(31 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.
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 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. The PSS introducer sheath is intened only for connectin with the Endophys Blood Pressure Monitor. The 6F 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.
The provided text is a 510(k) summary for the Endophys Pressure Sensing Sheath Kit. It outlines the device, its intended use, and a comparison to a predicate device, along with a list of performance tests conducted.
However, the document does not describe the acceptance criteria for these tests, nor does it provide a detailed study that proves the device meets specific acceptance criteria. It only states that the modified device "met all specified criteria" and "did not raise new safety or performance questions" based on the design verification performance.
Therefore, many of the requested items cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated based on the text:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests but does not provide specific acceptance criteria or quantitative performance results. It only states that the device "met all specified criteria."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided | Met all specified criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. 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)
This information is not provided in the document. The studies mentioned are performance tests on the device itself, not studies on diagnostic accuracy requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an introducer sheath with an integrated pressure sensor, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical instrument, not an algorithm. The "Sensor functionality" test would assess the standalone performance of the pressure sensor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance tests would be based on engineering specifications and direct measurements against established standards for medical device functionality (e.g., pressure calibration against a known standard, dimensional accuracy against design drawings). The document does not specify the exact ground truth methodologies but implies standard engineering and laboratory testing.
8. The sample size for the training set
This is not applicable as the device is a physical medical instrument, not a learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This 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).