(113 days)
Not Found
No
The device description and performance studies focus on traditional oximetry principles and statistical analysis of trends, with no mention of AI or ML algorithms.
No.
The device is described as an "adjunct monitor" of trends in regional hemoglobin oxygen saturation, and the "Intended Use" explicitly states it "should not be used as the sole basis for decisions as to diagnosis or therapy." This indicates it provides information to aid in clinical decisions, but does not directly deliver therapy itself.
No
The device is an "adjunct monitor of trends in regional hemoglobin oxygen saturation" and explicitly states it "should not be used as the sole basis for decisions as to diagnosis or therapy." This indicates it provides supportive information rather than making a definitive diagnosis itself.
No
The device description explicitly details hardware components including a disposable sensor with a light source and detectors, a preamplifier, and a display unit. It is a system that includes both hardware and software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD). Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Operation: The INVOS® 3100A Cerebral Oximeter is a noninvasive device that measures regional hemoglobin oxygen saturation directly on the patient's forehead using light. It does not involve the collection or analysis of specimens taken from the body.
- Intended Use: The intended use is to monitor trends in regional hemoglobin oxygen saturation of blood in the brain of an individual, acting as an adjunct monitor. This is a direct measurement on the patient, not an analysis of a specimen.
Therefore, the INVOS® 3100A Cerebral Oximeter falls under the category of a noninvasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The noninvasive INVOS 3100A Cerebral Oximeter should be used in adults as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood in the brain of an individual. Because INVOS values are relative within an individual, the INVOS should not be used as the sole basis for decisions as to diagnosis or therapy. The value of data from the INVOS has not been demonstrated in disease states.
Product codes
Not Found
Device Description
The principles of operation of the cerebral oximeter system are based on the assumption that hemoglobin exists in two principal forms in the blood: oxygenated hemoglobin (HbO2) and reduced hemoglobin (Hb). Functional oxygen saturation (SO2) is defined as the ratio of oxyhemoglobin (HbO2) to total hemoglobin (HbO2 + Hb) and is commonly presented as a percentage. Since oxygenated and reduced hemoglobin are different colors and absorb light as a known function of wavelength, selected wavelengths of light can be used to assess the relative percentage of these two constituents. This fundamental approach of assessing the color of blood using various wavelengths of light to measure hemoglobin oxygen saturation trends is used in all currently marketed oximetry systems.
A disposable sensor of medical grade materials is applied to the patient's forehead (Figure 1). The sensor incorporates a light source and two return signal detectors at different predetermined distances from the light source. The signal detector nearest the light source (3 cm) is considered the "shallow detector" and the further detector from the light source (4 cm) the "deep detector."
While the light reaching the deep detector has sampled about the same amount of skin, scalp, and skull as the light reaching the shallow detector, it has sampled more brain This difference is used to help separate out the brain signal and suppress tissue. anatomical differences in patients. The additional information unique to the deep signal return is predominately from brain tissue blood which is composed mostly of venous blood. The information contained in the shallow and deep signal returns is processed by an algorithm to measure changes in hemoglobin oxygen saturation in a small region of tissue beneath the sensor, predominately in the brain.
The SomaSensor is connected to a preamplifier (1.75 x 7.4 x 5.4 in.) which is placed close to the patient and amplifies the rSO2 signal. The signal is then carried to a display unit (6.5 x 12.5 x 13.5 in.) where the values and trends are displayed on the screen. The display unit controls all functions of the system with selections made by keys with onscreen labels. The system will operate for up to 20 minutes on battery, enabling patient transport without loss of data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
adults
Intended User / Care Setting
clinician / Not Found
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
Volunteer hypoxia study:
Sample size: 30 volunteers (21 light, 5 medium, 4 dark skinned subjects; 19 males and 11 females). Age ranged from 19 to 40 years, with a median of 25 years.
Data source: Not explicitly stated, but implies healthy volunteers undergoing controlled hypoxia and hypercapnia.
Annotation protocol: Six sets of data were collected comparing rSO2 to a combination of arterial and jugular venous blood oxygen saturations over an arterial saturation range of 73-100%. The six steps were then repeated at an elevated level of cerebral blood flow (CBF) obtained by increasing inspired CO2 such that CBF increased about 12-30%.
Carotid endarterectomy (CEA) study:
Sample size: 27 patients (21 males and 6 females, all Caucasian). One patient was operated twice for both left and right CEAs. One additional subject (008) had a sensor placed but TCD monitoring could not be accomplished.
Data source: Patients undergoing carotid endarterectomy.
Annotation protocol: Changes in rSO2 index were compared to changes in mean middle cerebral artery flow velocity (MCAVm) as measured by transcranial Doppler (TCD) and EEG changes as evaluated by a trained observer using 10-channel analog recordings. Comparison of the changes in MCAVm and rSO2 index were made during cross-clamp of only the external carotid artery in six of the 27 subjects. Skin condition was observed before and after sensor placement, including 24-hour follow-up in eleven cases. Operational time was calculated from continuous data recorded during the CEA study on disk.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing:
1. Volunteer hypoxia study:
- Study type: Clinical study, volunteer hypoxia study.
- Sample size: 30 volunteers.
- Key results:
- Trend agreement between fSO2 (calculated from arterial and jugular venous blood samples) and rSO2 index at both levels of CBF was very high in individuals, mean individual r^2=0.947 (range 0.805 to 0.991).
- The ability of the INVOS to accurately measure trends in saturation was within ±4.9% (combined bias and standard deviation).
- The trend measurement correlation coefficient was r=0.935 and bias and standard deviation were 0.219 ± 4.61.
- The overall mean bias between fSO2 and rSO2 index was 1.33. Standard deviations of the absolute difference between fSO2 and rSO2 index for individuals averaged 3.08.
- No instances of irritation were observed (skin condition).
2. Carotid endarterectomy (CEA) study:
- Study type: Clinical study, carotid endarterectomy (CEA).
- Sample size: 27 patients.
- Key results:
- Correlation between changes in rSO2 index and changes in MCAVm during cross-clamp of the common carotid artery was r=0.806.
- The INVOS detected changes in oxygenation which preceded EEG changes during cross-clamp of the carotid artery, p
§ 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
| Section 8 | K960614 | JUN - 5 1996 | 510(k) Summary |
|---|---|---|---|
| ----------- | --------- | -------------- | ---------------- |
| Date Prepared: | May 31, 1996 |
|---|---|
| ---------------- | -------------- |
| 1. | Date Prepared: | May 31, 1996 |
|---|---|---|
| 2. | Submitter/Contact Person: | Ronald A. Widman |
| Director of Medical Affairs | ||
| Somanetics Corporation | ||
| 1653 East Maple Road | ||
| Troy, MI 48083 | ||
| Phone: (810) 689-3050 | ||
| Fax: (810) 689-4272 | ||
| 3. | Trade Name: | Somanetics INVOS® 3100A Cerebral Oximeter |
| (INVOS) | ||
| Accessories: | ||
| 3100-SD Single-patient use sensor (SomaSensor) | ||
| 3100-DD Disk Drive | ||
| 3100-TC Travel Case | ||
| 3100A-M Additional User Manual | ||
| 4. | Classification Name: | Oximeters |
| 5. | Common Name: | Cerebral Oximeter |
| 6. | Predicate Devices: | Nellcor N-200 Pulse Oximeter (K863784) |
| Baxter SAT-II Intravascular Oximetry System | ||
| (K884329) |
Indications for Use: The noninvasive INVOS 3100A Cerebral Oximeter should 7. be used in adults as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood in the brain of an individual. Because INVOS values are relative within an individual, the INVOS should not be used as the sole basis for decisions as to diagnosis or therapy. The value of data from the INVOS has not been demonstrated in disease states.
Contraindications: None.
8. Device Description:
The principles of operation of the cerebral oximeter system are based on the assumption that hemoglobin exists in two principal forms in the blood: oxygenated hemoglobin (HbO2) and reduced hemoglobin (Hb). Functional oxygen saturation (SO2) is defined as the ratio of oxyhemoglobin (HbO2) to total hemoglobin (HbO2 + Hb) and is commonly presented as a percentage.
1
$$SO_1 = \frac{HbO_2}{HbO_2 + Hb} \times 100%$$
Since oxygenated and reduced hemoglobin are different colors and absorb light as a known function of wavelength, selected wavelengths of light can be used to assess the relative percentage of these two constituents. This fundamental approach of assessing the color of blood using various wavelengths of light to measure hemoglobin oxygen saturation trends is used in all currently marketed oximetry systems.
Image /page/1/Figure/3 description: This image is a cross-section of a sensor on a forehead. The sensor has a light source, a shallow detector, and a deep detector. The light source emits light that travels through the skin, tissue, bone, and brain. The shallow detector detects light that has traveled through the skin and tissue, while the deep detector detects light that has traveled through the skin, tissue, bone, and brain.
A disposable sensor of medical grade materials is applied to the patient's forehead (Figure 1). The sensor incorporates a light source and two return signal detectors at different predetermined distances from the light source. The signal detector nearest the light source (3 cm) is considered the "shallow detector" and the further detector from the light source (4 cm) the "deep detector."
While the light reaching the deep detector has sampled about the same amount of skin, scalp, and skull as the light reaching the shallow detector, it has sampled more brain This difference is used to help separate out the brain signal and suppress tissue. anatomical differences in patients. The additional information unique to the deep signal return is predominately from brain tissue blood which is composed mostly of venous blood. The information contained in the shallow and deep signal returns is processed by an algorithm to measure changes in hemoglobin oxygen saturation in a small region of tissue beneath the sensor, predominately in the brain.
The SomaSensor is connected to a preamplifier (1.75 x 7.4 x 5.4 in.) which is placed close to the patient and amplifies the rSO2 signal. The signal is then carried to a display unit (6.5 x 12.5 x 13.5 in.) where the values and trends are displayed on the screen. The display unit controls all functions of the system with selections made by keys with onscreen labels. The system will operate for up to 20 minutes on battery, enabling patient transport without loss of data.
ರಿ. Substantial Equivalence:
The INVOS is substantially equivalent to the common pulse oximeter and to intravascular oximetry systems. It has the same intended use as generic oximeters (e.g. pulse oximeters, ear oximeters, and intravascular catheter oximeters), namely to measure blood oxygen saturation. All such devices utilize spectrophotometric techniques to assess the color of blood in order to determine the hemoglobin oxygen saturation.
2
The INVOS is similar to the common pulse oximeter in its patient interface and method of operation. Both devices are applied to the surface of the skin. pass light through highly vascularized tissue, capture returned light, and analyze it to provide an estimate of functional hemoglobin oxygen saturation in the in vivo blood by analyzing the color of that blood. Both employ a two-wavelength near-infrared spectrophotometric technique using LED light sources and photodiode detectors. Pulse oximeters make their measurements on a finger, toe, or earlobe. The INVOS makes its measurement on the forehead.
Whereas pulse oximeters emphasize arterial hemoglobin oxygen saturation and the INVOS measures predominately venous hemoglobin oxygen saturation, the clinical interpretation of the INVOS measurement is similar to that of currently marketed intravascular catheter oximeter systems that measure mixed venous oxygen saturation. Specifically, intravascular catheter oximeter systems continuously measure trends in blood oxygen saturation in the pulmonary artery which is comprised of mixed venous blood. The INVOS measures trends in oxygen saturation in the region of the brain beneath the sensor which contains blood that is a majority venous blood. As with intravascular catheter oximeter systems, changes in INVOS values reflect changes in the balance between oxygen delivery and oxygen consumption and alert the clinician of the potential for a problem that is worthy of investigation.
Unlike pulse oximeters, the INVOS does not depend on a pulse signal to function. During periods when pulse signals are low or non-existent (e.g. cardiopulmonary bypass, hypothermia, hypotension, cardiac arrhythmias, etc.) the INVOS is able to continue to function, providing potentially important noninvasive information regarding oxygenation.
Unlike intravascular catheter oximetry systems, the INVOS is noninvasive and the INVOS makes venous oxygen saturation information available with less risk, enabling its use on patients for whom the use of a pulmonary artery catheter is not warranted.
10. ~ Nonclinical Testing:
The INVOS has been tested in the following areas to ensure substantial equivalence with the predicate devices:
INVOS linearity, accuracy, noise levels, operating and storage temperatures, input voltage, altitude, patient safety, user safety, EMI/RFI interference and susceptibility, battery discharge time, power consumption, component stress, component heating, fan cooling capacity, shipping carton validation and compliance with voluntary standards CSA C22.2 No. 601.1, UL 2601.1, EC Directive 93/42/EEC Annex III, Medical Devices and EN 60601-1/08.90.
The SomaSensor has been tested in the following areas to ensure substantial equivalence with the predicate devices:
Linearity, repeatability, operating and storage temperatures, potential overheating, light output, patient and user safety, biocompatability, EMI/RFI interference and
3
susceptibility and compliance with voluntary standards CSA C22.2 No. 601.1, UL 2601.1, EC Directive 93/42/EEC Annex III, Medical Devices and EN 60601-1/08.90.
The INVOS system has been granted the GS and CE marks as certification of compliance with EN 60601-1/08.90 and EC Directive 93/42/EEC Annex III. Medical Devices. The INVOS system has been granted the ETL mark as certification of compliance with UL 2601.1 and CSA C22.2 No. 601.1 safety standards.
Clinical Testing: 11.
Two clinical studies were performed in support of the premarket notification as described below.
The first was a volunteer hypoxia study whose objective was to compare the INVOS rSO2 index with blood oxygen saturation measurements performed off-line on a cooximeter during moderate hypoxia and hypercapnia. The study consisted of 30 volunteers with demographics as follows: 21 light, 5 medium and 4 dark skinned subjects; 19 males and 11 females. Age ranged from 19 to 40 years, with a median of 25 years. Six sets of data were collected comparing rSO2 to a combination of arterial and jugular venous blood oxygen saturations over an arterial saturation range of 73-100%. The six steps were then repeated at an elevated level of cerebral blood flow (CBF) obtained by increasing inspired CO2 such that CBF increased about 12-30%.
Trend agreement between fSO2 (as calculated from arterial and jugular venous blood samples) and rSO2 index at both levels of CBF was very high in individuals, mean individual r2=0.947 (range 0.805 to 0.991). The ability of the INVOS to accurately measure trends in saturation was within ±4.9% (combined bias and standard deviation). The trend measurement correlation coefficient was r=0.935 and bias and standard deviation were 0.219 ± 4.61. The overall mean bias between fSO2 and rSO2 index was 1.33. Standard deviations of the absolute difference between fSO2 and rSO2 index for individuals averaged 3.08. Skin condition was observed before and after placement of the SomaSensor. No instances of irritation were observed.
The second study evaluated 27 patients during carotid endarterectomy (CEA) with demographics as follows: 21 males and 6 females, all Caucasian. Its purpose was to evaluate the ability of the INVOS system to detect and differentiate mild to severe ischemia caused by clamping of the common carotid artery. Twenty-two of this group had surgery performed under general anesthesia and five under regional anesthesia. One patient was operated twice for both left and right CEAs. Changes in rSO2 index were compared to changes in mean middle cerebral artery flow velocity (MCAVm) as measured by transcranial Doppler (TCD) and EEG changes as evaluated by a trained observer using 10-channel analog recordings.
Correlation between changes in rSO2 index and changes in MCAVm during cross-clamp of the common carotid artery was r=0.806. The INVOS detected changes in oxygenation
4
which preceded EEG changes during cross-clamp of the carotid artery, p