(90 days)
The PULSION Pulsiocath Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor are intended for use with the PULSION PiCCO Cardiac Output System for the measurement of cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis. The PULSION PiCCO Cardiac Output System with Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. Such as patients in surgical, medical, cardiac, and burn specialty units as well as other specialty units where cardiovascular monitoring is desired and patients undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.
The Pulsion Pulsiocath PiCCO Monitoring Kit, Injectate Sensor Temperature Housing PV 4046 is an injectate in-line sensor. The primary modifications are changes to the injectate in-line sensor design, materials, and dimensions. Corresponding dimensional changes have been made to the housing to accommodate additional components and their positioning within the housing resulting from the change.
The provided text describes a 510(k) summary for the Pulsion Pulsiocath PiCCO Monitoring Kit, Injectate Sensor Temperature Housing PV 4046. Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Based on Predicate Device Specifications) | Reported Device Performance (Summary) |
|---|---|
| Substantial equivalence to the predicate device cleared under K991886 in terms of performance and reliability characteristics. | "Test results showed substantial equivalence." |
| Safety (from risk analysis) | Verification and validation testing included safety testing from risk analysis. |
| Performance (laboratory studies) | Verification and validation testing included laboratory studies for performance. |
| Mechanical properties (laboratory studies) | Verification and validation testing included laboratory studies for mechanical properties. |
| Biocompatibility (laboratory studies) | Verification and validation testing included laboratory studies for biocompatibility. |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated in the provided text. The text only mentions "laboratory studies."
- Data provenance: Not explicitly stated. The studies were conducted by the manufacturer, Pulsion Medical Systems, AG, but the country of origin of the data is not specified. The studies were likely prospective to verify and validate the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the text. The device is a physical medical device (injectate in-line sensor) for measuring cardiac output, not an AI/software device that typically relies on expert-established ground truth from image or medical record interpretation.
4. Adjudication method for the test set
This information is not applicable/provided as the device's performance is based on physical and functional characteristics verified through laboratory studies, not on interpretations that would require adjudication.
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
This is not applicable. This is a physical medical device, not an AI medical device that involves human readers or interpretation of data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical device, not an algorithm, so "standalone performance" in the context of AI is not relevant.
7. The type of ground truth used
The ground truth for the performance of this device would be established by objective measurements of the injectate in-line sensor's functionality, accuracy, mechanical integrity, and biocompatibility in laboratory settings, compared against established engineering and medical device specifications, which were based on the predicate device. It is not an "expert consensus, pathology, or outcomes data" type of ground truth in the context of diagnostic AI.
8. The sample size for the training set
This information is not applicable/provided. The device is a physical medical device, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable/provided as there is no "training set" for this physical medical device.
§ 870.1915 Thermodilution probe.
(a)
Identification. A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes.(b)
Classification. Class II (performance standards).