MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES by MASIMO CORP.

The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories 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.

The Masimo SET® Radical Pulse Oximeter with SatShare™ 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® Radical Pulse Oximeter with SatShare™ 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. In addition the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is indicated to provide the continuous nonitoring data obtained from the Masimo SET® Radical Pulse Oximeter with SatShare™ of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) to multiparameter devices for display on those devices.

Device Description

The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is a device consisting of the Masimo SET technology, connecting cable, and oximetry sensors to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It features an easy-to-read display that presents patient data and status information: a LCD (liquid crystal display) display that shows the SpO2, pulse rate values, and a plethysmographic waveform, the current high and low SpO2 and pulse rate limit setting, and messages as appropriate.

AI/ML Overview

The Masimo SET® Radical Pulse Oximeter with SatShare™ is a pulse oximeter intended for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in adult, pediatric, and neonatal patients across various healthcare settings.

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (from Specifications)	Reported Device Performance (from Clinical Studies)
Saturation (% SpO2) - No Motion Conditions (70%-100%)	Adults, Pediatrics: ± 2 digitsNeonates: ± 3 digits	The clinical studies show: - Adults and Pediatrics: within ± 2 digits - Neonates: within ± 3 digits
Saturation (% SpO2) - Motion Conditions (70%-100%)	Adults, Pediatrics: ± 3 digitsNeonates: ± 3 digits	The clinical studies show: - Adults and Pediatrics: within ± 3 digits- Neonates: within ± 3 digits
Pulse Rate (bpm) - No Motion Conditions (25-240)	Adults, Pediatric, Neonates: ± 3 digits	The clinical studies show: - Adults, Pediatric, Neonates: within ± 3 digits
Pulse Rate (bpm) - Motion Conditions (25-240)	Adults, Pediatric, Neonates: ± 5 digits	The clinical studies show: - Adults, Pediatric, Neonates: within ± 5 digits
Low Perfusion Performance (SpO2)	± 2 digits (> 0.02% Pulse Amplitude, % Transmission > 5%)	The clinical studies on healthy adult volunteers show performance within ± 2 digits. (Note: Neonate low perfusion clinical studies were also performed, and the results claim the device meets performance).
Low Perfusion Performance (Pulse Rate)	± 3 digits (> 0.02% Pulse Amplitude, % Transmission > 5%)	The clinical studies on healthy adult volunteers show performance within ± 3 digits. (Note: Neonate low perfusion clinical studies were also performed, and the results claim the device meets performance).

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

The document mentions "human blood studies on healthy adult volunteers" and "clinical studies...on neonates." However, specific sample sizes (number of subjects/cases) for the test sets are not explicitly stated in the provided text for any of the clinical or bench tests.

Data Provenance:

Clinical Studies: Healthy adult volunteers and neonates.
Country of Origin: Not explicitly stated, but the studies followed US FDA regulations (21 CFR Part 812, Part 50, Part 56), implying they were conducted in the US or under US regulatory oversight.
Retrospective or Prospective: The wording "clinical studies were performed" and "subjects during no motion and motions who were subjected to a progressive induced hypoxia" indicates these were prospective studies.

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

This information is not provided in the document. The ground truth for SpO2 was established by a laboratory co-oximeter and for pulse rate by an ECG monitor, not by expert consensus.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. The ground truth was established by objective medical devices (co-oximeter and ECG monitor), not through expert adjudication.

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

No, a multi-reader multi-case comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is a standalone pulse oximeter, not an AI-assisted diagnostic imaging tool that would typically involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, the overall study, particularly the clinical trials, can be considered a standalone performance evaluation. The device (algorithm + hardware) directly measures SpO2 and pulse rate, and its performance is compared directly against reference devices (co-oximeter and ECG), not with human interpretation as an intermediate step. The document explicitly states the "Masimo SET® Radical Pulse Oximeter with SatShare™...returned the same saturation accuracy values...and pulse rate values" when compared to simulators in bench testing and against co-oximeters/ECG in clinical studies.

7. The Type of Ground Truth Used:

The ground truth for the clinical studies was established using objective medical reference devices:

For oxygen saturation (SpO2): Laboratory CO-Oximeter analysis of arterial blood samples.
For pulse rate: ECG Monitor.

8. The Sample Size for the Training Set:

The document mentions that 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 nonmotion conditions." This refers to the development/calibration of the device's a-priori look-up tables. However, like the test set, the specific sample size for this internal "training" or calibration set is not explicitly stated in the provided text.

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

The ground truth for the training/calibration set (which informed the device's look-up tables) was established by:

Human blood studies on healthy adult volunteers.
Induced hypoxia states (to achieve various saturation levels).
Measurement of arterial hemoglobin oxygen using a laboratory co-oximeter.
These studies were conducted during both motion and non-motion conditions.

Summary

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K013792

0042

DEC 1 1 2001

Submitted by:	Masimo Corporation2852 Kelvin AveIrvine, CA 92614-5826(714) 250-9688FAX (714) 250-9686
Company Contact:	James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance
Date Summary Prepared:	November 13, 2001
Trade Name	Masimo SET ® Radical Pulse Oximeter with SatShare ™ and accessories
Common Name	Pulse Oximeter and Sensor
Classification Name	Oximeter (74DQA) (870.2700)Cable, Transducer and Electrode (74DSA) (870.2900)
Substantially Equivalent Devices	Masimo SET Radical Pulse Oximeter with SatShare ™ and LNOP series of Sensors and Cables510(k) Number - K000126

Description of Masimo SET® Radical Pulse Oximeter with SatShare™

Features

Ability to perform as a stand alone monitor and a detachable portable monitor
Several types of Masimo LNOP® sensors for flexibility.
An automatic self-test at start-up.
Ability to be connected to the sensor port of multi-parameter devices that allows the multi-parameter device to share the Masimo SET® Radical Pulse Oximetry measurements
Ability to be connected to digital communication modules
Backlit display for excellent visibility in subdued lighting conditions.
Direct access to user-selectable high and low alarm limits for SpO2 and pulse rate.
An audible pulse indicator with an adjustable volume
Visual and audible (adjustable volume) alarms.
An alarm-silence feature; silences audible alarms for 120 seconds or continuously until deactivated.
Status and alarm informational messages appear on the LCD.

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4, 6, 8, 12, or 16 second SpO2 response averaging modes.
Trend data storage of up to 8 hours .
Automatic scaled plethysmographic waveform
Large SpO2 digital display for clear differentiation from the pulse rate value.

The PC series of connecting cables connects the monitor to the oximetry sensors and transfers LED drive power to the oximetry sensors from the monitor and the monitor receives the detector signals from the oximetry sensor.

This filing included additional SatShare cables that attach to the docking station and the oximeter sensor connector/port of additional validated multi-parameter device/modules enabling the SatShare™ feature of the Radical Pulse Oximeter with these multi-parameter devices.

The LNOP® series of oximetry sensors measure the light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently than unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood.

Intended use

Indications For Use:

Principles of Operation

The principles of operation of the Masimo SET® Radical Pulse Oximeter with SatShare™ 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 arterio-venous shunting is highly variable and that fluctuating absorbance by venous blood is a major component of noise during the pulse. Because oxyhemoglobin and decxyhemoglobin differ in light absorption, the amount of red and infrared light absorbed by the blood is related to hemoglobin oxygen saturation. The Masimo SET Radical Pulse Oximeter with SatShare™ 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 used to find the SpO2 saturation in an empirically derived equation in the Masimo SET® Radical II's software. 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 nonmotion conditions.

Method of Operation

The Masimo SETº Radical Pulse Oximeter with SatShare™ is attached to a paient's finger and one end of a patient cable is connected to the sensor and the other end connected to the Masimo SET "Radical Pulse Oximeter with SatShare™ module.

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The monitor will begin continuously displaying the patient's pulse plethysmographic waveform, pulse rate, and SpO-yalue. 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 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® Radical Pulse Oximeter with SatShare™ is powered either with a voltage input of 100-230 Vac, 47 -63 Hz. The detachable portable monitor operates on 4 rechargeable Nickel Metal Hydride batteries with and operating time of 2-4 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 digits
	0% - 69% unspecified
Neonates	70% - 100% ± 3 digits
	0% - 69% unspecified
Saturation (% SpO2) - During Motion Conditions2,3
Adults, Pediatrics2	70% - 100% ± 3 digits
	0% - 69% unspecified
Neonates3	70% - 100% ± 3 digits
	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 Performance4
> 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 approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual arterial pigmentation may cause erroneous readings.

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Power

Voltage Input Range
Maximum AC Power Consumption:

100-230 Vac, 47-63 Hz 55 VA

Battery

Type Operating Time Charge Time

4 Rechargeable Nickel Metal Hydride Batteries > 3 hours < 3 hours

Fuses

1 ASB, Metric, (5x20mm), 250V

Isolation

Chassis Leakage Current Ground resistance

Less than 100 u Amp Less than 1.0 Ω

Environmental

Operating Temperature Storage Temperature Relative Humidity

41°F to + 104°F (5°C to +40°C) -40°F to + 158°F (-40°C to +70°C) 5% to 95% noncondensing

Circuitry

Microprocessor controlled Automatic self-test of oximeter when powered on Automatic setting of default parameters Automatic alarm messages Trend data output of SpO2, pulse rate - up to 8 hours of stored data

Display

Type Pixels Dot Pitch Data Displayed

Backlit LCD 480 x 160 dots 0.24 mm Pulse Rate, SpO2 %, Pleth wave, Alarms, Trends, Status messages

Audio indicators

Adjustable volume audible pulse: OFF and 25% to 100% in 4 steps Adjustable volume audible alarm tone: levels and 25% to 100% in 4 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

Modes

Averaging mode:
Sensitivity

Audible Volumes

Alarm Pulse Beep 4, 6, 8, 12, and 16 seconds Normal and High

25% to 100% in 4 steps OFF and 25% to 100% in 4 steps

0045

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COM 1: A digital interface for network communication.

Data output every second; SpO2, and pulse rate
9600 Baud bidirectional
Number of bits per character:	8
Parity	None
Bits	1 start, 1 stop
Handshaking	None
Connector type	9-pin standard D, female
Connector pin functions:
1	No Connection
2	Receive data – RS-232 ±9 V (±5 Vmin)
3	Transmit data - RS-232 ±9 V (±5 Vmin)
4	No Connection
5	Signal Ground Reference for COM 1 signals
6	No Connection
7	Request to send - Not used
8	Clear to send - Not used
9	No Connection

PRINTER: A connection for optional printer.

Connector pin functions:

1	No Connection
2	Receive data - Not used
3	Transmit data – RS-232 ±9 V (±5 Vmin)
4	No Connection
5	Signal Ground - Reference for Printer signal
6	No Connection
7	Request to send - Not used
8	Clear to send -- RS-232 ±9 V (±5 Vmin)
9	No Connection

Dimensions

Docking Station
Height	3.5 in (8.9 cm)
Width	10.5 in (26.7 cm)
Depth	7.7 in (19.6 cm)
Weight	4.7 lbs (2.14 kg)
Portable
Height	8.9 in (22.6 cm)
Width	3.3 in (8.4 cm)
Depth	2.1 in (5.3 cm)
Weight	1.3 lbs (0.59 kg)

The Masimo SET® Radical pulse oximeter with LNOP+Adt sensors has been validated for no motion accuracy in human I hod 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 68% of the population.

The Masimo SET® Radical Pulse Oximeter with SatShare™ with LNOP-Adt sensors has been validated for motion 2 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. Plus or minus one standard deviation encompasses 68% of the population.

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The Masimo SET® Radical Pulse Oximeter with SatShare™ with LNOP-Neo and Neo Pt sensors has deen validated for I he Mashino SET - Radien I also Onlineter than on neonates while moving the neonate's foot at 2 to 4 Hz at an neonalian notion accoracy in numal brood scareer and ECG monitor. This variation equals plus or minus one amplitude of 1 to 2 en agains as one standard deviation encompasses 68% of the population.
The Masimo SET® Radical Pulse Oximeter with SatShare™ has been validated for low perfusion accuracy in bench op 4 I he Masino SET " Radical I this Oximolor with signal strengths of greater than 0.02% and a % lesting against a Diotek than 5% for saturations from 70 to 100%. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.

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.

Biocompatibility Testing

All patient contact materials were tested as Surface Devices with skin contact for prolonged contact duration (>24 hr to 30 days) All patient conact materials were costo as Baluation of Medical Devices - Part 1: Guidance on Selection of Tests. All patient contacting material passed.

Nonclinical tests performed that support a determination of substantial equivalence.

The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories was subjected to bench testing using a simulator that I he masmo DDF - tuation I die 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® Radical Pulse Oximeter with SatShare™ and accessories returned I he 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 usino SET® Radical Pulse Oximeter with SatShare™ on healthy adult volunteer subjects during no motion and motions who were subjected to a progressive induced hypoxia and measuring the arterial subjects and the notion and motion of the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.

Clinical studies were performed using the Masimo SET® Radical Pulse Oximeter with SatShare™ 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 Radical Pulse Oximeter with SatShare™ 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.

Clinical studies were performed using the Masimo SET® Radical Pulse Oximeter with SatShare™ on neonates with low perfusion 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 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® Radical Pulse Oximeter with Saturacy values for adults and pediatrics within ± 2 digits during no motion conditions and ± 3 digits during motion conditions when

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compared to the CO-Oximeter and the pulse rate accuracy values within ± 3 digits during no motion conditions and ± 5 digits during motion conditions when compared to the ECG.

The specified saturation accuracy from 70% - 100% for neonates is based on the results from clinical studies with I no specifica sudration accuracy now row - 1 clinical studies on adults to show that the Masimo SET® Radical Pulse Oximeter with SatShare™ to be within ± 3 digits during both motion conditions when compared to the CO-Oximeter, and the Dulse 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 Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories met the requirements of Reviewers Guidance for Premarket Submissions - November 1993.

The results of the biocompatibility testing demonstrates the all patient contactial met the requirements of ISO-10993-1: 1992 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests for Surface Devices with skin contact for prolonged contact duration (>24 hr to 30 days).

The results of the bench testing demonstrates that the Masimo SET® Radical Pulse Oximeter with SatShare™ meets its performance requirements.

The results of the clinical testing demonstrates that the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories meet its performance requirements during no motion conditions and low perfusion conditions.

The non-clinical and clinical testing performed demonstrates that the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is safe, effective.

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 2001

Mr. James J. Cronin Masimo Corp. 2852 Kelvin Avenue Irvine, CA 92614-5826

Re: K013792

Masimo SET Radical Pulse Oximeter with SatShare Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: Class II (two) Product Code: 74 DQA Dated: November 13, 2001 Received: November 14, 2001

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.

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Nalattill
Bram D. Zuckerman, M.D.

Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K013792 510(k) Number (if known):

Masimo SET® Radical Pulse Oximeter with SatShare™ and the LNOP® Series of Sensors and Cables Device Name:

Indications For Use:

The Masimo SET® Radical Pulse Oximeter with SatShare™ 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® Radical Pulse Oximeter with SatShare™ and accessories are indicated for use with adult, pediatric, and noonaal patients during both no motion and motions, for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition the Masimo SET Radical Pulse Oximeter with SatShare™ and accessories is indicated to provide the continuous nonitoring data obtained from the Masimo SET Radical Pulse Oximeter with SatShare™ of functional oxygen saturation of arterial hemoglobin (SpO+) and pulse rate (measured by an SpO2 sensor) to multiparameter devices for display on those devices.

The Masimo LNOP® Series of Sensors are indicated for the following:

A single use oximetry sensor intended for adults and pediatrics greater than 30 kg
A single use oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg
A single use oximetry sensor intended for neonates with good skin integrity less than 10 kg
A single use oximetry sensor intended for neonates with poor skin integrity less than 1 kg
A reusable oximetry sensor intended for adults and pediatrics greater than 30 kg
A reusable oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg

The Masimo PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SET® Radical Pulse Oximeter with SatShare™.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number	K03792

Prescription Use(Per 21 CFR 801.109)	or	Over-The-Counter Use(Optional Format 1-2-96)
------------------------------------------	----	--------------------------------------------------

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).