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.

Device Description

The Pacifica Model 01 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. The Pacifica Model 01 uses three low energy laser light sources for illuminating the tissue at three discrete wavelengths, and measures the optical attenuation of each light wavelength (mu, mu', mu'') as a function of depth, in the tissue. From the ratio of differences of the three optical attenuations, the oxygen saturation level is determined.

The Pacifica Model 01 comprises a display and processing unit and a probe that is coupled to the patient using a single use biocompatible adhesive. When the probe is attached to the patient, the system is operated to monitor the tissue blood oxygen saturation level. The probe is connected to the display and processing unit via optical fibers and electronic cables. The display and processing unit includes three separate units (a power unit, a transmitter-receiver unit and a processing unit) and a display.

The Pacifica Model 01 can be operated in two modes: Cerebral mode and Muscle mode. Muscle mode should only be used when the probe is attached to a muscle or soft tissue. Cerebral mode should be used when the probe is applied to the skull

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pacifica Model 01 device:

Important Note: The provided document is a 510(k) summary and the FDA's clearance letter. While it states that "clinical studies indicate the device is substantially equivalent to the predicates cited," it does not detail the specific acceptance criteria or the full study methodology, results, or sample sizes used to demonstrate this equivalence. It only generally states that safety and effectiveness evaluations were done. Therefore, much of the requested information cannot be definitively extracted from this document alone.

Acceptance Criteria and Device Performance (Based only on the provided text)

Acceptance Criteria Category	Specific Acceptance Criteria (as implied or stated)	Reported Device Performance
Substantial Equivalence	Device is as safe and effective as identified predicate devices.	The results of the evaluation support the conclusion that it is as safe and effective as, and is substantially equivalent to, the cited predicate devices.
Technical Parameters	Differences in technical parameters (compared to predicates) are minor and do not affect safety or effectiveness.	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.
Clinical Performance	Demonstrated clinical performance comparable to predicate devices in animal and human studies.	Safety and effectiveness evaluations based on animal and clinical studies indicate the device is substantially equivalent to the predicates cited.

Study Details (Based only on the provided text)

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document. The text only vaguely mentions "animal and clinical studies."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not provide details about how ground truth was established for any clinical evaluations.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance?
- Not applicable. The Pacifica Model 01 is an oximeter, not an AI-assisted diagnostic imaging device for human readers. Its primary output is a numerical oxygen saturation level.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device itself appears to be a standalone monitor providing a direct measurement (hemoglobin oxygen saturation). The study would likely evaluate its accuracy against a gold standard or predicate device. The document states it is "intended for use as an adjunct monitor," implying a human-in-the-loop for diagnosis and therapy, but the performance evaluation would be of the device's accuracy in producing a reading. However, the details of such a "standalone" performance study (its specific methodology, sample size, and results) are not provided in this summary.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. For an oximeter, "ground truth" would typically involve a co-oximetry reference method on arterial blood samples. The document does not specify what method was used for the "clinical studies."
The sample size for the training set:
- Not applicable/Not specified. This device is a hardware oximeter, and the summary does not mention any "training set" in the context of an algorithm or machine learning model. If a calibration or internal algorithm development process was involved, details are not provided.
How the ground truth for the training set was established:
- Not applicable/Not specified for the reasons above.

Summary of Limitations:

This 510(k) summary is a high-level overview. It confirms that "animal and clinical studies" were performed to demonstrate substantial equivalence to predicate devices, and that these studies "indicate the device is substantially equivalent." However, it does not provide the detailed scientific evidence, specific acceptance criteria, study methodologies, exact sample sizes (for either training or testing if applicable), ground truth establishment methods, or performance metrics that would typically be found in a full study report. To get that level of detail, one would need to review the complete 510(k) submission, which is not publicly available in this format.

Summary

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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 StreetLod, 71291Israel
Contact Person:	Michal Balberg, PhDActing Chief Executive Officer and Chief TechnicalOfficerTel: +972-8-9282801Fax: +972-8-9282805michalb@ornim.com

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)Somanetics Corp.Class II
	Adult Cerebral Oximeter Monitor Model 2040 (K051257)CAS Medical Inc.Class II
	InSpectra StO2 Tissue Oxygenation Monitor (K061619)Hutchinson Technology, Inc.Class II
Device Description:	The Pacifica Model 01 uses the well established principlesof near infrared spectroscopy (NIRS) to monitor theconcentration of oxygenated hemoglobin relative to thetotal concentration of hemoglobin in the blood. The
	Pacifica Model 01 uses three low energy laser light sourcesfor illuminating the tissue at three discrete wavelengths,and measures the optical attenuation of each lightwavelength ( $\mu$ , $\mu'$ , $\mu''$ ) as a function of depth, in the tissue.From the ratio of differences of the three opticalattenuations, the oxygen saturation level is determined.
	The Pacifica Model 01 comprises a display and processingunit and a probe that is coupled to the patient using a singleuse biocompatible adhesive. When the probe is attached tothe patient, the system is operated to monitor the tissueblood oxygen saturation level. The probe is connected tothe display and processing unit via optical fibers andelectronic cables. The display and processing unit includesthree separate units (a power unit, a transmitter-receiverunit and a processing unit) and a display.
	The Pacifica Model 01 can be operated in two modes:Cerebral mode and Muscle mode. Muscle mode shouldonly be used when the probe is attached to a muscle or softtissue. Cerebral mode should be used when the probe isapplied to the skull
Intended Use:	The Pacifica Model 01 is intended to monitor oxygensaturation of blood in the body.
Indications for Use:	The noninvasive Or-Nim Pacifica Model 01 monitor isintended for use as an adjunct monitor of regionalhemoglobin oxygen saturation of blood in the brain of anadult. It is also intended for use as an adjunct monitor ofhemoglobin oxygen saturation of blood in a region ofskeletal muscle tissue beneath the sensor in adults. Theprospective clinical value of data from the Pacifica monitorhas not been demonstrated in disease states. The Pacificamonitor should not be used as the sole basis for diagnosisor 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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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:

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

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).