(272 days)
For photocoagulation and illumination during ophthalmic surgery. This device delivers illumination as well as laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.
The 23ga Curved Illuminating Laser Probe is an ophthalmic light and laser delivery device. It consists of glass fiber with PVC jacket, an SMA connector, an acetal handpiece and a needle set consisting of 304 stainless steel and nitinol. There is also an acrylic fiber with PVC jacket and an acetal connector. Both connectors plug into existing laser and light sources.
The device is designed to be an accessory for an Iridex medical laser (cleared under K071687) in the Vis-NIR transmission range of 532 nm to 810 nm with a maximum power output of 2.5 Watts and that is appropriate for photocoagulation. The device can be used with other lasers but they must be FDA approved and also meet the above specifications. The light portion of the device was designed for use with the Bausch & Lomb Stellaris PC light source which is a component of the Bausch & Lomb Stellaris PC Vision Enhancement System (cleared under K101325). The Stellaris PC uses a 75 Watt Xenon arc lamp that emits light with an output of 30 lumens within the wavelength range of 441nm to 665nm (photocoagulation is not applicable to the illumination aspect of the probe).
Here's an analysis of the provided text regarding the acceptance criteria and study for the 23ga Curved Illuminating Laser Probe (K122997).
It's important to note that this 510(k) summary is for a substantially equivalent device, meaning much of the performance evaluation relies on demonstrating equivalence to an already cleared predicate device (Peregrine's Illuminated Laser Probe, K031023) rather than proving de novo safety and effectiveness through extensive clinical trials. Therefore, the information provided isn't as detailed as what might be found for a novel device.
Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for substantial equivalence, the "acceptance criteria" are primarily defined by the performance characteristics of the predicate device. The goal is to show that the new device either meets or performs similarly to the predicate in key areas, or that any differences do not raise new questions of safety or effectiveness.
| Performance Characteristic | Acceptance Criteria (from Predicate) | Reported Device Performance (23ga Curved Illuminating Laser Probe) |
|---|---|---|
| Max Threshold of Laser Fiber | 3000 mW | 3000 mW |
| Transmission Range of Laser Fiber | 180nm to 1,150nm | 180nm to 1,150nm |
| Laser Power Efficiency | ≈ 95.5% | ≈ 95.0% |
| Laser Spot Size | ≈ 2.0 inches | ≈ 1.90 inches |
| Illumination Output | Not explicitly quantified, but assumed to be adequate for ophthalmic surgery. | Less than predicate device, considered acceptable by surgeons for smaller gauge instruments. |
| Laser Field Clarity | Not explicitly quantified, but assumed to be adequate. | Nearly identical to predicate device. |
| Biocompatibility | Compliant with medical use standards. | 100% biocompatibility; all materials are safe for intended use. |
| Cannula Insertion | Ability to pass through cannula without resistance/damage. | Displayed no resistance when passing through cannula system. |
| Bend Testing (Needle Set) | Safe and effective. | Proved to be safe and effective. |
| Transmission Efficiency | Nearly identical to predicate device. | Nearly identical to predicate device (across 3 types of lasers). |
| Sterility (SAL) | 10⁻⁶ | 10⁻⁶ |
| Shelf Life | Not specified for predicate. | 4 years from sterilization. |
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated as a number of "samples" in a traditional clinical study sense. The testing involved comparing parameters of one new device (23ga Curved Illuminating Laser Probe) against one predicate device (PD600.10).
- Data Provenance: The testing was conducted by the manufacturer, Peregrine Surgical. No information on the country of origin or whether it was retrospective/prospective is provided, but it would have been prospective testing specifically for this 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable in the context of this device. This is a comparison of physical and functional characteristics of medical instruments, not an evaluation requiring expert consensus on images or diagnoses. The "ground truth" for performance is established by direct measurement and comparison to the predicate's known performance or accepted engineering standards.
- The document mentions that "Surgeons understand that light outputs are compromised due to the use of smaller needle/tube gauges," implying a general expert consensus or understanding within the ophthalmic surgical community, but no specific experts were involved in a formal ground truth establishment process for the test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study requiring adjudication of findings. Performance measurements were objective.
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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
- Not applicable. This is a physical ophthalmic instrument, not an AI-powered diagnostic device, so no MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm. Performance tests were done on the device itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for demonstrating substantial equivalence was the measured performance of the legally marketed predicate device (PD600.10) and established engineering/biocompatibility standards. For biocompatibility, testing results demonstrating 100% biocompatibility according to recognized standards served as the ground truth. For sterility, the specified SAL and validation method (AAMI Overkill, ISO 11135-1) serve as the ground truth.
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The sample size for the training set
- Not applicable. This is a physical device, not an AI-based system requiring a training set.
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How the ground truth for the training set was established
- Not applicable given that no training set was used.
§ 886.4690 Ophthalmic photocoagulator.
(a)
Identification. An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.(b)
Classification. Class II.