(60 days)
Phenom® Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.
The Phenom® 27 Catheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface of the catheter is coated to aid in navigation in the vessel. The catheter also incorporates a liner to facilitate movement of introduction devices passing through its lumen. The distal tip has radiopaque marker(s) to aid visualization and positioning under fluoroscopy.
This document describes the pre-clinical bench testing conducted for the Phenom® 27 Catheter, a medical device. The purpose of the study was to demonstrate that a modified version of the catheter (with an increased effective length) is substantially equivalent to the previously cleared predicate device.
Here's an analysis of the acceptance criteria and study as per your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with numerical thresholds for each test. Instead, it describes each test, its purpose, and concludes with a qualitative "Results" section, often stating that the results are "within the expected range" or "equivalent" to the predicate device, or that all samples "passed."
Here's an adapted table based on the provided information, interpreting the "Test Method Summary" as implicitly defining the acceptance criteria (i.e., meeting the standard, providing a reference, or demonstrating functional equivalence) and "Results" as the device's performance against these criteria.
| Test Description | Implicit Acceptance Criterion (based on Test Method Summary) | Reported Device Performance |
|---|---|---|
| Catheter Flow Rate | Provide user with flow rate reference using various contrast media and pressure conditions. | Flow rate data collected, new geometry resulted in slightly lower flow rates, but within expected range and equivalent to predicate. |
| Flow rate for each lumen, according to ISO 10555-1 | Compliance to catheter standard BS EN ISO 10555-1: 2013. | Flow rate data collected, new geometry resulted in slightly lower flow rates, but within expected range and equivalent to predicate. All passing results. |
| Dead Space Volume | Provide user with dead space volume (fill volume) of the catheters. | New geometry resulted in slightly larger dead space volume, but passing results within expected range and equivalent to predicate. |
| Accessibility/ Tractability Test | Modified Catheter can reach M1 region of tortuous neurovascular model when tested at body temperature with appropriate accessories and flushing conditions. | All tested articles (modified and predicate) were able to reach M1 region. All samples passed, confirming functional equivalence. |
| Dimensional Verification | All dimensional requirements meet specified attributes; visual and dimensional inspection on pre- and post-sterile. | Test samples inspected, passed specified attributes. All test articles met visual and dimensional specifications pre- and post-sterilization. Modified and predicate meet same equivalent requirements. |
| Material verification | All materials are as specified in raw material, final assembly, subassembly specifications and vendor certifications. | Results verified all materials are as specified and identical to predicate, therefore equivalent. |
| Catheter/ Guide Catheter Compatibility | Catheter can track through a guiding catheter with an I.D. ≥ 0.0445". | Added length to proximal shaft does not affect working (distal) shaft; passing test results of predicate apply and are equivalent. Confirmed with Accessibility/Tractability Test. |
| Catheter/Guide Wire Compatibility | Catheter is able to track over a guide wire ≤ 0.025" in diameter. | Added length to proximal shaft does not affect working (distal) shaft; passing test results of predicate apply and are equivalent. Confirmed with Accessibility/Tractability Test. |
| Catheter/ RHV Compatibility and Leakage Verification | Catheter is compatible with rotating hemostasis value (RHV) in dimension and RHV will not leak during use. | Added length does not affect RHV connection (identical RHV); passing test results of predicate apply and are equivalent. |
| Shaft Stiffness | Catheter shaft to meet specification on stiffness. | Added length to proximal shaft does not affect stiffness of working (distal) shaft; passing test results of predicate apply and are equivalent. Confirmed with Accessibility/Tractability Test. |
| Chemical Compatibility | Catheter should show no damage when exposed to saline and contrast medium. | Materials are all identical; passing test results of predicate apply and are equivalent. |
| Shaping Mandrel compatibility & shapeability | Steam shaping mandrel fits distal lumen; tip meets retention specification and dimensional shrinkage OD and ID requirements. | Added length to proximal shaft does not affect working (distal) shaft subjected to tip shaping; passing test results of predicate apply and are equivalent. |
| Kink Resistance | Catheter distal shaft will not kink when tested per BS EN 13868:2002 Annex A; and lumen integrity when catheter is looped to predetermined diameter. | Added length to proximal shaft does not affect working (distal) shaft subjected to kinking; passing test results of predicate apply and are equivalent. |
| Conical Fitting for Hub | Catheter hub will meet testing requirements as specified in BS EN 1707:1997. | Added length does not affect hub connection (identical hub); passing test results of predicate apply and are equivalent. |
| Corrosion Resistance | Catheter shall show no sign of corrosion per ISO10555-1:2013 Annex A. | Materials are all identical; passing test results of predicate apply and are equivalent. |
| Tensile Strength of catheter body, hub attachment, distal attachment | Tip, distal, mid, proximal and hub junctions meet tensile strength requirement per EN ISO-10555-1: Annex B. | Added length does not affect various catheter segments, hub or distal attachments; passing test results of predicate apply and are equivalent. |
| Liquid Leakage at Hub | No liquid leakage detected per BS EN ISO 10555-1:2013 Annex C. | Added length modification does not affect hub attachments; passing test results of predicate apply and are equivalent. |
| Air Leakage During Aspiration | No leak detected when tested BS EN ISO 10555-1:2013 Annex D. | Added length does not affect various catheter segments and joints; passing test results of predicate apply and are equivalent. |
| Rupture Pressure | Catheter can withstand predetermined static and dynamic rupture pressure testing. | Added length does not affect various catheter segments, joints or methods of fabrication; passing test results of predicate apply and are equivalent. |
| Particulate | Verify particulate levels catheter. | Added length does not affect material, method and environment of fabrication affecting particulates; passing test results of predicate apply and are equivalent. |
| Outer Surface Coating Lubricity and Durability | Predetermined friction force of the coating. | Added length to proximal shaft does not affect working (distal) shaft which is coated; passing test results of predicate apply and are equivalent. |
| Flexural Fatigue | Catheter structure remains intact after predetermined number of cycles when used to access in a simulated torturous path model. | Added length does not affect design of shaft segments or joints affecting flexural fatigue; passing test results of predicate apply and are equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size for each test (e.g., "n=X catheters were tested"). It uses phrases like "All test samples," "All samples," or implies multiple units were tested (e.g., "Flow rate data was collected for the modified (160cm) device and the predicate device (150cm)").
- Data Provenance: The study described is a pre-clinical bench testing study. This means the data was generated in a laboratory setting, not from human or animal subjects. The provenance is internal Cathera, Inc. testing, not from any specific country of origin in terms of patient data. It is prospective in the sense that the testing was conducted on the modified device to demonstrate its performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable as the study is a pre-clinical bench test of a physical device, not an AI/imaging diagnostic study that requires expert ground truth for interpretation.
4. Adjudication Method for the Test Set
- This information is not applicable as the study is a pre-clinical bench test of a physical device, not an AI/imaging diagnostic study that requires human adjudication. The "results" are objective measurements or observations against predefined standards or comparison with a predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance for diagnostic tasks, which is not the subject of this document.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This document describes the bench testing of a physical medical device (catheter), not an AI algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this pre-clinical bench testing is based on engineering specifications, international and national standards (e.g., ISO 10555-1, BS EN 13868:2002, BS EN 1707:1997), and comparison to the established performance of the legally marketed predicate device. For example, for flow rate, the "expected range" and "equivalence" to the predicate served as the reference. For dimensional verification, the "specified attributes" were the ground truth. For accessibility/tractability, reaching the M1 region of the neurovascular model was the ground truth for success.
8. The Sample Size for the Training Set
- This information is not applicable as this document describes the testing of a physical medical device, not an AI system that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- This information is not applicable for the same reason as point 8.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).