(146 days)
The Surveyor S4 Mobile Monitor is indicated for use:
• The Surveyor S4 Mobile Monitor is indicated for use to acquire, analyze and output multi-lead ECG and SpO2 signals.
The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG and SpO2 parameters when used in conjunction with alarm annunciating devices such as the Surveyor Central Station for telemetric monitoring; however, the Surveyor S4 has no alarming capabilities of its own.
• The Surveyor S4 processes Heart Rate, ST segment deviation and arrhythmias such as, but not limited to, Ventricular Tachycardia, Ventricular Fibrillation, and Asystole by utilizing Mortara VERITAS™ ECG algorithm.
• The Surveyor S4 can deliver data from a 3/5-lead cable and diagnostic 12-lead ECG data to a receiving Surveyor Central station
• The Surveyor S4 Mobile Monitor is indicated for use as a mobile radio transceiver, allowing the patient to be ambulatory within the range of a Wi-Fi information infrastructure.
• The Surveyor S4 Mobile Monitor is indicated for use in adults, adolescents and children.
• The Surveyor S4 Mobile Monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare or clinical setting. It is not intended as a sole means of diagnosis.
The Surveyor™ S4 Mobile Monitor is a battery operated patient worn transceiver that communicates via IEEE 802.11 Wi-Fi technology to the Surveyor™ Central Station (K131929) which is the primary monitoring display and alarm source.
The Surveyor S4 transmitter has a touch sensitive, color display allowing for operational conveniences such as a battery level indicator, Wi-Fi Signal Strength and Surveyor Central Station slot information. The Surveyor S4 can display physiological waveforms, measured parameters, demographic data and other status information. The Surveyor S4 acquires, filters, and processes ECG or ECG and SpO2 parameters and sends filtered signals and parameters to the Surveyor Central Station where alarm processing and annunciation occurs.
The Surveyor Central is designed to communicate with the Surveyor S4 within a healthcare facilities Wi-Fi network infrastructure. The Surveyor Central provides primary monitoring of telemetry patients when used with the Surveyor S4. The central station displays numeric values, waveforms, alarm generation and management, data storage, individualized patient management, report generation and printing functionality.
The Surveyor S4 provides continuous data acquisition which can be visualized on the S4 itself for the following parameters:
- o Electrocardiography (ECG) including heart rate and ECG waveforms
- · Saturation percentage of peripheral oxygen (SpO2), including SpO2 plethysmogram waveform, pulse rate, and signal quality index.
- o No alarm status or processing information of ECG or SpO2 is shown on the Surveyor S4 device.
- o The Surveyor S4 processes Heart rate, ST segment deviation and arrhythmias, by utilizing Mortara VERITAS™ ECG algorithm and sends ECG data packets, including arrhythmias such as, but not limited to, Ventricular Tachycardia, Ventricular Fibrillation, and Asystole to the Surveyor Central Station for alarm processing and annunciation.
- o The Surveyor S4 utilizes proprietary ECG lead cables available in AHA or IEC, snap or clip, 3-Lead, 5-Lead, and diagnostic 12 Lead configurations.
- o The Surveyor S4 processes SpO2 percentage, pulse rate and signal quality through the Mortara SpO2 algorithm and sends data packets for SpO2 to the Surveyor Central Station for alarm processing and annunciation.
- o Multiple SpO2 sensor styles allow connection of adults, adolescents, and children. SpO2 sensors are specified for use with the Surveyor S4 and available through Mortara Instrument.
The device in question is the Mortara Surveyor S4 Mobile Monitor. The provided text primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study for acceptance criteria. However, it does mention one basic clinical study for SpO2 compliance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of acceptance criteria with corresponding device performance for the entire device. It states that software verification and validation testing was conducted, and the device was designed and tested for compliance with specific standards (listed below). The only specific performance claim related to a study is for SpO2.
| Acceptance Criteria (Standard/Guideline) | Reported Device Performance |
|---|---|
| IEC 60601-1:2005 Ed:3 | "The Surveyor S4 Mobile Monitor was designed and tested for compliance with the applicable clauses of the following standards..." (Implies compliance, but no specific performance metrics are given for this general safety standard). |
| IEC 60601-2-49: 2011 | "The Surveyor S4 Mobile Monitor was designed and tested for compliance with the applicable clauses of the following standards..." (Implies compliance, but no specific performance metrics are given for this multi-function patient monitoring standard). |
| IEC 60601-1-2:2007 | "The Surveyor S4 Mobile Monitor was designed and tested for compliance with the applicable clauses of the following standards..." (Implies compliance, but no specific performance metrics are given for this EMC standard). |
| ISO 80601-2-61:2011 Clause 201.12.1 | "A basic pulse oximeter clinical study was conducted to demonstrate the Surveyor S4 Mobile Monitor SpO2 compliance to IEC 80601-2-61. The study met the requirements of ISO 80601-2-61-2011 Clause 201.12.1." (This indicates the study successfully demonstrated compliance, but specific performance values like accuracy, bias, or RMSE are not provided in this summary). The standard itself would define the acceptable limits for these. |
| IEC 60601-2-25:2011-10 Edition 2.0 | "The Surveyor S4 Mobile Monitor was designed and tested for compliance with the applicable clauses of the following standards..." (Implies compliance, but no specific performance metrics are given for this electrocardiographs standard). Relevant to ECG accuracy, heart rate calculation, etc. |
| ANSI/AAMI EC57:2012 | "The Surveyor S4 Mobile Monitor was designed and tested for compliance with the applicable clauses of the following standards..." (Implies compliance, but no specific performance metrics are given for cardiac rhythm, ST segment measurement, and ventricular fibrillation algorithms. This standard specifies performance requirements and test methods for these algorithms, so compliance would mean meeting its defined accuracy, sensitivity, and specificity limits, among others). |
| Mortara VERITAS™ ECG algorithm | The device "processes Heart rate, ST segment deviation and arrhythmias such as, but not limited to, Ventricular Tachycardia, Ventricular Fibrillation, and Asystole by utilizing Mortara VERITAS™ ECG algorithm." No specific performance metrics (sensitivity, specificity, accuracy) are explicitly stated for this algorithm in the provided text, but compliance with ANSI/AAMI EC57 suggests it meets the performance requirements of that standard. |
| Mortara SpO2 algorithm | The device "processes SpO2 percentage, pulse rate and signal quality through the Mortara SpO2 algorithm." Compliance to ISO 80601-2-61 implies meeting the performance requirements for SpO2 and pulse rate accuracy. |
Note: The FDA 510(k) summary typically establishes substantial equivalence, often by demonstrating adherence to recognized standards and comparing to predicate devices, rather than presenting full clinical trial results and specific acceptance criterion tables for every feature. The statement "The study met the requirements of ISO 80601-2-61-2011 Clause 201.12.1" is the most direct mention of acceptance criteria being met.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "A basic pulse oximeter clinical study was conducted to demonstrate the Surveyor S4 Mobile Monitor SpO2 compliance to IEC 80601-2-61."
- Sample Size for Test Set: Not specified for the SpO2 clinical study.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided for the SpO2 clinical study or any other part of the evaluation. For a pulse oximeter study conforming to ISO 80601-2-61, ground truth is typically established by comparing the device's SpO2 readings against co-oximeter readings from arterial blood samples, with interpretation often overseen by a qualified physician or clinical team, but details are absent here.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document describes a "basic pulse oximeter clinical study" for SpO2 compliance and otherwise focuses on engineering testing against standards and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
For the SpO2 functionality, a standalone clinical study was done as "A basic pulse oximeter clinical study was conducted to demonstrate the Surveyor S4 Mobile Monitor SpO2 compliance to IEC 80601-2-61." This evaluates the algorithm's performance directly against established ground truth.
For ECG aspects (Heart rate, ST segment deviation, arrhythmias using VERITAS™ ECG algorithm), the document states the device "was designed and tested for compliance with the applicable clauses of... ANSI/AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm, ST segment measurement algorithms, ventricular fibrillation algorithm, and irregular rhythm (atrial fibrillation) algorithm." This standard specifically outlines methods for standalone algorithm performance testing, implying such testing was conducted to demonstrate compliance. However, specific performance metrics or detailed study descriptions are not provided in this summary.
7. The Type of Ground Truth Used
For the SpO2 clinical study, the ground truth would typically be established using co-oximetry from arterial blood samples, as dictated by the ISO 80601-2-61 standard for pulse oximeter accuracy testing. This involves comparing the device's SpO2 readings with direct measurements of oxygen saturation in arterial blood. While not explicitly stated, adherence to the standard implies this methodology.
For the ECG algorithms (Heart Rate, ST-segment, arrhythmia detection), ground truth for compliance with ANSI/AAMI EC57:2012 would typically be established by expert consensus of cardiologists or other qualified medical professionals reviewing annotated ECG recordings. This could also involve comparison against known, validated datasets or simulated waveforms. Again, the specific details are not provided in this summary but are implied by the standard.
8. The Sample Size for the Training Set
The document does not provide information regarding the training set sample size for any of its algorithms (VERITAS™ ECG algorithm or Mortara SpO2 algorithm). This submission focuses on the performance of the final, developed device and algorithm.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established. As this is a 510(k) submission for substantial equivalence, such details about algorithm development and training data are typically not included unless specifically requested or if it's a novel AI device requiring detailed algorithm transparency.
§ 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.