The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatric individuals during both no motion and motion conditions and for individuals who are well or poorly perfused and in clinical and non-clinical settings (e.g., hospital-type facilities, home, clinics, physician offices, blood donation facilities, and ambulatory surgery centers).

Device Description

The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories in this filing are the same as the Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories in K082052. The reason for this filing is to clarify the intended use and the labeling of the device.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are presented as "Specifications" in the document. The reported device performance is presented as "Accuracy" values.

Feature	Acceptance Criteria (Specification)	Reported Device Performance (Accuracy)
SpO2, No Motion Conditions	N/A (implied by accuracy ranges)	Adults, Pediatrics: 60-80% ± 3%; 70-100% ± 2%
SpO2, Motion Conditions	N/A (implied by accuracy ranges)	Adults, Pediatrics: 70-100% ± 3%
SpO2, Low Perfusion	N/A (implied by accuracy ranges)	Adults, Pediatrics: 70-100% ± 2%
Pulse Rate, No Motion	N/A (implied by accuracy ranges)	Adults, Pediatrics: 25-240 ± 3 bpm
Pulse Rate, Motion	N/A (implied by accuracy ranges)	Adults, Pediatrics: 25-240 ± 5 bpm
Pulse Rate, Low Perfusion	N/A (implied by accuracy ranges)	Adults, Pediatrics: 25-240 ± 3 bpm
SpHb, No Motion Conditions	N/A (implied by accuracy range)	Adults, Pediatrics: 8-17 g/dl ± 1 g/dl (Arterial or Venous)

Additional Specifications/Features (not directly accuracy-related):

Display Ranges: Saturation (SpO2): 0-100%; Pulse Rate: 25-240 bpm; Total Hemoglobin (SpHb): 0-25 g/dl; Total Oxygen Concentration (SpOC): 0-35 ml/dl; Perfusion Index: 0.02-20%
Resolution: SpO2: 1%; Pulse Rate: 1 bpm; SpHb: 0.1 g/dl
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: 500 mbar to 1,060 mbar pressure; -1,000 ft to 18,000 ft

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample size for each test. However, it indicates:

SpO2 Accuracy (No Motion): "healthy adult volunteers" (Footnote 1)
SpO2 Accuracy (No Motion, Inducible Hypoxia): "healthy adult male and female volunteers with light to dark skin pigmentation" (Footnote 2)
SpO2 Accuracy (Motion, Inducible Hypoxia): "healthy adult male and female volunteers with light to dark skin pigmentation" (Footnote 3)
SpHb Accuracy: "(arterial/venous) blood from healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation" (Footnote 6)

The data provenance is prospective human blood studies for SpO2 and SpHb measurements, conducted on healthy adult volunteers and surgical patients. Additional testing for low perfusion and pulse rate accuracy was done via benchtop testing using simulators. The country of origin is not specified but implied to be the US given the FDA submission.

3. Number of Experts and Qualifications for Ground Truth

No external experts were used to establish the ground truth for the SpO2, Pulse Rate, or SpHb measurements. The ground truth was established by laboratory instruments, as detailed below.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the tests primarily involved comparison against laboratory reference instruments, not expert interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The device is an oximeter, not an AI for image interpretation or diagnosis requiring human-in-the-loop comparison.

6. Standalone Performance

Yes, the accuracy specifications provided are for the standalone (algorithm only) performance of the device. The listed accuracies (e.g., ± 2%, ± 3%, ± 1 g/dl) refer to the device's ability to measure physiological parameters against a reference standard.

7. Type of Ground Truth Used

The ground truth for the various measurements was established using objective, established clinical and laboratory methods:

SpO2 Accuracy (No motion, induced hypoxia, SpHb): A laboratory CO-Oximeter was used as the reference standard.
SpO2 Accuracy (Motion): A laboratory CO-Oximeter and ECG monitor were used as reference standards.
Pulse Rate Accuracy: A Biotek Index 2 simulator was used as the reference standard.
Low Perfusion SpO2 Accuracy: A Biotek Index 2 simulator and Masimo's simulator were used as reference standards.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. This type of device (oximeter) is generally validated through accuracy studies against a reference standard, rather than a machine learning training/test set paradigm. The "development" of the device would involve calibration and algorithm refinement, but the number of samples or data points used for these internal processes is not disclosed in this regulatory submission.

9. How the Ground Truth for the Training Set was Established

Since no distinct training set is described for a machine learning model, the method for establishing ground truth for a "training set" is not applicable in the context of this submission. The device's underlying technology (Masimo Rainbow SET) would have been developed and calibrated using similar physiological studies and laboratory reference instruments during its initial development.

Summary

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09105

Submitted by:

Masimo Corporation 40 Parker Irvine, CA 92618 949-297-7000 FAX 949-297-7001

JUL - 9 2009

Company Contact:

Date Summary Prepared:

April 10, 2009

Trade Name

Common Name

Oximeter

Classification Name and Product Code:

Oximeter (74DQA) (870.2700) Cable, Transducer and Electrode (74DSA) (870.2900)

Marguerite Thomlinson; Manager of Regulatory Affairs

Substantially Equivalent Devices:

Masimo Rainbow SET RadCheck Pulse CO-Oximeters and Accessories, 510(k) Number K082052

Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories

Device Description

Predicate Device

The predicate device used in this filing is the Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories, 510(k) Number K082052.

Intended Use

The Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET® Pronto Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatic individuals during both no motion and motion conditions, and for individuals who are well or poorly perfused in clinical and nonclinical settings (e.g., hospitals, hospital-type facilities, mobile environments, homes, clinics, physician offices, blood donation facilities, and ambulatory surgery centers).

Technology Comparison

The Masimo Rainbow SET® Pronto Pulse CO-Oximeter is the same in design, principles of operation, materials, and performance to the predicate device (the RadCheck).

Page 1 of 4

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The Pronto has the following specifications:

1. 1

FEATURES	SPECIFICATIONS
Display Ranges	Saturation (SpO2): 0-100%
	Pulse Rate (bpm): 25-240 bpm
	Total Hemoglobin (SpHb): 0-25 g/dl
	Total Oxygen Concentration (SpOC): 0-35 ml/dl
	Perfusion Index: 0.02-20%
Accuracy	See Footnotes 1, 2, 3, 4, 5, 6, and 7
SpO2, No Motion Conditions	Adults, Pediatrics: 60-80% ± 3%; 70-100% +2%
SpO2, Motion Conditions	Adults, Pediatrics: 70-100% ± 3%
SpO2, Low Perfusion	Adults, Pediatrics: 70-100% ± 2%
Pulse Rate, No Motion Conditions	Adults, Pediatrics: 25-240 ± 3 bpm
Pulse Rate, Motion Conditions	Adults, Pediatrics: 25-240 ± 5 bpm
Pulse Rate, Low Perfusion	Adults, Pediatrics: 25-240 ± 3 bpm
SpHb, No Motion Conditions	Adults, Pediatrics: 8-17 g/dl +1 g/dl (Arterial or Venous)
General
Resolution	SpO2: 1%
	Pulse Rate: 1 bpm.
	SpHb: 0.1 g/dl
Measurements	Low Signal IQ
	Perfusion Index (PI)
	Total Oxygen Concentration (SpOC)
Electrical	See Footnote 8
Batteries	Non-rechargeable alkaline batteries
Circuitry	Microprocessor controlled
Firmware	Rainbow SET technology, MX 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 to 18,000 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

11.0

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FEATURES	SPECIFICATIONS
Display and Indicators	SpO2 (%)
	Pulse rate (bpm)
	SpHb (g/dl)
	SpHbv (g/dl)
	Perfusion index (%)
	SpOC (ml/dl)
	Signal IQ
	Pulse indicator
	Spot Check Progress
	Sensor Use 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
Enclosure Degree of Protection	IPX1
Mode of Operation	Spot check

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 piomentation 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.
3 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.
The Masimo SET Technology has been validated for low perfusion accuracy in র্ণ 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.
The Masimo sensors have been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator. This variation

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equals plus or minus one standard deviation which encompasses 68% of the population.

િ SpHb accuracy has been validated with (arterial/venous) blood from healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation in the range of 8 - 17 g/dl SpHb against a laboratory CO-oximeter. This variation equals plus or minus one standard deviation which encompasses 68% of the population. The SpHb accuracy has not been validated with motion or low perfusion
7 The following substances may interfere with pulse CO-oximetry measurements:
- · Elevated levels of Methemoglobin (MetHb) may lead to inaccurate SpO2 measurements
- · Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO2 measurements.
- · Severe anemia may cause erroneous SpO2 readings.
- · Dyes, or any substance containing dyes, that change usual blood pigmentation may cause erroneous readings.
- · Elevated levels of total bilirubin may lead to inaccurate SpO2 and SpHb readings
8 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 Summarv

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

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 Pronto Pulse CO-Oximeter and Accessories are substantially equivalent to the predicate device, with respect to safety, effectiveness, and performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 2009

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

Re: K091057

Trade/Device Name: Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 5, 2009 Received: June 16, 2009

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 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. Thomlinson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 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.

Susan Runnes

Susan Runner, D.D.S., M.A. Acting 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

K091057

510(k) Number (if known):

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

Indications For Use:

Prescription Use	X	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)

Goncurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Masimo Pronto, Special 510(k), 4/10/09 Page 12 of 88

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).