CEROX, MODEL 321OF

K100875 · Or-Nim Medical , Ltd. · MUD · Jan 25, 2011 · Cardiovascular

Device Facts

• Record ID: K100875
• Device Name: CEROX, MODEL 321OF
• Applicant: Or-Nim Medical , Ltd.
• Product Code: MUD · Cardiovascular
• Decision Date: Jan 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Indications for Use

The non-invasive CerOx 3210F monitor is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in a region of skeletal muscle tissue beneath the sensor. It is also intended for monitoring of microcirculation blood flow in tissue. The CerOx 3210F monitor is intended for monitoring of adults. The prospective clinical value of data from the CerOx 3210F monitor has not been demonstrated in disease states. The CerOx 3210F monitor should not be used as the sole basis for diagnosis or therapy.

Device Story

CerOx 3210F is a non-invasive monitor for adult patients; utilizes near-infrared spectroscopy (NIRS) to measure regional hemoglobin oxygen saturation; employs Laser Doppler flowmetry principles to monitor microcirculatory blood flow in brain or skeletal muscle tissue. Device inputs are light signals from tissue; processed to output oxygenation and blood flow metrics. Used in clinical settings as an adjunct monitor; provides data to healthcare providers to assist in patient assessment. Not intended as sole basis for diagnosis or therapy; prospective clinical value in disease states not demonstrated.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Uses near-infrared spectroscopy (NIRS) for oxygen saturation and Laser Doppler flowmetry principles for microcirculation blood flow. Non-invasive sensor placed on brain or skeletal muscle. Standalone monitor for adult use.

Indications for Use

Indicated for adult patients as an adjunct monitor for regional hemoglobin oxygen saturation in brain or skeletal muscle tissue and for monitoring microcirculation blood flow in tissue. 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

• CerOx 3210 (Or-Nim Medical Ltd.)
• Laserflo Blood Perfusion Monitor BPM2 (Vasamedics L.L.C.)

Submission Summary (Full Text)

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K 100875
Or-Nim Medical Ltd.

## 9. 510(K) SUMMARY

Submission Date: March 25, 2010

Submitter Information:

Company Name:

Or-Nim Medical Ltd.

Company Address:

1 Yodfat Street Lod, 71291 Israel

## Contact Person:

Michal Balberg, PhD Chief Technical Officer Or-Nim Medical Ltd. Tel: [phone] Fax: [phone] [e-mail]

## Device Information:

| Trade Name: | CerOx Model 3210F |
|-------------------------|---------------------------------------------------------------------------------------------------|
| Common<br>Name: | Oximeter/Cerebral Oximeter/Tissue Oximeter<br>Flowmeter, blood, cardiovascular |
| Classification<br>Name: | Oximeter, Tissue Saturation (21 CFR 870.2700)<br>Cardiovascular blood flowmeter (21 CFR 870.2100) |
| Product<br>Code: | MUD, DPW |
| Regulatory<br>Class: | II |

Predicate Device: CerOx 3210, Or-Nim Medical Ltd. Laserflo Blood Perfusion Monitor. BPM2, Vasamedics L.L.C. Device Description: The CerOx Model 3210F uses the well-established principles of near infrared spectroscopy (NIRS) to monitor the concentration of oxygenated hemoglobin relative to the total concentration of hemoglobin in the blood. In addition, it employs principles similar to those of Laser Doppler flowmetry to monitor the microcircular blood flow in tissue.

CONFIDENTIAL

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CerOx Model 3210F is identical to the CerOx Model 3210. It utilizes the same technical and operational methods.

- Intended Use: The CerOx Model 3210F is intended to monitor oxygen saturation and blood flow in tissue
The non-invasive CerOx 3210F monitor is intended for use as an adjunct Indications for Use: monitor of regional hemoglobin oxygen saturation of blood in the brain or in a region of skeletal muscle tissue beneath the sensor. It is also intended for monitoring of microcirculation blood flow in tissue. The CerOx 3210F monitor is intended for monitoring of adults.

> The prospective clinical value of data from the CerOx 3210F monitor has not been demonstrated in disease states. The CerOx 3210F monitor should not be used as the sole basis for diagnosis or therapy.

Comparison to Predicate Device: The CerOx 3210F is identical to the CerOx 3210 in hardware and operation, and has the same intended use and indications for use for tissue oximetry as the CerOx 3210. The CerOx 3210F performs an additional analysis of the light signals to enable monitoring of microcirculatory blood flow in tissue. In this respect it is substantially equivalent to the Laserflo Blood Perfusion Monitor BPM2 for this indication.

Conclusions: The tests performed on CerOx Model 3210F support the conclusion that it remains as safe and effective as, and remains substantially equivalent to, the cleared predicate device CerOx 3210 for the monitoring of tissue blood oxygen saturation. The data presented and the tests performed also support the conclusion that the CerOx 3210F is substantially equivalent to the cleared predicate device Laserflo Blood Perfusion Monitor BPM2, for the monitoring of microcirculation blood flow in tissue.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

Or-Nim Medical Ltd. % Michal Balberg, Ph.D. 1 Yodfat Street Lod, 71291, Israel

JAN 2 5 2011

Re: K100875

Trade/Device Name: CerOx Model 3210F Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD, DPW Dated: December 08, 2010 Received: December 15, 2010

Dear Dr. Balberg:

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. Iisting 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 -- Michal Balberg, Ph.D.

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 (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/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" (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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

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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## 8. STATEMENT OF INDICATIONS FOR USE

K 100875 510(k) Number (if known):

Device Name:

CerOx Model 3210F

Indications for Use:

The non-invasive CerOx 3210F monitor is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in a region of skeletal muscle tissue beneath the sensor. It is also intended for monitoring of microcirculation blood flow in tissue. The CerOx 3210F monitor is intended for monitoring of adults.

The prospective clinical value of data from the CerOx 3210F monitor has not been demonstrated in disease states. The CerOx 3210F monitor should not be used as the sole basis for diagnosis or therapy.

| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|----------------------------------------------|--------|
| | AND/OR |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)

Division of Surgical, Orthopedic,

and Restorative Devices

510(k) Number K100875

Concurrence of CDRH. Office of Device Evaluation (ODE)

CONFIDENTIAL