The Masimo SET® Radical Pulse Oximeter 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, and home environments.

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

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

A single use oximenty 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 oximery 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

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.

Device Description

The Masimo SET® Radical pulse oximeter and accessories is a device consisting of the Masimo SET technology, connecting cable, and oximetry sensors to noninvasively calculate the function 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

The Masimo SET® Radical Pulse Oximeter and accessories are designed for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in adult, pediatric, and neonatal patients, across various conditions (no motion, motion, well-perfused, poorly perfused) and environments (hospital, home).

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Saturation (% SpO2) - During No Motion Conditions
Adults, Pediatrics: 70% - 100% ± 2 digits	Adults and Pediatrics: within ± 2 digits (against CO-Oximeter)
Neonates: 70% - 100% ± 3 digits	Neonates: within ± 3 digits (against CO-Oximeter)
Saturation (% SpO2) - During Motion Conditions
Adults, Pediatrics: 70% - 100% ± 3 digits	Adults and Pediatrics: within ± 3 digits (against CO-Oximeter)
Neonates: 70% - 100% ± 3 digits	Neonates: within ± 3 digits (against CO-Oximeter)
Pulse Rate (bpm) - During No Motion Conditions
Adults, Pediatric, Neonates: 25 to 240 ± 3 digits	Adults, Pediatric, Neonates: within ± 3 digits (against ECG)
Pulse Rate (bpm) - During Motion Conditions
Adults, Pediatric, Neonates: 25 to 240 ± 5 digits	Adults, Pediatric, Neonates: within ± 5 digits (against ECG)
Low Perfusion Performance (> 0.02% Pulse Amplitude and % Transmission > 5% for saturations ranging from 70 to 100%)	Saturation (% SpO2): ± 2 (against Biotek Index 2 simulator and Masimo's simulator). Pulse Rate: ± 3 digits (against Biotek Index 2 simulator and Masimo's simulator).
Note: All accuracy values are stated as plus or minus one standard deviation, encompassing 68% of the population.	Note: All reported accuracy values are described as "within ± X digits," consistent with the acceptance criteria's definition of plus or minus one standard deviation.

Study Information

Sample size used for the test set and the data provenance:
- No Motion Accuracy (Adults/Pediatrics): Data collected from "healthy adult volunteers in induced hypoxia studies." Specific numerical sample size is not provided.
- Motion Accuracy (Adults/Pediatrics): Data collected from "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." Specific numerical sample size is not provided.
- Motion Accuracy (Neonates): Data collected from "neonates while moving the neonate's foot at 2 to 4 Hz at an amplitude of 1 to 2 cm." Specific numerical sample size is not provided.
- Low Perfusion Accuracy: Benchtop testing using a "Biotek Index 2 simulator and Masimo's simulator." This implies an experimental setup rather than human subjects for this specific test.
- Data Provenance: The studies were conducted as human blood studies, implying a prospective and controlled approach, likely within a clinical or laboratory setting. The country of origin is not explicitly stated but generally for FDA submissions, such studies are often conducted in the US. The "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," suggesting adherence to US regulatory standards for human studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided. The ground truth for saturation was established using a laboratory co-oximeter, and for pulse rate using an ECG monitor, which are objective measurement devices rather than expert interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as the ground truth was established using objective measurement devices (co-oximeter and ECG monitor), not through expert consensus requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a pulse oximeter, and its performance is evaluated against objective medical standards for SpO2 and pulse rate, not against human reader interpretation of images or other data. This study focuses on the device's accuracy in measuring physiological parameters.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the accuracy evaluation described for the Masimo SET® Radical Pulse Oximeter is a standalone performance assessment. The device's measurements of SpO2 and pulse rate are directly compared against established objective ground truth measurements (laboratory co-oximeter and ECG monitor). Human interpretation is not part of establishing the device's accuracy in this context.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Saturation (SpO2): Laboratory co-oximeter on arterial blood samples.
- Pulse Rate: ECG monitor.
- Low Perfusion: Biotek Index 2 simulator and Masimo's simulator (bench top testing).
The sample size for the training set:
- The document does not explicitly mention a separate "training set" for the device's algorithm in the context of clinical studies for accuracy. The "empirically derived equation" and "look-up table" are stated to be "based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states during motion and non-motion conditions." This implies that these initial human studies contributed to the development and calibration of the device's algorithms, which could be considered the basis for its "training." However, a specific numerical sample size for this development phase is not provided, nor is it referred to as a "training set."
How the ground truth for the training set was established:
- As mentioned above, 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 non-motion conditions." Therefore, the ground truth for the underlying algorithm (which could be likened to a training set) was established using a laboratory co-oximeter as the reference standard for blood oxygen saturation and likely an ECG monitor for pulse rate, conducted in controlled human studies involving induced hypoxia and simulated motion conditions.

Summary

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Image /page/0/Picture/3 description: The image shows the logo and contact information for Masimo. The logo is a stylized, bold typeface. Below the logo is the address: 2852 Kelvin Avenue, Irvine, CA 92614. The telephone and fax numbers are both listed as 949-250-9688.

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:	September 27, 1999
Trade Name	Masimo SET ® Radical Pulse Oximeter 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 2000 Pulse Oximeter and accessories510(k) Number - K990966

Description of Masimo SET® Radical Pulse Oximeter

Features

Ability to perform as a stand alone monitor and a portable monitor
Several types of Masimo LNOP® sensors for flexibility.
. An automatic self-test at start-up.
Backlit display for excellent visibility in subdued lighting conditions.
. Direct access to user-selectable high and low alarm limits for SpO, and pulse rate.
. An audible pulse indicator with an adjustable volume
. Visual and audible (adjustable volume) alarms.
An alarm-silence feature; silences audible alarms continuously until deactivated. .
Status and alarm informational messages appear on the LCD.
. 8, 12, or 16 second SpO2 response averaging modes.
Trend data storage of up to 8 hr.
Automatic scaled plethysmographic waveform
Large SpO, digital display for clear differentiation from the pulse rate value.

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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.

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 are that oxyhemoglobin differ in their absorption of red and infrared light (spectrophotomery), the volume of arterial blood in tissue (and hence, light absorption by that blood) changes during the pulse (plethysmography), and that arterio-venous shunting is highly variable and that fluctuating absorbance by venous blood is a major component of noise during the pulse. Because oxyhemoglobin and deoxyhemoglobin differ in light absorption, the anount of red and infraced light absorbed by the blood is related to hemoglobin oxygen saturation. The Masimo SET® Radical pulse oximeter decomposes the red and infrared pulsatile absorbance signal into an arterial signal plus a noise component and calculates the ratio of the arterial signals without noise. The ratio of the two arterial pulse-added absorbance signals and its value is used to find the SpO2, saturation in an empirically derived equation in the Masino SET® Radical'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 non-motion conditions.

Method of Operation

The Masimo SET® Radical pulse oximeter is turned on. An oximetery sensor is attached to a patient's finger and of a patient cable is connected to the sensor and the other end connected to the Masimo SET® Radical pulse oximeter module.

The monitor will begin continuously displaying the patient's pulse pletors, pulse rate, and SoO, 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 alam 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 is powered either with a voltage input of 100-230 Vac, 47 - 63 Hz. The detachable portable monitor operates on 4 AA batteries with and operating time of 2 hours.

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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) ± 2Pulse 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.

digits

Power

Voltage Input Range Maximum AC Power Consumption: 100-230 Vac, 47-63 Hz રડ VA

Fuses

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

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Isolation

Chassis Leakage Current Ground resistance

Environmental

Operating Temperature Storage Temperature Relative Humidity

Less than 1.0 Ω

Less than 100 uAmp

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

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

Audio indicators

Type

Pixels

Dot Pitch

Data Displayed

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 8, 12, and 16 seconds Normal and High

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 signals
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.

2 The Masimo SET® Radical pulse oximeter 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.

The Masimo SET® Radical pulse oximeter with LNOP-Neo and Neo Pt sensors has been validated for neonatal motion 3 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

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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 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.

Technological characteristics of the Masimo SET® Radical Pulse Oximeter compared to the Masimo SET® 2000 Pulse Oximeter.

The technological characteristics of the Masimo SET® Radical Pulse Oximeter and the Masimo SET® 2000 Pulse Oximeter both have the same or similar technological characteristics in design, materials, and energy source.

The design of both devices is the similar in that both devices that monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor) for adult, pediativ, and neonatal patients. The Masimo SET® Radical Pulse Oximeter also has fully functional detachable portable of operation and methods of operation for both devices is the same.

The materials used in both devices are similar. The instrument cases are formed of themoplastic materials. The electronics within the instruments are standard electronic parts (resistors, integrated circuits, wiring, connectors, etc.). The sensors and cables for both devices are formed of thermoplastic materials, adhesives, wires, electrical contacts, light emitting diodes, and photodetectors.

The Masimo SET® Radical Pulse Oximeter and the Masimo SET® 2000 Pulse Oximeter operate under 100 - 230 VAC 47-63 Hz and battery power.

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 and accessories was subjected to bench testing using a simulator 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 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 using SET® Radical Pulse Oximeter on healthy adult volunteer subjects during no motion and motion conditions who were subjected to a progressive induced hypoxia and measuring the arterial hemoglobin saturation value with the instruments against themoglobin oxygen determined from arterial blood samples with a CO-Oximeter.

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

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Clinical studies were performed using the Masimo SET® Radical Pulse Oximeter 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 on neonates with low perfusions 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 saturation accuracy values for adults and pediatics within ± 2 digits during no motion conditions and ± 3 digits during motion when 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 results from the clinical studies also show that the Masimo SET® Radical Pulse Oximeter saturation accuracy values for neonates to be within ± 3 digits during both motion conditions when compared to the CO-Oximeter and the pulse rate accuracy values to be within ± 3 digits during no motion conditions when conditions when compared to the ECG.

Conclusions

The results of the environmetal testing demonstrated that the Masimo SET® Radical Pulse Oximeter 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-1093-1: 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 meets its performance requirements.

The results of the clinical testing demonstrates that the Masimo SET® Radical Pulse Oximeter 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 and accessories is safe, effective, and performs as well as the predicate device, the Masimo SET® 2000 Pulse Oximeter, it is substantially equivalent to the Masimo SET® 2000 Pulse Oximeter.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures or profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 OCT

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

K992238 Re: ·Masimo SET® Radical Pulse Oximeter and the LNOP® Series of Sensors and Cables Regulatory Class: II (two) Product Code: 74 DQA September 28, 1999 Dated: September 29, 1999 Received:

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 leqally 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, Druq, 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 requlation (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 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.

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Page 2 - Mr. James J. Cronin

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 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 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,

Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 3 - Indications for Use

510(k) Number (if known): K992238

Device Name:

Masimo SET* Radical Pulse Oximeter and the LNOP® Series of Sensors and Cables

Indications For Use:

The Masimo SET® Radical Pulse Oximeter are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO) and pulse rate (measured by an SpO, sensor). The Masimo SET® Radical Pulse Oximeter and accessories are indicated for use with adult, pediatic, and neomatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, and home environments.

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

A single use oximenty 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 oximery 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

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.

(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 Cardiovascular, Respiratory, and Neurological Device

510(k) Number

Prescription Use	×
(Per 21 CFR 801.109)

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).