INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C

K082327 · Somanetics Corp. · MUD · Apr 3, 2009 · Cardiovascular

Device Facts

• Record ID: K082327
• Device Name: INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C
• Applicant: Somanetics Corp.
• Product Code: MUD · Cardiovascular
• Decision Date: Apr 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

INVOS 5100C is a 2-wavelength, diffuse reflectance near-infrared spectroscopy system. Adhesive sensors containing a light source and 2 photodiodes are applied to skin over target tissue. Device measures light absorption of oxyhemoglobin and deoxyhemoglobin. Spatial resolution technique subtracts signals from the proximal photodiode from the distal photodiode to isolate deeper tissue signals, suppressing superficial interference (skin pigmentation, subcutaneous tissue) and estimating scattering to improve accuracy. System provides regional hemoglobin oxygen saturation (rSO2) values. Used in clinical settings by healthcare providers to monitor tissue oxygenation. Output assists clinicians in identifying potential ischemic states; supports clinical decision-making regarding patient perfusion status. Benefits include noninvasive, real-time monitoring of regional oxygen saturation.

Clinical Evidence

Extensive literature references and clinical studies were submitted to demonstrate substantial equivalence. No specific performance metrics (e.g., sensitivity, specificity) are detailed in the provided text.

Technological Characteristics

2-wavelength diffuse reflectance near-infrared spectroscopy. Adhesive sensors with light source and 2 photodiodes. Spatial resolution signal processing. Identical to predicate device in design, materials, and energy source.

Indications for Use

Indicated for individuals >2.5 kg at risk for reduced-flow or no-flow ischemic states, and as an adjunct trend monitor for any individual. Not for use as sole basis for diagnosis or therapy.

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 5100C Cerebral/Somatic Oximeter System (K080769)

Submission Summary (Full Text)

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APR - 3 2009

K082327

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,<br>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 5100C Cerebral/Somatic<br>Oximeter System, K080769 | |
| Device Description: | The INVOS 5100C is a 2 wavelength, diffuse<br>reflectance spectroscopy system employing near<br>infrared light to estimate the percentage of<br>hemoglobin saturated with oxygen in tissue<br>underneath the sensor. An adhesive sensor<br>containing a light source and 2 photodiodes is<br>applied to the skin over the tissue of interest and the<br>returning light is analyzed for oxyhemoglobin and<br>deoxyhemoglobin light absorption. Absorption<br>signals from the photodiode closer to the light<br>source are subtracted from those from the farther<br>photodiode where the returning photons penetrate<br>more deeply in the tissue. This suppresses<br>absorption events originating in the outer layers of<br>tissue that are common to both photodiodes,<br>including the effects of skin pigmentation and<br>subcutaneous tissues. This method of “spatial<br>resolution” also allows estimation of scattering to<br>improve measurement accuracy. | |
| Accessories | SAFB-SM | Small Adult SomaSensor (>40 kg) |
| | SPFB | Pediatric SomaSensor (<40 kg) |
| | IS-C | Infant/Neonatal Cerebral OxyAlert<br>NIRSensor (<40 kg) |
| | IS-S | Infant/Neonatal Somatic OxyAlert<br>NIRSensor (<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 |
| | 5100-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 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>individuals greater than 2.5 kg at risk for reduced-<br>flow or no-flow ischemic states. It is also intended<br>for use as an adjunct trend monitor of regional<br>hemoglobin oxygen saturation of blood in the brain<br>or in other tissue beneath the sensor in any<br>individual. The clinical value of trend data has not<br>been demonstrated in disease states. The INVOS<br>System should not be used as the sole basis for<br>diagnosis or therapy. | |
| Technological Characteristics: | .Technological characteristics of the device,<br>including design, material, chemical composition<br>and energy source are identical to the INVOS<br>5100C predicate device. | |
| Performance Data: | .Extensive literature references and clinical studies<br>are submitted demonstrating the substantial<br>equivalence of the device for its stated indication. | |

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## SOMANETICS INVOS 5100C 510(K) PREMARKET NOTIFICATION

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### SOMANETICS INVOS 5100C 510(K) PREMARKET NOTIFICATION

Conclusion Drawn from the Testing:............The conclusion drawn is that the revised indications for use and labeling are substantially equivalent to the predicate device and do not raise new questions of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird figure.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR - 3 2009

Somanetics Corporation % Mr. Ronald A. Widman VP of Medical Affairs 1653 East Maple Road Troy, Michigan 48083-4208

Re: K082327

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: February 16, 2009 Received: February 17, 2009

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

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Page 2 - Mr. Ronald A. Widman

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.

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,

David Krone

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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### Section 4

510(k) Number (if known) K 082327

Device Name: Somanetics INVOS® 5100C System and Accessories

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.

Prescription Use X (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)

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Sign-Division of General, Restorative, and Neurological Devices

**510(k) Number** L082327

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