(288 days)
The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). 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 multiparameter devices for the display on those devices.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
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 in hospital-type facilities. 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 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 in hospital-type facilities.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatic patients during no motion conditions in hospital-type facilities.
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 hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
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, pediativ and infant patients.
The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in hospitals, hospital-type facilities, mobile, and home environments. 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 subject device (Rad-97 product family) is substantially the same as the predicate (Rad-97 product family) cleared under K170168. and has the same indications for use. The Rad-97 comprises 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), 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-9, an instrument model within the Rad-97 product family, is an embodiment with a simplified configuration. The Rad-9 was also cleared in K170168. 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.
Masimo's Rad-97 has improved SpO2 measurement accuracy for motion and no motion conditions with RD SET Disposable sensors previously cleared under K170168. Masimo improved its RD SET Disposable sensors through sensor characterization, facilitating a SpO2 measurement accuracy claim of 1.5% Ams during no-motions conditions for patient populations (adults, pediatrics, infants, and neonates) when used with Masimo's MX/MS-2000 boards. Masimo's SpO2 measurement accuracy claim with RD SET Disposable Sensors is 1.5% Arms during motion conditions for patient population (adults, pediatrics, infants, and neonates) when used with Masimo's MX/MS-2000 boards. Although they now include improved sensor characterization, the RD SET Disposable sensors are substantially equivalent to the currently marketed product.
Additionally, this submission includes the following sensors that have non-significant changes: the Multisite Reusable Sensors (K111888), the RD Specialty Sensors (K101896), and the RD reusable sensors (K051212).
Here is a summary of the acceptance criteria and study information for the Masimo Rad-97 and Accessories, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are presented as "Accuracy (ARMS)" specifications in the document.
| Feature / Condition | Acceptance Criteria (ARMS) | Reported Device Performance (Adjusted RMS) - Clinical Study | Patient Population |
|---|---|---|---|
| SpO2, no motion (70-100%) | 1.5% | 1.16% | Adults/pediatrics/infants |
| SpO2, motion (70-100%) | 1.5% | 1.31% | Adults/pediatrics/infants |
| SpO2, no motion (70-100%) | 3% | Not explicitly reported from study (but claimed) | Neonates |
| SpO2, motion (70-100%) | 3% | Not explicitly reported from study (but claimed) | Neonates |
| SpO2, low perfusion (70-100%) | 2% | Not explicitly reported from study (but claimed) | Adults/pediatrics/infants/neonates |
| Pulse rate, no motion (25-240 bpm) | 3 bpm | Not explicitly reported from study (but claimed) | Adults/pediatrics/infants/neonates |
| Pulse rate, motion (25-240 bpm) | 5 bpm | Not explicitly reported from study (but claimed) | Adults/pediatrics/infants/neonates |
| Pulse rate, low perfusion (25-240 bpm) | 3 bpm | Not explicitly reported from study (but claimed) | Adults/pediatrics/infants/neonates |
| SpCO (1-40%) | 3% | Not explicitly reported from study (but claimed) | Adults/pediatrics/infants |
| SpMet (1-15%) | 1% | Not explicitly reported from study (but claimed) | Adults/pediatrics/infants/neonates |
| SpHb (8-17 g/dL) | 1 g/dL | Not explicitly reported from study (but claimed) | Adults/pediatrics |
| RRa (4-70 breaths per minute) | 1 breath per minute | Not explicitly reported from study (but claimed) | Adults/pediatrics |
Note: The clinical study specifically focused on SpO2 accuracy claims for no-motion and motion conditions for adult, pediatric, and infant populations. The document states that "Accordingly, the claimed Ams value is 1.5% during no-motion conditions for adults, pediatrics, and infants, and the claimed Arms value is 1.5% during motion conditions for adult, pediatrics, and infants." This implies that the reported study results support these specific claims, which are the acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The study was done on healthy adult volunteers".
- Sample Size: Not explicitly stated as a number, but refers to "healthy adult volunteers."
- Data Provenance: Clinical study, likely prospective, conducted on "healthy adult volunteers" at an unspecified location (typically assumed to be U.S. unless otherwise specified in FDA submissions).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of device and study. The ground truth for SpO2 accuracy is typically established by comparing the device's readings to arterial blood samples analyzed by a laboratory CO-Oximeter (as stated in the document: "in comparison to blood measurements from a laboratory CO-Oximeter"). No human expert "adjudication" of the ground truth is mentioned or implied for SpO2 measurements.
4. Adjudication Method for the Test Set
Not applicable. The ground truth for SpO2 is directly derived from laboratory CO-Oximeter analysis of blood samples, not from expert adjudication of images or signals that would require an adjudication method like 2+1 or 3+1.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The study described is a clinical accuracy study comparing the device's measurements directly to a reference standard (laboratory CO-Oximeter). It does not involve human readers or assess their improvement with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the clinical study performed was a standalone performance evaluation of the device (algorithm only) comparing its SpO2 measurements against a reference standard. The "human-in-the-loop" aspect for a device like a pulse oximeter is generally the medical professional interpreting the device's output, but the accuracy study assesses the device's measured values directly.
7. The Type of Ground Truth Used
Laboratory Standards: The ground truth for SpO2 measurements was established by "blood measurements from a laboratory CO-Oximeter."
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for the training set. It focuses on the validation study (test set).
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. This information is typically not included in a 510(k) summary for device modifications unless the model itself is novel and the training process is a key part of the submission. The device (Masimo Rad-97) and its underlying Rainbow SET technology are described as substantially similar to a cleared predicate (K170168), even with improved sensor characterization.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).