NICOM ELECTRODES

K071631 · Cheetah Medical, Inc. · DXG · Jan 18, 2008 · Cardiovascular

Device Facts

• Record ID: K071631
• Device Name: NICOM ELECTRODES
• Applicant: Cheetah Medical, Inc.
• Product Code: DXG · Cardiovascular
• Decision Date: Jan 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1435
• Device Class: Class 2

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, and was cleared under K042144. NICOM Electrodes are disposable electrodes used in conjunction with the NICOM signal processing product line.

Device Story

Cheetah NICOM is a portable, non-invasive cardiac output monitoring system. It utilizes electrical bio-impedance measurement; a high-frequency sine wave is injected into the thorax via disposable dual-electrode stickers; voltage is measured at adjacent electrodes. The system calculates impedance to current flow and constructs an electrical bio-reactance waveform to determine cardiac output. Used in clinical settings by healthcare providers to monitor hemodynamic status. Output is displayed in L/min, assisting clinicians in hemodynamic decision-making and patient management.

Clinical Evidence

Clinical testing included: 1) 119 post-cardiac surgery patients requiring PAC; 2) 36 patients undergoing stress testing; 3) Comparative study of 10 subjects using NICOM electrodes vs. 3M Red Dot electrodes. No adverse events reported. Results confirmed substantial equivalence of NICOM electrodes to 3M Red Dot electrodes.

Technological Characteristics

Portable non-invasive cardiac output monitor. Uses electrical bio-impedance/bio-reactance. Employs disposable dual-electrode stickers. Bench testing per ANSI/AAMI EC12:2000/(R)2005. Biocompatibility per ISO-10993. Signal processing product line.

Indications for Use

Indicated for monitoring and displaying cardiac output (L/min) in patients via non-invasive bio-impedance cardiography. Prescription use only.

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

• VIGILANCE CCO/SVO2/CEDV Monitor (K000664)
• NICOM Monitoring System (K042144)

Reference Devices

• 3M Health Care Red Dot electrodes

Submission Summary (Full Text)

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K071631/52
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10291 N M Suito 10 Indianapolis, IN . I ISA

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# SECTION 5: 510(k) Summary

#### Submitter

Cheetah Medical, Inc. 2138 East 62nd Street, Suite 132 Indianapolis, IN 46250 USA Toll Free: ([phone] Fax: [phone]

#### Contact Person

Rhona Shanker Z & B Enterprises, Inc. 12154 Darnestown Road, #236 Gaithersburg, MD 20878 Ph: 301-251-9570 Fax: [phone] [e-mail]

#### Date Prepared

January 10, 2008

#### Device Information

Trade name: Cheetah NICOM System

#### Common name: Cheetah NICOM

Classification Name: Pre-Programmable Diagnostic Computer (21 CFR 870.1435, Product Code: DXG; 21 CFR 870.2360 Product Code DRX)

> Tel. [phone] ● Fax.[phone] 新闻 发布时间: 上一篇:

JAN 18 2008

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K071631/52
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Indianapolis, IN 46290

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### Devices to which substantial equivalence is claimed:

The Cheetah NICOM system was found substantially equivalent to the VLIGILANCE CCO/CEDV 7 VIGILANCE CCO/SVO2/CEDV Monitor (K000664) under K042144.

The NICOM Electrodes are substantially equivalent to the electrodes cleared for marketing with the original NICOM Monitoring System (K042144), when used with the NICOM system. The electrodes cleared in the original submission were the Red Dot™ electrodes by 3M Health Care.

#### Device Description:

The Cheetah NICOM is a portable, non-invasive, Cardiac Output detector system. The NICOM system measures the Cardiac Output by employing the electrical bio-impedance 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 NICOM electrode is a double electrode sticker. Within each sticker, one electrode is used to inject 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 the electrical bio-reactance waveform constructed.

#### 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, and was cleared under K042144.

NICOM Electrodes are disposable electrodes used in conjuction with he NICOM signal processing product line.

#### Brief Description of Non-Clinical Testing

- 1. Electrodes were tested per ANSI/AAMI EC12:2000/(R)2005; Disposable ECG electrodes, 3ed.
- 2. Biocompatibility was confirmed per ISO-10993 standard; Biological Evaluation of Medical Devices.

Tel. [phone] · Fax.[phone] · www.cheetah.medical.com

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Image /page/2/Picture/1 description: The image shows the logo for Cheetah Medical. The logo includes a stylized image of a cheetah leaping forward. The text "Cheetah Medical" is written in a simple, sans-serif font below the cheetah image.

10291 N Meric Suite 100 Indianapolis, IN 46290 USA

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### Brief Description of Clinical Testing

NICOM Electrodes were tested on:

- 1. 119 consecutive patients requiring PAC in the immediate postoperative period following cardiac surgery - No adverse events were reported.
- 2. 36 patients undergoing cardiac output evaluation during stress testing in Lonestar Heart Center, Amarillo, Texas, US. No adverse events were reported.
- 3. Cardiac output was measured in 10 subjects with the NICOM System using the NICOM electrodes and using the 3M Health Care Red Dot electrodes. The results demonstrate that the NICOM electrodes are substantially equivalent to the 3M Health Care Red Dot electrodes when used with the NICOM System.

#### Conclusion

The NICOM Electrode is a dual electrode sticker, used in conjunction with its NICOM system to monitor cardiac output by measuring electrical impedance changes in the thorax region. The Cheetah NICOM system is intended for prescription use only.

NICOM electrodes were extensively tested (bench, animal, clinical) and proved to be safe and effective.

The data demonstrate that the NICOM electrodes are substantially equivalent to the 3M Red Dot Electrodes that were cleared with the original NICOM System (K042144) when used with the NICOM system.

Tel. [phone] · Fax.[phone] · www.cheetah-medical.con

· Dr. Dr. 257 255 255 255 255 255 2

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 18 2008

Cheetah Medical c/o Ms. Rhona Shanker Z & B Enterprises, Inc. 12154 Darnestown Road # 236 Gaithersburg, MD 20878

Re: K071631

Cheetah NICOM System Regulation Number: 21 CFR 870.1435 Regulation Name: Single-function preprogrammed diagnostic computer Regulatory Class: Class II (two) Product Code: DXG Dated: June 14, 2007 Received: June 14, 2007

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, 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.

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Page 2 - Ms. Rhona Shanker

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 forth in the quality systems (OS) 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 Office 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 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 yours.

Dma R. Vochner

A 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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K071631/52
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Image /page/5/Picture/1 description: The image shows the logo for Cheetah Medical. The logo features a stylized image of a cheetah leaping, with the text "Cheetah Medical" printed below the image. A trademark symbol is located to the right of the cheetah image.

10291 N. Meri Suite 100 Indianapolis, IN 46 USA

Image /page/5/Picture/3 description: The image appears to be a gradient that transitions from white to black. The left side of the image is predominantly white, with a high density of white pixels. As one moves towards the right, the white gradually fades into shades of gray, eventually becoming completely black on the right side. The transition is smooth, creating a visual effect of fading or blending.

# SECTION 4: Indications for Use

510(k) Number: K6716 3)

Device Name: Cheetah NICOM System

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, and was cleared under K042144.

NICOM Electrodes are disposable electrodes used in conjunction with the NICOM signal processing product line.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

sumar R. de Amez

ardiovascular Devices

10(k) Number. Tel. {[phone] @ Fax.[phone] . www.cheetah-medical.com A STAND STATE A