MASIMO SET INTELLIVUE PULSE OXIMETER MODULE

K040259 · Masimo Corp. · DQA · Apr 22, 2004 · Cardiovascular

Device Facts

• Record ID: K040259
• Device Name: MASIMO SET INTELLIVUE PULSE OXIMETER MODULE
• Applicant: Masimo Corp.
• Product Code: DQA · Cardiovascular
• Decision Date: Apr 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Masimo SET® Intelli Vue Pulse Oximeter Module is intended for the continuous noninvasive monitoring of functional oxygen saturerial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals and hospital-type facilities.

Device Story

The Masimo SET IntelliVue Pulse Oximeter Module is a plug-in module for Philips IntelliVue patient monitors. It uses an external SpO2 sensor to measure red and infrared light absorption in tissue. The device employs Masimo SET (Signal Extraction Technology) algorithms to decompose pulsatile absorbance signals into arterial and noise components, enabling accurate SpO2 and pulse rate calculation during patient motion and low perfusion. The module is operated by clinicians in hospital settings. Output is displayed on the host Philips monitor, providing real-time SpO2 and pulse rate data to assist in patient assessment and clinical decision-making. The device benefits patients by providing reliable monitoring even when motion artifacts or low perfusion would typically cause errors in conventional pulse oximeters.

Clinical Evidence

Clinical studies were conducted on healthy adult volunteers under induced hypoxia, motion, and low-perfusion conditions. Accuracy was validated against CO-Oximeter (SpO2) and ECG (pulse rate) references. Results demonstrated SpO2 accuracy within ±2 digits (no motion) and ±3 digits (motion) for adults/pediatrics, and ±3 digits for neonates. Pulse rate accuracy was within ±3 digits (no motion) and ±5 digits (motion). Testing followed 21 CFR Parts 50, 56, and 812.

Technological Characteristics

Microprocessor-controlled pulse oximeter module; compatible with Philips IntelliVue FMS. Uses Masimo SET signal processing algorithms. Dimensions: 36mm x 99.6mm x 97.5mm; Weight: 209g. Powered by host monitor. Operating range: 1-100% SpO2, 25-240 bpm. Connectivity: proprietary module interface. Environmental: 0°C to 55°C operating temperature.

Indications for Use

Indicated for continuous monitoring of functional arterial hemoglobin oxygen saturation (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 in hospital and hospital-type settings.

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)
• Philips Medizin Systeme MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitor (K032858)

Submission Summary (Full Text)

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APR 2 2 2004

| 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: | February 2, 2004 |
| Trade Name | Masimo SET® Intellivue Pulse Oximeter Module |
| Common Name | Pulse Oximeter |
| Classification Name | Oximeter (74DQA) (870.2700) |
| Substantially Equivalent Devices | Masimo SET Radical Pulse Oximeter with SatShare™ and LNOP series of Sensors and<br>Cables 510(k) Number - K031330<br>Philips Medizin Systeme MP40, MP50, MP60, MP70 and MP90 Intellivue Patie<br>Monitor - K032858 |

The Masimo SET® IntelliVue Pulse Oximeter Module is a continuous noninvasive, arterial oxygen saturation and pulse rate montor. The Masimo SET Intellivue Module features Masimo SET algorithms in a Philips single-width Intellivae compatible module.

The following list outlines the key features and benefits of the Masimo SET IntelliVue Module

### Features and Benefits

Clinically proven Masimo SET'1M technology performance Applicable for use on neonate, pediatric and adult patients Proven for accurate monitoring in motion and low perfusion environments SpO2, pulse rate, alarm, and signal quality displays BP27 police with Philips IntelliVue models MP 40/50, MP 60/70 and MP90 must be equipped with Philips Intellivue Flexible Module Server (FMS) with at least one available module slot. Compatible with all Masimo LNOP SpO2 sensors (except LNOP DCSC)

### Intended use

The Masimo SET® Intelli Vue Pulse Oximeter Module is intended for the continuous noninvasive monitoring of functional oxygen saturerial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals and hospital-type facilities.

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### Indications for use

The IntelliVue Pulse Oximeter Module is indicated for the continuous nonitoring of functional organization of financed for I ne ment vice culse oximicle moduced by an Spo-sensor). The Intellivie Pulse Oximeter Module is indicated for are with adult, pediatric and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

### Principles of Operation

The principles of operation of the Masimo SET® Intellivue pulse oximeter Module are that oxyhemoglobin and deoxyhemoglobin I he principes of operation of the Masmo BDF - intentrade ers), the volume of arterial blood in tissue (and hence, light ative in then absorphon of real and minuted in (specifysmocraphy), and that arterio-venous shunting is highly variable and that also putin by that 0100) changed anning in paise 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® Intellivue pulse oximeter module decomposes the red and infraced 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 is used to find the SpO2 saturation in an empirically derived equation into the Masimo SET® Intellivue software. The values in the look-up table are based upon human blood studies against a mu the Masmo 021 - miedir as betwarers in induced hypoxia states during motion and non-motion conditions.

### Method of Operation

The Masimo SET® Intellivue pulse oximeter Module is installed in an empty slot in a compatible Philips Intelli Vue Patient I homoring System. 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® Intellivue pulse oximeter Module.

The monitor will begin continuously displaying the patient's pulse rate, and SpO2 value. The practitioner can then use the I no motion wat is continuously displayed on the monitor 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® Intellivue pulse oximeter module is powered by the Philips IntelliVue Patient Monitoring System.

### 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 |
| Pulse Rate (bpm) - During No Motion Conditions1<br>Adults, Pediatric, Neonates | 25 to 240 ± 3 digits | |
| Pulse Rate (bpm) - During Motion Conditions2,3<br>Adults, Pediatric, Neonates | 25 to 240 ± 5 digits | |
| Resolution | | |
| Saturation (% SpO2)<br>Pulse Rate (bpm) | 1%<br>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<br>amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual arterial<br>pigmentation may cause erroneous readings. | | |
| Isolation | | |
| Patient Leakage current<br>Dielectric Withstand (mains to patient) | Less than 100 μAmp<br>>4000 VAC | |
| Environmental | | |
| Operating Temperature<br>Storage Temperature | 32°F to + 131°F (0°C to +55°C)<br>-40°F to + 158°F (-40°C to +70°C) | |
| Relative Humidity | 5% to 95% noncondensing | |
| Operating Altitude | up to 15,000 ft | |
| Circuitry | | |
| Microprocessor controlled<br>Automatic self-test of oximeter when powered on<br>Automatic setting of parameters<br>Automatic alarm messages | | |
| Audio indicators | | |
| Controlled by Philips IntelliVue Patient Monitoring System | | |
| Physical characteristics | | |
| Dimensions:<br>Weight: | 1.4" x 3.9" x 3.8" (36 mm x 99.6 mm x 97.5 mm)<br>7.4oz. (209 g) | |
| Modes | | |
| Averaging mode:<br>Sensitivity | 5, 10, 20 seconds<br>Normal | |

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### 0% - 69% unspecified

- The Masimo SET Technology with LNOP Adt sensors has been validated for no motion accuracy in human blood 1 studies on healthy adult volunteers in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory cooximeter and ECG monitor. This variation equals plus or minus one standard deviation which encompasses 68% of the population.

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- 2 The Masimo SET Technology with LNOP Adt sensors has been validated for motion accuracy in human blood The Husening OD - Feet.net By - I counters 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 which encompasses 68% of the population.
- The specified saturation accuracy from 70% 100% for neonates is based on the results from clinical studies on adult I its specifics saturation account for the properties of fetal hemoglobin to be within ± 3 digits during both motion and no 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.. This variation equals plus or minus one standard deviation which encompasses 68% of the population
- The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek র্ণ 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 which 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.

### Nonclinical tests performed that support a determination of substantial equivalence.

The Masimo SET® Intellivue Pulse Oximeters Module 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® Intellivue Pulse Oximeter Module returned the same saturation accuracy values within ± 2 digits and pulse rate values within ± 3 digits when compared to the simulators used.

### Clinical tests performed that support a determination of substantial equivalence.

Clinical studies were performed using the Masimo SET® technology 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 the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.

Clinical studies were performed using the Masimo SET® technology on healthy adult volunteer 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 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® technology saturation accuracy values and pediatrics within ± 2 digits during no motion conditions and ± 3 digits during motion conditions 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 specified saturation accuracy from 70% - 100% for neonates is based on the results from clinical studies on adult volunteers and 1% was added to account for the properties of fetal hemoglobin to be within ± 3 digits during both motion and no 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.

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### Conclusions

The results of the environmetal testing demonstrated that the Masimo SET® Intellivue Pulse Oximeter Module met the requirements of Reviewers Guidance for Premarket Submissions - November 1993.

The results of the bench testing demonstrates that the Masimo SET® Intellivue Pulse Oximeters Module met its performance requirements.

The results of the clinical testing demonstrates that the Masimo SET® Intellivue Pulse Oximeters 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® Intellivue Pulse Oximeters Module is safe, effective.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2004

Mr. James Cronin Vice President, Regulatory Affairs/Quality Assurance Masimo Corporation 2852 Kelvin Ave. Irvine, CA 92614-5826

Re: K040259

Trade/Device Name: Masimo SET Intellivue Pulsc Oximeter Module Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, DPZ Dated: February 2, 2004 Reccived: February 4, 2004

Dear Mr. Cronin:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave roviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use autod in the encreations of the enactment date of the Medical Device Amendments, or to conniored prior to rial 2011a) 2011 devices that have been roomstined in assess approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The rod may, mercrove, include requirements for annual registration, listing of general controls provisions of ractice, 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 If your de rice is exassino (sional controls. Existing major regulations affecting your device can may be subject to back adden addess, 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 I hat FDA has made a determination that your device complies with other requirements of the Act that I Dri has Intaliations and regulations administered by other Federal agencies. You must or any I edolia surated and sequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. James Cronin

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 Actily of in veur Section S product radiation control provisions (occiolis 501 Clescribed in your Section 510(k)
This letter will allow you to begin marketing your device of your device to legal This letter will anow you to begin manxoning your antial equivalence of your device to a legally premarket notification. The PDA micing of basification 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 If you desire specific advice for your ac rise of the more the regulation entitled, Contiact the Office of Compullios at (001) of Station" (21CFR Part 807.97). You may obtain Misbrailding by terefected to premarket nother the Act from the Division of Small other geleral information on your responsible at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at the local development treal Manufacturers, International and Consembers: http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Chris Lin, Ph.D.

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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### Section 3 - Indications for Use

### 510(k) Number (if known):

Masimo SET Intellivue Pulse Oximeter Module Device Name:

#### Indications For Use:

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

Prescription Use _ X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use J (Per 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

seth

(Owision Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

Int., Dental Devices
510(k) Number: K040756