ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA

K100523 · Hygia Health Services, Inc. · NMD · May 4, 2010 · Cardiovascular

Device Facts

• Record ID: K100523
• Device Name: ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA
• Applicant: Hygia Health Services, Inc.
• Product Code: NMD · Cardiovascular
• Decision Date: May 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Hygia Health Services Reprocessed Pediatric and Adult Cerebral-Somatic Oximetry Sensors are indicated for use when continuous noninvasive oxygen saturation is required for pediatric patients weighing < 40 kg and adult patients weighing > 40 kg, respectively. The Hygia reprocessed sensor has been validated with the OEM's Cerebral/Somatic Oximeter, Model 5100C and is intended to be used with the Cerebral/Somatic Oximeter, Model 5100C only. The noninvasive 5100C Cerebral/Somatic Oximeter 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 5100C Cerebral/Somatic Oximeter has not been demonstrated in disease states. The OEM suggests the 5100C Cerebral/Somatic Oximeter should not be used as the sole basis for diagnosis or therapy.

Device Story

Reprocessed optical sensors for cerebral-somatic oximetry; applied to forehead or body tissue. Device emits dual-wavelength (red/near-infrared) light; photodiodes measure reflected light. Signal transmitted to Somanetics 5100C monitor for calculation of regional oxygen saturation trends. Used in hospital settings during surgery or anesthesia. Provides clinicians with trend data for patients at risk of ischemia; serves as adjunct monitor; not for sole diagnostic use. Reprocessing restores OEM sensors for up to 2 cycles.

Clinical Evidence

No clinical data. Evidence consists of bench testing, cleaning validation, and biocompatibility assessment to demonstrate that reprocessed sensors perform as intended.

Technological Characteristics

Optical sensor using dual-wavelength (red/near-infrared) light source and photodiodes. Identical to OEM predicate devices. Designed for use with Somanetics Model 5100C Oximeter. Reprocessed for a maximum of 2 cycles.

Indications for Use

Indicated for continuous noninvasive regional hemoglobin oxygen saturation monitoring in pediatric patients (< 40 kg) and adult patients (> 40 kg) at risk for reduced-flow or no-flow ischemic states. Intended for use with Somanetics Model 5100C Oximeter only.

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 Corp. (K082327)
• Somanetics Corp. (K080769)
• Somanetics Corp. (K051274)
• Somanetics Corp. (K001842)
• Somanetics Corp. (K971628)
• Somanetics Corp. (K960614)

Submission Summary (Full Text)

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# 510(k) Summary

MAY - 4 2010

K 100523

In accordance with 21 CFR Part 807.92, this summary is submitted by:

Hygia Health Services, Inc. 434 Industrial Lane Birmingham, Alabama 35211 Phone: [phone] Fax: [phone]

Date Prepared: February 23, 2010

1. Contact Person

Mr. Lake Trechsel R&D Engineer Phone: [phone] Fax: [phone] Email: lake.trechsel(@hygia.net

2. Name of Device

Classification Name: Oximeter, Tissue Saturation Common Name: Oximeter, Cerebral/Somatic Trade or Proprietary Name: Hygia Health Services Reprocessed Cerebral-Somatic Oximetry Sensors

#### 3. Predicate Device

Corresponding Somanetics oximetry sensors legally marketed under various 510(k) premarket notifications:

| Somanetics Corp. | K082327 |
|------------------|---------|
| Somanetics Corp. | K080769 |
| Somanetics Corp. | K051274 |
| Somanetics Corp. | K001842 |
| Somanetics Corp. | K971628 |
| Somanetics Corp. | K960614 |

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# 4. Device Description

The Hygia Health Services Reprocessed Cerebral-Somatic Oximetry Sensors (CSS) are optical devices which use dual-wavelength light to determine a patient's current regional oxygen saturation level. Once a sensor has been applied to the patient, a light source in the sensor sends red and near-infrared light through the skin surface and photodiodes measure the reflected light. This signal is sent back to a monitor which calculates the patient's trending oxygenation levels.

### 5. Device Intended Use

The Hygia Health Services Reprocessed CSS are intended to be used in the same manner as the predicate devices. They are designed to be applied to the forehead and other appropriate portions of the body to measure regional oxygenation saturation during surgery or other applications related to the use of anesthesia. The devices are intended to be used in hospitals.

### 6. Indications For Use

The Hygia Health Services Reprocessed Pediatric and Adult Cerebral-Somatic Oximetry Sensors are indicated for use when continuous noninvasive oxygen saturation is required for pediatric patients weighing < 40 kg and adult patients weighing > 40 kg, respectively. The Hygia reprocessed sensor has been validated with the OEM's Cerebral/Somatic Oximeter, Model 5100C and is intended to be used with the Cerebral/Somatic Oximeter, Model 5100C only.

The noninvasive 5100C Cerebral/Somatic Oximeter 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 5100C Cerebral/Somatic Oximeter has not been demonstrated in disease states. The OEM suggests the 5100C Cerebral/Somatic Oximeter should not be used as the sole basis for diagnosis or therapy.

#### 7. Technological Characteristics

The Hygia Health Services CSS are identical to the original OEM devices in reference to the technological characteristics.

#### 8. Performance Data

Functional testing, cleaning validation, and biocompatibility data demonstrates that the reprocessed oximetry sensors perform as intended, and are safe and effective.

#### 9. Conclusion

Based on the assessment of functional testing, cleaning validation, and biocompatibility data, Hygia Health Services concludes that the Hygia Health Services Reprocessed CSS are substantially equivalent to the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

# MAT - 4 2010

Hygia Health Services, Inc. % Mr. Lake Trechsel R & D Engineer 434 Industrial Lane Birmingham, Alabama 35211

Re: K100523

Trade/Device Name: Hygia Health Services Reprocessed Cerebral-Somatic Oximetry Sensor (CSS) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: NMD Dated: February 23, 2010 Received: February 25, 2010

Dear Mr. Trechsel:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. Lake Trechsel

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 (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.

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/CDRHQffices/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" (21CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark M. Millers

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications For Use

510(k) Number (if Known): K 100 523

Device Name:

Hygia Health Services Reprocessed Cerebral-Somatic Oximetry Sensor (CSS)

Indications For Use:

The Hygia Health Services Reprocessed Pediatric and Adult Cerebral-Somatic Oximetry Sensors are indicated for use when continuous noninvasive oxygen saturation is required for pediatric patients weighing < 40 kg and adult patients weighing > 40 kg, respectively. The Hygia reprocessed sensor has been validated with the OEM's Cerebral/Somatic Oximeter, Model 5100C and is intended to be used with the Cerebral/Somatic Oximeter, Model 5100C only.

The noninvasive 5100C Cerebral/Somatic Oximeter 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 noflow ischemic states. The prospective clinical value of data from the 5100C Cerebral/Somatic Oximeter has not been demonstrated in disease states. The OEM suggests the 5100C Cerebral/Somatic Oximeter should not be used as the sole basis for diagnosis or therapy.

Prescription Use Yes (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use No (21 CFR 801 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nuth Rp Qala for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100523

Page 1 of 1

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| OEM<br>Catalog # | Hygia<br>Catalog # | Product<br>Description | Intended<br>Oximeter | Maximum<br># of Reprocessing<br>Cycles |
|------------------|--------------------|-----------------------------------------------|---------------------------|----------------------------------------|
| SAFB-SM | HHS-SAFB-<br>SM | Adult Cerebral-Somatic<br>Oximetry Sensor | Somanetics<br>INVOS 5100C | 2 |
| SPFB-<br>USA | HHS-SPFB-<br>USA | Pediatric Cerebral-Somatic<br>Oximetry Sensor | Somanetics<br>INVOS 5100C | 2 |

# PRODUCT SUBMISSION CHART

Neil R.P. Gade, Sr. mem

(Division Sign-Off) (Division Sign of Surgical, Orthopedic, Division of Surgers and Restorative Devices

510(k) Number K100523

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