Masimo O3 Regional Oximeter System

{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. 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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 < 40 kg. When used with the 03 Neonatal Sensor, the 03 Regional Oximeter is indicated for measuring only trending regional hemoglobin oxygen saturation of blood (rSO2) in neonates < 10 kg. | Type of Use (Select one or both, as applicable) | |-----------------------------------------------------------------------------------------| | <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | | <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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To the right of the logo is the text "MASIMO CORPORATION" 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: (949) 297-7541<br>FAX: (949) 297-7592 | |-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | Date: | September 4, 2018 | | Contact: | Sindura Penubarthi<br>Regulatory Affairs Manager | | Trade Name: | Masimo O3 Regional Oximeter System | | Common Name: | Oximeter, Tissue Saturation | | Classification Regulation/<br>Product Code: | 21 CFR 870.2700, Class II/MUD | | Establishment Registration<br>Number: | 2031172 | | Reason for Premarket<br>Notification: | New Device - Masimo O3 Neonatal Sensor | | Predicate Device: | K160526 – Masimo O3 Regional Oximeter System<br>Reference Predicate: K082327- Somanetics Invos 5100C<br>with Infant/Neonatal Cerebral OxyAlert NIRSensor | | Performance Standards | There are no performance standards pursuant to Section 514<br>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%<br>(Δbase is the difference between regional and baseline rSO2) | | Display Resolution for Measurements | rSO2: 1% | | | Δbase: 1% | | SO2 Measurement Accuracy,<br>Neonates < 10 kg | Trending ARMS, 3% for SavO2 of 45%-85% | | General | | {5}------------------------------------------------ Image /page/5/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 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". | O3 System Specifications | | |----------------------------------------------------------|-------------------------------------------------------------------------------------------| | FEATURE | SPECIFICATION | | Visual/audible alarm | Host/backboard device (Root per K140188, K151644 and K153225) is IEC60601-1-8 compliant | | Storage/recording | Host/backboard device (Root per K140188, K151644 and K153225) trend/data storage | | Electrical | | | AC Power or<br>Battery, Rechargeable | Host/backboard device (Root per K140188, K151644 and K153225) provides power to O3 System | | Interface | | | 03 Module Connection | MOC-9 interface with host/backboard device (Root per K140188, K151644 and K153225) | | Mechanical | | | 03 Module: Dimensions/Weight | 5x1.8x0.6 inch/ 7 oz | | 03 Neonatal Sensor: Dimensions/Weight | 2.6x1.1x0.1 inch/0.18 oz. | | Environmental | | | 03 Module | | | • Operating Temperature | 0°C to +40°C, ambient humidity | | • Storage Temperature | -40°C to +70°C, ambient humidity | | • Operating/ Storage Humidity | 10% to 95%, non-condensing | | • Altitude | Up to 12,000 feet (3700 meters) | | 03 Adult Sensor, O3 Pediatric, and O3<br>Neonatal Sensor | | | • Operating Temperature | +5°C to +40°C | | • Storage Temperature | -40°C to +60°C | | • Humidity | 15% to 90% relative humidity | SavO2 = 0.3 SaO2 + 0.7 SjvO2 ### Intended 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 patients 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. ### 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 patients 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. {6}------------------------------------------------ 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 black, stylized font. To the right of the logo, the text "MASIMO CORPORATION 52 Discovery Irvine, CA 92618" is displayed in a smaller, sans-serif font. 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 < 40 kg. When used with the O3 Neonatal Sensor, the O3 Regional Oximeter is indicated for measuring only trending regional hemoglobin oxygen saturation of blood (rSO2) in neonates < 10 kg. ### Technological Characteristics ### Principle of Operation (same as in K160526) The O3 System's operating principle is based on multi-distance diffuse reflectance spectroscopy. The O3 System use light to examine a cross-section tissue microvasculature (a mixed bed of arterioles, capillaries and venules) and analyzes the light returned after having passed through the tissues. The spectroscopic analysis determines concentrations of hemoglobin in its oxygenated and deoxygenated states. Mechanism of Action for Achieving the Intended Effect (same as in K160526) The O3 Sensor is noninvasively applied to the patient on one end. The other end of the O3 Sensor connects to the O3 Module. In turn, the O3 Module connects to a Host/Backboard device. The O3 Sensor collects patient physiological signals which are processed by the O3 Module. The processed signals which resulted in rSO2 measurements are displayed on the Host/Backboard device. {7}------------------------------------------------ ## Non-clinical Testing Masimo performed the following tests, as applicable, for the qualification of the subject devices, O3 System under K160526 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 - Biocompatibility testing per ISO-10993 - Software verification per FDA Software Guidance - Mechanical and environmental testing . Masimo performed the following tests, as applicable, for the qualification of the subject devices, O3 Neonatal sensor in accordance with the requirements of the design control regulations in and established quality assurance processes to demonstrate substantial equivalence with the predicate device cleared in K160526 - . Usability testing per FDA Human Factors and Usability Guidance 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 Masimo performed a clinical study to determine the O3 Neonatal Sensor's Trending ARMS. Previously, Masimo performed a clinical study on the O3 Adult Sensor to establish its trending accuracy with respect to blood testing. In this submission. Masimo collected relative rSO2 data for both the O3 Adult Sensor and O3 Neonatal Sensor on the same subject to calculate the O3 Neonatal Sensor's Trending Arms relative to the O3 Adult Sensor. Masimo then calculated the Trending ARMs for the O3 Neonatal Sensor relative to blood from a combination of the O3 Adult Sensor's Trending ARMs relative to blood testing and 03 Neonatal Sensor's Trending ARMs relative to the 03 Adult Sensor. Masimo also conducted a study to test the absolute accuracy of the subject sensor on 11 hospitalized patients weighing less than 10 kg with invasive SavO2 blood draws of 46 % to 82 %. The study showed a favorable trend of rSO2 with SavO2 with an accuracy of less than 6 %. Note that absolute accuracy is not a claim that is being pursued in this submission. These data are merely being reported as convenience samples. {8}------------------------------------------------ ## Conclusion The clinical evaluation, non-clinical testing including safety testing, as included in this 510(k) submission, demonstrate that the subject device, O3 Neonatal Sensor, is substantially equivalent to its predicate with respect to safety and effectiveness.