CHEETAH NICOM SYSTEM

K101487 · Cheetah Medical, Inc. · DXG · Jul 2, 2010 · Cardiovascular

Device Facts

• Record ID: K101487
• Device Name: CHEETAH NICOM SYSTEM
• Applicant: Cheetah Medical, Inc.
• Product Code: DXG · Cardiovascular
• Decision Date: Jul 2, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1435
• Device Class: Class 2

Intended Use

The Cheetah Reliant with NIBP functionality is a portable, non-invasive Cardiac Output monitoring device that monitors and displays a patient' Cardiac Output (CO) in Ltr/Min with a non-invasive blood pressure function that non-invasively measures and displays blood pressure (diastolic, systolic, and mean). In addition, the device measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the Cheetah Reliant. These parameters are: Cardiac Index (CI), Ventricular Ejection Time (VET), Total Peripheral Resistance Index (TPRI), Stroke Volume Index (SVI), Stroke Volume Variation (SVV), Cardiac Power (CP), Cardiac Power Index (CPI) and Thoracic Fluid Content (TFC). The Cheetah Reliant with NIBP functionality is intended for use within hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient care. The alternative NICOM Sensors are disposable electrodes used in conjunction with the Cheetah Medical NICOM signal processing product line.

Device Story

Cheetah NICOM System is a portable, non-invasive cardiac output (CO) monitor; utilizes electrical bioimpedance/bioreactance technology. System inputs: electrical signals from disposable NICOM sensor array placed on thorax; high-frequency sine wave injected into body; voltage measured at adjacent electrodes. Processing: calculates impedance to current flow; constructs electrical bio-reactance waveform; derives CO and hemodynamic parameters (CI, VET, TPRI, SVI, SVV, CP, CPI, TFC). Output: real-time display of CO, blood pressure, and hemodynamic indices. Used in hospitals/clinics by healthcare providers to assess patient hemodynamic status; aids clinical decision-making regarding fluid management and cardiovascular therapy. Benefits: provides continuous, non-invasive hemodynamic monitoring without risks associated with invasive catheters.

Clinical Evidence

Clinical testing performed on 15 patients undergoing cardiac output evaluation. Compared alternative NICOM sensors against previously cleared NICOM electrodes. Data demonstrated substantial equivalence in performance.

Technological Characteristics

Non-invasive electrical bioimpedance/bioreactance monitoring. Disposable double-electrode stickers. Standards: AAMI/ANSI EC12:2000/(R)2005, EC53:1995/1998, IEC 60601-1, ASTM F640, ISO 10993-1/5/10. System includes signal processing unit for waveform construction and hemodynamic calculation.

Indications for Use

Indicated for patients requiring non-invasive cardiac output and hemodynamic monitoring in hospital or outpatient clinical settings. No specific age or gender contraindications stated.

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.

Predicate Devices

• NICOM electrodes (K071631)
• Cheetah Reliant (K083093)

Submission Summary (Full Text)

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Cheetah Medical

Cheetoh Medical Inc 2828 SW Corbett Avenue Portland, Oregon 97201 USA

K101487

SECTION 5: 510(k) Summary

Cheetah Medical, Inc. Submitter: 2828 SW Corbett Avenue, Suite 214-C Portland, Oregon 97201, USA

JUL -- 2 2010

## Contact Person:

Rhona Shanker Regulatory Consultant to Cheetah Medical, Inc. Z & B Enterprises, Inc. North Potomac, MD 20878 Ph: [phone] Fax: [phone]

Date Prepared: May 27, 2010

### Device Information

Trade name: Cheetah NICOM System

Classification Name: Pre-Programmable Diagnostic Computer, 21 CFR 870.1435, Product code: DXG; Electrocardiograph electrode, 21 CFR 870.2360, Product Code DRX

# Devices to which substantial equivalence is claimed:

| 510(k) number | Trade or propriety name | Submitter |
|---------------|-------------------------|----------------------|
| K071631 | NICOM electrodes | Cheetah-Medical Inc. |
| K083093 | Cheetah Reliant | Cheetah Medical Inc. |

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Portland, Oregon 9720 USA

#### Device Description:

The Cheetah Reliant non-invasive CO monitor (NICOM) is a portable, non-invasive, Cardiac Output detector system. The NICOM system measures the Cardiac Output by employing the electrical bioimpedance measurement technique. Electrical bio-impedance is the characteristic impedance of a volume of tissue and fluid. In the case of Cardiac Output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood.

Cheetah Medical's alternative NICOM Sensor is a double electrode sticker. Within each sticker, one electrode is used to inject the a high frequency sine wave into the body, while the resulting voltage is measured at the adjacent electrode. An array of such electrodes is placed at specific areas of the thorax, the impedance to the current flow calculated, and finally the electrical bio-reactance waveform constructed.

#### Indication for Use:

The Cheetah Reliant with NIBP functionality is a portable, noninvasive Cardiac Output monitoring device that monitors and displays a patient' Cardiac Output (CO) in Ltr/Min with a non-invasive blood pressure function that non-invasively measures and displays blood pressure (diastolic, systolic, and mean). In addition, the device measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the Cheetah Reliant. These parameters are: Cardiac Index (CI), Ventricular Ejection Time (VET), Total Peripheral Resistance Index (TPRI), Stroke Volume Index (SVI), Stroke Volume Variation (SVV), Cardiac Power (CP), Cardiac Power Index (CPI) and Thoracic Fluid Content (TFC). The Cheetah Reliant with NIBP functionality is intended for use within hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient care.

The alternative NICOM Sensors are disposable electrodes used in conjunction with the Cheetah Medical NICOM signal processing product line.

## Brief Description of Non-Clinical Testing

The electrodes were tested for and meet the requirements in the following documents:

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Image /page/2/Picture/0 description: The image shows the logo for Cheetah Medical. The logo features a stylized silhouette of a cheetah leaping forward. Below the cheetah is the text "Cheetah Medical" in a simple, sans-serif font.

Cheetah Medical. 2828 SW Corbett Avenue Portland, Oregon 97201 USA

| AAMI/ANSI EC12:2000/(R)2005,<br>3rd edition | Disposables ECG Electrodes |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| AAMI/ANSI EC53:1995 ECG | Cables and Lead Wires |
| AAMI/ANSI EC53:1998 ECG | Cables and Lead Wires |
| IEC 60601-1: 1988 +A1 1991+A2 | Medical electrical equipment - Part 1: |
| 1995 § -56.3(c) | General requirements for basic safety and<br>essential performance: - Connectors |
| ASTM F640 | Radio Opacity degree |
| AAMI/ANSI EC12-4.3 | Biological Response |
| ISO 10993-1 | Biological evaluation of medical devices Part<br>1:<br>Evaluation and testing |
| ISO 10993-5 | Biological evaluation of medical devices Part<br>5: Tests for in vitro cytotoxicity. |
| USP AGAR diffusion method | |
| ISO 10993-10 | Biological evaluation of medical devices Part<br>10:<br>Tests for irritation and delayed-type<br>hypersensitivity |

## Brief Description of Clinical Testing

The alternative NICOM Electrodes were tested on 15 patients who underwent cardiac output evaluation at Cheetah-Medical Ltd. with the alternative NICOM sensors and the NICOM electrodes cleared for use with the Reliant System.

The data demonstrated that the alternative NICOM Sensors are substantially equivalent to the NICOM electrodes cleared for use with the Reliant System.

## Conclusion

The alternative NICOM Sensors manufactured by INTEGRAL PROCESS / Conflans Sainte Honorine, France for Cheetah Medical were extensively tested (bench and clinical) and shown to be substantially equivalent to the NICOM electrodes cleared under K071631 and with K08209

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

JUL-2-2010-

Cheetah Medical, Inc. c/o Ms. Rhona Shanker Regulatory Consultant Z&B Enterprises, Inc. 12154 Darnestown Road Gaithersburg, MD 20878

Re: K101487

Trade/Device Name: Cheetah NICOM System Regulation Number: 21 CFR 870.1435 Regulation Name: Pre-programmable diagnostic computer Regulatory Class: Class II (two) Product Code: DXG Dated: May 27, 2010 Received: May 28, 2010

## Dear Ms. Shanker:

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, Trug 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 misbrandijng and adulteration.

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 over 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 not the Act

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Page 2 - Ms. Rhona Shanker

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.

http://www.fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm.

Sincerely yours,

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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# SECTION 4: Indications for Use

K101487 510(k) Number:

Device Name: Cheetah NICOM System

#### Indications for Use:

The Cheetah Reliant with NIBP functionality is a portable, non-invasive Cardiac Output monitoring device that monitors and displays a patient' Cardiac Output (CO) in Ltr/Min with a non-invasive blood pressure function that non-invasively measures and displays blood pressure (diastolic, systolic, and mean). In addition, the device measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the Cheetah Reliant. These parameters are: Cardiac Index (CI), Ventricular Ejection Time (VET), Total Peripheral Resistance Index (TPRI), Stroke Volume Index (SVI), Stroke Volume Variation (SVV), Cardiac Power (CP), Cardiac Power Index (CPI) and Thoracic Fluid Content (TFC). The Cheetah Reliant with NIBP functionality is intended for use within hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient care.

The alternative NICOM Sensors are disposable electrodes used in conjunction with the Cheetah Medical NICOM signal processing product line.

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

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

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

W. Wood.

Division Sign-Off) Division of Cardiovascular Devices

510(k) Number.