(44 days)
The Endophys Pressure Sensing Sheath Kit (Endophys Pressure Sensing Sheath and vessel dilator) 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 (PSAS™).
The Endophys Pressure Sensing Sheath Kit is comprised of the Endophys Pressure Sensing Sheath and vessel dilator. 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 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.
This FDA 510(k) summary for the Endophys Pressure Sensing Sheath Kit (K190098) primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study proving performance against specific acceptance criteria in the manner you've described.
The document emphasizes a comparison of technological characteristics and non-clinical performance data to show that the new device is as safe and effective as the predicate. It does not describe a multi-reader multi-case (MRMC) study, an algorithm-only standalone study, or specific clinical performance metrics with detailed acceptance criteria for a new AI/medical device.
Therefore, many of your specific questions cannot be answered from the provided text because the regulatory pathway chosen (510(k) Substantial Equivalence) does not typically require the level of detailed clinical efficacy testing or AI-specific validation you've outlined.
However, I can extract information related to the device's performance as presented in this 510(k) submission:
1. A table of acceptance criteria and the reported device performance
The document lists "Sensor Accuracy" as a performance data item. While it doesn't provide specific numerical acceptance criteria (e.g., "accuracy > X%"), it states that the device "met all specified criteria." This implies internal design specifications were met.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Sensor Accuracy | Met all specified criteria. |
| Dimensional Analysis | Met all specified criteria. |
| Guide Wire / Device Compatibility | Met all specified criteria. |
| Flexibility - Tip Deflection | Met all specified criteria. |
| Flexibility - Kink Resistance | Met all specified criteria. |
| Flexibility - Sensor Functionality | Met all specified criteria. |
| Pouch Peel Strength | Met all specified criteria. |
| Dilator to Hemostasis Valve Separation Force | Met all specified criteria. |
| L929 MEM Elution - ISO | Met all specified criteria. |
| L929 Neutral Red Uptake Test (4 Concentrations) - ISO | Met all specified criteria. |
| Rabbit Pyrogen Test (Material Mediated - ISO) | Met all specified criteria. |
| Rabbit Blood Hemolysis Complete ASTM | Met all specified criteria. |
Important Note: These are primarily non-clinical, engineering, and biocompatibility tests, not clinical performance metrics on patient data.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document. The tests performed are primarily benchtop and material-based, not clinical trials on patient populations.
- Data Provenance: Not specified, but given the non-clinical nature of the tests, it would be laboratory data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. This type of information is relevant for studies involving human interpretation (e.g., radiologists reading images), which is not detailed here. The "ground truth" for the listed tests would be established by validated measurement techniques and scientific standards for material and mechanical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically used in clinical studies where expert consensus on subjective findings is required.
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
- No. This device is a physical medical device (sheath with a pressure sensor), not an AI algorithm for interpreting medical images or data. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical device, and its primary function is to facilitate access and measure blood pressure continuously. It does not appear to employ a standalone AI algorithm that provides diagnostic outputs without human interaction. The pressure sensor's output is displayed on a monitor for human clinicians to use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests listed:
- Sensor Accuracy: Likely established against a highly accurate reference pressure measurement system.
- Dimensional, Flexibility, Force, Pouch Peel tests: Established against engineering specifications and industry standards for physical properties.
- Biocompatibility (L929, Rabbit Pyrogen, Hemolysis): Established against ISO and ASTM standards for material safety and biological response.
- No "expert consensus," "pathology," or "outcomes data" are mentioned as ground truth for these specific performance tests.
8. The sample size for the training set
- Not applicable. This document is for a physical medical device, not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable for the reason above.
Summary of Device and Study Context:
The Endophys Pressure Sensing Sheath Kit is an introducer sheath with an integrated fiber optic pressure transducer. It is intended to facilitate device introduction into the vasculature and continuously measure blood pressure. This 510(k) submission demonstrates substantial equivalence to a previously cleared predicate device (K173399). The performance data cited are primarily non-clinical benchtop, engineering, and biocompatibility tests, which confirmed that the modified device met its specified design criteria and is as safe and effective as the predicate. This is a common approach for device modifications under the 510(k) pathway, where extensive new clinical studies are often not required if substantial equivalence can be demonstrated through comparative data.
§ 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).