Search Results

The Infinity CNAP SmartPod is indicated for the continuous, non-invasive monitoring of arterial blood pressure in adults by medical professionals. The Infinity CNAP SmartPod is intended for uses with the Infinity Modular patient monitors of the Delta series (Delta XL, Kappa, SC7000, SC8000, SC9000XL). Derived arterial values and pressure waveforms are displayed when a pod is connected to one of the previously identified patient monitors.

The Infinity CNAP SmartPod supports the following parameters:

Continuous and oscillometric blood pressure Pulse rate CNAP-S (systolic pressure) CNAP-D (diastolic pressure) CNAP-M (mean pressure)

The Infinity CNAP Smartpod performance may be affected in situations where the flow of blood to the finger is severely inhibited or in the presence of pathologically increased stiffness of the finger arteries. Included as examples:

• Cases of severe shock or hypothermia ●
• Severe arteriosclerosis of the upper extremities .
• Primary or secondary Raynaud's syndrome and related diseases
• . Endarteritis obliterans
• . Collagenosis affecting peripheral arteries

The Infinity CNAP SmartPod is not intended for use on patients with vascular implants at the site of measurement.

The Infinity CNAP SmartPod is not compatible for use in a MRI magnetic field.

The Draeger Infinity CNAP SmartPod technology was developed with CNSystems and is similar to their CNAP Monitor System 500i (K082599).

The Draeger Infinity CNAP SmartPod connects to an Infinity modular monitor (K070566) for the display and alarming of continuous non-invasive blood pressures: CNAP-S (Systolic), CNAP-D (Diastolic), and CNAP-M (Mean). CNAP parameter alarms can be set via the alarm limits menu of the monitor.

The Infinity CNAP SmartPod is a device for continuous non-invasive blood pressure monitoring. The device measures continuous and oscillometric blood pressure as well as pulse rate. CNAP is a joint solution, where absolute blood pressure values are coming from an integrated OEM Oscillometric blood pressure device and beat-to-beat changes as well as waveform are measured with the CNAP finger sensor. Finger-BP is automatically calibrated to absolute NIBP-values. Immediately after a NIBP, the CNAP computer puts systolic and diastolic finger BP on the same level as NIBP values. NIBP calibration can be obtained ipsilateral as well as contralateral to the CNAP-cuff,

The Infinity CNAP SmartPod works by utilizing integrated photo-plethysmograph (lightemitting diode and detector) sensors. These sensors are located in an occluding Dual Finger cuff placed around the patient's fingers. While the cuff is maintained at the mean arterial pressure, the sensor detects changes in blood volume based on the amount of light transmitted through the finger. With the cuff inflated to mean arterial pressure, the signal output varies directly with any change in blood volume. Systemic blood pressure can then be calculated beat to beat, and a correlation with arterial pressure obtained via a standard oscillometric measurement from the patient monitor. The resulting derived arterial values and pressure waveforms are then displayed on the monitor.

The provided text does not contain detailed information about a specific study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for the Draeger Infinity CNAP SmartPod, focusing on its equivalence to a predicate device and adherence to general safety standards.

Therefore, I cannot fulfill all parts of your request as the information is not present in the given document.

However, I can extract the following relevant information:

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

The document does not explicitly list acceptance criteria or reported device performance in a numerical or statistical format. It states generally:

• "The Infinity CNAP SmartPod was tested in accordance with the applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate device."
• "Testing performed indicate that the software modifications described in this submission are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)."
• "The results of testing demonstrate that the device is safe and effective and substantially equivalent to its predicate device."

2. Other requested information:

• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified in the provided text.
• 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 specified.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
• 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, as this is a medical device for continuous blood pressure monitoring, not an AI-assisted diagnostic imaging system.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone continuous monitoring device. The document does not describe the specific performance studies in detail.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified.
• The sample size for the training set: Not applicable/specified. The device is not purely an AI algorithm in the context of a training/test set for image interpretation, but a physical monitoring device.
• How the ground truth for the training set was established: Not applicable/specified.

Summary of available information:

The document is a regulatory submission (510(k) summary) aiming to demonstrate substantial equivalence to a predicate device (CNSystems CNAP Monitor 500i, K082599). It asserts that the device was tested per applicable standards and internal design control procedures and found safe and effective. However, it does not provide the granular details of performance studies, specific acceptance criteria, or statistical results that would typically be found in a detailed study report.

Ask a specific question about this device