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, blood donation facilities, and ambulatory surgery centers).

Device Description

The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories (Pronto-7) include the noninvasive technology 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, the Masimo Rainbow SET® Pronto Pulse CO-Oximeter and Accessories (Pronto), 510(k) no. K091057.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories, based on the provided text:

Acceptance Criteria and Device Performance

Parameter	Acceptance Criteria (Specification)	Reported Device Performance (Clinical Results)
SpO2 Accuracy (Adults and Pediatrics > 30kg)	70-100% ± 2%	< 2% (rms)
Pulse Rate Accuracy (Adults and Pediatrics > 30kg)	30-250 bpm ± 3 bpm	< 3 bpm (rms)
SpHb Accuracy (Adults and Pediatrics > 30kg)	6-18 g/dl ± 1 g/dl	< 1 g/dl (rms)

Note: The reported device performance (clinical results) are presented as "rms" (root mean square) values, which indicate the standard deviation of the accuracy, implying that a smaller RMS value is better and meets the stated ± X% or ± X bpm/g/dl criteria. The document states "The variation in these studies equals plus or minus one standard deviation encompasses 68% of the population."

Study Details

2. Sample Sizes and Data Provenance

Test Set Sample Sizes:
- SpO2: Not explicitly stated, but "human blood studies on healthy adult male and female volunteers... with light to dark skin pigmentation." The studies involved inducing hypoxia.
- SpHb: Not explicitly stated, but "blood from healthy adult male and female volunteers and on patients with light to dark skin pigmentation."
- Pulse Rate: Not explicitly stated, but "healthy adult male volunteers and on patients with light to dark skin pigmentation."
Data Provenance: The studies were conducted on "healthy adult male and female volunteers" and "patients," suggesting prospective clinical studies. The country of origin is not specified, but the submission is to the U.S. FDA, implying the studies were likely conducted to meet U.S. regulatory standards.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Not Applicable. This device measures physiological parameters directly. The "ground truth" was established using established reference methods, not expert consensus.

4. Adjudication Method (Test Set)

Not Applicable. As the ground truth was established by direct reference measurements, there was no adjudication of expert opinions.

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

No. This is a medical device for direct measurement of physiological parameters, not an imaging or diagnostic algorithm that assists human readers. Therefore, an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance

Yes. The reported "Clinical Results" directly reflect the performance of the device (algorithm and hardware) in measuring SpO2, Pulse Rate, and SpHb against reference standards. This is a standalone performance assessment.

7. Type of Ground Truth Used (Test Set)

Reference Measurements:
- SpO2: Compared against a "laboratory CO-oximeter and ECG monitor."
- SpHb: Compared against a "laboratory CO-oximeter."
- Pulse Rate: Compared against an unspecified reference in the range of 40-110 bpm, likely an ECG or other validated heart rate monitor.
Compliance: The clinical studies were performed in accordance with ISO 9919:2005, which specifies requirements for pulse oximeters.

8. Sample Size for the Training Set

Not explicitly stated in the provided text. The document describes clinical validation studies but does not detail the size of any potential dataset used for training the device's algorithms.

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

Not explicitly stated in the provided text. Assuming there was a training phase for the device's algorithms, the ground truth would likely have been established using similar reference methods (laboratory CO-oximeters, ECG monitors) as for the test set, but details are not provided.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text reads 'Klo 403' in a bold, slightly irregular font. The characters are closely spaced, and the overall impression is that of a quick, informal note.

510(k) SUMMARY

Submitted by:	Masimo Corporation40 ParkerIrvine, CA 92618949-297-7000FAX 949-297-7592
Company Contact:	Marguerite Thomlinson, Manager of Regulatory Affairs
Date Summary Prepared:	April 23, 2010
Trade Name	Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter andAccessories
Common Name	Oximeter
Classification Name/ Product Code:	Oximeter Section 870.2700/ Product Code DQA
Predicate Device:	Masimo Rainbow SET® Pronto Pulse CO-Oximeter andAccessories, 510(k) Number - K091057

Device Description

Intended Use/ 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 (SpO3), 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, blood donation facilities, and ambulatory surgery centers).

Technology Comparison

Features in the Pronto-7, which are not in the Pronto, include touch-screen user interface, pleth waveform display, rechargeable batteries or AC power, USB connection, flash memory, earphone jack, and wireless connection. The Pronto-7 has the following specifications:

FEATURES	SPECIFICATIONS
Display Range	Saturation (SpO2): 0-100%; Pulse Rate (bpm): 30-250 bpm(Total Hemoglobin (SpHb): 0-25 g/dl; Perfusion Index (PI): 0.02-20%
Accuracy:Adults and Pediatrics > 30kg	SpO2: 70-100±2%; Pulse Rate: 30-250±3 bpm; SpHb: 6-18 g/dl ±1 g/dl
Resolution	SpO2: 1%; Pulse Rate: 1 bpm; SpHb: 0.1 g/dl
AC Power	Voltage Input: 100-240 VAC, 50-60 Hz; Max Power Consumption: 15 VA
Batteries	Rechargeable lithium polymer

{1}------------------------------------------------

510(k) SUMMARY

FEATURES	SPECIFICATIONS
Temperature	Operating/ Storage: 41 to 104°F (5 to 40°C)/ -40 to 158°F (-40 to 70°C)
Relative Humidity	5 to 95% noncondensing
Operating Altitude	500 to 1,060 mbar pressure; -1,000 to 18,000 ft (-304 to 5,486m)
Alarm	System Failure; Low Battery Alarm
Display and Indicators	SpO2 (%); Pulse Rate (bpm); SpHb (g/dl); Perfusion Index (%)
Display and Indicators	Pleth Waveform; Sensor Status; Status Messages; Battery Status
Connection/ Output	Wireless: Bluetooth 2.0; WiFi b/g; Flash Memory: Micro SD card slot
Earphone jack	Connection for standard 3.5 mm earphone jack
EMC/ Electrical SafetyCompliance	EN 60601-1-2, Class B
EMC/ Electrical SafetyCompliance	IEC 60601-1, UL 60601-1, Internally Powered, AC Power Class 2
EMC/ Electrical SafetyCompliance	Type BF-Applied Part, IPX1, Class 2
Mode of Operation	Spot check

Clinical Data Summary

Clinical Studies: 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 range of 6-18 g/dl SpHb, with Pronto-7 measurements compared against a laboratory CO-oximeter. Pulse rate accuracy has been validated on healthy adult male 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.

Clinical Results: No device-related adverse events.

The clinical studies were performed in accordance with ISO 9919:2005. The studies resulted in SpO3 accuracy (rms) < 2%, pulse rate accuracy (rms) < 3bpm, and SpHb accuracy (rms) < 1g/d.

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 was substantially 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. effectiveness, and performance.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the eagle.

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

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

JUN 2 3 2010

Re: K100403

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 Dated: June 11, 2010 Received: June 14, 2010

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. 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.

{3}------------------------------------------------

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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Susan Rioner

Anthony D. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital

Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure .

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

Masimo Rainbow SET Pronto-7 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)

rrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K100403
510(k) Traditional, Masimo Pronto-7
Page 10 of 1254. 2/5/2010

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).