(228 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) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of pulse rate (PR) of adult, pediatic, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions.
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 be connected 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, pediatic 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
Devices with Masimo technology are only indicated for use with Masimo sensors and cables.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) for adults and pediatics during no motion conditions in hospitals and hospital-type facilities.
PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.
Masimo Rad-97 System and Accessories (Rad-97 product family), features a touchscreen display that continuously displays numeric values for the connected monitoring parameters. The Rad-97 product family can be operated on AC power or internal rechargeable battery.
The subject device (Rad-97 product family) is the same as the predicate (Rad-97 product family) cleared under K183697. The Rad-97 comprises of the same measurement technologies as cleared in the predicate, 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), 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 subject of this submission is the addition of indications for PVi, an index previously cleared as an informational index.
Here's a breakdown of the acceptance criteria and study information for the Masimo Rad-97 Pulse CO-Oximeter and Accessories, specifically for the PVi indication, based on the provided text:
Acceptance Criteria and Reported Device Performance for PVi
| Acceptance Criteria | Reported Device Performance (AUC) |
|---|---|
| Not explicitly stated as a numerical threshold in the provided text. The submission references "acceptability of the PVi feature for its updated indications" and support via published studies. | Study 1: 0.785 |
| Study 2: 0.95 | |
| Study 3: 0.97 | |
| Study 4: 0.82 | |
| Study 5: 0.74 | |
| Study 6: 0.934 |
Note: The provided text does not explicitly define acceptance criteria as a specific numerical benchmark for AUC. Instead, it states that the "test results supported the ability of PVi to provide an indication of fluid responsiveness."
Study Details for PVi Indication
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: A combined total of 182 subjects were included across 6 highlighted studies that involved mechanically ventilated adult patients.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective as they involved "undergoing surgeries, where PVi was monitored for fluid responsiveness using volume expansion changes (fluid bolus infusions)."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The ground truth was established by monitoring "cardiac output response" to "fluid bolus infusion," which suggests physiological measurements rather than expert consensus on a subjective interpretation. The text does not mention expert review for establishing ground truth for PVi functionality.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. The determination of fluid responsiveness based on cardiac output response to fluid bolus infusion is a direct physiological measurement, not an interpretation requiring adjudication by multiple experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. The PVi feature is a non-invasive monitoring parameter, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, this was a standalone performance evaluation. The PVi feature provides a continuous non-invasive measurement (algorithm only) and is intended as an "indicator of fluid responsiveness." The assessment focused on the device's ability to correlate PVi changes with fluid responsiveness, without a human interpretation step being part of the primary evaluation of the PVi's accuracy itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth was established by monitoring the cardiac output response to fluid bolus infusion. This represents physiological outcomes data (changes in a patient's hemodynamic status).
8. The sample size for the training set
- Not specified. The provided information focuses on the validation of the PVi feature for its updated indications, using published studies. It does not detail the initial development or training phases of the PVi algorithm itself.
9. How the ground truth for the training set was established
- Not specified. As mentioned above, the document focuses on the validation studies for the expanded PVi indication, not the initial development or training.
§ 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).