(14 days)
The Peregrine System is intended for the infusion of diagnostic and therapeutic agents into the perivascular area.
The Peregrine System Infusion Catheter is a percutaneous catheter designed to deliver diagnostic and therapeutic agents through a vessel wall and into the perivascular space. The catheter contains three distal needles which are deployed using the control handle. Fluids are administered through the proximal injection lumen in the handle, which delivers the fluid through the needles at the distal end of the device. The micro-needles and the guide tubes are radiopaque for fluoroscopic visibility. The device is intended for vessels 5-7 mm in diameter and is compatible with guide catheters of at least 7F.
The provided text describes the 510(k) summary for the ABLATIVE SOLUTIONS, INC. PEREGRINE SYSTEM™ INFUSION CATHETER. It focuses on the device's technological characteristics and non-clinical performance data to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting performance in a way that aligns with typical AI/algorithm-related studies.
Therefore, many of the requested elements for an AI device study are not present in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the way one would for an AI algorithm. Instead, it lists various non-clinical tests conducted to demonstrate the device's functional integrity and safety.
| Acceptance Criteria Category | Specific Tests Conducted | Outcome/Reported Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity | Met ISO 10993 standards |
| Sensitization | Met ISO 10993 standards | |
| Irritation/Intracutaneous | Met ISO 10993 standards | |
| Acute systemic toxicity | Met ISO 10993 standards | |
| Materials mediated pyrogenicity | Met ISO 10993 standards | |
| Hemocompatibility hemolysis (direct contact) | Met ISO 10993 standards | |
| Hemocompatibility hemolysis (extract) | Met ISO 10993 standards | |
| Complement activation of C3a and SC5b-9 | Met ISO 10993 standards | |
| Thrombogenicity in Sheep | Met ISO 10993 standards | |
| Functional Performance | Visual/Dimensional Inspection | Functions as intended |
| Air Ingress/Negative Collapse | Functions as intended | |
| Tensile Strength | Functions as intended | |
| Liquid Leakage under Pressure/Leakage at Hub | Functions as intended | |
| Flexibility and Kink | Functions as intended | |
| Tip Stiffness | Functions as intended | |
| Guide Tube Deployment Force | Functions as intended | |
| Catheter Torque | Functions as intended | |
| Guidewire Torque | Functions as intended | |
| Corrosion Resistance | Functions as intended | |
| Chemical Compatibility | Functions as intended | |
| Simulated Use Testing | Functions as intended | |
| Device Integrity | Packaging/Simulated Shipping Testing | Functions as intended |
| Sterilization validation | Functions as intended | |
| Clinical Performance | In-vivo testing | Functions as intended |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a comprehensive non-clinical testing program as outlined in the "Non-Clinical Performance Data" section.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in terms of individual units tested for each specific test. The document mentions "testing performed on the proposed device," implying an adequate number of devices were tested per standard practice for each test type, but specific quantities are not provided.
- Data Provenance: The tests are described as "non-clinical bench testing, simulated-use testing and in-vivo testing." This indicates the data is generated through laboratory experiments and animal (sheep) studies, not human clinical data. The country of origin for these labs is not specified. It is prospective in the sense that the tests were designed and executed to evaluate the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the document describes the testing of a medical device (catheter), not an AI algorithm requiring expert-established ground truths on medical images or patient data. The "ground truth" here is adherence to engineering standards (ISO 10993, ISO 10555-1) and functional performance criteria. The experts involved would be engineers, scientists, and technicians conducting the tests and interpreting results against established standards. Their qualifications are not detailed.
4. Adjudication method for the test set
Not applicable for a device testing report of this nature. Adjudication methods like 2+1 or 3+1 typically refer to conflicts in expert labelers for AI ground truth, which is not relevant here.
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 document pertains to a physical medical device (infusion catheter), not an AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm; it's a medical device.
7. The type of ground truth used
The "ground truth" for this device's performance evaluation is established by:
- Adherence to International Standards: ISO 10993 (Biocompatibility) and ISO 10555-1 (Catheter standards).
- Functional Performance Specifications: Predefined engineering specifications for mechanical, chemical, and fluid delivery characteristics.
- In-vivo observations: Performance in animal models (e.g., thrombogenicity in sheep) against expected physiological responses.
8. The sample size for the training set
Not applicable. This is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).