(255 days)
No
The document does not mention AI, ML, or related terms, and the device description focuses on standard pulse oximetry technology (Masimo SET).
No.
The device is indicated for noninvasive spot checking of oxygen saturation and pulse rate, which are diagnostic measurements, not therapeutic interventions.
Yes
The device measures physiological parameters (functional oxygen saturation and pulse rate) which are used to assess a patient's health status, fitting the definition of a diagnostic device.
No
The device description explicitly states it is a "fingertip pulse oximeter" that includes hardware components like an OLED color display, plastic housing, and is powered by batteries. While it has optional Bluetooth connectivity to a mobile device for data display/storage, the core measurement function is performed by the physical device itself.
Based on the provided information, the Masimo MightySat Rx Fingertip Pulse Oximeter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information about a physiological state, health, or disease.
- The Masimo MightySat Rx is a noninvasive device that measures oxygen saturation and pulse rate directly from the patient's finger. It does not analyze a specimen taken from the body.
The device's function and intended use clearly fall under the category of a noninvasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
hospitals, hospital-type facilities, and mobile environments.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Predicate Device(s)
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/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
1
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
2
Section 4. Indications for Use Statement
Indications for Use
510(k) Number: K150314
Device Name: Masimo MightySat Rx Fingertip Pulse Oximeter
Indications for Use:
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.
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)
3
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 of
Manufacturing Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7000
FAX: (949) 297-7592 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Date: | October 21, 2015 |
| Contact: | Marguerite Thomlinson
Senior 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 Registration
Number: | 2031172 |
| Reason for Premarket
Notification: | New Device |
| Predicate Device: | K081285 – Nonin Medical, Inc. Onyx II Model 9560
K142394 - Masimo Root Monitoring System (Radius-7) |
| Performance Standards | No performance standards for the above device have been
promulgated pursuant to Section 514. |
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.
4
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 in | |
| Accordance 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.
5
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
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.
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:
6
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.
7
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.