(57 days)
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.
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.
The SOMANETICS INVOS 5100C is a cerebral/somatic oximeter system. The provided document is a 510(k) Premarket Notification. Substantial equivalence was claimed for the INVOS 5100C system against the INVOS 5100B, and the FDA determined it was substantially equivalent.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state specific quantitative "acceptance criteria" for the INVOS 5100C or detailed "reported device performance" against those criteria. It states: "Performance data and extensive literature references were submitted demonstrating the substantial equivalence of the device for its stated indication."
The general conclusion drawn from testing regarding performance is: "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." This describes a capability rather than a quantified performance metric against a specific threshold.
Therefore, a table of acceptance criteria and reported performance cannot be generated from the given text. The FDA's decision was based on "substantial equivalence" to a predicate device, which implies the new device performs acceptably similarly to the predicate, but specific performance metrics are not detailed here.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any test set or the data provenance (country of origin, retrospective/prospective). It generally mentions "Performance data and extensive literature references were submitted."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document does not provide information on the number or qualifications of experts used to establish ground truth for any test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not mention any adjudication method used for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The INVOS 5100C is an oximeter, a device that measures and displays physiological parameters (regional hemoglobin oxygen saturation). It is not an AI-powered diagnostic tool that human readers would use to interpret images or other complex data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device type and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a standalone monitor: "The noninvasive INVOS 5100C is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation...". The description focuses on the device's ability to measure and trend, not on an algorithm operating in isolation without a human connecting the sensor and interpreting the displayed trend. The concept of "standalone (algorithm only)" as typically applied to AI/ML devices is not directly relevant here, as the device's primary function is direct measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used for performance evaluation, beyond the general statement "Performance data and extensive literature references were submitted." For an oximeter, ground truth would typically refer to a gold standard measurement of tissue oxygen saturation, but no details are provided here.
8. The sample size for the training set
The INVOS 5100C is described as a "2 wavelength, diffuse reflectance spectroscopy system" and mentions "subtracting" absorption signals, indicating a hardware-based measurement and processing method rather than an AI/ML system that would require a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable to this device.
9. How the ground truth for the training set was established
As there is no mention or indication of a "training set" for an AI/ML algorithm, this question is not applicable.
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SOMANETICS INVOS 5100C 510(K) PREMARKET NOTIFICATION
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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 Corporation1653 East Maple RoadTroy, MI 48083Phone: 248-689-3050Fax: 248-689-4272 | ||
| Contact Person: | Ronald A. WidmanVice President, Medical Affairs248-526-5865rwidman@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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| Accessories | SAFB-SM | Small Adult SomaSensor (>40 kg) |
|---|---|---|
| SPFB | Pediatric SomaSensor (<40 kg) | |
| RSC-1 | Reusable Sensor Cable Channel 1 | |
| RSC-2 | Reusable Sensor Cable Channel 2 | |
| RSC-3 | Reusable Sensor Cable Channel 3 | |
| RSC-4 | Reusable Sensor Cable Channel 4 | |
| 5100C-W | One-year Extension of Warranty | |
| 5100C-M | 5100C System Operations Manual | |
| 4100-FTD | Field Test Device | |
| 5100C-RS | Portable Mobile Stand | |
| 5100C-SA | Swivel Arm | |
| 5100C-GCX | Mounting Plate | |
| 5100C-TC | Travel Case | |
| 5100C-USB | USB Flash Drive | |
| 312170 | Computer Connection Serial Cable | |
| VL1 | Philips VueLink Adaptor Cable | |
| Indications for Use: | The noninvasive INVOS 5100C is intended for useas an adjunct trend monitor of regional hemoglobinoxygen saturation of blood in the brain or in othertissue beneath the sensor. It is intended for use inany individual at risk for reduced-flow or no-flowischemic states.The prospective clinical value of data from theINVOS System has not been demonstrated indisease states. The INVOS System should not beused as the sole basis for diagnosis or therapy. | |
| Technological Characteristics: | Technological characteristics of the device,including design, material, chemical compositionand energy source are similar to the INVOS 5100Bpredicate device. | |
| Performance Data: | Performance data and extensive literature referenceswere submitted demonstrating the substantialequivalence of the device for its stated indication |
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SOMANETICS INVOS 5100C 510(K) PREMARKET NOTIFICATION
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.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Somanetics Corporation % Mr. Ronald A. Widman VP, Medical Affairs 1653 East Maple Road Troy, Michigan 48083
MAY 1 4 2008
Re: K080769
Trade/Device Name: Somanetics INVOS® 5100C System and Accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: MUD Dated: March 13, 2008 Received: March 18, 2008
Dear Mr. Widman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Ronald A. Widman
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millican
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Section 4
510(k) Number (if known) K 080769
Device Name: Somanetics INVOS® 5100C System and Accessories
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.
Prescription Use (Part 21 CFR 801 subpart D)
OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nilko Blan Grxem
Division of General, Restorative, and Neurological Devices
510(k) Number K080769
Page 1_of 1
Posted November 13, 2003
§ 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).