(90 days)
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.
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.
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.
§ 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.