(30 days)
The INFINITY Modular monitors are capable of monitoring:
- Heart rate
- Respiration rate
- Invasive pressure
- Non-invasive pressure
- Arrhythmia
- Temperature
- Cardiac output
- Arterial oxygen saturation
- Pulse rate
- Apnea
- ST Segment Analysis
- 12-Lead ST Segment Analysis
- tcp02/tcpC02
- EEG signals
- FiO2
The SCIO module samples breathing gases from adults and pediatrics. The gas modules continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, halothane, isoffurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.
With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored. The monitors can interface with specific third party devices via an MIB protocol converter.
The intent of this 510(k) is to submit a modification specific to Scio, a gas module used exclusively with Draeger Medical Systems' Infinity monitors. The modification is the addition of a sample gas return kit identifical to that of Draeger Medical's Vamos, 510(k) K040847. The modification allows the user the option of returning the sample gas from the Scio gas module to the breathing circuit.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Infinity Monitors with Scio Modifications:
The provided documents do not contain detailed acceptance criteria or a comprehensive study report as typically expected for demonstrating device performance. This submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full performance study with specific acceptance criteria and detailed results.
The key statement regarding performance is:
"Scio with sample gas return was tested in accordance with internal design control procedures and was determined to be as safe and effective for its intended use as the predicate device."
This statement is very general and lacks the specific details requested in the prompt. Therefore, much of the requested information cannot be extracted from these documents.
1. Table of Acceptance Criteria and Reported Device Performance
As stated above, no specific acceptance criteria or quantitative performance metrics are provided in the document. The general statement is that the device was determined to be "as safe and effective for its intended use as the predicate device."
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Summary) |
|---|---|
| Safe for intended use | "Determined to be as safe... for its intended use as the predicate device." |
| Effective for intended use | "Determined to be as effective... for its intended use as the predicate device." |
| Sample gas return functions as intended | Implied by the modification being the "addition of a sample gas return kit" and the overall substantial equivalence claim. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. It's implied that "internal design control procedures" were followed, but whether this involved human or animal testing, or purely bench testing without biological samples, is not detailed. The origin (e.g., country, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided. The term "ground truth" implies a reference standard, which is not described.
4. Adjudication Method for the Test Set
- Not applicable/Not provided. There is no mention of expert review or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study is not mentioned. The device is a physiological monitor, not typically evaluated with MRMC studies as a diagnostic imaging device would be. The focus is on the accuracy and reliability of the physiological measurements and alarms.
6. Standalone (Algorithm Only) Performance Study
- The document implies testing of the "Scio with sample gas return" module itself, which would be a standalone component of the monitoring system. However, the details of what "standalone performance" means in this context (e.g., accuracy of gas measurements in a lab setting) are not provided beyond the general statement of being "safe and effective."
7. Type of Ground Truth Used
- Not specified. Given the nature of a physiological monitor, ground truth would typically involve:
- Reference gas standards: For accuracy of gas measurements (CO2, N2O, O2, anesthetic agents).
- Simulated physiological signals: For monitoring heart rate, respiration, pressures, etc., against known inputs.
- Clinical observation/comparison to established devices: For alarm functionality and overall patient monitoring effectiveness.
- However, the document does not specify which, if any, of these were used.
8. Sample Size for the Training Set
- Not applicable/Not provided. This device is a hardware modification to a physiological monitor, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not provided, as there is no training set mentioned for this type of device.
Summary of Limitations:
The provided 510(k) summary is extremely high-level. It serves its purpose of demonstrating substantial equivalence to a predicate device by stating that "internal design control procedures" were followed and the device was determined to be "as safe and effective." However, it lacks the granular detail about specific performance metrics, test methodologies, sample sizes, and ground truth establishment that would be present in a detailed study report. This is typical for 510(k) summaries where the focus is on equivalence rather than novel performance claims.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.