(85 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.
Peregrine's 25ga Curved Illuminating Laser Probe is an ophthalmic light and laser delivery device. It consists of glass fiber with PVC jacket, an SMA connector, a Delrin handpiece and a needle set consisting of 304 stainless steel and nitinol. There is also an actylic fiber with PVC jacket and an aluminum illumination connector. Both connectors plug into existing laser and light sources.
The Laser Probe can only be used in combination with a medical laser in the Vis-NIR transmission range of 532nm to 810mm with a maximum power output of 2.5 Watts and that is appropriate for photocoagulation. The light portion of the device is designed for use with the Alcon Constellation Vision System. The Constellation uses a 50 Watt Xenon arc lamp that emits light with an output of 30 lumens within the wavelength range of 400nm to 700mm.
The outer dimension of the glass fiber to be used in the proposed device is 98 microns or about .004 inches, which is about 25% of the size of the glass fiber in Peregrine's predicate device.
The acrylic fiber that will be used has an outer dimension of 254 microns or .01 inches, which is 25% of the size of the acrylic fiber used in the predicate device. The decrease in size of both fibers has created an acceptable device.
Here's a breakdown of the acceptance criteria and study information for the Peregrine 25ga Curved Illuminating Laser Probe, based on the provided text:
Device: Peregrine 25ga Curved Illuminating Laser Probe (PD725.37SA)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly derived from the comparison to the predicate device and the successful completion of performance tests. The goal was to demonstrate substantial equivalence, meaning the new device performs at least as safely and effectively as the predicate.
| Acceptance Criterion (implicitly derived from predicate) | Reported Device Performance (Peregrine 25ga Curved Illuminating Laser Probe) |
|---|---|
| Laser Fiber: | |
| - Optical Fiber Material: Glass - Silica Core | Glass - Silica Core |
| - Glass Fiber Diameter: 0.008" (200 microns) | 0.0030" (73 microns) * (Smaller, but deemed acceptable) |
| - Max Threshold of Laser Fiber: 3 mW | 3 mW |
| - Transmission Range of Laser Fiber: 180 nm to 1,150 nm | 180 nm to 1,150 nm |
| - Laser Power Efficiency: ≈ 95.0% | ≈ 94.5% (Slightly lower, but deemed acceptable) |
| - Laser Spot Size: ≈ 2.45 inches | ≈ 2.4 inches (Slightly smaller, but deemed acceptable) |
| - PVC Jacket (Black) | PVC Jacket (Black) |
| - PVC Jacket - ID: 0.040" / 0.070" | PVC Jacket - ID: 0.040" / 0.070" |
| - Length: 101 Inches | 101 Inches |
| - Weight: 31.6 | 30.8 |
| Needle: | |
| - Needle Type: 304 Stainless Needle | 304 Stainless and Nitinol Needle (Nitinol addition deemed acceptable) |
| - Gauge: 20 Gauge | 25 Gauge (Smaller gauge, primary design change, deemed acceptable) |
| Illumination Fiber: | |
| - Acrylic Illumination Fiber OD: 0.01" | 0.0095" OD (Smaller, but deemed acceptable) |
| - Aluminum Illumination Connector | Aluminum Illumination Connector |
| Other: | |
| - Illumination and laser transmission for photocoagulation | Illumination and laser transmission for photocoagulation |
| - Connector Material: Delrin® / Ni / Cu Stainless Alloy | Delrin® / Ni / Cu Stainless Alloy |
| - Handpiece Material: Delrin® Handpiece | Delrin® Handpiece |
| - Biocompatibility | 100% biocompatibility (all materials) |
| - Sterilization (ETO, SAL 10^-6, ISO 11135-1, ECH limits) | Compliant |
| - Shelf Life | 4 years |
| - Optical Radiation Safety (transmission only) | Compliant with stated responsibility limitations |
2. Sample size used for the test set and the data provenance
The document does not explicitly state a "test set" in the context of human data or a specific number of devices tested for each performance characteristic. Instead, it refers to:
- "3 performance tests" to evaluate light output, laser power output, and laser field clarity. The sample size for these tests is not specified.
- "Bend testing" performed on both the existing and proposed designs. The number of samples for bend testing is not specified.
- Biocompatibility testing. The number of material samples tested is not specified.
- Sterilization and shelf-life validation. This would involve a specific number of packages/devices, but the exact count is not given.
The data provenance is Peregrine Surgical Ltd. internal testing. The document does not specify country of origin for test data, nor does it explicitly state if it was retrospective or prospective, though performance and material testing are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes engineering and material performance testing rather than studies involving expert human review of medical images or diagnoses. The "ground truth" here is based on measurable physical properties and compliance with established material and manufacturing standards.
4. Adjudication method for the test set
Not applicable. This type of adjudication (e.g., 2+1, 3+1) is relevant for studies where human experts interpret data (like images) and resolve discrepancies. The provided document details technical performance and material testing.
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
Not applicable. This device is a surgical tool (laser probe), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI assistance are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence, standalone performance tests were done. The "3 performance tests" (light output, laser power output, laser field clarity), "bend testing," and biocompatibility testing represent the standalone performance evaluation of the device itself, without human interpretation in a diagnostic context. The device's function is to transmit laser and light energy, and these tests evaluate that function directly.
7. The type of ground truth used
The ground truth used for this device's evaluation is primarily based on:
- Physical measurements and engineering specifications: Metrics like laser power efficiency, spot size, fiber dimensions, length, weight, etc., are directly measured and compared against the predicate device's established performance parameters.
- Material standards: Biocompatibility is assessed against established biological safety standards. Nitinol's use is justified by its existing approval in other ophthalmic devices and by specific bend testing.
- Sterilization and shelf-life validation standards: Compliance with AAMI Overkill Method according to ISO 11135-1 and residual testing.
8. The sample size for the training set
Not applicable. This device's development and evaluation do not involve machine learning or AI, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is not relevant.
§ 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.