CHEETAH RELIANT

K103166 · Cheetah Medical, Inc. · DSB · Jan 25, 2011 · Cardiovascular

Device Facts

• Record ID: K103166
• Device Name: CHEETAH RELIANT
• Applicant: Cheetah Medical, Inc.
• Product Code: DSB · Cardiovascular
• Decision Date: Jan 25, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

The Cheetah Reliant with NIBP and SpO2 functionalities is a portable, hemodynamic monitoring and non-invasive Cardiac Output monitoring device that monitors and displays a patient' Cardiac Output (CO) in Ltr/Min with a Non Invasive Blood Pressure (NIRP) function that non-invasively measures and displays blood pressure (diastolic, systolic and mean arerial pressure) and heart rate and with a SpO2 function that non-invasively measures and displays blood oxygen saturation (SpO2). The device displays associated heamodynamic parameters based on calculations with measurements incorporated into the Cheetah Reliant. Phean parameters are: - Cardiac Index (CI), - Stroke Volume (SV), - Stroke Volume Index (SVI), - Stroke Volume Variation (SVV). - Heart Rate (HR), - Ventricular Ejection Time (VET), - Total Peripheral Resistance (TPR), - Total Peripheral Resistance Index (TPRI), - Cardiac Power (CP). - Cardiac Power Index (CPI), - Oxygen Delivery Index (DO2I), - Electrical impedance of the chest cavity (Z0), - Thoracic Fluid Content (TFC). - Thoracic Fluid Content change from preset time period (TFCd) and - Thoracic Fluid Content from baseline (TFCd0). - Orthostatic Bioreactance (Postural changes in SV, CO and other hemodynamic parameters which are derived by Bioreactance) The Cheetah Reliant with NIBP and SpO2 functionalities is intended for use within hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient care.

Device Story

Portable, non-invasive hemodynamic monitor; utilizes Bioreactance technology to measure cardiac output and thoracic fluid content; integrates NELLCOR OxiMax NELL-1 module for SpO2 and oscillometric NIBP functionality. Device inputs: electrical impedance signals (chest cavity), NIBP cuff pressure, and SpO2 sensor data. Host system processes inputs via software commands; calculates hemodynamic parameters (e.g., SV, CI, TPR, DO2I); displays results on integrated user interface. Used in hospitals/clinics by healthcare providers to assess patient hemodynamic status; supports clinical decision-making regarding fluid management and cardiovascular therapy. Benefits include non-invasive, real-time monitoring of cardiac performance and oxygenation status.

Clinical Evidence

Bench testing only. Verification included software validation, electrical safety, EMC, and performance testing to ensure integrity of SpO2 data communication between the OEM module and the host system.

Technological Characteristics

Portable hemodynamic monitor; uses Bioreactance (impedance plethysmography) for cardiac output; integrates NELLCOR NELL-1 pulse oximetry module and oscillometric NIBP module. Connectivity via asynchronous serial data port. Software-controlled host system. Class II device.

Indications for Use

Indicated for hemodynamic and cardiac output monitoring in patients within hospitals and outpatient clinics. Measures and displays CO, NIBP, heart rate, SpO2, and derived hemodynamic parameters (CI, SV, SVI, SVV, VET, TPR, TPRI, CP, CPI, DO2I, Z0, TFC, TFCd, TFCd0) and orthostatic bioreactance.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Cheetah Reliant with NIBP functionality (K083093)
• NELLCOR /N-600x OxiMax pulse oximeter (K060576)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Cheetah Medical. The logo includes a stylized image of a cheetah running. The text "Cheetah Medical" is written in a simple, sans-serif font to the left of the cheetah image.

Cheetah Medical, Inc
2828 SW Corbett Avenue, Suite 214-C
Portland, Oregon 97201

K103166 1/3

# 510(k) Summary

JAN 2 5 2011

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: [phone] Fax: [phone]

Device:

## Trade Name:

Cheetah Reliant

Common/Usual Name

Portable, non-invasive Cardiac Output and hemodynamic monitoring device

Non-invasive blood pressure monitor

- Non-invasive blood oxygen saturation monitor
Classification Name:

21 CFR 870.2770/DSB - Impedance plethysmograph

- 21 CFR 870.1130/DXN Non-invasive blood pressure monitor
21 CFR 870.2700/DQA- Non-invasive blood oxygen saturation monitor

## Predicate Devices:

K083093 - Cheetah Reliant with NIBP functionality K060576 - NELLCOR /N-600x Oximax pulse oximeter

#### Device Description:

The Cheetah Reliant with oxygen saturation (SpO2) function is a modification of the Cheetah Reliant device cleared under K083093. The significant modification is the addition of a non invasive Oxygen Saturation (SpO2) module to the system which involved updating the user interface to allow operating the SpO2 module and for displaying the results and saving them within the device's database.

The SpO2 Module is the NELLCOR OxiMax NELL-1 Pulse Oximetry Module, manufactured by NELLCOR Pleasanton, CA ,USA, a division of Covidien. It is the same module that is in the NELLCOR OxiMax N-600x Pulse Oximeter (K060576).

Tel. [phone] ● Fax.[phone] ●

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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. The text "Cheetah Medical" is written in a simple, sans-serif font below the cheetah graphic.

2828 SW Corbett Avenue, Suite 214-C Portland, Orecon 97201 USA

The NELL-1 pulse oximeter board that is integrated into the Cheetah Reliant. uses calibration data contained in the OxiMax pulse oximetry sensor when calculating the patient's SpO2.

The NELL-1 Module connects to a OxiMax pulse oximetry sensor (DS-100A Durasensor®, the same sensor cleared with the OxiMax N-600x, K060576), through a Pulse Oximetry Cable (NELLCOR, DOC-10) that was also cleared with the OxiMax N-600x Pulse Oximeter (K060576) and provides oscillometric oxygen saturation to the Host system. The Module is controlled via software commands issued from the Host system through an asynchronous serial data port. All Module operations are initiated by the Reliant as the Host The Module is designed to take blood oxygen saturation svstem. measurements on demand.

#### Indications for Use:

The Cheetah Reliant with NIBP and SpO2 functionalities is a portable, hemodynamic monitoring non-invasive Cardiac Output monitoring device that monitors and displays a patient' Cardiac Output (CO) in Ltr/Min with a Non Invasive Blood Pressure (NIBP) function that non-invasively measures and displays blood pressure (diastolic, systolic and mean arterial pressure) and heart rate and with a SpO2 function that non-invasively measures and displays blood oxygen saturation (SpO2). The device displays associated heamodynamic parameters based on calculations with measurements already incorporated into the Cheetah Reliant. These parameters are:

- Cardiac Index (CI). .
- Stroke Volume (SV), .
- . Stroke Volume Index (SVI),
- Stroke Volume Variation (SVV), .
- Heart Rate (HR), .
- . Ventricular Ejection Time (VET),
- Total Peripheral Resistance (TPR), .
- Total Peripheral Resistance Index (TPRI), .
- . Cardiac Power (CP),
- Cardiac Power Index (CPI), .
- Oxygen Delivery Index (DO2I), .
- Electrical impedance of the chest cavity (Z0), .
- Thoracic Fluid Content (TFC), .
- Thoracic Fluid Content change from preset time period (TFCd) and .
- Thoracic Fluid Content from baseline (TFCd0). .
- Orthostatic Bioreactance (Postural changes in SV, CO and other . hemodynamic parameters which are derived by Bioreactance)

The Cheetah Reliant with NIBP and SpO2 functionalities is intended for use within hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient Tel, ([phone] ● Fax.[phone] ● www.cheetah-medical.com care.

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

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Image /page/2/Picture/0 description: The image shows the logo for Cheetah Medical. The logo features a stylized outline of a cheetah leaping forward. The text "Cheetah Medical" is written in a simple, sans-serif font below the cheetah graphic.

Cheetah Medical, Inc
2828 SW Corbett Avenue, Suite 214-C
Portland, Oregon 97201

K103166 3/3

The revised "indications for use" includes the SpO2 functionality and Orthostatic Bioreactance. Orthostatic Bioreactance will display the changes in SV, CO and other hemodynamic parameters displayed by the Reliant, as a result of changes in posture.

## Comparison to Predicates

The Cheetah Reliant with NIBP and SpO2 functionalities is substantially equivalent to the following:

- Cheetah Reliant with NIBP functionality (K083093). .
- . NELLCOR OxiMax N-600x Pulse Oximeter (K060576) for the SpO2 function

#### Test Summary:

The following assessments were conducted to verify performance:

- . Software verification and validation
- . Electrical Safety
- . EMC
- Performance testing to verify that SpO2 values calculated by the OEM . SpO2 module are not corrupted during communication with the Reliant (i.e., verified that calculated and displayed values are identical)

#### Conclusion:

The Cheetah Reliant with NIBP and SpO2 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, contains the same SpO2 OEM parts (module, cable and sensor) as the cleared SpO2 predicate, and testing demonstrates that its performance is substantially equivalent. As such, the Cheetah Reliant with NIBP and SpO2 functionality is safe and effective for use as described in the indications for use statement.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

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

JAN 2 5 201

Re: K103166

Trade/Device Name: Cheetah Reliant with NIBP and SpO2 Regulation Number: 21 CFR 870.2270 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II Product Code: DSB, DXN, DQA Dated: October 26, 2010 Received: October 27, 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, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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); 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M.S.Hellemann

for Bram 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): K 103/66

Device Name: Cheetah Reliant

## Indications for Use:

The Cheetah Reliant with NIBP and SpO2 functionalities is a portable, hemodynamic monitoring and non-invasive Cardiac Output monitoring device that monitors and displays a patient' Cardiac Output (CO) in Ltr/Min with a Non Invasive Blood Pressure (NIRP) function that non-invasively measures and displays blood pressure (diastolic, systolic and mean arerial pressure) and heart rate and with a SpO2 function that non-invasively measures and displays blood oxygen saturation (SpO2). The device displays associated heamodynamic parameters based on calculations with measurements incorporated into the Cheetah Reliant. Phean parameters are:

- . Cardiac Index (CI),
- Stroke Volume (SV), .
- Stroke Volume Index (SVI), .
- Stroke Volume Variation (SVV). .
- . Heart Rate (HR), Jose
- Ventricular Ejection Time (VET), .
- . Total Peripheral Resistance (TPR),
- . Total Peripheral Resistance Index (TPRI),
- Cardiac Power (CP).
- Cardiac Power Index (CPI),
- Oxygen Delivery Index (DO2I),
- Electrical impedance of the chest cavity (Z0), .
- Thoracic Fluid Content (TFC).
- Thoracic Fluid Content change from preset time period (TFCd) and
- Thoracic Fluid Content from baseline (TFCd0).
- Orthostatic Bioreactance (Postural changes in SV, CO and other hemodynamic parameters which are derived by Bioreactance)

The Cheetah Reliant with NIBP and SpO2 functionalities is intended for use within hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient care.

| Prescription Use √<br>(Per 21 C.F.R. 801 Subpart D) | OR | Over-The-Counter Use<br>(Optional Format Subpart) |
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Solel penne

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sian-Off) Division of Cardiovascular Devices

510(k) Number_K10'S16'b