(204 days)
This device is capable of monitoring Heart rate, Respiration rate, Invasive pressure, Non-invasive pressure, Arrhythmia, Temperature, Cardiac output, Arterial oxygen saturation, Pulse rate, End-tidal carbon dioxide, (central) apnea, ST segment analysis. With the MultiGas™ and MultiGas+™ modules the SC9000/SC9015 is capable of measuring: Respiration rate, Inspired and expired Carbon Dioxide (CO2), Inspired and expired Oxygen (MultiGas+TM only), Average inspired Oxygen (MultiGas™ only), Inspired and expired concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, and Nitrous Oxide. The SC9000/SC9015 is capable of performing 12-lead ST Segment analysis. This device can be connected to third party devices: Siemens SV 300™ ventilator, the Baxter Vigilance™ blood gas system, the Puritan Bennett 7200™, Draeger Evita IV™, & Babylog™, and Siemens SV900™ ventilators. The device is intended to be used in the environment where patient care is provided by Healthcare professionals, and use of the device is indicated, based upon their professional assessment of the patient's medical condition. The device is intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the 12-Lead ST Segment Analysis which are intended for use in the adult and pediatric populations only; and Arrhythmia which is intended for use in the adult population only.
The Siemens SC9000/SC9015 Bedside Monitoring System Enhanced with 12-Lead ST Segment Analysis is an updated version of the Siemens SC9000/SC9015 Bedside Monitoring System. The system is comprised of the following components: MultiMed-12™ ECG pod, SC9000 with a new, optional processing board and enhanced software, MultiView WorkStation with enhanced software, Cardiology Review Station (optional). A new 12-lead ECG patient cable, the MultiMed-12™ "pod', collects data from the patient and transmits it to the SC9000 unit. To enable 12-lead ST processing, the new, optional processing board must be installed in the SC9000 unit. In addition, the SC9000 must have the new software version VC0 installed. The SC9000 unit receives the signals from the MultiMed-12™ ECG pod, downsamples them to 500 samples/s and performs QRS detection. The SC9000 then performs 12-lead ST analysis on the ECG leads provided, using the same algorithm as the predicate device (Siemens Megacart™, K915225) with minor modifications to generate ST vector magnitude (STVM) and an ST change magnitude (STCVM) vector. The SC9000 may be connected to a central station, the MultiView WorkStation (K955059). If connected to a commercially available LaserPrinter™, ECG reports can be printed. VC0 software needs to be installed in the MultiView WorkStation to enable printing of 12-lead reports. This requires no hardware modifications. The Cardiology Review Station (CRS), a derivative of a MVWS, receives all available ST data from the SC9000, and collects and archives the trend data for review by the user.
The provided 510(k) summary for the Siemens SC9000/SC9015 Bedside Monitoring System Enhanced with 12-Lead ST Segment Analysis includes limited information regarding acceptance criteria and study details. Based on the document, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states: "Currently there are no FDA standards for this device." and "Performance was qualified by testing versus a standard clinical database per AAMI recommendations." However, it does not list specific quantitative acceptance criteria for ST segment analysis or the reported performance metrics against those criteria. It only mentions that the device uses "the same algorithm as the predicate device" for 12-lead ST analysis.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "a standard clinical database per AAMI recommendations," but the size of this database is not provided.
- Data Provenance: Not explicitly stated. It refers to "a standard clinical database," which implies a collection of existing data, likely retrospective. The country of origin is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not explicitly stated. The document mentions "testing versus a standard clinical database," but it does not describe how the ground truth within this database was established or the number and qualifications of experts involved.
4. Adjudication Method for the Test Set
Not explicitly stated. Given the reference to a "standard clinical database," it's possible that the ground truth within that database was already established through some form of expert consensus or adjudication, but the method is not detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or indicated in the document. The study described focuses on the device's performance against a clinical database, not on its impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation of the algorithm appears to have been done. The document states, "Performance was qualified by testing versus a standard clinical database per AAMI recommendations." This implies the algorithm's output was compared directly against the ground truth of the database, without human intervention in the analysis process being explicitly mentioned as part of this qualification.
7. The Type of Ground Truth Used
The ground truth used was based on a "standard clinical database per AAMI recommendations." This suggests that the ground truth for ST segment analysis within this database would typically be derived from expert consensus by cardiologists or other qualified medical professionals, often using established criteria for ST segment evaluation. However, the exact nature (e.g., pathology, outcomes data) is not specified beyond "standard clinical database."
8. The Sample Size for the Training Set
Not applicable. This device is an updated version of a previously cleared device (Siemens MEGACART™ K915225 and SC9000/SC9015 K946306). The document mentions the new device uses "the same algorithm as the predicate device" for ST analysis. This suggests that the algorithm was developed and validated prior to this submission, likely using training data, but the details of that training set and its size are not provided in this 510(k) summary. The current submission focuses on demonstrating substantial equivalence, not re-training a new algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as details about a training set for this specific submission are not provided. The algorithm is stated to be the "same as the predicate device," implying its ground truth establishment would have occurred during the development of the original algorithm, which is not described here.
§ 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.