Search Results
Found 1 results
510(k) Data Aggregation
(229 days)
OBSERVER * CENTRAL STATION
The OBSERVER Central Station with ST-segment measurement is a prescription device intended for use only by health care professionals. The device is used for the remote monitoring of physiological parameters, including non-invasive and invasive blood pressure; invasive hemodynamic and intracranial pressures; oxygen saturation via pulse oximetry; temperature; ECG ; and pulse/heart rate of adult, pediatric and neonatal patients. The device is located at a distance from the patient but within the same facility, including settings such as hospital and outpatient services, including general medical/surgical, critical care, intermediate/step-down care, emergency room, radiology, labor and delivery, operating and recovery room, cardiac catheterization lab, endoscopy and same-day surgery.
Arrhythmia detection and ST-segment measurement are optional ECG features limited to the adult population. ST-segment measurement is contraindicated in paced patients. The ST-segment feature of the OBSERVER Central Station provides for the measurement of the ST-segment level and slope of the ECG waveform, alerting the clinician to ST-segment changes. The significance of ST-segment changes must be determined by a clinician. The device is not designed, sold or intended for use except as indicated.
The OBSERVER Central Station with ST-segment measurement is an optional feature of the OBSERVER Central Station with arrhythmia analysis. This feature allows for the measurement of the ST-segment level and slope and the issuance of alarms for ST elevations and depressions. The clinician may adjust certain waveform points and alarm priority and limits or rely on default settings for each patient to be analyzed.
The OBSERVER Central Station (K933404) is a PC-based monitoring system designed to provide remote surveillance with alarms, trending and retrieval of wave-form and numeric physiological data for up to 8 patients who are monitored via various DINAMAP* Physiological Monitors or other appropriate bedside/patient monitors.
The OBSERVER Central Station displays, records and stores physiological data including ECG, non-invasive and invasive blood pressure, heart rate, temperature and pulse oximetry. The system is designed to be used with a hardwire interface using RS 232; wireless connectivity using 900 MHz spread spectrum or fixed frequency; or VHF (174-216 MHz, TV channels 7 through 13), including patient-worn telemetry. Monitors that may be networked with the OBSERVER Central Station for ECG include members of the Johnson & Johnson Medical Inc. DINAMAP* family of monitors, such as the DINAMAP MPS* Select* Monitor (K955113) and the DINAMAP* PLUS Monitor (K943709 and K912188), and patient-worn ECG VHF telemetry (VitalCom, Inc. K942147). The OBSERVER Central Station uses a Pentium PC with an SVGA, touch or non-touch, color monitor. Recordings can be made on either the built-in two-channel thermal recorder or with an optional HP LaserJet* Printer. Also optional is full disclosure (history) of all waveforms.
The OBSERVER* Central Station with ST-segment measurement is a continuous monitoring device. The device was found to be substantially equivalent to the currently marketed OBSERVER Central Station with arrhythmia analysis (K933404) and the ST-segment measurement feature of the VitalCom, Inc. VCOM Central Monitor (K942147).
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria for each performance metric. It mentions that the software was "tested against" databases to "measure" the algorithm's performance. The conclusion states that the modified device is "safe, effective and substantially equivalent" to predicate devices.
| Performance Metric | Acceptance Criteria (Not explicitly stated, assumed to meet predicate device performance) | Reported Device Performance (Summary) |
|---|---|---|
| QRS detection sensitivity | Implied to be acceptable for substantial equivalence | Measured against AHA and MIT databases |
| QRS detection positive predictivity | Implied to be acceptable for substantial equivalence | Measured against AHA and MIT databases |
| Ventricular beat identification sensitivity | Implied to be acceptable for substantial equivalence | Measured against AHA and MIT databases |
| Ventricular beat identification positive predictivity | Implied to be acceptable for substantial equivalence | Measured against AHA and MIT databases |
| Ventricular beat identification false positive rate | Implied to be acceptable for substantial equivalence | Measured against AHA and MIT databases |
| ST sensitivity | Implied to be acceptable for substantial equivalence | Measured against the European ST-T database |
| ST positive predictivity | Implied to be acceptable for substantial equivalence | Measured against the European ST-T database |
| ST peak error | Implied to be acceptable for substantial equivalence | Measured against the European ST-T database |
| Software validation for ST information processing | Implied to demonstrate correct processing and no adverse effect on other system parts | Performed to show correct processing and no system interference |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated, as the document refers to "AHA and MIT databases" and the "European ST-T database." These are established public databases containing numerous ECG recordings.
- Data Provenance: The databases used are:
- AHA (American Heart Association) database
- MIT (Massachusetts Institute of Technology) database
- European ST-T database
These are generally retrospective, publicly available datasets for ECG algorithm testing, often compiled from various clinical sources. The specific country of origin for each sample within these databases is not detailed in this summary, but they are recognized international benchmarks.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not specify the number of experts or their qualifications for establishing the ground truth within the AHA, MIT, or European ST-T databases. These databases are typically curated with expert-validated annotations, but the details of that validation process are external to this 510(k) summary.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method for the test set as part of this submission. The ground truth for the databases is assumed to be established by the curators of those databases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned for this device. The regulatory submission focuses on the algorithm's performance against standard databases and its substantial equivalence to predicate devices, not on human-in-the-loop performance improvement.
6. Standalone (Algorithm Only) Performance:
Yes, a standalone performance evaluation was done. The "Performance" section explicitly states that "The ST-enabled arrhythmia analysis software was tested against the AHA and MIT databases" and "The algorithm was also tested against the European ST-T database." This indicates an algorithm-only performance evaluation.
7. Type of Ground Truth Used:
The ground truth used is implied to be expert-annotated ECG waveforms from established public databases (AHA, MIT, European ST-T). These databases typically provide reference annotations for QRS complexes, arrhythmias, and ST-segment changes, which are considered the ground truth for evaluating such algorithms.
8. Sample Size for the Training Set:
The document does not specify the sample size for the training set. It focuses on the validation of the algorithm against known test databases.
9. How the Ground Truth for the Training Set Was Established:
The document does not describe how the ground truth for any training set was established. Given that the software was developed by VitalCom, Inc. (who also developed the ST-segment software for a predicate device), it's likely they used proprietary or established datasets for training, with ground truth established through expert review, but this is not detailed in the 510(k) summary.
Ask a specific question about this device
Page 1 of 1