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510(k) Data Aggregation
(55 days)
The proposed device, Smart BiteBloc™, will be used during endoscopy procedures that require a bite block that enables and supports the convenient use of, and will not interfere with, an oral nasal cannula (K011536) for collecting samples of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose for inhalation. It can be used for non intubated patients who weigh more than 55 lbs (25 kg).
Bite blocks indicated for use as an endoscopy accessory are usually classified, according to 21CFR876.1500, as exempt from pre market notification. The submitted endoscopy accessory, Smart BiteBloc™, has been modified to allow the convenient use of an oral nasal cannula (K011536) for sampling of EtCO2 and administration of O2 during endoscopic procedures. Oridion considers this device to be a capnography accessory.
The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria.
The document is a 510(k) summary for a medical device (Smart BiteBloc™), which focuses on establishing substantial equivalence to previously marketed predicate devices rather than detailing performance studies against specific acceptance criteria.
Therefore, I cannot provide the requested table and information.
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(129 days)
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.
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(250 days)
The Medley™ EtCO2 Module is a capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). The monitor is intended for use by professional healthcare providers where continuous, non-invasive monitoring of these parameters is desired. The Medley™ EtCO2 Module is indicated for use on adults, pediatrics and infant/neonates for both intubated and non-intubated patients.
The EtCO2 Module is the newest module to the currently marketed Medley™ Medication Safety System (Medley™ System). ALARIS Medical will incorporate currently marketed Oridion capnograph technology and accessories into the Medley™ EtCO2 Module. The Medley™ EtCO2 Module will be used to measure inspired and expired carbon dioxide (FiCO2 and EtCO2 respectively) and Respiration Rate (RR) on patients in the operating room, ICU, NICU, transport and emergency treatment. This capnograph technology originates from the MediCap/NPB-75 (K964239).
The provided text describes the Alaris Medical Systems Medley EtCO2 Module, a capnograph designed to continuously monitor end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). The document is a 510(k) premarket notification summary.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) summary, does not explicitly state specific numerical acceptance criteria or performance metrics (like accuracy, precision, or bias) for EtCO2, FiCO2, or RR measurements. Instead, it makes a general statement:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (typically quantitative thresholds for accuracy, precision, etc.) | "The performance data included in this submission indicate that the Medley™ EtCO2 Module meets specified requirements, and is substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details about a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The evaluation appears to be based on demonstrating "substantial equivalence" to a predicate device and relies on the predicate's established performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not available in the provided text. No ground truth establishment by experts for a test set is described.
4. Adjudication Method for the Test Set
This is not applicable/not provided as no test set requiring expert adjudication for ground truth is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not mentioned in the document. The device is a monitor, not an AI diagnostic tool requiring human reader interpretation or assistance.
6. Standalone Performance Study (Algorithm Only)
The document does not describe a standalone performance study in the context of an algorithm's performance. The Medley EtCO2 Module is a hardware device that incorporates "currently marketed Oridion capnograph technology." Its performance is evaluated against (or shown to be equivalent to) an existing predicate device rather than undergoing a separate standalone algorithm performance study. The statement "The performance data included in this submission indicate that the Medley" EtCO2 Module meets specified requirements" suggests internal testing was done, but no details of such a study are provided.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any performance evaluation. Given it's a capnograph, ground truth would typically come from a gold-standard CO2 measurement method, but this is not detailed. The primary basis for approval appears to be substantial equivalence to a predicate device.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. As a hardware medical device based on existing technology, the concept of a training set for an algorithm is not directly applicable in the information provided.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as no training set is described.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Oridion MicroCap/NPB-75, K964239) rather than detailing specific standalone performance studies with quantitative acceptance criteria, test sets, or ground truth establishment relevant to AI/algorithm performance. The approval hinges on the assertion that the "technological characteristics" and "performance data" show the device is "substantially equivalent" to the predicate.
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