(128 days)
Not Found
No
The device description details standard optical measurement and signal processing techniques, and there is no mention of AI, ML, or related concepts in the document.
No.
The device is described as an "adjunct trend monitor" that should "not be used as the sole basis for diagnosis or therapy." This indicates it is a diagnostic or monitoring device, not one that directly provides therapy.
No
The "Intended Use / Indications for Use" explicitly states: "The VO200 - NeurOs Cerebral Oximetry should not be used as the sole basis for diagnosis or therapy." This indicates it is a monitor providing trend data, not a standalone diagnostic device.
No
The device description explicitly states that the system consists of a reusable sensor, a single use disposable adhesive, and display software. The sensor is a hardware component containing LEDs, photo detectors, and other electronic parts.
Based on the provided information, the VO200 - NeurOs Cerebral Oximetry 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 obtain information for diagnostic or monitoring purposes.
- VO200 - NeurOs Function: The VO200 - NeurOs Cerebral Oximetry device measures regional hemoglobin oxygen saturation in the brain tissue beneath the sensor. It does this non-invasively using optical principles applied directly to the body.
- No Specimen Collection/Examination: The device does not collect or examine specimens taken from the body. It interacts directly with the tissue.
Therefore, while it provides diagnostic information, it does so through an in-vivo measurement rather than an in-vitro examination of a specimen.
N/A
Intended Use / Indications for Use
The VO200 - NeurOs Cerebral Oximetry is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain tissue beneath the sensor. The prospective clinical value of data from the VO200 - NeurOs Cerebral Oximetry has not been demonstrated in disease states. The VO200 - NeurOs Cerebral Oximetry should not be used as the sole basis for diagnosis or therapy.
Product codes (comma separated list FDA assigned to the subject device)
QEM
Device Description
The Mesepre VO 200 - NeurOs Cerebral Oximetry System is based on the same optical operating principles of multi-distance diffuse reflectance spectroscopy as the predicate device. It measures oxygenated and de-oxygenated hemoglobin content underneath the sensor probe and allows clinicians to monitor the blood oxygenation level of cerebral tissue.
The VO 200 - NeurOs Cerebral Oximetry System consists of a reusable sensor, a single use disposable adhesive, and a display software. The sensor uses two wavelengths within the range from 660nm to 905nm to measure light absorption of tissue, with one wavelength is more sensitive to deoxygenated hemoglobin, the other is more sensitive to oxygenated hemoglobin. Regional cerebral tissue oxygen saturation is calculated through the ratio of tissue absorption to the two wavelengths and validated aqainst blood sample testing through the blood gas analyzer. Sensors are sized to provide desired depth and area coverage for the measurement.
The sensor consists of LEDs, photo detectors, pre-amplifier, analogue to digital convertor, and a CUP for controlling the light emission and detection sequence, auto power adjustment for LED, gain adjustment for photo detectors to ensure optimized signal to noise ratio, and data processing and calculations. It also has an isolator between the monitor and the sensor to ensure the electric safety of the sensor. The enclosure of the sensor is made of medical grade ABS.
The single use sensor adhesive is made of a soft foam with medical grade adhesives.
The Mespere Display Software can be loaded to a tablet, laptop, or stationary PC. The sensor is then connected through a standard USB connector. It displays the measurement through the computer user interface at a refresh rate of approximately one second. Screenshots of the measurement can be saved to a user specified file and can be exported through USB ports or the internet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
near infrared
Anatomical Site
brain tissue, Cerebral
Indicated Patient Age Range
adult patients.
Intended User / Care Setting
Hospital, clinic and other health care facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The primary objective of this study was to validate the accuracy of the Mespere VO200 – NeurOs Cerebral Oximetry system for measuring the regional cerebral tissue blood oxygenation saturation (StO2), by comparing it to invasive blood samples drawn from the jugular bulb and radial artery, and compared by a co-oximeter. The subjects recruited for this study were healthy volunteers.
Methods: With IRB approval and written Informed Consent Forms, healthy volunteers were recruited. An ultrasound-quided small diameter internal jugular vein catheter was inserted and placed at the position of the subject's superior jugular bulb. A radial arterial line was inserted into a radial artery on the left arm. Two standard pulse oximeters were attached to the patient's fingers to help guide the hypoxia state plateau levels. The VO200 -NeurOs Cerebral Oximetry sensor was placed on the forehead. Blood gas analysis to determine oxyhemoglobin saturation was performed using a Co-Oximeter. Each subject had control data taken at the beginning of each experiment, with two control blood samples drawn while breathing room air. Hypoxia was induced to different levels of oxyhemoglobin saturation (between 70-100% SpO2) by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide. Once a steady state level of hypoxia is achieved, a 1.0ml sample of blood are obtained simultaneously from the jugular line and radial arterial line. A second blood pair of samples, at the same steady-state saturation, is taken 30 seconds later. The VO200 - NeurOs Cerebral Oximetry samples were recorded simultaneously to the blood samples. The blood samples were immediately analyzed by the Co-Oximeter. Up to 27 paired samples were obtained on the plateaus across this span for each subject.
Primary Clinical Site: University of San Francisco California (UCSF) Hypoxia Labs 513 Parnassus Ave., San Francisco, CA, 94143-0542.
Subjects/data points: The subjects recruited for this study consisted of healthy, non-smoking individuals of age 21-49 years' old who underwent hypoxia testing at the University of California at San Francisco (UCSF) located in San Francisco, California. No subjects was anemic (Hemoglobin ≤ gm·dl-1). Twelve (12) healthy subjects were recruited for the study. A total of 284 paired venous and arterial blood sample readings, and 284 VO200 - NeurOs Cerebral Oximetry system readings were used to perform the comparison and statistical analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Tests: Clinical tests were performed to verify and validate the clinical performance of the VO200 -NeurOs Cerebral Oximetry system and support the determination of substantial equivalence. The following clinical data was submitted: Clinical Validation: The primary objective of this study was to validate the accuracy of the Mespere VO200 – NeurOs Cerebral Oximetry system for measuring the regional cerebral tissue blood oxygenation saturation (StO2), by comparing it to invasive blood samples drawn from the jugular bulb and radial artery, and compared by a co-oximeter. The subjects recruited for this study were healthy volunteers.
Results: The results showed the absolute accuracy of ± 4.9% and trending accuracy of ±1.5% (in range of 40%-80%), which is equivalent or better than the reported absolute accuracy of 5.0% and trending accuracy of ± 4.0 % of the predicate device. No adverse events were reported.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
StO2 Measurement Range: 0 - 100%
StO2 Validated Measurement Range: 40 - 80%
Trending Accuracy of StO2 (40%-80%): ± 1.5%
Absolute Accuracy of StO2 (40%-80%): ± 4.9%
Resolution of StO2: 1%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
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December 26, 2018
Mespere LifeSciences Inc. Rebecca Li Manager of Quality Assurance and Regulatory Affairs 180 Frobisher Drive, Suite 1C Waterloo, N2V 2A2 Ca
Re: K182242
Trade/Device Name: VO200 - NeurOs Cerebral Oximetry System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: QEM Dated: August 10, 2018 Received: August 20, 2018
Dear Rebecca Li:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause =S -S -S -S -S -S -S -S -S -S -S -S -S -S -S -S -S -S -05' -05' -05' -05' -05' -05' -05' -05' -05' -05' -05' -05' 00'
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182242
Device Name
VO200 - NeurOs Cerebral Oximetry System
Indications for Use (Describe)
The VO200 - NeurOs Cerebral Oximetry is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain tissue beneath the sensor. The prospective clinical value of data from the VO200 - NeurOs Cerebral Oximetry has not been demonstrated in disease states. The VO200 - NeurOs Cerebral Oximetry should not be used as the sole basis for diagnosis or therapy.
| 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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3
Appendix 5-1
Image /page/3/Picture/1 description: The image shows the logo for "Mespere Life Sciences". The logo features a large, stylized "M" in gray, with the rest of the company name spelled out in a similar font. Below "Mespere", the words "LIFE SCIENCES" are written in a smaller, blue font. To the left of the "M", there is a vertical blue bar.
180 Frobisher Drive, Suite 1C
Waterloo, ON,
T: 519-884-7575
F: 519-884-8810
510(k) SUMMARY
| Submitted by: | Mespere LifeSciences Inc.
180 Frobisher Drive, Suite 1C
Waterloo, Ontario, Canada
N2V 2A2
Phone: 519-884-7575
Fax: 519-884-8810 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Rebecca S. Li, Manager of Quality Assurance and Regulatory Affairs |
| Date Summary
prepared: | 8/30/2018 |
| Trade Name: | VO200 - NeurOs Cerebral Oximetry System |
| Common Name: | NeurOs Cerebral Oximetry |
| Classification
name: | Oximeter, Tissue Saturation (21CFR 870.2700) |
| Classification: | Class II Medical Device |
| Product Code: | QEM |
| Predicate Device: | K082327
INVOS 5100C Cerebral/Somatic Oximeter System
Product Code: QEM
Regulation Number: 870.2700
This predicate has not been subject to a design related recall |
4
Image /page/4/Picture/0 description: The image shows the logo for Mespere Life Sciences. Next to the logo is the text "VO200 – NeurOs Cerebral Oximetry System - Traditional 510(k) Notification". The logo is a stylized "M" with the words "LIFE SCIENCES" below it.
Intended Use/Indications For Use:
The VO200 – NeurOs Cerebral Oximetry is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain tissue beneath the sensor. The prospective clinical value of data from the VO200 - NeurOs Cerebral Oximetry has not been demonstrated in disease states. The VO200 - NeurOs Cerebral Oximetry should not be used as the sole basis for diagnosis or therapy.
Device Description:
The Mesepre VO 200 - NeurOs Cerebral Oximetry System is based on the same optical operating principles of multi-distance diffuse reflectance spectroscopy as the predicate device. It measures oxygenated and de-oxygenated hemoglobin content underneath the sensor probe and allows clinicians to monitor the blood oxygenation level of cerebral tissue.
The VO 200 - NeurOs Cerebral Oximetry System consists of a reusable sensor, a single use disposable adhesive, and a display software. The sensor uses two wavelengths within the range from 660nm to 905nm to measure light absorption of tissue, with one wavelength is more sensitive to deoxygenated hemoglobin, the other is more sensitive to oxygenated hemoglobin. Regional cerebral tissue oxygen saturation is calculated through the ratio of tissue absorption to the two wavelengths and validated aqainst blood sample testing through the blood gas analyzer. Sensors are sized to provide desired depth and area coverage for the measurement.
The sensor consists of LEDs, photo detectors, pre-amplifier, analogue to digital convertor, and a CUP for controlling the light emission and detection sequence, auto power adjustment for LED, gain adjustment for photo detectors to ensure optimized signal to noise ratio, and data processing and calculations. It also has an isolator between the monitor and the sensor to ensure the electric safety of the sensor. The enclosure of the sensor is made of medical grade ABS.
The single use sensor adhesive is made of a soft foam with medical grade adhesives.
The Mespere Display Software can be loaded to a tablet, laptop, or stationary PC. The sensor is then connected through a standard USB connector. It displays the measurement through the computer user interface at a refresh rate of approximately one second. Screenshots of the measurement can be saved to a user specified file and can be exported through USB ports or the internet.
Technology Characteristics:
The VO200 - NeurOs Cerebral Oximetry System has the same technology characteristics as the predicate.
Similarities:
5
Image /page/5/Picture/0 description: The image shows the logo for Mespere Life Sciences. The text next to the logo reads "VO200 - NeurOs Cerebral Oximetry System - Traditional 510(k) Notification". The logo is a stylized "M" with the words "LIFE SCIENCES" written below it.
- Both are based upon multi-distance, diffuse reflectance, near infrared spectroscopy . for analyzing oxygenated and deoxygenated hemoglobin content of blood within cerebral tissue.
- Both use near infrared light emitters (LED) and photo detectors. .
- Both uses two near infrared wavelengths ●
Differences:
- . NeurOs sensor probe are reusable, only the medical grade sensor adhesives are one time disposables. The predicate sensor probes are single-use disposables.
- . For the predicate sensor, analogue to digital conversion and pre-Amp is made through boxes connected to the probe through cables.
Comparison Table:
| Characteristics | Mespere VO200 - NeurOs
Cerebral Oximetry System
(Subject Device) | INVOS 5100C
Cerebral/Somatic Oximeter
System
(Predicate) |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications For Use | NeurOs Cerebral Oximetry System
is intended for use as an adjunct
monitor of regional hemoglobin
oxygen saturation of blood in the
brain tissue beneath the sensor. | INVOS 5100C is intended for use as
an adjunct monitor of regional
hemoglobin oxygen saturation of
blood in the brain or in other tissue
beneath the sensor. |
| Target Population | For adult patients. | For adult, pediatric, and neonate
patients. |
| Anatomical Sites | Cerebral | Cerebral |
| Where used
(hospital, home,
ambulance, etc.) | Hospital, clinic and other health
care facilities | Hospital, clinic and other health care
facilities |
| Technology | near infrared, multi-distance diffuse
reflectance spectroscopy, light
emitters and photo detectors | near infrared, multi-distance diffuse
reflectance spectroscopy, light
emitters and photo detectors |
| Sterility | Non-sterile | Non-Sterile |
| Calibration | No need | No Need |
| Features/Method of
Use | Non-invasive | Non-Invasive |
| Monitored
parameters | Regional Oxygen Saturation | Regional Oxygen Saturation |
| Components | - Sensor
- Sensor cables
- display software
- adhesive patch | - Sensor
- Sensor cables
- Preamplifiers
- Monitor |
| Display | Real-time, continuous | Real-time, continuous |
| Risks | No compromise to patient care | No compromise to patient care |
| Optical | Yes - LEDs and photodetectors | Yes
- LED and photodetector |
6
Image /page/6/Picture/0 description: The image shows the logo for Mespere Life Sciences. The text next to the logo reads "VO200 – NeurOs Cerebral Oximetry System - Traditional 510(k) Notification". The logo is a stylized "M" in blue and gray.
| Characteristics | Mespere VO200 - NeurOs
Cerebral Oximetry System
(Subject Device) | INVOS 5100C
Cerebral/Somatic Oximeter
System
(Predicate) |
|-------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Embedded Software | Yes | Yes |
| | Integrated software provides
analytics for measurements to be
displayed | Integrated software provides
analytics for measurements to be
displayed |
| Display | Display StO2 value (right and left)
and trend data graphs | Display rSO2 values (right and left)
and trend data graphs |
| Probe Attachment | Adhesive to skin | Adhesive to skin |
| Alarm | No | Yes |
| Device Type | Needs to be connected to a
computer | Standalone Device |
Complied Standards:
The design of the Mespere VO200 - NeurOs Cerebral Oximetry system conforms to the following voluntary standards:
- EN ISO 13485:2016 ●
- EN ISO 14971:2012 ●
- EN 60601-1:2006/A1:2013 ●
- EN 60601-1-2:2007/AC:2010 ●
- EN 60601-1-6:2010 ●
- EN 62366:2008 ●
- EN ISO 14155:2011 ●
- EN 62304:2006/AC:2008
- EN 1041:2008 ●
- EN 980:2008
- EN 15223-1:2012 ●
- EN ISO 10993-1:2009 ●
- EN ISO 10993-5:2009 ●
- EN ISO 10993-10:2013 .
Non-Clinical Tests:
The VO200 - NeurOs Cerebral Oximetry System was subjected to extensive safety, performance, and verification testing. Extensive benchtop tests verified the performance of the device to meet the design requirements in an ideal non-clinical environment. All tests were performed to ensure that the device complies with industry and safety standards.
7
Image /page/7/Picture/0 description: The image shows the logo for Mespere Life Sciences, followed by the text "VO200 – NeurOs Cerebral Oximetry System - Traditional 510(k) Notification". The logo consists of the word "Mespere" in a combination of blue and gray, with the words "LIFE SCIENCES" in smaller font below. The text indicates that the VO200 is a cerebral oximetry system that has received traditional 510(k) notification.
Clinical Tests:
Clinical tests were performed to verify and validate the clinical performance of the VO200 -NeurOs Cerebral Oximetry system and support the determination of substantial equivalence. The following clinical data was submitted:
Clinical Validation: The primary objective of this study was to validate the accuracy of the Mespere VO200 – NeurOs Cerebral Oximetry system for measuring the regional cerebral tissue blood oxygenation saturation (StO2), by comparing it to invasive blood samples drawn from the jugular bulb and radial artery, and compared by a co-oximeter. The subjects recruited for this study were healthy volunteers.
Methods: With IRB approval and written Informed Consent Forms, healthy volunteers were recruited. An ultrasound-quided small diameter internal jugular vein catheter was inserted and placed at the position of the subject's superior jugular bulb. A radial arterial line was inserted into a radial artery on the left arm. Two standard pulse oximeters were attached to the patient's fingers to help guide the hypoxia state plateau levels. The VO200 -NeurOs Cerebral Oximetry sensor was placed on the forehead. Blood gas analysis to determine oxyhemoglobin saturation was performed using a Co-Oximeter. Each subject had control data taken at the beginning of each experiment, with two control blood samples drawn while breathing room air. Hypoxia was induced to different levels of oxyhemoglobin saturation (between 70-100% SpO2) by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide. Once a steady state level of hypoxia is achieved, a 1.0ml sample of blood are obtained simultaneously from the jugular line and radial arterial line. A second blood pair of samples, at the same steady-state saturation, is taken 30 seconds later. The VO200 - NeurOs Cerebral Oximetry samples were recorded simultaneously to the blood samples. The blood samples were immediately analyzed by the Co-Oximeter. Up to 27 paired samples were obtained on the plateaus across this span for each subject.
Results: The results showed the absolute accuracy of ± 4.9% and trending accuracy of ±1.5% (in range of 40%-80%), which is equivalent or better than the reported absolute accuracy of 5.0% and trending accuracy of ± 4.0 % of the predicate device.
No adverse events were reported.
| Parameter | Specification | Notes |
|---|---|---|
| StO2 Measurement Range | 0 - 100% | |
| StO2 Validated Measurement Range | 40 - 80% | 1,2,3 |
| Trending Accuracy of StO2 | ||
| (40%-80%) | $\pm$ 1.5% | 1,2,3 |
| Absolute Accuracy of StO2 | $\pm$ 4.9% | 1,2,3 |
Performance specifications
Appendix 5-1
8
O200 – NeurOs Cerebral Oximetry System - Traditional 510(k) Notification
| (40%-80%) | |
|---|---|
| Resolution of StO2 | 1% |
NOTES:
- 1 Validation was performed on a measurement range of 40% - 80%
- 2 Accuracy is based on a validation study comparison with venous jugular bulb and radial arterial blood samples and a Co-Oximeter on healthy volunteers. In the StO2 range of 40-80%, the trending accuracy was ± 1.5% and the absolute accuracy was ± 4.9% in the study STP-9200001 at the University of California San Francisco, UCSF (San Francisco, California, USA).
3 Summary of validation study STP-9200001 at the University of California San Francisco, UCSF (San Francisco, California, USA)
Number of Study Sites:
Primary Clinical Site:
University of San Francisco California (UCSF)
Hypoxia Labs
513 Parnassus Ave.,
San Francisco, CA, 94143-0542
Subjects/data points:
The subjects recruited for this study consisted of healthy, non-smoking individuals of age 21-49 years' old who underwent hypoxia testing at the University of California at San Francisco (UCSF) located in San Francisco, California. No subjects was anemic (Hemoglobin ≤ gm·dl-1).
Twelve (12) healthy subjects were recruited for the study. A total of 284 paired venous and arterial blood sample readings, and 284 VO200 - NeurOs Cerebral Oximetry system readings were used to perform the comparison and statistical analysis.
Patient Demographics:
| Subject | Gender | Age | Skin Tone | Fitzpatrick Skin
Tone |
|------------|--------|-----|-----------------------|--------------------------|
| Subject #1 | Male | 26 | Olive | IV |
| Subject #2 | Female | 25 | Medium/light
olive | III |
| Subject #3 | Male | 26 | Medium/light | III |
Appendix 5-1
9
VO200 – NeurOs Cerebral Oximetry System - Traditional 510(k) Notification
| olive | ||||
|---|---|---|---|---|
| Subject #4 | Female | 33 | Fair | II |
| Subject #5 | Male | 24 | Brown | V |
| Subject #6 | Female | 32 | Medium/light | |
| olive | III | |||
| Subject #7 | Male | 23 | Brown | V |
| Subject #8 | Female | 23 | Fair | II |
| Subject #9 | Male | 24 | Brown | V |
| Subject #10 | Male | 30 | Fair | II |
| Subject #11 | Male | 31 | Fair | II |
| Subject #12 | Male | 26 | Brown | V |
Agreement Analysis Results:
The calculated statistical results from the study are as follows:
| Trending Accuracy | ± 1.5% |
|---|---|
| Absolute Accuracy | ± 4.9% |
Bland Altman Plot of Absolute Measurement
Image /page/9/Figure/6 description: This scatter plot shows the difference between Mespere readings and blood gas readings in percentage on the y-axis versus blood gas readings in percentage on the x-axis. The plot includes data points representing the difference, along with three horizontal lines indicating the lower limit of agreement (LoA) at approximately -10, the upper LoA at around 10, and the mean difference near 0. The blood gas readings range from 40% to 85%, while the difference between readings varies from -15% to 15%.
Linear Regression Analysis of Absolute Measurement with 95% Confidence Interval of Slope and
Appendix 5-1
10
Image /page/10/Picture/0 description: The image displays the logo for Mespere Life Sciences, followed by the text "VO200 - NeurOs Cerebral Oximetry System - Traditional 510(k) Notification". The logo features a stylized "M" in blue and gray, with the words "LIFE SCIENCES" in smaller font below. The text describes the VO200 NeurOs Cerebral Oximetry System and indicates that it is a Traditional 510(k) Notification.
Intercept using Bootstrap Method
Slope = 0.7346
Intercept = 15.161
Image /page/10/Figure/4 description: The image is a scatter plot comparing Mespere readings to blood gas readings. The x-axis represents blood gas readings in percentage, ranging from 35 to 85. The y-axis represents Mespere readings in percentage, also ranging from 35 to 85. The plot includes data points representing Mespere readings, a line representing y=x, and a linear regression line for the Mespere readings.
Bland Altman of Absolute Trending Measurement
Image /page/10/Figure/6 description: This image is a scatter plot comparing Mespere Trend Readings to Blood Gas Trend Readings. The x-axis represents Blood Gas Trend Readings (%), ranging from approximately -15 to 25. The y-axis represents the difference between Mespere Trend Readings and Blood Gas Trend Readings (%), ranging from -9 to 5. The plot includes a cluster of data points, labeled as 'Difference', along with horizontal lines indicating 'Lower LoA' at approximately -3, 'Upper LoA' at approximately 3, and 'Mean' at approximately 0.
Linear Regression Analysis of Absolute Trending Measurement with 95% Confidence Interval of Slope and Intercept using Bootstrap Method
11
VO200 – NeurOs Cerebral Oximetry System - Traditional 510(k) Notification
Image /page/11/Figure/1 description: This image is a scatter plot comparing Mespere Trend Readings (%) to Blood Gas Trend Readings (%). The x-axis represents Blood Gas Trend Readings (%), ranging from -15 to 30, while the y-axis represents Mespere Trend Readings (%), also ranging from -15 to 30. The plot includes a scatter of blue points representing Mespere Readings, an orange line representing y=x, and a dotted blue line representing a linear trendline with the equation y = 0.9497x + 0.0004.
Conclusions:
The clinical data demonstrates that the VO200 – NeurOs Cerebral Oximetry system is substantially equivalent in performance to the predicate device when measuring regional cerebral tissue blood oxygenation saturation.