MASIMO SET RAD-8 PULSE OXIMETER

K053269 · Masimo Corporation · DQA · Dec 21, 2005 · Cardiovascular

Device Facts

• Record ID: K053269
• Device Name: MASIMO SET RAD-8 PULSE OXIMETER
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Dec 21, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Masimo SET" Rad-8 pulse oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

Device Story

Handheld pulse oximeter; uses spectrophotometry and plethysmography to measure SpO2 and pulse rate. Input: red and infrared light absorption signals from finger-mounted sensor. Operation: Masimo SET technology decomposes pulsatile absorbance into arterial signal and noise components; calculates SpO2 via empirical look-up table. Output: continuous display of SpO2, pulse rate, perfusion index, and signal quality (Signal IQ). Used in hospitals, mobile, and home settings by clinicians or patients. Features adjustable alarms (Hi/Low saturation/pulse rate), averaging (2-16s), and sensitivity modes (Max, Normal, APOD). Provides trend data storage. Helps clinicians assess patient condition and determine intervention needs. Benefits: accurate monitoring during motion and low perfusion.

Clinical Evidence

Clinical studies conducted on healthy adult volunteers under induced hypoxia. Subjects tested during no-motion and motion (rubbing/tapping) conditions, and low-perfusion states. Primary endpoints: SpO2 and pulse rate accuracy compared to CO-Oximeter and ECG. Results: SpO2 accuracy ±2-3 digits; pulse rate accuracy ±3-5 digits. Bench testing confirmed performance across specified ranges.

Technological Characteristics

Handheld pulse oximeter; microprocessor-controlled. Sensing: spectrophotometry/plethysmography. Connectivity: trend data output. Power: 90-240 VAC or rechargeable battery (6-hour life). Dimensions: 8.2" x 6.0" x 3.0". Weight: 32oz. Software: proprietary Masimo SET algorithm for signal processing and SpO2 calculation. Sterilization: N/A (device is monitor; sensors are separate).

Indications for Use

Indicated for continuous noninvasive monitoring of functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate in adult, pediatric, and neonatal patients. Suitable for use during motion and no-motion conditions, and for patients who are well or poorly perfused in hospital, mobile, and home environments.

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 SET Radical Pulse Oximeter with SatShare and the LNOP series of Sensors and Cables (K031330)
• Masimo SET Rad-5 Pulse Oximeter (K033296)

Submission Summary (Full Text)

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K053269

# DEC 2 1 2005

| Submitted by: | Masimo Corporation<br>40 Parker<br>Irvine, CA 92618<br>[phone]<br>FAX [phone] |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance |
| Date Summary Prepared: | November 18, 2005 |
| Trade Name | Masimo SET Rad-8 Pulse Oximeter, Model Rad-8, Kestrel |
| Common Name | Pulse Oximeter |
| Classification Name | Oximeter (74DQA) (870.2700) |
| Substantially Equivalent Devices | Masimo SET Radical Pulse Oximeter with SatShare and the LNOP" series<br>of Sensors and Cables<br>510(k) Number - K031330<br><br>Masimo SET Rad-5 Pulse Oximeter<br>510(k) Number - K033296 |

## Device Description

The Masimo SET" Rad-8 Pulse Oximeter has the following features and benefits:

- · Clinically proven Masimo SET technology performance
- Applicable for use on neonate, pediatric and adult patients .
- Proven for accurate monitoring in motion and low perfusion environments .
- Sp()2, pulse rate, alarm, and perfusion index displays .
- · Signal IQ™ for signal identification and quality indication
- Lightweight, convenient handheld design
- · · Audible alarm for sensor-off and low battery
- · Alarms for Hi/Low saturation and Hi/Low pulse rate
- · Trauma and FastSat™
- Three sensitivity levels Max, Normal and APODIN .
- Adjustable alarm volume
- Adjustable averaging 2 to 16 seconds
- Trend data storage and output .
- · Two models: Horizontal or Vertical position

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## Intended use

The Masimo SET" Rad-8 pulse oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

## Indications For Use:

The Masimo SET® Rad-8 pulse oximeter is indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Rad 8 pulse oximeter is indicated for use with adult, pediatric, and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

## Principles of Operation:

The principles of operation of the Masimo SET® Rad-8 pulse oximeter are that oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (spectrophotometry), the volume of arterial blood in tissue (and hence, light absorption by that blood) changes during the pulse (plethysmography), and that arterious shunting is highly variable and that thuctuating absorbance by venous blood is a major component of noised wing the pulse. Because oxyhemoglobin and deoxyhemoglobin differ in light absorption, the amount of red and infrared light absorbed by the blood is related to hemoglobin oxygen saturation. The Masimo SFT® Rad-8 pulse oximeter decomposes the red and infrared pulsatile absorbance signal into an arterial signal plus a noise component and calculates the ratio of the arterial signals without noise. The two arterial pulse-added absorbance signals and its value is used to find the SpO3 saturation in an empirically derived equation in the Masimo SET® Rad-8 software. The values in the look-up table are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states during motion and non-motion conditions.

## Method of Operation

The Masimo SET "Rad-8 pulse oximeter is turnetty sensor is attached to a patient's finger and one end of a patient cable is connected to the sensor and the other end connected to the Rad-8 pulse oximeter.

The monitor will begin continuously displaying the patient's pulse rate, and SpO2 value, The practitioner can adjust the high and low alarm limits to their desired value, if required. The practitioner can the information that is continuously displayed on the monitor, and hear if an alarm limit is reached, 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 oximetry sensor is removed (and disposed of if it is a single use device), and the power to the monitor is turned off.

## Power Source

The Masimo SET - Rad-8 pulse oximeter is powered either with a voltage input of 90-240 VAC, 47 - 63 Hz. The detachable portable monitor operates on a rechargeable battery with and operating time of 6 hours".

## Specifications and Operating Ranges

Range

Saturation (% SpO)s) Pulse Rate (bpm) Perfusion

19 - 100% 25 240 0.02" « - 20" 6

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| Accuracy | | |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| | Saturation (% SpO2) - During No Motion Conditions¹ | |
| | Adults, Pediatrics | 70% - 100% ± 2 digits<br>0% - 69% unspecified |
| | Neonates | 70% - 100% ± 3 digits<br>0% - 69% unspecified |
| | Saturation (% SpO2) - During Motion Conditions2,3 | |
| | Adults, Pediatrics2 | 70% - 100% ± 3 digits<br>0% - 69% unspecified |
| | Neonates3 | 70% - 100% ± 3 digits<br>0% - 69% unspecified |
| | Pulse Rate (bpm) - During No Motion Conditions¹ | |
| | Adults, Pediatric, Neonates | 25 to 240 ± 3 digits |
| | Pulse Rate (bpm) - During Motion Conditions2,3 | |
| | Adults, Pediatric, Neonates | 25 to 240 ± 5 digits |
| Resolution | | |
| | Saturation (% SpO2) | 1% |
| | Pulse Rate (bpm) | 1 |
| | | |
| | Low Perfusion Performance³ | |
| | > 0.02% Pulse Amplitude<br>and % Transmission > 5% | Saturation (% SpO2) ± 2 digits<br>Pulse Rate ± 3 digits |
| | Interfering Substances | |
| | Carboxyhemoglobin may erroneously increase readings. The level of increase is approximately<br>equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that<br>change usual arterial pigmentation may cause erroneous readings. | |
| Power | | |
| | Voltage Input Range | 90-240 Vac. 47-63 Hz |
| | Maximum AC Power Consumption: | 15 VA |
| Fuses | 0.75 A, Time Delay, 250V | |
| Isolation | | |
| | Chassis Leakage Current | Less than 100 μAmp |
| | Ground resistance | Less than 1.0 Ω |
| 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 | 500 mbar to 1,060 mbar pressure<br>-1,000 ft to 18,000 ft (-304 m to 5.486m) |
| Circuitry | | |
| | Microprocessor controlled<br>Automatic self-test of oximeter when powered on | |

Automatic setting of default parameters Automatic alarm messages

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Trend data output of SpO2, pulse rate

Display

Type Data Displayed LED, 7-segment Pulse rate, SpO2 %, alarm status, alarm silenced status, Perfusion Index Bar, Signal IQ Bar, battery status, APOD, Normal, FastSat, Trauma

Audio Indicators

Adjustable volume audible pulse: OFF and 33% to 100% in 3 steps Adjustable volume audible alarm tone: levels and 33% to 100% in 3 steps Alarm silence (120 seconds); all mute (continuous silence) Pulse rate out-of-limits alarm Sp()> level out-of limits alarm Sensor condition alarms System failure and battery low alarms

Physical Characteristics Dimension Weight

8.2" x 6.0" x 3.0" (20.8 cm x 15.2 cm x 7.6 cm) 32oz. (0.908 kg)

Modes

ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

Averaging mode: Sensitivity

2, 4, 6, 8, 10, 12, and 16 seconds Normal, APOD, and Max

The Masimo SFT Technology with LNOP+Adt sensors has been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals plas or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.

The Masimo SET Technology with LNOP-Adt sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers 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 cooximeter 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 SET Technology with LNOP-Neo and Neo Pt sensors for neonatal motion accuracy is based : on human blood studies for adults (see Notes 1 and 2 above), with added 1% to adult accuracy specifications.
- The Masimo SFT Technology has been validated for low perfusion accuracy in bench top testing against a . ﺍ Biotek Index 2 simulator and Masimo`s simulator with signal strengths of greater than 0.02% and a % transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
- This represents approximately run time at lowest indicator brightness and pulse tone turned off. using new, fully charged battery.

## Environmental Testing

Applicable environmental testing per the Reviewers Guidance for Premarket Submissions - November 1993. i.e. electrical, mechanical and environmental were performed and all tests passed.

## Nonclinical tests performed that support a determination of substantial equivalence.

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The Masino SET* Rad-8 Pulse Oximeter was subjected to bench testing using a simulator that determined the ITIC Mashilo SET "Rad-6 False CAmeler was subjective to conner the range of saturation and pulse rates that both devices specify.

The results of the bench testing showed that the Masimo SET® Rad-8 Puise Oximeter returned the same saturation The results of the belief teather survey within ± 3 digits when compared to the simulators ascd.

# Clinical tests performed that support a determination of substantial equivalence.

Clinical studies were performed using the Masimo SFT™ technology on healthy adult volunteer subjects during no e minu and motion conditions who were subjected to a progressive induced hypoxia and measuring the arterial hemoglobin saturation value with the instruments against the arterial homoglobin oxygen determined from arterial blood samples with a CO-Oximeter.

Clinical studies were performed using the Masino SET® technology on healthy adult volunteer subjects who were e thirected to low perfusion conditions and to a progressive induced hypoxia and measuring the arterial hemoglobin satureded to low perfusion vononents and the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.

Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21CFR), Part 812 - Investigational Device Excmptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards.

The results from the clinical studies show that the Masimo SET® technology saturation accuracy values for adults and pediatics within and peblacter and the pulse rate accuracy values within 2. 3 digits during no motion conditions and ± 5 digits during motion conditions when compared to the F.CG.

## Conclusions

The results of the environmetal testing demonstrated that the Masimo SET® Rad-8 Pulse Oximeter met the requirements of Reviewers Guidance for Premarket Submissions - November 1993.

The results of the bench testing demonstrates that the Masimo SET® Rad-8 Pulse Oximeter met its performance requirements.

The results of the clinical testing demonstrates that the Masimo SET® technology meets its performance requirements during no motion and motion conditions and low perfusion conditions.

The non-clinical and clinical testing performed demonstrates that the Masino SET® Rad-S Pulse Oximeter is safe, r ffe nize and performs as well as the predicate device, Masimo SET* Radical Pulse Oximeter with SatShare™ and the LNOP" series of Sensors and Cables and Masimo SET* Rad-5 Pulse Oximeter.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2005

Mr. Jim Cronin Vice President, Regulatory Affairs/Quality Assurance Masimo Corporation 40 Parker Irvine, California 92618

Re: K053269

Trade/Device Name: Masimo SET® Rad-8 Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: November 22, 2005 Received: November 23, 2005

Dear Mr. Cronin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to rowed your ed your entermined the device is substantially equivalent (for the It it creed doove and have attermillosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to act reservatio Act (Act) that do not require approval of a premarket the Federal Food, Drag, aAa Coou may, therefore, market the device, subject to the general approvin uppheaten (1 the Act. The general controls provisions of the Act include confors providens of the ristration, 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 (I WF), it may of such in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be round ther announcements concerning your device in the Eederal Register.

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## Page 2 - Mr. Cronin

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 mean that I Dri nab made statutes and regulations administered by other Federal agencies. of the Act of ally I outhal but serequirements, including, but not limited to: registration T out must comply with and are rabeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 077), accling systems (QS) regulation (21 CFR Part 820); and if requirences as bet form 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) I rins feter notification. The FDA finding of substantial equivalence of your device to a promative them of the 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), n you desire specific at Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other generational 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,

Snute Y. Mehuin Omd.

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

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# Indications for Use

510(k) Number (if known):

Masimo SET® Rad-8 Pulse Oximeter Device Name:

#### Indications For Use:

The Masimo SET® Rad-8 Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional 11/2 Mastino SET - Race of this Oximoter is matable rate (measured by an SpO2 sensor). The Masimo SET® oxygell saturation of arcelar nemogroom (op 2) and patients during both no motion and Kau-o Fulst Oxinceler is marcased for ass well or poorly perfused, in hospital-type facilities, mobile, and home environments.

Prescription Use _ (Per 21 CFR 801.109 Subpart D) AND/OR

Over-The-Counter Use (Per 21 CFR 801.109 Subpart C)

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

Am Sulon

K053269

Concurrence of CDRH, Office of Device Evaluation (ODE)