MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 by MASIMO CORPORATION

The Masimo SET® Rad-8 Pulse Oximeter and Accessories are 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 and Accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, for patients who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.

Device Description

The Masimo SET® Rad-8 Pulse Oximeter and Accessories (Rad 8) have 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 pulse rate .
Trauma and FastSat™ .
Three sensitivity levels Max, Normal and APOD™ .
· Adjustable alarm volume
· Adjustable averaging 2 to 16 seconds
· Trend data storage and output
· Two models: Horizontal or Vertical position

The Rad 8 in this filing is substantially equivalent to the predicate device (K053269). The reason for this filing is to revise the upper limit of the pulse rate accuracy range.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Masimo SET® Rad-8 Pulse Oximeter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Condition	Acceptance Criteria (Specification)	Reported Device Performance (Implied by adherence to specifications)
SpO2 Accuracy (No Motion)
Pediatrics, Infants, Neonates	60 - 80% ± 4%	Meets ± 4%
Adults, Pediatrics	70% - 100% ± 2%	Meets ± 2%
Neonates	70% - 100% ± 3%	Meets ± 3%
SpO2 Accuracy (Motion)
Adults, Pediatrics, Neonates	0% - 69% unspecified	Unspecified
Adults, Pediatrics, Neonates	70% - 100% ± 3%	Meets ± 3%
SpO2 Accuracy (Low Perfusion)
Adults, Pediatrics, Neonates	0% - 69% unspecified	Unspecified
Adults, Pediatrics, Neonates	70% - 100% ± 2%	Meets ± 2%
Pulse Rate Accuracy (No Motion)
Adults, Pediatrics, Neonates	25 - 300 ± 3 bpm	Meets ± 3 bpm
Pulse Rate Accuracy (Motion)
Adults, Pediatrics, Neonates	25 - 300 ± 5 bpm	Meets ± 5 bpm
Pulse Rate Accuracy (Low Perfusion)
Adults, Pediatrics, Neonates	25 - 300 ± 3 bpm	Meets ± 3 bpm

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

The exact sample sizes for all studies are not explicitly stated, however, the following can be inferred:

No Motion Accuracy (Adults): "human blood studies on healthy adult volunteers" – specific number not given.
No Motion Accuracy (Neonates, Infants, Pediatrics): "human blood studies... on neonates, infants and pediatric patients with congenital cyanotic cardiac lesions" – specific number not given.
Motion Accuracy (Adults): "human blood studies on healthy adult volunteers" – specific number not given.
Motion Accuracy (Neonates, Pediatrics): "human blood studies for adults... with added 1% to adult accuracy specifications." This implies the neonate/pediatric motion accuracy was extrapolated from adult studies with an adjustment, rather than entirely separate human studies for motion on neonates/pediatrics.
Low Perfusion Accuracy: "bench top testing against a Biotek Index 2 simulator and Masimo's simulator" – This indicates a non-human, laboratory-based test.

Data Provenance: The human blood studies were conducted on "healthy adult volunteers" and "neonates, infants and pediatric patients with congenital cyanotic cardiac lesions." The document does not specify the country of origin of this data, but the company is based in Irvine, CA, USA, and the FDA submission is to the US FDA. The studies involved "induced hypoxia," indicating prospective human studies.

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

The concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists interpreting images) is not applicable here. For SpO2 and pulse rate accuracy, the ground truth was established using:

Laboratory co-oximeter and ECG monitor: These are considered gold-standard clinical instruments for measuring blood oxygen saturation and heart rate, respectively. Their measurement methods effectively serve as the "ground truth."
Biotek Index 2 simulator and Masimo's simulator: For low perfusion testing, these simulators provided controlled, known values for saturation and signal strength.

No human experts were explicitly mentioned as interpreting data to establish ground truth for these physiological measurements.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by direct measurement from calibrated gold-standard instruments (co-oximeter, ECG monitor) or simulators, not through expert consensus or adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a pulse oximeter for direct physiological measurement, not an AI-assisted diagnostic imaging device that involves human readers interpreting results. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies described are inherently "standalone" in functionality. The device directly measures and reports SpO2 and pulse rate. The studies validated the device's ability to accurately perform these measurements against established gold standards (laboratory co-oximeter, ECG monitor, and simulators). There isn't a "human-in-the-loop" component in the fundamental accuracy evaluation; the device produces a reading that is then compared to a reference standard.

7. The Type of Ground Truth Used

SpO2 Accuracy: Ground truth was established using a laboratory co-oximeter in human blood studies during induced hypoxia.
Pulse Rate Accuracy: Ground truth was established using an ECG monitor.
Low Perfusion Accuracy: Ground truth was established using bench top testing against a Biotek Index 2 simulator and Masimo's simulator with controlled saturation and signal strengths.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. The Masimo SET® technology is described as "clinically proven" and "Masimo SET technology performance." Given the nature of a pulse oximeter, its algorithms are likely developed and refined through extensive R&D and calibration rather than a distinct "training set" as understood in modern AI/ML development. The studies mentioned are primarily for validation of the device's accuracy against established physiological measurements.

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

As no specific "training set" for an AI/ML model is described, this question is not directly applicable. The underlying "Masimo SET® Technology" itself would have been developed and refined using a combination of physiological understanding, signal processing, and iterative testing, with ground truth established through similar methods as the validation studies (e.g., co-oximetry, ECG).

Summary

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OCT 1 5 2009

Submitted by:	Masimo Corporation40 ParkerIrvine, CA 92618(949) 297-7000FAX (949) 297-7001
Company Contact:	Marguerite Thomlinson, Manager of Regulatory Affairs
Date Summary Prepared:	September 14, 2009
Trade Name	Masimo SET® Rad-8 Pulse Oximeter and Accessories, Model Rad-8
Common Name	Pulse Oximeter
Classification Name	Oximeter (74DQA) (870.2700)
Substantially Equivalent Devices	Masimo SET® Rad 8 Pulse Oximeter510(k) Number – K053269

Device Description

The Masimo SET® Rad-8 Pulse Oximeter and Accessories (Rad 8) have 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 pulse rate .
Trauma and FastSat™ .
Three sensitivity levels Max, Normal and APOD™ .
· Adjustable alarm volume
· Adjustable averaging 2 to 16 seconds
· Trend data storage and output
· Two models: Horizontal or Vertical position

The Rad 8 in this filing is substantially equivalent to the predicate device (K053269). The reason for this filing is to revise the upper limit of the pulse rate accuracy range.

Predicate Device

The predicate device used in this filing is the Masimo SET® Rad 8 Pulse Oximeter, 510(k) No. K053269.

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Indications For Use/ Intended Use

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

Technology Comparison

The Rad 8 in this filing is substantially equivalent in design, principles of operation, materials, and performance to predicate device (K053269). The only difference is the change of the upper limit of the pulse rate range from 240 to 300 beats per minute.

Similar to the predicate, the Rad 8 in this filing is designed, and manufactured for full compatibility with Masimo sensors.

Specifications

The following are the device specifications for the Rad 8:

FEATURES	SPECIFICATIONS
Display Range	Saturation (SpO2): 1% - 100%Pulse Rate (bpm): 25 - 480 bpmPerfusion Index: 0.02% - 20%
Accuracy	See footnotes 1, 2, 3, 4 and 5
SpO2, No Motion Conditions	Pediatrics, Infants, Neonates: 60 - 80% + 4%Adults, Pediatrics: 70% - 100% ± 2%Neonates: 70% - 100% ± 3%
SpO2, Motion Conditions	Adults, Pediatrics, Neonates: 0% - 69% unspecifiedAdults, Pediatrics, Neonates: 70% - 100% ± 3%
SpO2, Low Perfusion	Adults, Pediatrics, Neonates: 0% - 69% unspecifiedAdults, Pediatrics, Neonates: 70% - 100% ± 2%
Pulse Rate, No Motion Conditions	Adults, Pediatrics, Neonates: 25 - 300 ± 3 bpm
Pulse Rate, Motion Conditions	Adults, Pediatrics, Neonates: 25 - 300 ± 5 bpm
Pulse Rate, Low Perfusion	Adults, Pediatrics, Neonates: 25 - 300 ± 3 bpm
General
Resolution	SpO2: 1%Pulse Rate: 1 bpm
Measurements	Low Signal IQPerfusion Index (PI)
Interfering Substances	• Elevated levels of Methemoglobin (MetHb) may lead to inaccurate SpO2 measurements• Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO2 measurements.• Severe anemia may cause erroneous SpO2 readings.• Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings.• Elevated levels of total bilirubin may lead to inaccurate SpO2 readings
FEATURES	SPECIFICATIONS
Electrical
Power (AC)	Voltage Input Range: 100-240 Vac, 47-63 HzMax. AC Power Consumption: 20 VA
Power (battery)	One rechargeable sealed lead acid batteryOperating time: up to 7 hoursCharging time: approximately 8 hours
Circuitry	Microprocessor controlled
Firmware	Masimo SET technology, MS-2000 Series Technology Board
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 ftto 18,000 ft (-304 m to 5,486m)
Mode & Sensitivity
Averaging Mode	General: 2, 4, 6, 8, 10, 12 and 16 secondsFastSat
Sensitivity	APOD, Normal, Maximum
Alarms
Out of Limits	High and low alarms for SpO2 and Pulse Rate
Sensor Condition	No Sensor, Sensor Off
Battery	Low battery
System	System failure
Display and Indicators
Data Display	%SpO2Pulse rateAlarm statusStatus messagesSignal IQPerfusion indexFastSatTraumaBattery statusSensor status
Display Type	LED
Output Interface
Serial Output Port	RS-232 Connector
Open/Close Switch	Nurse Call
Compliance
EMC Compliance	EN 60601-1-2, Class B
Electrical Safety	IEC 60601-1,UL 60601-1
Type of Protection (AC power)	Class 1
Type of Protection (battery power)	Internally Powered
Degree of Protection-Patient Cable	Type BF Defib Proof-Applied Part
Enclosed Degree of Ingress Protectionfrom Solids/ Liquids	IPX1
Mode of Operation	Continuous

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Footnotes:

The Masimo SET 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 plus or minus one standard deviation. Plus or minus one standard deviation encompasses approximately 68% of the population.
2 The Masimo SET Technology with LNOP Blue sensors has been validated for no motion accuracy in human blood studies in the range of 60 - 100% on neonates, infants and pediatric patients with congenital cyanotic cardiac lesions.
3 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% SpO2against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses approximately 68% of the population.
4 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.
5 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 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 approximately 68% of the population.

Test Summary

The Rad 8 complies with the voluntary standards as detailed in this submission. The following quality assurance measures were applied to the development of the Rad 8:

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 SET® Rad 8 Pulse Oximeter and Accessories are substantially equivalent to the predicate device, with respect to safety, effectiveness, and performance.

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an eagle-like emblem with three wing-like shapes extending upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

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

OCT 1 5 2009

Re: K092838

Trade/Device Name: Masimo SET® Rad-8 Pulse Oximeter and Accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DPZ Dated: September 14, 2009 Received: September 15, 2009

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 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 hotification" (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/cdrh/mdr/ 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

h for

Susan Runner, D.D.S., M.A. Acting Division 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 and Accessories Device Name:

Indications For Use:

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultheis

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

510(k) Number: K092838

Masimo Special 510(k) Rad8 w/ 300 bpm, 9/14/09 Page 98 of 249

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).