MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES

K091057 · Masimo Corporation · DQA · Jul 9, 2009 · Cardiovascular

Device Facts

• Record ID: K091057
• Device Name: MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Jul 9, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET® Pronto Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatic individuals during both no motion and motion conditions, and for individuals who are well or poorly perfused in clinical and nonclinical settings (e.g., hospitals, hospital-type facilities, mobile environments, homes, clinics, physician offices, blood donation facilities, and ambulatory surgery centers).

Device Story

Handheld pulse CO-oximeter for noninvasive spot-checking of SpO2, pulse rate, and total hemoglobin (SpHb). Uses Rainbow SET technology to process optical signals from patient-applied sensors; measures light absorption to calculate hemoglobin saturation and concentration. Operated by trained personnel in diverse settings (hospitals, clinics, homes). Provides real-time digital display of SpO2, pulse rate, SpHb, perfusion index, and total oxygen concentration (SpOC). Signal IQ indicator provides signal quality feedback. Output assists clinicians in rapid assessment of patient oxygenation and hemoglobin status. Device is battery-powered and microprocessor-controlled.

Clinical Evidence

Validated via human blood studies on healthy adult volunteers (light to dark skin pigmentation) in induced hypoxia (70-100% SpO2) against laboratory CO-oximeters. Motion testing performed at 2-4 Hz and 1-5 Hz. SpHb accuracy validated against laboratory CO-oximeter in range of 8-17 g/dl. Low perfusion and pulse rate accuracy validated via bench-top testing against Biotek Index 2 and Masimo simulators.

Technological Characteristics

Polycarbonate/ABS blend enclosure. Microprocessor-controlled circuitry using Rainbow SET technology/MX board. Internally powered by non-rechargeable alkaline batteries. Type BF applied part. IPX1 enclosure rating. Connectivity: standalone spot-check device.

Indications for Use

Indicated for noninvasive spot checking of SpO2, pulse rate, and total hemoglobin (SpHb) in adult and pediatric patients. Suitable for use in motion/no-motion conditions and varying perfusion states by trained personnel in clinical and non-clinical 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 RadCheck Pulse CO-Oximeters and Accessories (K082052)

Submission Summary (Full Text)

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# 09105

Submitted by:

Masimo Corporation 40 Parker Irvine, CA 92618 949-297-7000 FAX [phone]

JUL - 9 2009

Company Contact:

Date Summary Prepared:

April 10, 2009

Trade Name

Common Name

Oximeter

Classification Name and Product Code:

Oximeter (74DQA) (870.2700) Cable, Transducer and Electrode (74DSA) (870.2900)

Marguerite Thomlinson; Manager of Regulatory Affairs

Substantially Equivalent Devices:

Masimo Rainbow SET RadCheck Pulse CO-Oximeters and Accessories, 510(k) Number K082052

Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories

#### Device Description

The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories in this filing are the same as the Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories in K082052. The reason for this filing is to clarify the intended use and the labeling of the device.

#### Predicate Device

The predicate device used in this filing is the Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories, 510(k) Number K082052.

#### Intended Use

The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET® Pronto Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatic individuals during both no motion and motion conditions, and for individuals who are well or poorly perfused in clinical and nonclinical settings (e.g., hospitals, hospital-type facilities, mobile environments, homes, clinics, physician offices, blood donation facilities, and ambulatory surgery centers).

### Technology Comparison

The Masimo Rainbow SET® Pronto Pulse CO-Oximeter is the same in design, principles of operation, materials, and performance to the predicate device (the RadCheck).

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The Pronto has the following specifications:

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| FEATURES | SPECIFICATIONS |
|----------------------------------|----------------------------------------------------------------------------------------------------|
| Display Ranges | Saturation (SpO2): 0-100% |
| | Pulse Rate (bpm): 25-240 bpm |
| | Total Hemoglobin (SpHb): 0-25 g/dl |
| | Total Oxygen Concentration (SpOC): 0-35 ml/dl |
| | Perfusion Index: 0.02-20% |
| Accuracy | See Footnotes 1, 2, 3, 4, 5, 6, and 7 |
| SpO2, No Motion Conditions | Adults, Pediatrics: 60-80% ± 3%; 70-100% +2% |
| SpO2, Motion Conditions | Adults, Pediatrics: 70-100% ± 3% |
| SpO2, Low Perfusion | Adults, Pediatrics: 70-100% ± 2% |
| Pulse Rate, No Motion Conditions | Adults, Pediatrics: 25-240 ± 3 bpm |
| Pulse Rate, Motion Conditions | Adults, Pediatrics: 25-240 ± 5 bpm |
| Pulse Rate, Low Perfusion | Adults, Pediatrics: 25-240 ± 3 bpm |
| SpHb, No Motion Conditions | Adults, Pediatrics: 8-17 g/dl +1 g/dl (Arterial or Venous) |
| General | |
| Resolution | SpO2: 1% |
| | Pulse Rate: 1 bpm. |
| | SpHb: 0.1 g/dl |
| Measurements | Low Signal IQ |
| | Perfusion Index (PI) |
| | Total Oxygen Concentration (SpOC) |
| Electrical | See Footnote 8 |
| Batteries | Non-rechargeable alkaline batteries |
| Circuitry | Microprocessor controlled |
| Firmware | Rainbow SET technology, MX Board/Circuitry |
| Mechanical | |
| Material | Polycarbonate/ABS Blend |
| Environmental | |
| Operating Temperature | 41°F to + 104°F (5°C to +40°C) |
| Storage Temperature | -40°F to + 158°F (-40°C to +70°C) |
| Relative Humidity | 5% to 95% noncondensing |
| Operating Altitude | Operating Altitude: 500 mbar to 1,060 mbar pressure; -<br>1,000 ft to 18,000 ft (-304 m to 5,486m) |
| Mode & Sensitivity | |
| Averaging Mode - SpO2 | Maximum sensitivity mode fixes perfusion limit to 0.02% |
| Alarms | |
| System | System failure |
| Battery Alarm | Low battery |

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| FEATURES | SPECIFICATIONS |
|------------------------------------|-------------------------|
| Display and Indicators | SpO2 (%) |
| | Pulse rate (bpm) |
| | SpHb (g/dl) |
| | SpHbv (g/dl) |
| | Perfusion index (%) |
| | SpOC (ml/dl) |
| | Signal IQ |
| | Pulse indicator |
| | Spot Check Progress |
| | Sensor Use indicator |
| | Sensor status |
| | Status messages |
| | Battery status |
| Compliance | |
| EMC Compliance | EN 60601-1-2, Class B |
| Electrical Safety | IEC 60601-1, UL 60601-1 |
| Type of Protection (battery power) | Internally Powered |
| Degree of Protection-Patient Cable | Type BF-Applied Part |
| Enclosure Degree of Protection | IPX1 |
| Mode of Operation | Spot check |

### Footnotes

- SpO2 accuracy was determined by testing on healthy adult volunteers in the range of 1 60-100% SpO2 against a laboratory CO-Oximeter.
- 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 piomentation 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.
- The Masimo SET Technology has been validated for low perfusion accuracy in র্ণ 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.
- 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

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equals plus or minus one standard deviation which encompasses 68% of the population.

- િ SpHb accuracy has been validated with (arterial/venous) blood from healthy adult male and female volunteers and on surgical 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
- 7 The following substances may interfere with pulse CO-oximetry measurements:
- · Elevated levels of Methemoglobin (MetHb) may lead to inaccurate SpO2 measurements
- · Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO2 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 and SpHb readings
- 8 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.

#### Test Summarv

The Pronto complies with the voluntary standards as detailed in this submission. The following quality assurance measures were applied to the development of the Pronto:

- 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 Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are substantially equivalent to the predicate device, with respect to safety, effectiveness, and performance.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL - 9 2009

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

Re: K091057

Trade/Device Name: Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 5, 2009 Received: June 16, 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 Runnes

Susan Runner, D.D.S., M.A. Acting 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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# Indications for Use

K091057

## 510(k) Number (if known):

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

### Indications For Use:

The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatric individuals during both no motion and motion conditions and for individuals who are well or poorly perfused and in clinical and non-clinical settings (e.g., hospital-type facilities, home, clinics, physician offices, blood donation facilities, and ambulatory surgery centers).

| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|--------------------------------|---|--------|--------------------------------|--|
| (Per 21 CFR 801.109 Subpart D) | | | (Per 21 CFR 801.109 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Goncurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Masimo Pronto, Special 510(k), 4/10/09 Page 12 of 88