(250 days)
The Distal Access Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents or therapeutic devices. It is not intended for use in coronary arteries.
The Distal Access Catheter consists of a catheter and accessories (hemostatic valve, introducer sheath, and a shaping mandrel). The catheter is a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steamshapeable, and a hydrophilic coating is applied for navigation of the catheter through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy.
The catheter body is constructed with a stainless-steel coil (less 2 cm of the catheter length) over the inner lumen liner comprised of polytetrafluoroethylene (PTFE). To provide additional shaft support, a stainless-steel wire braiding has been added over the stainless-steel coil from the proximal end to distal end. A platinum/iridium alloy radiopaque marker band is located at the distal tip of the catheter. An outer layer of varying durometers and lengths of polyamide (PA), polyether block amide (Pebax) and polyurethane (PU) covers the entire catheter body from proximal to distal end, respectively.
A hub (PC) is attached to the proximal end of the catheter. A strain relief made from polyether block amide (Pebax) is placed at the proximal end of the catheter and distal end of the hub. The hub-strain relief provides for the kink resistance for the proximal end. A luer fitting on the catheter hub is used for the attachment of accessories.
The outer surface of the catheter (distal 60 cm) is coated with a hydrophilic coating to reduce friction during navigation in the vasculature.
A shaping mandrel (stainless steel, 80 mm in length) is provided with the catheter to be used by the physician for tip shaping. An introducer sheath (PTFE) is included to facilitate the introduction of the catheter into guide catheters during clinical use. A hemostatic valve is used to connect to the proximal section of the catheter.
The Distal Access Catheter is provided sterile and for single use only. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (HDPE) that is provided in a sterile barrier PET/PE film and Tyvek pouch and placed in a carton box.
This document describes the regulatory clearance for a medical device called a "Distal Access Catheter," not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, expert ground truth, MRMC studies, and human-in-the-loop performance, are not applicable.
The acceptance criteria and the study that proves the device meets them are based on bench testing (physical and mechanical properties) and biocompatibility testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Specification) | Reported Device Performance (Conclusion) |
|---|---|---|
| Bench Testing | ||
| Surface Inspection | External surface free from extraneous matter, process, and surface defects that could cause trauma to vessels. | The surface integrity is suitable for intended clinical use. |
| Surface Contamination | Free from surface contaminants from uncured coating surface particulates > 0.02 mm², embedded particulates. Distal tip smooth and tapered. PTFE inner layer not delaminated. | The surface integrity is suitable for intended clinical use. |
| Dimensional | Meet specified dimensional requirements (catheter OD, ID, effective length, distal tip length, total accessories length). | The device met the dimensional and physical specifications. |
| Distal Tip | Smooth, rounded, tapered, or similarly finished to minimize trauma to vessels. | Distal tip is suitable for intended clinical use. |
| Radiodetectability | Tip of the catheter visible under fluoroscopy. | Device radiopacity is suitable for intended clinical use. |
| Corrosion Resistance | Metallic components show no signs of corrosion. | Corrosion resistance is suitable for intended clinical use and met requirements of ISO 10555-1. |
| Peak Tensile Force | 6F Catheter: ≥15N for distal section and hub/catheter junction. 5F Catheter: ≥10N for distal section and hub/catheter junction. | Peak tensile force is suitable for intended clinical use and met requirements of ISO 10555-1. |
| Fluid Leakage | No liquid leakage from hub and catheter shaft at 46 psi for 30 seconds. | Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1. |
| Air Leakage | No air leakage at hub into syringe when negative pressure was applied for 15 seconds. | Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1. |
| Gauging | Plane of maximum diameter at opening of female conical fitting lies between two limit planes of the gauge. | The device hub met the requirements of ISO 80369-7. |
| Separation Force | Mating parts separation force > 35 N. | The device hub met the requirements of ISO 80369-7. |
| Unscrewing Torque | Test article luer remains attached after applying unscrewing torque not less than 0.02 N·m for a minimum of 10 seconds. | The device hub met the requirements of ISO 80369-7. |
| Stress Cracking | No stress cracks on the test article hub. | The device hub met the requirements of ISO 80369-7. |
| Ease of Assembly | Components fit together securely with no resistance between test article luer and reference fitting. | The device hub met the requirements of ISO 80369-7. |
| Resistance to Overriding | Test article luer does not override reference fitting threads. | The device hub met the requirements of ISO 80369-7. |
| Particulate | Amount of particulate matter during simulated use determined and compared to predicate device. | The amount and size of particles from the subject device was comparable to the predicate device. |
| Static Burst Pressure | Evaluate burst pressure under static conditions per ISO 10555-1:2013(E) Annex F. | Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1. |
| Lubricity and Durability | Frictional force equivalent to predicate device and less than 0.3N. No coating cracking or separation. | Frictional force is suitable for intended clinical use, no coating cracking or separation, and is equivalent to the predicate device. |
| Equipment Interface | Compatible with 0.035" guidewire, ≥ 0.088" ID guide catheter/introducer sheath, ≤ 0.027" OD microcatheters, and common hemostatic valve. | The device is compatible with the accessories as specified. |
| Tip Shapeability | Distal tip steam shapeable and equivalent to predicate devices. | Shapeability of the distal tip after steam shaping is equivalent to predicate device. |
| Kink Resistance | No kinks when wrapped around pin gauges of clinical use relevant radii. No kinks during simulated use. Equivalent to predicate devices. | The device is resistant to kinking around relevant radii turns. |
| Simulated Use | Catheter reaches target locations in tortuous vessel model; delivered and retracted smoothly with 0.035" guidewire; no device damage or defects after simulated use. | Device performs as intended under simulated use conditions. |
| Torque Response | Torque response no worse than the predicate device. | Device torque response is equivalent to the predicate device. |
| Torque Strength | No catheter breakage after 50 rotations. | Device torque strength is equivalent to the predicate device. |
| Pushability/Retractability | Pushability/retractability in tortuous vessel model no worse than the predicate device. | Device pushability/retractability is equivalent to the predicate device. |
| Catheter Stiffness | Catheter stiffness equivalent to the predicate devices. | The catheter stiffness is equivalent to the predicate device. |
| Catheter Flexural Fatigue | No flexural fatigue following repeated bending or hoop stress. | The catheter flexural fatigue is equivalent to the predicate device. |
| Dynamic Burst | Catheter does not burst under dynamic pressure of 300 psi for 30 seconds. | The device met the test acceptance criteria. |
| Flow Rate | Catheter withstands manual injection of contrast media and saline at clinically relevant flow rates. | The device can withstand flow rates suitable for intended clinical use. |
| Ethylene Oxide Residue | Residual amount of ethylene oxide in single package ≤ 10µg/g. | Ethylene Oxide Residue met the acceptance criteria per ISO 10993-7:2008. |
| Sterility | Product shall be sterile. | Sterility of the catheter met the acceptance criteria per ISO 11135:2014. |
| Bacterial Endotoxins | Endotoxin content ≤ 2.15 EU/kit. | Bacterial endotoxins met the acceptance criteria per USP . |
| Biocompatibility Testing | ||
| Cytotoxicity Test (ISO 10993-5) | Cell viability of 100% test article extract shall be acceptable (not cytotoxic). | The cell viability of 100% test article extract was 95.5%. (Conclusion: Non-cytotoxic) |
| Skin Sensitization Test (ISO 10993-10) | No significant evidence of skin sensitization. | The positive rate of the test article was 0%. (Conclusion: No significant evidence of skin sensitization) |
| Intracutaneous Reactivity Test (ISO 10993-10) | Non-irritant. Final test article score acceptable. | The final test article score was calculated to be 0. (Conclusion: Non-irritant) |
| Acute Systemic Toxicity Test (ISO 10993-11) | No significant evidence of systemic toxicity. Body weight data acceptable and equivalent between groups. | Body weight data were acceptable and equivalent between the corresponding test and control treatment groups. (Conclusion: No significant evidence of systemic toxicity) |
| Hemolytic Properties Test (ASTM F756) | No influence on hemolytic properties. | The hemolysis index was 0.44% (direct contact) and 0.00 (indirect contact). (Conclusion: No influence on hemolytic properties) |
| Partial Thromboplastin Time (PTT) Test (ISO 10993-4) | No effect on PTT—no significant differences between sample group and negative group. | No significant differences between the sample group and the negative group. (Conclusion: No effect on PTT) |
| In Vivo Thrombogenicity Test (ISO 10993-4) | Equivalent to the control article—no significant differences between test and control articles. | No significant differences between the test and control articles. (Conclusion: Equivalent to the control article) |
| Pyrogen Test (ISO 10993-11) | Non-pyrogenic—no rabbit shows an individual rise in temperature of 0.5 °C or more. | No rabbit shows an individual rise in temperature of 0.5 °C or more. (Conclusion: Non-pyrogenic) |
| Complement Activity (C3a, SC5b-9) Test (ISO 10993-4) | Equivalent to the negative control group—no significant difference between sample group and negative control group. | No significant difference between the sample group and negative control group. (Conclusion: Equivalent to the negative control group) |
Study Proving Device Meets Acceptance Criteria:
The device met its acceptance criteria through a series of bench tests and biocompatibility evaluations.
Bench Test Study:
- Study Design: The bench testing of the Distal Access Catheter was performed using the applicable sections of the ISO 10555-1 international standard for sterile, single-use intravascular catheters. This standard specifies requirements for sterile, single-use intravascular catheters. The tests covered various physical and mechanical properties crucial for safe and effective device function.
- Methodology: The document lists 24 distinct bench tests (e.g., Surface Inspection, Dimensional Verification, Corrosion Resistance, Peak Tensile Force, Fluid Leakage, Kink Resistance, Simulated Use, Dynamic Burst, Flow Rate, etc.). Each test had specific acceptance criteria derived from the ISO standard or established engineering specifications for the device. The results consistently concluded that the device was "suitable for intended clinical use," "met requirements," or was "equivalent to the predicate device."
- Conclusion: The bench testing demonstrated that "the in vitro behavior of the device is well characterized within design specifications."
Biocompatibility Study:
- Study Design: The biocompatibility evaluation was conducted in accordance with FDA's biocompatibility guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"."
- Methodology: The biological tests were conducted in compliance with the Good Laboratory Practice (GLP) Regulation 21 CFR 58. These tests included Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemolytic Properties, Partial Thromboplastin Time (PTT), In Vivo Thrombogenicity, Pyrogen, and Complement Activity tests. Each test had specific criteria for acceptable biological response. The conclusions for these tests consistently indicated that the device was non-cytotoxic, non-sensitizing, non-irritant, non-systemically toxic, had no effect on hemolytic properties or PTT, was equivalent to control/predicate for thrombogenicity and complement activity, and was non-pyrogenic.
- Conclusion: The biocompatibility testing confirmed the device material safety for its intended biological contact.
The following information is not applicable (N/A) as this is a traditional medical device (catheter) and not an AI/ML powered device.
- Sample size used for the test set and the data provenance: N/A (for AI/ML test sets). These are physical and biological tests, not data-driven evaluations.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (for AI/ML expert annotation). Ground truth for physical/biological tests is based on objective measurements against established standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (for AI/ML expert adjudication).
- 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: N/A (not an AI-assisted device).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (not an AI algorithm).
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For this device, the "ground truth" or acceptance standard is derived from established international medical device standards (e.g., ISO 10555-1, ISO 80369-7, ISO 10993 series, USP ) and internal design specifications, verified through objective bench and biological testing.
- The sample size for the training set: N/A (not an AI/ML device; no training set in this context).
- How the ground truth for the training set was established: N/A (not an AI/ML device).
§ 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).