Note: There is no proposedchange with respect toIntended Use and Indicationsfor Use. | SubstantiallyEquivalent |
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Image /page/8/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle with a dotted outline on the left, followed by the word "IRIDEX" in a bold, sans-serif font. The color of the text is also purple, matching the color of the circle.
| Characteristic | PASCAL® Synthesis™Ophthalmic Scanning Laser System(Predicate Device) | Iridex PASCAL®(532 nm and 577 nm models)(Subject Device) | Bearing onSubstantialEquivalence | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Where thedevice is used | Professional Healthcare Facility Environment• Physician offices, clinics, multiple treatment facilities,hospitals except for near active HF surgical equipmentand the RF shielded room of an ME system for magneticresonance imaging, where the intensity of EMdisturbances is high | Identical (no change) | SubstantiallyEquivalent | ||||||
| Design/Technological Characteristics | |||||||||
| OperatingPrinciples | A laser system console with an integrated slit lamp. The systemconnects to the slit lamp to enable laser energy to be deliveredthrough the slit lamp illumination path. The system may be used forstandard single shot photocoagulation and laser scanning patternsThe system enables the physician to deliver multiple laser spots witha single footswitch depression by automating the emission of laserlight. The aiming beam displays the pattern, allowing the physicianto place it in the appropriate location. | Identical (no change) | SubstantiallyEquivalent | ||||||
| Laser Type | Optically Pumped Semiconductor Laser (OPSL) (Treatment)Laser Diode (Aiming) | Identical (no change) | SubstantiallyEquivalent | ||||||
| OutputWavelength | • 532 nm or 577 nm (Treatment)• 635 nm (Aiming) | Identical (no change) | SubstantiallyEquivalent | ||||||
| Output Mode | Continuous-Wave | Identical with addition ofMicroPulse® | SubstantiallyEquivalent | ||||||
| Electrical VAC | 100-240 VAC, 50/60 Hz | Identical (no change) | SubstantiallyEquivalent | ||||||
| ElectricalCurrent | < 10 Amperes | Identical (no change) | SubstantiallyEquivalent | ||||||
| User Interface | • Touchscreen LCD Control Panel,• Slit Lamp,• Micro Manipulator (slit lamp),• Power Knob (slit lamp),• 3D Controller (optional),• Footswitch (wired) | Identical with the followingchanges:• addition of WirelessFootswitch as an optionalaccessory,• the removal of 3DController as an option | Substantiallyequivalent | ||||||
| LaserActivation | Footswitch (wired) | Identical with addition ofWireless Footswitch as anoptional accessory | SubstantiallyEquivalent | ||||||
| Performance | |||||||||
| Treatmentwavelength(Nominal) | • 532 nm for 532 model• 577 nm for 577 model | Identical (no change) | SubstantiallyEquivalent | ||||||
| Aiming beamwavelength(Nominal) | 635 nm | Identical (no change) | SubstantiallyEquivalent | ||||||
| Power Output(mW) | • 0 to 2000 mW (Treatment)• Adjustable 0 to <1 mW (Aiming) | Identical (no change) | SubstantiallyEquivalent | ||||||
| Duty Cycle | 100% | Enable a variable Duty Cyclewith no change to maximumduty cycle (i.e., no change tothe maximum percentage of100%) | SubstantiallyEquivalent |
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Image /page/9/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle made of dots on the left, followed by the word "IRIDEX" in purple. The font is sans-serif and the letters are evenly spaced.
| Characteristic | PASCAL® Synthesis™Ophthalmic Scanning Laser System(Predicate Device) | Iridex PASCAL®(532 nm and 577 nm models)(Subject Device) | Bearing onSubstantialEquivalence |
|---|---|---|---|
| Pulse duration | 10 ms to 1000 ms | Maintain maximum pulse (1000ms) while enabling thelower end of the pulse range.The enabled exposure timerange is 0.05ms -1000ms | SubstantiallyEquivalent |
| Pulse Interval | 1, 1.5, 2, 3, 4, 5, 6, 7 and 8 Hz (single spot or LIO) | Identical (no change) | SubstantiallyEquivalent |
| Pulse Counter | 0 – 99,999 | Identical (no change) | SubstantiallyEquivalent |
| Laser Beamdiameter | 50, 100, 200, 400 μm (in air) | 400 μm was replaced with 300 μm | SubstantiallyEquivalent |
| Compatibility | |||
| CompatibleDeliveryDevices | Laser Indirect Ophthalmoscopes (LIO) | Identical (no change) | SubstantiallyEquivalent |
| Packaging & Sterilization | |||
| Packaging &Sterilization | • Supplied non-sterile.• Shipping packaging has been designed to safely transportthe device to end user facility | Change to packaging designand materials that wasvalidated per ISTA 3B | SubstantiallyEquivalent |
Performance Data
The following table summarizes nonclinical testing relevant to the Iridex PASCAL® 532 and Iridex PASCAL® 577 in accordance with the requirements of the design control regulations and established quality assurance procedures.
Clinical testing was not required for this product change.
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| Verification/ Validation Method(s) | Acceptance Criteria | Summary of Results |
|---|---|---|
| IEC 60601-1 Electrical Safety | Meet appliable clauses of IEC 60601-1 | PASS.Device meets requirements of appliable clauses of IEC 60601-1 |
| IEC 60601-1-2 EMI/EMC | Meet IEC 60601-1-2 Requirements | PASS.The unit met the requirements of appliable clauses of IEC 60601-1-2. |
| IEC 60601-1-6 Usability | Meet the requirements of the appliable clauses IEC 60601-1-6 | PASS.Device meets requirements of appliable clauses of IEC 60601-1-6 |
| IEC 60601-2-22 Laser Safety | Meet all appliable IEC 60601-2-22 test items except for EMC, Biocompatibility | PASS.Device meets requirements of appliable clauses of IEC 60601-2-22. |
| IEC 60825-1 Laser Safety | Meet appliable IEC 60825-1 requirements | PASS.Device meets IEC 60825-1 Requirements |
| IEC 62304, Medical device software, Software life-cycle processes | Software lifecycle processes and activities meet requirements of appliable clauses of IEC 62304 | PASSSoftware lifecycle processes and activities meet IEC 62304 Requirements |
| Shipping and Packaging Testing | Meet ISTA 3B Testing and Acceptance Requirements for:• Climatic Conditioning-Package• Climatic Conditioning-Product• Atmospheric Preconditioning• Shock (First Sequence)• Vertical Vibration (Random Vibration with Top Load)• Shock (Second Sequence)Meet Iridex performance specifications pre- and post-conditioning testing. | PASS.Test unit passed ISTA-3B conditioning and testing (Westpak testing)Test unit passed Iridex performance testing Pre-and Post-conditioning (Iridex testing). |
Conclusions
The Iridex PASCAL® (532 nm and 577 nm models) (SUBJECT device) shares identical Intended Use, Indications for Use, Principles of Operation (technology) including energy source, Design/Technological Characteristics, and Performance, as the PASCAL® Synthesis™ Ophthalmic Scanning Laser System (PREDICATE device), all of which do not raise new questions of safety and effectiveness.
The proposed SUBJECT device is at least as safe and effective as the legally marketed predicate device.
§ 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.