(139 days)
This device is capable of monitoring heart rate, respiration rate, invasive pressure, non-invasive pressure, arthythmia (adult only), temperature, cardiac output (adult only), arterial oxygen saturation, pulse rate, end-tidal carbon dioxide and (central) apnea and ST Segment Analysis (adult only). This device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
The Siemens SC9000/ SC9015 Bedside Monitoring System enhanced with ST Segment Analysis is an updated software version of the Siemens SC9000/ SC9015 Bedside Monitoring System. The modification adds software to determine the ST Segment of the ECG signal and to compute the deviation of this ST Segment from the iso-electric point (baseline). This is the same algorithm that is used in the Siemens 1481(T) Digital Telemetry System with S-T Segment Analysis Option (K951371). The hardware of the SC9000/SC9015 is unchanged.
The ST Segment Analysis is not active when the Siemens SC9000/SC9015 Monitor is in the neonatal functionality
The modified software (version VB2) is compatible with previously sold versions of the monitor. A retrofit will be offered to the owners of units with previous software versions. There are no hardware changes required for the upgrade.
Here's an analysis of the provided 510(k) summary regarding the Siemens SC9000/SC9015 Bedside Monitoring System enhanced with ST Segment Analysis:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and the stated accuracy improvements.
| Acceptance Criteria (Predicate Device) | Reported Device Performance (Applicant Device) |
|---|---|
| ST segment deviation measurement accuracy: +/- 1 mm | ST segment deviation measurement accuracy: +/- 0.5 mm |
| Leads processed: I, II, III, aVR, aVL, aVF, V | Leads processed: I, II, III, aVR, aVL, aVF, V, V+, V1 - V6 |
| Iso point default: QRS onset - 30 msec | Iso point default: QRS onset - 28 msec |
| Sample rate: 100 samples/ second | Sample rate: 250 samples/sec. |
| Update interval: 20 seconds | Update interval: 15 seconds |
Study Proving Acceptance Criteria:
The submission states: "Performance was qualified by testing versus a standard clinical patient database per AAMI recommendations."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document only mentions "a standard clinical patient database."
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It is referred to as a "standard clinical patient database."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not explicitly stated. The document refers to "standard clinical patient database per AAMI recommendations," implying a pre-existing, validated dataset where ground truth would have been established, but the details of its establishment are not part of this submission.
4. Adjudication Method for the Test Set
Not explicitly stated.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission focuses on the standalone performance of the device and its comparison to a predicate device based on technical specifications and database testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The document states, "Performance was qualified by testing versus a standard clinical patient database." This implies evaluating the algorithm's output against the ground truth derived from the database, without a human in the loop interpretating the device's results.
7. The Type of Ground Truth Used
The ground truth was established by a "standard clinical patient database per AAMI recommendations." This suggests that the database contains reference ST segment measurements and related ECG annotations established through expert consensus or other validated methods that align with AAMI (Association for the Advancement of Medical Instrumentation) guidelines for ECG analysis.
8. The Sample Size for the Training Set
Not explicitly stated. The 510(k) summary focuses on the performance of the algorithm (which was previously cleared in K951371) in a new monitoring system, rather than the development of the algorithm itself. Therefore, training set details are not provided here.
9. How the Ground Truth for the Training Set Was Established
Not explicitly stated. As mentioned above, the submission pertains to the application of an existing algorithm to a new device, not the development of the algorithm.
§ 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.