(135 days)
No
The summary focuses on standard physiological monitoring technologies (SpO2, PR, SpCO, SpMet, SpHb, RRa, Capnography, NIBP) and their performance metrics. There is no mention of AI, ML, or any algorithms that would typically be associated with these technologies for advanced analysis or prediction. The device description highlights the display, power source, and communication capabilities, not advanced computational methods.
No.
The device is indicated for continuous non-invasive monitoring of various physiological parameters and provides data to multi-parameter devices or for remote viewing and alarming. It explicitly states it is "not intended to be used as the sole basis for making diagnosis or treatment decisions," which means it does not provide therapy or directly influence patient treatment.
Yes
Explanation: The device is indicated for continuous non-invasive monitoring of various physiological parameters (SpO2, PR, SpCO, SpMet, SpHb, RRa, CO2, NIBP), which involve gathering data about a patient's health status for the purpose of informing clinical decisions. While one indication states it's not intended as the sole basis for diagnosis, the act of monitoring these parameters for clinical use inherently contributes to the diagnostic process.
No
The device description explicitly states that the Masimo Rad-97 System and Accessories (Rad-97 product family) features a touchscreen display and can be operated on AC power or internal rechargeable battery. It also describes the Centroid O2 sensor as a wearable, battery-operated sensor with disposable and reusable components, including hardware for wireless data transfer. These are all physical hardware components, not solely software.
Based on the provided text, the Masimo Rad-97 and Accessories are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description of the Masimo Rad-97 and Accessories clearly states that it is a non-invasive monitoring device. It measures physiological parameters directly from the patient's body (e.g., through sensors on the skin) without requiring the collection and analysis of biological specimens.
- Measured Parameters: The parameters measured (SpO2, PR, SpCO, SpMet, SpHb, RRa, CO2, NIBP) are all obtained through non-invasive means.
Therefore, the Masimo Rad-97 and Accessories fall under the category of non-invasive physiological monitoring devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multiparameter devices for the display on those devices.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.
The Masimo Rad-97 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 Masimo Rad-97 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 optional Nomoline Capnography product family is intended to be connected to other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient room. The intent population is adult, pediatric and infant patients.
The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in hospital-type facilities, mobile, and home environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:
Patient Population Approximate Age Range
Newborn (neonate) Birth to 1 month of age
Infant 1 month to 2 years of age
Child 2 to 12 years of age
Adolescent 12-21 years of age
Adult 21 years of age and older
The optional Masimo Centroid O2 is intended for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).
The optional Masimo Centroid 02 is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO2) and pulse rate (PR) for use with adult, pediatric and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospital, hospital-type facilities and home environments. Devices with Masimo technology are only to be used with Masimo sensors and cables.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DQA, DPZ, DXN, CCK, BZQ, FLL
Device Description
The subject device, Masimo Rad-97 System and Accessories (Rad-97 product family), features a touchscreen display that continuously displays numeric values for the measured monitoring parameters. The Rad-97 product family can be operated on AC power or internal rechargeable battery.
The subject device (Rad-97 product family) is substantially the same as the predicate (Rad-97 product family) cleared under K180046, and has the same indications for use. The Rad-97 comprises of the same measurement technologies as cleared in the predicate, which includes the Masimo rainbow SET technology, capnography technology, and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.
The subject of this submission, is the inclusion of Masimo Centroid 02 sensor to be used with the Rad-97 and similar devices that utilize Masimo SET technology.
The Centroid O2 is a family of wearable, battery operated, sensors that support Masimo SET technology. The Centroid O2 uses wireless communication to a host device (e.g., Rad-97, Radical-7) in order to support the continuous monitoring of Masimo SET parameters (SpO2 and PR). Centroid O2, similar to the previously cleared RD SET sensors (K180046), are intended for the noninvasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).
The Centroid O2 consists of both disposable and reusable components. The disposable components include the sensor and wrist strap: the reusable component contains the hardware to transfer the measured data wirelessly. Centroid 02 uses a battery as a power source for the sensor and to enable measurement data to be transferred wirelessly to a host device (e.g. Rad-97, Radical-7).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, pediatric, neonatal, infant. For NIBP: Newborn (neonate - Birth to 1 month of age), Infant (1 month to 2 years of age), Child (2 to 12 years of age), Adolescent (12-21 years of age), Adult (21 years of age and older).
Intended User / Care Setting
Hospital-type facilities, mobile, home environments, transport within healthcare facilities, operating suite, intensive care unit, patient room.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
- Electrical safety testing per IEC 60601-1
- EMC testing per IEC 60601-1-2
- Usability testing per FDA Human Factors and Usability Guidance
- Software verification and validation testing per FDA Software Guidance
- Biocompatibility testing per ISO-10993
- Mechanical testing per IEC 60601-1 and ISO 80601-2-61
The non-clinical testing was conducted in accordance with Masimo requirements to ensure that the specifications of the subject device were met. The testing was found to support the substantial equivalence of the subject device.
Clinical Testing:
- Study Type: Clinical study performed in accordance with ISO 80601-2-61.
- Sample Size: healthy adult volunteers (specific number not provided).
- Data Source: Blood measurements from a laboratory CO-Oximeter.
- Key Results:
- % SpO2 No Motion Accuracy: Bias -0.5, Adjusted Precision 1.2, Adjusted RMS 1.3. ARMs value is 2%.
- % SpO2 Motion Accuracy: Bias -0.9, Adjusted Precision 2.0, Adjusted RMS 2.2. ARMs value is 3%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy (ARMS) for Rad-97:
- SpO2, no motion: 70-100%, 2%, adults/pediatrics/infants; 70-100%, 3%, neonates
- SpO2, motion: 70-100%, 3% adults/pediatrics/infants/neonates
- SpO2, low perfusion: 70-100%, 2%, adults/pediatrics/infants; 70-100%, 3%, neonates
- Pulse rate, no motion: 25-240 bpm, 3 bpm, adults/pediatrics/infants/neonates
- Pulse rate, motion: 25-240 bpm, 5 bpm, adults/pediatrics/infants/neonates
- Pulse rate, low perfusion: 25-240 bpm, 3 bpm, adults/pediatrics/infants/neonates
- RRa: 4-70 breaths per minute, 1 breath per minute, adults/pediatrics
- SpCO: 1-40%, 3%, adults/pediatrics/infants
- SpMet: 1-15%, 1%, adults/pediatrics/infants/neonates
- SpHb Limits of Agreement (LOA) over a range of 8-17 g/dL: -1.83 to 1.57 g/dL
- CO2 (Single dry gasses at 22+ 5°C and 1013 + hPa): 0-15 volume % +0.2 volume% +2% or reading; All conditions: 0.3 kPa + 4% of reading
- Respiration rate: 0-150 breaths/min + 1 breaths/min
- NIBP: 0-300 mmHg, +3 mmHg
Accuracy (ARMS) for Centroid O2:
- SpO2, no motion: 70-100%, 2%, adults/pediatrics/infants; 70-100%, 3%, neonates
- SpO2, motion: 70-100%, 3% adults/pediatrics/infants/neonates
- SpO2, low perfusion: 70-100%, 2%, adults/pediatrics/infants; 70-100%, 3%, neonates
- Pulse rate, no motion: 25-240 bpm, 3 bpm, adults/pediatrics/infants/neonates
- Pulse rate, motion: 25-240 bpm, 5 bpm, adults/pediatrics/infants/neonates
- Pulse rate, low perfusion: 25-240 bpm, 3 bpm, adults/pediatrics/infants/neonates
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K180046 - Masimo Rad-97 and Accessories
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K153225 - Masimo Root Monitoring System and Accessories
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
Masimo Corporation Sindura Penubarthi Regulatory Affairs Manager 52 Discovery Irvine, California 92618
Re: K183697
Trade/Device Name: Masimo Rad-97 and Accessories Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DQA, DPZ, DXN, CCK, BZQ, FLL Dated: April 15, 2019 Received: April 16, 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
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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/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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Michael Ryan 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
2
Indications for Use
510(k) Number (if known) K183697
Device Name Masimo Rad-97 with Accessories
Indications for Use (Describe)
The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multiparameter devices for the display on those devices.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospital-type facilities. The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal pation conditions in hospitals and hospitals and hospital-type facilities.
The Masimo Rad-97 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 hospital-type facilities.
The Masimo Rad-97 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 optional Nomoline Capnography product family is intended to other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediatric and infant patients.
The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in hospitals, hospital-type facilities, mobile, and home environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:
Patient Population Approximate Age Range Newborn (neonate) Birth to 1 month of age Infant 1 month to 2 years of age Child 2 to 12 years of age Adolescent 12-21 years of age Adult 21 years of age and older
FORM FDA 3881 (7/17)
Form Approved: OMB No. 0910-0120
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The optional Masimo Centroid O2 is intended for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).
The optional Masimo Centroid O2 is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO2) and pulse rate (PR) for use with adult, pediatric and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospital-type facilities and home environments.
Devices with Masimo technology are only to be used with Masimo sensors and cables.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 201.5 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201.5 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------ |
X | Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a bold, sans-serif font, with a stylized red symbol to the left of the word. To the right of the word "Masimo" are the words "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".
| Submitter and Address of
Manufacturing Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7000
FAX: (949) 297-7592 |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | December 27, 2018 |
| Contact: | Sindura Penubarthi
Regulatory Affairs Manager
Masimo Corporation
Phone: (949) 297-7541 |
| Trade Name: | Masimo Rad-97 and Accessories |
| Common Name: | Patient Monitor |
| Classification Regulation/ Product
Code: | 21 CFR 878.2300, Class II/MWI |
| Additional Product Code: | 21 CFR 870.2700, Class II/DQA
21 CFR 880.2910, Class II/CCK
21 CFR 862.3220, Class II/JKS
21 CFR 868.2375, Class II/BZQ
21 CFR 870.1130, Class II/DXN
21 CFR 880.2910, Class II/FLL |
| Establishment Registration
Number: | 2031172 |
| Reason for Premarket
Notification: | New Device |
| Predicate Device: | K180046 - Masimo Rad-97 and Accessories |
| Reference Predicate: | K153225 - Masimo Root Monitoring System and Accessories |
| Performance Standards | No performance standards for the above device have been promulgated
pursuant to Section 514. |
5.1. Device Description
The subject device, Masimo Rad-97 System and Accessories (Rad-97 product family), features a touchscreen display that continuously displays numeric values for the measured monitoring parameters. The Rad-97 product family can be operated on AC power or internal rechargeable battery.
The subject device (Rad-97 product family) is substantially the same as the predicate (Rad-97 product family) cleared under K180046, and has the same indications for use. The Rad-97 comprises of the same measurement technologies as cleared in the predicate, which includes the Masimo rainbow SET technology, capnography technology, and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive
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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 stylized red symbol to the left. Below the logo, the text "62 Discovery, Irvine, CA 92618" is present, indicating the company's address.
monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.
The subject of this submission, is the inclusion of Masimo Centroid 02 sensor to be used with the Rad-97 and similar devices that utilize Masimo SET technology.
The Centroid O2 is a family of wearable, battery operated, sensors that support Masimo SET technology. The Centroid O2 uses wireless communication to a host device (e.g., Rad-97, Radical-7) in order to support the continuous monitoring of Masimo SET parameters (SpO2 and PR). Centroid O2, similar to the previously cleared RD SET sensors (K180046), are intended for the noninvasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).
The Centroid O2 consists of both disposable and reusable components. The disposable components include the sensor and wrist strap: the reusable component contains the hardware to transfer the measured data wirelessly. Centroid 02 uses a battery as a power source for the sensor and to enable measurement data to be transferred wirelessly to a host device (e.g. Rad-97, Radical-7).
| Feature | Rad-97 Specification |
|---|---|
| Display | |
| Display Type | Touchscreen, Color LCD (Backlit Active Matrix TFT LCD) |
| Measurement Display Range | Functional Oxygen Saturation (SpO2): 0-100% |
| Pulse Rate (PR): 25-240 beats per minute (bpm) | |
| Perfusion Index (Pi): 0.02-20% | |
| Pleth Variability Index (PVi): 0-100% | |
| Respiration Rate (RRa): 0-70 breaths per minute | |
| Carboxyhemoglobin Saturation (SpCO): 0-99% | |
| Methemoglobin Saturation (SpMet): 0-99.9% | |
| Total Hemoglobin (SpHb): 0-25g/dL; 0-250g/L(0-15.52 mmol/dL) | |
| Oxygen Concentration (SpOC): 0-35ml of O2/dL | |
| Carbon Dioxide (CO2); 0 vol%-15 vol % | |
| End Tidal CO2 (EtCO2): 0-25 %, 0-32.5 kPa, 0-244 mmHg | |
| Fractional Inspired CO2 (FiCO2): 0-25 %, 0-32.5 kPa, 0-244 mmHg | |
| Respiratory Rate (RR): 0-150 breaths/min | |
| Adult, Systolic: 40-260 mmHg, Diastolic: 20-200 mmHg, MAP 26-220mmHg | |
| Pediatric, Systolic: 40-230 mmHg, Diastolic: 20-160 mmHg, MAP 26-183 mmHg | |
| Neonatal, Systolic: 40-130 mmHg, Diastolic: 20-100 mmHg, MAP 26-110mmHg | |
| Feature | Rad-97 Specification |
| Display Resolution | SpO2: 1% |
| PR: 1 bpm | |
| RRa: 1breath per minute | |
| SpCO: 1% | |
| SpMet: 0.1% | |
| SpHb: 0.1 g/dL | |
| SpOC: 0.1 ml/dL | |
| Accuracy (ARMS)* | Masimo Rainbow SET/ Masimo SET Parameters |
| SpO2, no motion | 70-100%, 2%, adults/pediatrics/infants |
| 70-100%, 3%, neonates | |
| SpO2, motion | 70-100%, 3% adults/pediatrics/infants/neonates |
| SpO2, low perfusion | 70-100%, 2%, adults/pediatrics/infants |
| 70-100%, 3%, neonates | |
| Pulse rate, no motion | 25-240 bpm, 3 bpm, adults/pediatrics/infants/neonates |
| Pulse rate, motion | 25-240 bpm, 5 bpm, adults/pediatrics/infants/neonates |
| Pulse rate, low perfusion | 25-240 bpm, 3 bpm, adults/pediatrics/infants/neonates |
| RRa | 4-70 breaths per minute, 1 breath per minute, adults/pediatrics |
| SpCO | 1-40%, 3%, adults/pediatrics/infants |
| SpMet | 1-15%, 1%, adults/pediatrics/infants/neonates |
| SpHb Limits of Agreement (LOA) over a | |
| range of 8-17 g/dL | -1.83 to 1.57 g/dL |
| Accuracy | Optional Nomoline Capnography or Optional NIBP Parameters |
| CO2 | Single dry gasses at 22+ 5°C and 1013 + hPa: |
| 0-15 volume % +0.2 volume% +2% or reading | |
| All conditions: 0.3 kPa + 4% of reading | |
| Respiration rate | 0-150 breaths/min + 1 breaths/min |
| NIBP | 0-300 mmHg, +3 mmHg |
| Displays/ Indicators | |
| Data displayed | SpO2, PR, SPCO, SpMet, SpHb, Rra, Pi, PVi, SpOC, NIBP, CO2, pleth |
| waveform, alarm status, status messages, sensor status, Signal IQ, APOD, | |
| FastSat, | |
| Alarm | Alarm limits (audible and visual), 3D alarm, alarm silence, sensor condition |
| alarms, system failure alarms, low battery alarms | |
| SpO2: 2-4, 4-6, 8, 10, 12, 14 and 16 seconds; | |
| RRa: Trending, No Averaging, Fast, Medium, or Slow | |
| Averaging time | PVi: Short or Long; |
| Pi: Short or Long; | |
| SpHb: Short, Medium, or Long | |
| Sensitivity mode | Normal, APOD, and MAX |
| Sleep study mode | 10 seconds |
| Electrical | |
| AC power | Input voltage: 100-240 VAC, 47-63 Hz; input power: 60 VA |
| Internal battery power | Rechargeable lithium ion battery |
| Input/ Output Interface | |
| Patient applied part connection | M-20 connector |
| Nomoline Capnography input connector | |
| NIBP Nib | |
| Feature | Rad-97 Specification |
| USB interface | SatShare module and external devices (e.g. barcode reader/scanner) connection |
| Wired (Ethernet) and wireless (Wi-Fi/Bluetooth) interface | Wired/wireless connection with networked Patient SafetyNet and/or EMR systems Wireless connection with presence tag, Kite, external devices (e.g. Caregiver thermometer) |
| Camera (MIPI camera interface) | Surveillance/conferencing capabilities with Patient SafetyNet |
| Audio | Microphone supporting video/audio modes for surveillance/conferencing capabilities with Patient SafetyNet |
| Mechanical | |
| Enclosure Material | Thermoplastic |
| Dimensions | 9×4×6.5 inch (22.9×10.2×16.5cm) |
| Weight | 0.92 kg. (2.03 lbs.) without Capnography and NIBP |
| Environmental | |
| Operating Temperature | 0 to 35 °C (32 to 95 °F) |
| Storage/Transport Temperature | -20 to 60 °C (-4 to 140 °F) |
| Operating Humidity | |
| Non NiBP/Nomoline Capnography | 10% to 95%, non-condensing |
| Operating Humidity | |
| NiBP/Nomoline Capnography | 15% to 95%, non-condensing |
| Storage/Transport Humidity | |
| Non NiBP/Nomoline Capnography | 10% to 90%, non-condensing |
| NiBP/Nomoline Capnography | 15% to 90% non-condensing |
| Operating Atmospheric Pressure | |
| Non-NiBP/ Nomoline Capnography | 540 mbar to 1,060 mbar (540 hPa to 1060 hPa) |
| Nomoline Capnography | 525 mbar to 1,200 mbar (525 hPa to 1200 hPa) (corresponding to a max altitude of 4572 m / 15 000 feet) |
| Compliance | |
| Electrical Safety/EMC | IEC 60601 compliant |
| Type of Protection | Class I, when on AC power; internally powered, when on battery power |
| Degree of Protection | Defibrillation proof, BF-applied part |
| Protection against harm from liquid ingress | IPX1, protection vertically falling water drops |
| IPX2, protection against falling water drops when enclosure is tilted at 15 degrees | |
| Mode of Operation per IEC 60601-1 | Continuous operation |
The specifications for Rad-97 are as follows:
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*Aws accuracy is a statistical calculation of the difference between device measurements. Approximately two-thirds of the device measurements fell within +/- Arms of the reference measurements in a controlled study.
The specifications for Centroid O2 are as follows:
| Feature | Centroid O2 Specification |
|---|---|
| Accuracy (ARMS)* | Masimo SET Parameters |
| SpO2, no motion | 70-100%, 2%, adults/pediatrics/infants |
| SpO2, no motion | 70-100%, 3%, neonates |
| SpO2, motion | 70-100%, 3% adults/pediatrics/infants/neonates |
| SpO2, low perfusion | 70-100%, 2%, adults/pediatrics/infants |
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| Feature | Centroid O2 Specification |
|---|---|
| 70-100%, 3%, neonates | |
| Pulse rate, no motion | 25-240 bpm, 3 bpm, adults/pediatrics/infants/neonates |
| Pulse rate, motion | 25-240 bpm, 5 bpm, adults/pediatrics/infants/neonates |
| Pulse rate, low perfusion | 25-240 bpm, 3 bpm, adults/pediatrics/infants/neonates |
| Mode of Operation per IEC 60601-1 | Continuous operation |
*ARMs accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- AxMs of the reference measurements in a controlled study.
5.2. Intended Use/ Indications for Use
The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multiparameter devices for the display on those devices.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.
The Masimo Rad-97 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 Masimo Rad-97 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 optional Nomoline Capnography product family is intended to be connected to other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to be connected to a patient breathing circuit for monitoring of
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inspired/expired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient room. The intent population is adult, pediatric and infant patients.
The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in hospital-type facilities, mobile, and home environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:
| Patient Population | Approximate Age Range |
|---|---|
| Newborn (neonate) | Birth to 1 month of age |
| Infant | 1 month to 2 years of age |
| Child | 2 to 12 years of age |
| Adolescent | 12-21 years of age |
| Adult | 21 years of age and older |
The optional Masimo Centroid O2 is intended for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).
The optional Masimo Centroid 02 is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO2) and pulse rate (PR) for use with adult, pediatric and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospital, hospital-type facilities and home environments. Devices with Masimo technology are only to be used with Masimo sensors and cables.
5.3. Technological Characteristics
Principle of Operation
The principle of operations for the measurement capabilities of the Rad-97 product family with Centroid 02 does not change from the predicate (K180046). The principles of operation are still based upon the use of red and infrared wavelengths of light provided by an emitter and the detection of the signal from the light absorption of oxygenated blood and deoxygenated blood to provide functional oxygen saturation of hemoglobin (SpO2).
In regards to the wireless transfer of data to a host device (e.g. Rad-97, Radical-7), the Rad-97 with Centroid O2 uses the same principle of operation as the reference predicate, Root with Radius-7 (K153225). The transferred data can then be used by the host device (e.g. Rad-97, Radical-7) to display and provide monitoring similar to the reference predicate, Root with Radius-7.
Mechanism of Action for Achieving the Intended Effect
The mechanism of action for the Rad-97 with the Centroid O2 involves the application of sensor
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emitter and detector of the Centroid O2 to the measurement site similar to the primary predicate. The sensor is then secured to the patient using the integral strap provided with the sensor, similar to the reference predicate.
To start the wireless communication from the host device (e.g. Rad-97, Radical-7) to the Centroid 02, the reusable module is paired to the wireless receiver connected to the host device, similar to reference predicate. Once the pairing operation is completed. the reusable module is connected to sensor to begin the measurement and communication of the measurement to the host device for display and monitoring. The Centroid O2 will securely pair with the wireless receiver upon successful confirmation that device is valid.
Upon successful secure wireless connection of Centroid O2 System with the host device (e.g., Rad-97, Radical-7), measurement data collected via the Centroid 02 is sent to the host device for display and monitoring, similar to the predicates.
5.4. Summary of Technological Characteristics of Subject Device Compared to Predicate Device
Similarities and Differences between Predicate and Subject Device
The subject device, Masimo Rad-97 and Accessories (Centroid O2) and the predicate device, Masimo Rad-97 and Accessories (RD SET sensor) (K180046), have the following key similarities:
- Both devices utilize Masimo SET and Rainbow SET Technology;
- . Both devices have the same intended use as a patient monitoring device;
- Both devices have the same performance specifications;
- . Both devices have the same input/ output interfaces that allows connection with external devices and with networked systems;
- . Both sensors continuously monitor and report patient activity to the host device;
- . The subject sensor includes wireless technology to connect to a host/backbone device, similar to the reference predicate Radius-7 cleared under K153225:
- . The subject sensor is internally powered by a battery module similar to the reference predicate Radius-7 cleared under K153225.
The subject device. Masimo Rad-97 with Centroid O2 System, and the predicate device, Masimo Rad-97 and Accessories (K180046), have the following key differences:
- . Both devices have similar indications for Use; however, the subject device includes addition of Centroid O2 to the existing indications
5.5. Performance Data
Biocompatibility Testing:
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Rad-97 product family is not intended for patient contact, thus the device does not include patient contacting materials. Therefore, biocompatibility testing is not applicable.
The Centroid O2 includes a single patient use adhesive sensor that includes patient contacting materials. These materials have been evaluated for biocompatibility and are compliant to ISO-10993. Testing performed and submitted supports the biocompatibility testing for the patient contacting materials.
Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning
Testing was performed and submitted with respect to the EMC compliance to IEC 60601-1-2, Electrical Safety compliance to IEC 60601-1, environmental, mechanical, and cleaning chemical resistance. The testing was found to support the substantial equivalence of the subject device.
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 Notification Submissions [510(k)s], dated March 3, 2013, because a failure or latent flaw in the software could directly result in minor to moderate injury to the patient. The testing was found to support the substantial equivalence of the subject device.
Wireless and Cybersecurity Testing
As the subject device uses wireless communication between the Centroid O2 to the wireless receiver attached to host device (e.g., Rad-97, Radical-7) wireless and cybersecurity considerations were made in accordance with FDA Guidance for Industry and Food and Drug Administration Staff- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, dated October 2, 2014 and draft guidance dated October 18, 2018. In accordance with the FDA guidance for Cybersecurity, the Rad-97 with Centroid O2 was considered a tier 2 device. A risk-based assessment and testing in accordance with referenced FDA guidance documents were conducted. The testing was found to support the substantial equivalence of the subject device.
Human Factors Usability Testing
Human factors and usability risk were evaluated and acceptably mitigated in accordance
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with FDA Guidance, Applying Human Factors and Usability Engineering to Optimize Medical Device Design, dated February 3, 2016. The testing was found to support the substantial equivalence of the subject device.
Non-clinical Testing
To support the substantial equivalence of the subject device, the following non-clinical bench testing was performed on the subject device Rad-97 with Centroid O2.
- . Electrical safety testing per IEC 60601-1
- EMC testing per IEC 60601-1-2 ●
- Usability testing per FDA Human Factors and Usability Guidance ●
- Software verification and validation testing per FDA Software Guidance ●
- Biocompatibility testing per ISO-10993
- Mechanical testing per IEC 60601-1 and ISO 80601-2-61 ●
The non-clinical testing was conducted in accordance with Masimo requirements to ensure that the specifications of the subject device were met. The testing was found to support the substantial equivalence of the subject device.
Clinical Testing
To establish the accuracy (Акмs) of the Centroid O2 sensors during no-motion and motion conditions, a clinical study was performed in accordance with ISO 80601-2-61. The study was done, as prescribed by the ISO 80601-2-61 standard, on healthy adult volunteers to evaluate the sensor's performance for no motion and motion conditions, in the range of 70% to 100% SaO2, in comparison to blood measurements from a laboratory CO-Oximeter. The results adjusted for the repeated measurements were as follows:
| % SpO2 No Motion Accuracy | ||
|---|---|---|
| Bias | Adjusted | |
| Precision | Adjusted | |
| RMS | ||
| -0.5 | 1.2 | 1.3 |
| % SpO2 Motion Accuracy | ||
|---|---|---|
| Bias | Adjusted | |
| Precision | Adjusted | |
| RMS | ||
| -0.9 | 2.0 | 2.2 |
Accordingly, the Arms value is 2% during no-motion conditions, and the Arms value is 3% during motion conditions.
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5.8 Conclusion
The non-clinical and clinical data support the substantial equivalence of the Rad-97 with Centroid 02.