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PiCCO Catheters are used as accessories for thermodilution and arterial blood pressure measurement.

PiCCO Catheters are 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 are undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.

The PiCCO Catheter uses a thermistor to measure the blood temperature change during thermodilution. This thermistor is located in one of the two catheter lumen. The second catheter lumen ends in a Luer-Lock for connection to a pressure monitoring kit.

The thermistor is connected to a patient monitor via a dedicated plug.

The placement of the catheter into a large arterial vessel is done using the Seldinger Technique and is intended to use of up to 10 days.

The PiCCO Catheter Sets contain the following parts:

1. PiCCO Catheter,
2. Guidewire with dispenser and advancer,
3. Introducer needles,
4. Dilator (exception: the 3F Set does not include a dilator).

Five PiCCO Catheter models are available which differ in diameter and length. The PiCCO catheter set contains accessories fitting to the respective PiCCO catheter model in size.

The Catheter Set is packed into a preformed blister (PET), sealed with a Tyvek® lid and EtO sterilized.

The provided text describes a 510(k) submission for the PiCCO Catheter, which is a thermodilution probe. This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested details about acceptance criteria, study design for proving performance, expert involvement, and ground truth establishment are not applicable to this type of regulatory submission as presented. The document focuses on demonstrating that the new device is as safe and effective as an already legally marketed predicate device, primarily through non-clinical performance and biocompatibility testing, along with a comparison of technological characteristics.

Here's an analysis of the provided text in response to your request, indicating where information is not applicable (N/A) to this 510(k) submission:

1. A table of acceptance criteria and the reported device performance

The document does not present specific acceptance criteria in a tabular format with corresponding reported device performance metrics in the way one would for a new device's efficacy study. Instead, it states that various tests were conducted and their results "demonstrate that the functionality and performance characteristics of the device are comparable to the predicate device."

For instance, performance testing for mechanical properties (e.g., gauging, leakage, separation force) were conducted against standards like ISO 594-1:1986 and ISO 594-2:1998, and shelf life testing was conducted according to ISO 10555-1:2013. The acceptance criterion for these tests is simply compliance with the applicable standard or demonstrated comparability, rather than specific quantitative performance targets against clinical metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size:
  • No specific sample sizes for clinical test sets are mentioned as clinical data were not required.
  • For biocompatibility and performance testing, the sample sizes would be those dictated by the respective ISO standards for material and device testing. These are not explicitly stated in the document.
• Data Provenance:
  • The testing was performed according to international standards (e.g., ISO, IEC). The location where the tests were physically performed is not specified, but the device owner is PULSION Medical Systems SE in Germany.
  • The data is non-clinical performance data from laboratory and material tests, not patient data.
  • It is prospective in the sense that these tests were conducted specifically for this submission.

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)

N/A. This is a non-clinical 510(k) submission. The "ground truth" for the test set is established by the specifications of the standards (ISO, IEC) for material and device performance, not by expert medical opinion in a diagnostic or clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Since this is a non-clinical submission, there is no "adjudication" of results in the sense of multiple clinical reviewers reaching consensus. Test results are objective measurements against defined standards.

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

N/A. This device is a physical catheter, not an AI-powered diagnostic tool requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This device is a physical catheter and does not involve an algorithm with standalone performance.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this 510(k) submission is based on adherence to recognized international standards and specifications for medical device materials (biocompatibility) and functional performance (e.g., mechanical integrity, shelf-life, EMC). There is no clinical ground truth (like pathology or outcomes data) directly used for this submission to prove efficacy, as clinical data was not required.

8. The sample size for the training set

N/A. There is no "training set" as this is a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established

N/A. As there is no training set, this question is not applicable.

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The VolumeView system is indicated for use in critical care patients in which cardio-respiratory function, fluid status, and vascular resistance need constant and/or intermittent assessment. The femoral arterial catheter is indicated for femoral artery insertion.

The VolumeView System consists of a 4 or 5 French, 16 or 20 cm, two lumen femoral artery catheter and a CVC thermistor manifold. One catheter lumen has a thermistor for making blood temperature measurements, and the other is used for pressure monitoring. The manifold is used for injecting thermodilution boli through a central venous catheter. The guidewire is a PTFE-coated nitinol guidewire.

The provided text is a 510(k) Summary for the Edwards Lifesciences VolumeView System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain specific details about acceptance criteria, a study proving the device meets those criteria, or information on aspects like sample sizes, ground truth establishment, or expert involvement in a study.

The 510(k) summary only states:

• "The VolumeView System has been demonstrated to be as safe and effective as the predicate devices for their intended use."
• "The VolumeView System has successfully undergone functional testing. This product has been shown to be equivalent to the predicate devices."

These statements indicate that some form of testing was performed to demonstrate substantial equivalence, but the details required for your request are not present in this summary.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, rather than a detailed study report with specific performance metrics and methodologies.

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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, 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.

Not Found

I am sorry, but based on the provided document, there is no information about acceptance criteria for a device, a study proving it meets acceptance criteria, or any details related to AI, machine learning, or algorithms.

The document is a US FDA 510(k) clearance letter for the "Pulsion Pulsiocath Thermodilution Catheters and Accessories". It primarily focuses on:

• Device Name: Pulsion Pulsiocath Thermodilution Catheters and Accessories
• Regulation Number & Name: 21 CFR 870.1915, Thermodilution Probe
• Regulatory Class: Class II
• Product Code: KRB
• Date of Clearance: September 19, 2007
• Purpose: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.
• Intended Use: For use with the Pulsion PiCCO Cardiac Output System for the measurement of cardiac output by thermodilution method, arterial blood pressure, and cardiac output determination by arterial pulse contour analysis. Indicated for patients requiring cardiovascular and circulatory volume status monitoring.

Therefore, I cannot provide the requested information because it is not present in the given text.

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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

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.

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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 monitorinq is desired and patients undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.

The PULSION Pulsiocath Thermodilution Catheter with J-Guidewire and needle, and a monitoring kit including an in-line injectate sensor used as accessories to the Pulsion Continuous Pulse Contour Cardiac Output System (PiCCO). When coupled with the Pulsion Continuous Pulse Contour Cardiac Output System (PiCCO), the above device accessories, in connection with a central venous catheter, operate to measure and display cardiac output parameters.

The provided document is a 510(k) summary for the PULSION Pulsiocath Thermodilution Catheter with J-Guidewire and needle, and a monitoring kit including an in-line injectate sensor. This submission is for market clearance based on substantial equivalence to predicate devices, not for a de novo device requiring extensive clinical trials and performance evaluation against predefined acceptance criteria. Therefore, the document does not contain the requested information regarding acceptance criteria and a study proving the device meets them.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on demonstrating substantial equivalence to existing devices.
2. Sample sized used for the test set and the data provenance: Not applicable as a performance study against acceptance criteria is not described. The document pertains to substantial equivalence.
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): Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a medical catheter and sensor system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The submission is based on the premise that the device has the "same intended use" and "technological characteristics are the same or similar" to legally marketed predicate devices. Performance is thus inferred through equivalence, rather than a new study against specific performance criteria.

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