(232 days)
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No
The description details a spectroscopy system using near-infrared light and spatial resolution for measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is described as an "adjunct monitor" and explicitly states it "should not be used as the sole basis for diagnosis or therapy," indicating it provides information for diagnosis and therapy but does not perform therapeutic actions itself.
No
The "Intended Use / Indications for Use" section 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 device.
No
The device description clearly outlines hardware components including a light source, photodiodes, and an adhesive sensor, indicating it is a hardware-based system, not software-only.
Based on the provided information, the INVOS 5100C is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro - "in glass"). This typically involves blood, urine, tissue biopsies, etc.
- The INVOS 5100C is a noninvasive device that measures oxygen saturation within the body (in vivo - "in the living"). It uses near-infrared light applied to the skin to analyze the tissue beneath.
The description clearly states it's a "noninvasive" system and that the sensor is "applied to the skin over the tissue of interest." This confirms it's an in vivo measurement, not an in vitro one.
N/A
Intended Use / Indications for Use
The noninvasive 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. It is intended for use in individuals greater than 2.5 kg at risk for reduced-flow or no-flow ischemic states. It is also 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 in any individual. The clinical value of trend data has not been demonstrated in disease states. The INVOS System should not be used as the sole basis for diagnosis or therapy.
Product codes (comma separated list FDA assigned to the subject device)
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. 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 oxyhemoglobin 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. This method of “spatial resolution” also allows estimation of scattering to improve measurement accuracy.
Mentions image processing
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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
Indicated Patient Age Range
individuals greater than 2.5 kg
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)
Extensive literature references and clinical studies are submitted demonstrating the substantial equivalence of the device for its stated indication.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
APR - 3 2009
SOMANETICS INVOS 5100C 510(K) PREMARKET NOTIFICATION
-SOMANETICS® Section 5 ____________________________________________________________________________________________________________________________________________________________________
510(k) Summary
| Date of Submission: | August 12, 2008 | |
|---|---|---|
| Device Trade Name: | INVOS 5100C Cerebral/Somatic Oximeter System | |
| 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 5100C Cerebral/Somatic | |
| Oximeter System, K080769 | ||
| 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. 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 oxyhemoglobin 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. This method of “spatial | ||
| resolution” also allows estimation of scattering to | ||
| improve measurement accuracy. | ||
| Accessories | SAFB-SM | Small Adult SomaSensor (>40 kg) |
| SPFB | Pediatric SomaSensor ( |