Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor

K201770 · Masimo Corporation · DQA · Sep 24, 2020 · Cardiovascular

Device Facts

• Record ID: K201770
• Device Name: Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 24, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Rad-G Pulse Oximeter and Accessories are intended for the noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Pleth Respiration Rate (RRp). The Rad-G Pulse Oximeter and Accessories are indicated for noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of adult, pediatric, infant, and neonate patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, transport, and home environments. The Rad-G Pulse Oximeter and Accessories are indicated for the spot-checking or continuous monitoring of Respiration Rate from the photoplethysmogram (RRp) of adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, transport, and home environments.

Device Story

Handheld pulse oximeter; provides Masimo SET pulse oximetry and Respiration Rate from Plethysmograph (RRp). Inputs: optical signals from finger-applied sensors (Rad-G Reusable/YI sensors). Operation: light absorption differences in oxyhemoglobin/deoxyhemoglobin used to estimate SpO2/PR; cyclic plethysmograph variations used for RRp. Output: SpO2, PR, RRp, and PVi values on touchscreen. Used in hospitals, transport, and home environments by clinicians or patients. Device includes internal rechargeable battery and external AC power supply. Output informs clinical decision-making regarding patient oxygenation and respiratory status; benefits include noninvasive, continuous, or spot-check monitoring of vital signs.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing and reliance on predicate device (K193242) technology.

Technological Characteristics

Handheld pulse oximeter with touchscreen. Parameters: SpO2, PR, RRp, PVi. Sensing: Optical sensor (red/IR light absorption). Power: Internal rechargeable Li-ion battery or external AC supply (100-240 VAC). Connectivity: Wi-Fi, Bluetooth. Dimensions: 19.8 x 7.4 x 2.5 cm. Weight: 0.27 kg. Operating conditions: 0-40°C, 10-95% humidity, 540-1060 hPa.

Indications for Use

Indicated for noninvasive spot-checking or continuous monitoring of SpO2 and PR in adult, pediatric, infant, and neonate patients (well or poorly perfused, no motion conditions) and RRp in adult and pediatric patients (no motion conditions) in hospitals, hospital-type facilities, transport, and home 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 Radical-7 Pulse Co-Oximeter and Accessories (K193242)

Reference Devices

• Masimo MightySat Rx Fingertip Pulse Oximeter (K181956)
• RD SET Disposable sensors (K191059)
• RD SET Reusable sensors (K180046)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 24, 2020

Masimo Corporation Katelynn Kirby Regulatory Affairs Specialist III 52 Discovery Irvine, California 92618

Re: K201770

Trade/Device Name: Masimo Rad-G Pulse Oximeter and Accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, DPZ, BZQ Dated: September 2, 2020 Received: September 3, 2020

Dear Katelynn Kirby:

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.

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K201770

Device Name

Masimo Rad-G Pulse Oximeter and Accessories

#### Indications for Use (Describe)

The Rad-C Pulse Oximeter and Accessories are intended for the noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Pleth Respiration Rate (RRp).

The Rad-G Pulse Oximeter and Accessories are indicated for noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of adult, pediatric, infant, and neonate patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, transport, and home environments.

The Rad-G Pulse Oximeter and Accessories are indicated for the spot-checking or continuous monitoring of Respiration Rate from the photoplethysmogram (RRp) of adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, transport, and home environments.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 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 circle containing a white checkmark 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".

| Submitter and Address of<br>Manufacturing Facility: | Masimo Corporation<br>52 Discovery<br>Irvine, CA 92618<br>Phone: [phone]<br>FAX: [phone] |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Date: | June 26 2020 |
| Contact: | Katelynn Kirby<br>Regulatory Affairs Specialist III<br>Masimo Corporation<br>Phone: [phone] |
| Trade Name: | Masimo Rad-G Pulse Oximeter and Accessories |
| Common Name: | Oximeter |
| Classification Regulation/<br>Product Code: | 21 CFR 870.2700, Class II/DQA |
| Additional Classification<br>Regulation/Product Code(s): | 21 CFR 868.2375, Class II/BZQ |
| Establishment Registration<br>Number: | 3011353843 |
| Reason for Premarket<br>Notification: | New Device |
| Predicate Device: | Masimo Radical-7 Pulse Co-Oximeter and Accessories (K193242) |
| Reference Predicate | Masimo MightySat Rx Fingertip Pulse Oximeter (K181956) |
| Performance Standards | No performance standards for the above device have been<br>promulgated pursuant to Section 514. |

The purpose of this premarket notification is to receive authorization to market the Masimo Rad-G and Accessories.

### 1. Device Description

The Rad-G is a handheld pulse oximeter that provides Masimo SET pulse oximetry and Respiration Rate from the Plethysmograph. The Rad-G is provided with an internal battery and a connection to an external power supply to support continuous monitoring. The technologies supported in the Rad-G are the same as what has been cleared with the Radical-7.

The Rad-G can be used with the following sensors:

Rad-G Reusable Sensor (As part of this submission) Rad-G YI Sensor (As part of this submission)

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Image /page/4/Picture/1 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".

RD SET Disposable sensors (K191059) RD SET Reusable sensors (K180046)

The following are specifications for the Rad-G Pulse Oximeter:

| General Information | |
|-------------------------------------------|--------------------------------------------------|
| Display | |
| Display Type | Touchscreen |
| Technological Characteristics | |
| Supported Parameters | SpO2, PR, RRp |
| Calculated or Derived Parameters | PVi |
| Performance Specification (Arms) | |
| SpO2, no motion (70-100%) | 2% (Adults/Pediatrics/Infants)<br>3% (Neonates) |
| SpO2, motion (70-100%) | 3% (Adults/Pediatrics/Infants/Neonates) |
| SpO2, low perfusion (70-100%) | 2% (Adults/Pediatrics/Infants)<br>3% (Neonates) |
| Pulse rate, no motion (25-240 bpm) | 3 bpm |
| Pulse rate, motion (25-240 bpm) | 5 bpm |
| Pulse rate, low perfusion (25-240 bpm) | 3 bpm |
| Respiration Rate from Pleth (4-70 rpm) | 3 rpm Arms, 1 rpm Mean Error (Adults/Pediatrics) |
| Environmental | |
| Operating Temperature | 0 to 40 oC (32 to 104 oF) |
| Storage Temperature | -20 to 60 oC (-4 to 140 oF) |
| Operational/ Storage Humidity | 10 to 95%, non-condensing |
| Operating Atmospheric Pressure | 540 mbar to 1,060 mbar (540 hPa to 1060 hPa) |
| Mechanical | |
| Instrument Dimensions | 7.8 x 2.9 x 1 inch (19.8 x 7.4 x 2.5 cm) |
| Instrument Weight | 0.27 kg (0.59 lbs) |
| Electrical | |
| AC Power Supply, External (Input Voltage) | 100-240 VAC, 50/60 Hz, 0.6A |
| Battery power | Internally rechargeable lithium ion battery |
| I/O Interface | |
| Wireless | Wi-Fi, Bluetooth |
| Mode of Operation per IEC 60601-1 | |
| Mode of operation | Continuous |

### 2. Intended Use/ Indications for Use

The Rad-G Pulse Oximeter and Accessories are intended for the noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Pleth Respiration Rate (RRp).

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Image /page/5/Picture/1 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 logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".

The Rad-G Pulse Oximeter and Accessories are indicated for noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of adult, pediatric, infant, and neonate patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, transport, and home environments.

The Rad-G Pulse Oximeter and Accessories are indicated for the spot-checking or continuous monitoring of Respiration Rate from the photoplethysmogram (RRp) of adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, transport, and home environments.

### 3. Technological Characteristics

### Principle of Operation

The Rad-G Pulse Oximeter and Accessories utilize the same principles of operation for functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Respiration Rate from the Pleth (RRp) as the Radical-7 previously FDA 510(k) cleared under K193242. The principles of operation of pulse oximetry is based upon the fundamental principle that hemoglobin bound to oxygen (oxyhemoglobin) and hemoglobin unbound to oxygen (deoxyhemoglobin) vary in the absorption of different wavelengths of the light and the absorptions can be used to estimate SpO2 and PR. RRp relies on the principle that the cyclic variations in plethysmograph can be used to establish a respiration rate measurement.

### Mechanism of Action for Achieving the Intended Effect

The Rad-G Pulse Oximeter and Accessories, the same as the predicate, provide the intended effect similar to the previously cleared Radical-7 in that it utilizes an optical sensor that is applied to the patient's finger to pass light through the tissue to the photodetector that detects the signal variation resulting from differences in the absorption of light. The signals are then passed to the Rad-G Pulse Oximeter where they are processed to provide the SpO2, PR, and RRp values that are then displayed.

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

Similarities and Differences between Predicate and Subject Device

The subject device, Masimo Rad-G and Accessories, and the predicate device, Masimo Radical-7 and Accessories (K193242), have the following key similarities:

- Both devices utilize the same technology to continuously monitor Masimo SET Technology and support Respiration rate through Plethysmograph (RRp)
- . Both devices have the same performance specifications for the parameters
- . Both devices utilize a touch screen user interface with a similar graphical user interface layout
- . Both devices are provide with internal rechargeable batteries so that they can operate on internal battery or AC power

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Image /page/6/Picture/1 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".

The subject device, Masimo Rad-G and Accessories, and the predicate device, Masimo Radical-7 and Accessories (K193242), have the following key differences:

- The subject device includes an indication for spot-checking
- . The subject device only provides a smaller subset of monitoring parameters
- . The subject device has different environmental specifications, including ingress protection rating
- . The subject device has a different physical appearance (e.g. enclosure size and shape)
- . The subject device does not require a docking station in order to be powered by AC power

See Table 4.1 for the comparison between the subject device and predicate device.

As compared to the Radical-7, the main modifications are in the added spot-checking indication, physical appearance, ability to connect directly to as external AC/DC power supply versus a docking station, environmental specifications, and the software which was modified to be compatible with the Rad-G hardware and support the simplification of the user interface to limit the number of displayed parameters, as compared to the Radical-7.

The substantial equivalence of the Rad-G to the predicate device. Radical-7, was supported by the same intended use and technological characteristics in providing SpO2, PR, and RRp. To support the indication for spot-checking do not raise different questions of safety and effectiveness, the MightySat (K181956), which is cleared for spot-checking and has similar technological characteristic, was included as a reference predicate. The non-clinical testing supported the other differences related to the software, environmental specifications, AC power source, and physical characteristics do not raise new questions of safety and effectiveness. The testing was found to support the substantial equivalence of the subject device to the predicate.

| Feature | Subject Device | Radical-7, Predicate device | Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| 510(k) Number | Pending | K193242 | |
| General Information | | | |
| Classification/Product<br>Code | 21 CFR 870.2700, Class<br>II/DQA | 21 CFR 870.2700, Class<br>II/DQA | Same |
| Additional<br>Classification/Product<br>Code | 21 CFR 868.2375, Class<br>II/BZQ | 21 CFR 868.2375, Class<br>II/BZQ<br>21 CFR 862.3200, Class<br>II/JKS<br>21 CFR 870.2710, Class<br>II/DPZ | Subject device supports a<br>smaller set of product codes. |
| Indications for Use | The Rad-G Pulse Oximeter<br>is intended for the | The Radical-7 and<br>Accessories are indicated | Subject device supports a<br>smaller set of monitoring |
| noninvasive spot-checking<br>or continuous monitoring<br>of functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2), Pulse<br>Rate (PR), and Pleth<br>Respiration Rate (RRp). | for the continuous non-<br>invasive monitoring of<br>functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and<br>pulse rate (PR) of adult,<br>pediatric, and neonatal<br>patients during both no<br>motion and motion<br>conditions, and for patients<br>who are well or poorly<br>perfused in hospitals,<br>hospital-type facilities,<br>mobile, and home<br>environments. | parameters.<br><br>Subject device supports both<br>spot-checking and<br>continuous monitoring. | |
| The Rad-G Pulse Oximeter<br>is indicated for use the<br>noninvasive spot-checking<br>or continuous monitoring<br>of functional oxygen<br>saturation of arterial<br>hemoglobin (SpO2) and<br>Pulse Rate (PR)of adult,<br>pediatric, infant, and<br>neonate patients during<br>both no motion and motion<br>conditions, and for patients<br>who are well or poorly<br>perfused in hospitals,<br>hospital-type facilities,<br>transport, and home<br>environments. | The Radical-7 and<br>Accessories are indicated<br>for the continuous non-<br>invasive monitoring of<br>carboxyhemoglobin<br>saturation (SpCO) of adult,<br>pediatric, and infant<br>patients during no motion<br>conditions in hospitals and<br>hospital-type facilities. The<br>Masimo Radical-7 and<br>Accessories are not<br>intended to be used as the<br>sole basis for making<br>diagnosis or treatment<br>decisions related to<br>suspected carbon monoxide<br>poisoning; it is intended to<br>be used in conjunction with<br>additional methods of<br>assessing clinical signs and<br>symptoms. | | |
| The Rad-G Pulse Oximeter<br>is indicated for use the<br>noninvasive spot-checking<br>or continuous monitoring<br>of Respiration Rate from<br>the photoplethysmogram<br>(RRp) of adult and<br>pediatric patients during no<br>motion conditions in<br>hospitals, hospital-type<br>facilities, transport, and<br>home environments. | The Radical-7 and<br>Accessories are indicated<br>for the continuous non-<br>invasive monitoring of<br>methemoglobin saturation | | |
| | (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities. | | |
| | The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities. | | |
| | The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities. | | |
| | The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate from the Pleth (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities. | | |
| Principle of operation | SpO2 and Pulse Rate relies | SpO2 and Pulse Rate relies | Same for the supported |
| | on the principle that | on the principle that | parameters |
| | hemoglobin at different | hemoglobin at different | |
| | oxygenation states absorb | oxygenation states absorb | |
| | light differently based upon | light differently based upon | |
| | the wavelength of light. | the wavelength of light. | |
| | | | |
| | RRp feature relies on the | RRp feature relies on the | |
| | principle subject's | principle subject's | |
| | respiration rate modulates | respiration rate modulates | |
| | the photoplethysmogram | the photoplethysmogram | |
| | (i.e. pleth or PPG), derived | (i.e. pleth or PPG), derived | |
| | from the absorption of | from the absorption of | |
| | red/infra-red absorption in | red/infra-red absorption in | |
| | SpO2 used in three ways: | SpO2 used in three ways: | |
| | respiratory induced | respiratory induced | |
| | amplitude variation | amplitude variation | |
| | (RIAV), respiratory | (RIAV), respiratory | |
| | induced intensity variation | induced intensity variation | |
| | (RIIV), and respiratory | (RIIV), and respiratory | |
| | sinus arrhythmia (RSA). | sinus arrhythmia (RSA). | |
| Display | | | |
| Display Type | Touchscreen | Touchscreen | Same |
| Alarm | | | |
| Alarm Type(s) | Visual, Audible | Visual, Audible | Same |
| Technological Characteristics | | | |
| Display/Indicators | | | |
| Supported Parameters | SpO2, PR, PVi, and RRp, | SpO2, PR, PVi, RRp, | Subject device supports a |
| | | SpCO, SpMet, SpHb, | smaller set of parameters |
| | | SpOC, RRa | |
| Display Range | | | |
| SpO2 | 0-100% | 0-100% | Same |
| Pulse Rate | 25-240 bpm | 25-240 bpm | Same |
| Pi | 0.02-20% | 0.02-20% | Same |
| PVi | 0-100% | 0-100% | Same |
| Respiratory Rate from | 4-70 respirations per…