(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 | PASS |
| Software 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.
§ 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.