The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and mobile environments.

Device Description

The subject device, MightySat Rx, is a fingertip pulse oximeter that includes Masimo SET technology for the measurement of functional oxygen arterial hemoglobin (SpO2) and pulse rate in adults and pediatrics. The device is a spot check pulse oximeter and does not include alarms. The device has the combined function of a pulse oximeter monitor and a reusable sensor. It includes an OLED color display, enclosed by plastic housing and powered by two alkaline AAA batteries. The MightySat Rx also includes optional Bluetooth wireless technology for the wireless transfer of patient data to mobiles devices, such as a smartphone.

The mobile device functions as a secondary display and it is not required for the intended use of pulse oximetry measurements. After measurements are made by the subject device, the data can be transferred to the mobile device via Bluetooth for the display and/or storage of the data.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Masimo MightySat Rx Fingertip Pulse Oximeter, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
SpO2, No Motion (70-100% range)	1.66% Arms (Accuracy meets requirement of ≤ 2%)
SpO2, Motion (70-100% range)	2.30% Arms (Accuracy meets requirement of ≤ 3%)

Note: The document also lists acceptance criteria for Pulse Rate (No motion, Motion, Low Perfusion) and SpO2 (Low Perfusion) in the "SPECIFICATION" table on page 5, but the reported clinical testing results only explicitly state the SpO2 accuracy under no motion and motion conditions. It does state that the device "meets the accuracy requirement" for SpO2, implying other parameters were also met (e.g., 2% Arms for SpO2 Low Perfusion), but specific values are not provided for those.

Study Information

2. Sample size used for the test set and the data provenance:

Sample Size: 14 healthy adult male and female volunteers (with at least a total of 356 blood samples).
Data Provenance: Not explicitly stated regarding country of origin, but it's a clinical study conducted. The study is prospective as it describes the validation of the SpO2 measurement "in accordance with ISO 80601-2-61" carried out on human volunteers.

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

The ground truth was established "against a laboratory CO-Oximeter." This implies the CO-Oximeter itself is the "expert" or standard, not human experts. Therefore, the concept of "number of experts" or their qualifications for establishing ground truth as typically understood in image-based AI studies does not apply here.

4. Adjudication method for the test set:

Not applicable/Not explicitly mentioned. The ground truth was established by a laboratory CO-Oximeter, which provides a direct measurement, not an interpretation requiring human adjudication.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a standalone measurement device (pulse oximeter), not an AI-assisted diagnostic tool that would typically involve human readers.

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

Yes, a standalone performance study was done. The clinical testing described validates the accuracy of the device's functional oxygen saturation and pulse rate measurements as performed by the device itself against a laboratory standard, without human intervention in the measurement process after initial placement.

7. The type of ground truth used:

Ground Truth Type: Laboratory CO-Oximeter measurements of functional oxygen saturation.

8. The sample size for the training set:

The document does not specify a separate "training set" sample size. This type of device relies on established physiological principles and signal processing, rather than machine learning models that require distinct training and test sets in the same way. The clinical testing described is primarily for validation (test set).

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

Not applicable, as a distinct "training set" with established ground truth as commonly understood in AI/ML contexts is not described for this device. The device's operation is based on its integrated Masimo SET technology and established algorithms for pulse oximetry, which would have been developed and refined through engineering and earlier research, not necessarily through a formal "training set" in the context of this 510(k) submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a way that suggests depth and connection. The profiles are simple and abstract, with smooth lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the image.

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

October 22, 2015

Masimo Corporation Marguerite Thomlinson Sr. Director, Regulatory Affairs 52 Discovery Irvine, CA 92618

Re: K150314

Trade/Device Name: Masimo MightySat Rx Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: September 16, 2015 Received: September 18, 2015

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.

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

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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 yours,

Teiashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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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Section 4. Indications for Use Statement

Indications for Use

510(k) Number: K150314

Device Name: Masimo MightySat Rx Fingertip Pulse Oximeter

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over The Counter Use (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/1 description: The image shows the logo for Masimo Corp. The logo consists of a red circle with a white plus sign inside, followed by the word "Masimo" in black, stylized font. To the right of the logo is the text "MASIMO CORP" followed by the address "Forty Parker, Irvine, CA 92618".

Submitter and Address ofManufacturing Facility:	Masimo Corporation52 DiscoveryIrvine, CA 92618Phone: (949) 297-7000FAX: (949) 297-7592
Date:	October 21, 2015
Contact:	Marguerite ThomlinsonSenior Director, Regulatory Affairs
Trade Name:	Masimo MightySat Rx Fingertip Pulse Oximeter
Common Name:	Oximeter
Classification Regulation/Product Code:	21 CFR 870.2700, Class II/DQA
Establishment RegistrationNumber:	2031172
Reason for PremarketNotification:	New Device
Predicate Device:	K081285 – Nonin Medical, Inc. Onyx II Model 9560K142394 - Masimo Root Monitoring System (Radius-7)
Performance Standards	No performance standards for the above device have beenpromulgated pursuant to Section 514.

Device Description

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Section 5. 510(k) Summary

The MightySat Rx noninvasively measures and displays the following Masimo SET parameters:

Functional Oxygen Saturation of Arterial Hemoglobin (SpO2): The amount of oxyhemoglobin expressed a percentage of the hemoglobin
Pulse Rate (PR): Measured in beats per minute (BPM) is based on the optical detection of . peripheral flow pulse
Perfusion Index (PI): The ratio of the pulsatile blood flow to the non-pulsatile in peripheral tissue. PI thus represents a non-invasive measurement of peripheral perfusion that can be obtained from the pulse oximeter.
. Optional Pleth Variablility Index (PVI): Measure of dynamic changes in perfusion index that occur during the respiratory cycle. The calculation is accomplished by measuring changes in PI over a time interval where one or more complete respiratory cycles have occurred. PVI is displayed as a percentage (0-100%).

The MightySat Rx base device includes SpO2, PR and PI parameters. It can also include the optional PVI and/or Bluetooth wireless features.

FEATURE	SPECIFICATION
Display
	Display Type
	Display Range
	Display Waveform
	Display Resolution
	Measurement Accuracy inAccordance with ISO 80601-2-61
SpO2, No Motion	70 – 100%, 2%, Arms, adults/pediatrics
SpO2, Motion	70-100%, 3% Arms, adults/pediatrics
SpO2, Low Perfusion	70–100%, 2%, Arms, adults/pediatrics
Pulse Rate, No Motion	25 – 240 bpm, 3 bpm Arms, adults/pediatrics
Pulse Rate, Motion	25 – 240 bpm, 5 bpm Arms, adults/pediatrics
Pulse Rate, Low Perfusion	25 – 240 bpm, 3 bpm Arms, adults/pediatrics
Power
	Internal battery
Interface
	Wireless
Mechanical
	Enclosure Material
	Dimensions/Weight
Environmental
	Operating Temperature

See the table below for the MightySat Rx specifications.

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Section 5. 510(k) Summary

FEATURE	SPECIFICATION
Storage Temperature	-40°C to +70°C, ambient humidity
Operating/ Storage Humidity	10% to 95%, non-condensing
Altitude	Up to 5,486 meters (18,000 feet)
Mode of Operation
Mode of Operation	Spot check

Intended Use/Indications for Use

Technological Characteristics

Principle of Operation

Pulse oximetry is governed by the following principles:

Oxyhemoglobin (oxygentated blood) and deoxyhemoglobin (non-oxygenated blood) ● differ in their absorption of red and infrared light (spectrophotometry).
The amount of arterial blood in tissue changes with your pulse (photoplethysymography). Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.

Mechanism of Action for Achieving the Intended Effect

MightySat Rx automatically turns on when the device is opened . The device is then positioned on the patient's finger. Once the device is applied on the finger, it collects, processes physiological signals, and then displays Masimo SET measurements on the device's display screen. The MightySat Rx automatically turns off after removing the device from the finger.

Summary of Technological Characteristics of Subject Device Compared to Predicate Device

Similarities and Differences between Primary Predicate Device, Nonin Onyx II 9560 Pulse Oximeter (K081285) and Subject Device, MightySat Rx

The subject device, MightySat Rx, and the primary predicate device, Nonin Onyx II 9560 Pulse Oximeter (K081285), have the following key similarities:

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Section 5. 510(k) Summary

· Both devices have the same intended use as a spot checking fingertip pulse oximeter with SpO2 and PR measurements;
· Both devices have the same principle of operations of pulse oximetry;
· Both devices do not have alarms;
· Both devices have the same measurement site;
· Both devices include wireless Bluetooth feature for transferring patient information from the device to a mobile device, such as a smartphone; and
· Both devices are internally powered by two AAA batteries

The subject device, MightySat Rx, and the primary predicate device, Nonin Onyx II 9560 Pulse Oximeter (K081285), have the following key differences:

· The subject device is indicated for use under motion conditions, whereas the predicate is not:
· The subject device includes a color OLED display and the predicate includes an LED display; and
· The subject device includes PVI calculation and the predicate does not have this feature.

Similarities and Differences between Predicate Device, Masimo Radius-7 (K142394) and Subject Device, MightySat Rx

The subject device, MightySat Rx, and the predicate device, Masimo Radius-7 (K142394), have the following key similarities:

· Both devices include the Masimo SET technology;
· Both devices display SpO2, PR, PL, PVI, and pleth and Signal IQ waveforms;
· Both devices have the same principle of operation for pulse oximetry;
· Both devices include wireless Bluetooth feature; and
· Both devices have an OLED color display and touchpad interface.

The subject device, MightySat Rx, and the predicate device, Masimo Radius-7 (K142394), have the following key differences:

The subject device is a spot check device without alarms and the predicate is a continuous monitoring device with alarms;
The subject device combines the functionality of an instrument and a sensor into a single device, whereas the predicate is an instrument that needs to connect with a sensor; and
· The subject device does not have acoustic respiratory rate measurement (RRa), whereas the predicate includes the RRa measurement.

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Section 5. 510(k) Summary

Non-clinical Testing

The subject device was subjected bench testing. The following non-clinical testing, as applicable, was performed in accordance with Masimo design control requirements and quality system to demonstrate substantial equivalence of the subject device with its predicates:

Electrical safety testing per IEC60601-1 ●
EMC testing per IEC60601-1-2 ●
Pulse oximetry testing per ISO 80601-2-61
Biocompatibility testing per ISO-10993-1, ISO-10993-5 and ISO-10993-10 ●
. Usability testing per FDA Human Factors and Usability Draft Guidance
Software verification per FDA Software Guidance
Mechanical and environmental testing including: ●
- shock and vibration, O
- shipping drop test, o
- mechanical durability and O
- storage/transport and operational temperatures о

Clinical Testing

The MightySat Rx was subjected to clinical testing. The functional oxygen saturation (SpO2) measurement has been validated in accordance with ISO 80601-2-61. The clinical testing was completed on a total of 14 healthy adult male and female volunteers (with at least a total of 356 blood samples) with light to dark skin pigmentations in the range of 70% to 100% against a laboratory CO-Oximeter. The SpO2 accuracy results include:

1.66% which meets the accuracy requirement of less than or equal to 2% under no ● motion condition and
2.30% which meets the accuracy requirement of less than or equal to 3% under motion conditions.

The accuracy specification is reported as accuracy root mean square (Arms).

Conclusion

The non-clinical and clinical testing provided in this 510(k) submission demonstrates that the subject device, MightySat Rx Fingertip Pulse Oximeter, as safe and as effective, and substantially equivalent to its predicates.

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).