The Masimo SET® Rad-8 Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) 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.

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 .
SpO2, 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

AI/ML Overview

The Masimo SET Rad-8 Pulse Oximeter is designed for continuous non-invasive monitoring of arterial hemoglobin oxygen saturation (SpO2) and pulse rate in adult, pediatric, and neonatal patients, across various environments including hospitals and homes. The device measures SpO2 and pulse rate, and includes features such as alarm functions, signal quality indication, and adjustable sensitivity levels.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Set by Masimo SET Technology)	Reported Device Performance (Masimo SET Rad-8 Pulse Oximeter)
Saturation (% SpO2) - No Motion	Healthy adult volunteers, induced hypoxia studies, 70-100% SpO2 range, validated against laboratory co-oximeter and ECG monitor. Variation equals ± 1 standard deviation (encompasses 68% of the population).	Adults, Pediatrics: 70% - 100% ± 2 digits, 0% - 69% unspecified. Neonates: 70% - 100% ± 3 digits, 0% - 69% unspecified. Clinical studies show accuracy for adults and pediatrics "within and peblacter" (likely a typo, intended to mean a specific range or agreement) during no motion conditions when compared to ECG.
Saturation (% SpO2) - Motion	Healthy adult volunteers, induced hypoxia studies, 70-100% SpO2 range, validated against laboratory co-oximeter and ECG monitor, while performing rubbing and tapping motions (2-4 Hz, 1-2 cm amplitude) and non-repetitive motion (1-5 Hz, 2-3 cm amplitude). Variation equals ± 1 standard deviation (encompasses 68% of the population). For neonates, an additional 1% is added to adult accuracy specifications.	Adults, Pediatrics: 70% - 100% ± 3 digits, 0% - 69% unspecified. Neonates: 70% - 100% ± 3 digits, 0% - 69% unspecified. Clinical studies show saturation accuracy values for adults and pediatrics during motion conditions (with pulse rate accuracy of ± 5 digits) when compared to ECG. (The exact saturation range for motion conditions is not explicitly stated in the performance section but is implied by the clinical study description).
Pulse Rate (bpm) - No Motion	(Implicitly from the SpO2 no motion study, as it's measured by the SpO2 sensor)	Adults, Pediatric, Neonates: 25 to 240 ± 3 digits. Clinical studies show pulse rate accuracy values within ± 3 digits during no motion conditions when compared to ECG.
Pulse Rate (bpm) - Motion	(Implicitly from the SpO2 motion study, as it's measured by the SpO2 sensor)	Adults, Pediatric, Neonates: 25 to 240 ± 5 digits. Clinical studies show pulse rate accuracy values within ± 5 digits during motion conditions when compared to ECG.
Low Perfusion Performance (SpO2 & PR)	Bench top testing against Biotek Index 2 simulator and Masimo's simulator, with signal strengths > 0.02% pulse amplitude and > 5% transmission, for saturations 70-100%. Variation equals ± 1 standard deviation (encompasses 68% of the population).	Saturation (% SpO2): ± 2 digits. Pulse Rate: ± 3 digits. Clinical studies demonstrate that the Masimo SET® technology meets its performance requirements for low perfusion conditions.
Bench Testing (Simulator Comparison)	(Implicitly, to demonstrate equivalence with devices that cover the same range of saturation and pulse rates)	Comparison to simulators showed results within ± 3 digits of the simulator's readings. The device was subjected to bench testing using a simulator that covered the range of saturation and pulse rates specified by both the device and predicate devices. The results showed that the Masimo SET® Rad-8 Pulse Oximeter returned the same saturation and pulse rate values within ± 3 digits when compared to the simulators used.

2. Sample Size Used for the Test Set and Data Provenance

The exact sample sizes for the clinical studies are not explicitly provided in the document.

The data provenance for the clinical studies is described as:

Country of Origin: Not explicitly stated, but the studies mention "human blood studies on healthy adult volunteers" and compliance with US regulations (21CFR), suggesting the studies were conducted in the United States.
Retrospective or Prospective: The clinical studies were conducted as "progressive induced hypoxia" and "low perfusion conditions" on healthy adult volunteers, indicating these were prospective studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts or their qualifications for establishing ground truth. However, the ground truth was based on measurements from a laboratory co-oximeter and an ECG monitor. These are established medical devices used for precise physiological measurements, implying expert operation and calibration, but not expert human interpretation for ground truth generation.

4. Adjudication Method for the Test Set

Not applicable, as the ground truth was established by objective measurements from a co-oximeter and ECG monitor, not by expert human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document describes studies comparing the device's performance against objective physiological measurements (co-oximeter, ECG, simulators) and a predicate device, but not a MRMC study evaluating human reader improvement with or without AI assistance. This device is a pulse oximeter, which provides direct physiological measurements, not an imaging or diagnostic AI system that assists human readers.

6. Standalone Performance

Yes, a standalone performance study was done. The entire set of clinical and bench tests evaluates the device's performance independently in various conditions (no motion, motion, low perfusion) against established ground truth methods (laboratory co-oximeter, ECG monitor, simulators). The reported accuracy specifications (e.g., ± 2 digits for SpO2 in no motion) represent the standalone performance of the algorithm/device.

7. Type of Ground Truth Used

The ground truth used for the clinical studies was primarily:

Laboratory Co-Oximeter: For arterial hemoglobin oxygen saturation (SpO2) measurements from arterial blood samples in induced hypoxia studies.
ECG Monitor: For pulse rate measurements and potentially as a reference for cardiac activity during the hypoxia studies.
Biotek Index 2 simulator and Masimo's simulator: For low perfusion accuracy and bench testing against specified ranges.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for a separate "training set." The values in the look-up table within the device's software 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." This implies that data from such studies was used to develop and "train" the algorithm, but a specific "training set sample size" as commonly defined for AI/ML validation is not provided. It's more likely that these refer to the pre-market development and calibration data.

9. How the Ground Truth for the Training Set Was Established

The ground truth for the underlying algorithm (which resulted in the device's "look-up table") was established through:

Human blood studies: On healthy adult volunteers.
Induced hypoxia states: To achieve a range of oxygen saturation levels.
Laboratory co-oximeter: Used to obtain the reference arterial hemoglobin oxygen saturation values from arterial blood samples.
Motion and non-motion conditions: To account for different physiological scenarios.

This process involves direct, highly precise measurements of arterial blood oxygenation under controlled conditions to create the empirical data points used to calibrate the device's SpO2 calculation algorithm.

Summary

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K053269

DEC 2 1 2005

Submitted by:	Masimo Corporation40 ParkerIrvine, CA 92618(949) 297-7000FAX (949) 297-7001
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" seriesof Sensors and Cables510(k) Number - K031330Masimo SET Rad-5 Pulse Oximeter510(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 digits0% - 69% unspecified
	Neonates	70% - 100% ± 3 digits0% - 69% unspecified
	Saturation (% SpO2) - During Motion Conditions2,3
	Adults, Pediatrics2	70% - 100% ± 3 digits0% - 69% unspecified
	Neonates3	70% - 100% ± 3 digits0% - 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 Amplitudeand % Transmission > 5%	Saturation (% SpO2) ± 2 digitsPulse Rate ± 3 digits
	Interfering Substances
	Carboxyhemoglobin may erroneously increase readings. The level of increase is approximatelyequal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, thatchange 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-1,000 ft to 18,000 ft (-304 m to 5.486m)
Circuitry
	Microprocessor controlledAutomatic 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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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)

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).