(130 days)
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 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), and total hemoglobin (ΔcHb) as measured from the Masimo O3 sensor when applied to the cerebral tissue in adults.
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.
- 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 document describes the Masimo O3 Regional Oximeter System and its update to include adjunct monitoring of absolute rSO2 in non-cerebral sites, specifically for adults. The performance data presented focuses on the accuracy (ARMS) of the Oximeter.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document provides the acceptance criteria in terms of accuracy (ARMS) specifications for different measurements and patient populations. It implicitly states that the clinical study data supports these specifications.
| Measurement / Patient Population | Acceptance Criteria (ARMS) | Reported Device Performance (Implied) |
|---|---|---|
| Cerebral Hemoglobin Oxygen Saturation of Blood (rSO2) | ||
| rSO2 (trending) (from 45% to 85% SavO2) - Adult, Pediatric, Neonate | 3% | Met (study supported performance) |
| rSO2 (absolute) (from 45% to 85% SavO2) - Adult | 4% | Met (study supported performance) |
| rSO2 (absolute) (from 45% to 85% SavO2) - Pediatric | 5% | Met (study supported performance) |
| Non-Cerebral Hemoglobin Oxygen Saturation of Blood (rSO2) | ||
| rSO2 (trending) (from 45% to 85% SavO2) - Adult, Pediatric, Neonate | 3% | Met (study supported performance) |
| rSO2 (absolute) (from 60% to 90% SavO2) - Adult | 5% | Met (clinical study supported this) |
2. Sample size used for the test set and the data provenance
- Sample Size for the Test Set: 25 subjects.
- Data Provenance: The document does not explicitly state the country of origin. It indicates the study was conducted clinically with "a controlled desaturation protocol," which implies a prospective study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states that the rSO2 readings were compared against "tissue oxygen saturation (SvO2) computed using a combination of arterial and venous blood samples." This indicates that the ground truth was established through direct physiological measurement rather than expert interpretation of images or other data. Therefore, the concept of "experts" to establish ground truth in the traditional sense of, e.g., radiologists interpreting images, does not directly apply here.
4. Adjudication method for the test set
Not applicable. The ground truth was established through physiological measurements (arterial and venous blood samples), not through human adjudication of interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an oximeter, a physiological monitoring device, not an AI-powered diagnostic imaging tool that would typically involve human readers. The study focuses on the device's accuracy in measuring rSO2.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the clinical testing described in the document is a standalone performance study. The Masimo O3 Regional Oximeter's rSO2 readings were recorded and directly compared to the physiological ground truth (SvO2 computed from blood samples). There is no mention of a human-in-the-loop component in evaluating the device's accuracy.
7. The type of ground truth used
The ground truth used was outcomes data directly related to physiological measurement: tissue oxygen saturation (SvO2) computed using a combination of arterial and venous blood samples.
8. The sample size for the training set
The document does not specify a separate "training set" or its size. This type of device relies on established biophysics and calibration rather than a machine learning model that requires a distinct training phase with annotated data. The clinical study described served as a validation (test) set for the device's performance against a gold standard.
9. How the ground truth for the training set was established
As no distinct training set for a machine learning model is described, this question is not applicable. The device's underlying principle relies on multi-distance diffusion spectroscopy, which is a physical measurement technique. Calibration and validation would have been performed during the device's development using known physiological states. The clinical study served as the final validation of its performance in a clinical setting against a direct physiological measure.
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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
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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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 ofManufacturing Facility: | Masimo Corporation52 DiscoveryIrvine, CA 92618Phone: (949) 297-7000FAX: (949) 297-7592 |
|---|---|
| Date: | May 6, 2022 |
| Contact: | Kertana ShankarRegulatory Specialist IIMasimo CorporationPhone: (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 RegistrationNumber: | 3011353843 |
| Reason for PremarketNotification: | Updated indications to include adjunct monitoring of absolute rSO2 innon-cerebral sites |
| Primary Predicate: | K201432 - Masimo O3 Regional Oximeter System |
| Performance Standards | There are no performance standards pursuant to Section 514 of theFood, 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 < 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),
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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.
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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.
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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(K201432) | Comparison to Predicate Device | |
| 510(k) Number | Subject Device | Primary Predicate Device | |
| General Information | |||
| Indications for Use(IFU) | The non-invasive Masimo O3® RegionalOximeter System and accessories are indicatedfor use as an adjunct monitor of regionalhemoglobin oxygen saturation of blood (rSO2)in the tissue under the sensors in patients inhealthcare environments. The O3® RegionalOximeter is only to be used with Masimo O3sensors. The use of any other sensor is notsupported or recommended by Masimo andcould give erroneous results.When used with the O3 Adult Sensor, the O3®Regional Oximeter is indicated for measuringabsolute and trending regional hemoglobinoxygen saturation of blood (rSO2) in adults ≥40kg.When used with the O3 Pediatric Sensor, theO3® Regional Oximeter is indicated formeasuring absolute and trending regionalhemoglobin 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, theO3® Regional Oximeter is indicated formeasuring only trending regional hemoglobin | The non-invasive Masimo O3® RegionalOximeter System and accessories are indicatedfor use as an adjunct monitor of regionalhemoglobin oxygen saturation of blood (rSO2)in the tissue under the sensors in patients inhealthcare environments. The O3® RegionalOximeter is only to be used with Masimo O3sensors. The use of any other sensor is notsupported or recommended by Masimo andcould give erroneous results.When used with the O3 Adult Sensor, the O3®Regional Oximeter is indicated for measuringabsolute and trending regional hemoglobinoxygen saturation of blood (rSO2) on cerebralsites and trending rSO2 on non-cerebral sites inadults ≥ 40kg.When used with the O3 Pediatric Sensor, theO3® Regional Oximeter is indicated formeasuring absolute and trending regionalhemoglobin 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, theO3® Regional Oximeter is indicated formeasuring only trending regional hemoglobin | Same. The subject device has anupdated indications for use to includeadjunct monitoring of absoluteregional oxygen saturation for non-cerebral sites on adults. |
| Table 2: Comparison between subject and predicate device | |||
| Masimo O3 Regional Oximeter | Masimo O3 Regional Oximeter(K201432) | Comparison to Predicate Device | |
| 510(k) Number | Subject Device | Primary Predicate Device | |
| oxygen saturation of blood (rSO2) on cerebralsites and trending rSO2 on non-cerebral sites inneonates < 10kg. | oxygen saturation of blood (rSO2) on cerebralsites and trending rSO2 on non-cerebral sites inneonates < 10kg. | ||
| The ΔcHb, ΔO2Hb, ΔHHb provided as part ofthe Masimo O3 are indicated for the monitoringof the relative hemoglobin changes ofoxygenated hemoglobin (ΔO2Hb),deoxygenated hemoglobin (ΔHHb), and totalhemoglobin (ΔcHb) as measured from theMasimo O3 sensor when applied to the cerebraltissue in adults. | The ΔcHb, ΔO2Hb, ΔHHb provided as part ofthe Masimo O3 are indicated for the monitoringof the relative hemoglobin changes ofoxygenated hemoglobin (ΔO2Hb),deoxygenated hemoglobin (ΔHHb), and totalhemoglobin (ΔcHb) as measured from theMasimo O3 sensor when applied to the cerebraltissue in adults. | ||
| ClassificationRegulation/ ProductCode | 21 CFR 870.2700/ MUD | 21 CFR 870.2700/ MUD | Same |
| Principle of Operation | Based on multi-distance diffusion spectroscopy.The spectroscopic analysis determinesconcentrations of hemoglobin in its oxygenatedand deoxygenated states monitored at differentpath lengths to monitor the oxygen saturation indeeper tissue. | Based on multi-distance diffusion spectroscopy.The spectroscopic analysis determinesconcentrations of hemoglobin in its oxygenatedand deoxygenated states monitored at differentpath lengths to monitor the oxygen saturation indeeper 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-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(K201432) | Comparison to Predicate Device | |
| 510(k) Number(Adult, Pediatric, andNeonate) | Subject Device | Primary Predicate Device | |
| rSO2 cerebral Absolute(Adult) | 4% for SavO2 of 45%-85% | 4% for SavO2 of 45%-85% | Same |
| rSO2 cerebral Absolute(Pediatric) | 5% for SavO2 of 45%-85% | 5% for SavO2 of 45%-85% | Same |
| rSO2 non-cerebralAbsolute (Adult) | 5% for SavO2 of 60%-90% | -- | The subject device is provided with anupdated indication to support theadjunct monitoring of absolute rSO2in non-cerebral sites. The substantialequivalence of the subject device tothe predicate device is supportedthrough clinical testing to support thedifference does not raise differentquestions of safety and effectiveness. |
| Electrical | |||
| Power Source | Host device | Host device | Same |
| Electrical Safety | Conformed to IEC 60601-1 | Conformed to IEC 60601-1 | Same |
| Electromagneticcompatibility | Conformed to IEC 60601-1-2 | Conformed to IEC 60601-1-2 | Same |
| Environmental | |||
| Operating Temperature(03 Module) | 32°F to 104°F (0°C to 40°C) | 32°F to 104°F (0°C to 40°C) | Same |
| Operating Temperature(03 Sensor) | 41°F to 104°F (5°C to 40°C) | 41°F to 104°F (5°C to 40°C) | Same |
| Mode of Operation per IEC 60601-1 | |||
| Mode of Operation | Continuous | Continuous | Same |
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ਟ Performance Data
Biocompatibility Testing
As there are no changes to the patient contacting materials as part of this submission from the previous clearance, no biocompatibility testing was included as part of this submission.
Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning
As there were no changes to the hardware or software as part of this submission from the previous clearance, no additional Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning testing was included with this submission.
Software Verification and Validation Testing
Masimo has established, implemented, and maintains procedures for software design, development, review, verification, and validation of its products in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).
As there are no software changes as part of this submission from the previous clearance, no additional software testing was included as part of this submission.
Wireless and Cybersecurity Testing
As the Masimo O3 System uses wired communication for the transfer of parameter data and alarm status, and does not have wireless features at this time, no wireless testing was included as part of this submission.
Human Factors and Usability Testing
There were no changes made to the usability of the O3 Regional Oximeter as part of this submission from the previous clearance (K201432). The O3 Sensor is still applied using the same application method. As there was no significant change to the critical user related steps from the predicate device, the testing provided under the previous clearance K201432 was determined to support the acceptability of the Human factors/ Usability risks. As such, the Human factors/ Usability risk of the subject device was still found to be acceptable
Non-clinical Testing
As there were no hardware, software or non-clinical performance changes made to the subject device when compared to the predicate device (K201432), no additional non-clinical testing was considered necessary to support the substantial equivalence.
Clinical Testing
To support the performance of the subject device in monitoring of absolute rSO2 in non-cerebral sites, clinical testing was provided with this submission. The study was conducted on 25 subjects, whose oxygen saturations were decreased using a controlled desaturation protocol. The Masimo O3 regional
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oximeter rSO2 readings on somatic tissue were recorded and compared against the tissue oxygen saturation (SvO2) computed using a combination of arterial and venous blood samples.
The results of the clinical study supported the absolute rSO2 performance on non-cerebral sites.
6 Conclusion
The data provided as part of this submission was found to support the Masimo O3 Regional Oximeter is substantially equivalent to the predicate device.
§ 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).