Search Results
Found 1 results
510(k) Data Aggregation
(129 days)
POLARIS 2004 CAPNOGRAPH
The Polaris 2004 Capnograph is intended for the continuous, non-invasive measurement and monitoring or respiration rate and carbon dioxide concentration of the expired and inspired breath of neonatal, pediatric and adult patients wherever these measurements are required by attending medical personnel.
The Oridion Polaris Capnograph (the device being modified-K950388) is a device that measures end tidal CO2 (EtCO2). As a derivative of the EtCO2 measurement the devices measure and display the breath rate (BR). The capnograph module of both devices function as a carbon dioxide gas analyzer that measures in mmHg, Vol %, or kPa the concentration of CO2 in a gas mixture to aid in determining the patient's ventilatory status.
This 510(k) summary does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, as it primarily focuses on demonstrating substantial equivalence to a predicate device. However, it does reference compliance with a standard.
Here's an attempt to extract and infer information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Compliance with EN864 for Capnographs | "The Polaris 2004 Capnograph...meets the standard EN864 for capnographs that has been accepted by the FDA." (This implies the device performance met the technical specifications and accuracy requirements outlined in EN864 for parameters like EtCO2 measurement accuracy, breath rate accuracy, response time, etc., although specific numerical values are not provided in this document.) |
| Basic design, intended use, and indication remain the same as predicate device | "The basic design, intended use and indication of the Polaris 2004 remain the same..." |
| Design modifications do not alter fundamental technology, materials, or manufacturing processes. | "...the design modifications have not altered the technology, materials or manufacturing processes of the Polaris." |
| No new issues of safety or efficacy | "The changes pose no new issues of safety or efficacy." |
| Equivalent flow and gas sampling system to predicate | "The Polaris and the modified device (Polaris 2004) use the identical flow and gas sampling system and pneumatic system." |
| Equivalent CO2 module function to predicate (MiniMediCO2 vs. generic CO2 module) | "The modified device, the Polaris 2004 Capnograph, incorporates all the functions of the Polaris monitor. It is equivalent, in terms of indications for use and technological characteristics to the Polaris Capnograph K950388." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document primarily discusses device modifications and equivalence to a predicate, not performance testing on a specific "test set" of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. As no specific "test set" or clinical study with patient data results are detailed, there is no mention of experts establishing ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the 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
There is no mention of an MRMC study. This device is a capnograph, a medical instrument that measures physiological parameters. It does not appear to involve image interpretation or AI for diagnostic assistance to human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not explicitly stated as a "standalone" study in the context of an algorithm. However, the device itself, the Polaris 2004 Capnograph, operates independently to measure and display CO2 and respiration rate. The document implies that its performance (e.g., accuracy of CO2 measurement) was validated against the EN864 standard. This standard would dictate the methods for testing the device's inherent measurement capabilities.
7. The Type of Ground Truth Used
The primary "ground truth" referenced for performance is the EN864 standard for capnographs. This standard likely specifies objective criteria and methods for evaluating the accuracy and performance of carbon dioxide analyzers, which would involve calibrated gas mixtures or other validated reference methods.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is a hardware medical instrument for physiological measurement, not an AI/machine learning algorithm that requires a "training set" of data in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as point 8.
Summary of what the document implies about validation:
The primary "study" proving the device meets acceptance criteria is the demonstration that the modified Polaris 2004 Capnograph conforms to the EN864 standard for capnographs. The 510(k) process for this device relies heavily on the concept of substantial equivalence to a previously cleared predicate device (Polaris Capnograph K950388). The document emphasizes that the modifications introduced (e.g., MiniMediCO2 module, aluminum manifold, removal of water trap with Filterline K980324) do not alter the fundamental safety, efficacy, or intended use, and leverage components or concepts already cleared by the FDA in other devices (e.g., MiniMediCO2 module in Microcap K981114, Filterline in K980324). Therefore, the "proof" is largely based on demonstrating that these changes maintain the performance characteristics of the predicate device and meet an internationally recognized standard.
Ask a specific question about this device
Page 1 of 1