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 (SpO-) and pulse rate (measured by an SpO- sensor) for adult, pediativ, 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 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 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™.

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 (SpO-) 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

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

Acceptance Criteria and Device Performance

Parameter	Acceptance Criteria (Stated Performance)	Reported Device Performance
Saturation (% SpO2) - No Motion Conditions
Adults, Pediatrics (70% - 100% SpO2)	± 2 digits	Adult and pediatric: 70% - 100% ± 2 digits (against laboratory co-oximeter and ECG monitor), 68% of population within this range (one standard deviation)
Neonates (70% - 100% SpO2)	± 3 digits (down to 83% from clinical studies, extrapolated to 70% based on adult studies)	Neonatal: 70% - 100% ± 3 digits (against laboratory co-oximeter and ECG monitor) based on clinical studies down to 83% and adult studies, 68% of population within this range (one standard deviation)
Saturation (% SpO2) - Motion Conditions
Adults, Pediatrics (70% - 100% SpO2)	± 3 digits	Adult and pediatric: 70% - 100% ± 3 digits (against laboratory co-oximeter and ECG monitor, during rubbing and tapping motions at 2-4 Hz and non-repetitive motion 1-5 Hz), 68% of population within this range (one standard deviation)
Neonates (70% - 100% SpO2)	± 3 digits (down to 83% from clinical studies, extrapolated to 70% based on adult studies)	Neonatal: 70% - 100% ± 3 digits (against laboratory co-oximeter and ECG monitor, while moving foot at 2-4 Hz) based on clinical studies down to 83% and adult studies, 68% of population within this range (one standard deviation)
Pulse Rate (bpm) - No Motion Conditions
Adults, Pediatric, Neonates (25 to 240 bpm)	± 3 digits	Adult, pediatric, neonates: 25 to 240 ± 3 digits (against ECG)
Pulse Rate (bpm) - Motion Conditions
Adults, Pediatric, Neonates (25 to 240 bpm)	± 5 digits	Adult, pediatric, neonates: 25 to 240 ± 5 digits (against ECG)
Low Perfusion Performance	Saturation (% SpO2) ± 2 digits, Pulse Rate ± 3 digits	Saturation (% SpO2) ± 2 digits, Pulse Rate ± 3 digits (in bench top testing with > 0.02% Pulse Amplitude and % Transmission > 5% for saturations 70-100% against a Biotek Index 2 simulator and Masimo's simulator), 68% of population within this range (one standard deviation)

Study Details:

Sample sizes used for the test set and the data provenance:
- Test Set (Clinical Studies): The document does not specify the exact number of subjects/cases used for each clinical study (adult, pediatric, neonatal, motion, no-motion, low perfusion). It only refers to "human blood studies on healthy adult volunteers" and "human blood studies on neonates."
- Data Provenance: The provenance is not explicitly stated in terms of country of origin of the data. However, the studies were conducted by Masimo Corporation, located in Irvine, CA, USA, and followed US regulatory standards (21CFR, Part 812, Part 50, Part 56). The studies were prospective, involving induced hypoxia in healthy volunteers and directly measuring performance in neonates.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish ground truth for the test set in the conventional sense of human readers interpreting images. Instead, the ground truth for oxygen saturation (SpO2) was established using a laboratory co-oximeter on arterial blood samples. For pulse rate, an ECG monitor served as the ground truth. These are objective gold-standard measurements rather than subjective expert consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The ground truth was established by objective laboratory instruments (co-oximeter, ECG), not through human adjudication of differing interpretations.
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. This type of study (MRMC comparative effectiveness with/without AI assistance) is not relevant for a pulse oximeter, which is a standalone measurement device, not an AI-assisted diagnostic imaging tool that requires human interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the entire clinical validation effectively demonstrates the standalone performance of the Masimo SET® Radical Pulse Oximeter. The device directly provides SpO2 and pulse rate readings, which were then compared against the established ground truth from co-oximeters and ECG monitors. There is no human-in-the-loop component in the primary function or performance evaluation described.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Physiological Measurement:
  - For SpO2: Laboratory co-oximeter measurements from arterial blood samples.
  - For Pulse Rate: ECG monitor.
  - For Low Perfusion: Bench top testing against simulators (Biotek Index 2 simulator and Masimo's simulator).
The sample size for the training set:
- The document states that the values in the device's 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." However, it does not specify the sample size for this training data.
How the ground truth for the training set was established:
- The ground truth for the training set (used to develop the empirically derived equation and look-up table) was established using human blood studies on healthy adult volunteers in induced hypoxia states, with comparisons made against a laboratory co-oximeter. This process involved collecting data under both motion and non-motion conditions.

Summary

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MAY 1 2 2003 510(k) SUMMARY

K031330

Image /page/0/Picture/2 description: The image shows the logo for Masimo, a medical technology company. Below the logo is the address "2852 Kelvin Avenue, Irvine, CA 92614" and the phone number "Tel: 949-250-9688". The logo is a stylized version of the company name, with a curved line above the "i".

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:	April 24, 2003
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.

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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 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 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 SpO3 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.

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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 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 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

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

Isolation

Chassis Leakage Current	Less than 100 uAmp
Ground resistance	Less than 1.0 Ω

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

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	Backlit LCD
Pixels	480 x 160 dots
Dot Pitch	0.24 mm
Data Displayed	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

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

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COM 1: A digital interface for network communication

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 blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70-100% SpO₂ against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.

The Masimo SET® Radical Pulse Oximeter with SatShare™ 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. 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 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 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 the same saturation accuracy values within ± 2 digits and pulse 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 themoglobin 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 motions 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 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 themoglobin oxygen determined from arterial blood samples with a CO-Oximeter.

Clinical studies were performed using 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 Saturation accuracy 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 saturations down 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 Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories meet 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® Radical Pulse Oximeter with SatShare™ and accessories is safe, effective.

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Image /page/7/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 12 2003

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

Re: K031330

Trade/Device Name: Masimo SET Radical Pulse Oximeter with SatShare Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II (two) Product Code: 74 DQA Dated: April 24, 2003 Received: April 28, 2003

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.

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);

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Page 2 - Mr. James J. Cronin

labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

JoAnne Arbuckle

Susan Runner, DDS, MA Interim 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): K031330

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 neonatal patients during both no motion conditions, 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 (Sp(2) and pulse rate (measured by an Sp) 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 Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K031330

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).