The Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial hemoglobin (SpO2), pulse rate, and total hemoglobin (SpHb). The Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in clinical and non-clinical settings.

Device Description

The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories (RadCheck) have modified intended use/indications for use in comparison to the Rad 57t Pulse CO-Oximeters and Accessories (Rad 57t) in the K080238 filing. The main difference is that the RadCheck in this filing is for spot checking, whereas the Rad 57t in K0808238 is for continuous monitoring. The keypad membrane and the software of the RadCheck also differ from the Rad 57t.

The RadCheck in this filing is similar in construction to the Rad 57t in the K0808238 filing, including the 12-wavelength technology for the measurement of total hemoglobin. The performance of the Radcheck is similar to the Rad 57t. Similar to the Rad 57t, the RadCheck provides noninvasive monitoring of arterial oxygen saturation (%SpO2), pulse rate, and total hemoglobin concentration (g/d) SpHb). Other information displayed by the RadCheck include: Low Signal IQ (Low SIQ), Perfusion Index (PI), Total Arterial Oxygen Content (SpOC), battery life, and sensor status.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories, based on the provided text:

Acceptance Criteria and Reported Device Performance

Parameter/Condition	Acceptance Criteria (Specification)	Reported Device Performance
SpO2 Accuracy (No Motion)	Adults, Pediatrics: 60% - 80% ± 3%	Not explicitly stated as a separate "reported performance" against this specific criterion, but the overall SpO2 accuracy studies (details below) support these ranges.
	Adults, Pediatrics: 70% - 100% ± 2%	Not explicitly stated as a separate "reported performance" against this specific criterion, but the overall SpO2 accuracy studies (details below) support these ranges.
	Adults, Pediatrics: 0% - 69% unspecified
SpO2 Accuracy (Motion)	Adults, Pediatrics: 70% - 100% ± 3%	Not explicitly stated as a separate "reported performance" against this specific criterion, but the overall SpO2 accuracy studies (details below) support these ranges.
	Adults, Pediatrics: 0% - 69% unspecified
SpO2 Accuracy (Low Perfusion)	Adults, Pediatrics: 70% - 100% ± 2%	Not explicitly stated as a separate "reported performance" against this specific criterion, but the overall SpO2 accuracy studies (details below) support these ranges.
	Adults, Pediatrics: 0% - 69% unspecified
Pulse Rate Accuracy (No Motion)	Adults, Pediatrics: 25 - 240 bpm ± 3 bpm	Not explicitly stated as a separate "reported performance" against this specific criterion, but the overall Pulse Rate accuracy studies (details below) support these ranges.
Pulse Rate Accuracy (Motion)	Adults, Pediatrics: 25 - 240 bpm ± 5 bpm	Not explicitly stated as a separate "reported performance" against this specific criterion, but the overall Pulse Rate accuracy studies (details below) support these ranges.
Pulse Rate Accuracy (Low Perfusion)	Adults, Pediatrics: 25 - 240 bpm ± 3 bpm	Not explicitly stated as a separate "reported performance" against this specific criterion, but the overall Pulse Rate accuracy studies (details below) support these ranges.
SpHb Accuracy (No Motion)	Adults, Pediatrics: 8 - 17 g/dl ± 1 g/dl	Masimo Rainbow SET RadCheck meets this specification with an accuracy of ±1 g/dl for SpHb values between 8-17 g/dl.

Note: The document explicitly states "The RadCheck performance is equivalent to those of the Rad 57t," implying that these specifications are met by the RadCheck device as well. The accuracy values provided are stated as "specifications" for the device, and the "Studies" section confirms its validation against these.

Study Information Proving Device Meets Acceptance Criteria

The document uses several "human blood studies" and "bench-top testing" to validate the accuracy claims.

Sample Size Used for the Test Set and Data Provenance:
- SpO2 Accuracy (No Motion): "healthy adult volunteers" (specific number not provided). Data provenance: Human blood studies.
- SpO2 Accuracy (No Motion) (extended 70-100% range): "healthy adult male and female volunteers with light to dark skin pigmentation" (specific number not provided). Data provenance: Induced hypoxia studies, human blood studies.
- SpO2 Accuracy (Motion): "healthy adult male and female volunteers with light to dark skin pigmentation" (specific number not provided). Data provenance: Induced hypoxia studies, human blood studies.
- SpO2 Accuracy (Low Perfusion): Not human subjects. Bench-top testing.
- Pulse Rate Accuracy (No Motion): Not explicitly detailed for no motion specifically, but the general pulse rate accuracy was evaluated via bench-top testing.
- Pulse Rate Accuracy (Motion): Not explicitly detailed for motion specifically, but the general pulse rate accuracy was evaluated via bench-top testing.
- Pulse Rate Accuracy (Low Perfusion): Not human subjects. Bench-top testing.
- SpHb Accuracy (No Motion): "healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation" (specific number not provided). Data provenance: Human subjects.
- For all human studies: The country of origin for the data is not specified in the provided text. The studies appear to be prospective as they involve induced hypoxia or direct measurement against a laboratory method.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable in the context of this device. The ground truth relies on laboratory instruments (CO-Oximeter, ECG monitor) and simulators, not human expert consensus for interpreting device output.
Adjudication Method:
- Not applicable. Ground truth is established by quantitative measurements from reference devices.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is typically performed for diagnostic imaging or interpretation tasks where human readers make assessments. This device is a measurement device.
Standalone (Algorithm only without human-in-the-loop performance) Study:
- Yes. The accuracy claims are for the device's measurements (SpO2, Pulse Rate, SpHb) directly against laboratory references or simulators, which represents the standalone performance of the algorithm and sensor.
Type of Ground Truth Used:
- Laboratory CO-Oximeter: Used as the ground truth for SpO2 and SpHb measurements.
- ECG monitor: Used as the ground truth for pulse rate during human blood studies.
- Biotek Index 2 simulator and Masimo's simulator: Used as the ground truth for SpO2 (low perfusion) and Pulse Rate (bench-top testing).
Sample Size for the Training Set:
- The document describes validation studies, not necessarily specific training sets for a machine learning model. The underlying "Rainbow SET technology, MX-1 Board/Circuitry" implies significant prior development and data but the size of a distinct "training set" is not provided here.
How the Ground Truth for the Training Set Was Established:
- Not explicitly detailed for a "training set" in this document. During product development and prior iterations (e.g., for the predicate device Masimo Rainbow SET Rad 57t), ground truth would have been established using the same reference methods as the validation studies (laboratory CO-Oximeters, ECG monitors, and simulators).

Summary

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K08.2052

Submitted by:	Masimo Corporation40 ParkerIrvine, CA 92618949-297-7000FAX 949-297-7001
Company Contact:	Marguerite Thomlinson, Manager of Regulatory Affairs
Date Summary Prepared:	July 16, 2008
Trade Name	Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories
Common Name	Oximeter Sensor
Classification Name and Product Code:	Oximeter (74DQA) (870.2700) Cable, Transducer and Electrode (74DSA) (870.2900)
Substantially Equivalent Devices:	Masimo Rainbow SET Rad 57t Pulse CO-Oximeters and Accessories, 510(k) Number K080238

Device Description

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Predicate Device

The predicate device used in this filing is the Masimo Rainbow SET® Rad 57t Pulse CO-Oximeter (Rad 57t) and Accessories, 510(k) Number K080238.

Intended Use

The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial hemoglobin (SpO2), pulse rate, and total hemoglobin (SpHb). The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatic patients during both no motion and motion conditions, and for patients who are well or poorly perfused in clinical and non-clinical settings.

Technology Comparison

The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter (Rad 57 Spotcheck) is substantially equivalent in design, principles of operation, materials, and performance to predicate device (the Rad 57t).

Similar to the Rad 57t, the RadCheck is designed, and manufactured for full compatibility with Masimo Rainbow pulse CO-Oximeter sensors with SpHb capabilities (K080238).

The RadCheck performance is equivalent to those of the Rad 57t, as following:

FEATURES	SPECIFICATIONS
Display Ranges	Saturation (SpO2): 0% - 100%Pulse Rate (bpm): 25 - 240 bpmTotal Hemoglobin (SpHb): 0-25 g/dlTotal Oxygen Concentration (SpOC): 0-35 ml/dlPerfusion Index: 0.02% - 20%
Accuracy: SpO2 and Pulse Rate	See Footnotes 1, 2, 3, 4, and 5
Accuracy – SpO2During No Motion Conditions	Adults, Pediatrics: 60% - 80% ± 3%Adults, Pediatrics: 70% - 100% ±2%Adults, Pediatrics: 0% - 69% unspecified
Accuracy – SpO2During Motion Conditions	Adults, Pediatrics: 70% - 100% ± 3%Adults, Pediatrics: 0% - 69% unspecified
Accuracy – SpO2Low Perfusion	Adults, Pediatrics: 70% - 100% ±2%Adults, Pediatrics: 0% - 69% unspecified
Accuracy – Pulse RateDuring No Motion Conditions	Adults, Pediatrics: 25 - 240 ± 3 bpm
Accuracy – Pulse RateDuring Motion Conditions	Adults, Pediatrics: 25 - 240 ± 5 bpm
Accuracy – Pulse RateLow Perfusion	Adults, Pediatrics: 25 - 240 ± 3 bpm
FEATURES	SPECIFICATIONS
Accuracy: SpHb
Accuracy - SpHbDuring No Motion Conditions	Adults, Pediatrics: 8 - 17 g/dl +1 g/dlSpHb accuracy has been validated on healthy adult male andfemale volunteers and on surgical patients with light to dark skinpigmentation in the range of 8 - 17 g/dl SpHb against alaboratory CO-oximeter. This variation equals plus or minusone standard deviation which encompasses 68% of thepopulation. The SpHb accuracy has not been validated withmotion or low perfusion.
General
Resolution	SpO2: 1%Pulse Rate: 1 bpmSpHb: 0.1 g/dl
Measurements	Low Signal IQPerfusion Index (PI)Total Oxygen Concentration (SpOC)
Interfering Substances	Elevated levels of Methemoglobin (MetHb) may lead toinaccurate SpO2 measurements Elevated levels of Carboxyhemoglobin (COHb) may lead toinaccurate SpO2 measurements. Severe anemia may cause erroneous SpO2 readings. Dyes, or any substance containing dyes, that change usualblood pigmentation may cause erroneous readings. Elevated levels of total bilirubin may lead to inaccurate SpO2,and SpHb readings
Electrical	See Footnote 6
Batteries	Non-Rechargeable
Circuitry	Microprocessor controlled
Firmware	Rainbow SET technology, MX-1 Board/Circuitry
Mechanical
Material	Polycarbonate/ABS Blend
Environmental
Operating Temperature	41°F to + 104°F (5°C to +40°C)
Storage Temperature	-40°F to + 158°F (-40°C to +70°C)
Relative Humidity	5% to 95% noncondensing
Operating Altitude	Operating Altitude: 500 mbar to 1,060 mbar pressure; -1,000 ft to18,000 ft (-304 m to 5,486m)
Mode & Sensitivity
Averaging Mode - SpO2	Maximum sensitivity mode fixes perfusion limit to 0.02%
Alarms
System	System failure
Battery Alarm	Low battery
FEATURES	SPECIFICATIONS
Display and Indicators
Data Display	SpO2 (%)
	Pulse rate (bpm)
	SpHb (g/dl)
	Perfusion index (%)
	SpOC (ml/dl)
	Signal IQ
	Pulse indicator
	Sensor life indicator
	Sensor status
	Status messages
	Battery status
Compliance
EMC Compliance	EN 60601-1-2, Class B
Electrical Safety	IEC 60601-1,
	UL 60601-1
Type of Protection (battery power)	Internally Powered
Degree of Protection-Patient Cable	Type BF-Applied Part
Enclosed Degree of Ingress	IPX1
Protection from Solids/ Liquids
Mode of Operation	Spot check

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Footnotes

SpO2 accuracy was determined by testing on healthy adult volunteers in the range of 1 60-100% SpO2 against a laboratory CO-Oximeter.
2 The Masimo sensors have been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population weight.
ന The Masimo sensors have been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-oximeter and ECG monitor. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
4 The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation which encompasses 68% of the population.

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The Masimo sensors have been validated for pulse rate accuracy for the range of 5 25-240 bpm in bench top testing against a Biotek Index 2 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
6 If the batteries are to be stored for extended periods of time, it is recommended that they be stored between -20 to +30°C, and at a relative humidity less than 85%. If stored for a prolonged period at environmental conditions beyond these limits, overall battery capacity may be diminished, and lifetime of the batteries may be shortened.

Test Summary

The RadCheck complies with the voluntary standards as detailed in this submission. The following quality assurance measures were applied to the development of the RadCheck:

. Risk Analysis
. Design Reviews
Biocompatibility Testing .
Performance Testing .
Safety Testing .
. Environmental Testing
. Clinical Testing

Conclusions

The information in this 510(k) submission demonstrates that the Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories are substantially equivalent to the predicate device, with respect to safety, effectiveness, and performance.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2008

Ms. Marguerite Thomlinson Manager of Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618

Re: K082052

Trade/Device Name: Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: July 16, 2008 Received: July 21, 2008

Dear Ms. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Ms. Thomlison

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Thlammels-Lund, mt for 11

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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):

Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories Device Name:

Indications For Use:

A.R. (MD)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Prescription UseX	AND/OR	Over-The-Counter Use
(Per 21 CFR 801.109 Subpart D)		(Per 21 CFR 801.109 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 10 of 259 Masimo RadCheck 510(k)

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).