(102 days)
Not Found
No
The document describes standard pulse oximetry technology and does not mention AI or ML in the intended use, device description, or performance studies. The "Masimo SET Technology" is a proprietary signal processing technology, but it is not explicitly stated to be AI/ML.
No
The device is described as a "Pulse CO-Oximeter and accessories," and its intended use is for "continuous noninvasive monitoring" of various physiological parameters. Monitoring devices collect data but do not directly treat or provide therapy to patients.
Yes
The device continuously monitors physiological parameters such as oxygen saturation, pulse rate, carboxyhemoglobin, methemoglobin, and total hemoglobin concentration, which are used to assess a patient's health status and can inform diagnosis.
No
The device description explicitly mentions "Pulse CO-Oximeter and accessories" and describes physical output interfaces (SatShare connection, Nurse Call analog output, RS-232 serial output), indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The intended use and device description clearly state that this device performs continuous noninvasive monitoring of various physiological parameters (SpO2, pulse rate, SpCO, SpMet, SpHb) by being placed on the patient's body (fingertip, hand, or foot). It does not analyze blood, urine, or other bodily fluids in vitro (outside the body).
- The measurements are taken in vivo. The device directly measures these parameters from the patient's body using sensors.
Therefore, while it is a medical device used for diagnostic purposes (providing information about a patient's condition), it does not fit the definition of an In Vitro Diagnostic device.
N/A
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 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 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 and motions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
Product codes (comma separated list FDA assigned to the subject device)
DQA, JKS, DPZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip (for adults), hand or foot (for neonates)
Indicated Patient Age Range
adult, pediatric, and neonatal patients
Intended User / Care Setting
Hospital-type facilities, mobile, and home environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
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.
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.
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%.
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.
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. The SpHb accuracy has not been validated with motion or low perfusion.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Accuracy testing for SpO2, SpCO, SpMet, Pulse Rate, and SpHb. Motion and no motion conditions, low perfusion.
Sample size:
- SpO2, SpCO, SpMet (adults): Healthy adult volunteers (sample size not specified beyond "healthy adult volunteers").
- SpO2, SpMet (neonates): 16 neonatal NICU patients (7-135 days old, 0.5-4.25 kg), 79 data samples.
- No motion accuracy (SpO2): Human blood studies on healthy adult male and female volunteers.
- Motion accuracy (SpO2): Human blood studies on healthy adult male and female volunteers.
- Low perfusion accuracy (SpO2): Bench top testing.
- Pulse rate accuracy: Bench top testing.
- SpHb accuracy: Healthy adult male and female volunteers and surgical patients.
Key results:
- Accuracy - SpO2 During No Motion Conditions:
- Adults, Pediatrics, Infants: 60% - 80% ± 3%
- Adults, Pediatrics, Infants, Neonates: 70% - 100% ± 2%
- Adults, Pediatrics, Infants, Neonates: 0% - 69% unspecified
- Accuracy - SpO2 During Motion Conditions:
- Adults, Pediatrics, Infants, Neonates: 70% - 100% ± 3%
- Adults, Pediatrics, Infants, Neonates: 0% - 69% unspecified
- Accuracy - SpO2 Low Perfusion:
- Adults, Pediatrics, Infants, Neonates: 70% - 100% ± 2%
- Adults, Pediatrics, Infants, Neonates: 0% - 69% unspecified
- Accuracy - Pulse Rate During No Motion Conditions: Adults, Pediatrics, Infants, Neonates: 25 - 240 ± 3 bpm
- Accuracy - Pulse Rate During Motion Conditions: Adults, Pediatrics, Infants, Neonates: 25 - 240 ± 5 bpm
- Accuracy - Pulse Rate Low Perfusion: Adults, Pediatrics, Infants, Neonates: 25 - 240 ± 3 bpm
- Accuracy - SpCO During No Motion Conditions: Adults, Pediatrics, Infants: 1% - 40% ± 3%
- Accuracy - SpMet During No Motion Conditions: Adults, Pediatrics, Infants, Neonates: 1% - 15% ± 1%
- Accuracy - SpHb During No Motion Conditions: Adults, Pediatrics: 7 - 17 g/dl +1 g/dl. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for accuracy specifications.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
MAY 12 2008
| Submitted by: | Masimo Corporation
40 Parker
Irvine, CA 92618
(714) 297-7000
FAX (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 Accessories
510(k) Number - K061204
Masimo Rainbow SET® Rad 57cm/m Pulse CO-Oximeters and Accessories
510(k) Number - K053477
Radiometer America, Inc. OSM3 Hemoximeter
510(k) Number - K853990 |
Description of the Device
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
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
1
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
Section 5, Page 2 of 9
2
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
3
Specifications
The specifications for the Radical 7, Rad 87, and Rad 57t are:
| FEATURES | SPECIFICATIONS | TYPE OF
PULSE CO-OXIMETER |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Display Ranges | | |
| | Saturation (SpO2): 0% - 100%
Pulse Rate (bpm): 25 - 240 bpm
Total Hemoglobin (SpHb): 0-25 g/dl
Total Oxygen Concentration (CaO2):
1-100 ml/dl
Perfusion Index: 0.02% - 20% | Radical 7
Rad 87
Rad 57t |
| | Carboxyhemoglobin Saturation
(SPCO): 0-99%
Methemoglobin Saturation (SpMet):
0-99.9%
Pleth Variability Index: 0% - 100% | Radical 7
Rad 87 |
| Rate | See Footnotes 1, 2, 3, 4, and 5 | |
| Accuracy - SpO2
During No Motion
Conditions | Adults, Pediatrics, Infants: 60% - 80%
$\pm$ 3%
Adults, Pediatrics, Infants, Neonates:
70% - 100% $\pm$ 2%
Adults, Pediatrics, Infants, Neonates:
0% - 69% unspecified | Radical 7
Rad 87
Rad 57t |
| Accuracy - SpO2
During Motion Conditions | Adults, Pediatrics, Infants, Neonates:
70% - 100% $\pm$ 3%
Adults, Pediatrics, Infants, Neonates:
0% - 69% unspecified | Radical 7
Rad 87
Rad 57t |
| Accuracy - SpO2
Low Perfusion | Adults, Pediatrics, Infants, Neonates:
70% - 100% $\pm$ 2%
Adults, Pediatrics, Infants, Neonates:
0% - 69% unspecified | Radical 7
Rad 87
Rad 57t |
| Accuracy - Pulse Rate
During No Motion
Conditions | Adults, Pediatrics, Infants, Neonates:
25 - 240 $\pm$ 3 bpm | Radical 7
Rad 87
Rad 57t |
| Accuracy - Pulse Rate
During Motion Conditions | Adults, Pediatrics, Infants, Neonates:
25 - 240 $\pm$ 5 bpm | Radical 7
Rad 87
Rad 57t |
| Accuracy - Pulse Rate
Low Perfusion | Adults, Pediatrics, Infants, Neonates:
25 - 240 $\pm$ 3 bpm | Radical 7
Rad 87
Rad 57t |
| Accuracy: SpCO | See Footnote 1 | |
| Accuracy - SpCO
During No Motion
Conditions | Adults, Pediatrics, Infants: 1% -
40% $\pm$ 3% | Radical 7
Rad 87 |
| Accuracy: SpMet | See Footnote 1 | |
| Accuracy - SpMet
During No Motion
Conditions | Adults, Pediatrics, Infants, Neonates:
1% - 15% $\pm$ 1% | Radical 7
Rad 87 |
| FEATURES | SPECIFICATIONS | TYPE OF
PULSE CO-OXIMETER |
| Accuracy: SpHb | | |
| Accuracy - SpHb
During No Motion
Conditions | 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. | Radical 7
Rad 87
Rad 57t |
| General | | |
| Resolution | SpO2: 1%
Pulse Rate: 1 bpm
SpHb: 0.1 g/dl | Radical 7
Rad 87
Rad 57t |
| Resolution | SpCO: 1%
SpMet: 0.1% | Radical 7
Rad 87 |
| Measurements | Low Signal IQ
Perfusion Index (PI)
Total Oxygen Concentration (CaO2) | Radical 7
Rad 87
Rad 57t |
| Measurements | Pleth Variability Index (PVI) | Radical 7
Rad 87 |
| Interfering Substances | • Elevated levels of Methemoglobin
(MetHb) may lead to inaccurate
SpO2 and SpCO measurements
• Elevated levels of
Carboxyhemoglobin (COHb) may
lead to inaccurate SpO2
measurements.
• Very low arterial Oxygen Saturation
(SpO2) levels may cause inaccurate
SpCO and SpMet measurements
• Severe anemia may cause erroneous
SpO2 readings.
• Dyes, or any substance containing
dyes, that change usual blood
pigmentation may cause erroneous
readings.
• Elevated levels of total bilirubin
may lead to inaccurate SpO2,
SpMet, SpCO and SpHb readings | Radical 7
Rad 87
Rad 57t
(Notes regarding SpCO
and SpMet measurements
are not applicable to Rad
57t) |
| Electrical | See Footnotes 6 and 7 | |
| Power (AC) | Voltage Input Range: 100-230 Volt,
47-63 Hz | Radical 7
Rad 87 |
| Batteries | Rechargeable | Radical 7
Rad 87 |
| Batteries | Non-Rechargeable | Rad 57t |
| Circuitry | Microprocessor controlled | Radical 7 |
| FEATURES | SPECIFICATIONS | TYPE OF
PULSE CO-OXIMETER |
| | Automatic self-test of oximeter when
powered on | Rad 87 |
| | Automatic setting of default
parameters | Rad 57t |
| | Automatic alarm messages | |
| | Trend data output | |
| Firmware | Rainbow SET technology, MX-1
Board/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 1,060
mbar 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 16
seconds
• With FastSat the averaging time is
dependent on the input signal
• For the 2 and 4 second settings the
averaging time may range from 2-4
and 4-6 seconds respectively
• Maximum sensitivity mode fixes
perfusion 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 | OFF
25% to 100% in 4 increments | Radical 7 |
| | | Rad 87 |
| Volume Level Adjustment:
Pulse/Tone | OFF
33% to 100% in 3 step | Rad 57t |
| Alarm Silence | 120 seconds delay
All 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 OF
PULSE CO-OXIMETER |
| Out of Limit Alarm:
SpCO, SpMet | High/ low alarms | Radical 7
Rad 87 |
| Sensor Condition Alarm | No Sensor
Sensor Off
Sensor Defect | Radical 7
Rad 87
Rad 57t |
| System | System failure | Radical 7
Rad 87
Rad 57t |
| Battery Alarm | Low battery | Radical 7
Rad 87
Rad 57t |
| Display and Indicators | | |
| Data Display | SpO2 (%)
Pulse rate (bpm)
SpHb (g/dl)
Perfusion index (%)
CaO2 (ml/dl)
Signal IQ
Sensitivity indicator
Sensor status
Status messages
Alarm status
Battery status | |
| | SpCO (%)
SpMet (%)
Pleth variability index (%) | Radical 7
Rad 87 |
| Output Interface | | |
| SatShare Port | SatShare connection to Multiparameter
monitors (SpO2 only) | Radical 7 |
| Analog output | Nurse Call | Radical 7
Rad 87 |
| Serial Port
(RS-232 connector) | PC/printer connetion
Philips Vuelink
RadNet
Patient Safety Net
Trends | Radical 7
Rad 87 |
| Sensor connector | Trends | Rad 57t |
| Compliance | | |
| EMC Compliance | EN 60601-1-2, Class B | Radical 7
Rad 87
Rad 57t |
| Electrical Safety | IEC 60601-1,
UL 60601-1 | Radical 7
Rad 87
Rad 57t |
| Type of Protection (AC
Power) | Class 1 | Radical 7
Rad 87 |
| Type of Protection (battery
power) | Internally Powered | Radical 7
Rad 87
Rad 57t |
| Degree of Protection-Patient
Cable | Type BF-Applied Part | Radical 7
Rad 87 |
| FEATURES | SPECIFICATIONS | TYPE OF
PULSE CO-OXIMETER |
| Degree of Protection –
SatShare Cable | Type CF | Rad 57t
Radical 7 |
| Enclosed Degree of Ingress
Protection from Solids/
Liquids | IPX1 | Radical 7
Rad 87
Rad 57t |
| Mode of Operation | Continuous | Radical 7
Rad 87
Rad 57t |
0015
Section 5, Page 4 of 9
4
0016
Section 5, Page 5 of 9
5
0017
Section 5, Page 6 of 9
6
0018
12
Section 5, Page 7 of 9
7
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
8
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.
9
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.
10
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
11
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