(274 days)
No
The summary describes standard signal processing techniques (Near Infra Red Spectroscopy - NIRS) and does not mention any AI or ML components. The performance studies focus on trending accuracy relative to blood testing and a predicate device, not on the performance of an AI/ML algorithm.
No
The device is described as an "adjunct monitor" of regional hemoglobin oxygen saturation and continuously determines the measurement of regional blood oxygen saturation. Its function is to measure and display physiological signals, not to deliver therapy or treat a condition.
Yes
The device is described as an "adjunct monitor" that measures "regional hemoglobin oxygen saturation of blood (rSO2)" and provides "Regional Oxygenation (rSO2)" and other derived metrics. These measurements provide information about the patient's physiological state, which can be used by healthcare professionals to inform diagnosis or treatment decisions.
No
The device description explicitly states that the system includes both O3 Sensors (hardware that acquires physiological signals) and the O3 Module (hardware that processes those signals). It also mentions a patient cable and connection to a Host/Backboard Device for power and display. This indicates the device is a hardware system with integrated software, not a software-only medical device.
Based on the provided information, the Masimo O3 Regional Oximeter System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- Masimo O3 System Function: The Masimo O3 Regional Oximeter System is a non-invasive device that measures regional hemoglobin oxygen saturation of blood (rSO2) directly on the patient's forehead using near-infrared light. It does not involve the collection or analysis of specimens taken from the body.
Therefore, the Masimo O3 Regional Oximeter System falls under the category of a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The non-invasive Masimo O3 Regional Oximeter System and accessories are indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors in healthcare environments. The O3 Regional Oximeter is only to be used with Masimo O3 sensors. The use of any other sensor is not supported or recommended by Masimo and could give erroneous results.
When used with the O3 Adult Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in adults ≥ 40 kg.
When used with the O3 Pediatric Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in pediatrics ≥ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Masimo Corporation Sindura Penubarthi Regulatory Affairs Manager 52 Discovery Irvine, California 92618
Re: K182429
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 30, 2019 Received: May 1, 2019
Dear Sindura Penubarthi:
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. 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 located 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.
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 803) for
1
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182429
Device Name Masimo O3 Regional Oximeter System
Indications for Use (Describe)
The non-invasive Masimo O3 Regional Oximeter System and accessories are indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood (tSO2) in the cerebral region under the sensors in healthcare environments. The O3 Regional Oximeter is only to be used with Masimo O3 sensors. The use of any other sensor is not supported or recommended by Masimo and could give erroneous results.
When used with the O3 Adult Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in adults ≥ 40 kg.
When used with the 03 Pediatric Sensor, the 03 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in pediatrics ≥ 5 kg and Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a stylized font, with a red checkmark symbol 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".
| Submitter and Address of
Manufacturing Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7541
FAX: (949) 297-7592 |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | September 4, 2018 |
| Contact: | Sindura Penubarthi
Regulatory Affairs Manager |
| 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 Neonatal Sensor |
| Predicate Device: | K160526 – Masimo O3 Regional Oximeter System
Reference Predicate: K082327- Somanetics Invos 5100C
with Infant/Neonatal Cerebral OxyAlert NIRSensor |
| Performance Standards | There are no performance standards pursuant to Section 514
of the Food, Drug and Cosmetic Act for the above device. |
Device Description
The Masimo Regional Oximetry System) monitors regional hemoglobin oxygen saturation of blood (rSO2) under the sensors. The O3 System includes the O3 Sensors that acquire physiological signals and the O3 Module that processes those signals. The FDA has previously cleared the O3 System in K160526 (with an O3 Adult Sensor) and K162603 (with an O3 Pediatric Sensor). In this submission, Masimo seeks clearance of its O3 System with an 03 Neonatal Sensor.
Similar to the cleared O3 Adult and Pediatric Sensors, the O3 Neonatal Sensor is a singlepatient use, adhesive sensor and is supplied non-sterile. The O3 Neonatal Sensor attaches to the patient's forehead. The sensor includes four emitters and two detectors. The emitters radiate multiple wavelengths of near infrared light, while the detectors sense the reflected light. The detector outputs are physiological signals and these signals pass through the other
4
Image /page/4/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 stylized red checkmark to the left of the word. To the right of the logo is the text "MASIMO CORPORATION" in a smaller font, followed by the address "52 Discovery, Irvine, CA 92618".
end of the sensor that connects to a patient cable, passing these signals to the O3 Module for processing.
The O3 Module is unchanged from K160526. It includes Masimo technology for processing those signals and outputting regional oximetry (tSO2) measurements. Specifically, the O3 Module includes Near Infra Red Spectroscopy (NIRS) technology. When O3 module is connected to an O3 Neonatal Sensor, the O3 Monitor continuously and accurately determines the trending measurement of regional blood oxygen saturation in the tissue (rSO2) in neonates. In turn, the Host/Backboard device displays this measurement. The O3 Module can connect to up to two O3 Sensors, both connected to a patient.
The O3 System does not have an internal battery or an AC power input. The O3 Module, instead, receives power via its connection to a Host/Backboard Device, such as the Root Monitoring System (Root). Root in turn receives power from either AC power or internal rechargeable batteries.
Similar to K160526, the O3 System using an O3 Neonatal Sensor 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 userdefined rSO2 low alarm limit (LAL)
- . Delta SpO2 (4SpO2): The difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).
The O3 System has the following specifications:
| 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% | |
| SO2 Measurement Accuracy, | |
| Neonates |