MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK

K082052 · Masimo Corporation · DQA · Oct 10, 2008 · Cardiovascular

Device Facts

• Record ID: K082052
• Device Name: MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial hemoglobin (SpO2), pulse rate, and total hemoglobin (SpHb). The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatic patients during both no motion and motion conditions, and for patients who are well or poorly perfused in clinical and non-clinical settings.

Device Story

RadCheck is a portable, microprocessor-controlled pulse CO-oximeter for spot-checking vital signs. It utilizes 12-wavelength optical sensor technology to measure arterial oxygen saturation (SpO2), pulse rate, and total hemoglobin (SpHb). Input signals from the sensor are processed to output SpO2, pulse rate, SpHb, Perfusion Index (PI), and Total Arterial Oxygen Content (SpOC). The device is operated by trained personnel in clinical or non-clinical settings. Output is displayed on the device screen, allowing clinicians to assess patient status immediately. The device provides a noninvasive alternative to laboratory blood analysis, facilitating rapid clinical decision-making regarding oxygenation and hemoglobin levels.

Clinical Evidence

Clinical validation performed on healthy adult volunteers and surgical patients with varying skin pigmentation. Accuracy for SpO2 and pulse rate validated against laboratory CO-oximeter and ECG monitors under no-motion, motion, and low-perfusion conditions. SpHb accuracy validated in the 8-17 g/dl range. Bench testing conducted using Biotek Index 2 and Masimo simulators. Results demonstrate performance within specified tolerances (±1 SD).

Technological Characteristics

Microprocessor-controlled; 12-wavelength optical sensing; Polycarbonate/ABS blend housing; internally powered by non-rechargeable batteries; Type BF-applied part; IPX1 ingress protection. Connectivity via Masimo Rainbow sensors. Complies with EN 60601-1-2 (EMC) and IEC/UL 60601-1 (Electrical Safety).

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 clinical and non-clinical settings by trained personnel under motion/no-motion conditions and varying perfusion states.

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 57t Pulse CO-Oximeters and Accessories (K080238)

Submission Summary (Full Text)

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K08.2052

| 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: | July 16, 2008 |
| Trade Name | Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories |
| Common Name | Oximeter Sensor |
| Classification Name and Product Code: | Oximeter (74DQA) (870.2700) Cable, Transducer and Electrode (74DSA) (870.2900) |
| Substantially Equivalent Devices: | Masimo Rainbow SET Rad 57t Pulse CO-Oximeters and Accessories, 510(k) Number K080238 |

### Device Description

The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories (RadCheck) have modified intended use/indications for use in comparison to the Rad 57t Pulse CO-Oximeters and Accessories (Rad 57t) in the K080238 filing. The main difference is that the RadCheck in this filing is for spot checking, whereas the Rad 57t in K0808238 is for continuous monitoring. The keypad membrane and the software of the RadCheck also differ from the Rad 57t.

The RadCheck in this filing is similar in construction to the Rad 57t in the K0808238 filing, including the 12-wavelength technology for the measurement of total hemoglobin. The performance of the Radcheck is similar to the Rad 57t. Similar to the Rad 57t, the RadCheck provides noninvasive monitoring of arterial oxygen saturation (%SpO2), pulse rate, and total hemoglobin concentration (g/d) SpHb). Other information displayed by the RadCheck include: Low Signal IQ (Low SIQ), Perfusion Index (PI), Total Arterial Oxygen Content (SpOC), battery life, and sensor status.

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## Predicate Device

The predicate device used in this filing is the Masimo Rainbow SET® Rad 57t Pulse CO-Oximeter (Rad 57t) and Accessories, 510(k) Number K080238.

### Intended Use

The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial hemoglobin (SpO2), pulse rate, and total hemoglobin (SpHb). The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatic patients during both no motion and motion conditions, and for patients who are well or poorly perfused in clinical and non-clinical settings.

## Technology Comparison

The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter (Rad 57 Spotcheck) is substantially equivalent in design, principles of operation, materials, and performance to predicate device (the Rad 57t).

Similar to the Rad 57t, the RadCheck is designed, and manufactured for full compatibility with Masimo Rainbow pulse CO-Oximeter sensors with SpHb capabilities (K080238).

The RadCheck performance is equivalent to those of the Rad 57t, as following:

| FEATURES | SPECIFICATIONS |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display Ranges | Saturation (SpO2): 0% - 100%<br>Pulse Rate (bpm): 25 - 240 bpm<br>Total Hemoglobin (SpHb): 0-25 g/dl<br>Total Oxygen Concentration (SpOC): 0-35 ml/dl<br>Perfusion Index: 0.02% - 20% |
| Accuracy: SpO2 and Pulse Rate | See Footnotes 1, 2, 3, 4, and 5 |
| Accuracy – SpO2<br>During No Motion Conditions | Adults, Pediatrics: 60% - 80% ± 3%<br>Adults, Pediatrics: 70% - 100% ±2%<br>Adults, Pediatrics: 0% - 69% unspecified |
| Accuracy – SpO2<br>During Motion Conditions | Adults, Pediatrics: 70% - 100% ± 3%<br>Adults, Pediatrics: 0% - 69% unspecified |
| Accuracy – SpO2<br>Low Perfusion | Adults, Pediatrics: 70% - 100% ±2%<br>Adults, Pediatrics: 0% - 69% unspecified |
| Accuracy – Pulse Rate<br>During No Motion Conditions | Adults, Pediatrics: 25 - 240 ± 3 bpm |
| Accuracy – Pulse Rate<br>During Motion Conditions | Adults, Pediatrics: 25 - 240 ± 5 bpm |
| Accuracy – Pulse Rate<br>Low Perfusion | Adults, Pediatrics: 25 - 240 ± 3 bpm |
| FEATURES | SPECIFICATIONS |
| Accuracy: SpHb | |
| Accuracy - SpHb<br>During No Motion Conditions | Adults, Pediatrics: 8 - 17 g/dl +1 g/dl<br>SpHb accuracy has been validated on healthy adult male and<br>female volunteers and on surgical patients with light to dark skin<br>pigmentation in the range of 8 - 17 g/dl SpHb against a<br>laboratory CO-oximeter. This variation equals plus or minus<br>one standard deviation which encompasses 68% of the<br>population. The SpHb accuracy has not been validated with<br>motion or low perfusion. |
| General | |
| Resolution | SpO2: 1%<br>Pulse Rate: 1 bpm<br>SpHb: 0.1 g/dl |
| Measurements | Low Signal IQ<br>Perfusion Index (PI)<br>Total Oxygen Concentration (SpOC) |
| Interfering Substances | Elevated levels of Methemoglobin (MetHb) may lead to<br>inaccurate SpO2 measurements Elevated levels of Carboxyhemoglobin (COHb) may lead to<br>inaccurate SpO2 measurements. Severe anemia may cause erroneous SpO2 readings. Dyes, or any substance containing dyes, that change usual<br>blood pigmentation may cause erroneous readings. Elevated levels of total bilirubin may lead to inaccurate SpO2,<br>and SpHb readings |
| Electrical | See Footnote 6 |
| Batteries | Non-Rechargeable |
| Circuitry | Microprocessor controlled |
| Firmware | Rainbow SET technology, MX-1 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; -1,000 ft to<br>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 |
| FEATURES | SPECIFICATIONS |
| Display and Indicators | |
| Data Display | SpO2 (%) |
| | Pulse rate (bpm) |
| | SpHb (g/dl) |
| | Perfusion index (%) |
| | SpOC (ml/dl) |
| | Signal IQ |
| | Pulse indicator |
| | Sensor life 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 |
| Enclosed Degree of Ingress | IPX1 |
| Protection from Solids/ Liquids | |
| Mode of Operation | Spot check |

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## 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 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 weight.
- ന 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.
- 4 The Masimo SET Technology has been validated for low perfusion accuracy in 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.

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- The Masimo sensors have been validated for pulse rate accuracy for the range of 5 25-240 bpm in bench top testing against a Biotek Index 2 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
- 6 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 Summary

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

- . 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® RadCheck 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 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 0 2008

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

Re: K082052

Trade/Device Name: Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: July 16, 2008 Received: July 21, 2008

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 such 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. Thomlison

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Thlammels-Lund, mt for 11

Chiu Lin, Ph.D. 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 RadCheck Pulse CO-Oximeter and Accessories Device Name:

### Indications For Use:

The Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial hemoglobin (SpO2), pulse rate, and total hemoglobin (SpHb). The Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in clinical and non-clinical settings.

A.R. (MD)

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

510(k) Number:

| Prescription Use<br>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)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 10 of 259 Masimo RadCheck 510(k)