The Masimo Rainbow SET Pronto-7 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-7 Pulse CO-Oximeter and Accessories are indicated for use by trained personnel, with adult and pediatric individuals, in clinical and non-clinical settings (e.g., hospital-type facilities, home, clinics, physician offices, and ambulatory surgery centers).

Device Description

The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories include the noninvasive technology spot check of measurement for functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate and total hemoglobin concentration (SpHb), which is based on the same technology of the predicate device. This submission introduces two new sensor sizes (medium and small) and an optional Maximum Sensitivity Mode that extends the detection range for SpHb.

AI/ML Overview

Here's analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Predicate Device)	Reported Device Performance (Subject Device)
SpO2 Accuracy	70-100% $\pm$ 2%	SpO2 accuracy (rms) of $\pm$ 2%
Pulse Rate Accuracy	30-250 bpm $\pm$ 3 bpm	Pulse rate accuracy (rms) of $\pm$ 3bpm
SpHb Accuracy (Normal Sensitivity Mode)	6-18 g/dl $\pm$ 1 g/dL	SpHb accuracy (rms) of $\pm$ 1g/dl
SpHb Accuracy (Maximum Sensitivity Mode)	Not applicable (New mode for subject device)	SpHb accuracy (rms) of $\pm$ 1.1g/dl (for 4.5-20 g/dl range)

Study Information

The provided text details multiple performance validations for SpO2, SpHb, and Pulse Rate accuracy.

Sample Size used for the test set and the data provenance:
- SpO2 Accuracy: "human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation." No specific number of volunteers given. The study involved inducing hypoxia.
- SpHb Accuracy: "with (arterial/ venous) blood from healthy adult male and female volunteers and on patients with light to dark skin pigmentation." No specific number of volunteers/patients given.
- Pulse Rate Accuracy: "on healthy adult male and female volunteers and on patients with light to dark skin pigmentation." No specific number of volunteers/patients given.
- Data Provenance: The studies were conducted with "human blood" and "volunteers/patients," suggesting prospective clinical studies. The country of origin is not explicitly stated, but it's likely the US given the FDA submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- SpO2: Ground truth was established by "a laboratory CO-Oximeter and ECG monitor." No human experts are mentioned for ground truth establishment; instrumentation provided the reference.
- SpHb: Ground truth was established by "a laboratory CO-Oximeter." No human experts are mentioned for ground truth establishment; instrumentation provided the reference.
- Pulse Rate: Ground truth was established by an unspecified method; often this is also derived from ECG or another reference monitor. No human experts are mentioned.
Adjudication method for the test set:
- Not applicable. The ground truth was established by reference devices (laboratory CO-Oximeter, ECG monitor), not through human expert adjudication.
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:
- No MRMC comparative effectiveness study was conducted. This device is an oximeter, which provides direct measurements (SpO2, SpHb, Pulse Rate) and does not involve human "readers" interpreting images or data that an AI might assist with.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance data presented is for the device (algorithm and sensor) operating in a standalone capacity. The accuracy metrics (rms of SpO2, Pulse Rate, SpHb) are direct measurements of the device's performance against reference standards. It's a "spot check" device, meaning it provides a reading without continuous human interaction for interpretation beyond reading the display.
The type of ground truth used:
- Instrumentation-based ground truth:
  - For SpO2, a "laboratory CO-Oximeter and ECG monitor" served as the reference.
  - For SpHb, a "laboratory CO-Oximeter" served as the reference.
  - For Pulse Rate, accuracy was validated, but the specific reference ground truth instrument is not explicitly named, though usually, an ECG monitor would be used.
The sample size for the training set:
- The document does not explicitly mention a "training set" or its sample size. Oximeters typically use empirical models and calibrations developed from extensive physiological data, rather than a distinct "training set" in the machine learning sense for each submission. This submission focuses on validation of the device's accuracy.
How the ground truth for the training set was established:
- As no specific "training set" is described, the method for establishing its ground truth is not provided. The device's underlying technology is stated to be the "same" as the predicate device, implying that the foundational calibration and algorithms were likely established in prior, more extensive studies. The current submission focuses on validating the performance of new sensor sizes and an extended sensitivity mode against established reference methods.

Summary

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K111403

DEC 3 0 2011

510(k) SUMMARY

Applicant:	Masimo Corporation40 ParkerIrvine, CA 92618949-297-7000FAX 949-297-7592
Company Contact:	Anil BhalaniDirector of Regulatory affairs
Date Summary Prepared:	November 10, 2011
Trade Name:	Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter andAccessories
Common Name:	Oximeter
Classification Name/ Product Code:	Oximeter (21CFR 870.2700/ Product Code: DQA)
Predicate Device:	K100403- Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories (Pronto-7)

Device Description

Intended Use/ Indications for Use

Technology Comparison

The Fundamental Scientific Technology of the previously cleared Pronto-7 device and Sensor and that of the Pronto-7 device and sensors is the same.

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Device	Masimo Rainbow SET Pronto Pulse CO-Oximeter and Accessories
	K100403	K111403 (Subject Device)
Display Range	Saturation (SpO2): 0-100%Pulse Rate: 30-250 bpmTotal Hemoglobin (SpHb): 0-25 g/dLPerfusion Index (PI): 0.02-20%	Same
AccuracyAdults andPediatrics(> 30kg)	SpO2: 70-100 $\pm$ 2%Pulse Rate: 30-250 $\pm$ 3 bpmNormal Sensitivity Mode:SpHb: 6-18 g/dl $\pm$ 1 g/dL	SameSameNormal Sensitivity Mode: SameMaximum Sensitivity Mode:SpHb: 4.5-20 g/dl $\pm$ 1.1 g/dL
Resolution	SpO2: 1%; Pulse Rate: 1 bpm, SpHb:0.1 g/dL	Same
AC Power	Voltage Input: 100-240 VAC, 50-60 Hz;Max Power Consumption: 15 VA	Same
Batteries	Rechargeable lithium polymer battery	Same
Temperature	Operating: 41 to 104°F (5 to 40°C)Storage: -40° to 158°F (-40 to 70°C)	Same
Relative Humidity	5 to 95% non-condensing	Same
Operating Altitude	500 to 1,060 mbar; -1,000 to 18,000 ft(-304 to 5,486m)	Same
Alarm	System Failure; Low Battery Alarm	Same
Display andIndicators	SpO2 (%); Pulse Rate (bpm); SpHb(g/dl); Perfusion Index (%); PlethWaveform; Sensor Status; StatusMessages; Battery Status	Same
Connection/Output	Wireless: Bluetooth 2.0; Wi-Fi b/g,Flash Memory: Micro SD card slot	Same
Earphone jack	Connection for standard 3.5 mmearphone jack	Same
EMC/ElectricalSafety Compliance	EN 60601-1 -2, Class BIEC 60601-1, UL 60601-1, CAN/CSASTD C22.2, Internally Powered, ACPower Class 2, Compliance Type BF-Applied Part, IPX1, Class 2	Same
Mode of Operation	Spot Check	Same

Performance Data Summary

SpO2 accuracy has been validated in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation. Pronto-7 measurements on volunteers induced hypoxia in the range of 70-100% SpO2 are compared against a laboratory CO-Oximeter and ECG monitor. SpHb accuracy has been validated with (arterial/ venous) blood from healthy adult male and female volunteers and on patients with light to dark skin pigmentation in the ranges of 6-18 g/dl SpHb (Normal Sensitivity Mode) and 4.5-20 g/dl SpHb (Maximum Sensitivity Mode), with Pronto-7 measurements compared against a laboratory CO-Oximeter. Pulse rate accuracy has been validated on healthy adult male and female volunteers and on patients with light to dark skin pigmentation in the range of 40-110 bpm. The variation in these studies equals plus or minus one standard deviation encompasses 68% of the population.

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Results: The studies were performed in accordance with ISO 9919:2005, Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use. The studies resulted in SpO2 accuracy (rms) of ±2%, pulse rate accuracy (rms) of ± 3bpm, and SpHb accuracy (rms) of ± 1g/dl (Normal Sensitivity Mode) and ± 1.1g/dl (Maximum Sensitivity Mode).

Non-Clinical Data Summary

The Pronto-7 complies with the voluntary standards as detailed in this submission. Laboratory testing for biocompatibility, safety and environmental was conducted to verify that the Pronto 7 met all design specifications and is considered equivalent to the predicate device.

Conclusions

The information in this 510(k) submission demonstrates that the Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are substantially equivalent to the predicate device with respect to safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Anil Bhalani Director of Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618

DEC 3 0 2011

Re: K111403

Trade/Device Name: Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, GLY Dated: December 22, 2011 Received: December 28, 2011

Dear Mr. Bhalani:

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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Page 2 - Mr. Bhalani

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/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 Small Manufacturers, International and Consumer Assistance 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 yours,

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known):

Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories Device Name:

Statement of Indications for Use:

The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SP02), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are indicated for use by trained personnel, with adult and pediatric individuals, in clinical and non-clinical settings (e.g., hospital-type facilities, home, clinics, physician offices and ambulatory surgery centers).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital The For of Anesthesiology, General
Infection Control, Dental Devices

510(k) Number: K111403

Page 1 of

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).