Masimo O3 Regional Oximeter System

K160526 · Masimo Corporation · MUD · Jun 9, 2016 · Cardiovascular

Device Facts

• Record ID: K160526
• Device Name: Masimo O3 Regional Oximeter System
• Applicant: Masimo Corporation
• Product Code: MUD · Cardiovascular
• Decision Date: Jun 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors, in individuals at risk for reduced flow or no-flow ischemic states and is indicated as follows: The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥ 40 kg in healthcare environments.

Device Story

The Masimo O3 Regional Oximeter System is a noninvasive monitor for regional hemoglobin oxygen saturation (rSO2) in cerebral tissue. It utilizes an adhesive sensor containing an emitter and two detectors applied to the patient's forehead. The system employs multi-distance diffuse reflectance near-infrared spectroscopy (NIRS) to measure light absorption in tissue microvasculature, determining oxygenated and deoxygenated hemoglobin concentrations. The O3 Sensor connects to an O3 Module, which processes physiological signals and transmits data to a host/backboard device (e.g., Masimo Root) for display. The system provides absolute rSO2, delta baseline (Δbase), area under the limit (AUL) index, and delta SpO2 (dSpO2) measurements. Used in healthcare environments by clinicians, the device provides continuous monitoring to assist in identifying ischemic states, potentially benefiting patients by enabling timely clinical intervention.

Clinical Evidence

Clinical study conducted on healthy adult male and female subjects with varying skin pigmentation. Trending and absolute rSO2 accuracies were validated in the 45% to 85% SavO2 range against laboratory CO-Oximeter measurements of 30% arterial and 70% jugular venous blood oxygen saturations. Results confirmed the O3 System meets performance requirements.

Technological Characteristics

Multi-distance diffuse reflectance NIRS; LED-based incoherent light source. Single-patient use adhesive sensors. Biocompatible materials per ISO 10993-1. Connectivity via MOC-9 interface to host device (e.g., Root). Powered by host device (AC or internal battery). Dimensions: O3 Module 5x1.8x0.6 inches; O3 Sensor 44x1.5x0.64 inches. Operating temperature 0°C to +40°C.

Indications for Use

Indicated for adults ≥ 40 kg in healthcare environments as an adjunct monitor of absolute and trended regional cerebral hemoglobin oxygen saturation (rSO2) for patients at risk of reduced flow or no-flow ischemic states.

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

• Fore-Sight Elite Absolute Tissue Oximeter (K133879)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 9, 2016

Masimo Corporation Marguerite Thomlinson Sr. Director, Regulatory Affairs 52 Discovery Irvine, California 92618

Re: K160526

Trade/Device Name: Masimo O3 Regional Oximeter System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: May 10, 2016 Received: May 11, 2016

Dear Marguerite Thomlinson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours. Shawn W. Forrest -S 2016.06.09 22:39:04 -04'00'

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known) K160526

Device Name

Masimo O3 Regional Oximeter System

#### Indications for Use (Describe)

The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (tSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥ 40 kg in healthcare environments.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Image /page/3/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the Masimo symbol, which is a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.

| Submitter and Address of<br>Manufacturing Facility: | Masimo Corporation<br>52 Discovery<br>Irvine, CA 92618<br>Phone: [phone]<br>FAX: [phone] |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Date: | May 09, 2016 |
| Contact: | Marguerite Thomlinson<br>Senior Director, Regulatory Affairs |
| Trade Name: | Masimo O3 Regional Oximeter System |
| Common Name: | Oximeter, Tissue Saturation |
| Regulation Number/ Name/<br>Product Class | 21 CFR 870.2700, Class II/MUD |
| Establishment Registration<br>Number: | 2031172 |
| Reason for Premarket<br>Notification: | New Device |
| Predicate Devices: | K133879 – Fore-Sight Elite Absolute Tissue Oximeter |
| Performance Standards | No performance standards for the above device have been<br>promulgated pursuant to Section 514. |

#### Device Description

The Masimo Regional Oximetry System (O3 System) includes the O3 Sensors and the O3 Module. The O3 System measures hemoglobin under the sensor, allowing clinicians to continuously and accurately determine the absolute and trend measurements of regional blood oxygenation saturation in the tissue (rSO2). The O3 Sensors includes optical components that collect physiological signals. The O3 Module includes Masimo technology for processing those signals which resulted in regional oximetry (rSO2) measurements. In turn, these measurements are displayed on the Host/Backboard device.

The O3 Sensor is a single-patient use adhesive sensor and is supplied non-sterile. The O3 Sensor, comprising of an emitter and two detectors, is applied to the patient's forehead at one end. The other end of the sensor is connected to a patient cable which in turn connected to the 03 Module. Up to two 03 Sensors can be connected to each O3 Module and both sensors can be connected to a patient.

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Image /page/4/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in bold, black letters, with a red circle containing a white checkmark to the left of the word. To the right of the word "Masimo" are the words "MASIMO CORPORATION" in smaller, gray letters, followed by the address "52 Discovery, Irvine, CA 92618".

The O3 Module includes Near InfraRed Spectroscopy (NIRS) technology. The O3 Sensor uses multiple wavelengths in the range of near infrared wavelengths to measure light absorption in the tissue. The O3 Sensors and O3 Module make up the O3 System for the monitoring of absolute regional hemoglobin oxygen saturation of blood (rSO2) under the sensors. The O3 System does not have its own power. The O3 Module is powered by connecting to a Host/Backboard Device such as the Root Monitoring System (Root). Root in turn is powered by either AC power or internal rechargeable batteries.

The O3 System provides the following key measurements:

- Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep o tissue local to the sensor site, including cerebral tissue
- o Delta Baseline (Abase): Relative difference in rSO2 with respect to baseline rSO2
- Area Under the Limit (AUL index): Index that quantifies the duration (amount of ● time the patient stays below rSO2 low alarm limit) and depth (refers to the gap between the patient's rSO2 level and the rSO2 low alarm limit) of patient's stay below the user-defined rSO2 low alarm limit (LAL)
- o Delta SpO2 (dSpO2): The difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).

| TABLE 5a O3 System Specifications | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| FEATURE | SPECIFICATION |
| Display | |
| Display Range | Regional Oxygen Saturation (rSO2): 0-99%<br>ΔSpO2: 0-99%<br>Δbase:0-99% |
| Display Resolution for Measurements | 1% |
| Measurement Accuracy | rSO2 (trending): ≤ 3% (RMS)<br>rSO2 (absolute): ≤ 4% (RMS)<br>Difference between Regional and Baseline rSO2 (Δbase): 1% |
| General | |
| Visual/audible alarm | Host/Backboard Device (Root) is IEC60601-1-8 compliant per K140188 |
| Storage/recording | Root has trend/data storage per K140188 |
| Electrical | |
| AC Power | Host/Backboard Device (Root) provides AC power per K140188 |
| Battery, Rechargeable | Host/Backboard Device (Root) provides internal battery power per K140188 |
| Interface | |
| O3 Module Connection | MOC-9 interface with Host/Backboard device (Root, per |

See the table below for the O3 System specifications.

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Image /page/5/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white lightning bolt inside, followed by the word "Masimo" in large, bold, black letters. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in a smaller, gray font, followed by the address "52 Discovery, Irvine, CA 92618".

| TABLE 5a O3 System Specifications | |
|-----------------------------------|-------------------------------------------------------------------------------------|
| FEATURE | SPECIFICATION |
| | K140188) |
| Mechanical | |
| O3 Module: Dimensions/Weight | 145.2x1.8x0.6 inch (including cable length)/7 oz.<br>5x1.8x0.6inch (without cable). |
| O3 Sensor: Dimensions/Weight | 44x1.5x0.64 inch (including max cable length)/1.3 oz. |
| Environmental | |
| O3 Module | |
| • Operating Temperature | 0°C to +40°C, ambient humidity |
| • Storage Temperature | -40°C to +70°C, ambient humidity |
| • Operating/ Storage Humidity | 10% to 95%, non-condensing |
| • Altitude | Up to 12,000 feet (3700 meters) |
| O3 Sensor | |
| • Operating Temperature | +5°C to +40°C |
| • Storage Temperature | -40°C to +60°C |
| • Humidity | 15% to 90% relative humidity |

#### Intended Use

The O3 System consisting of the O3 Sensor and O3 Module are intended for noninvasive monitoring of regional oxygen saturation. The computed saturation values are displayed on a Host/Backboard monitor such as the Masimo Root Monitoring System. The 03 System is intended to be used in healthcare environments.

#### Indications For Use

The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥ 40 kg in healthcare environments.

#### Technological Characteristics

#### Principle of Operation

The O3 System's operating principle is based on multi-distance diffuse reflectance spectroscopy. The O3 System use light to examine a cross-section tissue microvasculature (a mixed bed of arterioles, capillaries and venules) and analyzes the

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Image /page/6/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a bold, sans-serif font, with a stylized red checkmark symbol to the left of the word. To the right of the word "Masimo" are the words "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".

light returned after having passed through the tissues. The spectroscopic analysis determines concentrations of hemoglobin in its oxygenated and deoxygenated states.

Mechanism of Action for Achieving the Intended Effect

The O3 Sensor is noninvasively applied to the patient on one end. The other end of the O3 Sensor connects to the O3 Module. In turn, the O3 Module connects to a Host/Backboard device. The O3 Sensor collects patient physiological signals which are processed by the O3 Module. The processed signal which resulted in rSO2 measurements are displayed on the Host/Backboard device.

### Summary of Technological Characteristics of Subject Device Compared to Predicate Device

The subject device. O3 System, and the predicate device, Casmed Fore-Sight Elite Oximeter (K133879), have the following key similarities:

- Both devices include near infrared technology (using LEDs) for rSO2 ● measurements;
- o Both devices have the same intended use;
- Both devices have the same measurement site;
- Both devices are intended for the same subject populations of individuals 0 weighing > 40 kg;
- o Both devices include single-use adhesive sensors.

The subject device, O3 System, and the predicate device, Casmed Fore-Sight Elite Oximeter (K133879), have the following key difference:

In the subject device, the regional measurement technology is in the 03 Module. Whereas, in the predicate device, the regional measurement technology is distributed in the module and the host device. This is simply a choice of where the technology hardware is placed in the housings.

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Image /page/7/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a bold, sans-serif font, with a stylized red symbol to the left of the word. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".

| Table 5b Substantial Equivalence Table- Comparison Between Predicate and Subject Device | | | |
|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Fore-Sight Elite Absolute<br>Tissue Oximeter | O3 Regional Oximeter<br>System (03 Sensor and<br>O3 Module) | Differences and Similarities<br>between Subject & Predicate<br>Device |
| 510(k) Number | K133879 (Predicate) | Pending (Subject Device) | |
| General<br>Information | | | |
| Parameter<br>monitored | Regional hemoglobin<br>oxygen saturation of blood in<br>the microvasculature of<br>tissue | Regional hemoglobin<br>oxygen saturation of blood<br>in the microvasculature of<br>brain tissue | Same |
| Patient population | Adults and transitional<br>adolescents ≥ 40 kg. | Adults ≥ 40 kg | Same |
| Sensor Type | Disposable adhesive sensor<br>with biocompatible patient<br>contact materials | Disposable adhesive sensor<br>with biocompatible patient<br>contact materials | Same |
| Performance<br>accuracy | Cerebral: 45% to 95%<br>±3.05% to 1 standard<br>deviation with large sensors. | Cerebral: 45% to 85% ±3%<br>to 1 standard deviation with<br>large sensors (trending)<br><br>Cerebral: 45% to 85% ±4%<br>to 1 standard deviation with<br>large sensors (absolute) | Similar<br><br>The proposed device is seeking<br>approval for a subset of the<br>range already cleared in the<br>predicate device. |
| Device<br>Regulation<br>description | Oximeter, Tissue Saturation | Oximeter, Tissue Saturation | Same |
| Regulation medical<br>specialty | Cardiovascular | Cardiovascular | Same |
| Review panel | Cardiovascular | Cardiovascular | Same |
| Product code | MUD | MUD | Same |
| Regulation number | 870.2700 | 870.2700 | Same |
| Device class | 2 | 2 | Same |
| Indications for Use | | | |
| Table 5b | Substantial Equivalence Table- Comparison Between Predicate and Subject Device | | |
| Feature | Fore-Sight Elite Absolute<br>Tissue Oximeter | 03 Regional Oximeter<br>System (03 Sensor and<br>O3 Module) | Differences and Similarities<br>between Subject & Predicate<br>Device |
| 510(k) Number | K133879 (Predicate) | Pending (Subject Device) | |
| | The noninvasive Fore-Sight<br>Elite Absolute Tissue<br>Oximeter is intended for use<br>as an adjunct monitor of<br>absolute regional<br>hemoglobin oxygen<br>saturation of blood under the<br>sensors in individuals at risk<br>for reduced flow or no-flow<br>ischemic states and is<br>indicated as follows:<br><br>When used with large<br>sensors, the Fore-Sight Elite<br>Oximeter is indicated for use<br>on adults and transitional<br>adolescents ≥ 40 kg. | The noninvasive Masimo<br>03 Regional Oximeter<br>System is intended for use<br>as an adjunct monitor of<br>absolute and trended<br>regional hemoglobin<br>oxygen saturation of blood<br>(rSO2) in the cerebral<br>region under the sensors, in<br>individuals at risk for<br>reduced flow or no-flow<br>ischemic states and is<br>indicated as follows:<br><br>The Masimo O3 Regional<br>Oximeter System and<br>accessories are indicated for<br>use on adults ≥ 40 kg in<br>healthcare environments. | Same<br><br>Predicate device specifies<br>absolute accuracy; subject<br>device specifies absolute and<br>trended accuracy, which is a<br>property of absolute accuracy. |
| Principle of operation | | | |
| | The Fore-Sight Elite's<br>operating principle is based<br>on multi-distance diffuse<br>reflectance spectroscopy.<br>The monitor use light to<br>examine a cross-section<br>tissue microvasculature (a<br>mixed bed of arterioles,<br>capillaries and venules) and<br>analyzes the light returned<br>after having passed through<br>the tissues. The<br>spectroscopic analysis<br>determines concentrations of<br>hemoglobin in its<br>oxygenated and<br>deoxygenated states. | The O3 System's operating Same<br>principle is based on multi-<br>distance diffuse reflectance<br>spectroscopy. The O3<br>System use light to examine<br>a cross-section tissue<br>microvasculature (a mixed<br>bed of arterioles, capillaries<br>and venules) and analyzes<br>the light returned after<br>having passed through the<br>tissues. The spectroscopic<br>analysis determines<br>concentrations of<br>hemoglobin in its<br>oxygenated and<br>deoxygenated states. | Same |
| Device display | | | |
| Display type | Touchscreen | Touchscreen | Same |
| Display | LCD | LCD | Same |
| Trend display | Yes | Yes | Same |
| Measurement | | | |
| Method<br>(Technology) | Near Infrared Spectroscopy<br>(NIRS) | Near Infrared Spectroscopy<br>(NIRS) | Same |
| Table 5b Substantial Equivalence Table- Comparison Between Predicate and Subject Device | | | |
| Feature | Fore-Sight Elite Absolute Tissue Oximeter | O3 Regional Oximeter System (O3 Sensor and O3 Module) | Differences and Similarities between Subject & Predicate Device |
| 510(k) Number | K133879 (Predicate) | Pending (Subject Device) | |
| Sensor placement site | Right and Left Forehead | Right and Left Forehead | Same |
| Anatomical measurement site | Brain (via forehead) non-invasive | Brain (via forehead) non-invasive | Same |
| Mode of operation | Continuous monitoring | Continuous monitoring | Same |
| Sensor Information | | | |
| Technology | Noninvasive LED-based technology<br>(incoherent light) | Noninvasive LED-based technology<br>(incoherent light) | Same |
| Materials | | | |
| Biocompatibility | Patient contact materials are biocompatible per ISO<br>10993-1 | Patient contact materials are biocompatible per ISO<br>10993-1 | Same |
| Power | | | |
| External AC power | 100 to 240 VAC, 50/60 Hz | 100-240 VAC, 47-63 Hz | Same |
| Internal battery | Rechargeable internal battery | Rechargeable internal battery | Same |
| Visual Comparison | | | |
| System components | Monitor, Module and Sensor | Host/Backboard (Monitor) Device, Module and Sensor | Same |

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Image /page/8/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white line running through it, followed by the word "Masimo" in black letters. To the right of the logo is the text "MASIMO CORPORATION" and the address "52 Discovery, Irvine, CA 92618".

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Image /page/9/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white line running through it, followed by the word "Masimo" in black, bold letters. To the right of the logo, the text "MASIMO CORPORATION" is displayed, followed by the address "52 Discovery, Irvine, CA 92618".

#### Non-clinical Testing

The following tests, as applicable, were performed for the qualification of the subject devices, O3 System, in accordance with the requirements of the design control regulations and established quality assurance processes to demonstrate substantial equivalence with the predicate device:

- Electrical safety testing per IEC-60601-1 ●
- EMC testing per IEC-60601-1-2 ●
- Alarm testing per IEC-60601-1-8
- Optical safety testing per IEC-62471
- Biocompatibility testing per ISO-10993
- Usability testing per FDA Human Factors and Usability Draft Guidance ●
- Software verification per FDA Software Guidance ●
- o Mechanical and environmental testing

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Image /page/10/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.

The results demonstrate that all requirements and performance specifications were satisfied, and that the subject device is substantially equivalent to the predicate device.

### Clinical Testing

The clinical study was done on healthy adult male and female subjects with light to dark skin pigmentation. The trending and absolute rSO2 accuracies were determined by testing in the range of 45% to 85% SavO2 against 30% arterial and 70% jugular venous blood oxygen saturations, measured by a laboratory CO-Oximeter. The study confirms that the O3 System measurements meet the requirements.

#### Conclusion

The clinical evaluation, non-clinical testing including safety testing, as included in this 510(k) submission, demonstrate that the subject device, 03 System, is substantially equivalent to its predicate with respect to safety and effectiveness.