(94 days)
Masimo Rad-97 Pulse CO-Oximeter and Accessories:
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 multi-parameter 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 hospitals and 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. 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 to be used with Masimo sensors and cables.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.
Masimo Radical-7 Pulse CO-Oximeter and Accessories
The Radical-7 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 Radical-7 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 hospitals and hospital-type facilities. The Masimo Radical-7 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 Radical-7 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 hospitals and hospital-type facilities.
The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospital-type facilities.
The Radical-7 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 hospital-type facilities, home environments, and transport within healthcare facilities.
The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.
Masimo Radius-7 Pulse CO-Oximeter and Accessories:
The Radius-7 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 Radius-7 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 hospitals and hospital-type facilities. The Masimo Radius 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 Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoplobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities.
The Radius-7 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 hospitaltype facilities, home environments, and transport within healthcare facilities.
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from Pleth (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.
The subject of the submission is to add Respiration Rate from photoplethysmogram (designated as RRp) feature to the previously cleared Masimo Pulse Oximetry devices. The RRp feature that was previously cleared as part of MightySat fingertip pulse oximeter under K181956. RRp feature determines the patient's respiration rate by analyzing cyclic variations in photoplethysmogram (pleth) to establish respiration measurement. The devices in which the RRp feature is being added as part of this submission are the previously cleared Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, and Masimo Radius-7 Pulse CO-Oximeter.
Rad-97 Pulse CO-Oximeter: Masimo Rad-97 System and Accessories (Rad-97), is a portable monitor that features a touchscreen that provides a display and control user interface for monitored parameters. The Rad-97 product family can be operated on AC power or internal rechargeable battery. The Rad-97 comprises of technologies that enable the device to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PV), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), and/or capnography parameters or noninvasive blood pressure (NIBP) parameters which were all previously cleared under K183697.
Radical-7 Pulse CO-Oximeter: Masimo Radical-7 and Accessories, is a pulse co-oximeter that features a touchscreen that provides a display and control user interface for monitored parameters. It can be used either as a handheld or standalone monitor. Radical-7 can interface with a multi-parameter patient monitor and send data in order to display on the monitor. The Radical-7 comprises of technologies that enable the Radical-7 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), and acoustic respiration rate (RRa) parameters which were all previously cleared under K171121.
Radius-7 Pulse CO-Oximeter: Masimo Radius-7 and Accessories, is a wearable Pulse CO-Oximeter. Radius-7 can interface with a multi-parameter patient monitor and send data in order to display on the monitor via Bluetooth or WiFi. The Radius-7 comprises of technologies that enable the Radius-7 to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PV), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), and acoustic respiration rate (RRa) parameters which were all previously cleared under K171121.
The document provided explains the regulatory clearance of Masimo Rad-97, Radical-7, and Radius-7 Pulse CO-Oximeters with the addition of a Respiration Rate from photoplethysmogram (RRp) feature. The acceptance criteria and the studies proving the device meets these criteria are detailed below, focusing on the newly added RRp feature.
Acceptance Criteria and Device Performance
The core acceptance criterion for the RRp feature is its accuracy (ARMS) and mean error when compared to a gold-reference capnography.
Table of Acceptance Criteria and Reported Device Performance (RRp Feature):
| Feature | Acceptance Criteria (Specification) | Reported Device Performance (ARMS) | Reported Device Performance (Mean Error) | Patient Population |
|---|---|---|---|---|
| RRp | ARMS ≤ 3 rpm | 1 rpm | Adults/Pediatrics | |
| Mean Error: Not explicitly stated in "Specification" column, but 1 rpm is stated for accepted performance. | ||||
| Clinical (Prospective) – Healthy Adults | - | 2.1 rpm | 0.2 rpm | Healthy Adults |
| Clinical (Retrospective) – Hospitalized Adults | - | 2.5 rpm | 0.5 rpm | Hospitalized Adults |
| Clinical (Retrospective) – Hospitalized Pediatrics | - | 2.0 rpm | 0 rpm | Hospitalized Pediatrics |
Note: The document states the performance specification of RRp is "ARMS of ≤ 3.0RPM and mean error of 1", which is explicitly met by the reported performance.
Study Details Proving Device Meets Acceptance Criteria
1. Sample Sizes Used for the Test Set and Data Provenance:
- Prospective Clinical Study (Healthy Adults):
- Number of Data Points: 7,751
- Data Provenance: Not explicitly stated but implied to be from a controlled clinical setting, likely in the US (given FDA submission). It's a prospective study.
- Retrospective Clinical Validation Study (Hospitalized Adults):
- Number of Data Points: 119,174
- Data Provenance: Collected from hospitalized adults. Retrospective study. Country of origin not explicitly stated, but common for such studies to be multi-site or from a single clinical institution, likely in the US.
- Retrospective Clinical Validation Study (Hospitalized Pediatrics):
- Number of Data Points: 35,390
- Data Provenance: Collected from hospitalized pediatrics. Retrospective study. Country of origin not explicitly stated.
2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not specify the number or qualifications of experts involved in establishing the ground truth. The ground truth method relies on an FDA-cleared capnography device (Oridion Capnostream20, K060065) as the "gold-reference method." This suggests that the ground truth is derived from instrumental measurements rather than human expert interpretation of raw data.
3. Adjudication Method for the Test Set:
- Not applicable as the ground truth is established by a medical device (capnography) and not human consensus or adjudication. The comparison is between the device's RRp measurement and the capnography's measurement.
4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The study focuses on the accuracy of the device's RRp measurement against a reference standard, not on how human readers' performance improves with or without AI assistance. The device is a monitor, not an AI-assisted diagnostic tool that requires human interpretation.
5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the studies conducted demonstrate the standalone performance of the RRp algorithm. The device produces a directly measurable respiration rate (RRp) which is then compared to a reference standard (capnography). Human interpretation is not part of the RRp measurement process itself.
6. The Type of Ground Truth Used:
- The ground truth used is an instrumental reference standard: an FDA-cleared capnography device (Oridion Capnostream20, K060065), which is considered a "gold-reference method" for respiration rate measurement. This is a direct physiological measurement, not expert consensus or pathology.
7. The Sample Size for the Training Set:
- The document does not explicitly state the sample size for the training set. It mentions that the "technological characteristics of the RRp feature is the same as that of previously cleared reference predicate MightySat (K181956)." This implies that the RRp algorithm was likely developed and potentially trained using data before this specific submission, possibly on data sets contributing to the MightySat clearance. The presented studies are validation studies for the implementation of this existing feature on new devices.
8. How the Ground Truth for the Training Set was Established:
- The document does not provide details on how the ground truth for the training set was established. Given that the RRp feature's technology is stated to be the same as a previously cleared predicate device (MightySat K181956), it can be inferred that the validation and potentially the training of the original algorithm would have followed similar rigorous methods, likely involving comparison to golden standards such as capnography. However, specific details for the training set's ground truth establishment are not present in this submission.
§ 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).