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, 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 (SpO-) 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 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) to multiparameter devices for display on those devices.

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

A single use oximery sensor intended for adults and pediatrics greater than 30 kg

A single use oximetry sensor intended for nediatics 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 pediatives 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 SETº Radical Pulse Oximeter with SatShare™

The following are additional SatShare cables indicated for connection to the following multi-parameter monitors:

Ohmeda - RGM Respiratory Monitor and

Datex-Ohmeda - M-EST and M-ESTP Modlucs

Draeger - Vitalert 1000, 3200, Evita 2 dura, Julian Anesthetic Workstation, and Narcomed 4 Monitors Airshields - Multiparameter Monitor with Ohmeda SpO2

Datascope - Passport Monitor with Datascope SpO2 and Accutor Monitors with Nellcor SpO2 and Datascope SpO2 GE/Marquette - Tram 100A and Tram 500A modules with Ohmeda SpO2

Device Description

The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is a device consisting of the Masimo SET I ho reasme of 2 - 1 the really and oximetry sensors to noninvasively calculate the functional oxygen saturation of arterial tecmoglobin (SpO2) and pulse rate. It features an easy-to-read display that presents patient data and status information: a LCD (liguid crystal display) display 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

Here's a breakdown of the acceptance criteria and the study information for the Masimo SET® Radical Pulse Oximeter with SatShare™:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document presents accuracy as "± X digits" which typically refers to the root mean square (RMS) difference when compared to a reference method, encompassing 68% of the population.

Metric (Accuracy)	Acceptance Criteria (Stated Performance)	Population	Conditions
Saturation (% SpO2) - No Motion Conditions	70% - 100% ± 2 digits	Adults, Pediatrics	No Motion
Saturation (% SpO2) - No Motion Conditions	70% - 100% ± 3 digits	Neonates	No Motion
Saturation (% SpO2) - Motion Conditions	70% - 100% ± 3 digits	Adults, Pediatrics	Motion
Saturation (% SpO2) - Motion Conditions	70% - 100% ± 3 digits	Neonates	Motion
Pulse Rate (bpm) - No Motion Conditions	25 - 240 bpm ± 3 digits	Adults, Pediatrics, Neonates	No Motion
Pulse Rate (bpm) - Motion Conditions	25 - 240 bpm ± 5 digits	Adults, Pediatrics, Neonates	Motion
Saturation (% SpO2) - Low Perfusion Performance	± 2 digits	N/A	> 0.02% Pulse Amplitude, > 5% Transmission
Pulse Rate - Low Perfusion Performance	± 3 digits	N/A	> 0.02% Pulse Amplitude, > 5% Transmission

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

Sample Size for Test Set:
- Adult/Pediatric No Motion & Motion: Not explicitly stated as a number, but studies were conducted on "healthy adult volunteers."
- Neonatal Motion: Not explicitly stated as a number, but studies were conducted on "neonates."
- Low Perfusion: Not explicitly stated, as this was primarily bench-top testing supplemented by clinical studies mentioned generically for "healthy adult volunteer subjects" and "neonates with low perfusion conditions."
Data Provenance: Clinical studies were performed on "human blood studies on healthy adult volunteers" and "neonates." The location (country of origin) is not specified, but the studies were conducted under U.S. regulations (Title 21 of Federal Regulations (21CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects, and Part 56 - Institutional Review Boards). This suggests a U.S. origin for the clinical data. The studies were prospective as induced hypoxia and motion conditions were deliberately applied.

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

Number of Experts: Not applicable in the traditional sense of experts interpreting images or conditions. The ground truth was established by laboratory co-oximetry and ECG monitors.
Qualifications of Experts: Not applicable. The reference methods are objective devices.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The ground truth was established directly by comparison to objective reference devices (laboratory co-oximeter for SpO2, ECG monitor for pulse rate). There was no mention of human adjudication of the reference standards themselves.

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

Was an MRMC study done? No. This device is a pulse oximeter, and its performance is assessed against physiological measurements, not against human reader interpretations of medical images or conditions.
Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was performed and the device is not an AI-assisted diagnostic tool that aids human readers.

6. Standalone Performance Study

Was a standalone performance study done? Yes. The entire description of accuracy in the document refers to the performance of the Masimo SET® Radical Pulse Oximeter with SatShare™ alone (algorithm only) compared to the reference standard. The goal was to validate the device's measurements of SpO2 and pulse rate.

7. Type of Ground Truth Used

Type of Ground Truth:
- SpO2: Laboratory co-oximeter measurements from arterial blood samples.
- Pulse Rate: ECG monitor.
- Low Perfusion SpO2/Pulse Rate: Bench-top testing against a Biotek Index 2 simulator and Masimo's simulator.

8. Sample Size for the Training Set

Sample Size for Training Set: Not explicitly stated within the 510(k) summary. The document mentions that the values in the look-up table (used by the device's software to find SpO2 saturation) are "based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states during motion and nonmotion conditions." However, the exact sample size for these initial studies used to develop the algorithm/look-up table is not provided. The accuracy results presented are for validation/testing, not training.

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

How Ground Truth for Training Set Was Established: According to the "Principles of Operation" section, the device uses "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." This indicates that the training ground truth for the look-up table was established by laboratory co-oximetry measurements from arterial blood samples under defined induced hypoxia, motion, and non-motion conditions in healthy adult volunteers.

Summary

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

K011851

061

510(k) SUMMARY

JUL 1 1 2001

Image /page/0/Picture/3 description: The image shows the logo and contact information for Masimo. The logo features the company name in a bold, sans-serif font with a small graphic above the 'i'. Below the logo is the address: 2852 Kelvin Avenue, Irvine, CA 92614, followed by the telephone number 949-250-9688 and fax number 949-250-9686.

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:	June 12, 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 andCables510(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.

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

1. 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 receives the detector signals from the oximetry sensor.

This filing included additional SatShare cables that attach to 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 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 pulse-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 Oximeter with SatShare™ module.

1062

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

The monitor will begin continuously displaying the patient's pulse plethysmographic waveform, pulse rate, and SpQ 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 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® 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 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 digits0% - 69% unspecified
Neonates	70% - 100% ± 3 digits0% - 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 Conditions' 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) Pulse Rate (bpm)

and % Transmission > 5%

1% 1

Low Perfusion Performance4 > 0.02% Pulse Amplitude

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.

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

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

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

Isolation

Chassis Leakage Current Ground resistance

Less than 100 µ Amp Less than 1.0 Ω

41°F to + 104°F (5°C to +40°C)

5% to 95% noncondensing

-40°F to + 158°F (-40°C to +70°C)

Environmental

Operating Temperature Storage Temperature Relative Humidity

Circuitry

Type

Pixels

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 480 x 160 dots 0.24 mm Dot Pitch Pulse Rate, SpO2 %, 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) 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

4, 6, 8, 12, and 16 seconds Normal and High

Audible Volumes

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

0064

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

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 hood 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 I ho manning 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 er with in madeou a promovis one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.

0065

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

The Masimo SET® Radical Pulse Oximeter with SatShare™ 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. 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 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 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 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 Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories was subjected to beach 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 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 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 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 notion. and motion conditions and measuring the arterial hemoglobin saturation value with 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 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 Saturation accuracy values for adults and pediatrics within ± 2 digits during no motion conditions and ± 3 digits during motion conditions when

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

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 satured on to 83% combined with 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 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 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 Masino 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.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

JUL 1 1 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Mr. James J. Cronin Masimo Corporation 2852 Kelvin Avenue Irvine, CA 92614

Re: K011851

Masimo SET® Radical Pulse Oximeter with SatShare™ and LNOP® series of Sensors and Cables Regulation Number: 870.2700 Regulatory Class: II (two) Product Code: 74 DQA Dated: June 12, 2001 Received: June 13, 2001

Dear Mr. Cronin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish

{8}------------------------------------------------

Page 2 - Mr. James J. Cronin

further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

to Allertshausen fa,

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{9}------------------------------------------------

Indications for Use

510(k) Number (if known): K011851

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 nominvasive 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, pediatio, and nonatal patients during both no motion and motions, for patients who are well or poorly perfused in hospitals, 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.