(602 days)
The Rad-97 and Accessories is a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital, hospital type facilities, mobile and home environments.
The Rad-97 and Accessories can communicate with network systems for supplemental remote viewing (e.g., at a central station).
The Rad-97 and Accessories are indicated for the non-invasive spot-checking and continuous 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.
The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions.
The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions.
The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions.
The Rad-97 and Accessories are indicated for the continuous monitoring rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions.
In addition, the Rad-97 and Accessories are indicated to provide the non-invasive spot-checking and continuous monitoring data obtained from the 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 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 messure 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 Rad-97 and accessories are indicated for the non-invasive continuous monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions.
PV i may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PV 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.
The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of respiratory rate from Pleth (RRp) for adult and pediatric patients during no motion conditions.
The Radical-7 and Accessories are indicated for the non-invasive spot-checking and continuous 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 non-invasive continuous monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Radical-7 and Accessories are not intended to be used as the sole basis 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 non-invasive continuous 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 non-invasive continuous 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 non-invasive continuous 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 non-invasive continuous 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.
This premarket notification [510(k)] is for the authorization to market the previously cleared Rad-97 (K193626) and Radical-7 (K193242) with an additional indication for spot-checking.
The cleared versions of the subject devices already support both continuous monitoring and spotchecking use through the activation and deactivation of alarms. This submission updates the indications to reflect both uses of the subject devices.
Rad-97: The Rad-97 is a patient monitor capable of providing multiple parameters. The Rad-97 product family provides the integrated ability of 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), Pleth Respiration Rate (RRp), capnography parameters, and noninvasive blood pressure (NiBP) parameters.
Radical-7: The Radical-7 is a noninvasive monitor that measures arterial oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi), Pleth Variability Index (PVi), totalhemoglobin (SpHb), carboxyhemoglobin (SpCO), total oxygen content (SpOC), methemoglobin (SpMet), acoustic respiration rate (RRa), and Pleth Respiration Rate (RRp).
The provided text describes a 510(k) premarket notification for the Masimo Radical-7 Pulse CO-Oximeter and Accessories and the Rad-97 and Accessories. The submission's primary purpose is to update the indications for use to explicitly include "spot-checking" functionality, which the devices already supported by allowing alarm deactivation.
The document asserts that the devices are substantially equivalent to their predicate devices (K193626 for Rad-97 and K193242 for Radical-7) because there are no changes to the device's fundamental technology, principle of operation, or performance specifications. The "spot-checking" capability was already inherent in the devices' design, as users could deactivate continuous monitoring alarms to achieve this function. Therefore, the update is primarily a labeling change to reflect existing functionality.
Based on the provided information, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based device is not directly applicable in the way one might expect for a new AI product. This submission is for a traditional medical device (patient monitor/oximeter), and the "study" is demonstrating substantial equivalence to a predicate device, not necessarily proving a new algorithm's performance against specific acceptance criteria for AI.
However, we can infer the "acceptance criteria" not as novel performance thresholds, but as the maintenance of the same performance characteristics as the predicate devices, and the "proof" coming from the assertion that no changes were made to the core technology that would alter these.
Here's an attempt to structure the information according to the requested format, interpreting "acceptance criteria" as maintaining the predicate's performance and "study" as the justification for substantial equivalence.
Acceptance Criteria and Device Performance (Interpreted)
The core "acceptance criteria" in this 510(k) submission are that the subject devices (Rad-97 and Radical-7) maintain substantial equivalence to their predicate devices (Rad-97 K193626 and Radical-7 K193242, respectively) and that the expanded "indications for use" to include "spot-checking" does not introduce new questions of safety or effectiveness. This is because the devices already possessed the capability for spot-checking by deactivating alarms.
The "study" that proves the device meets these criteria is an assertion of no change in fundamental technological characteristics, principles of operation, or performance specifications compared to the predicate devices, supported by software verification and validation that confirm the integrity of the existing as-cleared software.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim for a traditional device with an expanded indication based on existing functionality, the "acceptance criteria" are implicitly the already cleared performance specifications of the predicate devices. The reported device performance is stated to be identical to these predicate devices. The change is in the stated use (labeling), not in the core performance.
| Parameter/Feature | Acceptance Criteria (from Predicate Device Specifications) | Reported Device Performance (Subject Device) |
|---|---|---|
| SpO2, no motion, 70-100% | Rad-97: 1.5% ARMS (adults/pediatrics/infants/neonates)**; Radical-7: 2% (adults/pediatrics/infants), 3% (neonates) | Same as Predicate |
| SpO2, motion, 70-100% | Rad-97: 1.5% Arms (adults/infants/pediatrics/neonates)**; Radical-7: 3% ARMS (adults/pediatrics/infants/neonates) | Same as Predicate |
| SpO2, low perfusion, 70-100% | Rad-97: 2% (adults/pediatrics/infants/neonates); Radical-7: 2% (adults/pediatrics/infants/neonates) | Same as Predicate |
| Pulse Rate, no motion, 25-240 bpm | Rad-97: 3 bpm (adults/pediatrics/infants/neonates); Radical-7: 3 bpm (adults/pediatrics/infants/neonates) | Same as Predicate |
| Pulse Rate, motion, 25-240 bpm | Rad-97: 5 bpm (adults/pediatrics/infants/neonates); Radical-7: 5 bpm (adults/pediatrics/infants/neonates) | Same as Predicate |
| Pulse Rate, low perfusion, 25-240 bpm | Rad-97: 3 bpm (adults/pediatrics/infants/neonates); Radical-7: 3 bpm (adults/pediatrics/infants/neonates) | Same as Predicate |
| SpCO, 1-40% | Both: 3% (adults/pediatrics/infants) | Same as Predicate |
| SpMet, 1-15% | Both: 1% (adults/pediatrics/infants/neonates) | Same as Predicate |
| SpHb, 8-17 g/dL | Both: 1 g/dL (adults/pediatrics) | Same as Predicate |
| RRa (Acoustic Respiration Rate) | 4-70 rpm: 1 rpm (adults/pediatrics); 4-120 rpm: 1 rpm (infants/neonates) | Same as Predicate |
| RRp (Pleth Respiration Rate) | 4-70 rpm: 3 rpm ARMS, 1 rpm Mean Error (adults/pediatrics) | Same as Predicate |
| CO2 (for Rad-97 with NomoLine Capnography) | Single dry gasses at 22±5°C and 1013±40 hPa, 0-15 volume%: ±(0.2 volume% +2% of reading); All conditions: ±(0.3 kPa + 4% of reading) | Same as Predicate |
| NiBP (for Rad-97) | 0-300 mmHg, ISO 81060-2 | Same as Predicate |
| Principle of Operation | Masimo Rainbow SET Technology, Capnography Technology, NiBP Technology (all same) | Same as Predicate |
| Display | Touchscreen LCD | Same as Predicate |
| Alarm Type | Visual/Audible alarm | Same as Predicate |
| Mode of Operation | Continuous operation | Same as Predicate |
Note: ARMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- ARMS of the reference measurements in a controlled study.
*Applicable with RD SET Disposable sensors.
2. Sample Size for the Test Set and Data Provenance
No new clinical or non-clinical testing was conducted for this submission (K212161) because the changes were limited to labeling to include existing functionality. The predicate devices' performance data implicitly serve as the "test set" and provenance.
- Sample Size for Test Set: Not applicable for this submission as no new testing was performed. The data and sample sizes supporting the original predicate clearances (K193626 and K193242) would have established these performance metrics. The document states that the devices are "the same as the predicate cleared... with exception of the updated indications for spot-checking."
- Data Provenance: Not explicitly stated for new data. The original predicate device data would have come from clinical studies, often including induced hypoxia studies for oximetry, which typically occur in controlled clinical environments (e.g., US, Europe). The studies for the original clearances would have been prospective to generate the performance data.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable for this submission as no new ground truth was established. The performance specifications are based on the device's technical capabilities, validated against reference standards in prior clearances.
- Qualifications of Experts: N/A for this particular submission. For the original clearances, such validation would involve highly trained clinical professionals and laboratory personnel.
4. Adjudication Method for the Test Set
Not applicable for this submission as no new test set requiring adjudication was generated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-assisted diagnostic device where human reader improvement with AI assistance would be measured. This is a traditional physiological monitor.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a medical device that measures physiological parameters. Its performance is inherent in its design and sensor technology, not a detached algorithm output. The "algorithm" here refers to the internal processing of physiological signals, which is proven through the device's accuracy specifications.
7. Type of Ground Truth Used
The ground truth for the device's performance (as established for the predicate devices) would typically be:
- Reference Devices/Methods: In a controlled study, the device's measurements (e.g., SpO2) would be compared against a gold standard reference (e.g., co-oximeter for blood gas analysis).
- Controlled Physiological Conditions: For SpO2 and PR, studies often involve inducing a range of oxygen saturation levels and heart rates in human volunteers under controlled conditions.
8. Sample Size for the Training Set
Not applicable in the context of traditional medical device validation. "Training set" is a concept primarily relevant to machine learning/AI models. The device's internal signal processing algorithms are engineered based on principles of physics and physiology, not "trained" on a dataset in the AI sense.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
§ 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).