(148 days)
The Infinity CentralStation (ICS) is intended for use by trained healthcare professionals for the purpose of centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.
Infinity CentralStation with Rest ECG is intended for the production of diagnostic electrocardiograms for adult and pediatric patients when connected to a monitor with diagnostic 12-Lead ECG monitoring enabled.
The Infinity M300/M300+ is intended for use with the ICS to monitor ECG and pulse oximetry and nonambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network.
The Infinity M300/M300+ with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.
The Infinity® CentralStation (ICS) Wide (or widescreen) is a Central monitoring station capable of real-time display and storage of multi-parameter physiological patient data and alarm annunciation for networked devices including but not limited to ambulatory and non-ambulatory wireless telemetry monitoring.
The Infinity M300/M300+ is a wireless telemetry, patient-worn device with rechargeable lithiumion battery which monitors ECG and SpO2 physiological data and features a color display, local alarm alerts and keypad interface. ECG functions include heart rate, arrhythmia detection and ST segment analysis and SpO2 functions include pulse plethysmogram and pulse rate. Infinity M300/M300+ with TruST allows for 12-lead ECG monitoring with a reduced set of electrodes by deriving values for missing leads.
The provided text is a 510(k) premarket notification summary for the Draeger Medical Systems Infinity CentralStation Wide, Infinity M300, and Infinity M300+ devices. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices. However, it does not explicitly contain detailed acceptance criteria tables with reported device performance or specific study details regarding sample sizes, ground truth establishment for test sets, expert qualifications, or adjudication methods for this specific submission's changes.
The document states that the changes related to cybersecurity and M300+ swappable battery were evaluated through verification and validation testing. It emphasizes that these modifications do not raise new issues of safety and effectiveness and do not change the fundamental scientific technology of the cleared devices, meaning the previous performance characteristics are considered to remain valid.
The key performance data described pertains to compliance with various standards related to electrical safety, EMC, alarm systems, electrocardiographic monitoring, and pulse oximetry. These standards implicitly contain acceptance criteria.
Based on the provided information, I can extract the following, though some requested details related to individual device performance metrics and specific study designs for this particular 510(k) are not explicitly stated in this summary.
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a table of performance acceptance criteria directly. Instead, it refers to compliance with established international and national standards for medical electrical equipment. The "reported device performance" is implicitly that the device meets these standards.
| Acceptance Criteria (Implied by Standards Compliance) | Reported Device Performance (as stated in document) |
|---|---|
| Electrical Safety: AAMI/ANSI ES60601-1:2005/(R)2012 and amendments (IEC 60601-1 MOD) | Complies with the standard. |
| Electromagnetic Compatibility (EMC): IEC60601-1-2:2014 | Complies with the standard. |
| Alarm Systems: IEC60601-1-8:2012 | Complies with the standard. |
| Electrocardiographic Monitoring: IEC 60601-2-27:2011 | Complies with the standard. |
| Cardiac Rhythm and ST-Segment Measurement Algorithms: ANSI/AAMI EC57:2012 | Complies with the standard. |
| Pulse Oximetry: ISO 80601-2-61:2017 | Complies with the standard. |
| Cybersecurity (Denial of Service, KRACK, FTP to SFTP, SSH, TLSv1.2): | Risk mitigation measures designed, developed, and tested; validation tests conducted to confirm implementation; results support substantial equivalence. |
| Biocompatibility: ISO 10993-1 assessment | Materials are biocompatible for intended use; testing results demonstrate compliance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not detail specific sample sizes for test sets for the verification and validation of the changes in this submission. The testing done refers to internal company verification and validation efforts rather than clinical studies with patient data for assessing core performance metrics like arrhythmia detection accuracy. Data provenance is not specified.
3. 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 applicable/Not provided. The document summarizes the regulatory submission for changes to existing devices, focusing on technical compliance and safety/effectiveness equivalence, not new clinical performance evaluation requiring external expert ground truth establishment for a diagnostic output. The modifications are for cybersecurity and hardware components (swappable battery).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Not provided. Adjudication methods are typically used in clinical studies involving interpretation of medical data, which is not the focus of the performance data section for this specific submission's changes.
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:
Not applicable. This submission is for modifications (primarily cybersecurity and a new battery component) to existing patient monitoring devices, not for a new AI/CAD system. Therefore, an MRMC study is not relevant to the described changes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The performance data focuses on compliance with technical standards for the device's functions (e.g., ECG monitoring, pulse oximetry, alarm systems) and validation of the cybersecurity and hardware changes. These are "standalone" in the sense that the device's technical functions are tested against defined standards. However, it's not "algorithm only" in the context of a new diagnostic algorithm. The monitoring functions (like arrhythmia detection, ST-segment measurement for 12-lead ECG) are inherent to the device and would have been evaluated in prior clearances against ANSI/AAMI EC57.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the specific changes in this submission (cybersecurity, swappable battery), the "ground truth" would be the successful implementation and verification of design requirements and risk mitigations, as tested internally by Dräger. For the underlying physiological monitoring capabilities (ECG, SpO2, arrhythmia, ST-segment), the ground truth for performance evaluation in predicate devices would typically be established through recognized test databases (e.g., MIT-BIH Arrhythmia Database for arrhythmia detection, or similar validated datasets for ST-segment analysis) or expert review against reference standards, as per standards like ANSI/AAMI EC57. The document for this submission does not detail these for the underlying performance.
8. The sample size for the training set:
Not applicable. The described changes and performance data do not relate to machine learning model training.
9. How the ground truth for the training set was established:
Not applicable. Not a machine learning submission.
§ 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.