PACIFICA

K073407 · Or-Nim Medical , Ltd. · MUD · Feb 28, 2008 · Cardiovascular

Device Facts

• Record ID: K073407
• Device Name: PACIFICA
• Applicant: Or-Nim Medical , Ltd.
• Product Code: MUD · Cardiovascular
• Decision Date: Feb 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Indications for Use

The Pacifica Model 01 is intended to monitor oxygen saturation of blood in the body.

Device Story

Pacifica Model 01 is a noninvasive tissue oximeter using near-infrared spectroscopy (NIRS). Device utilizes three low-energy laser light sources at discrete wavelengths to illuminate tissue; measures optical attenuation as a function of depth. Processing unit calculates oxygen saturation level from the ratio of differences of the three optical attenuations. System comprises a display/processing unit connected via optical fibers and electronic cables to a probe attached to the patient with biocompatible adhesive. Operates in Cerebral mode (skull) or Muscle mode (skeletal muscle/soft tissue). Used in clinical settings by healthcare professionals. Output displayed on monitor to provide real-time regional hemoglobin oxygen saturation data. Serves as an adjunct monitor to assist clinicians in assessing tissue oxygenation; not intended as the sole basis for diagnosis or therapy.

Clinical Evidence

Substantial equivalence supported by animal and clinical studies. No specific performance metrics (e.g., sensitivity, specificity) provided in the summary document.

Technological Characteristics

NIRS-based tissue oximeter. Uses three low-energy laser light sources. Components: display/processing unit (power, transmitter-receiver, and processing modules), optical fibers, electronic cables, and single-use biocompatible adhesive probes. Operates in Cerebral or Muscle modes.

Indications for Use

Indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or skeletal muscle tissue of adults. Not for use as sole basis for diagnosis or therapy. Prospective clinical value in disease states not demonstrated.

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 5100B (K051274)
• Adult Cerebral Oximeter Monitor Model 2040 (K051257)
• InSpectra StO2 Tissue Oxygenation Monitor (K061619)

Submission Summary (Full Text)

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Traditional 510(k) Premarket Notification Pacifica Model 01

#### 7.0 510(K) SUMMARY

December 4, 2007 Submission Date:

# Submitter Information:

| Company Name: | Or-Nim Medical Ltd. |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Address: | 1 Yodfat Street<br>Lod, 71291<br>Israel |
| Contact Person: | Michal Balberg, PhD<br>Acting Chief Executive Officer and Chief Technical<br>Officer<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |

# Device Information:

| Trade Name: | Pacifica Model 01 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Oximeter/Cerebral Oximeter/Tissue Oximeter |
| Classification Name: | Oximeter, Tissue Saturation |
| Device Class: | Oximeter, 21 CFR §870.2700 |
| Predicate Devices: | INVOS 5100B (K051274)<br>Somanetics Corp.<br>Class II |
| | Adult Cerebral Oximeter Monitor Model 2040 (K051257)<br>CAS Medical Inc.<br>Class II |
| | InSpectra StO2 Tissue Oxygenation Monitor (K061619)<br>Hutchinson Technology, Inc.<br>Class II |
| Device Description: | The Pacifica Model 01 uses the well established principles<br>of near infrared spectroscopy (NIRS) to monitor the<br>concentration of oxygenated hemoglobin relative to the<br>total concentration of hemoglobin in the blood. The |
| | Pacifica Model 01 uses three low energy laser light sources<br>for illuminating the tissue at three discrete wavelengths,<br>and measures the optical attenuation of each light<br>wavelength ( $\mu$ , $\mu'$ , $\mu''$ ) as a function of depth, in the tissue.<br>From the ratio of differences of the three optical<br>attenuations, the oxygen saturation level is determined. |
| | The Pacifica Model 01 comprises a display and processing<br>unit and a probe that is coupled to the patient using a single<br>use biocompatible adhesive. When the probe is attached to<br>the patient, the system is operated to monitor the tissue<br>blood oxygen saturation level. The probe is connected to<br>the display and processing unit via optical fibers and<br>electronic cables. The display and processing unit includes<br>three separate units (a power unit, a transmitter-receiver<br>unit and a processing unit) and a display. |
| | The Pacifica Model 01 can be operated in two modes:<br>Cerebral mode and Muscle mode. Muscle mode should<br>only be used when the probe is attached to a muscle or soft<br>tissue. Cerebral mode should be used when the probe is<br>applied to the skull |
| Intended Use: | The Pacifica Model 01 is intended to monitor oxygen<br>saturation of blood in the body. |
| Indications for Use: | The noninvasive Or-Nim Pacifica Model 01 monitor is<br>intended for use as an adjunct monitor of regional<br>hemoglobin oxygen saturation of blood in the brain of an<br>adult. It is also intended for use as an adjunct monitor of<br>hemoglobin oxygen saturation of blood in a region of<br>skeletal muscle tissue beneath the sensor in adults. The<br>prospective clinical value of data from the Pacifica monitor<br>has not been demonstrated in disease states. The Pacifica<br>monitor should not be used as the sole basis for diagnosis<br>or therapy. |

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### Comparison to Predicate Device:

The Pacifica Model 01 and the cited predicate devices have the same intended use and are used on the same sites of the body. Some technical parameters differ between the Pacifica Model 01 and the predicate devices, but these differences are minor and do not affect safety or effectiveness. Safety and effectiveness evaluations based

#### CONFIDENTIAL

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on animal and clinical studies indicate the device is substantially equivalent to the predicates cited.

The results of the evaluation of the Pacifica Model 01 Conclusion: support the conclusion that it is as safe and effective as, and is substantially equivalent to, the cited predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and a human profile in the negative space between the wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle.

FEB 28 With

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Or-Nim Medical, Ltd. % Becker & Associates Consulting, Inc. Campbell Hutton Project Manager 2001 Pennsylvania Avenue, Northwest Suite 950 Washington, District of Columiba 20006

Re: K073407

Trade/Device Name: Pacifica Model 01 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: MUD Dated: December 4, 2007 Received: December 4, 2007

Dear Campbell Hutton:

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 – Campbell Hutton

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 vours.

Mark N Millman

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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#### 6.0 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K073407

Device Name: Pacifica Model 01

Indications for Use:

The noninvasive Or-Nim Pacifica Model 01 is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain of an adult. It is also intended for use as an adjunct monitor of hemoglobin oxygen saturation of blood in a region of skeletal muscle tissue beneath the sensor in adults. The prospective clinical value of data from the Pacifica monitor has not been demonstrated in disease states. The Pacifica monitor should not be used as the sole basis for diagnosis or therapy.

Caution: Federal law restricts this device to sale by or on the order of a medical practitioner licensed by the law of the State in which he / she practices to use or order the use of the device.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Mark A. Malthaner
concurrence of CDRH, Office of Device Evaluation (ODE)

(Divis ... Sign-Cit) Division of General, Restorative. and Neurological Devices

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**510(k) Number** K073407

CONFIDENTIAL