Search Results
Found 5 results
510(k) Data Aggregation
(366 days)
PULSION MEDICAL SYSTEMS AG
The PULSION PICCO-2 is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVOX™ oximetry module connected to a compatible oximetry probe, the PiCCO-2 measures oxygen saturation to assess oxygen delivery and consumption in adults and pediatrics. Cardiac output is determined both continuously through pulse contour analysis and intermittently thermodilution technique. In addition, the PiCCO-2 measures heart rate, systolic, and diastolic and derives mean arterial venous pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for the determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PiCCO-2 monitor presents the derived parameters indexed to body surface area.
The PULSION PiCCO-2 is a microprocessor-based instrument intended for the determination and monitoring of cardiopulmonary and circulatory variables. When the optional CeVOX™ optical module and probe are connected to the PiCCO-2, the monitor measures oxygen samuation in adults or pediatrics. In addition, the PiCCO-2 measures heart rate, systelic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PiCCO-2 presents the derived parameters indexed to body surface area.
The Pulsion PiCCO-2 with Optional CeVOX Accessories is a device intended for measuring and monitoring cardiopulmonary and circulatory variables. The provided text, K091786, describes the device and claims substantial equivalence to predicate devices, but does not include any study data or detailed acceptance criteria for the quantitative performance of the device based on a clinical or non-clinical study involving a specific test set. Instead, it lists specifications for various parameters.
Here’s a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document lists "Accuracy" and "Remark" for each parameter, which can be interpreted as the acceptance criteria and the stated performance. However, it's crucial to note that these are specifications for "actual production output" and not the results of a specific study comparing the device to a ground truth as typically understood in a performance study.
| Label | Unit | Lower limit | Upper limit | Acceptance Criteria (Accuracy*) | Reported Device Performance |
|---|---|---|---|---|---|
| CO | l/min | 0.25 | 25 | Coefficient of variation ≤ 2% | Coefficient of variation ≤ 2% (Valid over full range) |
| GEDV | ml | 40 | 4800 | Coefficient of variation ≤ 3% | Coefficient of variation ≤ 3% (Valid over full range) |
| ITBV | ml | 50 | 6000 | Coefficient of variation ≤ 3% | Coefficient of variation ≤ 3% (Valid over full range) |
| EVLW | ml | 10 | 5000 | Coefficient of variation ≤ 6% | Coefficient of variation ≤ 6% (Valid over full range) |
| PCCO | l/min | 0.25 | 25 | Coefficient of variation ≤ 2% | Coefficient of variation ≤ 2% (Valid over full range) |
| SV | ml | 1 | 250 | Coefficient of variation ≤ 2% | Coefficient of variation ≤ 2% (Valid over full range) |
| SO2 | % | 1 | 99 | ±2% | ±2% (Valid from 40 - 99%) |
| SvO2 | % | 1 | 99 | ±2% | ±2% (Valid from 40 - 99%) |
| ScvO2 | % | 1 | 99 | ±2% | ±2% (Valid from 40 - 99%) |
Note: The "Reported Device Performance" column directly mirrors the "Acceptance Criteria" because the document states these are "Statistical evaluation based on random examination of actual production output," implying these are the designed and expected performance characteristics, rather than empirically derived results from a specific clinical study detailed in this submission.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The provided document does not describe a specific clinical or non-clinical study with a defined test set, sample size, or data provenance for the purpose of demonstrating device performance against specific acceptance criteria. The performance claims are based on "Statistical evaluation based on random examination of actual production output," which is primarily a manufacturing quality control statement rather than a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical study or test set with expert-established ground truth is described in the provided document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical study or test set requiring adjudication is described in the provided 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
Not applicable. The PULSION PiCCO-2 is a microprocessor-based instrument for measuring physiological variables, not an AI-assisted diagnostic imaging device that typically involves human readers. No MRMC study is mentioned or implied.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device functions as a standalone monitor, providing measurements of cardiopulmonary and circulatory variables. The "Functional/Safety Testing" section states, "The PULSION PiCCO-2 with optional CeVOX™ accessories has successfully undergone functional testing demonstrating equivalence to the predicate devices. The subject and predicate devices are similar in design, principle of operation, materials of construction, intended use, labeling and manufacturing processes. In vivo non-clinical testing, sterilization validation and biocompatibility testing was conducted. Results of all non-clinical testing met associated acceptance criteria and did not raise new issues of safety and/or effectiveness."
While functional testing and "in vivo non-clinical testing" were conducted, the document does not detail the results against the specific performance metrics listed in the table or explicitly state a "standalone performance study" in a quantifiable manner as understood for diagnostic algorithms. The primary claim is substantial equivalence to predicate devices, supported by functional and safety testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used for the "Statistical evaluation based on random examination of actual production output" or for the "in vivo non-clinical testing." For a device measuring physiological parameters, ground truth would typically come from highly accurate reference instruments or established clinical gold standards, but this is not detailed in the submission provided.
8. The sample size for the training set
Not applicable. This device is described as a "microprocessor-based instrument" that measures and monitors physiological variables. It is not an artificial intelligence or machine learning model that typically undergoes "training" on a dataset in the conventional sense. Therefore, no training set sample size is applicable or mentioned.
9. How the ground truth for the training set was established
Not applicable. As noted in point 8, no training set is described for this device.
Ask a specific question about this device
(21 days)
PULSION MEDICAL SYSTEMS AG
The PULSION PiCCO-2 is intended for determination and monitoring of cardiopulmonary and circulatory variables. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PiCCO-2 measures heart rate, systolic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PiCCO-2 presents the derived parameters indexed to body surface area.
Not Found
This document is a 510(k) clearance letter for the Pulsion PiCCO-2 device, a monitoring system for cardiopulmonary and circulatory variables. It does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.
The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, which means it meets the regulatory requirements based on existing devices, rather than through a new, independent set of clinical trials with pre-defined acceptance criteria tested against a new cohort.
Therefore, I cannot provide the requested information from the provided text. To get this information, you would typically need to consult the original 510(k) submission summary or any associated clinical study reports, which are not included in this FDA clearance letter.
Ask a specific question about this device
(28 days)
PULSION MEDICAL SYSTEMS AG
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.
Ask a specific question about this device
(113 days)
PULSION MEDICAL SYSTEMS AG
The PULSION PiCCO Plus is intended for determination and monitoring of cardiopulmonary and circulatory variables. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PiCCO Plus measures heart rate, systolic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered. the PiCCO Plus presents the derived parameters indexed to body surface area.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a device called "Pulsion Continuous Pulse Contour Cardiac Output (PiCCO Plus) System." This document primarily addresses the FDA's determination of substantial equivalence to a predicate device for market clearance. It does not contain the detailed study information, acceptance criteria, or performance data that would be necessary to answer the questions about device acceptance criteria and the study proving it meets those criteria.
Therefore, I cannot provide the requested information based solely on this document. The document confirms the device's classification, regulation number, and indications for use, but it does not delve into the specifics of the clinical or technical studies that led to its clearance.
Ask a specific question about this device
(90 days)
PULSION MEDICAL SYSTEMS AG
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.
Ask a specific question about this device
Page 1 of 1