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.

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.

AI/ML Overview

The document describes the Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter (Rainbow IVM) and its substantial equivalence to predicate devices, K150975 and K040259. However, it explicitly states that no clinical testing was done to demonstrate the device meets acceptance criteria. The submission relies solely on non-clinical testing.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and multi-reader comparative effectiveness studies cannot be extracted from the provided text.

Based on the provided information, here's what can be answered:

1. A table of acceptance criteria and the reported device performance

The document lists "Measurement Accuracy" specifications in the "Rainbow IVM Specifications" table, which serve as the acceptance criteria for performance. The "reported device performance" is essentially that these specifications are met based on non-clinical testing (although specific results of that testing are not detailed beyond a general statement that "all requirements and performance specifications were satisfied").

Feature (Parameter)	Acceptance Criteria (Specification)	Reported Device Performance
SpO2, No Motion	60-80%, 3%, adults/pediatrics/infants70-100%, 2%, adults/pediatrics/infants	Met (Based on non-clinical testing statement)
SpO2, Motion	70-100%, 3%, neonates	Met (Based on non-clinical testing statement)
SpO2, Low Perfusion	70-100%, 3%, adults/pediatrics/infants/neonates	Met (Based on non-clinical testing statement)
Pulse Rate, No Motion	25-240 bpm, 3 bpm, adults/pediatrics/infants/neonates	Met (Based on non-clinical testing statement)
Pulse Rate, Motion	25-240 bpm, 5 bpm, adults/pediatrics/infants/neonates	Met (Based on non-clinical testing statement)
Pulse Rate, Low Perfusion	25-240 bpm, 3 bpm, adults/pediatrics/infants/neonates	Met (Based on non-clinical testing statement)
SpCO	1-40%, 3%, adults/pediatrics/infants	Met (Based on non-clinical testing statement)
SpMet	1-15%, 1%, adults/pediatrics/infants/neonates	Met (Based on non-clinical testing statement)
SpHb	8-17 g/dL, 1 g/dL, adults/pediatrics	Met (Based on non-clinical testing statement)
RRa	4-70 breaths per minute, 1 breath per minute, adults/pediatrics	Met (Based on non-clinical testing statement)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical testing was performed for the Rainbow IVM device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical testing was performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical testing was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No clinical testing was performed, and the device is a measurement module, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a non-invasive physiological monitoring device. Its "performance" refers to the accuracy of its measurements (SpO2, SpCO, SpMet, SpHb, RRa, etc.) against a reference, which would typically be measured in a controlled environment or in clinical studies. The document states "no clinical testing was done," meaning no standalone clinical performance study was conducted on this specific device. However, the performance specifications listed are for the device (algorithm and hardware) itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated for the non-clinical testing. For physiological measurements like these, ground truth would typically come from a clinical reference standard (e.g., co-oximetry for SpO2, SpCO, SpMet, SpHb, or capnography/direct observation for RRa) during clinical trials or controlled laboratory settings (e.g., human desaturation studies for SpO2). Since no clinical testing was performed for this specific submission, the "ground truth" for the non-clinical tests would refer to the expected electrical and optical signals/simulations used to verify the device's adherence to its specifications.

8. The sample size for the training set

Not applicable. No clinical testing was performed, and a "training set" is typically associated with machine learning or AI models, which is not directly indicated here. The device relies on established principles of spectrophotometry and acoustic monitoring.

9. How the ground truth for the training set was established

Not applicable. No clinical testing was performed or described.

Summary

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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.

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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

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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 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 ofManufacturing Facility:	Masimo Corporation52 DiscoveryIrvine, CA 92618Phone: (949) 297-7683FAX: (949) 297-7592
Date:	December 23, 2016
Contact:	Marguerite ThomlinsonSenior 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
EstablishmentRegistration Number:	2031172
Reason for PremarketNotification:	New Device
Predicate Device:	K150975, Philips Patient MonitorsK040259, Masimo SET Intellivue Pulse Oximeter Module
Performance Standards	No performance standards for the above device have beenpromulgated pursuant to Section 514.

Device Description

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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/infants70-100%, 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), Acousticrespiration 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 modeSpO2 Averaging mode: 2-8 seconds = ShortSpO2 Averaging mode: 10-16 seconds = Long
PVI	Automatically set based on SpO2 averaging modeSpO2 Averaging mode: 2-6 seconds = ShortSpO2 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 (DesatIndex)	% Threshold: 2-10%, in 1% incrementsOccurrence count: 1-25 in 1 step incrementsPeriod: 1-4 hours in 1 hour increments
Perfusion index delta alarm (PI Delta)	% Delta: 10-100%, in 2% incrementsDuration: 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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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

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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.

Regulation Number and Section

§ 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).