Masimo O3 Regional Oximeter System
Device Facts
| Record ID | K214072 |
|---|---|
| Device Name | Masimo O3 Regional Oximeter System |
| Applicant | Masimo Corporation |
| Product Code | MUD · Cardiovascular |
| Decision Date | May 6, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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 (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 < 40 kg. When used with the O3 Neonatal Sensor, the O3® Regional Oximeter is indicated for measuring regional hemoglobin oxygen saturation of blood (rSO2) on cerebral sites and trending rSO2 on non-cerebral sites in neonates < 10kg. The ΔcHb, ΔO2Hb, ΔHHb provided as part of the Masimo O3 are indicated for the relative hemoglobin changes of oxygenated hemoglobin (ΔO2Hb), deoxygenated hemoglobin (ΔHHb), and total hemoglobin (ΔcHb) as measured from the Masimo O3 sensor when applied to the cerebral tissue in adults.
Device Story
Non-invasive regional oximeter system; measures rSO2 in deep tissue. Inputs: physiological signals collected via O3 sensors applied to patient skin. Principle: multi-distance diffusion spectroscopy; uses differing light wavelengths diffused into tissue; analyzes light detected at two distances from source. Components: O3 module, O3 sensors, host display monitor (e.g., Root). Outputs: rSO2, Delta Baseline (Abase), Area Under the Limit (AUL index), Delta SpO2, and relative hemoglobin indices (ΔHHb, ΔO2Hb, ΔcHb). Used in healthcare environments; operated by clinicians. Output displayed on host device; assists clinicians in monitoring tissue oxygenation status; aids in clinical decision-making regarding patient oxygenation levels.
Clinical Evidence
Clinical study conducted on 25 subjects using a controlled desaturation protocol. rSO2 readings on somatic tissue were recorded and compared against tissue oxygen saturation (SvO2) computed from arterial and venous blood samples. Results supported the absolute rSO2 performance on non-cerebral sites.
Technological Characteristics
Multi-distance diffusion spectroscopy; uses differing light wavelengths. Components: O3 module, O3 sensors, host display monitor. Connectivity: wired communication. Power: host device. Electrical safety: IEC 60601-1. EMC: IEC 60601-1-2. Operating temperature: 32°F-104°F (module), 41°F-104°F (sensor). Mode of operation: continuous.
Indications for Use
Indicated for adjunct monitoring of regional hemoglobin oxygen saturation (rSO2) in healthcare environments. Adult sensors: absolute/trending rSO2 in adults ≥ 40kg. Pediatric sensors: absolute/trending rSO2 on cerebral sites, trending rSO2 on non-cerebral sites in pediatrics ≥ 5kg and < 40kg. Neonatal sensors: trending rSO2 on cerebral sites, trending rSO2 on non-cerebral sites in neonates < 10kg. Also indicated for relative hemoglobin changes (ΔcHb, ΔO2Hb, ΔHHb) in adult cerebral tissue.
Regulatory Classification
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.
Predicate Devices
- Masimo O3 Regional Oximeter System (K201432)
Submission Summary (Full Text)
{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 < 40 kg.
When used with the O3 Neonatal Sensor, the O3® Regional Oximeter is indicated for measuring regional hemoglobin oxygen saturation of blood (fSO2) on cerebral sites and trending rSO2 on non-cerebral sites in neonates < 10kg.
The AcHb, AO2Hb, AHHb provided as part of the Masimo O3 are indicated for the relative hemoglobin changes of oxygenated hemoglobin (ΔΟ2Ηο), deoxygenated hemoglobin (ΔΗΗο), and total hemoglobin (ΔcHb) as measured from the Masimo O3 sensor when applied to the cerebral tissue in adults.
Type of Use (Select one or both, as applicable)
| <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-------------------------------------------------------------------|
| <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> 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<br>Manufacturing Facility: | Masimo Corporation<br>52 Discovery<br>Irvine, CA 92618<br>Phone: (949) 297-7000<br>FAX: (949) 297-7592 |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Date: | May 6, 2022 |
| Contact: | Kertana Shankar<br>Regulatory Specialist II<br>Masimo Corporation<br>Phone: (949) 297-7260 |
| 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: | 3011353843 |
| Reason for Premarket<br>Notification: | Updated indications to include adjunct monitoring of absolute rSO2 in<br>non-cerebral sites |
| Primary Predicate: | K201432 - Masimo O3 Regional Oximeter System |
| Performance Standards | There are no performance standards pursuant to Section 514 of the<br>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. ●
{4}------------------------------------------------
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)<br>(from 45% to 85% SavO2) | Adult, Pediatric, Neonate | 3% |
| rSO2 (absolute)<br>(from 45% to 85% SavO2) | Adult | 4% |
| | Pediatric | 5% |
| Non-Cerebral Hemoglobin Oxygen Saturation of Blood (rSO2) | | |
| rSO2 (trending)<br>(from 45% to 85% SavO2) | Adult, Pediatric, Neonate | 3% |
| rSO2 (absolute)<br>(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 < 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) on cerebral sites and trending rSO2 on non-cerebral sites in neonates < 10kg.
The ΔcHb, ΔΟ2Hb, ΔΗΗb provided as part of the Masimo Ο3 are indicated for the monitoring of the relative hemoglobin changes of oxygenated hemoglobin (ΔΟ2Ηb), deoxygenated hemoglobin (ΔΗΗΒ),
{5}------------------------------------------------
Image /page/5/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 bold, black letters. To the right of the logo is the text "MASIMO CORPORATION" in gray letters, followed by the address "52 Discovery, Irvine, CA 92618".
## 510(k) Summarv - K214072
and total hemoglobin (ΔcHb) as measured from the Masimo O3 sensor when applied to the cerebral tissue in adults.
#### 3 Technological Characteristics
### Principle of Operation
There are no changes to the principle of operation from the previous clearance under K201432. The principle of operation for the O3 Regional Oximeter is still based on multi-distance diffusion spectroscopy. Multi-distance diffusion spectroscopy relies on the use of differing wavelengths of light that is diffused into a cross-section of tissue consisting of microvasculature (a mixed bed of arterioles, capillaries and venules) and analyzes the light detected after having passed through the tissue from detectors at two different distances from the light source.
### Mechanism of Action for Achieving the Intended Effect
There are no changes to the mechanism of action from the previous clearance under K201432. The O3 sensor is noninvasively applied to the patient to collect the patient's physiological signals which are processed by the 03 Module. The processed data which mainly consists of the rSO2 values are then communicated and displayed on the host/backboard device.
### Summary of Technological Characteristics of the subject device compared to the predicate ব device
### Similarities and Differences between Predicate and Subject Device
The subject device, 03 Regional Oximeter, and the predicate device, 03 Regional Oximeter (K201432) have the following key similarities:
- Both devices have the same intended use for regional oxygen tissue saturation ●
- Both devices are indicated for the same patient population ●
- Both devices have the same principle of operation and mechanism of action
- Both devices have the same components (such as 03 Module, 03 Sensors) ●
- Both devices have the same mechanical and environmental specifications ●
- Both device have the same performance specifications for absolute and trending rSO2 on . cerebral sites and trending rSO2 on non-cerebral sites
The subject device, O3 Regional Oximeter, and the predicate device, O3 Regional Oximeter (K201432) have the following key difference:
- . The subject device is provided with an updated indication to include adjunct monitoring of absolute regional hemoglobin oxygen saturation of blood (rSO2) in non-cerebral sites in adults.
To support the substantial equivalence, clinical performance testing was performed to support the non-cerebral absolute accuracy. The results of this clinical testing support the added indication does not raise different questions of safety and effectiveness.
{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, bold font. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.
There are no changes to the principles of operation or the mechanism of action from the predicate device and the update to the indications did not modify the intended use of the subject device from the predicate device.
See Table 2 for the comparison between the subject and predicate device.
{7}------------------------------------------------
Image /page/7/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 logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618".
| Table 2: Comparison between subject and predicate device | | | |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Masimo O3 Regional Oximeter | Masimo O3 Regional Oximeter<br>(K201432) | Comparison to Predicate Device |
| 510(k) Number | Subject Device | Primary Predicate Device | |
| General Information | | | |
| Indications for Use<br>(IFU) | The non-invasive Masimo O3® Regional<br>Oximeter System and accessories are indicated<br>for use as an adjunct monitor of regional<br>hemoglobin oxygen saturation of blood (rSO2)<br>in the tissue under the sensors in patients in<br>healthcare environments. The O3® Regional<br>Oximeter is only to be used with Masimo O3<br>sensors. The use of any other sensor is not<br>supported or recommended by Masimo and<br>could give erroneous results.<br><br>When used with the O3 Adult Sensor, the O3®<br>Regional Oximeter is indicated for measuring<br>absolute and trending regional hemoglobin<br>oxygen saturation of blood (rSO2) in adults ≥<br>40kg.<br><br>When used with the O3 Pediatric Sensor, the<br>O3® Regional Oximeter is indicated for<br>measuring absolute and trending regional<br>hemoglobin oxygen saturation of blood (rSO2)<br>on cerebral sites and trending rSO2 on non-<br>cerebral sites in pediatrics ≥ 5 kg and < 40 kg.<br><br>When used with the O3 Neonatal Sensor, the<br>O3® Regional Oximeter is indicated for<br>measuring only trending regional hemoglobin | The non-invasive Masimo O3® Regional<br>Oximeter System and accessories are indicated<br>for use as an adjunct monitor of regional<br>hemoglobin oxygen saturation of blood (rSO2)<br>in the tissue under the sensors in patients in<br>healthcare environments. The O3® Regional<br>Oximeter is only to be used with Masimo O3<br>sensors. The use of any other sensor is not<br>supported or recommended by Masimo and<br>could give erroneous results.<br><br>When used with the O3 Adult Sensor, the O3®<br>Regional Oximeter is indicated for measuring<br>absolute and trending regional hemoglobin<br>oxygen saturation of blood (rSO2) on cerebral<br>sites and trending rSO2 on non-cerebral sites in<br>adults ≥ 40kg.<br><br>When used with the O3 Pediatric Sensor, the<br>O3® Regional Oximeter is indicated for<br>measuring absolute and trending regional<br>hemoglobin oxygen saturation of blood (rSO2)<br>on cerebral sites and trending rSO2 on non-<br>cerebral sites in pediatrics ≥ 5 kg and < 40 kg.<br><br>When used with the O3 Neonatal Sensor, the<br>O3® Regional Oximeter is indicated for<br>measuring only trending regional hemoglobin | Same. The subject device has an<br>updated indications for use to include<br>adjunct monitoring of absolute<br>regional oxygen saturation for non-<br>cerebral sites on adults. |
| Table 2: Comparison between subject and predicate device | | | |
| | Masimo O3 Regional Oximeter | Masimo O3 Regional Oximeter<br>(K201432) | Comparison to Predicate Device |
| 510(k) Number | Subject Device | Primary Predicate Device | |
| | oxygen saturation of blood (rSO2) on cerebral<br>sites and trending rSO2 on non-cerebral sites in<br>neonates < 10kg. | oxygen saturation of blood (rSO2) on cerebral<br>sites and trending rSO2 on non-cerebral sites in<br>neonates < 10kg. | |
| | The ΔcHb, ΔO2Hb, ΔHHb provided as part of<br>the Masimo O3 are indicated for the monitoring<br>of the relative hemoglobin changes of<br>oxygenated hemoglobin (ΔO2Hb),<br>deoxygenated hemoglobin (ΔHHb), and total<br>hemoglobin (ΔcHb) as measured from the<br>Masimo O3 sensor when applied to the cerebral<br>tissue in adults. | The ΔcHb, ΔO2Hb, ΔHHb provided as part of<br>the Masimo O3 are indicated for the monitoring<br>of the relative hemoglobin changes of<br>oxygenated hemoglobin (ΔO2Hb),<br>deoxygenated hemoglobin (ΔHHb), and total<br>hemoglobin (ΔcHb) as measured from the<br>Masimo O3 sensor when applied to the cerebral<br>tissue in adults. | |
| Classification<br>Regulation/ Product<br>Code | 21 CFR 870.2700/ MUD | 21 CFR 870.2700/ MUD | Same |
| Principle of Operation | Based on multi-distance diffusion spectroscopy.<br>The spectroscopic analysis determines<br>concentrations of hemoglobin in its oxygenated<br>and deoxygenated states monitored at different<br>path lengths to monitor the oxygen saturation in<br>deeper tissue. | Based on multi-distance diffusion spectroscopy.<br>The spectroscopic analysis determines<br>concentrations of hemoglobin in its oxygenated<br>and deoxygenated states monitored at different<br>path lengths to monitor the oxygen saturation in<br>deeper tissue. | Same |
| Patient Population | Adult, pediatric, and neonate | Adult, pediatric, and neonate | Same |
| Anatomical Site | Cerebral (forehead) and non-cerebral (body) | Cerebral (forehead) and non-cerebral (body) | Same |
| Type of use (sensor) | Single patient use | Single patient use | Same |
| Sterility | Supplied non-sterile | Supplied non-sterile | Same |
| Performance (ARMS) | | | |
| rSO2 cerebral and non-<br>cerebral Trending | 3% for SavO2 of 45%-85% | 3% for SavO2 of 45%-85% | Same |
| Table 2: Comparison between subject and predicate device | | | |
| | Masimo O3 Regional Oximeter | Masimo O3 Regional Oximeter<br>(K201432) | Comparison to Predicate Device |
| 510(k) Number<br>(Adult, Pediatric, and<br>Neonate) | Subject Device | Primary Predicate Device | |
| rSO2 cerebral Absolute<br>(Adult) | 4% for SavO2 of 45%-85% | 4% for SavO2 of 45%-85% | Same |
| rSO2 cerebral Absolute<br>(Pediatric) | 5% for SavO2 of 45%-85%…
