OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S

K091224 · Somanetics Corp. · MUD · Jul 9, 2009 · Cardiovascular

Device Facts

• Record ID: K091224
• Device Name: OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S
• Applicant: Somanetics Corp.
• Product Code: MUD · Cardiovascular
• Decision Date: Jul 9, 2009
• Decision: SESE
• Submission Type: Special
• 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.

Device Story

INVOS 5100C system uses near-infrared (NIR) light to monitor regional hemoglobin oxygen saturation (rSO2) in brain or somatic tissue. Adhesive sensors containing light source and two photodiodes are applied to skin; device measures light absorption of oxyhemoglobin and deoxyhemoglobin. Spatial resolution technique subtracts signals from closer photodiode from farther photodiode to isolate deeper tissue signals, suppressing superficial interference like skin pigmentation. System provides real-time rSO2 trends to clinicians to assist in identifying ischemic states. Used in clinical settings; aids decision-making regarding tissue perfusion and oxygenation status; potential patient benefit includes early detection of ischemia.

Clinical Evidence

Bench testing only; no clinical data presented. Testing demonstrated substantial equivalence of sensors with modified photodiodes.

Technological Characteristics

2-wavelength diffuse reflectance spectroscopy system. Adhesive sensors with light source and 2 photodiodes. Spatial resolution sensing principle. Measures light absorption to estimate hemoglobin oxygen saturation. Connectivity via system cables to INVOS 5100C monitor.

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 regional hemoglobin oxygen saturation in brain or other tissue in any individual.

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

• INVOS 5100C Cerebral/Somatic Oximeter System (K082327)

Submission Summary (Full Text)

{0}------------------------------------------------

# SOMANETICS OxyAlert NIRSensors SPECIAL 510(K) PREMARKET NOTIFICATUON .

| Date of Submission: | | K091224 510(k) Summary |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device Trade Name:<br>and IS-S | |
| Device Common Name: | | |
| | Device Classification Name:<br>Product Code MUD) | |
| Submitted by: | 1653 East Maple Road<br>Troy, MI 48083<br>Phone: [phone]<br>Fax: [phone] | |
| Contact Person: | Ronald A. Widman<br>248-526-5865<br>[e-mail] | Vice President, Medical Affairs |
| | Predicate Device:<br>Oximeter System, K082327 | |
| Accessories | SPFB<br>IS-C<br>IS-S | Small Adult SomaSensor (>40 kg)<br>Pediatric SomaSensor (<40 kg)<br>Infant/Neonatal Cerebral OxyAlert<br>NIRSensor (<40 kg)<br>Infant/Neonatal Somatic OxyAlert |
| | RSC-1<br>RSC-2<br>RSC-3<br>RSC-4<br>5100C-W<br>5100C-M<br>5100-FTD<br>5100C-RS<br>5100C-SA<br>5100C-GCX<br>5100C-TC<br>5100C-USB<br>312170<br>VLI | NIRSensor (<40 kg)<br>Reusable Sensor Cable Channel 1<br>Reusable Sensor Cable Channel 2<br>Reusable Sensor Cable Channel 3<br>Reusable Sensor Cable Channel 4<br>One-year Extension of Warranty<br>5100C System Operations Manual<br>Field Test Device<br>Portable Mobile Stand<br>Swivel Arm<br>Mounting Plate<br>Travel Case<br>USB Flash Drive<br>Computer Connection Serial Cable<br>Philips VueLink Adaptor Cable |

.

: ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・

{1}------------------------------------------------

## SOMANETICS OxyAlert NIRSensors SPECIAL 510(K) PREMARKET NOTIFICATION

.

:

्र

| 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. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device | INVOS® 5100C Cerebral/Somatic Oximeter<br>System |
| Technological Characteristics: | 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. |
| Performance Data: | Bench testing is submitted demonstrating the<br>substantial equivalence of the new sensors with<br>modified photodiodes for the stated indication. |
| Substantial Equivalence: | The new sensors have the same intended use and<br>indications, principles of operation and<br>technological characteristics as the predicate device.<br>The change in photodiodes does not raise any new<br>questions of safety or effectiveness. Performance<br>data demonstrates that the new photodiodes are as<br>safe and effective as the predicate. Thus, the |

:

:

:

Attachment 7

.

:

.

،

· :

:

{2}------------------------------------------------

## SOMANETICS OxyAlert NIRSensors SPECIAL 510(K) PREMARKET NOTIFICATION

.

ﺗﺮﺗ

:

. '

modified sensors are substantially equivalent to the predicate sensors.

.

Santa Parti :

:

{3}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring an eagle-like figure with outstretched wings. The emblem is rendered in black and white, and the overall design appears to be a government or official seal.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 2009

Somanetics Corporation c/o Ronald A. Widman 1653 East Maple Rd., Troy, MI 48083-4208

Re: K091224

Trade/Device Name: OxyAlert NIRSensor Models IS-C and IS-S Accessories for Somanetics INVOS 5100C System

Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: June 12, 2009 Received: June 16, 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

### Page 2 - Mr. Ronald A. Widman

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Joe Callaway for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

### 510(k) Number K091224

## 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.

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)

Beylin

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K091224

Page 1 of 1

A8-1