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 (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 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 care.

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).

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 system. The Module is designed to take blood oxygen saturation measurements on demand.

AI/ML Overview

The provided text describes the Cheetah Reliant with NIBP and SpO2 functionalities, comparing it to predicate devices and outlining the testing performed to demonstrate substantial equivalence. However, it does not explicitly detail specific acceptance criteria values or the results of a statistically powered clinical study for the device's performance in a quantitative manner (e.g., accuracy, sensitivity, specificity, or error rates for SpO2, NIBP, or cardiac output).

Instead, the submission focuses on demonstrating substantial equivalence primarily through:

Component Equivalence: The SpO2 module, cable, and sensor are identical to those in a previously cleared predicate device (NELLCOR OxiMax N-600x Pulse Oximeter, K060576).
Functional Verification: Testing was performed to ensure that SpO2 values calculated by the OEM SpO2 module are not corrupted during communication with the Reliant device.
Software Verification and Validation, Electrical Safety, and EMC testing.

Therefore, I cannot fully complete the requested table and many of the numbered points as the specific information is not present in the provided text.

Here is what can be extracted and inferred based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance
SpO2 Performance	Not explicitly stated in quantitative terms (e.g., accuracy range against co-oximetry). The performance is implied to be equivalent to the predicate device (NELLCOR OxiMax N-600x Pulse Oximeter) as it uses the same OEM module, cable, and sensor. The core acceptance was that the integration does not corrupt the SpO2 values.	"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)" — This indicates successful integration without data corruption, leveraging the established performance of the predicate's SpO2 components.
NIBP Performance	Not explicitly stated. The NIBP functionality was part of the previous predicate (K083093).	"substantially equivalent ... as it has the same indications for use, incorporates the same fundamental scientific technologies as the predicates" — Implies NIBP performance is equivalent to K083093.
Cardiac Output & Hemodynamic Parameters	Not explicitly stated. The core CO and hemodynamic monitoring functionality was part of the previous predicate (K083093). The device "displays associated heamodynamic parameters based on calculations with measurements already incorporated into the Cheetah Reliant."	"substantially equivalent ... as it has the same indications for use, incorporates the same fundamental scientific technologies as the predicates" — Implies CO and hemodynamic performance is equivalent to K083093.
Software Verification & Validation	Assumed to meet industry standards for medical device software.	"Software verification and validation" (completed)
Electrical Safety	Assumed to meet relevant electrical safety standards.	"Electrical Safety" (completed)
EMC	Assumed to meet relevant electromagnetic compatibility standards.	"EMC" (completed)

2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" in the context of a clinical performance study with human subjects for the SpO2 functionality review for this specific 510(k). The performance testing mentioned ("Performance testing to verify that SpO2 values calculated by the OEM SpO2 module are not corrupted") implies more of an engineering verification of data integrity during communication, rather than a clinical accuracy study with patient data.

The data provenance for such an engineering test would likely be simulated or internal test data, not patient data from a specific country. The original clinical data for the NELLCOR OxiMax N-600x SpO2 module (the predicate component) would have been used for its prior clearance (K060576), but that study is not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical ground truth determination is described for a test set in this submission regarding the added SpO2 functionality.

4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physiological monitor, not an AI-assisted diagnostic imaging device that involves human "readers."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The SpO2 module itself operates in a standalone (algorithm only) manner, converting sensor data to SpO2 values. The performance verification for this 510(k) focused on ensuring the integration of this pre-cleared standalone module into the Cheetah Reliant system did not corrupt its output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the SpO2 component, the original ground truth for the NELLCOR OxiMax N-600x would have been co-oximetry, but its specific details are not provided in this 510(k) summary. For the integration testing described here, the "ground truth" was the expected SpO2 values from the OEM module itself, prior to transmission to the main device display.

8. The sample size for the training set
Not applicable. This submission describes the integration of a pre-cleared COTS (Commercial Off-The-Shelf) module and system modifications, not the development of a novel algorithm that would typically require a training set.

9. How the ground truth for the training set was established
Not applicable, as no training set for a novel algorithm is described in this submission.

Summary

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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: (301) 251-9570 Fax: (301) 251-9571

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:

Tel. (+1) 317-660-6649 ● Fax.(+1) 503-345-6890 ●

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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, (+1) 317-660-6649 ● Fax.(+1) 503-345-6890 ● www.cheetah-medical.com care.

Tel. (+1) 317-660-6649 Fax. (+1) 503-345-6890 www.cheetah-medical..

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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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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 (800) 638-2041 or (301) 796-7100 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 √(Per 21 C.F.R. 801 Subpart D)	OR	Over-The-Counter Use(Optional Format Subpart)
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Solel penne

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

510(k) Number_K10'S16'b

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.