MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER

K091241 · Masimo Corporation · DQA · Nov 6, 2009 · Cardiovascular

Device Facts

• Record ID: K091241
• Device Name: MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Nov 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RR). 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 and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

Device Story

The Rad 87 is a pulse CO-oximeter using Masimo Rainbow SET technology to monitor arterial blood parameters. Inputs include multi-wavelength optical signals from finger sensors for SpO2, SpCO, SpMet, and SpHb, and vibratory signals from neck sensors for respiratory rate. The device processes these signals via an internal MX board to calculate physiological values and indices like Perfusion Index (PI), Pleth Variability Index (PVI), and Total Arterial Oxygen Content (SpOC). It is operated by clinicians in hospitals, mobile, or home settings. Output is displayed on the device screen and can be transmitted via RS-232 or Nurse Call interfaces. Clinicians use this real-time data to assess patient status and guide clinical interventions. The device benefits patients by providing continuous, noninvasive monitoring of critical blood parameters and respiratory status, reducing the need for invasive blood sampling.

Clinical Evidence

Clinical validation included studies on healthy adult volunteers (light to dark skin) and neonatal NICU patients. SpO2, SpCO, and SpMet accuracy were validated against laboratory CO-oximeters during induced hypoxia. SpHb accuracy was validated in adults and surgical patients. Pulse rate and low perfusion accuracy were validated via bench testing against simulators. Motion accuracy was validated in human blood studies with induced motion (2-5 Hz).

Technological Characteristics

Polycarbonate/ABS construction. Multi-wavelength optical sensing for CO-oximetry; vibratory sensing for respiratory rate. Microprocessor-controlled MX board. Connectivity: RS-232, Nurse Call, 802.11 a/b/g. Power: 100-240 VAC or internal rechargeable battery. Electrical safety: IEC 60601-1, 2nd Ed. EMC: EN 60601-1-2. IPX1 liquid ingress protection.

Indications for Use

Indicated for continuous noninvasive monitoring of SpO2, pulse rate, SpCO, SpMet, SpHb, and respiratory rate in adult, pediatric, and neonatal patients. Suitable for use in hospital, mobile, and home environments, including patients with motion or poor perfusion.

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 (K080238)
• Oridion Capnography Inc., Capnostream 20 with Integrated Pulmonary Index (K082268)

Reference Devices

• Andromed Inc., Biological Sound Monitor (BSM) Sensor (K021389)

Submission Summary (Full Text)

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KO91241

| Submitted by: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>Phone: [phone]<br>FAX: [phone]<br>NOV - 6 2009 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Marguerite Thomlinson, Manager of Regulatory Affairs |
| Date Summary Prepared: | August 14, 2009 |
| Trade Name | Masimo Rainbow SET® Rad 87 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 – K080238<br><br>Oridion Capnography Inc., Capnostream 20 with Integrated<br>Pulmonary Index, 510(k) Number – K082268 |

Andromed Inc., Biological Sound Monitor (BSM) Sensor 510(k) Number - K021389

## Description of the Device

The Rainbow SET® Rad 87 Pulse CO-Oximeter and accessories (Rad 87) include the MX board with Masimo Rainbow SET technology.

The Rad 87 provides noninvasive monitoring of arterial oxygen saturation (%SpO₂), pulse rate, carboxyhemoglobin saturation (%SpCO), methemoglobin saturation (%SpMet), total hemoglobin concentration (g/dl SpHb), and/or respiratory rate (RR). Other information displayed by the Rad 87 includes: Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), Total Arterial Oxygen Content (SpOC), Respiratory Signal Quality (RSQ), 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 87 in this filing are the Rad-87 in the K080238 filing, but with the addition of respiratory rate monitoring.

## Intended Use/Indications for Use

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, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RR). The Masimo Rainbow SET® Rad 87 Pulse CO-

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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.

## Principles of Operation

## SpO2 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 visible and infrared light. The amount of arterial blood in tissue changes with the pulse (photoplethysography). Therefore the amount of light, absorbed by the varying quantities of arterial blood, changes accordingly.

## SpCO. SpMet, and SpHb General Description

The Rad-87 include the Masimo Rainbow SET technology for SpCO, SpMet and SpHb measurements, based on the same principles of pulse oximetry. The Masimo Rainbow SET technology uses a multiwavelength sensor to distinguish between oxygenated blood, deoxygenated blood, blood with carbon monoxide, blood with oxidized hemoglobin and blood plasma.

Once the Masimo Rainbow SET technology receives the signal from the sensor, it calculates the patient's functional oxygen saturation (SpO2), fractional concentration of carboxyhemoglobin (SpCO), fractional concentration of methemoglobin (SpMet), total hemoglobin concentration (SpHb) and pulse rate.

## Respiratory Rate General Description

The Masimo Rainbow SET technology also provides respiratory rate measurements, based on vibratory signals from respiratory sounds.

## Method of Operation

## SpO2, SpCO, SpMet, and SpHb

The instrument (Rad 87) is turned on. A sensor is attached to a patient's finger. The other end of the sensor is attached to a patient cable. The other end of the patient cable is connected to the Dual Channel cable or directly to the instrument. The connection of the patient cable to the Dual Channel cable is only needed when pulse CO-oximetry monitoring is concurrent with respiratory rate monitoring.

The instrument 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 SpOC. The practitioner can then use 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 sensor is removed (and disposed of if it is a single use device), and the power to the instrument is turned off.

## Respiratory Rate

The instrument (Rad 87) is turned on. A sensor is attached to a patient's neck. The other end of the sensor is connected to a patient cable. The other end of the cable is connected to the Dual Channel cable. The Dual Channel cable is then connected to the instrument.

The instrument will begin continuously display the patient's respiratory rate. The practitioner can then use 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 patient cable is disconnected from the sensor, the sensor is disposed and the power to the instrument is turned off.

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## Specifications

The specifications for the Rad 87 are the following:

| FEATURES | SPECIFICATIONS |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display Ranges | Oxygen Saturation (SpO2): 0-100%<br>Pulse Rate (beat per minute or bpm): 25-240 bpm<br>Carboxyhemoglobin Saturation (SpCO): 0-99%<br>Methemoglobin Saturation (SpMet): 0-99.9%<br>Total Hemoglobin (SpHb): 0-25 g/dL<br>Respiratory Rate (RR): 0-150 breaths per minute<br>Total Oxygen Concentration (SpOC): 0-35 ml/dl<br>Perfusion Index: 0.02-20%<br>Pleth Variability Index: 0-100% |
| Accuracy | See Footnotes 1, 2, 3, 4, 5, 6, and 7 |
| SpO2, No Motion | 60-80 ± 3%, adults/pediatrics/infants |
| SpO2, Motion | 70-100 ± 2%, adults/pediatrics/infants; ± 3%, neonates |
| SpO2, Low Perfusion | 70-100 ± 2%, adults/pediatrics/infants/neonates |
| Pulse Rate, No Motion | 25-240 ± 3 bpm, adults/pediatrics/infants/neonates |
| Pulse Rate, Motion | 25-240 ± 5 bpm, adults/pediatrics/infants/neonates |
| Pulse Rate, Low Perfusion | 25-240 ± 3 bpm, adults/pediatrics/infants/neonates |
| SpCO | 1-40 ± 3%, adults/pediatrics/infants |
| SpMet | 1-15 ± 1%, adults/pediatrics/infants/neonates |
| SpHb | 8-17 ±1 g/dl (arterial or venous), adults/pediatrics/infants |
| RR | 4-70 ± 1 breath per minute, adults (> 30kg) |
| General | |
| Resolution | SpO2: 1%<br>Pulse Rate: 1 bpm<br>SpCO: 1%<br>SpMet: 0.1%<br>SpHb: 0.1 g/dl<br>RR: 1 breath per minute |
| Measurements | Low Signal IQ<br>Perfusion Index (PI)<br>Total Oxygen Concentration (SpOC)<br>Pleth Variability Index (PVI)<br>Respiratory Signal Quality (RSQ) |
| Electrical | |
| Power (AC) | Voltage Input Range: 100-240 VAC, 47-63 Hz |
| Batteries | Rechargeable |
| Circuitry | Microprocessor controlled<br>Automatic self-test of pulse CO-oximeter when powered on<br>Automatic setting of default parameters<br>Automatic alarm messages<br>Trend data output |
| Firmware | Rainbow SET technology, MX Board/Circuitry |
| Mechanical | |
| Material | Polycarbonate/ABS Blend |
| FEATURES | SPECIFICATIONS |
| Environmental | |
| Operating Temperature | 32 to 122°F (0 to 50°C) |
| Storage Temperature | -40 to 158°F (-40 to 70°C) |
| Relative Storage Humidity | 10 to 95% non-condensing |
| Operating Altitude | Pressure: 500-1,060 mbar<br>Altitude: -1,000-18,000 ft (-304-5,486m) |
| Mode & Sensitivity | |
| SpO2 Averaging Mode | 2, 4, 6, 8, 10, 12 and 16 seconds; FastSat |
| SpO2 Sensitivity | APOD, Normal, Maximum |
| Alarms | |
| Volume Level Adjustment: Pulse/Tone | OFF; 25% to 100% in 4 increments |
| Alarm Silence | 120 seconds delay; All mute: continuous silence |
| Out of Limit Alarms: SpO2, Pulse Rate, SpCO, SpMet, SpHb, RR, PI, PVI | High/low alarms |
| Sensor Condition Alarm | No Sensor; Sensor Off; Sensor Defect |
| System | System failure |
| Battery Alarm | Low battery |
| Display and Indicators | |
| Data Display | SpO2 (%)<br>Pulse rate (bpm)<br>SpCO (%)<br>SpMet (%)<br>SpHb (g/dl)<br>SpHbv(g/dl)<br>RR<br>SpOC(ml/dl)<br>Perfusion Index-PI (%)<br>Pleth Variability Index-PVI (%)<br>Signal IQ<br>Respiratory Signal Quality (RSQ)<br>Sensitivity indicator<br>Sensor status<br>Sensor time<br>Status messages<br>Alarm status<br>Battery status |
| Output Interface | |
| Analog output | Nurse Call |
| Serial Port<br>(RS-232 connector) | PC/printer connection<br>Philips Vuelink<br>RadNet<br>Patient Safety Net<br>Trends |
| Compliance | |
| EMC Compliance | EN 60601-1-2, Class B |
| Electrical Safety | IEC 60601-1, 2nd Edition; UL 60601-1 |
| Radio | 802.11 a/b/g |
| Type of Protection (AC Power) | Class 1 |
| Type of Protection (battery power) | Internally Powered |
| Degree of Protection-Patient Cable | Type BF-Applied Part |
| Liquid Ingress-Degree of Protection | IPX1 |
| Mode of Operation | Continuous |

:

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#### Footnotes

- SpO2, SpCO and SpMet accuracy was determined by testing on healthy adult volunteers in the 1 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.
- ನ 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.
- The Masimo sensors have been validated for motion accuracy in human blood studies on healthy ന 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% SpO- against a laboratory CO-oximeter and ECG monitor. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
- The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing য 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:
- The Masimo sensors have been validated for pulse rate accuracy for the range of 25-240 bpm in ട് bench top testing against a Biotek Index 2 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
- SpHb accuracy has been validated on healthy adult male and female volunteers and on surgical റ patients with light to dark skin pigmentation in the range of 8-17 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.
- The following substances may interfere with pulse CO-oximetry measurements: 7
- · 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

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## Test Summary

The Rad 87 comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the Rad 87:

- . 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 Rad 87 are substantially equivalent to the predicate devices, with respect to safety, effectiveness, and performance.

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Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name arranged in a circular fashion around an emblem. The emblem is a stylized representation of an eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Ms. Marguerite Thomlinson Manager of Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618

M-M-M

Re: K091241

Trade/Device Name: Masimo Rainbow SET Rad 87 Pulse CO-Oximeter and Accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, BZQ,DPZ, JKS Dated: October 29, 2009 Received: October 30, 2009

NOV - 6 2009

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 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); 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/cdrh/mdr/ 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Susan Rose

Susan Runner, D.D.S., M.A. Acting Division 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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## Section 4 - Indications for Use

510(k) Number (if known):

Masimo Rainbow SET Rad 87 Pulse CO-Oximeter and Accessories Device Name:

Indications For Use:

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, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RR). 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 hospitals, hospital-type facilities, mobile, and home environments.

Prescription Use X (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 CD/RH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091241

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

K091241-Rad 87 w/ ARRM Masimo Response, 8/14/09 Page 7 of 180