(69 days)
For use during ophthalmic surgery for photocoagulation and aspiration in conjunction with Coherent/Alcon laser and aspiration units. Laser wavelengths range from 193nm to 633nm.
The Peregrine Soft Tip Aspirating Laser Probe is an ophthalmic laser delivery device with aspirating capability. It consists of a connector that gets plugged into the Coherent/Alcon laser, a silicone aspirating line with female luer which attaches to an aspiration line associated with the operating system, a glass fiber with PVC jacket, a silicone reflux boot, a Delrin handpiece, a 304 stainless needle and silicone sleeve (soft tip) attached to the distal tip of the stainless needle. The specific laser source to which the probe is connected will be specified in the "Indications for Use."
The provided document is a 510(k) Premarket Notification for the Peregrine Soft Tip Aspirating Laser Probe. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with detailed acceptance criteria and performance metrics. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not available in these documents.
Here's the information that can be extracted or deduced from the provided text, along with an explanation of why other requested information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. A 510(k) submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria for novel safety and effectiveness endpoints. The document lists comparative characteristics to predicate devices, but these are not presented as acceptance criteria for specific performance metrics of the new device.
2. Sample Size Used for the Test Set and the Data Provenance
This information is not applicable/provided. The 510(k) submission does not describe a clinical study with a "test set" in the context of evaluating performance against acceptance criteria. The comparison is based on device characteristics and intended use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable/provided. As no clinical study or test set for performance evaluation is described, there's no mention of experts establishing ground truth for such a study.
4. Adjudication Method for the Test Set
This information is not applicable/provided. No test set and associated adjudication method are described.
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
This information is not applicable. The device is an ophthalmic laser delivery and aspiration probe, not an AI-assisted diagnostic or treatment system. Therefore, an MRMC study or AI-related effectiveness analysis is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a medical instrument, not an algorithm.
7. The type of ground truth used
This information is not applicable/provided. No specific ground truth establishment for performance evaluation is discussed since it's a 510(k) submission for a device, not a diagnostic algorithm. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices.
8. The Sample Size for the Training Set
This information is not applicable/provided. As it's a physical medical device and not an AI/algorithm, there is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided. As there is no training set, there's no ground truth establishment for it.
Summary of Relevant Information from the Document:
While the document doesn't provide the requested study design details, it demonstrates the basis for its substantial equivalence claim, which is the regulatory standard for a 510(k) submission.
- Device Description: The Peregrine Soft Tip Aspirating Laser Probe is an ophthalmic laser delivery device with aspirating capability, consisting of a connector, silicone aspirating line, glass fiber with PVC jacket, silicone reflux boot, Delrin handpiece, 304 stainless needle, and silicone sleeve (soft tip).
- Indications for Use: For use during ophthalmic surgery for photocoagulation and aspiration in conjunction with Coherent/Alcon laser and aspiration units. Laser wavelengths range from 193nm to 633nm.
- Substantial Equivalence Basis: The device is compared to two predicate devices: "Aspirating Laser Probe" (K954308, Manufactured by Gamp & Assoc.) and "Infinitech Aspirating Laser Probe" (K946135, Manufactured by Infinitech). The comparison table highlights similarities in:
- Light transmission for photocoagulation
- 905 SMA laser connector
- Delrin Handpiece
- Optical Fiber (Glass - Silica Core, .008" / 200 microns)
- Silicone aspirating line
- Female connector
- Silicone Reflux Boot
- Silicone Soft Tip
- PVC Jacket
- 304 Stainless Needle (20 Gauge)
- Max power output (1 watt)
- One difference noted is the length: Peregrine's device is 101 inches, while predicates are 96 inches.
- Sterilization: The device will be ETO Sterilized, validated using the AAMI Overkill Method.
The FDA's letter on page 2 confirms that the agency "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination is the "proof" that the device meets the regulatory requirements for market entry under a 510(k), based on its similarity to already approved devices.
§ 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.