(130 days)
K201432 - Masimo O3 Regional Oximeter System
Not Found
No
The summary describes a regional oximeter that measures and calculates physiological parameters based on optical measurements. There is no mention of AI or ML in the device description, intended use, or performance studies. The calculations described are standard physiological indices.
No.
The device is described as an "adjunct monitor" that measures and monitors regional hemoglobin oxygen saturation. It provides data for monitoring but does not directly treat or alleviate a medical condition.
Yes
The device is intended as an "adjunct monitor of regional hemoglobin oxygen saturation of blood (rSO2) in the tissue under the sensors" and measures various oxygenation parameters (rSO2, ΔcHb, ΔΟ2Hb, ΔΗΗb), which are used to assess physiological states and indicate the need for medical intervention. This function aligns with the definition of a diagnostic device, even if it's an "adjunct" rather than a primary diagnostic tool.
No
The device description explicitly lists hardware components: "O3 Module, O3 Sensors (e.g. O3 Adult, O3 Pediatric, and O3 Infant/Neonatal Sensors), and a display monitor (e.g. Root)." This indicates it is a hardware-based medical device with associated software.
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 examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This examination is performed outside of the living body (in vitro).
- Masimo O3 Function: The Masimo O3 Regional Oximeter is described as a non-invasive device that measures regional hemoglobin oxygen saturation in the tissue under the sensors. It does not involve the collection or analysis of specimens derived from the human body. It directly measures physiological parameters within the living body.
Therefore, the Masimo O3 Regional Oximeter System falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
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 tissue 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.
When used with the 03 Adult Sensor, the 03® Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in adults ≥ 40kg.
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) on cerebral sites and trending rSO2 on non-cerebral sites 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). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
Masimo Corporation Kertana Shankar Regulatory Specialist II 52 Discovery Irvine, California 92618
Re: K214072
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: March 31, 2022 Received: April 1, 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 (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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 medical devices and radiation-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,
For Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K214072
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 (rSO2) in the tissue 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.
When used with the 03 Adult Sensor, the 03® Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in adults ≥ 40kg.
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) on cerebral sites and trending rSO2 on non-cerebral sites 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 a red circle with a white heart rate symbol inside, followed by the word "Masimo" in black, bold font. 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) 297-7000
FAX: (949) 297-7592 |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Date: | May 6, 2022 |
| Contact: | Kertana Shankar
Regulatory Specialist II
Masimo Corporation
Phone: (949) 297-7260 |
| 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: | 3011353843 |
| Reason for Premarket
Notification: | Updated indications to include adjunct monitoring of absolute rSO2 in
non-cerebral sites |
| Primary Predicate: | K201432 - Masimo O3 Regional Oximeter System |
| Performance Standards | There are no performance standards pursuant to Section 514 of the
Food, Drug and Cosmetic Act for the above device. |
1 Device Description
The Masimo O3 Regional Oximeter is a noninvasive regional oximeter designed to continuously measure and monitor regional hemoglobin oxygen saturation (rSO2) in the tissue under the sensor. The Masimo O3 Regional Oximeter consists of the following components: 03 Module, 03 Sensors (e.g. O3 Adult, O3 Pediatric, and O3 Infant/Neonatal Sensors), and a display monitor (e.g. Root).
The O3 Regional Oximeter System provides the following key measurements and calculated features:
- Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep tissue local to the sensor site.
- Delta Baseline (Abase): Calculation of the 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 (4SpO2): Calculation of the difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).
- Delta HHb (1HHb): Index associated with the change in deoxygenated hemoglobin. ●
- Delta O2Hb (ΔO2Hb): Index associated with the change in the oxygenated. ●
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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 black, bold letters. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.
510(k) Summarv - K214072
- Delta cHb (AcHb): Calculation of the sum of the Delta HHb and Delta O2Hb, and is an index, ● associated with the change in the total (oxygenated and deoxygenated) hemoglobin.
The purpose of this submission is to receive clearance for the Masimo O3 Regional Oximeter with updated indications to include adjunct monitoring of absolute rSO2 in non-cerebral sites.
The performance specifications for Masimo O3 Regional Oximeter are provided in Table 1 below
| Table 1 Masimo O3 Regional Oximeter Accuracy (ARMS) Specifications | ||
|---|---|---|
| Cerebral Hemoglobin Oxygen Saturation of Blood (rSO2) | ||
| rSO2 (trending) | ||
| (from 45% to 85% SavO2) | Adult, Pediatric, Neonate | 3% |
| rSO2 (absolute) | ||
| (from 45% to 85% SavO2) | Adult | 4% |
| Pediatric | 5% | |
| Non-Cerebral Hemoglobin Oxygen Saturation of Blood (rSO2) | ||
| rSO2 (trending) | ||
| (from 45% to 85% SavO2) | Adult, Pediatric, Neonate | 3% |
| rSO2 (absolute) | ||
| (from 60% to 90% SavO2) | Adult | 5% |
2 Intended Use/ Indications For Use
The proposed intended use/ indications for use for the 03 Regional Oximeter is provided below:
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 tissue under the sensors in patients in healthcare environments. The 03® 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 ≥ 40kg.
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) on cerebral sites and trending rSO2 on non-cerebral sites in pediatrics ≥ 5 kg and