(228 days)
Not Found
No
The document describes standard physiological monitoring technologies (SpO2, PR, SpCO, SpMet, SpHb, RRa, PVi, capnography, NIBP) and their indications. There is no mention of AI, ML, or any algorithms that learn or adapt from data. The performance studies focus on the clinical utility of PVi as a fluid responsiveness indicator, not on the performance of an AI/ML model.
No
The device is indicated for continuous non-invasive monitoring of various physiological parameters, not for providing therapy or treatment.
Yes
The device provides "continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2)", "pulse rate (PR)", "carboxyhemoglobin saturation (SpCO)", "methemoglobin saturation (SpMet)", "total hemoglobin concentration (SpHb)", "respiratory rate (RRa)", and "PVi as a measure of relative variability of the photoplethysmograph (pleth)". It also indicates that "PVi may be used as a noninvasive dynamic indicator of fluid responsiveness". While it states "not intended to be used as the sole basis for making diagnosis or treatment decisions", the primary function is to measure and provide physiological data, which is then used by clinicians to diagnose and make treatment decisions.
No
The device description explicitly states that the Masimo Rad-97 System and Accessories feature a touchscreen display and can be operated on AC power or internal rechargeable battery, indicating the presence of hardware components beyond just software.
Based on the provided information, the Masimo Rad-97 and Accessories are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- Masimo Rad-97 Function: The Masimo Rad-97 is described as a device for continuous non-invasive monitoring of various physiological parameters (SpO2, PR, SpCO, SpMet, SpHb, RRa, PVi, optional capnography, optional NIBP). It uses sensors applied to the body (like a photoplethysmograph) to obtain these measurements directly from the patient, not from a specimen taken from the body.
The device's intended use and description clearly indicate it's a patient monitoring device that measures physiological parameters directly from the patient's body, which falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Masimo Rad-97 and Accessories are indicated for hospital-type facilities, mobile, and home environments.
The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station).
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of pulse rate (PR) of adult, pediatic, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused.
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.
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.
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.
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 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 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 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 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, pediatic 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 indicated for use with Masimo sensors and cables.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) for adults and pediatics during no motion conditions in hospitals and hospital-type facilities.
PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DQA, CCK, DPZ, DXN, FLL, BZQ
Device Description
The Masimo Rad-97 System and Accessories (Rad-97 product family), features a touchscreen display that continuously displays numeric values for the connected 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 the same as the predicate (Rad-97 product family) cleared under K183697. 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), 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 addition of indications for PVi, an index previously cleared as an informational index.
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
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.
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
To support the acceptability of the PVi feature for its updated indications, a comparison of the performance in the determination of fluid responsiveness using a fluid bolus infusion and monitoring the cardiac output response was conducted. To support the indication, 30 published studies were provided. Highlighted were 6 studies, which included a combined 182 subjects undergoing surgeries, where PVi was monitored for fluid responsiveness using volume expansion changes (fluid bolus infusions) on mechanically ventilated adults.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing: To support the acceptability of the PVi feature for its updated indications, a comparison of the performance in the determination of fluid responsiveness using a fluid bolus infusion and monitoring the cardiac output response was conducted. To support the indication, 30 published studies were provided. Highlighted were 6 studies, which included a combined 182 subjects undergoing surgeries, where PVi was monitored for fluid responsiveness using volume expansion changes (fluid bolus infusions) on mechanically ventilated adults. The test results supported the ability of PVi to provide an indication of fluid responsiveness in those studied mechanically ventilated adult patients.
| Study Number | AUC |
|---|---|
| 1 | 0.785 |
| 2 | 0.95 |
| 3 | 0.97 |
| 4 | 0.82 |
| 5 | 0.74 |
| 6 | 0.934 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
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.
Not Found
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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 10, 2020
Masimo Corporation Linus Park Vice President, Regulatory Affairs 52 Discovery Irvine, California 92618
Re: K193626
Trade/Device Name: Masimo Rad-97 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, DQA, CCK, DPZ, DXN, FLL, BZQ Dated: July 28, 2020 Received: July 29, 2020
Dear Linus Park:
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,
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)
Device Name Masimo Rad-97 Pulse CO-Oximeter and Accessories
Indications for Use (Describe)
The Masimo Rad-97 and Accessories are indicated for hospital-type facilities, mobile, and home environments.
The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station).
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of pulse rate (PR) of adult, pediatic, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused.
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.
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.
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.
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 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 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 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 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, pediatic 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:
3
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 indicated for use with Masimo sensors and cables.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) for adults and pediatics during no motion conditions in hospitals and hospital-type facilities.
PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.
| 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)
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Image /page/4/Picture/2 description: The image shows the Masimo Corporation logo. 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, the text "MASIMO CORPORATION" is written in gray, 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 |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | July 28, 2020 |
| Contact: | Linus Park
Vice President, Regulatory
Masimo Corporation
Phone: (949) 297-7337 |
| Trade Name: | Masimo Rad-97 Pulse CO-Oximeter and Accessories |
| Common Name: | Oximeter. |
| Classification Regulation/
Product Code: | 21 CFR 870.2300, Class II/MWI |
| Additional Product Code: | 21 CFR 870.2700, Class II/DQA
21 CFR 862.3200, Class II/JKS
21 CFR 880.2910, Class II/CCK
21 CFR 870.2710, Class II/DPZ
21 CFR 870.1130, Class II/DXN
21 CFR 880.2910, Class II/FLL
21 CFR 868.2375, Class II/BZQ |
| Establishment Registration
Number: | 2031172 |
| Reason for Premarket
Notification: | Expanded indications for PVi |
| Predicate Device: | K183697 - Masimo Rad-97 and Accessories |
| Performance Standards | No performance standards for the above device have been
promulgated pursuant to Section 514. |
5.1. Device Description
Masimo Rad-97 System and Accessories (Rad-97 product family), features a touchscreen display that continuously displays numeric values for the connected 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 the same as the predicate (Rad-97 product family) cleared under K183697. 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), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total
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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 stylized font, with a red circle containing a white checkmark to the left of the word. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
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 addition of indications for PVi, an index previously cleared as an informational index.
| General Information | |
|---|---|
| Display | |
| Display Type | Touchscreen LCD |
| Alarm | |
| Type of alarm | Visual/Audible alarm |
| Technological Characteristics | |
| Measured Parameters | NIBP, SpO2, PR, SpCO, SpMet, SpHb, RRa, Pi, CO2 |
| Calculated or Derived Parameters | PVi |
| Performance Specification | |
| SpO2, no motion | 70-100%, 1.5%, adults/pediatrics/infants 3% neonates |
| SpO2, motion | 70-100%, 1.5% Arms ,adults/ infants/ pediatrics; 3% neonates |
| SpO2, low perfusion | 70-100%, 2%, adults/pediatrics/infants/neonates |
| Pulse Rate, no motion | 25-240 bpm, 3 bpm, adults/ infants/ pediatrics/ neonates |
| Pulse Rate, motion | 25-240 bpm, 5 bpm, adults/ infants/ pediatrics /neonates |
| Pulse Rate, low perfusion | 25-240 bpm, 3 bpm, adults/ infants/ pediatrics / neonates |
| SpCO | 1-40%, 3% , adults/ infants/ pediatrics |
| SpMet | 1-15%, 1%, adults/ infants/ pediatrics/ neonates |
| SpHb | 8-17 g/dL, 1g/dL adults/ pediatrics |
| RRa | 4-70 rpm, 1 rpm, adults/pediatrics |
| 4-120 rpm, 1 rpm, infants/neonates | |
| CO2 | Single dry gasses at 22±5°C and 1013±40 hPa: |
| 0-15 volume %: ±(0.2 volume% +2% or reading) | |
| All conditions: | |
| ±(0.3 kPa + 4% of reading) | |
| NIBP | 0-300 mmHg, ISO 81060-2 |
| Environmental | |
| Operating temperature | 0 to 35 °C (32 to 95 °F) |
| Storage temperature | -20 to 60 °C (-4 to 140 °F) |
| Operational/ storage humidity | 10 to 95%, non-condensing |
| Operating atmospheric pressure | 540 mbar to 1,060 mbar (540 hPa to 1060 hPa) |
| Mechanical | |
| Instrument Dimensions | 9 x 6.5 x 4 inch (22.9 x 16.5 x 10.2 cm) |
| Instrument Weight | 0.92 kg (2.03 lbs) without NiBP and Nomoline capnography |
| Electrical | |
| AC power | Input Voltage: 100-240 VAC, 47-63 Hz |
| Battery power | Internally rechargeable lithium ion battery |
| I/O Interface | |
| USB | USB interface |
| Nurse call | Analog output |
| Ethernet | Provides network connection to the device using RJ-45 cable |
| Wireless | Wi-Fi, Bluetooth |
| Mode of Operation | |
| Mode of operation | Continuous operation |
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Image /page/6/Picture/2 description: The image shows the Masimo Corporation logo. On the left is a red circle with a white checkmark inside. To the right of the circle is the word "Masimo" in bold, black letters. Further to the right is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.
5.2. Intended Use/ Indications for Use
The Masimo Rad-97 and Accessories are indicated for hospitals, hospital-type facilities, mobile, and home environments.
The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station).
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused.
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.
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.
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.
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 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 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 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.
7
Image /page/7/Picture/2 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a bold, sans-serif font, with a red circle containing a white 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 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 indicated for use with Masimo sensors and cables.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) for adults and pediatrics during no motion conditions in hospitals and hospital-type facilities.
PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PV i measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.
5.3. Technological Characteristics
Principle of Operation
The subject of this submission is the addition of the indication for the continuous non-invasive monitoring of Pleth Variability index (PVi) which is a measure of the relative variability of the photo plethysmograph (PPG or pleth) due to respiration. Clinically, the variations in blood pressure and blood volume is used for the monitoring of cardiac output as an indicator of hemodynamic stability, which can be affected by the balance of dynamic factors such as cardiac function, fluid changes, and vascular resistance.
Through the use of the pleth waveform used in SpO2 monitoring, the variations associated with the changes in the stroke volume can also be detected. The ability to detect these changes in blood saturation and pulsatile blood flow is based upon the Beer-Lambert law, which establishes the relationship between the absorption of light to the concentration of the absorption media. The variations in the absorption (Pi) are then used to calculate PVi.
The PVi feature relies on the relationship defined by the Frank-Starling curve along with principles used for pulse oximetry to allow for the continuous and noninvasive indication of fluid responsiveness by
8
Image /page/8/Picture/2 description: The image shows the logo for Masimo Corporation. On the left is 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".
continuously calculating the detected variability in the pleth waveform associated with a respiration cycle. Following the Frank-Starling curve, the relationship of a high, low, increasing, or decreasing PVi can also be indicative of the relative stability of the stroke volume associated with the amount of ventricular end-diastolic volume or restated as the fluid responsiveness. As many factors such as the patient and procedure may affect the accuracy of the indication of fluid responsiveness, the current submission is for PVi as an indicator of fluid responsiveness for select populations of mechanically ventilated adult patients.
Mechanism of Action for Achieving the Intended Effect
The mechanism of action for the monitoring of PVi does not change as part of this submission. PVi is monitored by application of a Masimo SpO2 sensor to an appropriate application site. The sensor utilizes the same SpO2 wavelengths of light form the sensor to detect differing absorption levels of light. The photodetector provided on the sensor detects the transmitted light and to establish the pleth waveform that is displayed on the monitor. The PVi is calculated continuously to provide an indication of the relative stability of the pleth.
5.4. Summary of Technological Characteristics of Subject Device Compared to Predicate Device
The subject device, Masimo Rad-97 with indications for PVi, and the primary predicate device, Masimo Rad-97 (K183697), 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 devices have the same principle of operation
The subject device, Masimo Rad-97 with indications for PVi, and the primary predicate, Masimo Rad-97 (K183697), have the following key differences:
- . Subject device includes proposed indication for PVi, where the predicate device did not have an indication associated with this particular calculation.
5.5. Performance Data
Biocompatibility Testing:
There were no new patient contacting parts or materials related to the introduction of indications for the PVi feature. Therefore, no additional biocompatibility testing was not included as part of this submission.
Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and
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Image /page/9/Picture/2 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo, the text "MASIMO CORPORATION" is displayed, followed by the address "52 Discovery, Irvine, CA 92618".
Cleaning
There were no hardware changes related to the introduction of indications for the PVi feature. Therefore, no additional EMC, Electrical Safety, Environmental, Mechanical, and Cleaning tests were not included as part of this submission.
Software Verification and Validation Testing
There were no software changes related to the PVi feature. Therefore, no additional software testing specific to the PVi feature was included as part of this submission.
Wireless and Cybersecurity Testing
There were no wireless or interconnectivity changes related to the PV i feature. There, no additional wireless or cybersecurity testing was included as part of this submission.
Human Factors Usability Testing
There were no change made to the software or hardware user interfaces related to the PVi feature. Thus, no additional human factors or usability testing was included as part of this submission.
Non-clinical Testing
There were no changes to the way the PVi feature is calculated as part of this submission. Therefore, no additional performance bench testing was included as part of this submission.
Clinical Testing
To support the acceptability of the PVi feature for its updated indications, a comparison of the performance in the determination of fluid responsiveness using a fluid bolus infusion and monitoring the cardiac output response was conducted. To support the indication, 30 published studies were provided. Highlighted were 6 studies, which included a combined 182 subjects undergoing surgeries, where PVi was monitored for fluid responsiveness using volume expansion changes (fluid bolus infusions) on mechanically ventilated adults. The test results supported the ability of PVi to provide an indication of fluid responsiveness in those studied mechanically ventilated adult patients.
| Study Number | Area Under the Curve (AUC) |
|---|---|
| 1 | 0.785 |
| 2 | 0.95 |
| 3 | 0.97 |
| 4 | 0.82 |
| 5 | 0.74 |
| 6 | 0.934 |
Table 5.5-1 Summary of Comparison
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Image /page/10/Picture/2 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a bold, sans-serif font, with a red circle containing a white checkmark to the left of the word. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".
5.6. Conclusion
The data provided as part of this submission for the subject device supports the substantially equivalence to the predicate device.