NICOM

K042144 · Cheetah Medical, Inc. · DXG · Nov 12, 2004 · Cardiovascular

Device Facts

• Record ID: K042144
• Device Name: NICOM
• Applicant: Cheetah Medical, Inc.
• Product Code: DXG · Cardiovascular
• Decision Date: Nov 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1435
• Device Class: Class 2

Intended Use

The Cheetah NICOM system is a portable, non-invasive Cardiac Output monitoring device based on bio-Impedance Cardiography. The Cheetah NICOM system is intended to monitor and display a patient's Cardiac Output in units of [Ltr/Min].

Device Story

Cheetah NICOM is a portable, non-invasive cardiac output monitor utilizing bio-impedance cardiography. Device measures thoracic electrical bio-impedance to calculate and display cardiac output in Ltr/Min. Used in clinical settings to provide hemodynamic data to healthcare providers; output assists in clinical decision-making regarding patient fluid management and cardiovascular status. Benefits include non-invasive assessment of cardiac function without the risks associated with invasive monitoring catheters.

Clinical Evidence

No clinical data provided in the document; substantial equivalence based on technological and intended use comparison.

Technological Characteristics

Portable bio-impedance cardiography monitor. Measures thoracic electrical bio-impedance. Outputs cardiac output in Ltr/Min. Class II device, product code DXG.

Indications for Use

Indicated for patients requiring non-invasive cardiac output monitoring. Intended for prescription use.

Regulatory Classification

Identification

A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2004

Cheetah Medical, Inc. c/o Mr. Benny Arazy Arazy Group Mizpe Aviv, Industrial Park 13 M. P. Misgav 20187 ISRAEL

Re: K042144

Trade Name: EnSite System: Cheetah NICOM System Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function Pre-Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DXG Dated: October 29, 2004 Received: November 2, 2004

Dear Mr. Arazy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the endrosale) to tegains and the Medical Device Amendments, or to connineres proct to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, de vices that have been received in asse approval of a premarket approval application (PMA). and Cosmetic Act (110) that to hot requesubject to the general controls provisions of the Act. The r ou may, merelove, manel of the Act include requirements for annual registration, listing of general controls provisions of use tice, 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 rr your device is elaboriou (oor as controls. Existing major regulations affecting your device can may or subject to outer to out Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Benny Arazy

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dr has made a corel meallations administered by other Federal agencies. You must or any I catales and the Act's requirements, including, but not limited to: registration and listing (21 comply with an the 110 % 21 CFR Part 801); good manufacturing practice requirements as set OI It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the qualis) by bections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of to begin marketing your device as described in your Section 510(k) I mis lotter with and h your e FDA finding of substantial equivalence of your device to a legally promative notineansmy - 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 if you desire of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Blymmar for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K042144

Device Name: NICOM - A NON-INVASIVE CARDIAC OUTPUT MONITOR

Indications For Use:

The Cheetah NICOM system is a portable, non-invasive Cardiac Output monitoring device based on bio-Impedance Cardiography. The Cheetah NICOM system is intended to monitor and display a patient's Cardiac Output in units of [Ltr/Min].

Dr Hanan Keren
Chief Executive Officer (Name & Signature)

10 November 2004 Date

Prescription Use (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

P. Zimmerman
.on sign-Off

Cardiovascular Devices
510(k) number K042144

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