(59 days)
No
The document describes a device that measures and calculates hemodynamic parameters based on electrical impedance and non-invasive blood pressure. It mentions standard oscillometric blood pressure measurement and calculations based on existing measurements. There is no mention of AI or ML algorithms being used for data processing, interpretation, or parameter calculation. The modifications described are related to hardware integration and user interface updates.
No
The device is described as a "monitoring device" that measures and displays various physiological parameters; it does not provide treatment.
Yes
The device monitors and displays various physiological parameters (Cardiac Output, blood pressure, heart rate, etc.) and associated hemodynamic parameters, which are used to assess a patient's health status and aid in diagnosis.
No
The device description explicitly states the addition of a Non Invasive Blood Pressure (NIBP) module, which is a hardware component (SunTech Medical Inc. Advantage mini OEM BP™ module). While software controls this module and displays results, the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Cheetah Reliant with NIBP functionality is a monitoring device that measures physiological parameters directly from the patient's body (electrical impedance of the chest cavity and blood pressure from the arm). It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring cardiac output and blood pressure, which are in-vivo measurements.
- Device Description: The description focuses on the hardware and software for non-invasive monitoring.
Therefore, the device falls under the category of a non-invasive physiological 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 hlood pressure (diastolic, systolic, and mean) and heart rate. 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), electrical impedance of the chest cavity (ZO) 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.
Product codes
DSB, DXN
Device Description
The Cheetah Reliant with NIPB functionality is a modification of the Cheetah Reliant device cleared under K072662. The significant modification discussed in this 510(k) submission is the addition of a Non Invasive Blood Pressure (NIBP) module to the system which involved updating the user interface to allow operating the NIBP module and for displaying the results and saving them within the device's database.
The NIBP Module is the Advantage mini OEM BP™ module (Model 2 Mini), manufactured by SunTech Medical Inc. (Morrisville, NC, USA). The ADVANTAGE mini OEM BPTM Module Series is an oscillometric OEM blood pressure system. The module is controlled via software commands issued from a host system through an asynchronous serial data port (factory configurable to Logic Level or RS-232). All Module operations must be initiated by the Host system (Reliant). The module is designed to take blood pressure measurements (systolic, diastolic, and heart rate) on demand. After each blood pressure measurement, the Module discards the previous blood pressure results.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-clinical:
Compliance with ANSI/AAMI SP10:2002
Software verification and validation
Electrical Safety
EMC
Clinical:
Clinical testing was performed that verified conformance with the clinical requirements ANSI/AAMI SP10:2002 for adult subjects.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072662 - Cheetah Reliant, K010164 - GE Medical Systems ICG Module, K081590 - Ya Horng Arm Type Digital Blood Pressure Monitor
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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Image /page/0/Picture/1 description: The image shows the logo for Cheetah Medical. The logo features a stylized drawing of a cheetah in mid-leap above the words "Cheetah Medical". To the right of the text and cheetah is a vertical line.
Cheetah Medical. 2828 SW Corbett Avenue, Suite 214-C Portland Oregon 97201 USA
DEC 1 5 2008
510(k) Summary
Submitter: Cheetah Medical, Inc. 2828 SW Corbett Avenue, Suite 214-C Portland, Oregon 97201
Contact Person:
Rhona Shanker Regulatory Consultant to Cheetah Medical, Inc. Ph: (301) 251-9570 Fax: (301) 251-9571
Device:
Trade Name:
Cheetah Reliant
Common/Usual Name
Portable, non-invasive Cardiac Output monitoring device Non-invasive blood pressure monitor
Classification Name:
21 CFR 870.2770/DSB - Impedance plethysmograph 21 CFR 870.1130/DXN - Non-invasive blood pressure monitor
Predicate Devices:
K072662 - Cheetah Reliant
K010164 - GE Medical Systems ICG Module
K081590 - Ya Horng Arm Type Digital Blood Pressure Monitor
Device Description:
The Cheetah Reliant with NIPB functionality is a modification of the Cheetah Reliant device cleared under K072662. The significant modification discussed in this 510(k) submission is the addition of a Non Invasive Blood Pressure (NIBP) module to the system which involved updating the user interface to allow operating the NIBP module and for displaying the results and saving them within the device's database.
The NIBP Module is the Advantage mini OEM BP™ module (Model 2 Mini), manufactured by SunTech Medical Inc. (Morrisville, NC, USA). The ADVANTAGE mini OEM BPTM Module Series is an oscillometric OEM blood pressure system. The module is controlled via software commands issued from a host system through an asynchronous serial data port (factory configurable to Logic Level or RS-232). All Module operations must be
Tol. (+1) 317-660-6649 ● Fax.(+1) 503-345-6890 ● www.chestah-medical.com
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Image /page/1/Picture/1 description: The image shows the logo for Cheetah Medical. The logo features a stylized image of a cheetah leaping forward. Below the cheetah image, the words "Cheetah Medical" are printed in a simple, sans-serif font.
Cheetah Medical, Inc. 2828 SW Corbett Avenue, Suite 214-C Portland, Oregon 97201 USA
initiated by the Host system (Reliant). The module is designed to take blood pressure measurements (systolic, diastolic, and heart rate) on demand. After each blood pressure measurement, the Module discards the previous blood pressure results.
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) and heart rate. 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), electrical impedance of the chest cavity (Z0) 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 original indications for use for the Cheetah Reliant stated the Cheetah Reliant is a portable, non-invasive Cardiac Output monitoring device based on bio-impedance Cardiography. The Cheetah Reliant system is intended to monitor and display a patient's Cardiac Output in units of Ltr/min.
The revised "indications for use" includes the NIBP functionality and has been revised to identify the hemodynamic parameters displayed by the unit that were measured by the original Reliant and that are based on calculations of those measurements. The statement has also been revised to indicate where the device may be used. This additional information is consistent with the indications for use statement for the GE Medical Systems ICG Module cleared under K010164.
Comparison to Predicates
Like the original Cheetah Reliant, the Cheetah Reliant with NIBP functionality is a portable, non-invasive Cardiac Output measurement system that measures cardiac output by employing an electrical bio-impedance based measurement technique. This technology is substantially equivalent to the GE Medical Systems ICG module that measures and processes a patient's hemodynamic parameters using non-invasive bioimpedance technology. The NIBP function of the Cheetah Reliant is substantially equivalent to the Ya Horng Arm Type Digital Blood Pressure Monitor in that both devices use the oscillometric method to determine systolic and diastolic blood pressures and pulse rate (heart rate). Further, the NIBP function meets the requirements of ANSI/AAMI SP10:2002.
Tol. (+1) 317-660-6649 @ Fax.(+1) 503-345-6890 @ www.cheetah.
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Image /page/2/Picture/1 description: The image shows the logo for Cheetah Medical. The logo features a stylized image of a cheetah running. The text "Cheetah Medical" is printed below the cheetah image.
Cheetah Medical, Inc 2828 SW Corbett Avenue, Suite 214-C Portland, Oregon 97201 usa
Test Summary:
The following tests were conducted to verify performance: Non-clinical
Compliance with ANSI/AAMI SP10:2002 Software verification and validation Electrical Safety EMC
Clinical
Clinical testing was performed that verified conformance with the clinical requirements ANSI/AAMI SP10:2002 for adult subjects.
Conclusion:
The Cheetah Reliant with NIBP functionality is substantially equivalent to the identified predicate devices as it has the same indications for use, incorporates the same fundamental scientific technologies as the predicates, and testing demonstrates that its performance is substantially equivalent. As such, the Cheetah Reliant with NIBP functionality is safe and effective for use as described in the indications for use statement.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted as a staff with a snake winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 2008
Cheetah Medical, Inc. Ms. Rhona Shanker Regulatory Consultant to Cheetah Medical, Inc. 2828 SW Corbett Avenue, Suite 214-C Portland, Oregon 97201
Re: K083093
Trade/Device Name: Cheetah Reliant Regulation Number: 21 CFR 870.2770 and 21 CFR 870.1130 Regulation Name: Impedance Plethysmograph and Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DSB and DXN Dated: October 17, 2008 Received: October 17, 2008
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. 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
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Page 2 - Ms. Rhona Shanker
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 (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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
una R. V. dines
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):_ΚΟ 83093
Device Name: Cheetah Reliant
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 hlood pressure (diastolic, systolic, and mean) and heart rate. 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), electrical impedance of the chest cavity (ZO) 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.
Prescription Use V OR Over-The-Counter Use (Per 21 C.F.R. 801 Subpart D) (Optional Format Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uma R.V. hnes
(Division Sign-Off)
Insion or Cardiovascular Devices
10(K) Number_K083093