(73 days)
Not Found
No
The device description details a spectroscopy system using near-infrared light and spatial resolution for measurement, with no mention of AI or ML algorithms. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is described as an "adjunct monitor" of regional hemoglobin oxygen saturation and does not provide therapy or treatment.
Yes
The device aids in monitoring regional hemoglobin oxygen saturation to identify individuals at risk for ischemic states, which is a diagnostic purpose.
No
The device description explicitly details 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:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of donations with potential recipients, or to monitor therapeutic measures.
- INVOS 5100C Function: The INVOS 5100C is a non-invasive 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 examine specimens in vitro (outside the body).
Therefore, the INVOS 5100C falls under the category of a non-invasive medical device used for monitoring physiological parameters directly on the patient, not an IVD.
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.
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. 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain or in other tissue beneath the sensor
Indicated Patient Age Range
individuals greater than 2.5 kg
Intended User / Care Setting
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing is submitted demonstrating the substantial equivalence of the new sensors with modified photodiodes for the stated indication.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Oximeter System, K082327
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 OxyAlert NIRSensors SPECIAL 510(K) PREMARKET NOTIFICATUON .
| Date of Submission: | K091224 510(k) Summary | |
|---|---|---|
| Device Trade Name: | ||
| and IS-S | ||
| Device Common Name: | ||
| Device Classification Name: | ||
| Product Code MUD) | ||
| Submitted by: | 1653 East Maple Road | |
| Troy, MI 48083 | ||
| Phone: 248-689-3050 | ||
| Fax: 248-689-4272 | ||
| Contact Person: | Ronald A. Widman | |
| 248-526-5865 | ||
| rwidman@somanetics.com | Vice President, Medical Affairs | |
| Predicate Device: | ||
| Oximeter System, K082327 | ||
| Accessories | SPFB | |
| IS-C | ||
| IS-S | Small Adult SomaSensor (>40 kg) | |
| Pediatric SomaSensor ( |