(87 days)
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.
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 Masimo 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 device's performance specifications are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (ARMS) | Reported Device Performance (ARMS) |
|---|---|---|
| SpO2, no motion (70-100%) | 2% (Adults/Pediatrics/Infants) | 2% (Adults/Pediatrics/Infants) |
| 3% (Neonates) | 3% (Neonates) | |
| SpO2, motion (70-100%) | 3% (Adults/Pediatrics/Infants/Neonates) | 3% (Adults/Pediatrics/Infants/Neonates) |
| SpO2, low perfusion (70-100%) | 2% (Adults/Pediatrics/Infants) | 2% (Adults/Pediatrics/Infants) |
| 3% (Neonates) | 3% (Neonates) | |
| Pulse rate, no motion (25-240 bpm) | 3 bpm | 3 bpm |
| Pulse rate, motion (25-240 bpm) | 5 bpm | 5 bpm |
| Pulse rate, low perfusion (25-240 bpm) | 3 bpm | 3 bpm |
| Respiration Rate from Pleth (4-70 rpm) | 3 rpm ARMS, 1 rpm Mean Error (Adults/Pediatrics) | 3 rpm ARMS, 1 rpm Mean Error (Adults/Pediatrics) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly detail the sample size for a specific clinical test set for the Masimo Rad-G. Instead, it states that "additional clinical testing was not deemed necessary to support the substantial equivalence" because the subject device "utilizes the same monitoring technologies as the predicate (K193242)," the Masimo Radical-7 Pulse Co-Oximeter and Accessories. The performance specifications listed are identical to those of the predicate device.
Therefore, the performance data for the Masimo Rad-G device is based on the data provenance of the predicate device, K193242, which is not detailed in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since "additional clinical testing was not deemed necessary" for the subject device due to its technological similarity to the predicate, this information is not provided for the Masimo Rad-G directly in this document. The ground truth would have been established during the development and clearance process of the predicate device (K193242), but details are not available here.
4. Adjudication Method for the Test Set
As "additional clinical testing was not deemed necessary" for the subject device, details on adjudication methods for a specific test set are not present in this document. This would have been part of the predicate device's (K193242) clinical validation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study is mentioned in the provided text for the Masimo Rad-G. The document focuses on demonstrating substantial equivalence to a predicate device rather than comparing against human readers or assessing improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
The performance specifications listed are for the device's direct measurements (SpO2, PR, RRp). These are standalone algorithms that continuously process physiological signals to output numerical values. The device itself is an automated measurement tool, thus its listed performance is inherently standalone (algorithm-only). The context implies that these are measurements derived directly from the device's sensor and internal processing, rather than requiring human interpretation for the primary output.
7. The Type of Ground Truth Used
Based on the nature of pulse oximetry and respiration rate measurements, the ground truth for establishing the accuracy of the predicate device (and by extension, the Masimo Rad-G) would typically involve:
- Fractional Arterial Oxygen Saturation (SaO2) from a co-oximeter and manual pulse rate counts for SpO2 and PR accuracy studies, often obtained from subjects undergoing induced hypoxia in controlled clinical settings.
- Reference respiration rate measurements (e.g., from capnography, impedance pneumography, or direct observation) for RRp accuracy studies.
The document states that the Masimo Rad-G utilizes the same principles of operation and has the same performance specifications as the predicate device (Masimo Radical-7, K193242). This indicates that the ground truth for the Masimo Rad-G's performance is derived from the ground truth established for the predicate device.
8. The Sample Size for the Training Set
The document does not describe the a "training set" in the context of machine learning, nor does it specify a sample size for such a set. The device utilizes established physiological measurement technologies (Masimo SET pulse oximetry and Respiration Rate from Plethysmograph) rather than a novel machine learning algorithm that would require a dedicated training set. The performance is validated against clinical trials previously conducted for the predicate technology.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a "training set" in the machine learning sense, this information is not applicable. The core technology and its accuracy were established during the development and clinical validation of the Masimo SET Pulse Oximetry and Respiration Rate from Plethysmograph system, which underlies both the predicate and subject devices. This would have involved comparing the device's measurements against accepted clinical reference standards (as described in point 7).
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 ofManufacturing Facility: | Masimo Corporation52 DiscoveryIrvine, CA 92618Phone: (949) 297-7000FAX: (949) 297-7592 |
|---|---|
| Date: | June 26 2020 |
| Contact: | Katelynn KirbyRegulatory Affairs Specialist IIIMasimo CorporationPhone: (949) 297-7408 |
| Trade Name: | Masimo Rad-G Pulse Oximeter and Accessories |
| Common Name: | Oximeter |
| Classification Regulation/Product Code: | 21 CFR 870.2700, Class II/DQA |
| Additional ClassificationRegulation/Product Code(s): | 21 CFR 868.2375, Class II/BZQ |
| Establishment RegistrationNumber: | 3011353843 |
| Reason for PremarketNotification: | 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 beenpromulgated 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)3% (Neonates) |
| SpO2, motion (70-100%) | 3% (Adults/Pediatrics/Infants/Neonates) |
| SpO2, low perfusion (70-100%) | 2% (Adults/Pediatrics/Infants)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/ProductCode | 21 CFR 870.2700, ClassII/DQA | 21 CFR 870.2700, ClassII/DQA | Same |
| AdditionalClassification/ProductCode | 21 CFR 868.2375, ClassII/BZQ | 21 CFR 868.2375, ClassII/BZQ21 CFR 862.3200, ClassII/JKS21 CFR 870.2710, ClassII/DPZ | Subject device supports asmaller set of product codes. |
| Indications for Use | The Rad-G Pulse Oximeteris intended for the | The Radical-7 andAccessories are indicated | Subject device supports asmaller set of monitoring |
| noninvasive spot-checkingor continuous monitoringof functional oxygensaturation of arterialhemoglobin (SpO2), PulseRate (PR), and PlethRespiration Rate (RRp). | for the continuous non-invasive monitoring offunctional oxygensaturation of arterialhemoglobin (SpO2) andpulse rate (PR) of adult,pediatric, and neonatalpatients during both nomotion and motionconditions, and for patientswho are well or poorlyperfused in hospitals,hospital-type facilities,mobile, and homeenvironments. | parameters.Subject device supports bothspot-checking andcontinuous monitoring. | |
| The Rad-G Pulse Oximeteris indicated for use thenoninvasive spot-checkingor continuous monitoringof functional oxygensaturation of arterialhemoglobin (SpO2) andPulse Rate (PR)of adult,pediatric, infant, andneonate patients duringboth no motion and motionconditions, and for patientswho are well or poorlyperfused in hospitals,hospital-type facilities,transport, and homeenvironments. | The Radical-7 andAccessories are indicatedfor the continuous non-invasive monitoring ofcarboxyhemoglobinsaturation (SpCO) of adult,pediatric, and infantpatients during no motionconditions in hospitals andhospital-type facilities. TheMasimo Radical-7 andAccessories are notintended to be used as thesole basis for makingdiagnosis or treatmentdecisions related tosuspected carbon monoxidepoisoning; it is intended tobe used in conjunction withadditional methods ofassessing clinical signs andsymptoms. | ||
| The Rad-G Pulse Oximeteris indicated for use thenoninvasive spot-checkingor continuous monitoringof Respiration Rate fromthe photoplethysmogram(RRp) of adult andpediatric patients during nomotion conditions inhospitals, hospital-typefacilities, transport, andhome environments. | The Radical-7 andAccessories are indicatedfor the continuous non-invasive monitoring ofmethemoglobin 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 | 4-70 respirations per | Same |
| Pleth | minute | minute | |
| Performance (Arms) | |||
| SpO2, No Motion (70- | 2% | 2% | Same |
| 100%) | (Adults/Pediatrics/Infants) | (Adults/Pediatrics/Infants) | |
| 3% (Neonates) | 3% (Neonates) | ||
| SpO2, Motion (70-100%) | 3% | 3% | Same |
| SpO2, Low Perfusion | 2% | 2% | Same |
| (70-100%) | (Adults/Pediatrics/Infants) | (Adults/Pediatrics/Infants) | |
| 3% (Neonates) | 3% (Neonates) | ||
| Pulse Rate, No Motion(25-250 bpm) | 3 bpm | 3 bpm | Same |
| Pulse Rate, Motion (25-250 bpm) | 5 bpm | 5 bpm | Same |
| Pulse Rate, LowPerfusion (25-250 bpm) | 3 bpm | 3 bpm | Same |
| Respiration Rate fromPleth (4-70 rpm) | 3 rpm ARMS, 1 rpm MeanError (Adults/Pediatrics) | 3 rpm ARMS, 1 rpm MeanError (Adults/Pediatrics) | Same |
| Environmental | |||
| Operating Temperature | 0 to 40 °C (32 to 104 °F) | 0 to 50 °C (32 to 122 °F) | Subject device has a lowerhigh temperaturespecification |
| Storage Temperature | -20 to 70 °C (-4 to 158 °F) | -40 to 70 °C (-40 to 158°F) | Subject device has a higherlow temperaturespecification |
| Operational/StorageHumidity | 10 to 95%, non-condensing | 10 to 95%, non-condensing | Same |
| Operating AtmosphericPressure | 540 mbar to 1,060 mbar(540 hPa to 1060 hPa) | 540 mbar to 1,060 mbar(540 hPa to 1060 hPa) | Same |
| Mechanical | |||
| Dimensions | 7.8 x 2.9 x 1 in. (19.8 x7.4 x 2.5 cm) | 8.8 x 3.5 x 1.7 in. (22.3 x8.9 x 4.3 cm) | Subject device is smaller insize |
| Weight | 0.27 kg (0.59 lbs) | 0.59 kg (1.3 lbs.) | Subject device is lighterweight |
| Electrical | |||
| Supported Power Source | AC Power or InternalBattery | AC Power or InternalBattery | Same |
| Internal Battery Type | Rechargeable Lithium Ion | Rechargeable Lithium Ion | Same |
| AC Power Source | External AC PowerSupply | External Docking Station(e.g., Root or RDS) | Subject device does notrequire a docking station. |
| AC Power | 100-240 VAC, 50/60 Hz,0.6A | 100-240 VAC, 47-63 Hz | Similar |
| I/O Interface | |||
| Network | Wireless (e.g., Wi-Fi,Bluetooth) | Wireless (e.g., Wi-Fi,Bluetooth) and Ethernet | Similar, subject device doesnot provide an Ethernetconnection |
| Classification per IEC60601-1 | |||
| Mode of Operation | Continuous | Continuous | Same |
Table 4.1- Comparison Table
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Image /page/7/Picture/1 description: The image shows the logo for Masimo, a medical technology company. 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 some smaller text, which is difficult to read due to the image quality.
MASIMO CORPORATION 52 Discovery Irvine, CA 92618
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Image /page/8/Picture/1 description: The image shows the logo for Masimo, a medical technology company. The logo features a red circle with a white checkmark inside, followed by the company name in bold, black letters. The text to the right of the logo is blurry and unreadable.
MASIMO CORPORATION 52 Discovery Irvine, CA 92618
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Image /page/9/Picture/1 description: The image shows the logo for Masimo, a medical technology company. 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 word "Masimo" is some smaller text that is difficult to read.
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Image /page/10/Picture/1 description: The image shows the logo for Masimo. 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 some smaller text, which is likely the company's address.
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Image /page/11/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".
5. Performance Data
Biocompatibility Testing:
The Masimo Rad-G is not intended to make direct patient contact. Therefore, biocompatibility testing was not considered necessary.
The accessories which are intended to make contact with the patient were evaluated for biocompatibility. The accessories to be used with the Rad-G are the same as those for the predicate, Radical-7 (K193242), with the exception of the Rad-G reusable and Rad-G YI sensors.
For the Rad-G reusable and Rad-G YI sensors, the patient contacting parts are the same as the previously cleared RD SET version under K193242. The difference between the Rad-G reusable DCI and Rad-G YI sensor is in the device connector which makes them compatible to the Rad-G device.
Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning
Electromagnetic Compatibility, Electrical Safety, Environmental, and Mechanical testing was conducted to support the Masimo Rad-G and Accessories meet its specification and its substantial equivalence. As the Rad-G is not intended to make direct patient contact, cleaning validation was not conducted.
Software Verification and Validation Testing
Software verification and validation testing were conducted and the documentation is provided as recommended by FDA's Guidance, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005. The software for this device was considered as a "moderate" level of concern, as defined by the FDA guidance, Guidance for Industry and FDA Staff -Pulse Oximeters - Premarket Notifications [510(k)s], dated March 3, 2013, which identifies that a failure or latent flaw in the software could directly result in minor to moderate injury to the patient. The test results were found to support the substantial equivalence of the subject device.
Human Factors Usability Testing
As the subject device and the predicate provide similar user interface, the previous human factors testing conducted on the predicate device was considered to support the acceptability of the human factors and usability risks of the subject device. The acceptability of the human factors and usability risks took into account the FDA Guidance, Applying Human Factors and Usability Engineering to Optimize Medical Device Design, dated February 3, 2016.
Non-clinical Performance Testing
As the subject device utilizes the same monitoring technologies as the predicate (K193242), non-clinical performance bench testing was performed to ensure the successful integration of the monitoring technologies and electrical sensor connection. The test results were found to support the substantial equivalence of the subject device.
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Image /page/12/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, sans-serif font. To the right of the logo is the text "MASIMO CORPORATION" in a smaller, gray font, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.
Clinical Testing
As the subject device utilizes the same monitoring technologies as the predicate (K193242), additional clinical testing was not deemed necessary to support the substantial equivalence.
6. Conclusion
The subject device and the predicate device have the same intended use, and the difference in technological features do not raise different questions of safety and effectiveness. The data provided supports the substantial equivalence of the Masimo Rad-G and Accessories to the proposed predicate device.
§ 870.2700 Oximeter.
(a)
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.(b)
Classification. Class II (performance standards).