(159 days)
The Oxitone Model 1000 Pulse Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate.
It is intended for spot-checking of adult patients with wrist between 13-22 cm circumferences in hospitals, clinics, long-term care, and home use.
The Oxitone 1000 pulse oximeter is an instrument for photoelectrically determining the oxygenation of blood in a part of the body, in this case the wrist.
This Oxitone 1000 contains the electronics, interface and sensor. The Oxitone pulse oximeter is mounted on a watch-like device and measures oxygen saturation at the wrist location. The Oxitone pulse oximeter exploits a reflectance sensor that includes the photodetector located at the wearer's Ulnar Bone near the Ulnar Bulge and a bi-color light source (LED's) that are located around the top of the wearer's Ulnar "Bulge", to align the light source properly to the Ulnar Bulge the LEDs surrounded by elastic concave shape surface. The Red and infrared light being transmitted through the tissue is partially absorbed by the blood oxyhemoglobin and is sensed by the photodetector. The blood oxygen saturation is measured using the well-established technology where the red and infrared light is absorbed in different amounts depending on the oxygenation of the blood that enables to calculate the blood functional pulse oximetry.
The Oxitone 1000 has the ability to determine both the percent of saturated hemoglobin and the pulse rate. It performs these functions on adult patient populations. It is designed for spot checking both the SpO2 and Pulse rate information. To perform this, the Oxitone 1000 displays digital values for both the SpO2 and Pulse.
Pulse amplitude is not displayed. The Oxitone 1000 is powered by an integral rechargeable Lithium Ion battery pack. The wavelength of red LED is 640nm and Infrared LED is 940 nm with maximum optical output power of less than 1 mW.
The device incorporates a battery state indicator and provides a visual indication of low battery.
Here's a breakdown of the acceptance criteria and study information for the Oxitone 1000, based on the provided document:
Acceptance Criteria and Reported Device Performance
Note: The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to standards rather than directly listing acceptance criteria with detailed outcome metrics for each. The key performance metric explicitly stated is SpO2 accuracy.
| Acceptance Criteria Category | Specific Criteria (Expected / Standard) | Reported Device Performance (Oxitone 1000) |
|---|---|---|
| SpO2 Accuracy Range | 70% to 100% | 70% to 100% ± 3% |
| Pulse Rate Accuracy Range | 30-250 BPM | 30-250 ± 3 |
| Intended Use | Measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate for spot-checking. | Meets this indication. |
| Patient Population | Adult patients. | Confirmed for adult patients. |
| Wrist Circumference | Between 13-22 cm. | Confirmed for wrist between 13-22 cm circumferences. |
| Environment of Use | Hospitals, clinics, long-term care, and home use. | Meets this environment of use (narrower than predicate by excluding some specific facilities, but considered substantially equivalent). |
| Motion | Non-motion. | Confirmed for non-motion. |
| Technology / Design | Reflectance sensor technology for SpO2 and pulse rate calculation; uses PPG signals of red and infrared light. | Uses reflectance sensor with LEDs and photodetector positioned at the ulnar bone/bulge. Calculates SpO2 and pulse using PPG signals of red and infrared light. |
| Compliance with Standards | AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-61, IEC 62471, IEC 62133 | Complies with all listed standards. |
| Biocompatibility | ISO 10993-1 and FDA Guidance for Cytotoxicity, Sensitization, and Irritation. | Tests performed and met requirements. |
Study Details
The document refers to clinical testing to ensure the clinical accuracy of the device.
-
Sample size used for the test set and the data provenance:
- Sample Size: 10 patients.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as "clinical testing... performed on 10 patients," suggesting a prospective study, likely conducted for this submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document states "Testing to insure clinical accuracy of the device in accordance with ISO 80601-2-61 was performed." ISO 80601-2-61 outlines methods for evaluating the accuracy of pulse oximeters, which typically involves comparing the device's readings to arterial blood gas measurements (co-oximetry) as the gold standard. It doesn't usually involve physician interpretation as ground truth.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. For pulse oximetry accuracy testing according to ISO standards, the "ground truth" is typically established by laboratory co-oximetry measurements, which are objective and do not require expert adjudication in the same way image-based diagnoses might.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools where human interpretation is involved. The Oxitone 1000 is a direct measurement device (pulse oximeter), not an AI-assisted diagnostic.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance evaluation conducted (clinical accuracy testing, bench testing) represents the standalone performance of the Oxitone 1000 device algorithm in measuring SpO2 and pulse rate. There is no human-in-the-loop aspect for the core measurement functions.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical accuracy testing, the ground truth would typically be established by arterial blood gas measurements (specifically co-oximetry), which is an objective laboratory gold standard for oxygen saturation. This is implied by the reference to ISO 80601-2-61.
-
The sample size for the training set:
- Not applicable/Not specified. The Oxitone 1000 is described as using "well-established technology" and "Photoplethysmography (PPG) signals." While algorithms are used to process these signals, the document does not suggest a machine learning model that would require a distinct "training set" in the modern AI sense. It's a measurement device based on established physiological principles and signal processing.
-
How the ground truth for the training set was established:
- Not applicable, as there's no mention of a "training set" for a machine learning model in the context of this device's approval. The device's calibration and performance would be based on physiological models and established oximetry principles.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 9, 2017
Oxitone Medical Ltd. % Paul Dryden Consultant Promedic, LLC 24301 Woodsage Dr. Bonita Springs, Florida 34134
Re: K163382
Trade/Device Name: Oxitone 1000 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: March 28, 2017 Received: March 29, 2017
Dear Paul Dryden:
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. 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.
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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Oxitone 1000
Indications for Use (Describe)
The Oxitone Model 1000 Pulse Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate.
It is intended for spot-checking of adult patients with wrist between 13-22 cm circumferences in hospitals, clinics, long-term care, and home use.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
|Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary May 8, 2017 Page 1 of 6
| Official Contact: | Leon Eisen, PhD Founder and CEOOxitone Medical Ltd.17 Atir Yeda StreetKfar Saba, Israel 4464312Tel: +972 (9) 834 6731 |
|---|---|
| Proprietary or Trade Name: | Oxitone 1000 |
| Common/Usual Name: | Oximeter |
| Classification Name: | OximeterDQA, Class II, CFR 870.2700 |
| Predicate Device:Reference Device: | Nonin Model 9590 - K112843Nonin 8000R Forehead sensor - K050056 |
Device Description:
The Oxitone 1000 pulse oximeter is an instrument for photoelectrically determining the oxygenation of blood in a part of the body, in this case the wrist.
This Oxitone 1000 contains the electronics, interface and sensor. The Oxitone pulse oximeter is mounted on a watch-like device and measures oxygen saturation at the wrist location. The Oxitone pulse oximeter exploits a reflectance sensor that includes the photodetector located at the wearer's Ulnar Bone near the Ulnar Bulge and a bi-color light source (LED's) that are located around the top of the wearer's Ulnar "Bulge", to align the light source properly to the Ulnar Bulge the LEDs surrounded by elastic concave shape surface. The Red and infrared light being transmitted through the tissue is partially absorbed by the blood oxyhemoglobin and is sensed by the photodetector. The blood oxygen saturation is measured using the well-established technology where the red and infrared light is absorbed in different amounts depending on the oxygenation of the blood that enables to calculate the blood functional pulse oximetry.
The Oxitone 1000 has the ability to determine both the percent of saturated hemoglobin and the pulse rate. It performs these functions on adult patient populations. It is designed for spot checking both the SpO2 and Pulse rate information. To perform this, the Oxitone 1000 displays digital values for both the SpO2 and Pulse.
Pulse amplitude is not displayed. The Oxitone 1000 is powered by an integral rechargeable Lithium Ion battery pack. The wavelength of red LED is 640nm and Infrared LED is 940 nm with maximum optical output power of less than 1 mW.
The device incorporates a battery state indicator and provides a visual indication of low battery.
Indications for Use:
The Oxitone Model 1000 Pulse Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate.
It is intended for spot-checking of adult patients with wrist between 13-22 cm circumferences in hospitals, clinics, long-term care, and home use.
Contraindications:
None
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Substantial Equivalence Discussion
The Oxitone 1000 Pulse Oximeter is similar to other small worn SpO2 monitors. There are pulse oximeters that use sensors that measure SpO2 at the extremities - fingers, toes, ear lobes, etc. They also have sensors which are placed on the forehead using reflectance technology for measuring SpO2
We have selected 2 devices for comparative purposes for demonstrating substantial equivalence. Table 1 outlines the rationale.
| Feature | Primary Predicate | Reference | Subject device |
|---|---|---|---|
| NoninModel 9590(K112843) | Nonin PalmSAT withPurelightForehead 8000R sensor(K050056) | Oxitone 1000 | |
| Classification | DQACFR 870.2700Pulse oximeter | DQACFR 870.2700Pulse oximeter | DQACFR 870.2700Pulse oximeter |
| Intended Use | Measure functional oxygensaturation of arterialhemoglobin (%SpO2) andpulse rate | Measure functional oxygensaturation of arterialhemoglobin (%SpO2) andpulse rate | Measure functional oxygensaturation of arterialhemoglobin (%SpO2) andpulse rate |
| For spot-checking | For spot-checking | For spot-checking | |
| Patients | AdultPediatrics | AdultPediatrics | Adult |
| Sensor location | Digits | DigitsForehead | Wrist |
Table 1 – Predicate and Reference Devices
The rationale for the selected devices is that the predicate has the indications for use and the reference shows that SpO2 measurements can be measure in other anatomical locations other than digits.
We demonstrate device pereformance by testing the subject device according to ISO 80601-2-61 and the FDA's Guidance for Pulse Oximeters (March 4, 2013).
Table of Comparison and Differences
The Oxitone 1000 Pulse Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate.
It is intended for spot-checking of adult patients with wrist between 13-22 cm circumferences in hospitals, clinics, long-term care and home use.
The monitor features an easy-to-read display that presents patient data, status information, and alarms when appropriate.
The Oxitone 1000 permits spot checking of functional oxygen saturation (SpO2) and Pulse Rate (PR) in clinical and non-clinical settings.
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510(k) Summary May 8, 2017 Page 3 of 6
The software monitors the signals, computes the PR and SpO2 values and displays the PR and SpO2 values.
Table 2 outlines the features of the Oxitone 1000 and compares it to the predicate and reference devices to establish substantial equivalence.
| Table 2 Device Comparison | |||||
|---|---|---|---|---|---|
| --------------------------- | -- | -- | -- | -- | -- |
| CHARACTERISTICS | Oxitone 1000 | PredicateNoninModel 9590 (K112843) | ReferenceNonin PalmSAT withForehead 8000R sensor(K050056) |
|---|---|---|---|
| Indications for Use | The Oxitone Model 1000Pulse Oximeter is a small,wrist-worn device indicatedfor use in measuring anddisplaying functionaloxygen saturation of arterialhemoglobin (% SpO2) andpulse rate.It is intended for spot-checking of adult patientswith wrist between 13-22cm circumferences inhospitals, clinics, long-termcare, and home use. | The Nonin Onyx Vantage 9590Finger Pulse Oximeter is a small,lightweight, portable device indicatedfor use in measuring and displayingfunctional oxygen saturation ofarterial hemoglobin (%Sp02) andpulse rate of patients who are well orpoorly perfused. It is intended forspot-checking of adult and pediatricpatients on digits, including thethumb and toes, that are between 0.3-1.0 inch (0.8 - 2.5 cm) thick. Thedevice's intended use environmentsinclude hospitals, clinics, long-termcare facilities, skilled nursingfacilities, emergency medicalservices, and home healthcareservices. | Indicated fornon-invasive spot-checkingand/or continuousmonitoring |
| Type of use | Spot checking | Spot-checking | Spot checkingContinuous use |
| Motion | Non-motion | Not specified | Non-motionMotion |
| Patient Population | Adults | AdultPediatric | AdultPediatric |
| Perfusion | Well | WellPoorly | WellPoorly |
| Environment of Use | Hospitals, clinics, long-termcare and home use | Hospitals, clinics, long-term carefacilities, skilled nursing facilities,emergency medical services, andhome healthcare services | Hospitals, long-termcare and home use |
| Technology | Reflectance | Transmissive | TransmissiveReflectance |
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510(k) Summary May 8, 2017 Page 4 of 6
| CHARACTERISTICS | Oxitone 1000 | PredicateNoninModel 9590 (K112843) | ReferenceNonin PalmSAT withForehead 8000R sensor(K050056) |
|---|---|---|---|
| System components / Configurations | |||
| Batteries | Rechargeable Li-On | 2 x 1.5 AAA batteries | BatteriesSensor has no power |
| SpO2 Display Range | 0% to 100% SpO2 | 0% to 100% SpO2 | The referenced sensor canbe placed on the forehead |
| Pulse rate declaredaccuracy range | 30-250 BPM | 20-250 BPM | |
| Accuracy | Determined by monitor | ||
| SpO2 Accuracy Range | 70% to 100% $\pm$ 3% | 70% to 100% $\pm$ 3% | |
| Pulse rate | 30-250 $\pm$ 3 | 20-250 $\pm$ 2 | |
| Display | |||
| LCD | Multi-pixel 3 digits | Multi-pixel 3 digits | |
| Pulse strength indicator | No pulse strength indicator.LCD, readings or dashesgive pulse quality indication | Tricolor LED gives indication ofquality | |
| Application site | Wrist | Digits | DigitsForehead |
| Data output | Front panel easy-to-readdisplay (LCD) | Front panel and USB | Monitor dependent |
| Operation mode | Spot checking | Spot checking | Spot checkingContinuous |
| LED wavelengths(multiple) | 640-940 nm | 660 and 910 nm | 660-910 nm |
| Radiant Power | Red 1.05 mW IR 0.95 mW | Red 0.8 mW IR 1.2 mW | Determined by monitor |
| Type of protection | Internally powered | Internally powered | Class II |
| Degree of protection -sensor | Type BF - applied part | Type BF - applied part | Type BF - applied part |
| Functional and safetytesting | ES 60601-1, IEC 60601-1-11, ISO 80601-2-61 | IEC 60601-1, IEC 60601-1-11,, ISO9919 | IEC ISO 9919 |
| Biocompatibility | Surface contactSkinLimited duration (<24 hrs) | Surface contactSkinLimited duration (<24 hrs) | Surface contactSkinLimited duration (<24 hrs) |
Substantial Equivalence Discussion and Rationale
In Table 2 we have compared the Oxitone 1000 to the predicate and reference devices for equivalence of:
Indications - The Oxitone Model 1000 Pulse Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate. It is intended for spot-checking of adult patients with wrist between 13-22 cm circumferences in hospitals, clinics, long-term care, and home use.
Discussion - The indications are similar to the predicate Nonin 9590 except the Nonin includes poor perfusion and pediatrics. The reference Nonin PalmSAT monitor, K050056, includes neonates but the use of the reference is for the Forehead sensor to demonstrate that other sensor location sites have been cleared.
Patient Population – Though the predicate Nonin 9590 is indicated for pediatrics. The Oxitone 1000 and predicate are both indicated for adults.
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510(k) Summary May 8, 2017 Page 5 of 6
Environment of Use – The environment of use for the subject device is narrower than the predicate and reference, but can still be considered substantially equivalent.
Prescriptive – The Oxitone 1000 and Nonin 9590 predicate and reference Nonin PalmSAT with forehead sensor are prescriptive.
Design and Technology – The Oxitone 1000 and Nonin 9590 have equivalent technological and design features. They both calculate SpO2 and pulse by use of the same technology - the ratio of red and infrared signals of light propagated through the tissue between light sources and detector. Both devices use Photoplethysmography (PPG) signals of red and infrared light through tissue to calculate SpO2 and pulse rate
The Oxitone 1000 and Nonin 9590 differ in sensor placement, the Oxitone 1000 being placed on the wrist and the Nonin 9590 on a finger. This placement is similar to the reference device Nonin Purelight Forehead 8000R in that they are both based on reflected light (red and IR).
Oxitone's reflectance optical sensor so that the optical elements (LEDs and detector) are placed at the same side of the wrist thereby having the same optical path features are similar to the reflectance used for the forehead sensors.
Performance Specifications - The Oxitone 1000 and Nonin 9590 predicate have equivalent specifications. The reference sensor does not have listed specifications, its performance is based upon the monitor to which it is attached.
Compliance with standards The Oxitone 1000 complies with AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO-80601-2-61, IEC 62471, and IEC 62133. The predicate complies with IEC 60601-1-2 and ISO 9919. The Oxitone 1000 complies with all applicable currently recognized standards.
Performance Testing
Non-clinical
Bench - We have performed bench tests and found that the Oxitone 1000 met all requirements specifications and standards requirements and was found to be equivalent in comparison to the predicate. Testing includes the following:
- . Verification Testing
- AAMI ES 60601-1 ●
- IEC 60601-1-2,
- IEC 60601-1-11
- . IEC 80601-2-61
The results demonstrate that the devices perform as intended are substantially equivalent to the performance of the predicate and in accordance with applicable standards.
Biocompatibility - The patient contacting materials of the Oxitone 1000 have been tested in accordance with ISO 10993-1 and FDA Guidance. The tests included Cytotoxicity, Sensitization, and Irritation, which is similar to the predicate and reference devices.
Clinical Testing - Testing to insure clinical accuracy of the device in accordance with ISO 80601-2-61 was performed. This testing was performed on 10 patients with results showing compliance to the standard.
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510(k) Summary May 8, 2017 Page 6 of 6
Differences –
The identified difference:
- Narrower environment of use .
- . Narrower patient population - adults only
- Narrower indications non-motion only .
- Detection on the wrist vs. digits of forehead .
Have been evaluated and tested and confirm that these differences do not raise different questions of safety or effectiveness when compared to the predicate and reference devices for the proposed indications for use.
Substantial Equivalence Conclusion
The Oxitone 1000 is substantially equivalent to the predicate in: indications for use, patient population, environment of use, technology characteristics, materials, specifications / performance and compliance with international standards. The differences do not raise different questions of safety or effectiveness when compared to the predicate and reference devices for the proposed indications for use.
§ 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).