(93 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the technology as based on established pulse oximetry and acoustic principles. There is no mention of AI/ML in the device description, intended use, or performance studies.
No.
The device is indicated for noninvasive monitoring of various physiological parameters (e.g., SpO2, pulse rate, SpCO, SpMet, SpHb), which falls under diagnostic or monitoring purposes, not for providing direct treatment or therapy. The "Intended Use" specifically states it is "not intended to be used as the sole basis for making diagnosis or treatment decisions."
Yes
The device is indicated for noninvasive monitoring of various physiological parameters (SpO2, pulse rate, SpCO, SpMet, SpHb, RRa) which are used to assess a patient's condition. While it notes it's "not intended to be used as the sole basis for making diagnosis or treatment decisions," it is clearly collecting and presenting data to aid in diagnosis, especially when used "in conjunction with additional methods of assessing clinical signs and symptoms."
No
The device description explicitly states it is a "Module" and mentions mechanical and environmental testing, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves testing samples like blood, urine, or tissue outside of the body.
- Device Function: The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is a noninvasive monitoring device. It measures physiological parameters (SpO2, pulse rate, SpCO, SpMet, SpHb, RRa) directly from the patient's body using optical and acoustic methods. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states "noninvasive monitoring" and describes its use with compatible patient monitors to assess patient condition.
Therefore, while it is a medical device used for monitoring and providing information to aid in clinical decisions, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is intended to be used with compatible Philips Intellivue Patient Monitors. The indications for use as specified for the Intellivue Patient Monitors applies.
The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is indicated for use during both no motion conditions, and for patients who are well or poorly perfused.
The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is 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.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The subject device, Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter (Rainbow IVM), resulted from simply taking the same Masimo Rainbow SET technology included in the primary predicate, Philips Multi-Measurement Module (MMS), cleared under K150975 and putting the Masimo Rainbow SET technology into the same form factor as the reference predicate, Masimo Intellivue Pulse Oximeter Module (IVM), cleared under K040259. The resulting Rainbow IVM provides continuous, noninvasive measurements of functional oxygen arterial hemoglobin (SpO2), pulse rate, perfusion index (PI), pleth variability index (PVI), carboxyhemoglobin (SpCO), methemoglobin (SpMet), oxygen content (SpOC) and respiration rate (RRa). The Rainbow IVM is intended to be used with compatible host monitors, Philips Monitors (K150975). Hence, the Rainbow IVM can be used in the same environment that the Philips Monitors are used. Furthermore, the subject device does not have its own power, monitoring alarms or display and must rely on the host monitor for those capabilities.
The Rainbow IVM is intended to be used with the compatible host monitors, Philips Monitors, which include the following models:
- IntelliVue MP40 in internal slots
- IntelliVue MP50 in internal slots
- IntelliVue MX500 in internal slots
- IntelliVue MX550 in internal slots
- IntelliVue MP60 via FMS-4 or FMS-8
- IntelliVue MP70 via FMS-4 or FMS-8
- IntelliVue MP80 via FMS-4 or FMS-8
- IntelliVue MP90 via FMS-4 or FMS-8
- IntelliVue MX600 via FMS-4 or FMS-8
- IntelliVue MX700 via FMS-4 or FMS-8
- IntelliVue MX800 via FMS-4 or FMS-8
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Measurements (SpO2, Pulse Rate, SpCO, SpMet, SpHb, PI, PVI, SpOC); Acoustic Measurement (RRa)
Anatomical Site
Not Found
Indicated Patient Age Range
adults, pediatrics, infants, neonates (SpO2, Pulse Rate, SpCO, SpMet); adults, pediatrics (SpHb, RRa)
Intended User / Care Setting
Clinician; Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
- Electrical safety testing per IEC-60601-1
- EMC testing per IEC-60601-1-2
- Usability testing per FDA Human Factors and Usability Draft Guidance
- Software verification, including integration testing with host monitors, per FDA Software Guidance
- Mechanical testing per ISTA-2A and MIL-STD 810E
- Environmental testing per IEC-60601-1
Clinical Testing:
No clinical testing was done.
Key results: The results of the testing demonstrate that all requirements and performance specifications were satisfied, and that the subject device is substantially equivalent to its predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measurement Accuracy:
SpO2, No Motion: 60-80%, 3%, adults/pediatrics/infants; 70-100%, 2%, adults/pediatrics/infants
SpO2, Motion: 70-100%, 3%, neonates
SpO2, Low Perfusion: 70-100%, 3%, adults/pediatrics/infants/neonates
Pulse Rate, No Motion: 70-100%, 2%, adults/pediatrics/infants/neonates
Pulse Rate, Motion: 25-240 bpm, 3 bpm, adults/pediatrics/infants/neonates
Pulse Rate, Low Perfusion: 25-240 bpm, 5 bpm, adults/pediatrics/infants/neonates
SpCO: 25-240 bpm, 3 bpm, adults/pediatrics/infants/neonates
SpMet: 1-40%, 3%, adults/pediatrics/infants
SpHb: 1-15%, 1%, adults/pediatrics/infants/neonates
RRas: 8-17 g/dL, 1 g/dL, adults/pediatrics; 4-70 breaths per minute, 1 breath per minute, adults/pediatrics
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
§ 870.2700 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 28, 2016
Masimo Corporation Marguerite Thomlinson Senior Director, Regulatory Affairs 52 Discovery Irvine, California 92618
Re: K162675
Trade/Device Name: Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: November 23, 2016 Received: November 28, 2016
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.
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 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,
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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
2
Indications for Use
510(k) Number (if known) K162675
Device Name
Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter
Indications for Use (Describe)
The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is intended to be used with compatible Philips Intellivue Patient Monitors. The indications for use as specified for the Intellivue Patient Monitors applies.
The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is indicated for the nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is indicated for use during both no motion conditions, and for patients who are well or poorly perfused.
The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is 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.
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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Image /page/3/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 a smaller, gray font, 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) 297-7683
FAX: (949) 297-7592 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Date: | December 23, 2016 |
| Contact: | Marguerite Thomlinson
Senior Director, Regulatory Affairs |
| Trade Name: | Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter |
| Common Name: | Pulse CO-oximeter |
| Classification Regulation/
Product Code: | 21 CFR 870.2700, Class II/DQA |
| Establishment
Registration Number: | 2031172 |
| Reason for Premarket
Notification: | New Device |
| Predicate Device: | K150975, Philips Patient Monitors
K040259, Masimo SET Intellivue Pulse Oximeter Module |
| Performance Standards | No performance standards for the above device have been
promulgated pursuant to Section 514. |
Device Description
The subject device, Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter (Rainbow IVM), resulted from simply taking the same Masimo Rainbow SET technology included in the primary predicate, Philips Multi-Measurement Module (MMS), cleared under K150975 and putting the Masimo Rainbow SET technology into the same form factor as the reference predicate, Masimo Intellivue Pulse Oximeter Module (IVM), cleared under K040259. The resulting Rainbow IVM provides continuous, noninvasive measurements of functional oxygen arterial hemoglobin (SpO2), pulse rate, perfusion index (PI), pleth variability index (PVI), carboxyhemoglobin (SpCO), methemoglobin (SpMet), oxygen content (SpOC) and respiration rate (RRa). The Rainbow IVM is intended to be used with compatible host monitors, Philips Monitors (K150975). Hence, the Rainbow IVM can be used in the same environment that the Philips Monitors are used. Furthermore, the subject device does not
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Image /page/4/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red symbol on the left, followed by the word "Masimo" in a bold, sans-serif font. To the right of the word "Masimo" are the words "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".
Section 5. 510(k) Summary
have its own power. monitoring alarms or display and must rely on the host monitor for those capabilities.
The Rainbow IVM is intended to be used with the compatible host monitors, Philips Monitors, which include the following models:
- IntelliVue MP40 in internal slots
- IntelliVue MP50 in internal slots ●
- IntelliVue MX500 in internal slots ●
- IntelliVue MX550 in internal slots
- IntelliVue MP60 via FMS-4 or FMS-8
- IntelliVue MP70 via FMS-4 or FMS-8 ●
- IntelliVue MP80 via FMS-4 or FMS-8 .
- IntelliVue MP90 via FMS-4 or FMS-8 ●
- IntelliVue MX600 via FMS-4 or FMS-8
- . IntelliVue MX700 via FMS-4 or FMS-8
- IntelliVue MX800 via FMS-4 or FMS-8 ●
See the table below for the Rainbow IVM specifications.
| RAINBOW IVM SPECIFICATIONS | |
|---|---|
| FEATURE | SPECIFICATION |
| Measurement Range | Arterial 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% | |
| Carboxyhemoglobin Saturation (SpCO): 0-99% | |
| Methemoglobin Saturation (SpMet): 0-99.9% | |
| Total Hemoglobin (SpHb): 0-25.0 g/dL | |
| Total Oxygen Concentration (SpOC): 0-35ml/dL of O2 dL of blood | |
| Respiratory Rate (RRa): 0-70 breaths per minute | |
| Display resolution | SpO2: 1% |
| PR: 1 bpm | |
| SpCO: 1% | |
| SpMet: 0.1% | |
| SpHb: 0.1 g/dL | |
| RRa: 1breath per minute | |
| RAINBOW IVM SPECIFICATIONS | |
| FEATURE | SPECIFICATION |
| Measurement Accuracy | |
| SpO2, No Motion | 60-80%, 3%, adults/pediatrics/infants |
| 70-100%, 2%, adults/pediatrics/infants | |
| SpO2, Motion | 70-100%, 3%, neonates |
| SpO2, Low Perfusion | 70-100%, 3%, adults/pediatrics/infants/neonates |
| Pulse Rate, No Motion | 70-100%, 2%, adults/pediatrics/infants/neonates |
| Pulse Rate, Motion | 25-240 bpm, 3 bpm, adults/pediatrics/infants/neonates |
| Pulse Rate, Low Perfusion | 25-240 bpm, 5 bpm, adults/pediatrics/infants/neonates |
| SpCO | 25-240 bpm, 3 bpm, adults/pediatrics/infants/neonates |
| SpMet | 1-40%, 3%, adults/pediatrics/infants |
| SpHb | 1-15%, 1%, adults/pediatrics/infants/neonates |
| RRa | 8-17 g/dL, 1 g/dL, adults/pediatrics |
| Display/Indicator for Host Monitor | 4-70 breaths per minute, 1 breath per minute, adults/pediatrics |
| SpO2%, pulse rate, alarm status, alarm silenced status, perfusion index, | |
| carboxyhemoglobin (SpCO%), methemoglobin (SpMet%), total hemoglobin | |
| (SpHb g/dL or mmol/l), SpOC, Pleth Variability Index (PVI), Acoustic | |
| respiration rate, (RRa), total oxygen content (SpOC), | |
| Modes | |
| SpO2 Averaging mode | 2, 4, 8, 10, 12, 14 and 16 seconds |
| Sensitivity mode | Normal, maximum and APOD |
| SpHb averaging mode | Long, medium, short |
| SpHb monitoring mode | Arterial or venous |
| SpHb precision mode | 1,0.5, 0.1 (g/dL or mmol/L) |
| PI averaging (smooth PI) | Automatically set based on SpO2 averaging mode |
| SpO2 Averaging mode: 2-8 seconds = Short | |
| SpO2 Averaging mode: 10-16 seconds = Long | |
| PVI | Automatically set based on SpO2 averaging mode |
| SpO2 Averaging mode: 2-6 seconds = Short | |
| SpO2 Averaging mode: 10-16 seconds = Long | |
| RRa averaging | None, fast, medium, slow, trending |
| RRa pause time | 15, 20, 25, 30, 35, and 40 seconds |
| RRa freshness timeout | 0, 1, 5, 10, and 15 minutes |
| Line frequency | 50/60Hz |
| SmartTone | On/Off |
| Desaturation index alarm (Desat | |
| Index) | % Threshold: 2-10%, in 1% increments |
| Occurrence count: 1-25 in 1 step increments | |
| Period: 1-4 hours in 1 hour increments | |
| Perfusion index delta alarm (PI Delta) | % Delta: 10-100%, in 2% increments |
| Duration: 1, 5, or 30 minutes, 1 hour, 4-48 hours (4 hour increments), infinite. | |
| Electrical | |
| Power requirement | Power supplied by Philips Monitor |
| Interface | |
| Power connector | Interface Philips Monitor standard 12-pin circular connector |
| Patient cable connector | Interface Masimo patient cable, which connects to Masimo sensor |
| RAINBOW IVM SPECIFICATIONS | |
| FEATURE | SPECIFICATION |
| Indicator/ Control | |
| Indicator | 1 LED indicator – green color |
| Control | 1 push button switch |
| Mechanical | |
| Enclosure material | Plastic |
| Dimensions/weight | 102.5 x 99.6 x 36 mm (4.0 x 3.9 x 1.4 in.)/ 195g (7.0 oz.) |
| Environmental | |
| Operating temperature | 0 to 55°C, ambient humidity (32 to 131°F) |
| Transport/storage temperature | -40 to 70°C, ambient humidity (-40 to +158°F) |
| Operating humidity | 95% RH max at 40°C |
| Transport/storage humidity | 95% RH max at 65°C |
| Operating altitude | Up to 4,600 m. (15,000 ft.) |
| Transport/storage altitude | -380 to 5,560 m (-1,250 to 18250 ft) |
| Compliance | |
| Electrical safety and EMC | IEC 60601 compliant |
| Degree of protection -electrical shock | Defibrillation proof type CF-applied part |
| Mode of Operation | Continuous operation |
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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" and the address "52 Discovery, Irvine, CA 92618".
Section 5. 510(k) Summary
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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 line running through it, followed by the word "Masimo" in a bold, sans-serif font. To the right of the logo, the text "MASIMO CORPORATION" is displayed in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".
Section 5. 510(k) Summary
Intended Use
The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is intended as a measurement module for use with compatible Philips Intellivue Patient Monitors (Philips Monitor).
Indications For Use
The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is intended to be used with compatible Philips Intellivue Patient Monitors. The indications for use as specified for the Intellivue Patient Monitors applies.
The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.
The Masimo Rainbow SET® Intellivue Module Pulse CO-Oximeter is not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.
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Image /page/7/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white line running through it, followed by the word "Masimo" in a bold, black font. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in a smaller, gray font, followed by the address "52 Discovery, Irvine, CA 92618".
Section 5. 510(k) Summary
Technological Characteristics
Principle of Operation
Optical Measurements (SpO2, Pulse Rate, SpCO, SpMet, SpHb, PI, PVI, SpOC) – The Masimo Rainbow SET technology utilizes the general principles of pulse oximetry for noninvasive optical measurements of SpO2, pulse rate, SpCO, SpMet and SpHb measurements. The perfusion index (PI), pleth variability index (PVI) and oxygen content (SpOC) values are derived from these measurements.
The Masimo Rainbow SET pulse CO-oximetry technology is governed by the following principles:
- Oxyhemoglobin (oxygentated blood) and deoxyhemoglobin (non-oxygenated . blood), carboxyhemoglobin (blood with carbon monoxide content), methemoglobin (blood with oxidized hemoglobin) and blood plasma constituents differ in their absorption of visible and infrared light (using spectrophotometry).
- The amount of arterial blood in tissue changes with pulse (photoplethysmography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.
The Rainbow Pulse CO-oximetry technology uses a multi-wavelength sensor to distinguish between oxygenated blood, deoxygenated blood, blood with carbon monoxide, oxidized blood and blood plasma.
Acoustic Measurement (RRa) – The Masimo Rainbow Acoustic Monitoring (RAM) technology uses acoustic signals for respiration rate (RRa) measurements. RRa measures a patient's respiration rate based on airflow sounds generated in the upper airway. RRa translates airflow sounds generated in the upper airway to an electrical signal that can be processed to produce a respiration rate, measured as breaths per minute.
Mechanism of Action for Achieving the Intended Effect
The subject device is connected to a compatible host/backboard device, Philips Monitor. A sensor is connected to Rainbow IVM on one end and applied to the patient at the other end. Monitoring begins when the power on the host/backboard device is turned on. The sensor collects physiological signals from the patient and sends the signals to the subject device for processing. The processed signals or measurements are then sent to the host/backboard for display. The clinician can use
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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-like shape inside, followed by the word "Masimo" in bold, black letters. To the right of the logo, the text "MASIMO CORPORATION" is displayed above the address "52 Discovery, Irvine, CA 92618".
Section 5. 510(k) Summary
the information to assess the patient condition and help determine if intervention is required. When use is complete, the sensor is removed from the patient and the power is turned off.
Summary of Technological Characteristics of Subject Device Compared to Predicates
The subject device and primary predicate (K150975) have the following key similarities:
- Both are intended for use as measurement modules; ●
- Both rely on connected host monitor for power, display and alarm functions; ●
- Both are intended to be used with compatible models of Philips Monitors (K150975):
- Both include the same Masimo Rainbow SET technology: ●
- Both include the same principles of operation for the Masimo Rainbow SET technology; and
- . Both are compatible with cleared Masimo sensors/cables for the measurement of pulse CO-oximeter parameters including SpO2, pulse rate, SpCO, SpMet and SpHb and respiration rate parameters.
The subject device and primary predicate (K150975) have the following key differences:
- . The subject device only includes the Masimo Rainbow SET technology, whereas the predicate includes other technologies such as NIBP and ECG in addition to the Masimo Rainbow SET technology; and
- . The subject device and the primary predicate have different form factor;
The subject device and reference predicate (K040259) have the following key similarities:
- Both are intended for use as measurement modules;
- Both rely on connected host monitor for power, display and alarm functions; ●
- Both are intended to be used with compatible models of Philips Monitors (K150975); ●
- Both include the same Masimo technology for pulse oximetry; ●
- Both include the same principles of operation for the Masimo pulse oximetry technology; and
- Both are compatible with cleared Masimo sensors/cables for the measurement of ● pulse oximetry parameters.
The subject device and reference predicate (K040259) have the following key differences:
- . The subject device includes Masimo Rainbow SET technology, whereas the predicate
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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-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 font, followed by the address "52 Discovery, Irvine, CA 92618".
Section 5. 510(k) Summary
only includes Masimo pulse oximetry technology, a subset of the Masimo Rainbow SET technology; and
- The subject device is compatible with cleared Masimo sensors/cables for . measurements of pulse CO-oximeter parameters including SpO2. pulse rate. SpCO. SpMet and SpHb and respiration rate parameters, whereas the predicate is compatible with Masimo sensors/cables only for the measurement of pulse oximetry parameters.
Non-clinical Testing
The following tests, as applicable, were performed for the qualification of the subject devices, Rainbow IVM, in accordance with the requirements of the design control regulations and established quality assurance processes to demonstrate substantial equivalence with its predicates:
- Electrical safety testing per IEC-60601-1
- EMC testing per IEC-60601-1-2 ●
- Usability testing per FDA Human Factors and Usability Draft Guidance ●
- Software verification, including integration testing with host monitors, per FDA ● Software Guidance
- Mechanical testing per ISTA-2A and MIL-STD 810E
- Environmental testing per IEC-60601-1 .
Clinical Testing
No clinical testing was done.
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 predicates. Thus, it is concluded that the subject device, Rainbow IVM, is substantially equivalent to the predicate based on the non-clinical tests discussed above.