MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES

K040214 · Masimo Corp. · DQA · Feb 25, 2004 · Cardiovascular

Device Facts

• Record ID: K040214
• Device Name: MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
• Applicant: Masimo Corp.
• Product Code: DQA · Cardiovascular
• Decision Date: Feb 25, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended 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 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 monitoring data obtained from the Masimo SET® Radical Pulse Oximeter with SatShare™ of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) to multiparameter devices for display on those devices.

Device Story

Pulse oximeter utilizing Masimo SET technology; inputs red and infrared light absorption signals from LNOP sensors via patient cables; processes signals by decomposing pulsatile absorbance into arterial signal and noise component; calculates SpO2 and pulse rate using empirically derived look-up tables; outputs SpO2, pulse rate, and plethysmographic waveform to integrated LCD or external multiparameter monitors via SatShare cables. Used in hospitals, mobile, and home settings by clinicians. Features include adjustable alarm limits, trend data storage (8 hours), and automatic self-test. Provides continuous monitoring to assist clinical intervention decisions; benefits patients through accurate saturation monitoring even during motion or low perfusion.

Clinical Evidence

Clinical studies conducted on healthy adult volunteers (induced hypoxia) and neonates. Evaluated SpO2 and pulse rate accuracy against CO-Oximeter and ECG references. Tested under no-motion, motion (2-4 Hz), and low-perfusion conditions. Results: Adult/pediatric SpO2 accuracy ±2 digits (no motion), ±3 digits (motion); Neonate SpO2 accuracy ±3 digits. Pulse rate accuracy ±3 digits (no motion), ±5 digits (motion). Bench testing confirmed performance against simulators.

Technological Characteristics

Microprocessor-controlled pulse oximeter; uses spectrophotometry and plethysmography. Materials: Biocompatible per ISO-10993-1. Power: 100-230 Vac or NiMH batteries. Connectivity: RS-232 digital interface, SatShare cable for multiparameter integration. Display: 480x160 dot backlit LCD. Sensors: LNOP series (reusable/single-use). Software: Rule-based algorithm using empirically derived look-up tables for SpO2 calculation.

Indications for Use

Indicated for continuous noninvasive monitoring of SpO2 and pulse rate in adult, pediatric, and neonatal patients. Suitable for use during motion and no-motion conditions, and for patients with good or poor perfusion. Used in hospitals, hospital-type facilities, mobile, and home environments. Provides data to multiparameter devices.

Regulatory Classification

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.

Predicate Devices

• Masimo SET Radical Pulse Oximeter with SatShare and LNOP series of Sensors and Cables (K031330)

Submission Summary (Full Text)

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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 Corporation<br>2852 Kelvin Ave<br>Irvine, CA 92614-5826<br>[phone]<br>FAX [phone] |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------|
| 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)<br>Cable, Transducer and Electrode (74DSA) (870.2900) |
| Substantially Equivalent Devices | Masimo SET Radical Pulse Oximeter with SatShare™ and LNOP series of Sensors and<br>Cables<br>510(k) Number - K031330 |

Description of Masimo SET® Radical Pulse Oximeter with SatShare™

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.

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

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.

#### 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, 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.

#### 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 Amplitude<br>and % Transmission > 5% | Saturation (% SpO2) ± 2 digits<br>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.

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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.

1

2

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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 [phone]. 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 [phone] or [phone] 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