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

K100403 · Masimo Corporation · DQA · Jun 23, 2010 · Cardiovascular

Device Facts

• Record ID: K100403
• Device Name: MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 23, 2010
• 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, blood donation facilities, and ambulatory surgery centers).

Device Story

The Masimo Rainbow SET Pronto-7 is a noninvasive pulse CO-oximeter for spot-checking SpO2, pulse rate, and total hemoglobin (SpHb). It utilizes optical sensors to measure light absorption, processing signals to derive physiological parameters. The device features a touch-screen interface, pleth waveform display, and wireless connectivity (Bluetooth/WiFi). It is intended for use by trained personnel in diverse settings including hospitals, clinics, and home environments. Output is displayed on the device screen, allowing clinicians to perform rapid assessments of patient oxygenation and hemoglobin status, facilitating immediate clinical decision-making and patient monitoring.

Clinical Evidence

Clinical validation performed per ISO 9919:2005. SpO2 accuracy validated in human blood studies on healthy adult volunteers (light to dark skin) during induced hypoxia (70-100% range) vs. laboratory CO-oximeter and ECG. SpHb accuracy validated in healthy adults and patients (6-18 g/dl range) vs. laboratory CO-oximeter. Pulse rate accuracy validated in healthy adults and patients (40-110 bpm). Results: SpO2 accuracy (rms) < 2%, pulse rate accuracy (rms) < 3 bpm, SpHb accuracy (rms) < 1 g/dl. No device-related adverse events reported.

Technological Characteristics

Noninvasive optical pulse CO-oximeter. Features: touch-screen, pleth waveform display, rechargeable lithium polymer battery, USB, Bluetooth 2.0, WiFi b/g, Micro SD slot. Standards: EN 60601-1-2 (EMC), IEC 60601-1/UL 60601-1 (Electrical Safety), Type BF-Applied Part, IPX1. Operates via spot-check mode. Connectivity: Wireless and wired data output.

Indications for Use

Indicated for noninvasive spot checking of SpO2, pulse rate, and total hemoglobin (SpHb) in adult and pediatric patients. For use 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 (K091057)

Submission Summary (Full Text)

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## 510(k) SUMMARY

| Submitted by: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>949-297-7000<br>FAX [phone] |
|------------------------------------|------------------------------------------------------------------------------------------|
| Company Contact: | Marguerite Thomlinson, Manager of Regulatory Affairs |
| Date Summary Prepared: | April 23, 2010 |
| Trade Name | Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and<br>Accessories |
| Common Name | Oximeter |
| Classification Name/ Product Code: | Oximeter Section 870.2700/ Product Code DQA |
| Predicate Device: | Masimo Rainbow SET® Pronto Pulse CO-Oximeter and<br>Accessories, 510(k) Number - K091057 |

#### Device Description

The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories (Pronto-7) include the noninvasive technology 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, the Masimo Rainbow SET® Pronto Pulse CO-Oximeter and Accessories (Pronto), 510(k) no. K091057.

### 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 (SpO3), 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, blood donation facilities, and ambulatory surgery centers).

### Technology Comparison

Features in the Pronto-7, which are not in the Pronto, include touch-screen user interface, pleth waveform display, rechargeable batteries or AC power, USB connection, flash memory, earphone jack, and wireless connection. The Pronto-7 has the following specifications:

| FEATURES | SPECIFICATIONS |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Display Range | Saturation (SpO2): 0-100%; Pulse Rate (bpm): 30-250 bpm<br>(Total Hemoglobin (SpHb): 0-25 g/dl; Perfusion Index (PI): 0.02-20% |
| Accuracy:<br>Adults and Pediatrics > 30kg | SpO2: 70-100±2%; Pulse Rate: 30-250±3 bpm; SpHb: 6-18 g/dl ±1 g/dl |
| Resolution | SpO2: 1%; Pulse Rate: 1 bpm; SpHb: 0.1 g/dl |
| AC Power | Voltage Input: 100-240 VAC, 50-60 Hz; Max Power Consumption: 15 VA |
| Batteries | Rechargeable lithium polymer |

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# 510(k) SUMMARY

| FEATURES | SPECIFICATIONS |
|--------------------------------------|-------------------------------------------------------------------------|
| Temperature | Operating/ Storage: 41 to 104°F (5 to 40°C)/ -40 to 158°F (-40 to 70°C) |
| Relative Humidity | 5 to 95% noncondensing |
| Operating Altitude | 500 to 1,060 mbar pressure; -1,000 to 18,000 ft (-304 to 5,486m) |
| Alarm | System Failure; Low Battery Alarm |
| Display and Indicators | SpO2 (%); Pulse Rate (bpm); SpHb (g/dl); Perfusion Index (%) |
| Display and Indicators | Pleth Waveform; Sensor Status; Status Messages; Battery Status |
| Connection/ Output | Wireless: Bluetooth 2.0; WiFi b/g; Flash Memory: Micro SD card slot |
| Earphone jack | Connection for standard 3.5 mm earphone jack |
| EMC/ Electrical Safety<br>Compliance | EN 60601-1-2, Class B |
| EMC/ Electrical Safety<br>Compliance | IEC 60601-1, UL 60601-1, Internally Powered, AC Power Class 2 |
| EMC/ Electrical Safety<br>Compliance | Type BF-Applied Part, IPX1, Class 2 |
| Mode of Operation | Spot check |

### Clinical Data Summary

Clinical Studies: 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 range of 6-18 g/dl SpHb, with Pronto-7 measurements compared against a laboratory CO-oximeter. Pulse rate accuracy has been validated on healthy adult male 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.

#### Clinical Results: No device-related adverse events.

The clinical studies were performed in accordance with ISO 9919:2005. The studies resulted in SpO3 accuracy (rms) < 2%, pulse rate accuracy (rms) < 3bpm, and SpHb accuracy (rms) < 1g/d.

#### 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 was substantially 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. effectiveness, and performance.

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

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

JUN 2 3 2010

Re: K100403

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 Dated: June 11, 2010 Received: June 14, 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 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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Susan Rioner

Anthony D. Watson, BS, MS, MBA 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

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

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

#### 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, 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)

rrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K100403
510(k) Traditional, Masimo Pronto-7
Page 10 of 1254. 2/5/2010