MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER
Device Facts
| Record ID | K100428 |
|---|---|
| Device Name | MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER |
| Applicant | Masimo Corporation |
| Product Code | DQA · Cardiovascular |
| Decision Date | Jul 9, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence, Pediatric |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K100428 · Jul 9, 2010 | MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER | Masimo Corporation | Neonatal Intensive Care Unit (NICU) patient records | Clinical data from 16 neonatal patients in a NICU setting was used to validate the accuracy of SpO2 and SpMet measurements for the device. | Neonatal; NICU; SpO2; SpMet; Clinical Accuracy |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Observational clinical data collection | 16 neonatal NICU patients (ages 7-135 days, weight 0.5-4.25 kg); Sample Size: 16 patients (79 data samples) | Not applicable for this study | SpO2 and SpMet accuracy |
Indications for Use
The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rainbow SET® Radical 7R 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 7R Pulse CO-Oximeter and accessories are indicated to provide the continuous noninvasive monitoring data obtained from the Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.
Device Story
Radical 7R is a pulse CO-oximeter using multi-wavelength sensor technology to measure arterial blood constituents. Inputs include optical signals from sensors and vibratory signals for respiration rate. The device processes these signals to calculate SpO2, pulse rate, SpCO, SpMet, SpHb, and RRa. It displays these parameters, along with perfusion index, pleth variability index, and pleth waveforms, on a touchscreen. Used in hospitals, mobile, and home environments by clinicians. Output interfaces include SatShare for multiparameter monitors, Nurse Call, and RS-232. Data supports clinical decision-making regarding patient oxygenation, hemoglobin status, and respiratory function. Benefits include continuous, noninvasive monitoring of critical physiological parameters.
Clinical Evidence
Clinical studies conducted on healthy adult volunteers and surgical patients (SpHb) and 16 NICU neonates (SpO2/SpMet). Accuracy validated against laboratory CO-oximeters. Neonatal study (n=16, 79 samples) showed 2.9% SpO2 and 0.9% SpMet accuracy. Adult studies covered 60-100% SpO2, 0-40% SpCO, 0-15% SpMet, and 8-17 g/dL SpHb. No device-related adverse events reported. Testing performed per ISO 9919:2005.
Technological Characteristics
Multi-wavelength optical sensor; photoplethysmography principle; vibratory signal processing for RRa. Powered by AC (100-240 VAC) or rechargeable batteries. Connectivity via SatShare, RS-232, and Nurse Call. Compliance with EN 60601-1-2, IEC 60601-1, and UL 60601-1. Applied parts: Type BF (patient cable) and Type CF (Satshare cable).
Indications for Use
Indicated for continuous noninvasive monitoring of SpO2, pulse rate, SpCO, SpMet, SpHb, and RRa in adult, pediatric, and neonatal patients. Applicable for patients in motion or no-motion conditions, and those with good or poor perfusion in hospital, mobile, or home settings.
Regulatory Classification
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.
Predicate Devices
- Masimo Rainbow SET Rad 87 Pulse CO-Oximeters and Accessories (K091241)
- Masimo Rainbow SET Radical 7 Pulse CO-Oximeter and Accessories (K080238)
Submission Summary (Full Text)
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## Section 5: 510(k) Summary
1111 -- 9 2010
| Submitted by: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>Phone: (949) 297-7000; FAX: (949) 297-7001 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Marguerite Thomlinson, Manager of Regulatory Affairs |
| Date Summary Prepared: | May 20, 2010 |
| Trade Name | Masimo Rainbow SET® Radical 7R CO-Oximeter and Accessories |
| Common Name | Pulse Oximeter and Sensor |
| Regulation Number: | 21 CFR 870.2700 |
| Regulation Name: | Oximeter |
| Regulation Class: | Class II |
| Product Code | DQA, BZQ, DPZ, JKS |
| Substantially Equivalent Devices | Masimo Rainbow SET® Rad 87 Pulse CO-Oximeters and Accessories, 510(k) Number – K091241<br>Masimo Rainbow SET® Radical 7 Pulse CO-Oximeter and<br>Accessories, 510(k) Number – K080238 |
#### Description of the Device
The Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories (Radical 7R) include the MX board with Masimo Rainbow SET technology. The Radical 7R provides noninvasive monitoring of arterial oxygen saturation (%SpO-), pulse rate (PR), carboxyhemoglobin saturation (%SpCO), methemoglobin saturation (%SpMet), total hemoglobin concentration (g/dl SpHb), and/or respiration rate (RRa). Other information displayed by the Radical 7R includes: Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), Total Arterial Oxygen Content (SpOC), Hematocrit (SpHct), Signal Identification Quality (SIQa), Respiration Indicator (RI), alarm silence, battery life, sensor status, trends, and pleth waveform. The Radical 7R has output interfaces include: SatShare connection to multiparameter monitors, Nurse Call analog output, and RS-232 serial output.
### Intended Use/Indications for Use
The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rainbow SET® Radical 7R 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 7R Pulse CO-Oximeter and accessories are indicated to provide the continuous noninvasive monitoring data obtained from the Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.
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# Section 5: 510(k) Summary
#### Principles of Operation
SpOz and Pulse Rate: Pulse oximetry is governed by the principles that oxyhemoglobin (oxygenated blood), deoxyhemoglobin (non-oxygenated blood), carboxyhemoglobin (blood with carbon monoxide content), and methemoglobin (blood with oxidized hemoglobin content) species differ in their absorption of red and infrared light. The amount of arterial blood in tissue changes with the pulse (photoplethysography). Thus, the amount of light, absorbed by the varying quantities of arterial blood, changes accordingly.
SpCO, SpMet, and SpHb General Description: The Radical 7R includes the Masimo Rainbow SET technology board, which uses a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood, blood with carbon monoxide, blood with oxidized hemoglobin and blood plasma. Once the technology board receives the signal from the sensor, it calculates the patient's functional oxygen saturation (SpOz), fractional concentration of carboxyhemoglobin (SpCO), fractional concentration of methemoglobin (SpMet), total hemoglobin concentration (SpHb) and pulse rate.
Respiration or Respiration Rate (RRa) General Description: The Masimo Rainbow SET technology also provides respiratory or respiration rate measurements, based on vibratory signals from respiratory sounds.
#### Comparison to Predicate Device
The Radical 7R in this filing is the same as the Masimo Rainbow SET Radical 7 Pulse CO-Oximeter and Accessories (Radical 7) in the K080238 filing, with the same performance. In addition to all the same product specifications and features of the Radical 7R also include respiratory or respiration rate monitoring and touch screen. Below are the specifications for the Radical 7R.
| FEATURES | SPECIFICATIONS |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display Range | SpO2: 0-100%; PR: 25-240 bpm; SpCO: 0-99%; SpMet: 0-99.9%;<br>SpHb: 0-25 g/dL; RRa: 0-70 breaths per minute; SpOC: 0-35 ml/dl<br>SpHct: 0-75%; PI: 0.02-20%; PVI: 0-100% |
| Accuracy: SpO2 | No Motion (adults/pediatrics/infants): 60-80 ± 3%; 70-100 ± 2%, ± 3%(neonates)<br>Motion (adults/pediatrics/infants/neonates): 70-100 ± 3%<br>Low Perfusion (adults/pediatrics/infants/neonates): 70-100 ± 2% |
| Accuracy: PR | No Motion (adults/pediatrics/infants/neonates): 25-240 ± 3 bpm<br>Motion (adults/pediatrics/infants/neonates): 25-240 ± 5 bpm<br>Low Perfusion (adults/pediatrics/infants/neonates): 25-240 ± 3 bpm |
| Accuracy: SpCO | 1-40 ± 3%, adults/pediatrics/infants |
| Accuracy: SpMet | 1-15 ± 1%, adults/pediatrics/infants/neonates |
| Accuracy: SpHb | 8-17 ±1 g/dl (arterial or venous), adults/pediatrics |
| Accuracy: RRa | 4-70 ± 1 breath per minute, adults |
| Resolution | SpO2: 1%; PR: 1 bpm; SpCO: 1%; SpMet: 0.1%; SpHb: 0.1 g/dl; RRa: 1 breath per minute |
| Measurements | Low Signal IQ, PI, SpOC, SpHct, PVI, SIQa, RI |
| Power | AC Input Range: 100-240 VAC, 47-63 Hz; Rechargeable batteries |
| Environmental | Operating temperature: 32-122°F (0 to 50°C); Storage temperature: -40 to 158°F (-40 to<br>70°C); Relative Humidity: 10-95% non-condensing |
| SpO2 Averaging | Averaging: 2, 4, 6, 8, 10, 12 and 16 seconds; FastSat |
| Mode/ Sensitivity | Sensitivity: APOD, Normal, Maximum |
| Alarm | Volume (pulse/tone): OFF; 25% to 100% in 4 increments; Silence: 120 sec delay; All mute-<br>continuous silence<br>Out of limit (high/low): SpO2, Pulse Rate, SpCO, SpMet, SpHb, RRa, PI, PVI<br>Sensor condition: No Sensor, Sensor Off, Sensor Defect<br>Other: system failure, low battery |
| Display/<br>Indicators | SpO2 (%), PR (bpm), SpCO (%), SpMet (%), SpHb (g/dl), SpHbv(g/dl), RRa, SpOC(ml/dl),<br>SpHct (%), PI (%), PVI (%), Pleth waveform, Signal IQ, SIQa, RI<br>Sensitivity indicator, Sensor status/ time/ messages, Alarm status, Battery status |
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# Section 5: 510(k) Summary
| FEATURES | SPECIFICATIONS |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Output Interface | Satshare: connection to Multiparameter monitors (SpO2 only)<br>Serial Port (RS-232): PC/printer, Vuelink, Spacelabs Flexport, RadNet, PSN, Trends |
| Compliance | EMC: EN 60601-1-2, Class B<br>Electrical Safety: IEC 60601-1 and UL 60601-1, Class 1 (AC Power), Internally Powered,<br>Patient Cable-Type BF applied part, Satshare cable-Type CF applied part |
| Operation Mode | Continuous |
#### Clinical Summary
Clinical Studies: SpO2, SoCO and SpMet accuracy was determined by testing on healthy adult volunteers in the range of 60-100% SpOz, 0-40% SpCO, and 0-15% SpMet against a laboratory CO-Oximeter. SpHb accuracy has been validated on healthy adult volunteers and on surgical patients with light to dark skin pigmentation in the range of 8-17 a/dl SpHb against a laboratory CO-oximeter. The variation in these studies equals plus or minus one standard deviation encompasses 68% of the population.
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.
Clinical Results: No device-related adverse events. The clinical studies were performed in accordance with ISO 9919:2005. The studies resulted in accuracies (rms) of equal to or less than the respective accuracies as stated above in the Radical 7R specifications.
#### Non-Clinical Summary
The Radical 7R complies with the voluntary standards as detailed in this submission. Laboratory testing for biocompatibility, safety and environmental was conducted to verify that the Radical 7R met all design specifications and was substantially equivalent to the predicate device.
#### Conclusions
The information in this 510(k) submission demonstrates that the Radical 7R is substantially equivalent to the predicate device, with respect to safety, effectiveness, and performance.
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
### JUL-- 9 2010
Ms. Marguerite Thomlinson Manager of Regulatory Affairs Mamiso Corporation 40 Parker Irvine, California 92618
Re: K100428
Trade/Device Name: Masimo Rainbow SET Radical 7R Pulse CO- Oximeter and accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulation Class: II Product Code: DOA Dated: June 28, 2010 Received: June 30, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 3- 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anrsthesiology, Geberal 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 7R Pulse CO-Oximeter and Accessories
#### Indications For Use:
The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rainbow SET® Radical 7R 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. In addition, the Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated to provide the continuous nonitoring data obtained from the Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.
× Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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: | K100428 |
|----------------|---------|
|----------------|---------|
