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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Cheetah Reliant with NIBP functionality, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the NIBP functionality are based on compliance with ANSI/AAMI SP10:2002. This standard sets requirements for automated sphygmomanometers. While the document broadly states compliance, it does not provide specific numerical acceptance limits for parameters like accuracy and precision (e.g., mean difference and standard deviation of blood pressure readings compared to a reference) or the detailed reported device performance against those specific limits.

Acceptance Criteria (Standard)	Reported Device Performance
ANSI/AAMI SP10:2002 Compliance	Clinical testing performed verifying conformance for adult subjects.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document only states "clinical testing was performed...for adult subjects." It does not specify the exact number of subjects or measurements included in the test set.
Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. Given the medical device submission context, it would typically be prospective clinical data collected specifically for the regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For NIBP validation against ANSI/AAMI SP10, ground truth is typically established by trained observers (auscultators) using a mercury sphygmomanometer, often with a double-blinded approach. The document does not detail how many such observers were used or their specific qualifications.

4. Adjudication Method for the Test Set

This information is not provided in the document. For NIBP studies conforming to ANSI/AAMI SP10, there isn't a typical "adjudication" in the sense of expert consensus on diagnostic interpretations. Instead, the standard outlines specific procedures for simultaneous or sequential measurements by a trained observer and the device, with statistical analysis of the differences.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done for this device. The submission focuses on the performance of the non-invasive blood pressure (NIBP) module against an industry standard (ANSI/AAMI SP10:2002), not on comparing human reader performance with and without AI assistance for interpretation. The Cheetah Reliant with NIBP is a measurement device, not an AI interpretation system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, a standalone performance evaluation was conducted for the NIBP function. The assessment against ANSI/AAMI SP10:2002 involves comparing the device's automated measurements (algorithm only) directly against a reference standard (likely observer auscultation). There is no "human-in-the-loop" component for the NIBP measurement itself; the device automatically measures blood pressure.

7. The Type of Ground Truth Used

For the NIBP functionality, the ground truth would be established through simultaneous or sequential measurements taken by trained observers using a reference standard (e.g., mercury sphygmomanometer or an equivalent validated device), as outlined by the ANSI/AAMI SP10:2002 standard. This is not "expert consensus" in the diagnostic interpretation sense, nor is it pathology or outcomes data.

8. The Sample Size for the Training Set

The document does not mention a training set for the NIBP module. The NIBP module (Suntech Medical Inc. Model 2 Mini) is an OEM component. While such components would have been developed and internally validated by Suntech Medical (which would involve development/training data), this information is not part of Cheetah Medical's 510(k) submission, which focuses on the integration and verification of the existing module within their system.

9. How the Ground Truth for the Training Set Was Established

Since a training set for the NIBP module's algorithm is not discussed in this submission, the method for establishing its ground truth for training purposes is not provided. This information would typically reside with the original manufacturer of the NIBP OEM module (SunTech Medical Inc.).

Summary

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K083093
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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 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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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 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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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

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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

Regulation Number and Section

§ 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.