(171 days)
No
The device description relies on established principles of oximetry and signal processing based on light absorption at different wavelengths and distances. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is described as a noninvasive monitor intended to track trends in regional hemoglobin oxygen saturation, and specifically states it "should not be used as the sole basis for diagnosis or therapy," indicating it is a diagnostic/monitoring tool, not a therapeutic one.
No
The "Intended Use" explicitly states, "The INVOS System should not be used as the sole basis for diagnosis or therapy." This indicates it is an adjunct monitor, not a primary diagnostic tool.
No
The device description explicitly details hardware components including a disposable sensor, preamplifier, and display unit. It describes the physical placement of the sensor and the connection to the preamplifier and display unit.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes the device as a "noninvasive adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain" and "in a region of skeletal muscle tissue." This involves measuring physiological parameters directly from the patient's body.
- Device Description: The description details how the device uses light absorption to measure hemoglobin oxygen saturation in vivo (within the living body) by placing a sensor on the patient's forehead or skeletal muscle.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body.
IVDs are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This device operates by directly interacting with the patient's body to measure physiological signals.
N/A
Intended Use / Indications for Use
The noninvasive INVOS 5100B is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain of an individual. It also is intended for use as an adjunct trend monitor of hemoglobin oxygen saturation of blood in a region of skeletal muscle tissue beneath the sensor in infants, children, or adults at risk for reduced-flow or no-flow ischemic states. The prospective clinical value of data from the INVOS System has not been demonstrated in disease states. The INVOS System should not be used as the sole basis for diagnosis or therapy.
Product codes
MUD
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.
SO1 = (HbO2 / (HbO2 + Hb)) x 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.
For cerebral monitoring, 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 tissue. This difference is used to help separate out the brain signal and suppress 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.
For non-cerebral monitoring, a somatic sensor which is similar to the cerebral sensor is placed on skeletal muscle in an area free of large fat deposits, bony protuberances and hair. Since the tissue being interrogated is relatively homogeneous, the resultant rSQ2 index is an average of the hemoglobin oxygen saturation of blood in the region of tissue below the sensor.
The SomaSensor is connected to a preamplifier (1.4 x 7.65 x 3.75 in.) which is placed close to the patient and amplifies the rSO2 signal. The signal is then carried to a display unit (8.4 x 9.6 x 8.5 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 120 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
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Anatomical Site
brain, skeletal muscle tissue
Indicated Patient Age Range
infants, children, or adults
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing:
The INVOS 5100B is identical to the INVOS 5100 Adult/Pediatric Cerebral Oximeter System (K001842) and the SSFB Somatic SomaSensor is identical to the SAFB (K001842) except that it is supplied with a larger adhesive pad and revised labeling. The result of previous validations, including software validations for a moderate level of concern, confirms that the model 5100B performs according to published specifications.
Clinical Testing:
- An adult volunteer hypoxia study (K971628) demonstrated that the INVOS System was . able to accurately track changes in cerebral blood oxygen saturation as compared with co-oximetry analysis of blood samples over a wide range of arterial saturation repeated at two levels of arterial carbon dioxide.
- A study in the pediatric cath lab (K001842) demonstrated that the INVOS System also . accurately tracked changes in cerebral oxygen saturation as compared with co-oximetry analysis of blood samples in children with congenital heart defects during sedation and during supplemental oxygen administration.
- . An animal study using isolated perfused porcine limbs demonstrated that the INVOS System was able to track changes in blood oxygen saturation in skeletal muscle tissue over a range of 5% to 95% with a bias of 1 and standard deviation of 7.
- . Multiple peer-reviewed studies have shown the INVOS System provides skeletal muscle somatic oxygen saturation readings in low and no flow ischemic states in human and animal trials.
- . Two published studies demonstrate the ability of the INVOS System somatic saturation to reflect the intensity of exercise.
- Somatic saturation has been shown to correlate with mixed venous oxygen saturation . and has the potential to predict the onset of anaerobic metabolism.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
| NOV - 4 2005 | K051274 | |
|---|---|---|
| Appendix A10 | 510(k) Summary | |
| Date Prepared: | 10/6/2005 | |
| Submitter/Contact: | Ronald A. Widman | |
| Vice President, Medical Affairs | ||
| Somanetics Corporation | ||
| 1653 East Maple Road | ||
| Troy, MI 48083 | ||
| Phone: (248) 689-3050 | ||
| Fax: (248) 689-4272 | ||
| Trade Name: | Somanetics INVOS® 5100B and SSFB Somatic SomaSensor® | |
| Accessories: | ||
| SAFB | Adult Cerebral SomaSensor (>40 kg) | |
| SAFB-SM | Small Adult Cerebral SomaSensor (>40 kg) | |
| SPFB | Pediatric Cerebral SomaSensor ( |