(203 days)
The intended use of this device is to measure heart rate, respiration rate, invasive pressure, noninvasive pressure, temperature, arterial oxygen saturation and provide ECG ectopic beat and arrhythmic rhythm detection. This device will produce visual and aural alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to the Siemens SIRENET network.
The Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring Systems with Cardiac Arrhythmia Detection Option is an enhanced version of the Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring Systems granted premarket approval under 510 K file number K944350. The enhanced system has modified software to suppor added features. The enhanced software is equivalent to the software used in the Siemens SC 9000 patient monitor. The Siemens SC 6000 & SC 6000 F with Optional Cardiac Arrhythmia Detection System is an enhanced software version of the Siemens SC 6000 & SC 6000 P portable patient monitor. The enhanced version adds cardiac arrhythmia monitoring and a number of user convenience features.
Here's an analysis of the Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring Systems with Cardiac Arrhythmia Detection Option, based on the provided text, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance (Cardiac Arrhythmia Detection Option Only)
The document primarily focuses on the Cardiac Arrhythmia Detection Option due to its regulatory classification as Class III and the specific testing mentioned. For other features, the document largely states equivalence to a predicate device or mentions software upgrades without specific, quantified acceptance criteria or performance metrics in this section.
| Feature / Criteria | Acceptance Criteria (Implicit) | Reported Device Performance (Summary from provided document) |
|---|---|---|
| Cardiac Arrhythmia Detection Option | ||
| Equivalence to Predicate Device (SC 9000) | To be substantially equivalent to the Cardiac Arrhythmia Detection System of the Siemens SC 9000 (K946306). | The Siemens SC 6000 & SC 6000 P Optional Cardiac Arrhythmia Detection System is stated to be equivalent to the Cardiac Arrhythmia Detection System of the Siemens SC 9000. It detects, alarms (visually and audibly), and generates recordings for ventricular tachycardia (VT) and PVCs/min, in addition to previously detected ventricular fibrillation and asystole. The system "has been tested using the test and results reporting called out in the AAMI (ECAR-1987) 'Recommended Practice for Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms' and the FDA 'Guidelines For Submitting Data In Support of Premarket Notification (510(k)) Applications for Arrhythmia Detectors' (1990)." Specific performance numbers (e.g., sensitivity, specificity, accuracy) are not provided in this summary but are referenced in "Exhibit R, sections; IRIS Arrhyhtmia Test QRS Classifiaciton Performance Consecutive VEB Performance Ventricular Fibrillation Performance Ventricular Tachicardia Performance." |
| Detection of VT and PVCs/min | Device should reliably detect, alarm, and record ventricular tachycardia (VT) and PVCs/min. | Device detects, alarms (visually and audibly), and generates recordings for ventricular tachycardia (VT) and PVCs/min. Performance is stated to be equivalent to the predicate SC 9000. |
| Temperature Alarms | Default upper limit: 39 °C (102 °F); Default lower limit: 34 °C (94 °F); Setup range: 17 to 50 °C (62.6 to 122 °F); Auto set range: +/- 7%. | The SC 6000/P's temperature alarm limits, setup range, and auto set range are presented as identical to those of the predicate SC 9000. This implies the device meets these criteria by design and implementation. |
| Other Software Upgrades | Functional as specified, equivalent to predicate where applicable. | The document states these features (Continuous Waveform Recordings, Trend Recordings, Diagnostic Log Recordings, User Initiated Stored Recording Dump, Siemens SC 9015 Display support, User Selectable Temperature Units, Configurable SpO2 Response Times, Respiration Rate Algorithm Improvements, ECG Baseline Recovery Improvement) are achieved with software upgrades and references Exhibit R for validation testing details. Specific performance metrics are not provided in this summary. |
| Electrical Safety | Compliance with IEC 601-1, Safety Class 1, Type CF, UL 544, and CSA C22.2 No.125. | The device "Complies with Standards - IEC 601-1, Safety Class 1, Type CF UL 544 and CSA C22.2 No.125." Results of these tests are presented in Appendix 1, Exhibit N. |
2. Sample Size Used for the Test Set and Data Provenance
- Cardiac Arrhythmia Detection Option: The document references "the AAMI (ECAR-1987) 'Recommended Practice for Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms' and the FDA 'Guidelines For Submitting Data In Support of Premarket Notification (510(k)) Applications for Arrhythmia Detectors' (1990)." These guidelines typically recommend testing against standardized arrhythmia databases (e.g., MIT-BIH Arrhythmia Database). However, the specific sample size (number of ECG recordings, duration, patients) and precise data provenance (country of origin, retrospective/prospective) are not provided in this summary. It only states that the testing was conducted per the recommended practices.
- Other Features: No specific sample sizes for test sets are mentioned for any other enhanced features. The document generally refers to "validation testing" in Exhibit R.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Cardiac Arrhythmia Detection Option: The document explicitly states that the testing followed AAMI and FDA guidelines for arrhythmia detection algorithms. These guidelines typically rely on expert-annotated databases where ground truth (e.g., arrhythmia labels, QRS complex identification) has been established by cardiologists or other qualified experts. However, the precise number of experts or their qualifications for the specific test set used are not detailed in this summary. It is implied that standard, independently annotated databases were used.
- Other Features: Not applicable, as detailed ground truth establishment for these features is not discussed in the provided text.
4. Adjudication Method for the Test Set
- Cardiac Arrhythmia Detection Option: For algorithm validation against standardized databases (as implied by AAMI/FDA guidelines), the ground truth in these databases is often established through expert consensus, typically involving multiple cardiologists to resolve discrepancies. However, the specific adjudication method for the test set used (e.g., N+1, N-way consensus) is not explicitly stated in this summary.
- Other Features: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, the document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the performance of the device's arrhythmia detection algorithm itself, comparing it to established guidelines and a predicate device. There is no mention of human readers or the effect size of AI assistance on human performance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, a standalone performance study of the Cardiac Arrhythmia Detection Option was performed. The document states: "the SC 6000 & SC 6000 P Cardiac Arrhythmia Detection system has been tested using the test and results reporting called out in the AAMI (ECAR-1987) "Recommended Practice for Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms" and the FDA "Guidelines For Submitting Data In Support of Premarket Notification (510(k)) Applications for Arrhythmia Detectors" (1990)." This implies testing the algorithm's performance against a ground truth database without human intervention during the detection process.
- The results for "IRIS Arrhyhtmia Test QRS Classifiaciton Performance Consecutive VEB Performance Ventricular Fibrillation Performance Ventricular Tachicardia Performance" are referenced in Exhibit R.
7. Type of Ground Truth Used
- Cardiac Arrhythmia Detection Option: The ground truth used for testing would be based on expert consensus annotations of ECG waveforms from standardized arrhythmia databases, as mandated by the AAMI and FDA guidelines referenced. This ground truth includes accurate identification and labeling of QRS complexes, ventricular ectopic beats (VEBs), ventricular tachycardia, and ventricular fibrillation episodes.
- Other Features: For other features like temperature alarms or respiration rate improvements, the ground truth would likely involve physical measurements against calibrated standards or human observation/annotation of physiological parameters. However, specific details are not provided in this text.
8. Sample Size for the Training Set
- The document does not provide any information regarding the sample size used for the training set for the software algorithms. This information is typically proprietary and not often disclosed in 510(k) summaries, which focus on testing and validation.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide any information regarding how the ground truth for the training set was established. Similar to the training set size, details on model development and training methodologies are generally not included in this type of regulatory summary. It can be inferred that if the algorithm was trained on similar data to what it was tested on, the training ground truth would also be established by expert annotations or standardized measurements.
§ 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.