Masimo Disposable Transflectance Forehead Sensor

K160940 · Masimo Corporation · DQA · Nov 23, 2016 · Cardiovascular

Device Facts

• Record ID: K160940
• Device Name: Masimo Disposable Transflectance Forehead Sensor
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Nov 23, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Masimo Disposable Transflectance Forehead Sensors are indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Masimo Disposable Transflectance Forehead Sensors are intended for use with adult and pediatric patients, weighing greater than 10 kg, who are well or poorly perfused in healthcare environments.

Device Story

Disposable transflectance forehead sensor; uses spectrophotometry and photoplethysmography to measure SpO2, pulse rate, perfusion index (PI), and pleth variability index (PVI). Sensor placed on patient forehead, secured with headband, and connected to Masimo SET or Rainbow SET technology-enabled pulse oximeter instruments. Provides continuous monitoring in healthcare environments. Healthcare providers use output to assess patient oxygenation and perfusion status; aids in clinical decision-making regarding respiratory and circulatory management. Benefits include noninvasive, continuous monitoring for patients >10 kg.

Clinical Evidence

Clinical testing per ISO 80601-2-61 conducted on healthy adult volunteers with varying skin pigmentation. SpO2 measurements (70-100% range) compared against laboratory CO-oximeter arterial blood samples. Accuracy determined via Arms (accuracy root mean square). Results demonstrated accuracy of ±2% for SpO2 and ±3 bpm for pulse rate under no motion and low perfusion conditions, consistent with predicate specifications.

Technological Characteristics

Transflectance pulse oximetry sensor; single-use; non-sterile. Materials: polycarbonate lens, polyurethane light barrier, acrylic adhesive, PVC cable jacket (all ISO-10993 compliant). Dimensions: 2.5 x 1.5 in. Connectivity: DB9, M15, or RD sensor connectors for Masimo SET/Rainbow SET technology boards. Sensing principle: spectrophotometry (red/IR light absorption) and photoplethysmography.

Indications for Use

Indicated for continuous noninvasive monitoring of SpO2 and pulse rate in adult and pediatric patients weighing >10 kg, including well or poorly perfused patients in healthcare environments.

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 LNOP TF-1 Reusable Transflectance Sensor (K032551)

Reference Devices

• K051271

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

November 23, 2016

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

Re: K160940

Trade/Device Name: Masimo Disposable Transflectance Forehead Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: October 24, 2016 Received: October 27, 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.

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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.

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,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, 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) K160940

Device Name

Masimo Disposable Transflectance Forehead Sensors

#### Indications for Use (Describe)

The Masimo Disposable Transflectance Forehead Sensors are indicated for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Masimo Disposable Transflectance Forehead Sensors are intended for use with adult and pediatric patients, weighing greater than 10 kg, who are well or poorly perfused in healthcare environments.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red symbol on the left, followed by the word "Masimo" in black, bold letters. To the right of the word "Masimo" 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: | November 21, 2016 |
| Contact: | Marguerite Thomlinson<br>Senior Director, Regulatory Affairs |
| Trade Name: | Masimo Disposable Transflectance Forehead Sensors |
| Common Name: | Oximeter |
| Classification Regulation/<br>Product Code: | 21 CFR 870.2700, Class II/DQA |
| Establishment Registration<br>Number: | 2031172 |
| Reason for Premarket<br>Notification: | New Device |
| Predicate Device: | K032551, Masimo LNOP TF-1 Reusable Transflectance<br>Sensor |
| Performance Standards | No performance standards for the above device have been<br>promulgated pursuant to Section 514. |

### Device Description

The subject device, Masimo Disposable Transflectance Forehead Sensor (Forehead Sensor), is a single-use sensor and is supplied non-sterile. The sensor is available in two configurations, consisting of the LNCS TFA-1 with the DB9 sensor connector and the M-LNCS TFA-1 with the M15 sensor connector. The different sensor connectors allow for sensor connection to instruments with corresponding mating DB9 or M15 connectors. The subject device shall also be available with RD sensor connector. The subject device is intended to be used with instruments that include Masimo SET technology for the monitoring of:

- Functional Oxygen Saturation of Arterial Hemoglobin (SpO2): The amount of ● oxyhemoglobin expressed a percentage of the hemoglobin that is available

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Image /page/4/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" followed by the address "52 Discovery, Irvine, CA 92618".

- Pulse Rate (PR): Measured in beats per minute (BPM) is based on the optical detection of peripheral flow pulse
- . Perfusion Index (PI): The ratio of the pulsatile blood flow to the non-pulsatile or static blood in peripheral tissue
- Pleth Variability Index (PVI): Measure of dynamic changes in perfusion index that occur ● during the respiratory cycle.

The Masimo SET technology is provided by the Masimo SET or Masimo Rainbow SET technology board, which is included in Masimo pulse oximeter instruments, Masimo pulse CO-oximeter instruments and third-party multi-parameter instruments.

| Forehead Sensor Specifications | |
|--------------------------------|----------------------------------------------------|
| Features | Specifications |
| Patient population | Adults and pediatrics > 10 kg |
| Measurement site | Forehead |
| Type of use | Single-use |
| Sterility | Supplied non-sterile |
| Accuracy* | |
| SpO2, no motion | 70-100 ± 2 % |
| SpO2, low perfusion | 70-100 ± 2 % |
| Pulse Rate, no motion | 25-240 ± 3 bpm |
| Pulse Rate, low perfusion | 25-240 ± 3 bpm |
| Mechanical | |
| Sensor dimensions/weight | Approximately 2.5 x 1.5 in/ 1.0 oz (without cable) |
| Sensor cable length | 36 in, nominal |
| Patient-contacting materials | ISO-10993 compliant |
| Environmental | |
| Storage temperature | -40°C to +70°C |
| Operating temperature | +5°C to +40°C |
| Humidity | 10-95% humidity, non-condensing |

The specifications of the Forehead Sensor are listed in the table below.

* Accuracy was determined in terms of Arms (accuracy root mean square) per ISO-80601-2-61.

#### Intended Use/Indications for Use

The Masimo Disposable Transflectance Forehead Sensors are indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Masimo Disposable Transflectance Forehead Sensors are intended for use with adult and pediatric patients, weighing greater than 10 kg, who are well or poorly perfused in healthcare environments.

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Image /page/5/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 "V" symbol to the left of the word. To the right of the word "Masimo" is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".

### Technological Characteristics

#### Principle of Operation

The subject device, Forehead Sensor, is a pulse oximetry sensor which is governed by the following principles:

- Oxyhemoglobin (oxygentated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry).
- The amount of arterial blood in tissue changes with a person's pulse (photoplethysymography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.

### Mechanism of Action for Achieving the Intended Effect

The Forehead Sensor is placed on the patient forehead and secured with a headband. The other end of the sensor is connected to a patient cable, which in turn is connected to a pulse oximeter. The instrument is turned on when use begins. Once use is complete, the user turns the instrument power "off" and removes the sensor from the patient.

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

#### Similarities and Differences between Subject Device and Predicate Device (K032551)

The subject device, Forehead Sensor, and the predicate (K032551) have the following key similarities:

- . Both devices have the same intended use of pulse oximetry measurements under no motion and low perfusion conditions;
- Both devices have the same forehead measurement site;
- Both devices are supplied non-sterile; and ●
- Both devices have the same accuracy specifications ●

The subject and predicate devices are mainly different in that:

- the subject device is single-use device whereas the predicate is reusable; and ●
- the subject device is intended for patients > 10 kg whereas the predicate is intended for ● patients >30 kg.

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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 red circle containing a white checkmark to the left of the word. To the right of the word "Masimo" is the text "MASIMO CORPORATION" and the address "52 Discovery, Irvine, CA 92618".

## Substantial Equivalent

| Table 12.5 Substantial Equivalent Discussion | | |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Masimo Disposable Forehead Sensor<br>Subject Device, Pending | Masimo Reusable Forehead Sensors, LNOP TF-1<br>Predicate, K032551 |
| 510(k) No.<br>General | | |
| Indications for use | The Masimo Disposable Transflectance<br>Forehead Sensors are indicated for<br>continuous noninvasive monitoring of<br>functional oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse rate. The<br>Masimo Disposable Transflectance<br>Forehead Sensors are intended for use<br>with adult and pediatric patients,<br>weighing greater than 10 kg, who are well<br>or poorly perfused in healthcare<br>environments. | The following additional Masimo Sensor is<br>indicated for the continuous noninvasive functional<br>oxygen saturation of arterial hemoglobin (SpO2) and<br>pulse rate:<br><br>Reusable oximetry transflectance sensor intended<br>for adults and pediatrics greater than 30 kg in<br>hospitals, hospital-type facilities, mobile, and home<br>environments. |
| Classification regulation/<br>product code | Same as K032551 | 21 CFR 870.2700, Class II / DQA |
| Principle of operation | Same as K032551 | Pulse oximetry is governed by the principles of a)<br>Oxyhemoglobin (oxygenated blood) and b)<br>deoxyhemoglobin (non-oxygenated blood) differ in<br>their absorption of red and infrared light<br>(spectrophotometry). The amount of arterial blood in<br>tissue changes with your pulse<br>(photoplethysymography). Therefore, the amount of<br>light absorbed by the varying quantities of arterial<br>blood changes as well. |
| Mechanism of actions for<br>achieving the intended use | Same as K032551 | The Forehead Sensor is placed on the patient<br>forehead and secured with a headband. The other<br>end of the sensor is connected to a patient cable,<br>which in turn is connected to a pulse oximeter. The<br>instrument is turned on when use begins. Once use<br>is complete, the user turns the instrument power<br>"off" and removes the sensor from the patient. |
| Patient population | Adults and pediatrics >10 kg | Adults and pediatrics >30 kg |
| Measurement site | Same as K032551 | Forehead |
| Type of use | Single-use | Reusable |
| Sterility | Same as K032551 | Supplied non-sterile |
| Compatibility | Instruments with Masimo SET<br>technology provided by Masimo SET or<br>Masimo Rainbow SET technology<br>boards, including the MS, MS-2K and<br>MX series boards | Instruments with Masimo SET technology provided<br>by Masimo SET technology boards, including the<br>MS series boards |
| Perfusion index (PI) | | |
| PI Function | Same as K032551 | PI is the measure of the ratio of the pulsatile blood<br>flow to the non-pulsatile or static blood in peripheral<br>tissue |
| Table 12.5 Substantial Equivalent Discussion | | |
| Feature | Masimo Disposable Forehead Sensor | Masimo Reusable Forehead Sensors, LNOP TF-1 |
| 510(k) No. | Subject Device, Pending | Predicate, K032551 |
| PI Range | Same as K032551 | 0.02% to 20% |
| Pleth variability index (PVI) | Same as K032551 | PVI is the measure of dynamic changes in perfusion index that occur during the respiratory cycle. PVI is available based on whether the feature is enabled in the instrument with Masimo SET technology |
| PVI Range | Same as K032551 | 0% to 100% |
| Accuracy, ARMS | | |
| SpO2, no motion | 70-100 ± 2 % | 70-100 ± 2 % |
| SpO2, low perfusion | 70-100 ± 2 % | 70-100 ± 2 % |
| Pulse rate, no motion | 25-240 ± 3 bpm | 25-240 ± 3 bpm |
| Pulse rate, low perfusion | 25-240 ± 3 bpm | 25-240 ± 3 bpm |
| Biocompatibility | | |
| Patient-contacting materials | Disposable adhesive sensor with<br>biocompatible patient contact materials:<br>Lens: optically clear material for light<br>transmission, polycarbonate<br>Light barrier: polyurethane<br>Sensor face: acrylic adhesive<br>Cable jacket: PVC medical grade | Reusable sensor with biocompatible patient contact<br>materials:<br>Lens: optically clear material for light transmission,<br>silicon rubber<br>Light barrier: PVC<br>Sensor face: PVC<br>Cable Jacket: PVC medical grade |

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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 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 a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".

The difference in the indications for use (IFU) between the subject and predicate devices does not raise different questions of safety and effectiveness because both devices have the same intended use as forehead sensors for pulse oximetry, same principle of operation and same accuracy specifications. Although the patient-contacting materials for the subject device and predicate are slightly different, the materials are the same in that they are compliant to ISO-10993-1. Additionally, since the patient population is the same for the subject device and the predicate, there is no expected difference in the subject device's performance with the slight extended weight range for the subject device. Please note the reference device in K051271, where the same patient population of greater than 10 kg does not require additional testing. Furthermore, the subject device has been validated in regards to human factors and usability.

In summary, the accompanied verification and validation data for the subject device, including testing for any differences, demonstrated that the subject device is as safe and effective as the predicate and therefore substantially equivalent to the predicate.

#### Non-clinical Testing

The subject devices were subjected to bench testing. The following non-clinical testing, as applicable, was performed in accordance with Masimo design control requirements and quality

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Image /page/8/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 to the left of the word. To the right of the logo is the text "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".

system to demonstrate substantial equivalence of the subject device with its predicates:

- Electrical safety testing per IEC60601-1
- . EMC testing per IEC60601-1-2
- Pulse oximetry testing, including simulator testing of pulse rate and low perfusion, per ISO 80601-2-61,
- Biocompatibility testing per ISO-10993-1, ISO-10993-5 and ISO-10993-10 ●
- Usability testing per FDA Human Factors and Usability Guidance
- Software verification per FDA Software Guidance
- Mechanical and environmental testing

#### Clinical Testing

Clinical performance testing was completed in accordance with ISO 80601-2-61 to evaluate the accuracy of functional oxygen saturation (SpO2) measurements. The Forehead Sensors, connected to MX technology boards with Masimo SET technology, were applied to healthy adult volunteers with light to dark skin pigmentation. SpO2 measurements were compared against arterial blood samples analyzed by a laboratory CO-oximeter, in the range of 70 to 100%, to determine accuracy specifications in terms of accuracy root mean square (Arms). The variation in the accuracy specifications equals plus or minus one standard deviation, which encompassed approximately 68% of the tested population. Arms calculation incorporates error due to bias and imprecision (standard deviation).

#### Conclusion

The non-clinical and clinical testing provided in this 510(k) submission demonstrates that the subject devices. Forehead Sensors are as safe and effective as the predicate and therefore substantially equivalent to the predicate in K032551.