(762 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard pulse oximetry technology (Masimo SET).
No
A therapeutic device is used for treatment. This device is for spot-checking oxygen saturation and pulse rate, and it is explicitly stated that it 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." This indicates it is a diagnostic or monitoring device, not a therapeutic one.
No.
The "Intended Use / Indications for Use" explicitly states, "The Masimo MightySat-OTC is not intended for diagnosis or screening of lung disease".
No
The device description explicitly states it is a fingertip pulse oximeter with a color display, plastic housing, and powered by batteries, indicating it is a hardware device. While it has optional Bluetooth for data transfer to a mobile app, the core device is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR)". This is a physiological measurement taken directly from the body, not a test performed on a sample of biological material in vitro (outside the body).
- Device Description: The device is described as a "fingertip pulse oximeter". Pulse oximeters measure oxygen saturation non-invasively through the skin.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or performing tests on these samples. The device directly measures a physiological parameter.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
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.
Product codes
OLK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years and older
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The clinical performance testing included data from 39 healthy volunteer subjects with varying skin pigmentation, which was measured using the color-based Massey-Martin scale. The results of the clinical study were also separated by skin pigment groups to support the performance of the MightySat-OTC across different skin pigment groups.
The clinical performance testing was conducted in accordance with ISO 80601-2-61 and the prospective study included 39 healthy volunteer subjects, including 22 dark and 17 light pigmented subjects with at least 7 subjects in each gender and skin pigment bin, which exceeded the ISO 80601-2-61 minimum sample size requirements and the minimum number of dark pigmented subjects in accordance with the FDA Guidance for Pulse Oximeters.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Bench Testing:
Bench testing using a low perfusion simulator was provided to support the performance of the subject device with the updated calibration curve under low perfusion conditions. Additional bench testing with opacity filters to simulate different skin pigments was performed to support the dynamic range of the signal detection under low perfusion.
Clinical Testing:
Study Type: Prospective clinical study
Sample Size: 39 healthy volunteer subjects (22 dark pigmented, 17 light pigmented; at least 7 subjects in each gender and skin pigment bin).
Key Results:
Overall performance (70%-100% SaO2 range): Bias -0.02, Precision 1.26, ARMS 1.26, Limits of Agreement [-2.50 2.45], Data Pairs 2030.
Overall performance (85%-95% SaO2 range): Bias -0.35, Precision 1.17, ARMS 1.22, Limits of Agreement [-2.63, 1.94], Data Pairs 738.
Sub-analysis by skin pigment and gender (70%-100% SaO2 range):
Light Male (10 subjects): Bias -0.13, Precision 1.26, ARMS 1.27, Limits of Agreement [-2.61, 2.35], Data Pairs 384.
Dark Male (15 subjects): Bias 0.11, Precision 1.44, ARMS 1.44, Limits of Agreement [-2.70, 2.93], Data Pairs 612.
Light Female (7 subjects): Bias -0.06, Precision 1.11, ARMS 1.11, Limits of Agreement [-2.11, 2.23], Data Pairs 258.
Dark Female (7 subjects): Bias -0.18, Precision 1.30, ARMS 1.32, Limits of Agreement [-2.73, 2.38], Data Pairs 216.
The accuracy was within 1.5% ARMS, without any clinically significant bias compared to the blood reference SaO2, or between the groups.
Bootstrapping for 1001 iterations confirmed the device met 1.5% ARMS across different subgroups.
Linear mixed effects (LME) models supported that performance was not impacted by gender and skin pigment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ARMS (Accuracy Root Mean Square) for SpO2
Predicate Device(s)
K181956 - Masimo MightySat Fingertip Pulse Oximeter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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).
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
Manufacturing Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7000
FAX: (949) 297-7592 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Date: | December 15, 2023 |
| Contact: | Kertana Shankar
Regulatory Specialist II
Masimo Corporation
Phone: (949) 297-7260 |
| Trade Name: | MightySat - OTC |
| Common Name: | Oximeter |
| Classification Regulation/
Product Code: | 21 CFR 870.2700, Class II/OLK |
| Establishment Registration
Number: | 3011353843 |
| Reason for Premarket
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
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% |
| Pulse Rate (PR): 25-240 beats per minute (BPM) | |
| Perfusion Index (Pi): 0.02-20% | |
| Display Resolution | SpO2: 1% |
| 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, | |
| Predicate | Comparison | ||
| 510(k) Number | Pending | K181956 | |
| General Information | |||
| 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. | The Masimo MightySat Fingertip Pulse
Oximeter is intended for hospitals, hospital-type
facilities, home environments, and transport.
The Masimo MightySat Fingertip Pulse
Oximeter is indicated for the noninvasive spot-
checking of functional oxygen saturation of
arterial hemoglobin (SpO2) and pulse rate (PR)
for adult and pediatric patients during both no
motion and motion conditions, and for patients
who are well or poorly perfused.
The Masimo MightySat Fingertip Pulse
Oximeter is indicated for the non-invasive spot
checking of respiration rate (RRp) for adult. | Same. The devices have the same
intended use, but the subject
device's indications for use has
been modified to be appropriate
for OTC lay users. There is no
change in the intended use from
the predicate device.
The subject device also provides
a subset of the parameters
supported by the predicate
device. The subject device does
not provide PVi and RRp
features. These features are
supplemental to the SpO2 and
Pulse Rate monitoring and
therefore does not change the
intended use from the predicate. |
| Classification Regulation/
Product Code | 21 CFR 870.2700, Class II/OLK | 21 CFR 870.2700, Class II/DQA
21 CFR 868.2375, Class II/BZQ | Same as predicate, except the
subject device is for OTC use
and does not provide respiration
rate monitoring. |
| | OTC | Rx | Different. Subject device is
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:
Oxyhemoglobin (oxygenated 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. | Pulse oximetry is governed by the following principles:
Oxyhemoglobin (oxygenated 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.
Respiration rate (RRp) is governed by the following principle:
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
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,
Predicate | Comparison |
| 510(k) Number | Pending | K181956 | |
| Measurement Ranges | | | |
| Oxygen Saturation
(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
provides improved
performance.
Testing is provided to support
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
older | 25 – 240 BPM, 3 BPM ARMS, adults/pediatrics | Same as predicate |
| Pulse Rate, Low
Perfusion | 25 – 240 BPM, 3 BPM ARMS, 18 years and
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
per ISO 10993-1 | Patient contacting materials are biocompatible
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 | | | |
| Feature | MightySat – OTC, Subject Device | MightySat Fingertip Pulse Oximeter, Predicate | Comparison |
| 510(k) Number | Pending | K181956 | |
| Storage Temperature | -40°F to 158°F (-40°C to 70°C) | -40°F to 158°F (-40°C to 70°C) | Same as predicate |
| Operational/Storage Humidity | 10 to 95%, non-condensing | 10 to 95%, non-condensing | Same as predicate |
| Atmospheric Pressure | 540 to 1060 mBar | 540 to 1060 mBar | Same as predicate |
| Mechanical | | | |
| General Overall Dimension | 2.9" x 1.6" x 1.2" (7.4 cm x 4.1 cm x 3.0 cm) | 2.9" x 1.6" x 1.2" (7.4 cm x 4.1 cm x 3.0 cm) | Same as predicate |
| Weight | 0.16 lbs (73g) | 0.16 lbs (73g) | Same as predicate |
| Electrical | | | |
| Type of power | Internal batteries, two standard “AAA” batteries | Internal batteries, two standard “AAA” batteries | Same as predicate |
| Electrical Safety/EMC | IEC 60601-1/ IEC 60601-1-2 | IEC 60601-1/ IEC 60601-1-2 | Same as predicate |
| Interface | | | |
| Wireless | Bluetooth | Bluetooth | Same as predicate |
| Mode of Operation per IEC 60601-1 | | | |
| Mode of Operation | Continuous | Continuous | Same as predicate |
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Image /page/8/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. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
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Image /page/9/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 bold, black 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.
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Image /page/10/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".
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Image /page/11/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 bold, black letters. To the right of the company name is the company's address, which is "52 Discovery, Irvine, CA 92618".
5.0 Performance Data
Performance Bench Testing
Performance bench testing is included as part of this submission to support the device performance and to support the substantial equivalence to the predicate device (K181956).
Additionally, to support the performance of the subject device with the updated calibration curve under low perfusion conditions, bench testing using a low perfusion simulator was provided as part of this submission. To support the dynamic range of the signal detection under low perfusion, additional bench testing with opacity filters to simulate different skin pigments was performed.
Biocompatibility Testing
Additional biocompatibility testing was not included as part of this submission as there was no change to the patient contacting materials from the previously cleared predicate device (K181956).
Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning
Additional electromagnetic compatibility, electrical safety, environmental, and cleaning testing was not included as part of this submission as there was no change to the mechanical, hardware or electrical components from the previous clearance of the predicate (K181956).
Software Verification and Validation Testing
Masimo has established, implemented, and maintains procedures for software design, development, review, verification, and validation of its products in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).
Consistent with the previously cleared predicate device (K181956), the subject device software is considered "Moderate" level of concern. This is because a failure or latent flaw in the device software could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
Software verification and validation testing was included as part of this submission to support the substantial equivalence of the subject device.
Wireless and Cybersecurity Testing
There were no changes made to the wireless capabilities of the MightySat-OTC from the predicate device (K181956) and therefore no additional wireless or cybersecurity testing was included as part of this submission.
Human Factors and Usability Testing
There were no changes made to the usability of the MightySat-OTC as part of this submission from the
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Image /page/12/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 word "Masimo" is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
previous clearance (K181956).
To support the OTC use of the subject device, additional human factors validation testing (self-selection and knowledge task) was performed to validate users can understand labeling materials and correctly interpret the device outputs. The validation testing included a self-selection process in accordance with the FDA Guidance, Self-Selection Studies for Nonprescription Drug Products, to identify the intended user to participate in the human factors and usability validation of the device.
Clinical Testing
To support the improved use by lay-users, the calibration curve was updated to improve the overall performance of the MightySat-OTC including across different skin pigments and genders to 1.5 % Arms.
To support the performance of the MightySat-OTC, clinical data is provided as part of this submission. The clinical performance testing included data from 39 healthy volunteer subjects with varying skin pigmentation, which was measured using the color-based Massey-Martin scale. The results of the clinical study were also separated by skin pigment groups to support the performance of the MightySat-OTC across different skin pigment groups.
The clinical performance testing was conducted in accordance with ISO 80601-2-61 and the prospective study included 39 healthy volunteer subjects, including 22 dark and 17 light pigmented subjects with at least 7 subjects in each gender and skin pigment bin, which exceeded the ISO 80601-2-61 minimum sample size requirements and the minimum number of dark pigmented subjects in accordance with the FDA Guidance for Pulse Oximeters.
The overall performance was found to be 1.26 % Arms across the 70%-100% SaO2 range and 1.22 % Arms in the 85%-95% SaO2 range. The summary of the performance in these saturation ranges are provided in the table below.
| SaO2 Range | Number
Subjects | Bias | Precision | ARMS | Limits of
Agreement | Data Pairs |
|------------|--------------------|-------|-----------|------|------------------------|------------|
| 70%-100% | 39 | -0.02 | 1.26 | 1.26 | [-2.50 2.45] | 2030 |
| 85%-95% | 39 | -0.35 | 1.17 | 1.22 | [-2.63, 1.94] | 738 |
Additional sub-analysis was performed based upon skin pigment and gender to support the performance of the subject device across different skin pigments and genders was within the 1.5 % Arms:
| Sub-Group | Number Subjects | SaO2 Range | Bias | Precision | ARMS (%) | Limits of Agreement | Data Pairs |
|---|---|---|---|---|---|---|---|
| Light Male | 10 | 70%-100% | -0.13 | 1.26 | 1.27 | [-2.61, 2.35] | 384 |
| Dark Male | 15 | 70%-100% | 0.11 | 1.44 | 1.44 | [-2.70, 2.93] | 612 |
| Light Female | 7 | 70%-100% | -0.06 | 1.11 | 1.11 | [-2.11, 2.23] | 258 |
| Dark Female | 7 | 70%-100% | -0.18 | 1.30 | 1.32 | [-2.73, 2.38] | 216 |
The result of the clinical testing supports the performance of the subject device, MightySat-OTC, across
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Image /page/13/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red symbol on the left, 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, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".
different skin pigmentation and gender combinations. The subject device demonstrated equitable performance for the intended user population across all the pigment and gender sub-groups and the accuracy was within 1.5% ARMS, without any clinically significant bias compared to the blood reference SaO2, or between the groups.
To further support the equitable performance, the data was bootstrapped for 1001 iterations with replacements. The bootstrapping was conducted both using all the data and also taking account flatteming of the data across the bins. The supported the subject device still met the 1.5 % Arms across the different subgroups.
The data was also analyzed using linear mixed effects (LME) models to support the performance was not impacted gender and skin pigment.
6.0 Conclusion
The data supported the MightySat-OTC is substantially equivalent.