(57 days)
Not Found
No
The description details a hardware-based optical spectroscopy system and signal processing techniques, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is described as an "adjunct trend monitor" that provides data, and it explicitly states that it "should not be used as the sole basis for diagnosis or therapy," indicating it is not a therapeutic device itself.
No
The device description 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 clearly details hardware components including a light source, photodiodes, sensors, a monitor, and preamplifiers, indicating it is a hardware-based medical device with associated software.
Based on the provided information, the INVOS 5100C is not an In Vitro Diagnostic (IVD) device.
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 diagnosis, monitoring, or screening.
- INVOS 5100C Function: The INVOS 5100C is a noninvasive device that uses near infrared light applied to the skin to measure regional hemoglobin oxygen saturation in vivo (within the living body). It does not involve the collection or analysis of specimens taken from the body.
Therefore, the INVOS 5100C falls under the category of a noninvasive medical device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The noninvasive INVOS 5100C is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in any individual 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 INVOS 5100C is a 2 wavelength, diffuse reflectance spectroscopy system employing near infrared light to estimate the percentage of hemoglobin saturated with oxygen in tissue underneath the sensor. This is similar to the noninvasive technology widely used in pulse oximeters to monitor oxygen saturated hemoglobin percentage in arterial blood.
An adhesive sensor containing a light source and 2 photodiodes is applied to the skin over the tissue of interest and the returning light is analyzed for hemoglobin and deoxyhemoglobin light absorption. Absorption signals from the photodiode closer to the light source are subtracted from those from the farther photodiode where the returning photons penetrate more deeply in the tissue. This suppresses absorption events originating in the outer layers of tissue that are common to both photodiodes, including the effects of skin pigmentation and subcutaneous tissues.
The INVOS 5100C tissue oximeter is a multi-channel monitor with continuous recording and display of readings of regional tissue hemoglobin oxygen saturation from 4 separate sensors simultaneously. The monitor is connected to 2 preamplifiers, each of which in turn supports 2 sensors. It has USB connectivity for dynamic data capture, storage and transfer as well as a digital output port.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
brain or in other tissue beneath the sensor, kidney and gut tissues, organ, intestinal, skeletal muscle tissue
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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)
Performance data and extensive literature references were submitted demonstrating the substantial equivalence of the device for its stated indication.
Conclusion Drawn from the Testing: INVOS System can respond with significant changes during isolated desaturation events in kidney and gut tissues. Monitoring the body with the INVOS System can include organ or intestinal oxygenation as well as skeletal muscle tissue oxygen saturation changes depending on the anatomy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
SOMANETICS INVOS 5100C 510(K) PREMARKET NOTIFICATION
.
K 080769
| Section 5 | 510(k) Summary | ||
|---|---|---|---|
| Date of Submission: | March 13, 2008 | ||
| Device Trade Name: | INVOS 5100C Cerebral/Somatic Oximeter System MAY 14 2008 | ||
| Device Common Name: | Oximeter, Cerebral/Somatic | ||
| Device Classification Name: | Oximeter, Tissue Saturation (21 CFR 870.2700, Product Code MUD) | ||
| Submitted by: | Somanetics Corporation | ||
| 1653 East Maple Road | |||
| Troy, MI 48083 | |||
| Phone: 248-689-3050 | |||
| Fax: 248-689-4272 | |||
| Contact Person: | Ronald A. Widman | ||
| Vice President, Medical Affairs | |||
| 248-526-5865 | |||
| rwidman@somanetics.com | |||
| Predicate Device: | Somanetics INVOS 5100B Cerebral/Somatic Oximeter System, K051274 | ||
| Device Description: | The INVOS 5100C is a 2 wavelength, diffuse reflectance spectroscopy system employing near infrared light to estimate the percentage of hemoglobin saturated with oxygen in tissue underneath the sensor. This is similar to the noninvasive technology widely used in pulse oximeters to monitor oxygen saturated hemoglobin percentage in arterial blood. | ||
| An adhesive sensor containing a light source and 2 photodiodes is applied to the skin over the tissue of interest and the returning light is analyzed for hemoglobin and deoxyhemoglobin light absorption. Absorption signals from the photodiode closer to the light source are subtracted from those from the farther photodiode where the returning photons penetrate more deeply in the tissue. This suppresses absorption events originating in the outer layers of tissue that are common to both photodiodes, including the effects of skin pigmentation and subcutaneous tissues. | |||
| The INVOS 5100C tissue oximeter is a multi- | |||
| channel monitor with continuous recording and | |||
| display of readings of regional tissue hemoglobin | |||
| oxygen saturation from 4 separate sensors | |||
| simultaneously. The monitor is connected to 2 | |||
| preamplifiers, each of which in turn supports 2 | |||
| sensors. It has USB connectivity for dynamic data | |||
| capture, storage and transfer as well as a digital | |||
| output port. | |||
. . . . .
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1
| Accessories | SAFB-SM | Small Adult SomaSensor (>40 kg) |
|---|---|---|
| SPFB | Pediatric SomaSensor ( |