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510(k) Data Aggregation
(22 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare facilities. The MP40 and MP50 are additionally intended for use in transport situations within healthcare facilities.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02) is restricted to neonatal patients only.
The Philips MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. The modification is the introduction of Release D.00 software for the IntelliVue patient monitor devices, MP40, MP50, MP60, MP70, MP80, and MP90.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Philips IntelliVue Patient Monitors, Release D.00:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table of numerical acceptance criteria or detailed performance metrics. Instead, it offers a general statement about meeting "specifications cleared for the predicate device." Therefore, the table below reflects this general statement.
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Performance, Functionality, and Reliability | "The results demonstrate that the Philips IntelliVue Patient Monitor meets all reliability requirements and performance claims." | This statement indicates that all the specified performance, functionality, and reliability requirements for the predicate device were met. Specific numerical criteria (e.g., accuracy ranges for physiological parameters, alarm response times) are not explicitly detailed in this summary but were likely part of the underlying documentation. |
| Safety Testing | "Safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." | This indicates that the device underwent safety testing based on a hazard analysis, and it met the safety specifications of the predicate device. |
| System Level Tests | "Testing involved system level tests... Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." | The device's overall system functionality was tested and found to be substantially equivalent to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature) for any of the testing. The testing described appears to be internal validation by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information regarding the number of experts used, nor their qualifications, for establishing ground truth. Given the nature of a patient monitor (measuring physiological parameters rather than diagnostic interpretation of images), the "ground truth" would likely be derived from established reference measurement devices rather than expert consensus on subjective data.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The device is a patient monitor, not an AI-assisted diagnostic tool, so such a study would not be applicable in this context. There is no mention of AI assistance in the context of human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone patient monitor, designed to measure and display physiological parameters directly. The testing described (system level tests, performance tests, safety testing) directly relates to the standalone performance of the monitor. The document describes a standalone performance evaluation of the device's functionality.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. However, for a patient monitor measuring physiological parameters, the ground truth would most typically be established through:
- Reference Measurement Devices: Using highly accurate and calibrated reference instruments (e.g., dedicated ECG machines for cardiac signals, precise pressure transducers for blood pressure, gas analyzers for gas measurements) to establish the true physiological values against which the monitor's readings are compared.
- Physical Simulators/Phantoms: Using controlled simulators that generate known physiological signals or conditions to test the monitor's accuracy and response.
It is highly unlikely that "expert consensus," "pathology," or "outcomes data" would be the primary ground truth for validating the fundamental performance of a patient monitor in the way it is for diagnostic imaging or clinical decision support AI.
8. The Sample Size for the Training Set
The document does not provide any information about a "training set." The device is a patient monitor with software (Release D.00) that likely incorporates established signal processing algorithms and control logic, rather than a machine learning model that requires a distinct training set in the modern sense. The text refers to "specifications cleared for the predicate device" as the basis for evaluation, implying a comparison to known benchmarks rather than an iterative learning process from a large data set.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied for a machine learning context, this question is not applicable based on the provided document. The "ground truth" for the device's development and validation would be the physical and physiological accuracy standards it must meet, as defined by its intended use and regulatory requirements.
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(238 days)
The device is intended for use in clinical and research applications to measure oxygen uptake.
The REEVUE is an indirect calorimeter. The REEVUE device measures oxygen consumption (VO2) and estimates Resting Metabolic Rate (RMR) based on the measured VO2 using an assumed respiratory quotient (RQ=0.83). Resting metabolic rate can also be referred to as Resting Energy Expenditure (REE).
Measurement of energy requirements can be used for nutritional assessment. A typical application would be for counseling obese patients on their caloric intake requirements.
During a test the patient breathes through a mouthpiece with unidirectional breathing valves. These valves allow the patient to breath in ambient air and then direct the expiratory gas down a hose to the device. The flow rate of the expiratory gas is measured and the patient's tidal volume and respiratory rate is calculated. The expiratory gas passes through a mixing chamber so that the mixed expiratory oxygen concentration can be found. The oxygen concentration of the mixed expiratory gas is measured.
Oxygen consumption can be expressed as the volume of oxygen breathed in minus the volume of oxygen breathed out. This can be described as:
[VO2 - VI|IO2 - VE|E O2] (1)
where VO2 is the oxygen consumption, VI is the inspiratory volume, FIO2 is the inspiratory oxygen fraction, VE is the expiratory volume, and FEO2 is the expiratory oxygen fraction.
Since the REEVUE only measures the expiratory volume of gas breathed out, the inspired volume must be estimated. This is similar to other legally marketed medical devices. When measuring both CO2 and O2 this is often referred as the Haldane method.
To estimate the inspired volume, the components of the expiratory and inspiratory volumes need to be accounted for. In estimating the inspiratory volume the REEVUE requires an estimate of the Respiratory Quotient (Ro). The REEVUE uses an assumed RO of 0.83. The RO is defined as:
RQ = VCO2 / VO2 (2)
where VCO2 is the carbon dioxide eliminated by the patient's breathing.
An estimate of Resting Energy Expenditure (REE) is calculated using the Weir Equation with the assumed RO value of 0.83. Substituting for the VCO2 using the RO and the VO2 the Weir Equation can be expressed as:
Calories = { 3.941 VO2-STPD + 1.106 RQ VO2-STPD } x { 1 - 0.082 PF } (3)
Where
Calories .......... is the calories burned per liter of oxygen consumed. PF ......................is the fraction of total energy production due to protein oxidation.
Typical values for Pr range from 0.08 to 0.2, corresponding to 8 to 20% protein. We selected a default value of 0.125 for our calculations. In reporting (REE) in Kcal/day, this simplifies to:
RMRKcal/day = 6.925 x VO2-ml/min-STPD (4)
Here's a breakdown of the acceptance criteria and study details for the REEVUE Indirect Calorimeter, based on the provided 510(k) summary:
REEVUE Indirect Calorimeter: Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
Non-Clinical Performance Criteria (Nitrogen Injection Method):
| Test | Acceptance Criteria (Bias) | Acceptance Criteria (Precision - 1 Std Dev) | Reported Device Performance (Bias) | Reported Device Performance (Precision - 1 Std Dev) | Pass/Fail Status |
|---|---|---|---|---|---|
| VO2 Accuracy (range 50-450 ml/min) |
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(80 days)
The Servo' Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport.
The ventilator is the same as described in the notification K010925. This application if for the following options to the Servo-i ventilator family.
The Bi-Vent mode is a Pressure controlled mode with added possibility to allow unrestricted spontaneous breathing, also at high level pressure.
The CO2 analyzer displays continuous CO2 curves of mainstream expired air and etCO2 figures. The aim is to measure the concentration of carbon dioxide to aid in determining the patient's ventilatory, circulatory, and metabolic status.
This document is a 510(k) summary for a Special 510(k) submission for the Siemens Servo Ventilator System, seeking clearance for two new options: Bi-Vent ventilation mode and a CO2 analyzer. The submission claims substantial equivalence to previously cleared devices.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria (e.g., accuracy percentages, error margins) for the CO2 analyzer or performance metrics for the Bi-Vent mode. Instead, it relies on claiming technological and clinical equivalence to predicate devices, implying that if the new options perform similarly to cleared devices, they meet implicit acceptance criteria.
The "reported device performance" is described through the lens of this equivalence:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| CO2 Analyzer Functional Equivalence: Measures CO2 concentration to aid in determining ventilatory, circulatory, and metabolic status; continuous CO2 curves, EtCO2, and VCO2 display. | "The CO2 functionality for the Servo-i CO2 module is equivalent to the CO2 analyzer in Siemens Infinity CO2 pod (file number K003550)... which also is technologically based and componentry sourced as Sensor and input electronics card from Novametrix (file number K963380)." This implies the Servo-i CO2 analyzer performs these functions with similar accuracy and reliability as the predicate device. |
| Bi-Vent Mode Functional Equivalence: Pressure-controlled ventilation with unrestricted spontaneous breathing; periodic switching between two levels of continuous positive airway pressure; allowing spontaneous breathing in any phase. | "Bi-Vent is a Biphasic positive airway pressure (BIPAP™) which is equivalent to airway pressure release ventilation (APRV)... These modalities operate by periodic switching between two levels of continuous positive airway pressure while allowing spontaneous breathing in any phase of the ventilatory cycle." |
| "The Bi Vent mode is substantially equivalent to Puritan Bennet 840 ventilator with NeoMode option (K001646), Dräger Evita 4 – (K980642)... Savina (Dräger – K003068), Galileo (Hamilton - K001686), and Harmony S/T Respironics - K984407 and KnightStar 330 (Nellcor - K003075)." This implies the Bi-Vent mode provides the intended ventilation support with equivalent clinical performance to these predicate devices. | |
| Clinical Performance Equivalence: Safe and effective for intended patient populations (neonates, infants, adults) and use environments (hospitals, in-hospital transport). | "The technology used is assessed, verification and design validation on animals show that the Servo Ventilator System has the equivalent clinical performance with the above options." This statement broadly confirms the clinical performance of the entire system with the new options. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for "test sets" in the typical sense of a clinical trial with a defined number of patients or samples.
- Data Provenance: The document mentions "verification and design validation on animals." This indicates that some form of pre-clinical testing data was used.
- Country of Origin: Not specified for the animal studies.
- Retrospective/Prospective: Animal studies are typically prospective by design.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not provided. The submission relies on technological and clinical equivalence to predicate devices. It doesn't describe a process of establishing ground truth on a new dataset by experts.
4. Adjudication Method
- Not applicable as the submission does not detail a study involving expert review or adjudication of a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or implied in this submission. The focus is on device function and equivalence, not on human reader performance with or without AI assistance (as this is a ventilator, not an AI-assisted diagnostic tool).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, for a ventilator and CO2 analyzer, the performance is inherently "standalone" in the sense that the device performs its functions and measurements independently. The clinical use involves a human operator (healthcare provider), but the performance metrics of the device itself (e.g., CO2 measurement accuracy, pressure delivery) are evaluated for the device alone. The "verification and design validation on animals" would assess this standalone performance.
7. Type of Ground Truth Used
- The ground truth is not explicitly defined as pathology, expert consensus, or outcomes data in the context of a new study on the Servo-i. Instead, the "ground truth" for the new options is essentially the performance of the legally marketed predicate devices. The new options are deemed to meet acceptance criteria if they exhibit "equivalent clinical performance" and "technological basis" to these established devices. For the animal study, the "ground truth" would be physiological measurements and observations in the animal model.
8. Sample Size for the Training Set
- This document does not refer to a "training set" as it would for a machine learning or AI algorithm. A ventilator's design and engineering are based on medical, physiological, and engineering principles rather than a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the context of this device and submission type. The design and validation are based on established engineering principles, regulatory standards, and comparative performance to predicates.
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