(267 days)
The PathBuilder™ Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
PathBuilder™ Steerable Introducer is composed of a steerable sheath, a dilator and a guidewire. It is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The steerable sheath is introduced into a body vessel, along with the dilator, over the guidewire, it is available in a variety of lengths, sizes and curve configurations; Dilator is assembled with the sheath and introduced into a body vessel over the guidewire. It is used to provide support to the sheath and ensure smooth advancement; the guidewire is percutaneously placed into the body vessel to function as a guide for the introduction into the chambers of the heart.
The distal end of steerable sheath is embedded with a marker band and vent holes. The steerable sheath is finished at the proximal end with a hemostasis valve and sideport with a three-way stopcock. By turning the rotating collar on handle, the steerable sheath can be bidirectionally bended to facilitate the steerable sheath to reach complex heart structures more conveniently. The distal end of dilator has a tip, while its proximal end is connected with luer fitting. The inner diameter of dilator distal end is smaller than the main body for the purpose of locking the position of a puncture needle. The distal end of dilator has a fixed curve to adapt to the heart structure.
The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise ≥180° and counter-clockwise ≥90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
The PathBuilder™ Steerable Introducer is a medical device designed for introducing various cardiovascular catheters into the heart, including into the left side of the heart through the interatrial septum. The device did not undergo clinical studies to prove these claims but a series of non-clinical, benchtop tests and analyses to establish substantial equivalence to a predicate device (Agilis™ NxT Steerable Introducer (K081645)).
Here's the breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria:
- Table of acceptance criteria and the reported device performance:
| Criteria | Acceptance Requirement | Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:2018 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) and FDA's modified ISO guidelines. | The biological safety of the introducer was verified per the requirements of ISO 10993-1:2018. Tests included: Cytocompatibility, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Complement Activation, and Thrombogenicity. The results demonstrated compliance. |
| Bench Validation | Successful validation of the device design through various mechanical and performance tests. | Validation testing included: visual inspection, dimensional verification, packaging testing (visual inspection, sealing strength, dye penetration), transit testing, and mechanical failure/performance tests (Peak tensile force of joints, flexion testing and fracture testing of guidewire). Compatibility of the introducer, guidewire, and dilator was validated with compatibility, bending load, controlling curve force, insertion withdrawal force, pushing force, simulated use fatigue testing (repeated physiologically relevant turns and observed for damage), radio detectability, freedom from leakage, dilator hub and 3-way stopcock Luer testing. All samples were sterilized and aged prior to testing. All tested samples passed bench testing. |
| Cleaning & Sterilization | Compliance with ISO 11135:2014 (Sterilization of health care products – Ethylene Oxide: Requirements for development, validation and routine control of a sterilization process for medical device), AAMI TIR 28:2009, and FDA guidance. | Validation testing was performed to demonstrate that the introducer could be sterilized in accordance with ISO 11135:2014, AAMI TIR 28:2009, and FDA guidance. The device met the sterilization requirements. |
| Shelf Life Validation | Demonstration of a 3-year shelf life. | Validation testing was performed and confirmed a shelf life of three years. |
| Functional Performance | Compliance with ISO 11070:2014. | The device was shown to comply with ISO 11070:2014. |
| Biological Characteristics | Compliance with ISO 10993-1. | The device was shown to comply with ISO 10993-1. |
| Dimensional Comparison | Substantial equivalence in dimensions (total length, outer diameter, inner diameter, curve shape) for steerable sheath, dilator, and guidewire compared to the predicate device. | Dimensional analysis showed that the proposed device's total length, outer diameter, inner diameter, and curve shape for the steerable sheath, dilator, and guidewire are substantially equivalent to the predicate device. |
| Intended Healthcare Env. | Professional healthcare environment. | The device is intended for use in a professional healthcare environment, consistent with the predicate. |
| Sterilization Method | EO Sterilized. | The device is EO sterilized, consistent with the predicate. |
| Single Use | Yes. | The device is single use, consistent with the predicate. |
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Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes for each non-clinical test (biocompatibility, bench validation, cleaning and sterilization, shelf life). It states that "All samples were sterilized and aged prior to testing. All tested samples passed bench testing." As these are bench tests and not clinical studies, the data provenance is from laboratory testing performed by the manufacturer, Shanghai MicroPort EP MedTech Co., Ltd., presumably in China as that is their location. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This was a non-clinical evaluation comparing device properties to established standards and a predicate device. There was no expert-derived "ground truth" for the test set in the way it would be for a diagnostic AI device. The ground truth was based on the performance standards themselves and the characteristics of the predicate device. -
Adjudication method for the test set:
Not applicable. There was no adjudication method described as it was not a study involving human interpretation of results. The tests measured physical and material properties against predefined specifications and standards. -
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:
No. This device is a steerable introducer (a physical medical device), not an Artificial Intelligence (AI) device, and thus an MRMC comparative effectiveness study was not performed. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical device, not an algorithm or AI system. -
The type of ground truth used:
The "ground truth" in this context refers to established national and international standards (e.g., ISO 10993-1, ISO 11135, ISO 11070, AAMI TIR 28) and the characteristics of the legally marketed predicate device (Agilis™ NxT Steerable Introducer K081645). The device's performance was compared against these benchmarks to demonstrate substantial equivalence. -
The sample size for the training set:
Not applicable. As this is not an AI/machine learning device, there is no training set. -
How the ground truth for the training set was established:
Not applicable. There is no training set for a physical medical device.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).