(94 days)
No
The document describes the addition of a feature (RRp) that analyzes cyclic variations in photoplethysmogram data to determine respiration rate. While this involves signal processing and analysis, there is no mention of AI, ML, or related terms like neural networks or deep learning in the provided text. The description focuses on the method of analysis ("analyzing cyclic variations") rather than employing learning algorithms.
No.
The device is indicated for continuous non-invasive monitoring of various physiological parameters (e.g., oxygen saturation, pulse rate, hemoglobin levels, respiratory rate, blood pressure). Its function is to provide data for clinical assessment, not to administer treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section repeatedly states the device is for "continuous non-invasive monitoring" of various physiological parameters (SpO2, PR, SpCO, SpMet, SpHb, RRa, RRp, NIBP, breath rate, CO2). While it states it's not intended as the sole basis for diagnosis in one instance (carbon monoxide poisoning), the act of monitoring these parameters to assess a patient's condition falls under the broad definition of diagnostics. Medical monitoring is a form of diagnostic activity, as it provides data used by clinicians to diagnose and manage medical conditions.
No
The device description explicitly states that the submission is adding a software feature (RRp) to previously cleared hardware devices (Masimo Rad-97, Radical-7, and Radius-7 Pulse CO-Oximeters and Accessories). These are described as portable monitors, handheld monitors, and wearable monitors, all of which are hardware devices.
Based on the provided information, the Masimo Rad-97, Radical-7, and Radius-7 Pulse CO-Oximeters and Accessories are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens, such as blood, urine, or tissue, that are taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The descriptions clearly state that these devices are non-invasive monitoring devices. They measure physiological parameters directly from the patient's body (e.g., through a sensor on the finger) without requiring the collection of a specimen.
- Measured Parameters: The parameters measured (SpO2, PR, SpCO, SpMet, SpHb, RRa, RRp, NiBP, CO2) are all obtained through non-invasive means.
- Intended Use: The intended use focuses on continuous non-invasive monitoring of these parameters for various patient populations and care settings.
Therefore, these devices fall under the category of non-invasive patient monitoring devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Masimo Rad-97 Pulse CO-Oximeter and Accessories:
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 multi-parameter 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 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 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 pediatic 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, pediativ and infant patients.
The optional non-invasive blood pressure (NiBP) module is indicated for the noninvasive measurement of arterial blood pressure. 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 |
Devices with Masimo technology are only to be used with Masimo sensors and cables.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.
Masimo Radical-7 Pulse CO-Oximeter and Accessories:
The Radical-7 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 Radical-7 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 Radical-7 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 Radical-7 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 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 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 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 photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.
Masimo Radius-7 Pulse CO-Oximeter and Accessories:
The Radius-7 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 Radius-7 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 Radius 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 Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoplobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.
The Radius-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 Radius-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 hospital-type facilities, home environments, and transport within healthcare facilities.
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from Pleth (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.
Product codes (comma separated list FDA assigned to the subject device)
MWI, BZQ, CCK, DQA, DPZ, DXN, FLL, JKS
Device Description
The subject of the submission is to add Respiration Rate from photoplethysmogram (designated as RRp) feature to the previously cleared Masimo Pulse Oximetry devices. The RRp feature that was previously cleared as part of MightySat fingertip pulse oximeter under K181956. RRp feature determines the patient's respiration rate by analyzing cyclic variations in photoplethysmogram (pleth) to establish respiration measurement. The devices in which the RRp feature is being added as part of this submission are the previously cleared Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, and Masimo Radius-7 Pulse CO-Oximeter.
Rad-97 Pulse CO-Oximeter:
Masimo Rad-97 System and Accessories (Rad-97), is a portable monitor that features a touchscreen that provides a display and control user interface for monitored parameters. The Rad-97 product family can be operated on AC power or internal rechargeable battery. The Rad-97 comprises of technologies that enable the device to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PV), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), and/or capnography parameters or noninvasive blood pressure (NIBP) parameters. The subject of this submission is the addition of the RRp feature to the Rad-97. The technological characteristics of the RRp feature is the same as that of previously cleared reference predicate MightySat (K181956). The RRp feature utilizes the same pleth waveform data from the same sensors used in SpO2 monitoring to detect the signals used for determining a respiration rate.
Radical-7 Pulse CO-Oximeter:
Masimo Radical-7 and Accessories, is a pulse co-oximeter that features a touchscreen that provides a display and control user interface for monitored parameters. It can be used either as a handheld or standalone monitor. Radical-7 can interface with a multi-parameter patient monitor and send data in order to display on the monitor. The Radical-7 comprises of technologies that enable the Radical-7 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), and acoustic respiration rate (RRa) parameters. The subject of this submission is the addition of RRp feature to the Radical-7. The technological characteristics of the RRp feature is the same as that of previously cleared reference predicate MightySat (K181956). The RRp feature utilizes the same pleth waveform data from the same sensors used in SpO2 monitoring to detect the signals used for determining a respiration rate.
Radius-7 Pulse CO-Oximeter:
Masimo Radius-7 and Accessories, is a wearable Pulse CO-Oximeter. Radius-7 can interface with a multi-parameter patient monitor and send data in order to display on the monitor via Bluetooth or WiFi. The Radius-7 comprises of technologies that enable the Radius-7 to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PV), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), and acoustic respiration rate (RRa) parameters. The subject of this submission is the addition of RRp feature to the Radius-7. The technological characteristics of the RRp feature is the same as that of previously cleared reference predicate MightySat (K181956). The RRp feature utilizes the same pleth waveform data from the same sensors used in SpO2 monitoring to detect the signals used for determining a respiration rate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Photoplethysmogram (pleth or PPG)
Anatomical Site
Finger (example given)
Indicated Patient 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)
Intended User / Care Setting
Hospital-type facilities, mobile, and home environments. Operating suite, intensive care unit, and patient room (for Nomoline Capnography).
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
Clinical (Prospective) – Healthy Adults: Number of Data Points: 7751. Reference method: FDA cleared capnography device (Oridion Capnostream20, K060065).
Clinical (Retrospective) – Hospitalized Adults: Number of Data Points: 119174. Data source: Raw photoplethysmogram (pleth) captured using Masimo SET sensors, and capnography waveforms collected on hospitalized adults. Reference method: FDA cleared capnography device (Oridion Capnostream20, K060065).
Clinical (Retrospective) – Hospitalized Pediatrics: Number of Data Points: 35390. Data source: Raw photoplethysmogram (pleth) captured using Masimo SET sensors, and capnography waveforms collected on hospitalized pediatrics. Reference method: FDA cleared capnography device (Oridion Capnostream20, K060065).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance Bench Testing: Bench simulation testing was conducted to support the RRp feature is substantially equivalent to the RRp feature provided on the reference device, MightySat Rx (K181956). The testing supported that the RRp feature does not raise new questions of substantial equivalence.
Clinical Testing: Two retrospective clinical studies and one prospective clinical study were performed. The results were found to be equivalent to the RRp feature previously FDA cleared on the MightySat (K181956).
Prospective Clinical Study – Healthy Adults: Compared RRp values from a representative Masimo device (Rad-97) against measurements from a FDA cleared capnography device (Oridion Capnostream20, K060065). Results: an Arms of 2.1 RPM.
Retrospective Clinical Validation Study – Hospitalized Adults: Compared calculated RRp values from raw photoplethysmogram (pleth) captured using Masimo SET sensors against respiration rates from a gold-reference capnography device (Oridion Capnostream20, K060065). Results: an Arms of 2.5 RPM.
Retrospective Clinical Validation Study – Hospitalized Pediatrics: Compared calculated RRp values from raw photoplethysmogram (pleth) captured using Masimo SET sensors against respiration rates from a gold-reference capnography device (Oridion Capnostream20, K060065). Results: an Arms of 2.0 RPM.
Key results: The clinical data supports the performance specification of the RRp feature as compared to a gold-reference capnography for the measurement of the respiration rate meets an Arms of ≤ 3.0RPM and mean error of 1, the same as the previously FDA cleared MightySat (K181956).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
RRp Accuracy (ARMS): 3 rpm (adults/pediatrics)
RRp Mean Error: 1 rpm (adults/pediatrics)
Clinical (Prospective) – Healthy Adults: Mean Error (RPM) 0.2, Standard Deviation (RPM) 2.1, ARMS (RPM) 2.1
Clinical (Retrospective) – Hospitalized Adults: Mean Error (RPM) 0.5, Standard Deviation (RPM) 2.5, ARMS (RPM) 2.5
Clinical (Retrospective) – Hospitalized Pediatrics: Mean Error (RPM) 0, Standard Deviation (RPM) 2.0, ARMS (RPM) 2.0
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.
K183697 - Masimo Rad-97 and Accessories, K171121 - Masimo Radical-7 Pulse CO-Oximeter and Accessories, K171121 - Masimo Radius-7 Pulse CO-Oximeter 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.
K181956 – Masimo MightySat Rx Fingertip Pulse Oximeter, K060065 - Oridion Capnostream20
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "HUMAN SERVICES-USA" around the edge. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
February 27, 2020
Masimo Corporation Sindura Penubarthi Regulatory Affairs Manager 52 Discovery Irvine, California 92618
Re: K193242
Trade/Device Name: Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, BZQ, CCK, DQA, DPZ, DXN, FLL Dated: January 24, 2020 Received: January 27, 2020
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
1
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 medical devices and radiation-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,
for 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
2
Indications for Use
510(k) Number (if known) K193242
Device Name Masimo Rad-97 Pulse CO-Oximeter and Accessories
Indications for Use (Describe) Masimo Rad-97 Pulse CO-Oximeter and Accessories:
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 multi-parameter 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 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 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 pediatic 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, pediativ and infant patients.
The optional non-invasive blood pressure (NiBP) module is indicated for the noninvasive measurement of arterial blood pressure. 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
3
Child 2 to 12 years of age Adolescent 12-21 years of age Adult 21 years of age and older
Devices with Masimo technology are only to be used with Masimo sensors and cables.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Indications for Use
510(k) Number (if known) K193242
Device Name
Masimo Radical-7 Pulse CO-Oximeter and Accessories
Indications for Use (Describe) Masimo Radical-7 Pulse CO-Oximeter and Accessories
The Radical-7 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 Radical-7 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 Radical-7 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 Radical-7 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 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 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 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 photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
5
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
6
Indications for Use
510(k) Number (if known) K193242
Device Name
Masimo Radius-7 Pulse CO-Oximeter and Accessories
Indications for Use (Describe) Masimo Radius-7 Pulse CO-Oximeter and Accessories:
The Radius-7 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 Radius-7 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 Radius 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 Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoplobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.
The Radius-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 Radius-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 hospital-type facilities, home environments, and transport within healthcare facilities.
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from Pleth (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
7
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
8
Image /page/8/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a bold, sans-serif font, with a red circle containing a white checkmark to the left of the word. Below the logo, the text "MASIMO CORPORATION" is displayed, followed by the address "52 Discovery, Irvine, CA 92618".
For the Rad-97
| Submitter and Address of
Manufacturing Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7000
FAX: (949) 297-7592 |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | November 21st 2019 |
| Contact: | Sindura Penubarthi
Regulatory Affairs Manager
Masimo Corporation
Phone: (949) 297-7541 |
| Trade Name: | Masimo Rad-97 Pulse CO-Oximeter and Accessories |
| Common Name: | Patient Monitor |
| Classification Regulation/
Product Code: | 21 CFR 870.2300, Class II/MWI |
| Additional Product Code: | 21 CFR 868.2375, Class II/BZQ
21 CFR 862.3200, Class II/JKS
21 CFR 868.1400, Class II/CCK
21 CFR 870.2700, Class II/DQA
21 CFR 870.2710, Class II/DPZ
21 CFR 870.1130, Class II/DXN
21 CFR 880.2910, Class II/FLL |
| Establishment Registration
Number: | 2031172 |
| Reason for Premarket
Notification: | Addition of RRp Feature |
| Predicate Device: | K183697 - Masimo Rad-97 and Accessories |
| Reference predicate: | K181956 – Masimo MightySat Rx Fingertip Pulse Oximeter |
| Performance Standards | No performance standards for the above device have been
promulgated pursuant to Section 514. |
For the Radical-7:
| Trade Name: | Masimo Radical-7 Pulse CO-Oximeter and Accessories |
|---|---|
| Common Name: | Oximeter |
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Image /page/9/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in a bold, sans-serif font. To the right of the logo is the text "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".
| Classification Regulation/
| Product Code: | 21 CFR 870.2700, Class II/DQA |
|---|---|
| Additional Product Code: | 21 CFR 868.2375, Class II/BZQ |
| 21 CFR 862.3200, Class II/JKS | |
| 21 CFR 870.2710, Class II/DPZ | |
| Establishment Registration | |
| Number: | 2031172 |
| Reason for Premarket | |
| Notification: | Addition of RRp Feature |
| Predicate Device: | K171121 - Masimo Radical-7 Pulse CO-Oximeter and |
| Accessories | |
| Reference predicate: | K181956 – Masimo MightySat Rx Fingertip Pulse Oximeter |
| Performance Standards | No performance standards for the above device have been |
| promulgated pursuant to Section 514. |
For the Radius-7:
| Trade Name: | Masimo Radius-7 Pulse CO-Oximeter and Accessories |
|---|---|
| Common Name: | Oximeter |
| Classification Regulation/ | |
| Product Code: | 21 CFR 870.2700, Class II/DQA |
| Additional Product Code: | 21 CFR 868.2375, Class II/BZQ |
| 21 CFR 862.3200, Class II/JKS | |
| 21 CFR 870.2710, Class II/DPZ | |
| Establishment Registration | |
| Number: | 2031172 |
| Reason for Premarket | |
| Notification: | Addition of RRP Feature |
| Predicate Device: | K171121 - Masimo Radius-7 Pulse CO-Oximeter and Accessories |
| Reference predicate: | K181956 - Masimo MightySat Rx Fingertip Pulse Oximeter |
| Performance Standards | No performance standards for the above device have been |
| promulgated pursuant to Section 514. |
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Image /page/10/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.
5.1. Device Description
The subject of the submission is to add Respiration Rate from photoplethysmogram (designated as RRp) feature to the previously cleared Masimo Pulse Oximetry devices. The RRp feature that was previously cleared as part of MightySat fingertip pulse oximeter under K181956. RRp feature determines the patient's respiration rate by analyzing cyclic variations in photoplethysmogram (pleth) to establish respiration measurement. The devices in which the RRp feature is being added as part of this submission are the previously cleared Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, and Masimo Radius-7 Pulse CO-Oximeter. These devices are described below.
Rad-97 Pulse CO-Oximeter:
Masimo Rad-97 System and Accessories (Rad-97), is a portable monitor that features a touchscreen that provides a display and control user interface for monitored parameters. The Rad-97 product family can be operated on AC power or internal rechargeable battery.
The Rad-97 comprises of technologies that enable the device to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PV), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), and/or capnography parameters or noninvasive blood pressure (NIBP) parameters which were all previously cleared under K183697.
The subject of this submission is the addition of the RRp feature to the Rad-97. The technological characteristics of the RRp feature is the same as that of previously cleared reference predicate MightySat (K181956). The RRp feature utilizes the same pleth waveform data from the same sensors used in SpO2 monitoring to detect the signals used for determining a respiration rate.
There are no changes to hardware and environmental specifications for Rad-97 and the hardware specifications remain the same as compared to the predicate. The performance specifications have been updated to include those of the RRp feature. See performance specifications for the Rad-97 listed in Table1 below.
| Table 1 - Rad-97 | |
|---|---|
| Feature | Specification |
| Accuracy (ARMS)* | Masimo Rainbow SET/ Masimo SET Parameters |
| SpO2, no motion | 70-100%, 1.5%, adults/pediatrics/infants |
| 70-100%, 3%, neonates | |
| SpO2, motion | 70-100%, 1.5% adults/pediatrics/infants |
| 70-100%, 3%, neonates | |
| SpO2, low perfusion | 70-100%, 2%, adults/pediatrics/infants/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 rpm, 1 rpm, adults/pediatrics |
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Image /page/11/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold font. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.
| 4-120 rpm, 1 rpm, infants/neonates | |
|---|---|
| RRp | 4-70 rpm, 3 rpm ARMS, 1 rpm Mean Error , 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 adults/pediatrics |
| Optional | Nomoline Capnography |
| CO2 | Single dry gasses at 22 $\pm$ 5°C and 1013 $\pm$ hPa: |
| 0-15 volume % $\pm$ 0.2 volume% +2% or reading | |
| All conditions: 0.3 kPa + 4% of reading | |
| Respiration rate | 0-150 bpm $\pm$ 1 bpm |
| Optional | Non-invasive blood pressure |
*ARMs accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- Apps of the reference measurements in a controlled study.
Radical-7 Pulse CO-Oximeter:
Masimo Radical-7 and Accessories, is a pulse co-oximeter that features a touchscreen that provides a display and control user interface for monitored parameters. It can be used either as a handheld or standalone monitor. Radical-7 can interface with a multi-parameter patient monitor and send data in order to display on the monitor.
The Radical-7 comprises of technologies that enable the Radical-7 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), and acoustic respiration rate (RRa) parameters which were all previously cleared under K171121.
The subject of this submission is the addition of RRp feature to the Radical-7. The technological characteristics of the RRp feature is the same as that of previously cleared reference predicate MightySat (K181956). The RRp feature utilizes the same pleth waveform data from the same sensors used in SpO2 monitoring to detect the signals used for determining a respiration rate.
There are no changes to hardware and environmental specifications for Radical-7 and the hardware specifications remain the same as compared to the predicate. The performance specifications have been updated to include those of the RRp feature. See performance specifications for the Radical-7 is listed in Table 2 below.
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Image /page/12/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a bold, sans-serif font, with a red circle containing a white checkmark to the left of the word. To the right of the logo is the text "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".
| Table 2 - Radical-7 | |
|---|---|
| Feature | Specification |
| Accuracy (ARMS)* | Masimo Rainbow SET/ 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/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 rpm, 1 rpm, adults/pediatrics |
| RRa | 4-120 rpm, 1 rpm, infants/neonates |
| RRp | 4-70 rpm, 3 rpm ARMS, 1 rpm Mean Error , adults/pediatrics |
| SpCO | 1-40%, 3%, adults/pediatrics/infants |
| SpMet | 1-15%, 1%, adults/pediatrics/infants/neonates |
| SpHb | 8-17 g/dL, 1 g/dL adults/pediatric |
*Arms accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- AsMs of the reference measurements in a controlled study.
Radius-7 Pulse CO-Oximeter:
Masimo Radius-7 and Accessories, is a wearable Pulse CO-Oximeter. Radius-7 can interface with a multi-parameter patient monitor and send data in order to display on the monitor via Bluetooth or WiFi.
The Radius-7 comprises of technologies that enable the Radius-7 to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PV), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), and acoustic respiration rate (RRa) parameters which were all previously cleared under K171121.
The subject of this submission is the addition of RRp feature to the Radius-7. The technological characteristics of the RRp feature is the same as that of previously cleared reference predicate MightySat (K181956). The RRp feature utilizes the same pleth waveform data from the same sensors used in SpO2 monitoring to detect the signals used for determining a respiration rate.
There are no changes to hardware and environmental specifications for Radius-7 and the hardware specifications remain the same as compared to the predicate. The performance specifications have been updated to include those of the RRp feature. See performance specifications for the Radius-7 listed in Table 3 below.
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Image /page/13/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the Masimo logo on the left and the words "MASIMO CORPORATION" and the address "52 Discovery, Irvine, CA 92618" on the right. The Masimo logo is a red circle with a white checkmark inside of it, followed by the word "Masimo" in black letters.
| Table 3 - Radius-7 | |
|---|---|
| Feature | Specification |
| Accuracy (ARMS)* | Masimo Rainbow SET/ 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/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 rpm, 1 rpm, adults/pediatrics |
| RRa | 4-120 rpm, 1 rpm, infants/neonates |
| RRp | 4-70 rpm, 3 rpm ARMS, 1 rpm Mean Error , adults/pediatrics |
| SpCO | 1-40%, 3%, adults/pediatrics/infants |
| SpMet | 1-15%, 1%, adults/pediatrics/infants/neonates |
| SpHb | 8-17 g/dL, 1 g/dL, adults/pediatric |
*ARMs accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- Arws of the reference measurements in a controlled study.
5.2. Intended Use/ Indications for Use
Masimo Rad-97 Pulse CO-Oximeter and Accessories:
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 multi-parameter 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 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.
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Image /page/14/Picture/0 description: The image shows the Masimo company logo. The logo consists of a red circle with a white checkmark inside, followed by the company name "Masimo" in black, bold letters. To the right of the logo, the text "MASIMO CORPORATION" is displayed, along with the address "52 Discovery, Irvine, CA 92618".
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 gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient room. The intended 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. 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 |
Devices with Masimo technology are only to be used with Masimo sensors and cables.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
Masimo Radical-7 Pulse CO-Oximeter and Accessories
The Radical-7 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.
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Image /page/15/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.
The Radical-7 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 Radical-7 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 Radical-7 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 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, hospitaltype 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 photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
Masimo Radius-7 Pulse CO-Oximeter and Accessories:
The Radius-7 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 Radius-7 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 Radius 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 Radius-7 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.
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Image /page/16/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a bold, sans-serif font, with a red circle containing a white checkmark to the left of the word. To the right of the logo is the text "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".
The Radius-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 Radius-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 hospitaltype facilities, home environments, and transport within healthcare facilities.
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from Pleth (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
5.3. Technological Characteristics
Principle of Operation
The subject of this submission is the addition of the optional RRp feature. The RRp feature is based upon the operating principle that a subject's respiration rate creates a cyclic variation in photoplethysmogram (i.e. pleth or PPG) that can be used to establish a respiration rate measurement. The Pleth is derived from the absorption of red/infra-red wavelengths of light used in SpO2 and Pulse rate monitoring.
Mechanism of Action for Achieving the Intended Effect
The RRp feature is provided through the same mechanism of action as SpO2 monitoring. The RRp respiration rate is provided by first applying a SpO2 sensor to the application site (e.g. finger). The SpO2 sensor then detects the physiological variations which result in the variation in the absorption of the wavelength that are signals used to display the pleth. The detected physiological signals are then processed to identify the cyclic variations associated with the expression of the respiration rate upon the pleth. The RRp feature further processes those cyclic variations to estimate the respiration rate which then displayed to the clinician. Alarm thresholds can then be set for RRp to support the continuous monitoring of the respiration rate by a clinician. Clinicians can discontinue the use of the RRp feature simply by removing the SpO2 sensor.
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Image /page/17/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in large, bold, black letters. To the right of the logo is the text "MASIMO CORPORATION" in smaller, gray letters, followed by the address "52 Discovery, Irvine, CA 92618" also in gray letters.
5.4. Summary of Technological Characteristics of Subject Device Compared to Predicate Device
The Subject Devices (Rad-97, Radical-7, and Radius-7) and the Predicate devices have the following key similarities:
- Both devices have the same intended use as a patient monitoring device;
- Both devices have the same hardware and environmental specifications;
- Both devices have the same input/output interfaces;
The Subject Devices (Rad-97, Radical-7, and Radius-7) and the Predicate devices have the following key differences:
- Subject device includes the addition of the Respiration Rate from pleth (RRp) feature
5.5. Performance Data
Biocompatibility Testing:
No additional biocompatibility testing was included, since there are no new patient contacting parts as part of this submission. The RRp feature utilizes the same already cleared sensors used for SpO2 monitoring. As a result, there was no change to the biocompatibility between the previously cleared patient contacting parts.
Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning
No additional testing was included, since there were no electrical, mechanical, environmental modifications made to the predicate devices since the latest clearance to support the addition of RRp feature. As a result, additional testing for Electrical Safety, Environmental, Mechanical and cleaning were not deemed necessary to demonstrate substantial equivalence to the predicate devices.
Additional EMC testing has been provided to support the compliance to IEC 60601-1-2 4th edition for Rad-97, Radical-7 and Radius-7.
Software Verification and Validation Testing
Software verification and validation testing was 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, 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
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the substantial equivalence of the subject device.
Cybersecurity Testing
In accordance with the FDA guidance for Cybersecurity, the subject devices (Rad-97, Radical-7 and Radius-7) were considered tier 2 devices. 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. To support the subject devices do not raise any new questions of safety and effectiveness a risk-based assessment and testing in accordance with referenced FDA guidance documents were conducted. The addition of RRp feature to the subject devices, do not introduce any new safety concerns from the previously cleared devices Rad-97 (K183697), Radical-7 (K171121), and Radius-7 (K171121).
Wireless Testing
Addition of RRp feature on the subject devices (Rad-97, Radical-7, and Radius-7) do not modify the wireless communications/capabilities (quality of service, coexistence, security and electromagnetic compatibility of the devices) from the cleared predicate devices. As a result, the previous wireless testing still supports the substantial equivalence to the predicate devices. The addition of RRp parameter to the subject devices, did not introduce any new safety concerns related to the wireless capabilities from the previously cleared devices Rad-97 (K183697). Radical-7 (K171121), and Radius-7 (K171121).
Human Factors Usability Testing
The previous human factors and usability testing conducted on the predicate devices was found to be acceptable based upon similarities in the user interface between the subject and the predicate devices even with the additional of RRp feature. There was no change to the prospective work flow from the cleared predicate devices. Previous testing already took account the human factors and usability of the parameter display when provided with a similar number of parameters. Additionally, there is no change to the intended environment where the devices were to be used with the RRp feature. To support the acceptability of the human factors and usability risk, as part of the predicate device clearances the acceptability of the human factors and usability risks were established in accordance with the FDA Guidance, Applying Human Factors and Usability Engineering to Optimize Medical Device Design, dated February 3, 2016. As part of the evaluation, the user related tasks were categorized based upon risk to establish critical user related tasks. Knowledge Task Assessment and Simulate Use testing was conducted to determine the completion of the critical user tasks and the assessment did not result in any unacceptable human factors and usability risks. Based on the previous evaluation, addition of RRp feature on the subject devices do not raise any new questions of safety and effectiveness. The previous testing conducted on the predicates as part of their clearances was found to
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support the substantial equivalence of the subject devices.
Non-clinical Performance Bench Testing
To support the substantial equivalence of the RRp feature to that of the predicate, non-clinical bench simulation testing was conducted to support the RRp feature is substantially equivalent. The bench testing supported the substantial equivalence of the performance of the RRp feature to be provided on the subject devices to the RRp feature provided on the reference device, MightySat Rx (K181956). The testing was found to support the RRp feature does not raise new questions of substantial equivalence.
Clinical Testing
In order to support the substantial equivalence of the subject devices with the addition of RRp to the previously cleared devices, Masimo performed clinical studies (two retrospective and one prospective) and provided the data as part of this submission. The results were found to be equivalent to RRp feature previously FDA cleared on the MightySat (K181956).
As part of the prospective clinical study, Masimo obtained multiple respiration rate measurements from healthy adult subjects using a representative Masimo device (Rad-97) which included the RRp feature and compared the RRp values against measurements from a FDA cleared capnography device as a gold-reference method (Oridion Capnostream20, K060065). The comparison of RRp against the reference supported an Arms of 2.1 RPM.
As part of the retrospective clinical validation study using adult data, the raw photoplethysmogram (pleth) captured using Masimo SET sensors, and the capnography waveforms, from a FDA cleared capnography device as a gold-reference method (Oridion Capnostream20, K060065), collected on hospitalized adults was used to compare the calculated RRp values against that of the respiration rates from the reference method. The comparison of RRp against that of the reference capnography an Arms of 2.5 RPM.
As part of the retrospective clinical validation study using pediatric data, the raw photoplethysmogram (pleth), captured using Masimo SET sensors, and the capnography waveforms, from a FDA cleared capnography device as a gold-reference method (Oridion Capnostream20, K060065), collected on hospitalized pediatrics was used to compare the calculated RRp values against that of the respiration rates from the reference method. The comparison of RRp against that of the reference capnography an Arms of 2.0 RPM.
The clinical data provided as part of this submission supports the performance specification of the RRp feature as compared to a gold-reference capnography for the measurement of the respiration rate meets an Arms of ≤ 3.0RPM and mean error of 1, the same as the previously FDA cleared MightySat (K181956). See summary of analysis in the Table 4 below.
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| Table 4 Summary of clinical data analysis | |||||||
|---|---|---|---|---|---|---|---|
| Study | Number of Data | ||||||
| Points | Mean Error (RPM) | Standard Deviation | |||||
| (RPM) | ARMS (RPM) | ||||||
| Clinical (Prospective) – | |||||||
| Healthy Adults | 7751 | 0.2 | 2.1 | 2.1 | |||
| Clinical (Retrospective) – | |||||||
| Hospitalized Adults | 119174 | 0.5 | 2.5 | 2.5 | |||
| Clinical (Retrospective) – | |||||||
| Hospitalized Pediatrics | 35390 | 0 | 2.0 | 2.0 |
5.6. Conclusion
The data provided as part of this submission supports the subject devices are substantially equivalent to the predicate devices.