(288 days)
No
The document describes standard physiological monitoring technologies (pulse oximetry, capnography, NIBP) and their performance characteristics. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is indicated for continuous non-invasive monitoring of various physiological parameters and is not described as providing treatment or therapy.
Yes
The device provides continuous non-invasive monitoring data for various physiological parameters like oxygen saturation, pulse rate, carboxyhemoglobin, methemoglobin, total hemoglobin, and respiratory rate, which are used to assess a patient's condition. Although it states it's "not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning," its primary function is to gather data that contributes to a diagnosis or assessment of a patient's health status.
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 an internally 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:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Masimo Rad-97's Function: The Masimo Rad-97 is a non-invasive monitoring device. It measures physiological parameters directly from the patient's body (e.g., through a sensor on the finger or other body part) without requiring a sample to be taken and analyzed in a laboratory.
- Parameters Measured: The parameters measured (SpO2, PR, SpCO, SpMet, SpHb, RRa, CO2, NIBP) are all obtained through non-invasive means. While some of these parameters relate to substances in the blood (like hemoglobin and carboxyhemoglobin), the device measures them in vivo (within the living body) rather than in vitro (in a test tube or laboratory setting).
Therefore, the Masimo Rad-97 falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multiparameter devices for the display on those devices.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospital-type facilities. The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal 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 in hospitals, hospital-type facilities, mobile, and home environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:
| Patient Population | Approximate Age Range |
|---|---|
| Newborn (neonate) | Birth to 1 month of age |
| Infant | 1 month to 2 years of age |
| Child | 2 to 12 years of age |
| Adolescent | 12-21 years of age |
| 21 years of age and older |
Product codes (comma separated list FDA assigned to the subject device)
MWI, FLL, DQA, DPZ, DXN, CCK, BZQ
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 subject device (Rad-97 product family) is substantially the same as the predicate (Rad-97 product family) cleared under K170168. and has the same indications for use. The Rad-97 comprises the same measurement technologies as cleared in the predicate, which includes the Masimo Rainbow SET technology, capnography technology and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.
The Rad-9, an instrument model within the Rad-97 product family, is an embodiment with a simplified configuration. The Rad-9 was also cleared in K170168. 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.
Masimo's Rad-97 has improved SpO2 measurement accuracy for motion and no motion conditions with RD SET Disposable sensors previously cleared under K170168. Masimo improved its RD SET Disposable sensors through sensor characterization, facilitating a SpO2 measurement accuracy claim of 1.5% Ams during no-motions conditions for patient populations (adults, pediatrics, infants, and neonates) when used with Masimo's MX/MS-2000 boards. Masimo's SpO2 measurement accuracy claim with RD SET Disposable Sensors is 1.5% Arms during motion conditions for patient population (adults, pediatrics, infants, and neonates) when used with Masimo's MX/MS-2000 boards. Although they now include improved sensor characterization, the RD SET Disposable sensors are substantially equivalent to the currently marketed product.
Additionally, this submission includes the following sensors that have non-significant changes: the Multisite Reusable Sensors (K111888), the RD Specialty Sensors (K101896), and the RD reusable sensors (K051212).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, pediatric, neonatal, infant.
Blood Pressure NIBP module:
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, patient room.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
- Software verification, including integration testing with host monitor for additional features, per FDA software guidance.
- Electrical safety testing per IEC-60601-1
- EMC testing per IEC-60601-1-2
- Alarm testing per IEC-60601-1-8
- Biocompatibility testing per ISO-10993
- Mechanical and Environmental Testing per IEC 60601-1 and ISO 80601-2-61
- Pulse rate accuracy for the range of 25-240 bpm in performance bench testing against a Biotek Index 2 Simulator.
Clinical Testing:
Study type: Clinical study conducted on healthy adult volunteers to evaluate sensor performance for no motion and motion conditions, focusing on SpO2 accuracy.
Sample size: Not specified (healthy adult volunteers).
Data source: In comparison to blood measurements from a laboratory CO-Oximeter.
Key results:
% SpO2 No Motion Accuracy: Bias -0.01%, Adjusted Precision 1.16%, Adjusted RMS 1.16%
% SpO2 Motion Accuracy: Bias 0.33%, Adjusted Precision 1.27%, Adjusted RMS 1.31%
Claimed Ams value: 1.5% during no-motion conditions for adults, pediatrics, and infants.
Claimed Arms value: 1.5% during motion conditions for adult, pediatrics, and infants.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 breaths per minute, 1 breath per minute, adults/pediatrics
SpCO: 1-40%, 3%, adults/pediatrics/infants
SpMet: 1-15%, 1%, adults/pediatrics/infants/neonates
SpHb: 8-17 g/dL, 1 g/dL, adults/pediatrics
CO2: Single dry gasses at 22+5°C and 1013 hPa: 0-15 volume % +/- 0.2 volume% +2% or reading; All conditions: 0.3 kPa + 4% of reading
Respiration rate: 0-150 breaths/min +/- 1 breaths/min
NIBP: 0-300 mmHg, +/- 3 mmHg
Predicate Device(s)
K170168 - Masimo Rad-97 and Accessories
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
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October 23, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" stacked below each other.
Masimo Corporation Sindura Penubarthi Regulatory Affairs Manager 52 Discovery Irvine, California 92618
Re: K180046
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, FLL, DQA, DPZ, DXN, CCK, BZQ Dated: September 12, 2018 Received: September 21, 2018
Dear Sindura Penubarthi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180046
Device Name Masimo Rad-97 and Accessories
Indications for Use (Describe)
The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multiparameter devices for the display on those devices.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospital-type facilities. The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal 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 in hospitals, hospital-type facilities, mobile, and home environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:
| Patient Population | Approximate Age Range |
|---|---|
| Newborn (neonate) | Birth to 1 month of age |
| Infant | 1 month to 2 years of age |
| Child | 2 to 12 years of age |
| Adolescent | 12-21 years of age |
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21 years of age and older
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/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" followed by the address "52 Discovery, Irvine, CA 92618".
Section 5. 510(k) Summary
| Submitter and Address of
Manufacturing Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7000
FAX: (949) 297-7592 |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Sindura Penubarthi |
| Date: | October 22nd 2018 |
| Official Correspondent | Sindura Penubarthi
Regulatory Affairs Manager
Masimo Corporation
Phone: (949) 297-7541
spenubarthi@masimo.com |
| Trade Name: | Masimo Rad-97 and Accessories |
| Common Name: | Oximeter |
| Classification Regulation/
Product Code: | 21 CFR 878.2300, Class II/MWI |
| Additional Product Code: | 21 CFR 870.2700, Class II/DQA
21 CFR 880.2910, Class II/CCK
21 CFR 868.2375, Class II/BZQ
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 and Accessories |
| Predicate Device: | K170168 - Masimo Rad-97 and Accessories |
| Performance Standards | No performance standards for the above device have been
promulgated pursuant to Section 514. |
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Image /page/5/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.
Section 5. 510(k) Summary
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 subject device (Rad-97 product family) is substantially the same as the predicate (Rad-97 product family) cleared under K170168. and has the same indications for use. The Rad-97 comprises the same measurement technologies as cleared in the predicate, which includes the Masimo Rainbow SET technology, capnography technology and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.
The Rad-9, an instrument model within the Rad-97 product family, is an embodiment with a simplified configuration. The Rad-9 was also cleared in K170168. 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.
Masimo's Rad-97 has improved SpO2 measurement accuracy for motion and no motion conditions with RD SET Disposable sensors previously cleared under K170168. Masimo improved its RD SET Disposable sensors through sensor characterization, facilitating a SpO2 measurement accuracy claim of 1.5% Ams during no-motions conditions for patient populations (adults, pediatrics, infants, and neonates) when used with Masimo's MX/MS-2000 boards. Masimo's SpO2 measurement accuracy claim with RD SET Disposable Sensors is 1.5% Arms during motion conditions for patient population (adults, pediatrics, infants, and neonates) when used with Masimo's MX/MS-2000 boards. Although they now include improved sensor characterization, the RD SET Disposable sensors are substantially equivalent to the currently marketed product.
Additionally, this submission includes the following sensors that have non-significant changes: the Multisite Reusable Sensors (K111888), the RD Specialty Sensors (K101896), and the RD reusable sensors (K051212).
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Image /page/6/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 word "Masimo" is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.
Section 5. 510(k) Summary
The table below provides the specifications for a fully loaded configuration of the Rad-97 instrument model with all parameters.
| Feature | Rad-97 Specification |
|---|---|
| Display | |
| Display type | Touchscreen, Color LCD (Backlit Active Matrix TFT LCD) |
| Measurement range | Functional Oxygen Saturation (SpO2): 0-100% |
| Pulse Rate (PR): 25-240 beats per minute (bpm) | |
| Perfusion Index (Pi): 0.02-20% | |
| Pleth Variability Index (PVi): 0-100% | |
| Respiration Rate (RRa): 0-70 breaths per minute | |
| Carboxyhemoglobin Saturation (SpCO): 0-99% | |
| Methemoglobin Saturation (SpMet): 0-99.9% | |
| Total Hemoglobin (SpHb): 0-25g/dL; 0-250g/L(0-15.52 mmol/dL) | |
| Oxygen Concentration (SpOC): 0-35ml of O2/dL | |
| Carbon Dioxide (CO2); 0 vol%-15 vol % | |
| End Tidal CO2 (EtCO2): 0-25 %, 0-32.5 kPa, 0-244 mmHg | |
| Fractional Inspired CO2 (FiCO2): 0-25 %, 0-32.5 kPa, 0-244 mmHg | |
| Respiratory Rate (RR): 0-150 breaths/min | |
| Adult, Systolic: 40-260 mmHg, Diastolic: 20-200 mmHg, MAP 26-220mmHg | |
| Pediatric, Systolic: 40-230 mmHg, Diastolic: 20-160 mmHg, MAP 26-183 mmHg | |
| Neonatal, Systolic: 40-130 mmHg, Diastolic: 20-100 mmHg, MAP 26-110mmHg | |
| Display resolution | SpO2: 1% |
| PR: 1 bpm | |
| RRa: 1breath per minute | |
| SpCO: 1% | |
| SpMet: 0.1% | |
| SpHb: 0.1 g/dL | |
| SpOC: 0.1 ml/dL | |
| Accuracy (ARMS)* | Masimo Rainbow SET/ Masimo SET Parameters |
| SpO2, no motion | 70-100%, 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 breaths per minute, 1 breath per minute, adults/pediatrics |
| Feature | Rad-97 Specification |
| 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 Nomoline Capnography or Optional NIBP Parameters |
| CO2 | Single dry gasses at 22+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 breaths/min $\pm$ 1 breaths/min |
| NIBP | 0-300 mmHg, $\pm$ 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 | |
| Averaging time | SpO2: 2-4, 4-6, 8, 10, 12, 14 and 16 seconds; |
| RRa: Trending, No Averaging, Fast, Medium, or Slow | |
| PVi: Short or Long; | |
| Pi: Short or Long; | |
| SpHb: Short, Medium, or Long | |
| Sensitivity mode | Normal, APOD, and MAX |
| Sleep study mode | 10 seconds |
| Electrical | |
| AC power | Input voltage: 100-240 VAC, 47-63 Hz; input power: 60 VA |
| Internal battery power | Rechargeable lithium ion battery |
| Input/ Output Interface | |
| Patient applied part connection | M-20 connector |
| Nomoline Capnography input connector | |
| NIBP Nib | |
| Analog output | Nurse call output |
| USB interface | SatShare module and external devices (e.g. barcode reader/scanner) |
| connection | |
| Wired (Ethernet) and wireless (Wi- | |
| Fi/Bluetooth) interface | • Wired/wireless connection with networked Patient SafetyNet and/or EMR |
| systems | |
| • Wireless connection with presence tag, Kite, external devices (e.g. | |
| Caregiver thermometer) | |
| Camera (MIPI camera interface) | Surveillance/conferencing capabilities with Patient SafetyNet |
| Audio | Microphone supporting video/audio modes for surveillance/conferencing |
| capabilities with Patient SafetyNet | |
| Mechanical | |
| Enclosure Material | Thermoplastic |
| Dimensions | 9×4×6.5 inch (22.9×10.2×16.5cm) |
| Weight | 0.92 kg. (2.03 lbs.) without Capnography and NIBP |
| Environmental | |
| Feature | Rad-97 Specification |
| Operating Temperature | 0 to 35 °C (32 to 95 °F) |
| Storage/Transport Temperature | -20 to 60 °C (-4 to 140 °F) |
| Operating Humidity | 10% to 95%, non-condensing |
| Non NiBP/Nomoline Capnography | |
| Operating Humidity | 15% to 95%, non-condensing |
| NiBP/Nomoline Capnography | |
| Storage/Transport Humidity | 10% to 90%, non-condensing |
| Non NiBP/Nomoline Capnography | |
| NiBP/Nomoline Capnography | 15% to 90% non-condensing |
| Operating Atmospheric Pressure | 540 mbar to 1,060 mbar (540 hPa to 1060 hPa) |
| Non-NiBP/Nomoline Capnography | |
| Nomoline Capnography | 525 mbar to 1,200 mbar (525 hPa to 1200 hPa) (corresponding to a max altitude of 4572 m / 15 000 feet) |
| Compliance | |
| Electrical Safety/EMC | IEC 60601 compliant |
| Type of Protection | Class I, when on AC power; internally powered, when on battery power |
| Degree of Protection | Defibrillation proof, BF-applied part |
| Protection against harm from liquid ingress | IPX1, protection vertically falling water drops |
| IPX2, protection against falling water drops when enclosure is tilted at 15 degrees | |
| Mode of Operation | Continuous operation |
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Image /page/7/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 letters. Below the logo, the text "MASIMO CORPORATION" is written in gray, followed by the address "52 Discovery, Irvine, CA 92618".
Section 5. 510(k) Summary
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Image /page/8/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 word "Masimo" is the text "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".
Section 5. 510(k) Summary
*Axusaccuracy is a statistical calculation of the difference between device measurements. Approximately two-thirds of the device measurements fell within +/- Arms of the reference measurements in a controlled study.
** Applicable to compatible sensors
Intended Use/Indications for Use
The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multiparameter devices for the display on those devices.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion 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/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 black, bold letters. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.
510(k) Summary Section 5.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
The optional Nomoline Capnography product family is intended to be connected to other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient room. The 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 in hospital-type facilities, mobile, and home environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:
| Patient Population | Approximate Age Range |
|---|---|
| Newborn (neonate) | Birth to 1 month of age |
| Infant | 1 month to 2 years of age |
| Child | 2 to 12 years of age |
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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 a bold, sans-serif font. 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".
510(k) Summary Section 5.
| Patient Population | Approximate Age Range |
|---|---|
| Adolescent | 12-21 years of age |
| Adult | 21 years of age and older |
Technological Characteristics
The Rad-97 principle of operation for Masimo SET/Masimo Rainbow SET technology is the same as the predicate (K170168). This section addresses the additional features of this submission.
The Masimo Rainbow SET technology utilizes the general principles of pulse oximetry for noninvasive optical measurements. Specifically, the Masimo Rainbow SET technology uses a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood, blood with carbon monoxide, oxidized blood, and blood plasma.
Mechanism of Action for Achieving the Intended Effect
The device is turned "on" for its operation.
One end of a patient applied part (e.g. patient cable and SpO2 sensor) is connected to the subject device, and the other end of the patient applied part is connected to the patient. Physiological signals collected via patient applied part are sent to the subject device for processing. The subject device then displays the processed signals or measurements.
Once use is complete, the user then turns the power "off" in the device.
Summary of Technological Characteristics of Subject Device Compared to Predicate
The subject device, Rad-97 product family, and the predicate device, Rad-97, have the following key similarities:
- both have the same intended use as patient monitoring device;
- both have the same principle of operation, mechanism of action, and similar performance specifications;
- . both have same input/output interfaces (e.g. USB, patient-applied part interface, wired/wireless connection) that allows connection with external devices and with networked systems; and
- both are compatible with the same applied patient parts (e.g. sensors, blood pressure ● cuffs).
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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".
510(k) Summary Section 5.
The subject device, Rad-97 product family, and the predicate device have the following key differences:
- The subject device claims a SpO2 measurement accuracy of 1.5% Arms during nomotions conditions for patient populations (adults, pediatrics, and infants) when used with RD SET Disposable sensors;
- . The subject device claims a SpO2 measurement accuracy of 1.5% Arms during motion conditions for patient population (adults, pediatrics, and infants) when used with RD SET Disposable Sensors.
Non-clinical Testing
The subject device Rad-97 is substantially the same as the predicate cleared under K170168. Non- clinical testing was performed to demonstrate substantial equivalence.
The following non-clinical testing was performed on subject device Rad-97.
- Software verification, including integration testing with host monitor for additional ● features, per FDA software guidance.
- Electrical safety testing per IEC-60601-1
- EMC testing per IEC-60601-1-2 ●
- Alarm testing per IEC-60601-1-8
- Biocompatibility testing per ISO-10993 ●
- Mechanical and Environmental Testing per IEC 60601-1 and ISO 80601-2-61
- Pulse rate accuracy for the range of 25-240 bpm in performance bench testing against a ● Biotek Index 2 Simulator.
Clinical Testing
To obtain the accuracy (RMS) of the RD SET Disposable sensors during no-motion and motion conditions, 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 and motion conditions, in the range of 70% to 100%, in comparison to blood measurements from a laboratory CO-Oximeter. The repeated measure adjusted results were as follows:
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Image /page/12/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark-like shape 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".
Section 5. 510(k) Summary
| % SpO2 No Motion Accuracy | ||
|---|---|---|
| Bias | Adjusted | |
| Precision | Adjusted | |
| RMS | ||
| -0.01% | 1.16% | 1.16% |
| % SpO2 Motion Accuracy | ||
|---|---|---|
| Bias | Adjusted Precision | Adjusted RMS |
| 0.33% | 1.27% | 1.31% |
Accordingly, the claimed Ams value is 1.5% during no-motion conditions for adults, pediatrics, and infants, and the claimed Arms value is 1.5% during motion conditions for adult, pediatrics, and infants.
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.