MightySat -OTC

K214115 · Masimo Corporation · OLK · Jan 31, 2024 · Cardiovascular

Device Facts

• Record ID: K214115
• Device Name: MightySat -OTC
• Applicant: Masimo Corporation
• Product Code: OLK · Cardiovascular
• Decision Date: Jan 31, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The Masimo MightySat-OTC is intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo MightySat-OTC is indicated for use with individuals 18 years and older who are well or poorly perfused under no motion conditions. The Masimo MightySat-OTC is not intended for diagnosis or screening of lung disease and treatment decisions using the device should only be under the advice of a healthcare provider.

Device Story

Fingertip pulse oximeter; measures functional oxygen saturation (SpO2) and pulse rate (PR) via photoplethysmography and spectrophotometry. Device automatically activates upon opening and placement on finger; collects physiological signals; displays measurements on OLED screen; automatically powers off upon removal. Includes Bluetooth LE for wireless data transfer to mobile applications. Intended for OTC use by lay users for spot-checking; excludes self-diagnosis or screening. Powered by two AAA alkaline batteries. Provides improved accuracy across diverse skin pigments and genders compared to predicate. Clinical benefit includes non-invasive, accessible monitoring of oxygen saturation and pulse rate for informed health management under professional guidance.

Clinical Evidence

Prospective clinical study of 39 healthy volunteers (22 dark, 17 light skin pigmentation; balanced gender). Primary endpoint: SpO2 accuracy (ARMS) per ISO 80601-2-61. Results: 1.26% ARMS (70-100% range) and 1.22% ARMS (85-95% range). Sub-analysis confirmed equitable performance across skin pigment and gender sub-groups (all <1.5% ARMS). Data validated via bootstrapping (1001 iterations) and linear mixed effects (LME) models.

Technological Characteristics

Fingertip pulse oximeter; OLED color display; Bluetooth LE connectivity. Powered by 2x AAA alkaline batteries. Biocompatible materials per ISO 10993-1. Principle: Spectrophotometry and photoplethysmography. Dimensions: 2.9" x 1.6" x 1.2"; Weight: 73g. Operating range: 5°C to 40°C. Software: Moderate level of concern.

Indications for Use

Indicated for individuals 18 years and older, well or poorly perfused, under no motion conditions. Not for diagnosis or screening of lung disease.

Regulatory Classification

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.

Predicate Devices

• Masimo MightySat Fingertip Pulse Oximeter (K181956)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it.

January 31, 2024

Masimo Corporation Kertana Shankar Regulatory Specialist II 52 Discovery Irvine, California 92618

### Re: K214115

Trade/Device Name: MightySat - OTC Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: OLK Dated: September 19, 2022 Received: September 20, 2022

### Dear Kertana Shankar:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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### Indications for Use

510(k) Number (if known) K214115

Device Name MightySat-OTC

Indications for Use (Describe)

The Masimo MightySat-OTC is intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).

The Masimo MightySat-OTC is indicated for use with individuals 18 years and older who are well or poorly perfused under no motion conditions.

The Masimo MightySat-OTC is not intended for diagnosis or screening of lung disease and treatment decisions using the device should only be under the advice of a healthcare provider.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold font. To the right of the word "Masimo" is the text "MASIMO CORPO" followed by the address "52 Discovery, Irvine, CA 92618".

| Submitter and Address of<br>Manufacturing Facility: | Masimo Corporation<br>52 Discovery<br>Irvine, CA 92618<br>Phone: [phone]<br>FAX: [phone] |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Date: | December 15, 2023 |
| Contact: | Kertana Shankar<br>Regulatory Specialist II<br>Masimo Corporation<br>Phone: [phone] |
| Trade Name: | MightySat - OTC |
| Common Name: | Oximeter |
| Classification Regulation/<br>Product Code: | 21 CFR 870.2700, Class II/OLK |
| Establishment Registration<br>Number: | 3011353843 |
| Reason for Premarket<br>Notification: | Over-the-counter use |
| Primary Predicate: | K181956 - Masimo MightySat Fingertip Pulse Oximeter |
| Performance Standards | No performance standards for the above device have been promulgated<br>pursuant to Section 514. |

### 1.0 Device Description

The subject device, MightySat-OTC, is a fingertip pulse oximeter that includes Masimo SET technology for the measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in individuals 18 years and older. The predicate MightySat that was previously cleared under K181956, has the same intended use as the subject device except it is cleared for prescription use only.

The subject device is identical to the predicate with the RRp and PVi parameters have been disabled in the subject device and the labeling has been modified to provide additional information on the role of pulse oximeters for OTC users. There were no hardware changes made to the MightySat Rx (predicate device, K181956) that resulted in the MightySat-OTC. Like the predicate device, the subject device, has the combined function of a pulse oximeter monitor and a reusable sensor. It includes a color display, enclosed by plastic housing, and powered by two alkaline "AAA" batteries. It also includes optional Bluetooth wireless technology for the wireless transfer of patient data to mobile device application.

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Image /page/4/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in large, bold, black letters. To the right of the word "Masimo" is the text "Masimo Corporation" in smaller, gray letters, followed by the address "52 Discovery, Irvine, CA 92618".

As part of this submission, the MightySat-OTC is being submitted to be marketed for Over-The-Counter (OTC) use.

The following are specifications for MightySat-OTC:

| FEATURE | SPECIFICATION |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Display | |
| Display Type | OLED color display |
| Display Range | Oxygen Saturation (SpO2): 0-100%<br>Pulse Rate (PR): 25-240 beats per minute (BPM)<br>Perfusion Index (Pi): 0.02-20% |
| Display Resolution | SpO2: 1%<br>PR: 1 BPM |
| Measurement Accuracy in Accordance with ISO 80601-2-61 | |
| SpO2, No Motion | 70 - 100%, 1.5%, ARMS, 18 years and older |
| SpO2, Low Perfusion | 70 - 100%, 2%, ARMS, 18 years and older |
| Pulse Rate, No Motion | 25 – 240 BPM, 3 BPM ARMS, 18 years and older |
| Pulse Rate, Low Perfusion | 25 – 240 BPM, 3 BPM ARMS, 18 years and older |
| Power | |
| Internal battery | Two Alkaline "AAA" batteries |
| Interface | |
| Wireless | Bluetooth LE |
| Mechanical | |
| Dimensions | 2.9" x 1.6" x 1.2" (7.4 cm x 4.1 cm x 3.0 cm) |
| Weight | 0.16 lbs (73 g) |
| Environmental | |
| Operating Temperature | 5°C to +40°C, ambient humidity |
| Storage Temperature | -40°C to +70°C, ambient humidity |
| Operating/ Storage Humidity | 10% to 95%, non-condensing |
| Atmospheric Pressure | 540 mBar to 1060 mBar |
| Mode of Operation per IEC 60601-1 | |
| Mode of Operation | Continuous |

### 2.0 Intended Use/ Indications For Use

The Masimo MightySat-OTC is intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).

The Masimo MightySat-OTC is indicated for use with individuals 18 years and older who are well or poorly perfused under no motion conditions.

The Masimo MightySat-OTC is not intended for diagnosis or screening of lung disease and treatment decisions using the device should only be under the advice of a healthcare provider.

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Image /page/5/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.

### 3.0 Technological Characteristics

#### Principle of Operation

There has been no change to the principle of operation as part of this submission. The subject device, MightySat-OTC, utilizes the same principle of operation as the predicate device cleared under (K181956). The MightySat-OTC still relies on the principle that light is absorbed differently for oxygenated hemoglobin and deoxygenated hemoglobin and the ratio of the absorptions can be used to monitoring the changes in oxygen saturation and pulse rate. However, as part of the MightySat-OTC, the calibration curve has been adjusted to allow for improved accuracy performance, including across different skin pigments and genders.

### Mechanism of Action for Achieving the Intended Effect

There has been no change to the mechanism of action as part of this submission. The subject device MightySat-OTC utilizes the same mechanism of action as the predicate device cleared under (K181956). MightySat automatically turns on when the device is opened. The device is then positioned on the patient's finger. Once the device is applied to the finger, it collects and processes physiological signals, and then displays the measurements on the device's display screen. The MightySat automatically turns off after removing the device from the finger.

### 4.0 Summary of Technological Characteristics of the subject device compared to the predicate device

### Similarities and Differences between Predicate and Subject Device

The subject device, MightySat-OTC, and the predicate device, MightySat (K181956), are identical in design and have the following key similarities:

- . Both devices have the same intended use;
- Both devices have the same technological characteristics;
- Both devices use the same principle of operation and mechanism of action; ●
- Both devices include wireless Bluetooth feature for transferring patient information from the device to a mobile device, such as a smartphone;

The subject device. MightySat-OTC, and the predicate device, MightySat (K181956), have the following key differences:

- The subject device is to be marketed for Over-The-Counter (OTC) use;
- The subject device is indicated for a subset of populations;
- The subject device is provided with an updated calibration curve for improved performance, ● including across different skin pigments and genders;
- . The subject device does not provide the RRp and PVi features.

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Image /page/6/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in a bold, sans-serif font. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in a smaller font, followed by the address "52 Discovery, Irvine, CA 92618".

Between the subject device and the predicate device, there was no change in the intended use. To address the difference in the OTC marketing, the indication for use has been modified to be more appropriate for lay users who would most benefit from the OTC availability of a medical pulse oximeter. To mitigate concerns around the OTC availability as compared to the predicate, the indications for use statement excludes the use for selfdiagnosis or self-screening of medical conditions.

To support the OTC availability does not affect the safety and effectiveness, consideration was made to the factors that may be necessary for a pulse oximeter to be used as an OTC device. These factors included the usability and the demonstrated effectiveness during low blood circulation, different genders, and dark to light skin. Additionally, the labeling was made appropriate for lay users to mitigate any remaining residual risks.

There are no changes to the principle of operation or the mechanism of action from the predicate device. However, there is an update to calibration curve to allow for improved performance, including across different skin pigments and genders. The subject device also provides a reduced number of parameters from the predicate. Otherwise, there are no technological differences for the parameters provided on both devices.

The differences did not change the intended use of the subject device from the predicate. Provided the same intended use and same technological characteristics, the subject device was found to be substantially equivalent to the predicate.

See Table 4.0-1 for the comparison between the subject and predicate devices.

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Image /page/7/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a bold, sans-serif font, with a red circle containing a white checkmark to the left of the word. Below the logo is the address "52 Discovery, Irvine, CA 92618".

| Table 4.0-1 Comparison between Subject and Predicate Device | | | |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | MightySat - OTC, Subject Device | MightySat Fingertip Pulse Oximeter,<br>Predicate | Comparison |
| 510(k) Number | Pending | K181956 | |
| General Information | | | |
| Indications for Use | The Masimo MightySat-OTC is intended for the<br>spot-checking of functional oxygen saturation of<br>arterial hemoglobin (SpO2) and pulse rate (PR).<br><br>The Masimo MightySat-OTC is indicated for<br>use with individuals 18 years and older who are<br>well or poorly perfused under no motion<br>conditions.<br><br>The Masimo MightySat-OTC is not intended for<br>diagnosis or screening of lung disease and<br>treatment decisions using the device should only<br>be under the advice of a healthcare provider. | The Masimo MightySat Fingertip Pulse<br>Oximeter is intended for hospitals, hospital-type<br>facilities, home environments, and transport.<br><br>The Masimo MightySat Fingertip Pulse<br>Oximeter is indicated for the noninvasive spot-<br>checking of functional oxygen saturation of<br>arterial hemoglobin (SpO2) and pulse rate (PR)<br>for adult and pediatric patients during both no<br>motion and motion conditions, and for patients<br>who are well or poorly perfused.<br><br>The Masimo MightySat Fingertip Pulse<br>Oximeter is indicated for the non-invasive spot<br>checking of respiration rate (RRp) for adult. | Same. The devices have the same<br>intended use, but the subject<br>device's indications for use has<br>been modified to be appropriate<br>for OTC lay users. There is no<br>change in the intended use from<br>the predicate device.<br><br>The subject device also provides<br>a subset of the parameters<br>supported by the predicate<br>device. The subject device does<br>not provide PVi and RRp<br>features. These features are<br>supplemental to the SpO2 and<br>Pulse Rate monitoring and<br>therefore does not change the<br>intended use from the predicate. |
| Classification Regulation/<br>Product Code | 21 CFR 870.2700, Class II/OLK | 21 CFR 870.2700, Class II/DQA<br>21 CFR 868.2375, Class II/BZQ | Same as predicate, except the<br>subject device is for OTC use<br>and does not provide respiration<br>rate monitoring. |
| | OTC | Rx | Different. Subject device is<br>indicated for OTC use. |
| Table 4.0-1 Comparison between Subject and Predicate Device | | | |
| Feature | MightySat - OTC, Subject Device | MightySat Fingertip Pulse Oximeter, Predicate | Comparison |
| 510(k) Number | Pending | K181956 | |
| Principle of operation | Pulse oximetry is governed by the following principles:<br><br>Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry).<br><br>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. | Pulse oximetry is governed by the following principles:<br><br>Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry).<br><br>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.<br><br>Respiration rate (RRp) is governed by the following principle:<br><br>Measures the respiration rate by analyzing cyclic variations in the photoplethysmogram | Same as predicate, except the subject device does not provide RRp and PVi features. |
| Indicated Population | 18 years and older | Adult, Pediatric | Similar. Subject device is indicated for a subset of populations supported by the predicate. |
| Display<br>Type | Color display | Color display | Same as predicate |
| Table 4.0-1 Comparison between Subject and Predicate Device | | | |
| Feature | MightySat - OTC, Subject Device | MightySat Fingertip Pulse Oximeter,<br>Predicate | Comparison |
| 510(k) Number | Pending | K181956 | |
| Measurement Ranges | | | |
| Oxygen Saturation<br>(SpO2) | 0-100% | 0-100% | Same as predicate |
| Pulse Rate (PR) | 25-240 beats per minute (BPM) | 25-240 beats per minute (BPM) | Same as predicate |
| Perfusion Index (Pi) | 0.02-20% | 0.02-20% | Same as predicate |
| Accuracy | | | |
| SpO2, No Motion | 70 - 100%, 1.5% ARMS, 18 years and older | 70 - 100%, 2% ARMS, adults/pediatrics | Different. Subject device<br>provides improved<br>performance.<br>Testing is provided to support<br>substantial equivalence. |
| SpO2, Low Perfusion | 70 - 100%, 2%, ARMS, 18 years and older | 70 - 100%, 2%, ARMS, adults/pediatrics | Same as predicate |
| Pulse Rate, No Motion | 25 – 240 BPM, 3 BPM ARMS, 18 years and<br>older | 25 – 240 BPM, 3 BPM ARMS, adults/pediatrics | Same as predicate |
| Pulse Rate, Low<br>Perfusion | 25 – 240 BPM, 3 BPM ARMS, 18 years and<br>older | 25 – 240 BPM, 3 BPM ARMS, adults/pediatrics | Same as predicate |
| Display Resolution | | | |
| SpO2 | 1% | 1% | Same as predicate |
| Pulse Rate | 1 BPM | 1 BPM | Same as predicate |
| Biocompatibility | | | |
| Materials | Patient contacting materials are biocompatible<br>per ISO 10993-1 | Patient contacting materials are biocompatible<br>per ISO 10993-1 | Same as predicate |
| Environmental | | | |
| Operating Temperature | 41°F to 104 °F (5°C to +40°C) | 41°F to 104 °F (5°C to +40°C) | Same as predicate |
| Table 4.0-1 Comparison between Subject and Predicate Device | |…