(217 days)
The Endophys Pressure Sensing Sheath Kit (Endophys Pressure Sensing Sheath, vessel dilator and guidewire) is intended to facilitate the introduction of diagnostic and interventional devices into the vasculature and to continuously measure blood pressure during the procedure when used with the Endophys Blood Pressure Monitor.
Together, the Pressure Sensing Sheath and the Blood Pressure Monitor comprise the Endophys Pressure Sensing Access System (PSASTM).
The Endophys Pressure Sensing Sheath Kit is comprised of the Endophys Pressure Sensing Sheath, vessel dilator and guidewire. The Endophys Pressure Sensing Sheath and accessories are provided sterile (EO).
The Pressure Sensing Sheath ("PSS") is an introducer sheath with an integrated fiber optic pressure transducer. The PSS is provided with a dilator and a guidewire, which together make up the Endophys Pressure Sensing Sheath Kit ("PSS Kit"). The PSS Kit is intended to be used only with the Endophys Blood Pressure Monitor ("BPM"), which connects to the PSS and displays the blood pressure measurements. Together with the BPM, the PSS is used to continuously monitor patient blood pressure during procedures requiring vascular access.
The PSS introducer sheath is used to assist vascular access in the same manner as do standard catheter introducers. The PSS introducer sheath has an integrated pressure sensor that provides high resolution, continuous and instantaneous pulse wave hemodynamics to monitor blood pressure. Together, the Pressure Sensing Sheath and the Blood Pressure Monitor comprise the Endophys Pressure Sensing Access System (PSASTM).
The vessel dilator is used to facilitate insertion of the PSS, and is packaged with the Endophys PSS Kit. Once the PSS has been properly positioned in the vessel, the dilator is removed.
The guidewire is J tipped, 50cm (length), 0.89mm (diameter), and is used to assist in the placement of the dilator/PSS Introducer Sheath through the skin and into the vasculature. Once the dilator and introducer are positioned over the guidewire, the guidewire is removed through the dilator.
Here's an analysis based on the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list acceptance criteria in a quantitative format for each test. Instead, it states that the device "met all specified criteria." Therefore, the table below will broadly indicate "Met all specified criteria" where specific numerical targets are not provided.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Dimensional Analysis | Met all specified criteria |
| Guide Wire / Device Compatibility | Met all specified criteria |
| Flexibility Kink Resistance | Met all specified criteria |
| Liquid Leak Under Pressure | Met all specified criteria |
| Liquid Leak through Hemostasis Valve | Met all specified criteria |
| Separation Force at Break | Met all specified criteria |
| Dilator to Hemostasis Valve Separation Force | Met all specified criteria |
| Acute Systemic Injection (Biocompatibility) | Met all specified criteria |
| Intracutaneous Injection Test (Biocompatibility) | Met all specified criteria |
| Kligman Maximization (Sensitization) Test (Biocompatibility) | Met all specified criteria |
| L929 MEM Elution (Biocompatibility) | Met all specified criteria |
| Rabbit Pyrogenicity Material Mediated (Biocompatibility) | Met all specified criteria |
| ASTM Hemolysis Complete - Direct / Indirect (Biocompatibility) | Met all specified criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each of the performance tests. It also does not explicitly state the provenance of the data (e.g., country of origin) or whether it was retrospective or prospective. Given the nature of these tests (design verification and biocompatibility), they are typically conducted in a controlled, prospective manner, often in laboratory settings.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The tests performed are primarily engineering and biocompatibility tests, which do not typically involve human "experts" establishing ground truth in the same way clinical studies do (e.g., for image interpretation). Instead, ground truth is based on established engineering standards and biological assay results.
4. Adjudication Method for the Test Set
This information is not applicable and is not provided in the document. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies involving multiple human readers, not for the types of engineering and biocompatibility tests described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. This type of study is typically associated with AI-driven diagnostic devices where human readers' performance is compared with and without AI assistance. The Endophys Pressure Sensing Sheath Kit is a medical device for facilitating vascular access and measuring blood pressure, not a diagnostic imaging device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone study (in the context of AI algorithms) was done. The device itself performs the pressure sensing; it's not an AI algorithm that generates a diagnosis or interpretation without human interaction. The studies performed focused on the physical and biological performance of the device components.
7. Type of Ground Truth Used
The ground truth used for the performance tests appears to be based on:
- Established engineering specifications and design requirements: For dimensional analysis, flexibility, kink resistance, liquid leak, and separation forces.
- Standard biological assay results and established biocompatibility guidelines: For the biocompatibility tests (acute systemic injection, intracutaneous injection, sensitization, MEM elution, pyrogenicity, hemolysis). These tests have predefined pass/fail criteria based on accepted scientific and regulatory standards.
8. Sample Size for the Training Set
This information is not applicable and is not provided. The Endophys Pressure Sensing Sheath Kit is not an AI/machine learning device that requires a "training set" in the conventional sense. Its function is based on physical and optical principles.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and is not provided, as there is no "training set" for this type of 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).