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510(k) Data Aggregation
(238 days)
The Masimo Rad-97 and Accessories are indicated for hospital-type facilities, mobile, and home environments.
The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station).
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rad-97 and Accessories are indicated for use with adult, pediatic, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused. In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multi-parameter devices for the display on those devices.
The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.
The optional Nomoline Capnography product family is intended to other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediatric and infant patients.
The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure. The NIBP module is designed to measure blood pressure for patient population described in the following table:
| Patient Population | Approximate Age Range |
|---|---|
| Newborn (neonate) | Birth to 1 month of age |
| Infant | 1 month to 2 years of age |
| Child | 2 to 12 years of age |
| Adolescent | 12-21 years of age |
| Adult | 21 years of age and older |
The subject device, Masimo Rad-97 System and Accessories (Rad-97) product family, features a touchscreen display that continuously displays numeric values for the measured monitoring parameters. The Rad-97 product family can be operated on AC power or internally rechargeable battery.
The Rad-97 product family comprises the same measurement technologies as cleared in the predicate, Root (with connected external Radical-7 and capnography (ISA) and internal NIBP modules), which includes the Masimo Rainbow SET technology, capnography technology and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (PI), Pleth Variability Index (PVI), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa) and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.
The Rad-97 product family is available with different measurement parameter configurations, ranging from a fully loaded configuration to a simplified configuration with pulse oximetry parameters only. In a fully loaded configuration, the Rad-97 model includes all parameters provided by the Masimo Rainbow SET technology including SpO2, PR, PI, PVI, SpCO, SpMet, SpHb, SpOC and RRa. Additionally, this fully loaded version can be optionally available with either NIBP or capnography technology.
The Rad-9 model, an instrument model within the Rad-97 product family, is an embodiment with a simplified configuration. The Rad-9 model includes the Masimo SET technology (a subset of Masimo Rainbow SET technology), which provides pulse oximetry parameters of SpO2, PR, PI and PVI. The Rad-9 model can be optionally available with NIBP technology.
Same as the predicate, the Rad-97 product family includes inout/output interfaces for connection to external devices. Furthermore, same as the predicate, the Rad-97 product family can communicate through wired/wireless connection with networked systems such as Patient SafetyNet (K071047) and/or hospital electronic medical/health record (EMR) systems.
The RD SET Disposable Sensors, listed with other cleared accessories in Section 11.7, are the same as the currently marketed product. The only change is the added labeling information regarding the sensors' performance in terms of limits of agreement (LOA) as defined by Bland-Altman.
Here's an analysis of the provided text to extract the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Requirement) | Reported Device Performance (Result) |
|---|---|---|
| SpO2, no motion (Upper 95% Limits of Agreement) | < 3% | 3.15% |
| SpO2, no motion (Lower 95% Limits of Agreement) | >= -3% | -2.21% |
Note: The reported performance for "Upper 95% LOA" (3.15%) indicates that the device did not meet the specified acceptance criterion of "< 3%". The reported performance for "Lower 95% LOA" (-2.21%) indicates that the device met the specified acceptance criterion of ">= -3%".
The document also lists other accuracy specifications for various parameters, but it does not explicitly state an "acceptance criteria" alongside them in the same format as the LOA for SpO2. These are presented as general "Accuracy (ARMS)" specifications.
Accuracy (ARMS) Specifications (not explicitly presented as acceptance criteria vs. performance in the provided text, but rather device specifications):
| Parameter | Accuracy Specification (ARMS)* | Patient Population |
|---|---|---|
| SpO2, no motion | 60-80%, 3%; 70-100%, 2% | Adults/pediatrics/infants |
| SpO2, no motion | 70-100%, 3% | Neonates |
| SpO2, motion | 70-100%, 3% | All |
| SpO2, low perfusion | 70-100%, 2% | All |
| Pulse rate, no motion | 25-240 bpm, 3 bpm | All |
| Pulse rate, motion | 25-240 bpm, 5 bpm | All |
| Pulse rate, low perfusion | 25-240 bpm, 3 bpm | All |
| RRa | 4-70 breaths per minute, 1 breath per minute | Adults, Pediatics |
| SpCO | 1-40%, 3% | Adults/pediatrics/infants |
| SpMet | 1-15%, 1% | All |
| SpHb | 8-17 g/dL, 1 g/dL | Adults/pediatrics |
| CO2 (Single dry gasses) | 0-15 volume % +0.2 volume% +2% of reading | - |
| CO2 (All conditions) | 0.3 kPa + 4% of reading | - |
| RR (Respiration rate) | 0-150 breaths/min + 1 breaths/min | - |
| NIBP | 0-300 mmHg, +3 mmHg | - |
- ARMS defined as a statistical calculation of the difference between device measurements fell within +/- ARMs of the reference measurements in a controlled study.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number. The study was conducted on "healthy adult volunteers."
- Data Provenance: Retrospective or Prospective is not explicitly stated, but clinical studies are generally prospective. The data is from "healthy adult volunteers," implying a clinical study setting. Country of origin is not specified, but the Masimo Corporation is based in Irvine, CA, USA, suggesting the study likely took place in the USA or under its regulations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the text. The ground truth for SpO2 was established by "blood measurements from a laboratory CO-Oximeter," which is an instrument, not human experts.
4. Adjudication Method for the Test Set
- Not applicable. The ground truth was established by an instrument (laboratory CO-Oximeter) comparing directly to the device measurements; there was no human adjudication process involved for establishing the ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers interpreting cases with and without AI assistance. This document describes the performance of a medical device (oximeter) and its various physiological monitoring capabilities, not an AI-powered diagnostic imaging tool that would typically undergo MRMC studies.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, a standalone performance study was done. The clinical study described "evaluate the sensor's performance for no motion condition, in the range of 70% to 100% in comparison to blood measurements from a laboratory CO-Oximeter." This evaluates the device directly against a reference standard, which is a standalone performance assessment.
7. Type of Ground Truth Used
- The ground truth used for SpO2 was instrumental measurement / reference standard. Specifically, it was "blood measurements from a laboratory CO-Oximeter."
8. Sample Size for the Training Set
- This information is not provided in the text. The document describes a clinical study for validating the device's accuracy, not for training a new algorithm. The device incorporates "Masimo Rainbow SET technology," which is a pre-existing technology, and the study is for the performance of the integrated product and its sensors.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided in the text, as no specific training set or new algorithm development is detailed. The technology itself (Masimo Rainbow SET) is described as utilizing principles of spectrophotometry and photoplethysmography, implying established scientific principles rather than a continuously trained machine learning model.
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