MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V by MASIMO CORP.

The Masimo SET® RAD-5 Pulse Oximeter is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, and mobile environments.

The Rad-5 Handheld Pulse Oximeter is indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (Sp() ) and pulse rate (measured by an SpO2 sensor). The Rad-5 Handheld Pulse Oximeter is indicated for use with adult, pediatric and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and mobile environments.

The Masimo SET® Rad 5 Pulse Oximeter is indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Rad 5 Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and ition conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

Device Description

The Masimo SET® Rad-5 Pulse Oximeter is a handheld pulse oximeter that measures functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It utilizes spectrophotometry and plethysmography principles. The device displays SpO2, pulse rate, alarm status, alarm silenced status, Perfusion Index Bar, Signal IQ Bar, Battery Status, APOD, and FastSat. It has adjustable alarm volume and averaging settings. It is powered by 4 AA batteries.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the Masimo SET® Rad-5 Pulse Oximeter, based on the provided text:

Acceptance Criteria and Device Performance

Parameter	Acceptance Criteria (Study Endpoint)	Reported Device Performance
Saturation (% SpO2) - No Motion
Adults, Pediatrics	70% - 100% ± 2 digits	Met: within ± 2 digits (70%-100% range)
Neonates	70% - 100% ± 3 digits	Met: within ± 3 digits (70%-100% range, based on 83%-100% neonatal data combined with adult studies)
Saturation (% SpO2) - Motion
Adults, Pediatrics	70% - 100% ± 3 digits	Met: within ± 3 digits (70%-100% range)
Neonates	70% - 100% ± 3 digits	Met: within ± 3 digits (70%-100% range, based on neonatal data combined with adult studies)
Pulse Rate (bpm) - No Motion
Adults, Pediatric, Neonates	25-240 bpm ± 3 digits	Met: within ± 3 digits (25-240 bpm range)
Pulse Rate (bpm) - Motion
Adults, Pediatric, Neonates	25-240 bpm ± 5 digits	Met: within ± 5 digits (25-240 bpm range)
Low Perfusion Performance	SpO2: ± 2 digits; Pulse Rate: ± 3 digits (for > 0.02% Pulse Amp & > 5% Transmission)	Met: (implied by statement that technology was "validated for low perfusion accuracy")
Environmental Testing	Per Reviewers Guidance for Premarket Submissions - November 1993	Met: All tests passed (electrical, mechanical, environmental)

Study Details

Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not explicitly stated as a number of subjects. The studies were conducted on:
  - Healthy adult volunteers (for no motion, motion, and low perfusion conditions).
  - Neonates (for no motion, motion, and low perfusion conditions).
- Data Provenance: The studies were described as "human blood studies" and were clinical tests. The location is not specified, but given the company is based in Irvine, CA, and the FDA approval process, they were likely conducted in the US. The studies are prospective, involving "induced hypoxia states."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The ground truth was established by a laboratory co-oximeter and an ECG monitor, not human experts for interpretation.
- Qualifications of Experts: N/A.
Adjudication method for the test set:
- Not applicable. The ground truth in this case is objective physiological measurements from a laboratory co-oximeter and an ECG monitor, not subjective interpretations requiring adjudication.
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:
- No, an MRMC study was not done. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that relies on human readers' interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance study. The device's accuracy was directly compared against a physiological ground truth (co-oximeter and ECG) under various conditions. The device's algorithm performs the measurements and calculations independently to determine SpO2 and pulse rate.
The type of ground truth used:
- Clinical Ground Truth:
  - Co-Oximetry (Laboratory Co-Oximeter): Used to determine arterial hemoglobin oxygen saturation (SaO2) through arterial blood samples. This is considered the gold standard for oxygen saturation measurement.
  - Electrocardiogram (ECG Monitor): Used to determine true pulse rate.
The sample size for the training set:
- The document implies that the "values in the look-up table are based upon human blood studies against a laboratory co-oximeters in induced hypoxia states during motion and non-motion conditions." This suggests that a dataset of human blood studies was used to develop and refine the algorithm's look-up table. However, the specific sample size of this training set is not explicitly stated.
How the ground truth for the training set was established:
- As indicated in the "Principles of Operation" section, the "values in the look-up table" (which essentially represent the training data for the internal algorithm's calibration) were based on:
  - Human blood studies: Healthy adult volunteers were subjected to induced hypoxia states.
  - Comparison against a laboratory co-oximeter: Arterial blood samples were analyzed by a co-oximeter to provide the true oxygen saturation (SaO2) values.
  - This process was performed under both motion and non-motion conditions to build a robust look-up table for the device's internal calculations.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the text string "K033296" in a handwritten style. The text is oriented diagonally, running from the lower-left to the upper-right corner of the image. The characters appear to be written with a thick marker or pen, giving them a bold appearance.

FEB 1 9 2004

Submitted by:	Masimo Corporation
	2852 Kelvin Ave
	Irvine, CA 92614-5826
	(714) 250-9688
	FAX (714) 250-9686
Company Contact:	James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance
Date Summary Prepared:	December 5, 2003
Trade Name	Masimo SET® Rad-5 Pulse Oximeter
Common Name	Pulse Oximeter
Classification Name	Oximeter (74DQA) (870.2700)
Substantially Equivalent Devices	Masimo SET Radical Pulse Oximeter with SatShare™ and LNOP series of Sensors and
	Cables510(k) Number - K031330
Features and Benefits
	Clinically proven Masimo SET TM technology performance
	Applicable for use on neonate, pediatric and adult patients
	Proven for accurate monitoring in motion and low perfusion environments
	SpO 2 , pulse rate, alarm, and perfusion index displays
	Signal IQ TM for signal identification and quality indication
	Lightweight, convenient handheld design
	Long battery life: over 36 hours on 4 "AA" alkaline batteries
	Audible Alarm for sensor-off and low battery
	Alarms for Hi/Low saturation and Hi/Low pulse rate
	FastSat TM
	Three sensitivity levels - Max, Normal and APOD TM
	Adjustable alarm volume

Adjustable averaging 2 to 16 seconds

Intended use

{1}------------------------------------------------

Indications for use

Principles of Operation

The principles of operation of the Masimo SET® Rad-Spulse oximeter are that oxyhemoglobin differ in their absorption of red and infrared light (spectrophotomery), the volume of arterial blood in tissue (and hence, light absorption by that blood) changes during the pulse (plethysmography), and that arterio-venous shunting is highly variable and that fluctuating absorbance by venous blood is a major component of noise. Because oxyhemoglobin and deoxyhemoglobin differ in light absorption, the amount of red and infrared light absorbed to hemoglobin oxygen saturation. The Masimo SET® Rad-Spulse 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 ratio of the two arterial pulse-added absorbance signals and its value is used to find the SpO2 saturation into the Masimo SET Rad-5 software. The values in the look-up table are based upon human blood studies against a laboratory co-oximeters in induced hypoxia states during motion and non-motion conditions.

Method of Operation

The Masimo SET® Rad-5 pulse oximeter is turned on. An oximetery 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-5 pulse oximeter.

The monitor will begin continuously displaying the patient's pulse . The practitioner can adjust the high and low alarm limits to their desired value, if required. The practitioner can then use 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 discomected from 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 5 pulse oximeter is powered by 4 AA batteries with an operating time of 36 hours'.

Specifications and Operating Ranges

Range
Saturation (% SpO2)	1% - 100%
Pulse Rate (bpm)	25 - 240
Perfusion	0.02% - 20%
Accuracy
Saturation (% SpO2) - During No Motion Conditions1
Adults, Pediatrics	70% - 100% ± 2 digit
	0% - 69% unspecified
Neonates	70% - 100% ± 3 digit
	0% - 69% unspecified
Saturation (% SpO2) - During Motion Conditions2,3
Adults, Pediatrics2	70% - 100% ± 3 digit
	0% - 69% unspecified
Neonates3	70% - 100% ± 3 digit

{2}------------------------------------------------

0% - 69% unspecified

Pulse Rate (bpm) - During No Motion Conditions1
Adults, Pediatric, Neonates	25 to 240 ± 3 digits

Pulse Rate (bpm) - During Motion Conditions233 25 to 240 ± 5 digits Adults, Pediatric, Neonates

Resolution

Saturation (% SpO2)	1%
Pulse Rate (bpm)	1

Low Perfusion Performance4

0.02% Pulse Amplitude and % Transmission > 5%

Saturation (% SpO2) ± 2 digits Pulse Rate ± 3 digits

Interfering Substances

Carboxyhemoglobin may erroneously increase readings. The level of increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual arterial pigmentation may cause erroneous readings.

Power

Internally powered by 4 "AA" Alkaline batteries

Isolation

No external power or ground connection, internally powered only

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 1060 mbar pressure-1,000 ft to 18,000 ft (-304 m to 5,486 m)

Circuitry

Microprocessor controlled Automatic self-test of oximeter when powered on Automatic setting of parameters Automatic alarm messages

Display

Type	LED, 7-segment
Data Displayed	Pulse Rate, SpO2 %, Alarm status, alarm silenced status, PerfusionIndex Bar, Signal IO Bar, Battery Status, APOD. FastSat.

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 SpO2 level out-of limits alarm Sensor condition alarms System failure and battery low alarms

{3}------------------------------------------------

Physical characteristics
Dimensions:	6.2" x 3.0" x 1.4" (15.8 cm x 7.6cm x 3.6 cm)
Weight:	13oz. (0.32 kg)

Modes

Averaging mode: Sensitivity

2, 4, 8, 10, 12, and 16 seconds Normal, APOD, and MAX

1 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 cooximeter and ECG monitor. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
2 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 co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
3 The Masimo SET Technology with LNOP Neo and Neo Pt sensors has been validated for neonatal motion accuracy in human blood studies on neonates while moving the neonate's foot at 2 to 4 Hz at an amplitude of 1 to 2 cm 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 a % 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.
રે This represents approximate run time at lowest indicator brightness, using a new, fully charged battery.

Environmental Testing

Applicable environmetal 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.

The Masimo SET® Rad-5 Pulse Oximeters was subjected to bench testing using a simulator that determined the performance accuracy of the instruments against the simulator under the range of saturation and pulse rates that both devices specify.

The results of the bench testing showed that the Masimo SET® Rad-5 Pulse Oximeters returned the same saturation accuracy values within ± 2 digits and pulse rate values within ± 3 digits when compared to the simulators used.

Clinical tests performed that support a determination of substantial equivalence.

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

Clinical studies were performed using the technology on neonates during no motion and motion conditions and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.

Clinical studies were performed using the technology on healthy adult volunteer subjects who were subjected to low perfusion conditions and to a progressive induced hypoxia and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.

{4}------------------------------------------------

Clinical studies were performed using the Masimo SET technology on neonates with low perfusion and measuring the arterial hemoglobin saturation value with the instruments against 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 Exemptions, 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 pediatrics within ± 2 digils during no motions and ± 3 digits during motion conditions when compared to the CO-Oximeter and the pulse rate accuracy values within ± 3 digits during no motion conditions and ± 5 digits during motion compared to the ECG.

The specified saturation accuracy from 70% - 100% for neonates is based on the results from clinical studies with saturations down to 83% combined with clinical studies on adults to show that the Masimo SET® technology to be within ± 3 digits during both motion and no motion conditions when compared to the CO-Oximeter, and the pulse rate accuracy values for neonates to be within ± 3 digits during no motion and ± 5 digits during motion conditions when compared to the ECG.

Conclusions

The results of the environmetal testing demonstrated that the Masmo SET® Rad-5Pulse Oximeter of Reviewers Guidance for Premarket Submissions - November 1993.

The results of the bench testing demonstrates that the Masimo SET® Rad-5 Pulse Oximeters 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 Masimo SET® Rad-5 Pulse Oximeters is safe, effective.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 image of an eagle or bird-like figure with three stylized lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2004

Mr. James J. Cronin Vice President, Regulatory Affairs/Quality Assurance Masimo Corporation 2852 Kelvin Avenue Irvine, California 92614-5826

Re: K033296

Trade/Device Name: Masimo SET RAD-5 Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: January 23, 2004 Received: January 26, 2004

Dear Mr. Cronin:

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.

{6}------------------------------------------------

Page 2 – Mr. James J. 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 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 Office of Compliance at (301) 594-4646. 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 Division of Small Manufacturers, International 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/dsma/dsmamain.html.

Sincerely yours,

Chris

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

{7}------------------------------------------------

Indications for Use

510(k) Number (if known): K033296

Masimo SET Rad 5 Pulse Oximeter Device Name:

Indications For Use:

The Masimo SET® Rads Pulse Oximeter is indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Rad 5 Pulse Oximeter is indicated for use with adult, pediatric, and neonatal patients during both no motion and ition conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

Prescription Use _ X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (Per 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anesthesiology, General Hospital, Intection Control. Der

510(k) Number:

1080

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).