(83 days)
The Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg).
Physiological parameters and waveforms supported are:
- Pulse oximetry (SpO2/pulse rate)
- Respiration rate (RR)
Continuous pulse oximetry and respiration rate monitoring may be used for patients at risk of cardiorespiratory and infectious complications.
The Portrait Mobile Monitoring Solution is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
This device is not an Apnea monitor (i.e., do not rely on the device for detection of alarm for the cessation of breathing).
This device should not be used for life sustaining/supporting purposes.
The Portrait Mobile Monitoring Solution is not intended for use in a controlled Magnetic Resonance (MR) environment.
The Portrait Mobile Monitoring Solution V1.1 is a wireless monitoring system for monitoring SpO2, pulse rate and respiration rate of adult and pediatric patients. The system can be used for monitoring adult and pediatric patients (3 years of age and older and weighing more than 10 kg) within a hospital or healthcare facility. The system acquires, stores, calculates, displays, and exports patient physiological parameter data, alarms, and information. It supports pulse oximetry (SpO2/pulse rate) and respiration rate parameters. Measurement values are displayed as graphic or numeric values, like waveforms and numbers, and when applicable, also as alarm messages.
The Portrait Mobile Monitoring Solution V1.1 consists of the following general categories of medical devices:
Central Monitoring Devices:
- Portrait Core Services hosted on the GE HealthCare nonmedical device Edison Health Link platform. Portrait Core Services is a set of software services that enable the communication and interaction of the system components and are capable of integrating into existing healthcare facility infrastructure and clinical information systems.
- Portrait Central Viewer Application software hosted on a Windows off-the-shelf computer. Portrait Central Viewer Application provides the ability to view patient real-time and historical data, capable of displaying data from multiple patients.
- Portrait Clinical Alarming Unit provides audible alarms at each Central Viewer.
Mobile Monitoring Devices:
- Portrait Mobile Patient Monitor Hardware, a battery-powered, wireless, hand-held patient monitor. The Portrait Mobile Patient Monitor is a completely wireless, hand-held device that is capable of acting as a standalone patient monitor including alarms, with a 3.7-inch capacitive touchscreen capable of displaying numeric data and waveforms for SpO2, Pulse Rate (PR), and Respiration Rate (RR). Compared to the predicate (K230626), the Portrait Mobile Patient Monitor has been split into separate hardware and software components for serviceability. The Portrait Mobile Patient Monitor Hardware is shipped with no clinical software installed. The clinical software (i.e., Portrait Mobile Patient Monitor Software) is installed at the customer site before the device is put into use. The Portrait Mobile Patient Monitor Hardware when the Portrait Mobile Patient Monitor Software is installed (prior to patient use) is then what we will refer to as the Portrait Mobile Patient Monitor. Portrait Wearable SpO2 sensors for acquiring SpO2 and pulse rate data from a patient wirelessly.
- Portrait Mobile Patient Monitor Software is the clinical software which gets installed at the customer site on the Portrait Mobile Patient Monitor Hardware. The Portrait Mobile Patient Monitor Software is this submission is equivalent to the software installed on the predicate Portrait Mobile Patient Monitor cleared in K230626 with minor changes as discussed in this submission.
- Portrait Wearable Respiration Rate sensor and Portrait RR electrode patch for acquiring impedance respiration data from a patient wirelessly.
- Portrait Sensor battery used for powering the wearable sensors and provide wireless communication to the Portrait Mobile Patient Monitor.
- Portrait Bedside Charger for charging the Portrait Sensor Batteries and Portrait Mobile Patient Monitor (including when the Portrait Mobile Patient Monitor is in clinical use).
- Portrait SpO2 Attachment accessory band which provides means to secure the SpO2 sensors to the patient's wrist
- Portrait Mobile Patient Monitor Pouch, which allows the Portrait Mobile Patient Monitor to be carried while the patient is ambulatory
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets said criteria in a table format. It focuses on demonstrating substantial equivalence to a predicate device, K230626 Portrait Mobile Monitoring Solution v1.0, through non-clinical testing and updates to software and standards compliance.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in a table format in the given document. The document lists "Specifications" for the proposed device and compares them to the predicate device, stating "Identical" or "Equivalent" for most technical specifications and performance characteristics, rather than specific acceptance criteria and detailed performance results from a study.
A table comparing the proposed device specifications to the predicate device is provided on pages 19-27, with "Identical" or "Equivalent" noted for each entry. The key takeaway is that the proposed device maintains the performance characteristics of the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench testing related to software, hardware and performance" but does not specify sample sizes for test sets.
- Sample Size for Test Set: Not specified for individual performance tests.
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective for the non-clinical tests. It focuses on compliance with FDA guidance and recognized standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document for the non-clinical performance and validation tests mentioned. The document describes compliance with standards and guidance documents but does not detail the process of establishing ground truth for testing data, nor the number or qualifications of experts involved in such a process.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This type of study is not mentioned in the document. The submission explicitly states: "The Portrait Mobile Monitoring Solution v1.1 does not contain clinical testing data."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
The document describes "SpO2 measurement," "Pulse Rate (PR) measurement," and "Impedance Respiration" for which "no changes have been made to the algorithms since K230626, only regression testing performed." This implies that the algorithms for these measurements are operating in a standalone capacity (device only), and their performance compared to the predicate device has been affirmed through regression testing. However, no specific standalone performance metrics or studies are detailed beyond this.
7. Type of Ground Truth Used
For the SpO2 and Pulse Rate measurements, the document mentions:
- "low perfusion condition (this testing covers the full accuracy range in challenging low-perfusion conditions using a simulator, proving that there has been no system regression)"
This indicates that simulators were used to establish reference data for certain conditions (low perfusion) for SpO2 and PR. For other measurements, the ground truth methodology is not explicitly specified beyond compliance with recognized standards.
8. Sample Size for the Training Set
This information is not provided. The document states that "no changes have been made to the SpO2 algorithms since K230626, only regression testing performed" and similarly for Respiration Rate algorithms. This suggests the underlying algorithms were developed and potentially trained earlier, but details of training data are absent.
9. How the Ground Truth for the Training Set was Established
This information is not provided, as details about training sets are omitted.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).