(30 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.
This document, a 510(k) Summary for the Endophys Pressure Sensing Sheath Kit, primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria with performance metrics. While it lists various performance data that were provided, it does not explicitly define acceptance criteria or present a study report with measured performance against those criteria.
Therefore, many of the requested details (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC study details) are not available in this document.
Here's a summary of what information can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The modified Endophys Pressure Sensing Sheath met all specified criteria and based on the design verification performance, the conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device."
However, the specific "specified criteria" and the quantitative "reported device performance" are not detailed in this summary. The summary lists types of tests performed. Without the actual test reports, the acceptance criteria and performance data cannot be presented in a table.
Here's an example of the types of performance data mentioned, but without acceptance criteria or reported values:
| Test Type | Acceptance Criteria (Not provided in source) | Reported Device Performance (Not provided in source) |
|---|---|---|
| 6% Luer Conical Fittings Gauge Test | (e.g., Must conform to ISO 594-1/2) | (e.g., All fittings conformed) |
| 6% Luer Conical Fittings Separation Force | (e.g., Must exceed X Newtons) | (e.g., Average separation force Y Newtons) |
| Sensor Accuracy | (e.g., +/- Z mmHg) | (e.g., Achieved +/- Z' mmHg) |
| Dimensional Analysis | (e.g., Within specified tolerance) | (e.g., All dimensions within tolerance) |
| Radiopacity | (e.g., Clearly visible under fluoroscopy) | (e.g., Visible as per standard) |
| Flexibility Tip deflection | (e.g., Deflection Q Newtons) | (e.g., Average break force R Newtons) |
| Pouch Peel Strength | (e.g., Peel strength S N/m) | (e.g., Average peel strength T N/m) |
| Dilator to Hemostasis Valve Separation Force | (e.g., Separation force > U Newtons) | (e.g., Average separation force V Newtons) |
| Biocompatibility Tests (e.g., Acute Systemic Injection, Ames Reverse Mutation Assay, In Vitro Hemocompatibility Test - Direct Contact, Mouse Lymphoma Mutagenesis Assay, Pyrogenicity, Rabbit Blood Hemolysis Test, Thrombogenicity, Unactivated PTT Test) | (e.g., Biocompatible per ISO 10993 standards) | (e.g., Passed all biocompatibility tests) |
| Shelf Life Testing | (e.g., Device meets specifications for X years) | (e.g., Device met specifications for Y years) |
| Corrosion Testing | (e.g., No corrosion after Z exposure) | (e.g., No corrosion observed) |
2. Sample Size for the Test Set and Data Provenance
The document does not specify the sample sizes used for each test listed. It also does not provide details on the data provenance (e.g., country of origin, retrospective or prospective nature). The tests appear to be bench and laboratory-based, as well as biocompatibility studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since the listed tests are primarily physical, mechanical, and biological (biocompatibility), establishing "ground truth" in the traditional sense of clinical diagnosis by experts is not applicable. For tests like "Sensor Accuracy," the ground truth would likely be a highly accurate reference instrument or method. The document does not specify who performed these technical evaluations or their qualifications.
4. Adjudication Method
This concept is not applicable to the types of tests listed. Adjudication methods are typically relevant in studies where human interpretation of data (e.g., medical images) is being compared or requires consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not mentioned or indicated in this document. The device is a physical medical device (introducer sheath with a pressure sensor), not an AI or diagnostic imaging device that would typically undergo MRMC studies comparing human readers with and without AI assistance.
6. Standalone Performance Study
The document describes various performance tests of the device itself (e.g., Sensor Accuracy, Dimensional Analysis, Biocompatibility). These would constitute standalone performance studies for the product's physical and functional properties. However, the details of these studies are not provided.
7. Type of Ground Truth Used
For the listed performance tests, the "ground truth" would be established by:
- Engineering specifications and standards: For dimensional analysis, luer fittings, flexibility, kink resistance, etc.
- Laboratory-validated reference methods/instruments: For sensor accuracy, pressure measurements, etc.
- Established biological and chemical testing protocols: For biocompatibility tests (e.g., ISO 10993 standards).
The document does not explicitly state these ground truth sources but implies their use by mentioning adherence to "specified criteria."
8. Sample Size for the Training Set
This device does not appear to be an AI/machine learning device that would have a "training set" in the conventional sense. The "training set" concept is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As there is no indication of a training set for an AI/machine learning component, this question is not applicable.
§ 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).