(102 days)
The Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), and total hemoglobin concentration (measured by an SpHb sensor). The Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for use with 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. In addition, the Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous monitoring data obtained from the Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) to multi-parameter devices for the display of those devices.
The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), and total hemoglobin concentration (measured by an SpHb sensor). The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The Masimo Rainbow SET® Rad-57 t Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) and total hemoglobin concentration (measured by an SpHb sensor). The Masimo Rainbow SET® Rad-57 t Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories (Radical 7), the Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories (Rad 87), and the Masino Rainbow SET® Rad 57t Pulse CO-Oximeter and accessories (Rad 57t) have the noninvasive monitoring Masimo Rainbow SET technology.
The Radical 7 provides monitoring of arterial oxygen saturation (%SpO2), pulse rate, carboxyhemoglobin saturation (%SpCO), methemoglobin saturation (%SpMet), and/or total hemoglobin concentration (g/dl SpHb). Other information displayed by the Radical 7 include: Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), Total Arterial Oxygen Content (CaO2), alarm status, alarm silence, battery life, sensor status, trends, and pleth waveform. The Radical 7 has output interfaces include: SatShare connection to multi-parameter monitors, Nurse Call analog output, and RS-232 serial output.
The Rad 87 provides noninvasive monitoring of arterial oxygen saturation (%SpO2), pulse rate, carboxyhemoglobin saturation (%SpCO), methemoglobin saturation (%SpMet), and/or total hemoglobin concentration (g/dl SpHb). Other information displayed by the Rad 87 include: Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), Total Arterial Oxygen Content (CaO2), alarm status, alarm silence, battery life, sensor status, and trends. The Rad 87 has output interfaces include: Nurse Call analog output, and RS-232 serial output.
The Rad 57t provides noninvasive monitoring of arterial oxygen saturation (%SpO2), pulse rate, and/or total hemoglobin concentration (g/dl SpHb). Other information displayed by the Rad 87 include: Low Signal IQ (Low SIQ), Perfusion Index (PI), Total Arterial Oxygen Content (CaO2), alarm status, alarm silence, battery life, sensor status, and trends.
The Radical 7, Rad 87, and Rad 57t are intended to be used with Masimo LNOP series of oximetry sensors and patient cables, Masimo LNCS series of oximetry sensors and patient cables, Masimo Rainbow (SpCO/SpMet) sensors and patient cables, and Masimo Rainbow (SpCO/SpMet/SpHb) sensors and patient cables.
The provided text describes the specifications and some testing details for the Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories, Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories, and Masimo Rainbow SET® Rad 57t Pulse CO-Oximeter and accessories.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The device performance is described in terms of "Accuracy" for various parameters. The acceptance criteria are implicitly those stated "Specifications" as the expected accuracy for each parameter.
| Feature | Type of Pulse CO-Oximeter | Acceptance Criteria (Specifications) | Reported Device Performance (Achieved Accuracy) |
|---|---|---|---|
| Accuracy - SpO2 | Radical 7, Rad 87, Rad 57t | Adults, Pediatrics, Infants: 60% - 80% ± 3%Adults, Pediatrics, Infants, Neonates: 70% - 100% ± 2%Adults, Pediatrics, Infants, Neonates: 0% - 69% unspecified | During No Motion Conditions:- Adults, Pediatrics, Neonates: 70-100% SpO2 with ±2% against a laboratory CO-Oximeter and ECG monitor. (Footnote 2)- Neonatal NICU patients (7-135 days, 0.5-4.25 kg): 70-100% SaO2 with a resultant accuracy of 2.9% SpO2. (Footnote 1)During Motion Conditions:- Adults, Pediatrics, Infants, Neonates: 70% - 100% ± 3%.- Human blood studies on healthy adult male and female volunteers in induced hypoxia studies while performing rubbing and tapping motions. (Footnote 3)Low Perfusion:- Adults, Pediatrics, Infants, Neonates: 70% - 100% ± 2%.- Benchtop testing against a Biotek Index 2 simulator and Masimo's simulator with signal strengths of >0.02% and transmission of >5% for saturations 70-100%. (Footnote 4) |
| Accuracy - Pulse Rate | Radical 7, Rad 87, Rad 57t | Adults, Pediatrics, Infants, Neonates: 25 - 240 ± 3 bpm (No Motion, Low Perfusion)Adults, Pediatrics, Infants, Neonates: 25 - 240 ± 5 bpm (Motion Conditions) | During No Motion Conditions: 25 - 240 ± 3 bpm.During Motion Conditions: 25 - 240 ± 5 bpm.Low Perfusion: 25 - 240 ± 3 bpm.- Validated for range 25-240 bpm in benchtop testing against a Biotek Index 2 simulator. (Footnote 5) |
| Accuracy - SpCO | Radical 7, Rad 87 | Adults, Pediatrics, Infants: 1% - 40% ± 3% | During No Motion Conditions:- Adults, Pediatrics, Infants: 1% - 40% ± 3%.- Determined by testing on healthy adult volunteers in the range of 0-40% SpCO against a laboratory CO-Oximeter. (Footnote 1) |
| Accuracy - SpMet | Radical 7, Rad 87 | Adults, Pediatrics, Infants, Neonates: 1% - 15% ± 1% | During No Motion Conditions:- Adults, Pediatrics, Infants, Neonates: 1% - 15% ± 1%.- Determined by testing on healthy adult volunteers in the range of 0-15% SpMet against a laboratory CO-Oximeter. (Footnote 1)- Neonatal NICU patients (7-135 days, 0.5-4.25 kg): 0.5-2.5% MetHb with a resultant accuracy of 0.9% SpMet. (Footnote 1) |
| Accuracy - SpHb | Radical 7, Rad 87, Rad 57t | Adults, Pediatrics: 7 - 17 g/dl ± 1 g/dl (*SpHb accuracy has been validated on healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation in the range of 7 - 17 g/dl SpHb against a laboratory CO-oximeter. This variation equals plus or minus one standard deviation which encompasses 68% of the population. The SpHb accuracy has not been validated with motion or low perfusion.) | During No Motion Conditions:- Adults, Pediatrics: 7 - 17 g/dl ± 1 g/dl.- Validated on healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation in the range of 7 - 17 g/dl SpHb against a laboratory CO-oximeter. (Specification Table, SpHb Accuracy)- Note: SpHb accuracy not validated with motion or low perfusion. |
2. Sample Size Used for the Test Set and Data Provenance
- SpO2, SpCO, SpMet (Adults): "Healthy adult volunteers" for SpO2 (60-100%), SpCO (0-40%), and SpMet (0-15%). The exact number of volunteers is not specified, but it's stated that "This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population weight." (Footnote 2). The data provenance is described as "human blood studies" and "induced hypoxia studies," implying prospective data collection in a controlled setting (likely the US, given the submission location).
- SpO2, SpMet (Neonates): "16 neonatal NICU patients ranging in age from 7-135 days old and weighing between 0.5-4.25 kg." "Seventy-nine (79) data samples were collected." This appears to be prospective clinical data. The country of origin is not specified but is likely in the US.
- SpO2 (Motion Conditions): "healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing rubbing and tapping motions." The specific number of volunteers is not provided. Data provenance is prospective human blood studies in a controlled environment.
- SpO2 (Low Perfusion): "Bench top testing against a Biotek Index 2 simulator and Masimo's simulator." This is simulated data, not human patient data.
- Pulse Rate: "Bench top testing against a Biotek Index 2 simulator." This is simulated data, not human patient data.
- SpHb (Adults/Pediatrics): "healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation." The specific number of volunteers/patients is not provided. Data provenance is described as human clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth was established by a "laboratory CO-Oximeter" for SpO2, SpCO, SpMet, and SpHb, and an "ECG monitor" for SpO2 (in conjunction with the laboratory CO-Oximeter) and a "Biotek Index 2 simulator" for pulse rate and low perfusion SpO2.
No human experts were explicitly stated to establish the ground truth for the measurements; rather, validated reference instruments were used. Therefore, the concept of "number of experts" and "qualifications of experts" as typically applied to image annotation (e.g., radiologists) is not directly applicable here. The accuracy of the reference instruments serves as the ground truth.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by reference instruments (laboratory CO-Oximeter, ECG monitor, Biotek Index 2 simulator), not by human adjudication of observations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The description focuses on the standalone performance of the device against reference standards, not on how human readers improve with or without AI assistance. This device is a measurement instrument, not an AI diagnostic tool that assists human readers.
6. Standalone (Algorithm-Only) Performance Study
Yes, this entire submission is primarily a standalone performance study. The reported accuracies (e.g., ±2%, ±3%, ±1 g/dl) are for the Masimo devices running their internal algorithms, comparing their output directly to established reference methods (laboratory CO-Oximeter, ECG, simulators). There is no human-in-the-loop component mentioned in these performance evaluations.
7. Type of Ground Truth Used
The type of ground truth used is reference standard measurements:
- Laboratory CO-Oximeter: For SpO2, SpCO, SpMet, and SpHb.
- ECG monitor: For SpO2 (used in conjunction with the CO-Oximeter).
- Biotek Index 2 simulator and Masimo's simulator: For SpO2 (low perfusion) and Pulse Rate.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms. The device utilizes "multi-wavelength calibration equations" (Section 5, Page 3), which would have been developed using a dataset, but the size of this dataset is not specified. The studies described appear to be validation (test set) studies for the final calibrated device.
9. How the Ground Truth for the Training Set Was Established
As with point 8, the document does not detail how a "training set" ground truth was established. The device relies on "multi-wavelength calibration equations." It can be inferred that these equations were developed and calibrated using a similar methodology to the validation studies (i.e., comparing non-invasive readings to invasive or gold-standard laboratory CO-oximetry measurements across a range of physiological states and patient types). However, the specifics of this development process, including sample size or ground truth establishment for that specific phase, are not provided.
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MAY 12 2008
| Submitted by: | Masimo Corporation40 ParkerIrvine, CA 92618(714) 297-7000FAX (714) 297-7001 |
|---|---|
| Official Correspondence: | James J. Cronin, Vice President, Regulatory Affairs |
| Contact for this Submission: | Marguerite Thomlinson, Manager, Regulatory Affairs |
| Date Summary Prepared: | January 28, 2008 |
| Trade Name | Masimo Rainbow SET® Radical 7 CO-Oximeter |
| Common Name | Pulse Oximeter and Sensor |
| Classification Name | Oximeter (74DQA)Transducer and Electrode Cable (including connector) (74DSA)Carbon monoxide test system (JKS)(862.3220) |
| Substantially Equivalent Devices | Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and Accessories510(k) Number - K061204Masimo Rainbow SET® Rad 57cm/m Pulse CO-Oximeters and Accessories510(k) Number - K053477Radiometer America, Inc. OSM3 Hemoximeter510(k) Number - K853990 |
Description of the Device
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The Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories (Radical 7), the Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories (Rad 87), and the Masino Rainbow SET® Rad 57t Pulse CO-Oximeter and accessories (Rad 57t) have the noninvasive monitoring Masimo Rainbow SET technology.
The Radical 7 provides nonitoring of arterial oxygen saturation (%SpO2), pulse rate, carboxyhemoglobin saturation (%SpCO), methemoglobin saturation (%SpMet), and/or total hemoglobin concentration (g/dl SpHb). Other information displayed by the Radical 7 include: Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), Total Arterial Oxygen Content (CaO2), alarm status, alarm silence, battery life, sensor status, trends, and pleth waveform. The Radical 7 has output interfaces include: SatShare connection to multi-parameter monitors, Nurse Call analog output, and RS-232 serial output.
Section 5, Page 1 of 9
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The Rad 87 provides noninvasive monitoring of arterial oxygen saturation (%SpO2), pulse rate, carboxyhemoglobin saturation (%SpCO), methemoglobin saturation (%SpMet), and/or total hemoglobin concentration (g/dl SpHb). Other information displayed by the Rad 87 include: Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), Total Arterial Oxygen Content (CaO2), alarm status, alarm silence, battery life, sensor status, and trends. The Rad 87 has output interfaces include: Nurse Call analog output, and RS-232 serial output.
The Rad 57t provides noninvasive monitoring of arterial oxygen saturation (%SpO2), pulse rate, cand/or total hemoglobin concentration (g/dl SpHb). Other information displayed by the Rad 87 include: Low Signal IQ (Low SIQ), Perfusion Index (PI), Total Arterial Oxygen Content (CaO2), alarm status, alarm silence, battery life, sensor status, and trends.
The Radical 7, Rad 87, and Rad 57t are intended to be used with Masimo LNOP series of oximety sensors and patient cables, Masimo LNCS series of oximetry sensors and patient cables, Masimo Rainbow (SpCO/SpMet) sensors and patient cables, and Masimo Rainbow (SpCO/SpMet/SpHb) sensors and patient cables.
Intended Use/Indications for Use
The Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for use with 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. In addition, the Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous noninvasive monitoring data obtained from the Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) to multi-parameter devices for the display of those devices.
The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories are indicated for the continuous noninyasive monitoring of functional oxygen saturation of arterial hemoglobin (SpOz), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The Masimo Rainbow SET® Rad-57 t Pulse CO-Oximeter and accessories are indicated for the continuous noninyasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO-sensor) and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo SET® Rad-57 t Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motions, and for patients who are well or poorly perfused in hospitals, hospitaltype facilities, mobile, and home environments.
Principles of Operation
SpO2 General Description
Pulse oximetry is a continuous and non-invasive method of measuring the level of arterial oxygen saturation in blood. The measurement is taken by placing a sensor on a patient, usually on the fingertip for adults, and the hand or foot for neonates. The sensor connects directly to the pulse oximetry instrument or with a patient cable. The sensor collects signal data from the patient and sends it to the instrument displays the calculated data in tw
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ways: 1) as a percent value for arterial oxygen saturation (SpO2), and 2) as a pulse rate (PR). Figure 1 shows the general monitoring setup ..
SpCO, SpMet, and SpHb General Description
Instruments containing Masimo Rainbow SET technology also offer a continuous and non-invasive method of measuring the levels of carboxyhemoglobin concentration (SpCO), methemoglobin concentration (SpMet) and total hemoglobin in blood (SpHb). It relies on the same principles of pulse oximetry to make SpCO, SpMet and SpHb measurements. The measurements are taken by placing a sensor on a patient, usually on the fingertip for adults. The sensor connects directly to the instrument or with a patient cable. The sensor collects signal data from the patient and sends it to the instrument. The instrument displays the calculated data as percentage values for the SpCO and the SpMet and as grams/deciliter (g/dL) for SpHb. Instruments containing Masimo Rainbow SET technology are a combined SpO2, SpMet and SpHb monitor with the same setup as that of a pulse oximeter, shown above, and can display percentage or concentration values for SpCO, SpMet and SpHb as well as SpO2 and pulse rate.
Pulse oximetry is governed by the following principles:
- Oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood), carboxyhemoglobin 1. (blood with carbon monoxide content), and methemoglobin (blood with oxidized hemoglobin content) species differ in their absorption of visible and infrared light.
- The amount of arterial blood in tissue changes with your pulse (photoplethysography). Therefore, the ં મં amount of light absorbed by the varying quantities of arterial blood changes as well.
Instruments containing Masimo Rainbow SET technology use a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood, blood with carbon monoxide, blood with oxidized hemoglobin and blood plasma. Signal data is obtained by passing various visible and infrared lights (LED's, 620 to 1270 mm) through a capillary bed (for example, a fingertip, a hand, a foot) and measuring changes in light absorption during the blood pulsatile cycle (see Figure 3). The photodetector receives the light, converts it into an electronic signal and sends it to the Radical 7/ Rad 87/ Rad-57t for calculation.
Once the instrument containing Rainbow SET technology receives the signal from the sensor, it utilizes Masimo Signal Extraction Technology (SET) to calculate the patient's functional oxygen saturation (SpO2), fractional concentration of carboxyhemoglobin (SpCO), fractional concentration of methemoglobin (SpMet), total hemoglobin concentration (SpHb) and pulse rate (PR). In instruments containing Masimo Rainbow SET technology. multi-wavelength calibration equations are used to estimate the saturation and concentration values.
Method of Operation
The Radical 7, Rad 87, and the Rad 57t have the same method of operation. The instrument is turned on. An oximetry sensor is attached to a patient's finger and one end of a patient cable is connected to the sensor and the other end connected to the instrument.
The monitor will begin continuously displaying the patient's pulse rate, and SpO2 value. Depending on the type and or configuration of the instrument, monitoring information would also include SpCO, SpMet, SpHb, PVI, and/or CaO2. The practitioner can the information to help assess the condition of the patient and as an aide in determining if any intervention is required by the practitioner.
Once the practitioner determines the patient no longer requires monitoring, the cable is disconnected from the sensor, the CO-oximetry sensor is removed (and disposed of if it is a single use device), and the power to the monitor is turned off.
Section 5, Page 3 of 9
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Specifications
The specifications for the Radical 7, Rad 87, and Rad 57t are:
| FEATURES | SPECIFICATIONS | TYPE OFPULSE CO-OXIMETER |
|---|---|---|
| Display Ranges | ||
| Saturation (SpO2): 0% - 100%Pulse Rate (bpm): 25 - 240 bpmTotal Hemoglobin (SpHb): 0-25 g/dlTotal Oxygen Concentration (CaO2):1-100 ml/dlPerfusion Index: 0.02% - 20% | Radical 7Rad 87Rad 57t | |
| Carboxyhemoglobin Saturation(SPCO): 0-99%Methemoglobin Saturation (SpMet):0-99.9%Pleth Variability Index: 0% - 100% | Radical 7Rad 87 | |
| Rate | See Footnotes 1, 2, 3, 4, and 5 | |
| Accuracy - SpO2During No MotionConditions | Adults, Pediatrics, Infants: 60% - 80%$\pm$ 3%Adults, Pediatrics, Infants, Neonates:70% - 100% $\pm$ 2%Adults, Pediatrics, Infants, Neonates:0% - 69% unspecified | Radical 7Rad 87Rad 57t |
| Accuracy - SpO2During Motion Conditions | Adults, Pediatrics, Infants, Neonates:70% - 100% $\pm$ 3%Adults, Pediatrics, Infants, Neonates:0% - 69% unspecified | Radical 7Rad 87Rad 57t |
| Accuracy - SpO2Low Perfusion | Adults, Pediatrics, Infants, Neonates:70% - 100% $\pm$ 2%Adults, Pediatrics, Infants, Neonates:0% - 69% unspecified | Radical 7Rad 87Rad 57t |
| Accuracy - Pulse RateDuring No MotionConditions | Adults, Pediatrics, Infants, Neonates:25 - 240 $\pm$ 3 bpm | Radical 7Rad 87Rad 57t |
| Accuracy - Pulse RateDuring Motion Conditions | Adults, Pediatrics, Infants, Neonates:25 - 240 $\pm$ 5 bpm | Radical 7Rad 87Rad 57t |
| Accuracy - Pulse RateLow Perfusion | Adults, Pediatrics, Infants, Neonates:25 - 240 $\pm$ 3 bpm | Radical 7Rad 87Rad 57t |
| Accuracy: SpCO | See Footnote 1 | |
| Accuracy - SpCODuring No MotionConditions | Adults, Pediatrics, Infants: 1% -40% $\pm$ 3% | Radical 7Rad 87 |
| Accuracy: SpMet | See Footnote 1 | |
| Accuracy - SpMetDuring No MotionConditions | Adults, Pediatrics, Infants, Neonates:1% - 15% $\pm$ 1% | Radical 7Rad 87 |
| FEATURES | SPECIFICATIONS | TYPE OFPULSE CO-OXIMETER |
| Accuracy: SpHb | ||
| Accuracy - SpHbDuring No MotionConditions | Adults, Pediatrics: 7 - 17 g/dl +1 g/dl• SpHb accuracy has been validatedon healthy adult male and femalevolunteers and on surgical patientswith light to dark skin pigmentationin the range of 7 - 17 g/dl SpHbagainst a laboratory CO-oximeter.This variation equals plus or minusone standard deviation whichencompasses 68% of the population.The SpHb accuracy has not beenvalidated with motion or lowperfusion. | Radical 7Rad 87Rad 57t |
| General | ||
| Resolution | SpO2: 1%Pulse Rate: 1 bpmSpHb: 0.1 g/dl | Radical 7Rad 87Rad 57t |
| Resolution | SpCO: 1%SpMet: 0.1% | Radical 7Rad 87 |
| Measurements | Low Signal IQPerfusion Index (PI)Total Oxygen Concentration (CaO2) | Radical 7Rad 87Rad 57t |
| Measurements | Pleth Variability Index (PVI) | Radical 7Rad 87 |
| Interfering Substances | • Elevated levels of Methemoglobin(MetHb) may lead to inaccurateSpO2 and SpCO measurements• Elevated levels ofCarboxyhemoglobin (COHb) maylead to inaccurate SpO2measurements.• Very low arterial Oxygen Saturation(SpO2) levels may cause inaccurateSpCO and SpMet measurements• Severe anemia may cause erroneousSpO2 readings.• Dyes, or any substance containingdyes, that change usual bloodpigmentation may cause erroneousreadings.• Elevated levels of total bilirubinmay lead to inaccurate SpO2,SpMet, SpCO and SpHb readings | Radical 7Rad 87Rad 57t(Notes regarding SpCOand SpMet measurementsare not applicable to Rad57t) |
| Electrical | See Footnotes 6 and 7 | |
| Power (AC) | Voltage Input Range: 100-230 Volt,47-63 Hz | Radical 7Rad 87 |
| Batteries | Rechargeable | Radical 7Rad 87 |
| Batteries | Non-Rechargeable | Rad 57t |
| Circuitry | Microprocessor controlled | Radical 7 |
| FEATURES | SPECIFICATIONS | TYPE OFPULSE CO-OXIMETER |
| Automatic self-test of oximeter whenpowered on | Rad 87 | |
| Automatic setting of defaultparameters | Rad 57t | |
| Automatic alarm messages | ||
| Trend data output | ||
| Firmware | Rainbow SET technology, MX-1Board/Circuitry | Radical 7 |
| Rad 87 | ||
| Rad 57t | ||
| Mechanical | ||
| Material | Polycarbonate/ABS Blend | Radical 7 |
| Rad 87 | ||
| Rad 57t | ||
| Environmental | ||
| Operating Temperature | 41°F to + 104°F (5°C to +40°C) | Radical 7 |
| Rad 87 | ||
| Rad 57t | ||
| Storage Temperature | -40°F to + 158°F (-40°C to +70°C) | Radical 7 |
| Rad 87 | ||
| Rad 57t | ||
| Relative Humidity | 5% to 95% noncondensing | Radical 7 |
| Rad 87 | ||
| Rad 57t | ||
| Operating Altitude | Operating Altitude: 500 mbar to 1,060mbar pressure; -1,000 ft to 18,000 ft (-304 m to 5,486m) | Radical 7 |
| Rad 87 | ||
| Rad 57t | ||
| Mode & Sensitivity | ||
| Averaging Mode | General: 2, 4, 6, 8, 10, 12 and 16seconds• With FastSat the averaging time isdependent on the input signal• For the 2 and 4 second settings theaveraging time may range from 2-4and 4-6 seconds respectively• Maximum sensitivity mode fixesperfusion limit to 0.02% | Radical 7 |
| Rad 87 | ||
| Rad 57t | ||
| Sensitivity | APOD | Radical 7 |
| Normal | Rad 87 | |
| Maximum | Rad 57t | |
| Alarms | ||
| Volume Level Adjustment:Pulse/Tone | OFF25% to 100% in 4 increments | Radical 7 |
| Rad 87 | ||
| Volume Level Adjustment:Pulse/Tone | OFF33% to 100% in 3 step | Rad 57t |
| Alarm Silence | 120 seconds delayAll mute: continuous silence | Radical 7 |
| Rad 87 | ||
| Rad 57t | ||
| Out of Limit Alarm:SpO2, Pulse Rate, SpHb | High/low alarms | Radical 7 |
| Rad 87 | ||
| Rad 57t | ||
| FEATURES | SPECIFICATIONS | TYPE OFPULSE CO-OXIMETER |
| Out of Limit Alarm:SpCO, SpMet | High/ low alarms | Radical 7Rad 87 |
| Sensor Condition Alarm | No SensorSensor OffSensor Defect | Radical 7Rad 87Rad 57t |
| System | System failure | Radical 7Rad 87Rad 57t |
| Battery Alarm | Low battery | Radical 7Rad 87Rad 57t |
| Display and Indicators | ||
| Data Display | SpO2 (%)Pulse rate (bpm)SpHb (g/dl)Perfusion index (%)CaO2 (ml/dl)Signal IQSensitivity indicatorSensor statusStatus messagesAlarm statusBattery status | |
| SpCO (%)SpMet (%)Pleth variability index (%) | Radical 7Rad 87 | |
| Output Interface | ||
| SatShare Port | SatShare connection to Multiparametermonitors (SpO2 only) | Radical 7 |
| Analog output | Nurse Call | Radical 7Rad 87 |
| Serial Port(RS-232 connector) | PC/printer connetionPhilips VuelinkRadNetPatient Safety NetTrends | Radical 7Rad 87 |
| Sensor connector | Trends | Rad 57t |
| Compliance | ||
| EMC Compliance | EN 60601-1-2, Class B | Radical 7Rad 87Rad 57t |
| Electrical Safety | IEC 60601-1,UL 60601-1 | Radical 7Rad 87Rad 57t |
| Type of Protection (ACPower) | Class 1 | Radical 7Rad 87 |
| Type of Protection (batterypower) | Internally Powered | Radical 7Rad 87Rad 57t |
| Degree of Protection-PatientCable | Type BF-Applied Part | Radical 7Rad 87 |
| FEATURES | SPECIFICATIONS | TYPE OFPULSE CO-OXIMETER |
| Degree of Protection –SatShare Cable | Type CF | Rad 57tRadical 7 |
| Enclosed Degree of IngressProtection from Solids/Liquids | IPX1 | Radical 7Rad 87Rad 57t |
| Mode of Operation | Continuous | Radical 7Rad 87Rad 57t |
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Footnotes
- 1 SpO2, SpCO and SpMet accuracy was determined by testing on healthy adult volunteers in the range of 60-100% SpO2, 0-40% SpCO, and 0-15% SpMet against a laboratory CO-Oximeter. SpO2 and SpMet accuracy was determined on 16 neonatal NICU patients ranging in age from 7-135 days old and weighing between 0.5-4.25 kg. Seventy-nine (79) data samples were collected over a range of 70-100% SaO2 and 0.5-2.5% MetHb with a resultant accuracy of 2.9% SpO2 and 0.9% SpMet.
- 2 The Masimo sensors have been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population weight.
- 3 The Masimo sensors have been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-oximeter and ECG monitor. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
- 4 The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
- 5 The Masimo sensors have been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
- This represents approximate run time at the lowest indicator brightness and pulse tone turned 6 off using fully charged battery.
- 7 If the batteries are to be stored for extended periods of time, it is recommended that they be stored between -20 to +30°C, and at a relative humidity less than 85%. If stored for a prolonged period at environmental conditions beyond these limits, overall battery capacity may be diminished, and lifetime of the batteries may be shortened.
Section 5, Page 8 of 9
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Test Summary
The Radical 7, Rad 87, and Rad 57t complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the the Radical 7, Rad 87, and Rad 57t:
- Risk Analysis ●
- . Design Reviews
- Biocompatibility Testing .
- Performance Testing .
- Safety Testing .
- Environmental Testing �
- Clinical Testing
Conclusions
The information in this 510(k) submission demonstrates that the Radical 7, Rad 87, and Rad 57t are substantially equivalent to the predicate device, with respect to safety, effectiveness, and performance.
Image /page/8/Picture/12 description: The image contains a sequence of four digits: "0020". The digits are rendered in a bold, sans-serif font, and they appear to be slightly distorted or aged, with some imperfections in the ink. The digits are arranged horizontally, with the two zeros on the left, followed by a two and another zero on the right.
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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird-like figure with three wing-like shapes extending from its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 12 2008
Ms. Marguerite Thomlinson Manager of Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618
Re: K080238
Trade/Device Name: Masimo Rainbow SET Radical 7 Pulse CO-Oximeter and Accessories Masimo Rainbow SET Radical 87 Pulse CO-Oximeter and Accessories Masimo Rainbow SET Radical 57 t Pulse CO-Oximeter and Accessories Regulation Number: 870.2700 Regulation Name: Oximeter
Regulatory Class: II Product Code: DQA, JKS, DPZ Dated: May 6, 2008 Received: May 7, 2008
Dear Ms. Thomlinson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Thomlinson
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sudie y. Michan Davis.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name:
Masimo Rainbow SET Radical 7 Pulse CO-Oximeter and accessories Masimo Rainbow SET Rad 87 Pulse CO-Oximeter and accessories Masimo Rainbow SET Rad 57 t Pulse CO-Oximeter and accessories
Indications For Use:
The Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatic, 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. In addition, the Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous nonitoring data obtained from the Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO2 sensor) to multi-parameter devices for the display of those devices.
The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), carboxyhemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), methemoglobin saturation (measured by an SpCO/SpMet/SpHb sensor), and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The Masimo Rainbow SET® Rad-57 t Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) and total hemoglobin concentration (measured by an SpCO/SpMet/SpHb sensor). The Masimo Rainbow SET® Rad-57 t Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
Prescription Use _ X
AND/OR
Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
(Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 大 080238
§ 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).