Masimo Rad-67 Pulse CO-Oximeter and Accessories

K182887 · Masimo Corporation · DQA · Mar 22, 2019 · Cardiovascular

Device Facts

• Record ID: K182887
• Device Name: Masimo Rad-67 Pulse CO-Oximeter and Accessories
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Mar 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are intended for use in clinical settings. The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are indicated for non-invasive spot-check monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions. The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb®) for adult patients. The rainbow DCI-mini sensor is intended for use in clinical and non-clinical settings. The rainbow DCI-mini sensor is indicated for non-invasive spot-check monitoring and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions. The rainbow DCI-mini sensor is indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb®) for adult patients.

Device Story

Handheld pulse CO-oximeter; uses multi-wavelength sensor (rainbow DCI-mini) to detect light absorption in tissue; applies Beer-Lambert Law and photoplethysmography to calculate SpO2, PR, Perfusion Index (Pi), Pleth Variability Index (PVi), and total hemoglobin (SpHb). Device features touchscreen color LCD; rechargeable lithium-ion battery; wired/wireless connectivity for data transfer. Used in clinical/non-clinical settings by clinicians to obtain spot-check measurements; provides real-time physiological data to assist in patient assessment. Benefits include non-invasive, rapid monitoring of hemoglobin and oxygenation status without blood draws.

Clinical Evidence

Clinical validation performed per ISO-80601-2-61. SpHb accuracy validated in 317 adult subjects (8-17 g/dL range) with 95% LOA of -1.82 to 2.04 g/dL. SpO2 accuracy validated in healthy adult volunteers (70-100% range): no motion ARMs 1.6%, motion ARMs 1.9%.

Technological Characteristics

Handheld device; touchscreen color LCD; rechargeable Li-ion battery. Multi-wavelength spectrophotometry sensing principle. Connectivity: wired and wireless. Safety standards: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61. Biocompatibility per ISO-10993. IPX4 ingress protection. Defibrillation-proof BF applied part.

Indications for Use

Indicated for non-invasive spot-check monitoring of SpO2 and PR in adult and pediatric patients (well/poorly perfused, motion/no motion) and SpHb in adult patients. rainbow DCI-mini sensor also supports continuous monitoring of SpO2 and PR.

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 Rainbow SET Pronto Pulse CO-Oximeter (K091057)

Reference Devices

• rainbow DCI sensor (K080238)

Submission Summary (Full Text)

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Masimo Corporation Sindura Penubarthi Regulatory Affairs Manager 52 Discovery Irvine, California 92618

Re: K182887

Trade/Device Name: Masimo Rad-67 Pulse CO-Oximeter and Accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: February 19, 2019 Received: February 21, 2019

## Dear Sindura Penubarthi:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Todd D. Courtney -5 for 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) K182887

Device Name Masimo Rad-67™ Pulse CO-Oximeter

Indications for Use (Describe) Indications For Use:

Masimo Rad-67™ Pulse CO-Oximeter

The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are intended for use in clinical settings.

The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are indicated for non-invasive spot-check monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions.

The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb®) for adult patients.

rainbow DCI-mini sensor

The rainbow DCI-mini sensor is intended for use in clinical and non-clinical settings.

The rainbow DCI-mini sensor is indicated for non-invasive spot-check monitoring and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions.

The rainbow DCI-mini sensor is indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb®) for adult patients.

Type of Use (Select one or both, as applicable)

| <div> <span style="font-family: DejaVu Sans, sans-serif;"> <span style="font-size: 12px;">☑</span> </span> Prescription Use (Part 21 CER 801 Subpart D) </div> |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-family: DejaVu Sans, sans-serif;"> <span style="font-size: 12px;">☐</span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/2 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 name is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".

### Section 5. 510(k) Summary

#### ട. 510(k) Summary

| Submitter and Address of<br>Manufacturing Facility: | Masimo Corporation<br>52 Discovery<br>Irvine, CA 92618<br>Phone: [phone]<br>FAX: [phone] |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Submitter | Sindura Penubarthi |
| Date: | October 11th 2018 |
| Official Correspondent | Sindura Penubarthi<br>Regulatory Affairs Manager<br>Masimo Corporation<br>Phone: [phone]<br>[e-mail] |
| Trade Name: | Masimo Rad-67TM Pulse CO- Oximeter and Accessories |
| 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 - Masimo Rad-67TM Pulse CO-Oximeter and<br>Accessories |
| Predicate Device: | K091057- Masimo Rainbow SET Pronto Pulse CO-Oximeter |
| Performance Standards | No performance standards for the above device have been<br>promulgated pursuant to Section 514. |

# 5.1 Device Description

The Masimo Rad-67™ Pulse CO-Oximeter is a handheld device that includes the Masimo Rainbow SET measurements.

The Rad-67™ has the same measurement technology and intended use as the cleared predicate, Pronto (K091057). The Rad-67™ includes Masimo Rainbow SET measurement technology, which enables the Rad-67™ to provide noninvasive spot-check monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi) and total hemoglobin concentration (SpHb®). The Rad-67™ can communicate through a wired or wireless connection to transfer data to external applications and devices.

The rainbow DCI-mini sensor, compatible accessory to the Rad-67™, is a reusable sensor that is compatible with Masimo rainbow SET technology and is intended for spot-check monitoring of

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Image /page/5/Picture/2 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 waveform to the left. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".

# Section 5. 510(k) Summary

functional oxygen saturation (SpO2), pulse rate (PR) and total hemoglobin (SpHb®). The rainbow DCImini sensor is indicated for adult, pediatic and infant populations≥ 3kg for SpO2 and PR. The rainbow DCI-mini sensor is indicated for adult populations for SpHb®. The rainbow DCI-mini sensor measurement technology is the same as the predicate (rainbow DCI sensor cleared under K080238), except that the rainbow DCI-mini sensor has been designed to be smaller to accommodate a smaller application sites such as the great toe or thumb (for the infant population) and the finger (for adults and pediatric).

# 5.2 Significant Physical and Performance Characteristics of the Device

The table below provides the specifications for the Rad-67TM.

| Table 5.2 Rad-67TM Pulse CO-Oximeter Specifications | |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FEATURE | Specification |
| Display | |
| Display type | Touchscreen, Color LCD (Backlit Active Matrix TFT LCD) |
| Measurement range | Functional Oxygen Saturation (SpO2):0-100%<br>Pulse Rate (PR): 0-240 beats per minute (bpm)<br>Perfusion Index (Pi): 0.00-20%<br>Pleth Variability Index (PVi): 0 to 100%<br>Total Hemoglobin (SpHb): 0 to 25g/dL; 0 to 250 g/L; 0 to 15.5mmol/L |
| Display resolution | SpO2:1%<br>PR:1bpm<br>SpHb: 0.1, 0.5, 1 g/dL; 1g/L; 0.1, 0.5, 1 mmol/L |
| Accuracy (ARMS) | Masimo rainbow SET Parameters |
| SpO2, no motion (70-100%) | 2%, adults/pediatrics/infants |
| SpO2, motion (70-100%) | 3%, adults/pediatrics/infants |
| SpO2, low perfusion (70-100%) | 2%, adults/pediatrics/infants |
| Pulse rate, no motion (25-240 bpm) | 3bpm, adults/pediatrics/infants |
| Pulse rate, motion (25-240 bpm) | 5bpm, adults/pediatrics/infants |
| Pulse rate, low perfusion (25-240 bpm) | 3 bpm, adults/pediatrics/infants |
| SpHb Limits of agreement (LOA) over a range of 8-17 g/dL | -1.82 to 2.04 g/dL |
| Mechanical | |
| Dimensions | 19.43 cm x 8.2 cm x 2.36 cm (7.6" x 3.2" x 0.9") |
| Weight | 0.37 kg. (0.81lbs) |
| Environmental | |
| Operating Temperature | 0 to 35 °C (32 to 95 °F) |
| Storage/Transport Temperature | -20°C to 45°C (-4°F to 113°F) |
| Operating Humidity | 10% to 95%, non-condensing |
| Storage/Transport Humidity | 10% to 95%, non-condensing |
| Operating Atmospheric Pressure | 540 mbar to 1060 mbar (540 hPa to 1060hPa) |
| Electrical | |
| AC power (power supply) requirements | 100-240Vac, 50/60 Hz, 0.5A |
| Power consumption | <15W |
| Safety Standard Compliance | IEC 60601-1:2005 |

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Image /page/6/Picture/2 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark-like shape inside, followed by the word "Masimo" in black, bold font. To the right of the logo is the text "MASIMO CORPORATION" in a smaller, lighter font, followed by the address "52 Discovery, Irvine, CA 92618".

### 510(k) Summary Section 5.

| Table 5.2 Rad-67TM Pulse CO-Oximeter Specifications | |
|-----------------------------------------------------|---------------------------------------------------------|
| FEATURE | Specification |
| | IEC 60601-1-2:2007 |
| | ISO 80601-2-61:2011 |
| Type of Protection | Class II (AC Power); internally powered (Battery power) |
| Degree of protection | Defibrillation proof, BF applied part |
| Protection against liquid ingress | IPX4 |
| Mode of Operation per IEC 60601-1 | Continuous operation |

#### Intended Use/Indications for Use 5.3

## Masimo Rad-67™ Pulse CO-Oximeter

The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are intended for use in clinical and nonclinical settings.

The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are indicated for non-invasive spot-check monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions.

The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb®) for adult patients.

## rainbow DCI-mini sensor

The rainbow DCI-mini sensor is intended for use in clinical and non-clinical settings.

The rainbow DCI-mini sensor is indicated for non-invasive spot-check monitoring and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions.

The rainbow DCI-mini sensor is indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb®) for adult patients.

#### 5.4 Technological Characteristics

#### 5.1.1. Principle of Operation - Pulse CO-Oximeter (Masimo SET and Masimo rainbow SET)

Pulse CO-Oximetry is governed by the following principles based upon the Beer-Lambert Law, which relates the attenuation of light to the properties of the material it passes through:

- Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood), and blood plasma constituents differ in their absorption of visible and infrared light (using spectrophotometry).

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Image /page/7/Picture/2 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 bold, black letters. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".

### Section 5. 510(k) Summary

- . The amount of arterial blood in tissue changes with pulse (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.
The Masimo rainbow SET technology uses a multi-wavelength sensor to detect the physiological signals required for the indicated parameters based on light absorption of various constituents in blood such as oxy- and deoxy- hemoglobin. The signal collected are processed to provide the measurements.

#### Mechanism of Action for Achieving the Intended Effect 5.1.2.

The mechanism for action for the Rad-67 is equivalent to the predicate in that it operates by connecting a multiple wavelength sensor and applying the sensor patient applied part to the measurement site. Once the sensor is applied to the measurement site, similar to the predicate device, the clinician can initiate the measurement through subject device interface. Once the measurement is initiated, physiological signals are detected via the patient applied part and sent to the subject device for processing to obtain a measurement. The measurement is then relayed to the clinician through the subject device's display.

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

The subject device, Rad-67™, and the predicate device, Pronto, have the following key similarities:

- both have substantially the same indications for use, ●
- both have the same principle of operation, mechanism of action, and performance specifications for Masimo rainbow SET technologies,
- both have substantially the same intended environment (e.g. clinical and non-clinical settings),

The subject device. Rad-67™, and the predicate device. Pronto, have the following key differences:

- the subject device includes modifications to the device software,
- the subject device includes a rechargeable lithium ion battery, whereas the predicate device uses non-rechargeable alkaline battery,
- the subject device includes touchscreen interface instead of membrane switch pad,
- the subject device includes wireless capabilities, whereas the predicate does not include wireless connectivity,
- the subject device includes a different sensor port connector

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Image /page/8/Picture/2 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".

### Section 5. 510(k) Summary

#### 5.5 Non-clinical Testing

The following tests, as applicable, were performed for the qualification of the subject Rad-67™ device and rainbow DCI-mini sensor in accordance with the requirements of the design control regulations and established quality assurance processes to demonstrate substantial equivalence with its predicates:

- Electrical safety testing per IEC 60601-1 ●
- EMC testing per IEC 60601-1-2
- Usability testing per FDA Human Factors and Usability Draft Guidance
- Software verification, including integration testing with host monitors, per FDA Software Guidance
- . Biocompatibility testing per ISO-10993 (rainbow DCI-mini)
- Mechanical testing per ISTA 2A and MIL-STD 810E
- Environmental testing per IEC 60601-1 ●

# 5.6 Clinical Testing

Masimo performed clinical studies on Rad-67™ and rainbow DCI-mini sensors in accordance with ISO-80601-2-61.

To establish substantial equivalence, clinical validation testing of the SpHb and SpO2 performance specification was conducted and included as part of this submission. The clinical studies for the Rad-67™ including the rainbow DCI-mini sensor supported the substantial equivalence to the predicate. The summary of the testing is provided below in Table 5.6.

## Table 5.6 Clinical Validation studies

| Objective | Test results | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|------------|------------------------|
| Clinical Validation Study (SpHb)<br>The clinical accuracy of the SpHb<br>performance was validated to obtain a 95%<br>Limits of Agreement (LOA) specification<br>over the range of 8-17g/dL as compared to<br>tHb values determined by a HiCN reference<br>method | Reference Method | # Subjects | 95% LOA Accuracy[g/dL] |
| | HiCN | 317 | -1.82 to 2.04 |
| Clinical Validation Study<br>(SpO2) (No motion)<br>The clinical accuracy of the SpO2<br>performance specification for no motion<br>conditions was validated to meet the 2%<br>Arms specification, the same as the predicate. | SpO2 Arms for no motion (70-100%) | | |
| | Bias | Prec | RMS |
| | No motion 0.05 | 1.63 | 1.63 |
| Clinical Validation Study<br>(SpO2)<br>The clinical accuracy of the SpO2<br>performance specification for motion<br>conditions was validated to meet the 2%<br>Arms specification, the same as the predicate | SpO2 Arms for motion | | |
| | Bias | Prec | RMS |
| | motion -0.49 | 1.92 | 1.98 |

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Image /page/9/Picture/2 description: The image shows the logo for Masimo Corporation. The logo consists of a red symbol on the left and the word "Masimo" in black letters to the right of the symbol. To the right of the word "Masimo" is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".

### 510(k) Summary Section 5.

- 5.6.1 Masimo performed the SpHb clinical validation testing of the SpHb performance using 317 adult subjects in the range of 8-17 g/dL. The 95% LOA was calculated for SpHb to be -1.82 to 2.04 g/dL over a specification range of 8-17 g/dL.
- 5.6.2 Masimo performed the clinical validation testing of the SpO2 performance under no motion on healthy, adult volunteers in the range of 70% to 100%. The ARMs for SpO2 under no motion was found to be 1.6% over the range of 70-100%.
- 5.6.3 Masimo performed the clinical validation testing of the SpO2 performance under motion on healthy, adult volunteers in the range of 70% to 100%. The ARMs for SpO2 under motion was found to be 1.9% over the range of 70-100%.

# 5.7 Conclusion

The results of the non-clinical testing demonstrate that all requirements and performance specifications were satisfied and support the subject device is substantially equivalent to its predicate.