(249 days)
No
The summary describes signal processing and measurement calculations based on NIRS technology, but does not mention AI or ML.
No
The device is described as an "adjunct monitor" that measures and displays regional hemoglobin oxygen saturation. It provides information to clinicians but does not directly treat or diagnose a condition.
Yes.
The device is intended for use as an "adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region," which provides measurements (e.g., Regional Oxygenation, Delta SpO2) that assist clinicians in determining the oxygenation levels in tissue. This information aids in the diagnosis or monitoring of a patient's physiological state.
No
The device description explicitly states that the system includes hardware components: O3 Sensors (with optical components) and the O3 Module (with NIRS technology).
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is intended for use as a noninvasive monitor of regional hemoglobin oxygen saturation in the cerebral region under the sensors. This involves directly measuring physiological signals from the patient's body.
- Device Description: The device uses Near InfraRed Spectroscopy (NIRS) technology and sensors applied to the patient's forehead to measure light absorption in the tissue. This is a method of in vivo measurement (within the living body).
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
Since this device directly measures physiological parameters from within the patient's body rather than analyzing samples taken from the body, it falls outside the definition of an In Vitro Diagnostic. It is an in vivo diagnostic or monitoring device.
N/A
Intended Use / Indications for Use
The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥ 40 kg and on pediatrics > 5 kg and 5 kg and
§ 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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2017
Masimo Corporation Marguerite Thomlinson Sr. Director, Regulatory Affairs 52 Discovery Irvine, California 92618
Re: K162603
Trade/Device Name: Masimo O3 Regional Oximeter System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: April 25, 2017 Received: April 26, 2017
Dear Marguerite 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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,
William J. Heetderks -S 2017.05.26 11:06:05 -04'00'
Carlos L. Peña, Ph.D., M.S. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162603
Device Name
Masimo O3 Regional Oximeter System
Indications for Use (Describe)
| The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥ 40 kg and on pediatrics > 5 kg and Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| 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 line running through it, followed by the word "Masimo" in black, bold letters. To the right of the word "Masimo" are the words "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.
| Submitter and Address of
Manufacturing Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7683
FAX: (949) 297-7592 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Date: | May 10, 2017 |
| Contact: | Marguerite Thomlinson
Senior Director, Regulatory Affairs |
| Trade Name: | Masimo O3 Regional Oximeter System |
| Common Name: | Oximeter, Tissue Saturation |
| Classification Regulation/
Product Code: | 21 CFR 870.2700, Class II/MUD |
| Establishment Registration
Number: | 2031172 |
| Reason for Premarket
Notification: | New Device - Masimo O3 Pediatric Sensor |
| Predicate Device: | K160526 – Masimo O3 Regional Oximeter System
K082327- Invos 5100C with Pediatric SomaSensor |
| Performance Standards | No performance standards for the above device have been
promulgated pursuant to Section 514. |
Device Description
The Masimo Regional Oximetry System (O3 System) includes the O3 Sensors and the O3 Module. The O3 System measures hemoglobin under the sensor, allowing clinicians to continuously and accurately determine the absolute and trend measurements of regional blood oxygenation saturation in the tissue (rSO2). The O3 Sensors includes optical components that collect physiological signals. The O3 Module includes Masimo technology for processing those signals which resulted in regional oximetry (rSO2) measurements. In turn, these measurements are displayed on the Host/Backboard device.
The O3 Sensor is a single-patient use adhesive sensor and is supplied non-sterile. The O3 Sensor, comprising of an emitter and two detectors, is applied to the patient's forehead at one end. The other end of the sensor is connected to a patient cable which in turn is connected to
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the 03 Module. Up to two 03 Sensors can be connected to each 03 Module and both sensors can be connected to a patient.
The O3 Module includes Near InfraRed Spectroscopy (NIRS) technology. The O3 Sensor uses multiple wavelengths in the range of near infrared wavelengths to measure light absorption in the tissue. The O3 Sensors and O3 Module make up the O3 System for the monitoring of absolute regional hemoglobin oxygen saturation of blood (rSO2) under the sensors. The O3 System does not have its own power. The O3 Module is powered by connecting to a Host/Backboard Device such as the Root Monitoring System (Root in turn is powered by either AC power or internal rechargeable batteries.
The O3 System provides the following key measurements:
- Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep tissue ● local to the sensor site, including cerebral tissue
- Delta Baseline (Abase): Relative difference in rSO2 with respect to baseline rSO2 ●
- Area Under the Limit (AUL index): Index that quantifies the duration (amount of time the patient stays below rSO2 low alarm limit) and depth (refers to the gap between the patient's rSO2 level and the rSO2 low alarm limit) of patient's stay below the user-defined rSO2 low alarm limit (LAL)
- Delta SpO2 (ΔSpO2): The difference between SpO2 and rSO2. The source of SpO2 . is from peripheral SpO2 measurement (using pulse oximeter).
| O3 System Specifications | |
|---|---|
| FEATURE | SPECIFICATION |
| Display | |
| Display Range | Regional Oxygen Saturation (rSO2): 0-99% |
| Δbase: 0-99% | |
| (Δbase is the difference between regional and baseline rSO2) | |
| Display Resolution for Measurements | rSO2: 1% |
| Δbase: 1% | |
| rSO2 Measurement Accuracy, Adults ≥ 40kg | Absolute ARMS, 4% for SavO2 of 45%-85% |
| Trending ARMS, 3% for SavO2 of 45%-85% | |
| SO2 Measurement Accuracy, | |
| Pediatrics ≥ 5 kg and 5 kg and 40 kg | Pediatrics * AMS accuracy is a statistical calculation of the difference between device measurements. Approximately wo-thirds of the device measurements fell within +/- ARMs of the reference measurements in a controlled study. |
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Non-clinical Testing
The following tests, as applicable, were performed for the qualification of the subject devices, O3 System, in accordance with the requirements of the design control regulations and established quality assurance processes to demonstrate substantial equivalence with the predicate device:
- Electrical safety testing per IEC-60601-1 ●
- EMC testing per IEC-60601-1-2 ●
- Alarm testing per IEC-60601-1-8
- Optical safety testing per IEC-62471 ●
- Biocompatibility testing per ISO-10993
- . Usability testing per FDA Human Factors and Usability Draft Guidance
- Software verification per FDA Software Guidance ●
- Mechanical and environmental testing ●
The results demonstrate that all requirements and performance specifications were satisfied, and that the subject device is substantially equivalent to the predicate device.
Clinical Testing
In the study for Absolute ARMS, rSO2 measurements were collected using the O3 System, including the O3 Module (K160526) and O3 Pediatric Sensor, on 33 male and female pediatric patients with ages ranging from less than one year to 12 years. Blood draws (arterial and jugular blood) were taken for each subject before and after his/her medical procedure. The rSO2 measurements were analyzed against blood draw measurements and the Absolute ARMs were calculated in the same manner as in K160526.
As the O3 Large Sensor trending accuracy was established with blood reference via K160526, the O3 Large Sensor was used as a reference in the comparative trending study with the O3 Pediatric Sensor. The rSO2 data was collected for both O3 Large Sensor and O3 Pediatric Sensor. The relative rSO2 value between the O3 Large Sensor and O3 Pediatric Sensor was then calculated. The Trending ARMs for the O3 Pediatric Sensor was derived by taking the relative error between the O3 Large Sensor and O3 Pediatric Sensor into account.
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Conclusion
The clinical evaluation, non-clinical testing including safety testing, as included in this 510(k) submission, demonstrate that the subject device, O3 Pediatric Sensor, is substantially equivalent to its predicate with respect to safety and effectiveness.