(89 days)
No
The summary describes a regional oximeter using multi-distance diffusion spectroscopy to measure oxygen saturation. There is no mention of AI or ML in the device description, intended use, or performance studies. The studies focus on comparing the device's measurements and trending capabilities to predicate and reference devices, not on validating an AI/ML algorithm.
No.
The device is indicated for use "as an adjunct monitor" for measuring regional hemoglobin oxygen saturation. It provides diagnostic information but does not claim to directly treat or provide therapy.
Yes
The device is indicated for "measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2)" and monitoring "relative hemoglobin changes of oxygenated hemoglobin (△O2Hb), deoxygenated hemoglobin (△HHb), and total hemoglobin (△cHb)". These are measurements and monitoring of bodily functions used to assess a patient's physiological state, which falls under the definition of a diagnostic device.
No
The device description explicitly states that the Masimo O3 Regional Oximeter consists of hardware components including the O3 Module, O3 Sensors, and a display monitor.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
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 provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Masimo O3 Regional Oximeter System is a non-invasive device that measures regional hemoglobin oxygen saturation directly in the tissue under the sensors. It does not involve the collection or analysis of specimens taken from the body.
- Intended Use: The intended use describes the device as an "adjunct monitor of regional hemoglobin oxygen saturation of blood (rSO2) in the tissue under the sensors." This is a direct measurement on the patient's body, not an analysis of a sample.
Therefore, the Masimo O3 Regional Oximeter System falls under the category of a non-invasive medical device used for monitoring physiological parameters, not an In Vitro Diagnostic.
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 O3 Adult Sensor, the O3® Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (tSO2) on cerebral sites and trending rSO2 on non-cerebral sites in adults > 40kg.
When used with the O3 Pediatric Sensor, the O3® Regional Oximeter 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 40kg, 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).
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August 29, 2020
Image /page/0/Picture/1 description: The image contains 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 text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
Masimo Corporation Sindura Penubarthi Regulatory Affairs Manager 52 Discovery Irvine. California 92618
Re: K201432
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: May 29, 2020 Received: June 1, 2020
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.
Colin Kejing Chen Acting 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
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Indications for Use
510(k) Number (if known) K201432
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 O3 Adult Sensor, the O3® Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (tSO2) on cerebral sites and trending rSO2 on non-cerebral sites in adults > 40kg.
When used with the O3 Pediatric Sensor, the O3® Regional Oximeter 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."
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Image /page/3/Picture/0 description: The image shows the logo for Masimo, a medical technology company. The logo features a red circle with a white checkmark inside, positioned to the left of the company name, "Masimo," which is written in a simple, sans-serif font. The overall design is clean and modern, reflecting the company's focus on innovation in healthcare.
MASIMO CORPORATION
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: | August 29, 2020 |
| 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: | 3011353843 |
| Reason for Premarket
Notification: | Expanded indications for use |
| Predicate Device: | K182429 – Masimo O3 Regional Oximeter System |
| Reference Predicate | K091224 - Somanetics INVOS 5100C
K112820 - CAS Medical ForeSight Elite
K113215 – Nonin Medical Model 7600
K162117 -- NIRO-200NX |
| 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 under the sensor. The Masimo O3 Regional Oximeter consists of the following components: 03 Module, O3 Sensors (e.g. O3 Adult, O3 Pediatric, and O3 Infant/Neonatal Sensors), and a display monitor (e.g. Root) same as those cleared under K182429.
The O3 System provides the following key measurements:
- Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep tissue local to the sensor site.
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Image /page/4/Picture/0 description: The image shows the logo for Masimo, a medical technology company. The logo features the company name in a bold, sans-serif font. To the left of the name is a stylized, red, circular symbol with a white checkmark-like shape inside. The overall design is clean and modern, reflecting the company's focus on innovation in healthcare.
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
- 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 (ASpO2): The difference between SpO2 and rSO2. The source of SpO2 is from ● peripheral SpO2 measurement (using pulse oximeter).
- Delta HHb (ΔHHb): a measure of the relative change in deoxygenated hemoglobin.
- Delta 02Hb (ΔΟ2Hb): a measure of the relative change in the oxygenated hemoglobin. ●
- Delta cHb (ΔcHb): the sum of the Delta HHbi and Delta O2Hbi, as a measure of the relative . change in the total hemoglobin.
The performance specifications are included in table below:
| Feature | Specification |
|---|---|
| Performance (Arms) | |
| Non-Cerebral Oxygen Monitoring | |
| rSO2 Trending (Adult, Pediatric, and Neonate) | 3% for SavO2 of 45%-85% |
| Cerebral Oxygen Monitoring | |
| rSO2 Absolute (Adult ≥ 40 kg) | 4% for SavO2 of 45%-85% |
| rSO2 Absolute (Pediatric ≥ 5 kg and 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 (tSO2) on cerebral sites and trending tSO2 on non-cerebral sites in pediatrics ≥ 5 kg and