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

K013792 · Masimo Corp. · DQA · Dec 11, 2001 · Cardiovascular

Device Facts

• Record ID: K013792
• 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: Dec 11, 2001
• 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 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, mobile, and home environments.

Device Story

Device uses red and infrared LED sensors to measure light absorption in tissue; calculates SpO2 and pulse rate via plethysmography. Decomposes pulsatile absorbance into arterial signal and noise component to isolate arterial signal. Features stand-alone or portable operation; connects to multi-parameter monitors via SatShare cables. Used by clinicians in hospitals, mobile, or home settings. Provides real-time SpO2, pulse rate, and plethysmographic waveform on LCD. Enables alarm limit setting for SpO2 and pulse rate; aids clinical assessment and intervention decisions. Benefits patients through continuous, noninvasive monitoring, including during motion and low perfusion states.

Clinical Evidence

Clinical studies conducted on healthy adult volunteers and neonates under induced hypoxia. Evaluated performance during no-motion, motion (2-4 Hz), and low-perfusion conditions. Primary endpoints: SpO2 and pulse rate accuracy compared to CO-Oximeter and ECG. Results: SpO2 accuracy ±2 digits (no motion), ±3 digits (motion); pulse rate accuracy ±3 digits (no motion), ±5 digits (motion). Studies followed 21 CFR Parts 812, 50, and 56.

Technological Characteristics

Microprocessor-controlled pulse oximeter. Uses red/IR LED spectrophotometry and plethysmography. Backlit LCD display. Powered by 100-230 Vac or NiMH batteries. Connectivity via RS-232 (COM 1, Printer). Biocompatible patient-contact materials (ISO 10993-1). Software-based signal processing for noise reduction.

Indications for Use

Indicated for continuous noninvasive monitoring of functional SpO2 and pulse rate in adult, pediatric, and neonatal patients. Suitable for well or poorly perfused patients in hospitals, hospital-type facilities, mobile, and home environments. Also indicated to provide monitoring data to multiparameter devices for display.

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 (K000126)

Submission Summary (Full Text)

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K013792

0042

DEC 1 1 2001

| 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: | November 13, 2001 |
| 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 Cables<br>510(k) Number - K000126 |

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 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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- 4, 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 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 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, 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, 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.

#### 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 decxyhemoglobin 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 used to find the SpO2 saturation in an empirically derived equation in the Masimo SET® Radical II's software. 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 SETº Radical Pulse Oximeter with SatShare™ is attached to a paient'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 SpO-yalue. The practitioner can adjust the high and low alarm limits to their desired value, if required. 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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#### 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

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

#### Isolation

Chassis Leakage Current Ground resistance

Less than 100 u Amp Less than 1.0 Ω

#### Environmental

Operating Temperature Storage Temperature Relative Humidity

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

Type Pixels Dot Pitch Data Displayed

Backlit LCD 480 x 160 dots 0.24 mm 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 |

#### Audible Volumes

Alarm Pulse Beep 4, 6, 8, 12, and 16 seconds Normal and High

25% to 100% in 4 steps OFF and 25% to 100% in 4 steps

0045

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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 sensors has been validated for no motion accuracy in human I hod 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 2 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 deen validated for I he Mashino SET - Radien I also Onlineter than on neonates while moving the neonate's foot at 2 to 4 Hz at an neonalian notion accoracy in numal brood scareer and ECG monitor. This variation equals plus or minus one amplitude of 1 to 2 en agains as 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 op 4 I he Masino SET " Radical I this Oximolor with signal strengths of greater than 0.02% and a % lesting against a Diotek than 5% for saturations 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

3

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) All patient conact materials were costo as Baluation 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 I he masmo DDF - tuation I die instruments against the simulator under 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 I he 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 subjects and the notion and motion of 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 using the 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 SET® Radical Pulse Oximeter with 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 with I no specifica sudration accuracy now row - 1 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 Dulse 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 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 2001

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

Re: K013792

Masimo SET Radical Pulse Oximeter with SatShare Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: Class II (two) Product Code: 74 DQA Dated: November 13, 2001 Received: November 14, 2001

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.

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Page 2 - Mr. James J. Cronin

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); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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,

Nalattill
Bram D. Zuckerman, M.D.

Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

#### K013792 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 Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for use with adult, pediatric, and noonaal patients during both no motion and motions, 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 (SpO+) 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™.

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Division of Cardiovascular & Respiratory Devices | |
|--------------------------------------------------|--------|
| 510(k) Number | K03792 |

| Prescription Use<br>(Per 21 CFR 801.109) | or | Over-The-Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------|----|--------------------------------------------------|
|------------------------------------------|----|--------------------------------------------------|