(218 days)
Not Found
No
The description focuses on bio-impedance measurement and signal processing techniques, with no mention of AI or ML.
No
The device is described as a "monitoring device" intended to "monitor and display" cardiac output, which indicates it provides diagnostic information rather than directly treating a condition.
Yes
The device is intended to "monitor and display a patient's Cardiac Output", which is a measurement of physiological parameters used to assess a patient's health status. This falls under the definition of a diagnostic device.
No
The device description explicitly details hardware components (portable system, electrodes) and their function in measuring bio-impedance, indicating it is not software-only.
Based on the provided information, the Cheetah NICOM system is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or treatment.
- Cheetah NICOM's Function: The Cheetah NICOM system measures cardiac output by applying electrical bio-impedance directly to the patient's thorax. It does not analyze samples taken from the body.
- Intended Use: The intended use is to "monitor and display a patient's Cardiac Output," which is a direct measurement on the patient, not an analysis of a sample.
- Device Description: The description details the application of electrodes to the body and the measurement of electrical impedance within the thorax. This is an in-vivo measurement, not an in-vitro test.
Therefore, the Cheetah NICOM system falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DXG; DRX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thorax
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
NICOM Electrodes were tested on:
-
- 119 consecutive patients requiring PAC in the immediate postoperative period following cardiac surgery - No adverse events were reported.
-
- 36 patients undergoing cardiac output evaluation during stress testing in Lonestar Heart Center, Amarillo, Texas, US. No adverse events were reported.
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- 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Brief Description of Non-Clinical Testing
-
- Electrodes were tested per ANSI/AAMI EC12:2000/(R)2005; Disposable ECG electrodes, 3ed.
-
- Biocompatibility was confirmed per ISO-10993 standard; Biological Evaluation of Medical Devices.
Brief Description of Clinical Testing
NICOM Electrodes were tested on:
-
- 119 consecutive patients requiring PAC in the immediate postoperative period following cardiac surgery - No adverse events were reported.
-
- 36 patients undergoing cardiac output evaluation during stress testing in Lonestar Heart Center, Amarillo, Texas, US. No adverse events were reported.
-
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).
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K071631/52
p1/3
Image /page/0/Picture/1 description: The image shows the logo for Cheetah Medical. The logo features a stylized drawing of a cheetah leaping forward. Below the cheetah drawing, the words "Cheetah Medical" are printed in a simple, sans-serif font.
10291 N M Suito 10 Indianapolis, IN . I ISA
Image /page/0/Picture/3 description: The image is a gradient that transitions from white to black. The left side of the image is predominantly white, with a gradual increase in black speckles and shading as it moves towards the right. The right side of the image is almost entirely black, with only a few scattered white pixels. The transition between the two colors is smooth and gradual.
SECTION 5: 510(k) Summary
Submitter
Cheetah Medical, Inc. 2138 East 62nd Street, Suite 132 Indianapolis, IN 46250 USA Toll Free: (+1) 866 751 9097 Fax: (+1) 916 367 6717
Contact Person
Rhona Shanker Z & B Enterprises, Inc. 12154 Darnestown Road, #236 Gaithersburg, MD 20878 Ph: 301-251-9570 Fax: 301-251-9571 rhonashanker@comcast.net
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. (+1) 317-660-6649 ● Fax.(+1) 317-660-6650 新闻 发布时间: 上一篇:
JAN 18 2008
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Image /page/1/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.
Indianapolis, IN 46290
Image /page/1/Picture/3 description: The image is mostly black with some white noise on the left side. The white noise appears to be concentrated on the left side of the image, gradually fading into the black background. The black background is uniform and covers most of the image. The image has a grainy texture.
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
-
- Electrodes were tested per ANSI/AAMI EC12:2000/(R)2005; Disposable ECG electrodes, 3ed.
-
- Biocompatibility was confirmed per ISO-10993 standard; Biological Evaluation of Medical Devices.
Tel. (+1) 317-660-6649 · Fax.(+1) 317-660-6650 · 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
Image /page/2/Picture/3 description: The image is a black and white gradient. The left side of the image is white, and the right side is black. The gradient is smooth, and there are no sharp edges. The image is simple and abstract.
Brief Description of Clinical Testing
NICOM Electrodes were tested on:
-
- 119 consecutive patients requiring PAC in the immediate postoperative period following cardiac surgery - No adverse events were reported.
-
- 36 patients undergoing cardiac output evaluation during stress testing in Lonestar Heart Center, Amarillo, Texas, US. No adverse events were reported.
-
- 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. (+1) 317-660-6649 · Fax.(+1) 317-660-6650 · www.cheetah-medical.con
· Dr. Dr. 257 255 255 255 255 255 2
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Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three wing-like strokes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sumar R. de Amez
ardiovascular Devices
10(k) Number. Tel. {+1) 317-660-6649 @ Fax.(+1) 317-660-6650 . www.cheetah-medical.com A STAND STATE A