MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES

K111403 · Masimo Corporation · DQA · Dec 30, 2011 · Cardiovascular

Device Facts

• Record ID: K111403
• Device Name: MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Dec 30, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Masimo Rainbow SET Pronto-7 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-7 Pulse CO-Oximeter and Accessories are indicated for use by trained personnel, with adult and pediatric individuals, in clinical and non-clinical settings (e.g., hospital-type facilities, home, clinics, physician offices, and ambulatory surgery centers).

Device Story

Device performs noninvasive spot-check measurements of SpO2, pulse rate, and total hemoglobin (SpHb) using optical sensor technology. Input consists of light signals processed to derive physiological parameters; output displayed on device screen. Operated by trained personnel in clinical/non-clinical settings (hospitals, clinics, home). Provides real-time data to assist healthcare providers in patient assessment. New features include small/medium sensor sizes and Maximum Sensitivity Mode for expanded SpHb detection range. Device utilizes rechargeable battery, wireless connectivity (Bluetooth/Wi-Fi), and SD card storage.

Clinical Evidence

Clinical validation performed on healthy adult volunteers (male/female, light to dark skin) and patients. SpO2 accuracy (70-100%) validated against laboratory CO-Oximeter and ECG. SpHb accuracy validated in ranges 6-18 g/dL (Normal Mode) and 4.5-20 g/dL (Maximum Sensitivity Mode). Pulse rate validated 40-110 bpm. Results: SpO2 accuracy ±2%, pulse rate ±3 bpm, SpHb ±1 g/dL (Normal) and ±1.1 g/dL (Maximum Sensitivity). Studies conducted per ISO 9919:2005.

Technological Characteristics

Noninvasive pulse CO-oximetry; optical sensing. Powered by rechargeable lithium polymer battery. Connectivity: Bluetooth 2.0, Wi-Fi b/g, Micro SD slot. Dimensions/form factor: handheld spot-check device. Compliance: EN 60601-1-2, IEC 60601-1, UL 60601-1, CAN/CSA STD C22.2. Type BF-Applied Part, IPX1.

Indications for Use

Indicated for noninvasive spot checking of SpO2, pulse rate, and total hemoglobin (SpHb) in adult and pediatric patients 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 Pronto Pulse CO-Oximeter and Accessories (K100403)

Submission Summary (Full Text)

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K111403

DEC 3 0 2011

## 510(k) SUMMARY

| Applicant: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>949-297-7000<br>FAX [phone] |
|------------------------------------|-----------------------------------------------------------------------------------------|
| Company Contact: | Anil Bhalani<br>Director of Regulatory affairs |
| Date Summary Prepared: | November 10, 2011 |
| Trade Name: | Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and<br>Accessories |
| Common Name: | Oximeter |
| Classification Name/ Product Code: | Oximeter (21CFR 870.2700/ Product Code: DQA) |
| Predicate Device: | K100403- Masimo Rainbow SET Pronto Pulse CO-<br>Oximeter and Accessories (Pronto-7) |

#### Device Description

The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories include the noninvasive technology spot check of measurement for functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate and total hemoglobin concentration (SpHb), which is based on the same technology of the predicate device. This submission introduces two new sensor sizes (medium and small) and an optional Maximum Sensitivity Mode that extends the detection range for SpHb.

#### Intended Use/ Indications for Use

The Masimo Rainbow SET Pronto-7 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-7 Pulse CO-Oximeter and Accessories are indicated for use by trained personnel, with adult and pediatric individuals, in clinical and non-clinical settings (e.g., hospital-type facilities, home, clinics, physician offices, and ambulatory surgery centers).

#### Technology Comparison

The Fundamental Scientific Technology of the previously cleared Pronto-7 device and Sensor and that of the Pronto-7 device and sensors is the same.

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| Device | Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories | |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| | K100403 | K111403 (Subject Device) |
| Display Range | Saturation (SpO2): 0-100%<br>Pulse Rate: 30-250 bpm<br>Total Hemoglobin (SpHb): 0-25 g/dL<br>Perfusion Index (PI): 0.02-20% | Same |
| Accuracy<br>Adults and<br>Pediatrics<br>(> 30kg) | SpO2: 70-100 $\pm$ 2%<br>Pulse Rate: 30-250 $\pm$ 3 bpm<br>Normal Sensitivity Mode:<br>SpHb: 6-18 g/dl $\pm$ 1 g/dL | Same<br>Same<br>Normal Sensitivity Mode: Same<br>Maximum Sensitivity Mode:<br>SpHb: 4.5-20 g/dl $\pm$ 1.1 g/dL |
| Resolution | SpO2: 1%; Pulse Rate: 1 bpm, SpHb:<br>0.1 g/dL | Same |
| AC Power | Voltage Input: 100-240 VAC, 50-60 Hz;<br>Max Power Consumption: 15 VA | Same |
| Batteries | Rechargeable lithium polymer battery | Same |
| Temperature | Operating: 41 to 104°F (5 to 40°C)<br>Storage: -40° to 158°F (-40 to 70°C) | Same |
| Relative Humidity | 5 to 95% non-condensing | Same |
| Operating Altitude | 500 to 1,060 mbar; -1,000 to 18,000 ft<br>(-304 to 5,486m) | Same |
| Alarm | System Failure; Low Battery Alarm | Same |
| Display and<br>Indicators | SpO2 (%); Pulse Rate (bpm); SpHb<br>(g/dl); Perfusion Index (%); Pleth<br>Waveform; Sensor Status; Status<br>Messages; Battery Status | Same |
| Connection/<br>Output | Wireless: Bluetooth 2.0; Wi-Fi b/g,<br>Flash Memory: Micro SD card slot | Same |
| Earphone jack | Connection for standard 3.5 mm<br>earphone jack | Same |
| EMC/Electrical<br>Safety Compliance | EN 60601-1 -2, Class B<br>IEC 60601-1, UL 60601-1, CAN/CSA<br>STD C22.2, Internally Powered, AC<br>Power Class 2, Compliance Type BF-<br>Applied Part, IPX1, Class 2 | Same |
| Mode of Operation | Spot Check | Same |

#### Performance Data Summary

SpO2 accuracy has been validated in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation. Pronto-7 measurements on volunteers induced hypoxia in the range of 70-100% SpO2 are compared against a laboratory CO-Oximeter and ECG monitor. SpHb accuracy has been validated with (arterial/ venous) blood from healthy adult male and female volunteers and on patients with light to dark skin pigmentation in the ranges of 6-18 g/dl SpHb (Normal Sensitivity Mode) and 4.5-20 g/dl SpHb (Maximum Sensitivity Mode), with Pronto-7 measurements compared against a laboratory CO-Oximeter. Pulse rate accuracy has been validated on healthy adult male and female volunteers and on patients with light to dark skin pigmentation in the range of 40-110 bpm. The variation in these studies equals plus or minus one standard deviation encompasses 68% of the population.

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Results: The studies were performed in accordance with ISO 9919:2005, Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use. The studies resulted in SpO2 accuracy (rms) of ±2%, pulse rate accuracy (rms) of ± 3bpm, and SpHb accuracy (rms) of ± 1g/dl (Normal Sensitivity Mode) and ± 1.1g/dl (Maximum Sensitivity Mode).

## Non-Clinical Data Summary

The Pronto-7 complies with the voluntary standards as detailed in this submission. Laboratory testing for biocompatibility, safety and environmental was conducted to verify that the Pronto 7 met all design specifications and is considered equivalent to the predicate device.

## Conclusions

The information in this 510(k) submission demonstrates that the Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are substantially equivalent to the predicate device with respect to safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Anil Bhalani Director of Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618

DEC 3 0 2011

Re: K111403

Trade/Device Name: Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, GLY Dated: December 22, 2011 Received: December 28, 2011

Dear Mr. Bhalani:

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 2 - Mr. Bhalani

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known):

Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories Device Name:

### Statement of Indications for Use:

The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SP02), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are indicated for use by trained personnel, with adult and pediatric individuals, in clinical and non-clinical settings (e.g., hospital-type facilities, home, clinics, physician offices and ambulatory surgery centers).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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 The For of Anesthesiology, General
Infection Control, Dental Devices

510(k) Number: K111403

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