(216 days)
The Zipline Access Catheter is indicated to facilitate the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.
The Zipline Access Catheter is a single-use device designed to deliver large-bore catheters to the neurovasculature using standard endovascular techniques. It is supplied sterile and nonpyrogenic. It is available in two sizes: Zipline 070. Zipline 070. Zipline 088 is designed for use with outer catheters with 0.088" or larger internal diameter, and Zipline 070 is designed for use with outer catheters with 0.070" or larger internal diameter.
During use, the Zipline Access Catheter is advanced over a guidewire to the desired location in the neurovasculature. An outer catheter is then advanced over the Zipline Access Catheter to the desired location.
The Zipline Access Catheter is a single lumen, variable stiffness catheter. It has a tapered flexible tip and a radiopague marker at its distal end. Proximal to the tapered section is a "bulb" and a radiopaque coil to facilitate bulb visualization under fluoroscopy. The outer of the bulb is designed to closely match the inner diameter of outer catheters, thereby minimizing the gap between the two catheters during navigation.
The Zipline Access Catheter has a hydrophilic coating on the outer surface of the distal end to enhance tracking through the vasculature. A luer fitting located on the catheter hub is used for attachment of ancillary devices. A continuous internal lumen spanning from the distal tip to the proximal hub accommodates guidewires up to 0.018" in diameter.
This document is a 510(k) Summary for a medical device called the "Zipline Access Catheter." It is a submission to the FDA seeking to demonstrate substantial equivalence to a legally marketed predicate device.
Therefore, it does not describe a study proving a device meets acceptance criteria for an AI/ML product, nor does it contain information about expert ground truth, adjudication methods, MRMC studies, or training data.
The document details the device's technical specifications, its comparison to a predicate device, and the non-clinical testing performed to establish its safety and effectiveness.
Here's why the requested information cannot be extracted from this document:
- This is a 510(k) for a physical medical device (catheter), not an AI/ML-driven diagnostic or therapeutic device. The acceptance criteria and testing described relate to the physical and functional performance of the catheter (e.g., buckling force, torque strength, biocompatibility, kink resistance, radiopacity), not to the performance of an algorithm.
- The document explicitly states "no clinical study was conducted" because "The non-clinical performance testing was determined to be sufficient to support the substantial equivalence of the subject device to the predicate." This means there was no human-in-the-loop or standalone performance evaluation against a clinical ground truth, which would be typical for AI/ML devices.
To directly answer your request based on the provided text, but with the understanding that the product is a physical medical device:
-
A table of acceptance criteria and the reported device performance:
The document presents several tables summarizing testing. I will consolidate the "Test" and "Conclusions" columns from the "Performance Testing - Bench" section as they effectively serve as acceptance criteria (the test performed) and reported performance (the conclusion, e.g., "met established specifications" or "suitable for its intended use").Acceptance Criteria (Test) Reported Device Performance (Conclusions) Visual Inspection The device surface characteristics are suitable for its intended use. Dimensional Inspection The device met established specifications. Buckling Force Test The device met established specifications. Simulated Use Testing The device performs as intended under simulated use conditions. Torque Strength The device met established specifications. Torque to Failure Resistance to torque failure was similar to control devices. Hydrophilic Coating Integrity The hydrophilic coating integrity is suitable for its intended use. Tensile Strength The device met established specifications. Air Leakage (per ISO 10555-1:2013 Annex D) The device integrity is suitable for its intended use. Liquid Leakage (per ISO 10555-1:2013 Annex C) The device integrity is suitable for its intended use. Luer Dimensions and Performance (per ISO The device met established specifications. 80369-7:2021 and ISO 80369-20:2015) Kink Resistance The device met established specifications. Radiopacity The radiopacity was similar to a control device. Particulate Recovery The particulate generation was similar to control devices. Biocompatibility: Cytotoxicity The test article is non-cytotoxic. Biocompatibility: Sensitization The test article did not elicit a sensitization response. Biocompatibility: Irritation Requirements of the ISO intracutaneous reactivity test were met for the test article. Biocompatibility: Acute Systemic Toxicity Requirements of the ISO acute systemic injection test were met for the test article. Biocompatibility: Material-Mediated Pyrogenicity The test article is non-pyrogenic. Biocompatibility: Hemocompatibility (SC5b-9) The test article is not considered to be a potential activator of the complement system. Biocompatibility: Hemocompatibility (PTT) The test article is not considered to be an activator of the intrinsic coagulation pathway. Biocompatibility: Hemocompatibility (Hemolysis) The test article is considered non-hemolytic. Biocompatibility: Hemocompatibility (Thromboresistance) The test articles have similar thromboresistance characteristics as the control devices. Animal Testing (In vivo performance & safety) Demonstrated acceptable results; histologic evaluations concluded comparable tissue response to control device. Sterilization (Ethylene Oxide) Validated using the overkill method according to ISO-11135, achieved 1x10-6 sterility assurance level. Shelf Life and Packaging 12-month shelf life verified by accelerated aging (ASTM F1980) and functional/performance testing on aged devices. -
Sample size used for the test set and the data provenance:
- Bench Testing: The document does not specify exact sample sizes for each bench test, but implies that "test specimens" and "catheters" were used. It signifies that multiple samples were tested to demonstrate conformity to specifications.
- Animal Testing: "Suitably sized branches of the carotid arteries in a porcine model." The number of animals or specific vessels tested is not provided, but it was "in comparison to a control device."
- Data Provenance: The testing was conducted internally by Perfuze Ltd. (Ireland) or by their contractors, as typically expected for device manufacturers. It is non-clinical laboratory data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is not an AI/ML device requiring human expert label ground truth. The "ground truth" for the physical device performance is established by standardized test methods (e.g., ISO, ASTM) and engineering specifications. For the animal study, histological evaluation would have been performed by qualified pathologists, but specific numbers or qualifications are not detailed. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This relates to consensus for human interpretation, not physical device testing. -
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 is for AI/ML devices, not a physical medical device. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is for AI/ML devices, not a physical medical device. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For physical and chemical attributes, the "ground truth" is defined by engineering specifications, validated test methods (e.g., ISO, ASTM), and established biocompatibility standards (e.g., ISO 10993). For the animal study, the ground truth was histological evaluations and angiographic assessments, which would typically be performed by veterinary pathologists and imaging specialists. -
The sample size for the training set:
Not applicable. There is no AI/ML algorithm or training set for this physical device. -
How the ground truth for the training set was established:
Not applicable. There is no AI/ML algorithm or training set for this physical 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).