CEROX

K131854 · Or-Nim Medical , Ltd. · DPW · Sep 13, 2013 · Cardiovascular

Device Facts

• Record ID: K131854
• Device Name: CEROX
• Applicant: Or-Nim Medical , Ltd.
• Product Code: DPW · Cardiovascular
• Decision Date: Sep 13, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2100
• Device Class: Class 2

Indications for Use

The non-invasive CerOx 3215FO monitor is intended for use as an adjunct monitor of microcirculation blood flow in tissue. The CerOx 3215FO monitor is intended for monitoring of adults. The prospective clinical value of data from the CerOx 3215FO monitor has not been demonstrated in disease states. The CerOx 3215FO monitor should not be used as the sole basis for diagnosis or therapy.

Device Story

The CerOx Model 3215FO is a non-invasive monitor for microcirculation blood flow in tissue. It utilizes near-infrared spectroscopy (NIRS) and flowmetry principles to acquire signals from tissue. The device processes these optical and acoustic inputs to provide blood flow monitoring data. It is intended for use in adults as an adjunct monitor. The device is operated by healthcare professionals to assist in clinical assessment, though it is not intended to serve as the sole basis for diagnosis or therapy. The device is technically and operationally identical to the predicate CerOx 3210F.

Clinical Evidence

No clinical data. Bench testing only: optical output power of lasers and acoustic output power of ultrasound transducers were tested and found equivalent to the predicate device. Laboratory setup testing confirmed equivalence of detected light signal amplitudes.

Technological Characteristics

Near-infrared spectroscopy (NIRS) and flowmetry sensing. Employs lasers and ultrasound transducers. Device is a non-invasive monitor for adult tissue. Technical specifications and output power are identical to the predicate CerOx 3210F.

Indications for Use

Indicated for non-invasive adjunct monitoring of microcirculation blood flow in adult tissue. Not for use as sole basis for diagnosis or therapy; clinical value in disease states not demonstrated.

Regulatory Classification

Identification

A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.

Predicate Devices

• CerOx 3210F

Submission Summary (Full Text)

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

KT31854

Special 510(k) Premarket Notification CerOx Model 3215FO

Or-Nim Medical Ltd.

### 9. 510(K) SUMMARY

par

a)

Submission Date: June 18, 2013

#### Submitter Information:

Company Name: Or-Nim Medical Ltd.

Company Address:

Atir Yeda St. Kfar Saba. 4464312 Israel

#### Contact Person:

Micha Oestereich QA/RA Director Or-Nim Medical Ltd. Tel: [phone] Fax: [phone] [e-mail]

#### Device Information:

| Trade Name: | CerOx Model 3215FO |
|-------------------------|-----------------------------------------------------|
| Common<br>Name: | Flowmeter, blood, cardiovascular |
| Classification<br>Name: | Cardiovascular blood flowmeter (21 CFR<br>870.2100) |
| Product<br>Code: | DPW |
| Regulatory<br>Class: | II |

Predicate Device: CerOx 3210F. Or-Nim Medical Ltd.

Device Description: The CerOx Model 3215FO uses the well-established principles of near infrared spectroscopy (NIRS) and flowmetry to monitor blood flow in tissue.

SEP 1 3 2013

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

.

CerOx Model 3215FO is identical to the CerOx Model 3210F technically and operationally.

The CerOx Model 3215FO is intended to monitor blood flow in Intended Use: tissue

Indications for Use: The non-invasive CerOx 3215FO monitor is intended for use as an adjunct monitor of microcirculation blood flow in tissue. The CerOx 3215FO monitor is intended for monitoring of adults. The prospective clinical value of data from the CerOx 3215FO monitor has not been demonstrated in disease states. The CerOx 3215FO monitor should not be used as the sole basis for diagnosis or therapy.

Comparison to Predicate Device: The CerOx 3215FO is identical to the CerOx 3210F technically and operationally, and has the same intended use and indications for use as the CerOx 3210F with respect to blood flow monitoring.

Tests performed: The optical output power of the lasers and the acoustic output power of the ultrasound transducers of the CerOx 3125FO was tested and found to be equivalent to that emitted by the CerOx 3210F. In addition the amplitude of the light signals detected by the CerOx 3215FO on a laboratory set up was tested and found to be equivalent to that detected by the CerOx 3210F.

The tests performed on CerOx Model 3215FO support the Conclusions: conclusion that it remains as safe and effective as, and remains substantially equivalent to the cleared predicate device CerOx 3210F for the monitoring of microcirculation blood flow in tissue.

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 13. 2013

Or-Nim Medical Ltd. Mr. Micha Oestercich QA/RA Director 15 Atir Yeda Street Kfar Saba, 4464312 l sraci

Re: K131854

Trade/Device Name: CerOx Model 3215FO Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular blood flowmeter Regulatory Class: Class II Product Code: DPW Dated: August 7, 2013 Received: August 16. 2013

Dear Mr. Oestereich:

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 Amendnents, or 10 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 cither 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 FIDA'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

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

Page 2 - Mr. Micha Oestereich

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 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 331-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 CDRI4'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.hum.

Sincerely yours.

# David Krause -S

- Mark N. Melkerson for: Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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

## Indications for Use

510(k) Number: K131854

Device Name: CerOx Model 3215FO

Indications for Use:

The non-invasive CerOx 3215FO monitor is intended for use as an adjunct monitor of microcirculation blood flow in tissue. The CerOx 3215FO monitor is intended for monitoring of adults.

The prospective clinical value of data from the CerOx 3215FO monitor has not been demonstrated in disease states. The CerOx 3215FO monitor should not be used as the sole basis for diagnosis or therapy.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Neil R Ogden 2013.09.13 10:41:26 -04'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number ___ K131854

Page 1 of __ 1 __ 1