INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C

K080769 · Somanetics Corp. · MUD · May 14, 2008 · Cardiovascular

Device Facts

• Record ID: K080769
• Device Name: INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C
• Applicant: Somanetics Corp.
• Product Code: MUD · Cardiovascular
• Decision Date: May 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended 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.

Device Story

INVOS 5100C is a 2-wavelength, diffuse reflectance near-infrared spectroscopy system; monitors regional tissue hemoglobin oxygen saturation (rSO2). Adhesive sensors containing light source and 2 photodiodes applied to skin; system measures light absorption by hemoglobin and deoxyhemoglobin. Principle of operation: absorption signals from closer photodiode subtracted from farther photodiode to isolate deeper tissue signals; suppresses superficial skin/subcutaneous tissue interference. Multi-channel monitor supports 4 sensors simultaneously via 2 preamplifiers. Used in clinical settings; operated by healthcare professionals. Provides continuous real-time display of oxygenation trends; includes USB data capture and digital output. Assists clinicians in identifying potential ischemic events; serves as adjunct monitor; not for sole diagnostic or therapeutic use.

Clinical Evidence

No clinical trials were required for this 510(k). Substantial equivalence was demonstrated through bench testing and literature references. Testing confirmed the system's ability to respond to significant changes during isolated desaturation events in kidney, gut, and skeletal muscle tissues.

Technological Characteristics

2-wavelength diffuse reflectance near-infrared spectroscopy; 4-channel monitoring; 2 preamplifiers; USB connectivity; digital output port. Materials and energy source are identical to the predicate INVOS 5100B. System includes adhesive sensors with light source and 2 photodiodes.

Indications for Use

Indicated for individuals of any age at risk for reduced-flow or no-flow ischemic states, for use as an adjunct trend monitor of regional hemoglobin oxygen saturation in the brain or other tissues.

Regulatory Classification

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.

Predicate Devices

• Somanetics INVOS 5100B Cerebral/Somatic Oximeter System (K051274)

Submission Summary (Full Text)

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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 Corporation<br>1653 East Maple Road<br>Troy, MI 48083<br>Phone: [phone]<br>Fax: [phone] | | |
| Contact Person: | Ronald A. Widman<br>Vice President, Medical Affairs<br>248-526-5865<br>[e-mail] | | |
| 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.<br>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 use<br>as an adjunct trend monitor of regional hemoglobin<br>oxygen saturation of blood in the brain or in other<br>tissue beneath the sensor. It is intended for use in<br>any individual at risk for reduced-flow or no-flow<br>ischemic states.<br>The prospective clinical value of data from the<br>INVOS System has not been demonstrated in<br>disease states. The INVOS System should not be<br>used as the sole basis for diagnosis or therapy. | |
| Technological Characteristics: | Technological characteristics of the device,<br>including design, material, chemical composition<br>and energy source are similar to the INVOS 5100B<br>predicate device. | |
| Performance Data: | Performance data and extensive literature references<br>were submitted demonstrating the substantial<br>equivalence 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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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

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Posted November 13, 2003