The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is intended for continuous nomitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatic, 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, pediatic, and neonatal patients during both no motion and motions, for patients who are well or poorly perfused in 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) 10 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 Masino PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SET® Radical Pulse Oximeter with SatShareTM.

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 submitter, Masimo Corporation, provided information on the performance validation of their Masimo SET® Radical Pulse Oximeter with SatShare™.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Patient Type	Condition	Acceptance Criteria (Specified Accuracy)	Reported Device Performance (Clinical Study Results)
Saturation (% SpO2)	Adults, Pediatrics	No Motion	70% - 100% ± 2 digits	± 2 digits (against CO-Oximeter)
Saturation (% SpO2)	Adults, Pediatrics	Motion	70% - 100% ± 3 digits	± 3 digits (against CO-Oximeter)
Saturation (% SpO2)	Neonates	No Motion & Motion	70% - 100% ± 3 digits	± 3 digits (against CO-Oximeter: specifications down to 83% combined with adult clinical studies)
Saturation (% SpO2)	All	Low Perfusion	> 0.02% Pulse Amplitude and % Transmission > 5%	Meets performance requirements (against CO-Oximeter)
Pulse Rate (bpm)	Adults, Pediatric, Neonates	No Motion	25 to 240 ± 3 digits	± 3 digits (against ECG)
Pulse Rate (bpm)	Adults, Pediatric, Neonates	Motion	25 to 240 ± 5 digits	± 5 digits (against ECG)

Note: The accuracy specifications (e.g., ± 2 digits) generally represent one standard deviation, encompassing 68% of the population, as stated in the document.

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

The document does not explicitly state the exact sample sizes (number of subjects) for each clinical study (test set). However, it does specify:

Adults, Pediatrics: "human blood studies on healthy adult volunteers"
Neonates: "human blood studies on neonates"
Data Provenance: The studies were conducted on "healthy adult volunteers" and "neonates" in induced hypoxia states and under various motion and low perfusion conditions. The studies appear to be prospective as they involved inducing specific conditions (hypoxia, motion) to assess device performance. The country of origin is not explicitly stated but is implicitly within the scope of FDA regulations, suggesting the US.

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

The document does not specify the number or qualifications of experts involved in establishing the ground truth. It relies on objective measurement devices for ground truth:

For SpO2: A laboratory co-oximeter was used for arterial blood samples.
For Pulse Rate: An ECG monitor was used.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by objective laboratory co-oximeters and ECG monitors, not through expert 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

No MRMC comparative effectiveness study was done. This device is a pulse oximeter, which provides direct physiological measurements, not interpretations that would typically involve human "readers" or AI assistance in that context. The "AI" (Masimo SET technology) is integral to the device's function, not an add-on for human interpretation.

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

Yes, the studies conducted demonstrate the standalone performance of the Masimo SET® Radical Pulse Oximeter with SatShare™. The device directly measures and displays SpO2 and pulse rate; the performance metrics are accuracy against established gold standards (co-oximeter and ECG), not human interpretation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used was:

Laboratory Co-Oximeter: For functional oxygen saturation of arterial hemoglobin (SpO2), determined from arterial blood samples. This is an objective, laboratory-based gold standard.
ECG Monitor: For pulse rate. This is an objective, clinical gold standard.

8. The Sample Size for the Training Set

The document does not explicitly state a separate "training set" sample size. 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 nonmotion conditions." This implies that data from human studies was used to develop and refine the device's algorithms and look-up tables (effectively the training data for the device's inherent "algorithm"). The size of these studies is not quantified.

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

The ground truth for what would be considered the "training set" (the data used to establish the device's empirically derived equations and look-up tables) was established by:

Human blood studies on healthy adult volunteers in induced hypoxia states during motion and non-motion conditions.
Measurements taken against a laboratory co-oximeter. This indicates that the device's internal algorithms were developed and calibrated by comparing its readings to highly accurate co-oximetry measurements from real human blood samples under various challenging conditions.

Summary

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FEB 2.5 2004

510(k) SUMMARY

Image /page/0/Picture/2 description: The image shows the logo and contact information for Masimo. The logo is a stylized, bold font with a small circle above the 'i'. Below the logo is the address: 2852 Kelvin Avenue, Irvine, CA 92614. The phone number is 949-250-9688, and the fax number is 949-250-9686.

KO40214

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:	January 29, 2004
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 andCables510(k) Number - K031330

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 mufti-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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2, 4, 8, 10, 12, 14, 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 oxybernoglobin 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 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 pilse-added absorbance signals and its value is used to find the SpO2 saturation in an empirically derived equation in the Masimo SET® Radical II's 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 nonmotion conditions.

Method of Operation

The Masimo SET® Radical Pulse Oximeter with SatShare™ 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 Masimo SET® Radical Pulse Oximater with SatShare™ module.

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The monitor will begin continuously displaying the patient's pulse plethysmographic waveform, pulse rate, and SpO2 value. The practitioner can adjust the high and low alarm limits to their desired. 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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55 VA

100-230 Vac, 47-63 Hz

Power

Voltage Input Range Maximum AC Power Consumption:

Battery

Type Operating Time Charge Time

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

Fuses

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

Isolation

Chassis Leakage Current Ground resistance

Less than 100 µAmp Less than 1.0 Ω

Environmental

41ºF to + 104ºF (5ºC to +40ºC) Operating Temperature Storage Temperature -40°F to + 158°F (-40°C to +70°C) 5% to 95% noncondensing Relative Humidity

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

Backlit LCD Type 480 x 160 dots Pixels Dot Pitch 0.24 mm Pulse Rate, Sp()2 %, Pleth wave, Alarms, Trends, Status messages Data Displayed

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

Modes

Averaging mode:	4, 6, 8, 12, and 16 seconds
Sensitivity	Normal and High
Audible Volumes

Alarm Pulse Beep 25% to 100% in 4 steps OFF and 25% to 100% in 4 steps

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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 schsors has been validated for no motion accuracy in human I hood studies on healthy adult volunteers in induced hypoxia studies in the range of 70-100% SpO₂ against a laboratory otooo baard on thoundy active 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 The riamin 127 - Tudical Pates 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 been validated for 3 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. Plus or minus 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 top 4 I to ridomio o a " " the 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.

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) as defined ISO-10993-1: 1992 Biological Evaluation 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 Masino SET® Radical Pulse Oximeter with SatShare™ and accessories was subjected to bench testing using a simulator that determined the performance accuracy of the instruments against 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 1 he round or alle bearn county 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® Radical Pulse Oximeter with SatShare™ on healthy adult volunteer subjects during no 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 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 usino SET® 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 SE1® Radical Pulse Oximeter with SatShare™ 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 on neonates with I the specifications down to 83% combined with clinical studies on adults to show that the Masimo SET® Radical Pulse Oximeter with Satshare™ to be writhin ± 3 digits during both 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 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 contacting material 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 beach testing demonstrates that the Masimo SET® Radical Pulse Oximoter 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 and motion 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 and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2004

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

Re: K040214

Trade/Devicc Name: Masimo SET Radical Pulse Oximeter with SatShare Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: January 29, 2004 Received: January 30, 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 (1 11 ) (1 ) 1 ) 1 ) 1 ) 1 ) 1 ) 1 ) 1 (1 ) 1 ) 1 ) 1 ) 1 ) 1 ) 1 ) 1 ) 1 ) 1 (1 8 ) 1 ) 1 ) 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 r lease oc advisod that 1 27 to lessmann in that your device complies with other requirements incall that I DX nas made a detes and regulations administered by other Federal agencies. of the Act of ally I oderal barrequirements, including, but not limited to: registration r out indist comply with and its interest to beling (21 CFR Part 801); good manufacturing practice alle listing (21 CFR Part 007), acciity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quadistion 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 mis letter will anon your be FDA finding of substantial equivalence of your device to a premarket notification - 11 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), 11 you deente 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 may obtain 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,

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

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Indications for Use

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 Masino 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.

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

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)

Ste Teno 7/24/2004

v. General Hospital.

510(k) Number:

0041

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).