(238 days)
No
The summary describes standard physiological monitoring technologies (pulse oximetry, capnography, NIBP) and does not mention any AI or ML algorithms for data processing, analysis, or interpretation.
No
The device is described as a non-invasive monitoring device for various physiological parameters, such as oxygen saturation, pulse rate, and blood pressure. Its intended use is for data collection and display, not for providing therapy or treatment.
Yes
The device is indicated for "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), and/or respiratory rate (RRa)." These parameters provide information that can contribute to a diagnosis or assessment of a patient's condition. While the text states it "is not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning," it is generally understood that monitoring devices providing such physiological parameters are used in a diagnostic capacity, even if in conjunction with other clinical information.
No
The device description explicitly states it is a "System and Accessories" and includes a touchscreen display, internal rechargeable battery, and input/output interfaces for external devices. It also mentions optional hardware modules like NIBP and capnography. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Masimo Rad-97 and Accessories are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is a medical device intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body in order to provide information concerning a physiological or pathological state, a congenital abnormality, to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Intended Use of the Masimo Rad-97: The intended use clearly states that the device is for the continuous non-invasive monitoring of various physiological parameters (SpO2, PR, SpCO, SpMet, SpHb, RRa, CO2, NIBP). This monitoring is performed directly on the patient's body or through their breath, not on specimens in vitro.
- Device Description: The device description details the technologies used for non-invasive measurement (Masimo Rainbow SET, capnography, NIBP). These are all methods of measuring physiological parameters in vivo or from exhaled breath.
- Lack of Specimen Handling: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in a laboratory setting.
While the device measures parameters that can be related to a patient's physiological state, it does so through non-invasive means on the patient themselves, not by analyzing specimens in vitro.
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), pulse rate (PR), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rad-97 and Accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused. 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 other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediatric and infant patients.
The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure.
Product codes (comma separated list FDA assigned to the subject device)
MWI, JKS, CCK, BZQ, DQA, DPZ, DXN, FLL
Device Description
The subject device, Masimo Rad-97 System and Accessories (Rad-97) product family, features a touchscreen display that continuously displays numeric values for the measured monitoring parameters. The Rad-97 product family can be operated on AC power or internally rechargeable battery.
The Rad-97 product family comprises the same measurement technologies as cleared in the predicate, Root (with connected external Radical-7 and capnography (ISA) and internal NIBP modules), which includes the Masimo Rainbow SET technology, capnography technology and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (PI), Pleth Variability Index (PVI), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa) and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.
The Rad-97 product family is available with different measurement parameter configurations, ranging from a fully loaded configuration to a simplified configuration with pulse oximetry parameters only. In a fully loaded configuration, the Rad-97 model includes all parameters provided by the Masimo Rainbow SET technology including SpO2, PR, PI, PVI, SpCO, SpMet, SpHb, SpOC and RRa. Additionally, this fully loaded version can be optionally available with either NIBP or capnography technology.
The Rad-9 model, an instrument model within the Rad-97 product family, is an embodiment with a simplified configuration. The Rad-9 model includes the Masimo SET technology (a subset of Masimo Rainbow SET technology), which provides pulse oximetry parameters of SpO2, PR, PI and PVI. The Rad-9 model can be optionally available with NIBP technology.
Same as the predicate, the Rad-97 product family includes inout/output interfaces for connection to external devices. Furthermore, same as the predicate, the Rad-97 product family can communicate through wired/wireless connection with networked systems such as Patient SafetyNet (K071047) and/or hospital electronic medical/health record (EMR) systems.
The RD SET Disposable Sensors, listed with other cleared accessories in Section 11.7, are the same as the currently marketed product. The only change is the added labeling information regarding the sensors' performance in terms of limits of agreement (LOA) as defined by Bland-Altman.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, pediatric, and neonatal patients for SpO2, PR, SpCO, SpMet, SpHb, and RRa.
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 for NIBP.
Adult, pediatric and infant patients for Nomoline Capnography family.
Intended User / Care Setting
Hospital-type facilities, mobile, and home environments.
Operating suite, intensive care unit and patient room for Nomoline Capnography family.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing:
To obtain the limits of agreement (LOA) information for the RD SET Disposable Sensors, a clinical study was performed in accordance with ISO-80601-2-61. The study was done on healthy adult volunteers to evaluate the sensor's performance for no motion condition, in the range of 70% to 100% in comparison to blood measurements from a laboratory CO-Oximeter. Using the Bland-Altman method, the mean difference between two methods of measurements (the 'bias') and 95% LOA as the mean difference, two standard deviations, (2 SD) for more precisely (1.96 SD)] was calculated. In this case, the 95% LOA calculation was between the noninvasive arterial oxygen (SpO2) measurements using RD SET Sensors and invasive measurements (blood draws).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Upper 95% LOA: 3.15% (Requirement = 3%)
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.
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.
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 14, 2017
Masimo Corporation Marguerite Thomlinson Sr. Director, Regulatory Affairs 52 Discoverv Irvine, California 92618
Re: K170168
Trade/Device Name: Masimo Rad-97 and Accessories Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, JKS, CCK, BZQ, DQA, DPZ, DXN, FLL Dated: August 11, 2017 Received: August 14, 2017
Dear Marguerite Thomlinson:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
M & Hillelien
for _ Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Masimo Rad-97 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), pulse rate (PR), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rad-97 and Accessories are indicated for use with adult, pediatic, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused. 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 other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediatric and infant patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
(Masimo Rad-97 and Accessories, continued from page 1)
Indications for Use
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 |
4
| Submitter and Address of
Manufacturing Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7000
FAX: (949) 297-7592 |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Marguerite Thomlinson |
| Date: | August 11, 2017 |
| Official Correspondent | Marguerite Thomlinson
Senior Director, Regulatory Affairs
Masimo Corporation
Phone: (949) 297-7683
Mthomlinson@Masimo.com |
| Trade Name: | Masimo Rad-97/Rad-9 and Accessories |
| Common Name: | Oximeter |
| Primary Classification
Regulation/ Product Code: | 21 CFR 878.2300, Class II/MWI |
| Secondary Classification
Regulation/ Product Code: | 21 CFR 862.3220, Class II/JKS
21 CFR 880.2910, Class II/CCK
21 CFR 868.2375, Class II/BZQ
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: | New Device – Masimo Rad-97/Rad-9 and Accessories |
| Predicate Device: | K151644- Masimo Root Monitoring System and
Accessories |
| Performance Standards | No performance standards for the above device have been
promulgated pursuant to Section 514. |
5
Device Description
The subject device, Masimo Rad-97 System and Accessories (Rad-97) product family, features a touchscreen display that continuously displays numeric values for the measured monitoring parameters. The Rad-97 product family can be operated on AC power or internally rechargeable battery.
The Rad-97 product family comprises the same measurement technologies as cleared in the predicate, Root (with connected external Radical-7 and capnography (ISA) and internal NIBP modules), which includes the Masimo Rainbow SET technology, capnography technology and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (PI), Pleth Variability Index (PVI), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa) and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.
The Rad-97 product family is available with different measurement parameter configurations, ranging from a fully loaded configuration to a simplified configuration with pulse oximetry parameters only. In a fully loaded configuration, the Rad-97 model includes all parameters provided by the Masimo Rainbow SET technology including SpO2, PR, PI, PVI, SpCO, SpMet, SpHb, SpOC and RRa. Additionally, this fully loaded version can be optionally available with either NIBP or capnography technology.
The Rad-9 model, an instrument model within the Rad-97 product family, is an embodiment with a simplified configuration. The Rad-9 model includes the Masimo SET technology (a subset of Masimo Rainbow SET technology), which provides pulse oximetry parameters of SpO2, PR, PI and PVI. The Rad-9 model can be optionally available with NIBP technology.
Same as the predicate, the Rad-97 product family includes inout/output interfaces for connection to external devices. Furthermore, same as the predicate, the Rad-97 product family can communicate through wired/wireless connection with networked systems such as Patient SafetyNet (K071047) and/or hospital electronic medical/health record (EMR) systems.
The RD SET Disposable Sensors, listed with other cleared accessories in Section 11.7, are the same as the currently marketed product. The only change is the added labeling
6
information regarding the sensors' performance in terms of limits of agreement (LOA) as defined by Bland-Altman1
The table below provides the specifications for a fully loaded configuration of the Rad-97 instrument model with all parameters from the Masimo Rainbow SET technology and optional parameters from the Nomoline Capnography technology or optional parameters from the NIBP technology. The Rad-9 model, a simplified configuration of the Rad-97 product family, has the same instrument specifications but only includes pulse oximetry parameters from the Masimo SET technology, a subset of the Masimo Rainbow SET technology included in the Rad-97 model.
| Feature | Rad-97 Specification |
|---|---|
| Display | |
| Display type | Touchscreen, Color LCD (Backlit Active Matrix TFT LCD) |
| Functional Oxygen Saturation (SpO2): 0-100% | |
| Pulse Rate (PR): 25-240 beats per minute (bpm) | |
| Perfusion Index (PI): 0.02-20% | |
| Pleth Variability Index (PVI): 0-100% | |
| Respiration Rate (RRa): 0-70 breaths per minute | |
| Carboxyhemoglobin Saturation (SpCO): 0-99% | |
| Methemoglobin Saturation (SpMet): 0-99.9% | |
| Measurement range | Total Hemoglobin (SpHb): 0-25g/dL; 0-250g/L(0-15.52 mmol/dL) |
| Oxygen Concentration (SpOC): 0-35ml of O2/dL | |
| Carbon Dioxide (CO2); 0 vol%-15 vol % | |
| End Tidal CO2 (EtCO2): 0-25 %, 0-32.5 kPa, 0-244 mmHg | |
| Fractional Inspired CO2 (FiCO2): 0-25 %, 0-32.5 kPa, 0-244 mmHg | |
| Respiratory Rate (RR): 0-150 breaths/min | |
| Adult, Systolic: 40-260 mmHg, Diastolic: 20-200 mmHg, MAP 26-220mmHg | |
| Pediatric, Systolic: 40-230 mmHg, Diastolic: 20-160 mmHg, MAP 26-183 mmHg | |
| Neonatal, Systolic: 40-130 mmHg, Diastolic: 20-100 mmHg, MAP 26-110mmHg | |
| SpO2: 1% | |
| PR: 1 bpm | |
| RRa: 1breath per minute | |
| Display resolution | SpCO: 1% |
| SpMet: 0.1% | |
| SpHb: 0.1 g/dL | |
| SpOC: 0.1 ml/dL |
1 Bland and Altman. Agreement between methods of measurement with multiple observations per individual. Journal of Biopharmaceutical Statistics (2007) vol. 17 pp. 571-582 [Note: This paper was cited by Guidance for Industry and Food and Drug Administration Staff - Pulse Oximeters - Premarket Notification Submissions 510(k)s, March 4, 2013]
7
| Feature | Rad-97 Specification |
|---|---|
| Accuracy (ARMS)* | Masimo Rainbow SET/ Masimo SET Parameters |
| [accuracy range , accuracy, patient population] | |
| 60-80%, 3%, adults/pediatrics/infants | |
| 70-100%, 2%, adults/pediatrics/infants | |
| SpO2, no motion | 70-100%, 3%, neonates |
| Upper 95% Limits of Agreement, 3% ** | |
| Lower 95% Limits of Agreement, -3%** | |
| 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 breaths per minute, 1 breath per minute for adults |
| 4-70 breaths per minute, 1 breath per minute for 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/pediatrics |
| Accuracy | Optional Capnography or Optional NIBP Parameters |
| Single dry gasses at 22+ 5°C and 1013 + hPa: | |
| CO2 | 0-15 volume % +0.2 volume% +2% or reading |
| All conditions: 0.3 kPa + 4% of reading | |
| RR (Respiration rate) | 0-150 breaths/min + 1 breaths/min |
| NIBP | 0-300 mmHg, +3 mmHg |
| Displays/ Indicators | |
| Data displayed | SpO2, PR, SPCO, SpMet, SpHb, Rra, PI, PVI, SpOC, NIBP, CO2, pleth waveform, alarm |
| status, status messages, sensor status, Signal IQ, APOD, FastSat | |
| Alarm | Alarm limits (audible and visual), 3D alarm, alarm silence, sensor condition alarms, system |
| failure alarms, low battery alarms | |
| SpO2: 2-4, 4-6, 8, 10, 12, 14 and 16 seconds; | |
| Rra: Trending, No Averaging, Fast, Medium, or Slow | |
| Averaging time | PVI: Short or Long; |
| PI: Short or Long; | |
| SpHb: Short, Medium, or Long | |
| Sensitivity mode | Normal, APOD, and MAX |
| Sleep study mode | 10 seconds |
| Electrical | |
| AC power | Input voltage: 100-240 VAC, 47-63 Hz; input power: 60 VA |
| Internal battery power | Rechargeable lithium ion battery |
| Input/Output Interface | |
| M-20 connector | |
| Patient applied part connection | Nomoline Capnography input connector |
| NIBP Nib | |
| Analog output | Nurse call output |
| USB interface | SatShare module and external devices (e.g. barcode reader/scanner) connection |
| Wired (Ethernet) and wireless (Wi- | Wired/wireless connection with networked Patient SafetyNet and/or EMR systems |
| Wireless connection with presence tag, Kite, external devices (e.g. Caregiver | |
| thermometer) | |
| Fi/Bluetooth) interface | |
| Camera (MIPI camera interface) | Surveillance/conferencing capabilities with Patient SafetyNet |
| Audio | Microphone supporting video/audio modes for surveillance/conferencing capabilities with |
| Patient SafetyNet | |
| Mechanical | |
| Enclosure Material | Thermoplastic |
8
| Feature | Rad-97 Specification |
|---|---|
| Dimensions | 9×4×6.5 inch (22.9×10.2×16.5cm) |
| Weight | =3% |
Conclusion
The results of the testing demonstrate that all requirements and performance specifications were satisfied and that the subject device is substantially equivalent to its predicate.