(141 days)
The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.
The SmartLinx Vitals Plus Patient Monitoring System operates on top of the SmartLinx Medical Device Information System (MDIS) to present patient information to the clinical user for active monitoring purposes at the point of care. It consists of the SmartLinx Vitals Plus Application (a mobile medical application operating on the SmartLinx Neuron 2 Mobile Platform), SmartLinx Vitals Plus NIBP Module, Masimo uSpO2 Pulse Oximetry Cable, Exergen TAT-5000S Thermometer, Covidien FILAC 3000 Thermometer, SmartLinx Vitals Plus Alarm Hub, SmartLinx Neuron 2 Mobile Platform, and optionally the SmartLinx Early Warning Scoring System (EWSS). The system collects vital signs data from sensors connected to the SmartLinx Neuron 2 Mobile Platform, which serves as the user interface and supports connectivity with the electronic medical record (eMR). The proposed device is identical to the predicate device (K171751) with the addition of the option for Nellcor SpO2 Pulse Oximetry solution and software upgrades.
The provided document is a 510(k) summary for the SmartLinx Vitals Plus Patient Monitoring System. It outlines changes to an already cleared device, primarily the addition of Nellcor SpO2 pulse oximetry solution and software upgrades.
The document explicitly states that "clinical studies to support substantial equivalence" were not required. Therefore, there is no information in this document regarding:
- Acceptance criteria expressed as performance metrics or targets.
- A specific study proving the device met such acceptance criteria.
- Sample sizes for test sets or training sets.
- Data provenance.
- Number of experts or their qualifications.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used or how it was established for training or testing sets.
Instead, the submission relies on:
- Comparison to a legally marketed predicate device (SmartLinx Vitals Plus Patient Monitoring System, K171751) and a reference device (Zoe Medical's 740 Select, K130411). The core argument is that the modifications (primarily the addition of Nellcor SpO2) do not raise new questions of safety and effectiveness, as the reference device already supports Nellcor SpO2.
- Performance testing: This is described as "hardware and software verification and validation, as well as testing to FDA recognized consensus standards."
- Conformance with FDA recognized consensus standards: A table of standards (such as ANSI AAMI ES 60601-1, IEC 60601-1-2, ISO 80601-2-61, IEC 62304, etc.) is provided to demonstrate adherence to established safety and performance requirements for medical electrical equipment, including pulse oximeters and software.
Therefore, the tables and information requested cannot be derived from the provided text, as this 510(k) relies on substantial equivalence through design and standards conformance, rather than new clinical performance data for the specific changes.
§ 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).