(35 days)
No
The document describes a device that uses electrical bio-impedance measurements and calculations based on these measurements to determine cardiac output and related parameters. There is no mention of AI, ML, or any related technologies in the description of the device's functionality or the performance studies.
No.
The device is a monitoring device that measures and displays cardiac output and associated hemodynamic parameters; it does not treat or alleviate a condition.
Yes
The device monitors and displays various physiological parameters (Cardiac Output, blood pressure, and other hemodynamic parameters), which are used to assess a patient's health status and can inform diagnosis.
No
The device description explicitly states that the system measures Cardiac Output by employing the electrical bio-impedance measurement technique using disposable electrodes placed on the thorax. This involves hardware components (electrodes and a system to inject current and measure voltage) in addition to any software processing.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The Cheetah Reliant with NIBP functionality is a monitoring device that measures physiological parameters directly from the patient's body using electrical bio-impedance and non-invasive blood pressure measurement. It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring cardiac output and blood pressure in patients within healthcare facilities. This is a direct patient monitoring function, not an in vitro diagnostic test.
- Device Description: The description details how the device applies electrodes to the thorax and measures electrical bio-impedance and blood pressure directly from the patient.
Therefore, the Cheetah Reliant with NIBP functionality falls under the category of a non-invasive patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DXG, DRX
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.
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
hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient care.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Cheetah Medical
Cheetoh Medical Inc 2828 SW Corbett Avenue Portland, Oregon 97201 USA
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: (301) 251-9570 Fax: (301) 251-9571
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. |
Page 1 of 3
1
Image /page/1/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.
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:
Image /page/1/Picture/10 description: The image shows the text "Page 2 of 3" in a handwritten style. The text is slightly slanted and the letters are connected. Below the text, there is a series of short, horizontal lines stacked on top of each other, resembling a brick wall pattern.
2
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,
| 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 |
| essential performance: - Connectors | |
| ASTM F640 | Radio Opacity degree |
| AAMI/ANSI EC12-4.3 | Biological Response |
| ISO 10993-1 | Biological evaluation of medical devices Part |
| 1: | |
| Evaluation and testing | |
| ISO 10993-5 | Biological evaluation of medical devices Part |
| 5: Tests for in vitro cytotoxicity. | |
| USP AGAR diffusion method | |
| ISO 10993-10 | Biological evaluation of medical devices Part |
| 10: | |
| Tests for irritation and delayed-type | |
| 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
PAGE 3 OF 3
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
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
4
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 (800) 638-2041 or (301) 796-7100 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
5
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.