(140 days)
The epoc® Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous, or capillary whole blood in the laboratory or at the point of care.
The Blood Gas Electrolyte and Metabolite (BGEM) Test Card panel configuration includes sensors that quantitate pH, pCO2, oO2, Sodium, Potassium, Ionized Calcium, Chloride, Total Carbon Dioxide, Glucose, Lactate, Blood Urea Nitrogen, Creatinine, and Hematocrit.
pH, pCO2, pO2 (blood gases) measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of lifethreatening acid-base disturbances.
Sodium and Potassium measurements from the epoc Blood Analysis System are treatment of diseases involving electrolyte imbalance.
lonized Calcium measurements from the epoc Blood Analysis System are treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Chloride measurements from the epoc Blood Analysis System are used in the treatment of electrolyte and metabolic disorders.
Total Carbon Dioxide measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of disorders associated with changes in body acid-base balance.
Glucose measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of carbolism disorders, including diabetes mellitus and idiopathic hypodycemia, and of pancreatic islet cell tumors.
Lactate measurements from the epoc Blood Analysis System are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood),
Blood Urea Nitrogen measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal and metabolic diseases.
Creatinine measurements from the epoc Blood Analysis System are used in the diagnosis and treatment diseases and in monitoring renal dialysis.
Hematocrit measurements from the epoc Blood Analysis System are used to distinguish normal states of blood volume, such as anemia and erythrocytosis.
The epoc® Blood Analysis System is an in vitro diagnostic device system for the quantitative testing of blood gases, electrolytes, and metabolites in venous, arterial, and capillary whole blood samples. The epoc® System is comprised of three (3) major subsystems: epoc® Host, epoc® Reader and epoc® BGEM Test Card.
- epoc® Blood Gas Electrolyte Metabolite (BGEM) Test Card: single-use, device with . port for blood sample introduction which contains the sensor configurations for testing Sodium (Na+), Potassium (K+), Calcium (Ca++), Chloride (C)I-, pH, partial pressure of carbon dioxide (pCO2), partial pressure of oxygen (pO2), Glucose (Glu), Lactate (Lact), Creatinine (Crea), Hematocrit (Hct), Blood Urea Nitrogen (BUN) and Total Carbon Dioxide (TCO2).
- . epoc® Reader: portable, battery-powered device component that measures electrical signals from the test card sensors during blood testing and transmits this sensor data wirelessly via Bluetooth to the epoc Host.
- . epoc® Host: mobile computer-based device component for calculating test results from the sensor data sent by the epoc Reader and displaying these results on the graphical user interface. The epoc Host component can be physically connected to the Reader by a cradle component. The epoc Host also incorporates an internal laser barcode scanner for scanning patient and operator IDs. The epoc Host component currently runs on Microsoft® Windows Mobile 6.5 Operating System (OS).
Based on the provided text, the "epoc® Blood Analysis System with NXS Host" is being submitted as a modified device, and the submission primarily focuses on hardware and software updates to the epoc Host component. The document explicitly states that "No performance data was required to evaluate the changes introduced with the alternate epoc Host component" and that there is "no change to labeled performance claims." Therefore, there isn't a comprehensive study proving the device meets new acceptance criteria. Instead, the submission argues for substantial equivalence to a previously cleared predicate device by demonstrating that the modifications do not negatively impact safety and effectiveness.
Here's an analysis based on the provided information, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not detail specific acceptance criteria for new performance claims or provide a table of performance data because the submission states "No performance data was required to evaluate the changes introduced with the alternate epoc Host component." The device is intended to meet the same performance specifications as the predicate device. The change is in the host component (hardware and OS), not the core measurement technology or labeled performance.
The submission is essentially asserting that the "epoc® Blood Analysis System with NXS Host" (Modified Device) is substantially equivalent to the "epoc® Blood Analysis System" (Predicate Device) and thus relies on the predicate device's existing performance data and acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No new clinical performance or analytical performance study with a test set is described. The submission focuses on verification and validation activities for hardware, software, and usability to support substantial equivalence due to a change in the host component.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. As no new performance study is described, there's no mention of experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. No new performance study is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This device is an in vitro diagnostic system for quantitative testing of blood parameters, not an imaging AI device that would typically involve a multi-reader multi-case study with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is an analytical instrument. Its performance is inherent to the system (sensors, reader, software). While the software is a key component, the "standalone" concept as typically applied to AI in imaging doesn't directly map. However, the document states: "No performance data was required to evaluate the changes introduced with the alternate epoc Host component." This implies that the core analytical performance (algorithm) is considered unchanged from the predicate device and its previous clearances. Verification and validation activities were done on the new host component, but not necessarily a "standalone" re-evaluation of the core measurement algorithm's performance on a new dataset.
7. The Type of Ground Truth Used
Not applicable for new performance data. The device measures objective chemical and physical properties of blood samples. The ground truth for such devices is typically established through reference methods and calibrated controls, not expert consensus or pathology in the same way as an imaging AI. The submission relies on the established ground truth methodologies for the predicate device.
8. Sample Size for the Training Set
Not applicable. This document describes a modification to an existing IVD device (updating hardware and operating system for the host component). It does not describe the development of a new AI algorithm or machine learning model that would involve a "training set" in the conventional sense. The "epoc Host Application Software has been modified to support the Android-based Operating System" but this is a software porting/adaptation, not a new algorithm being trained on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for a new AI algorithm.
Summary of the Study and Why it Meets (Implied) Acceptance Criteria:
The study detailed in this 510(k) submission is not a clinical performance study generating new acceptance criteria or performance data for the analytes measured. Instead, it is a Special 510(k) submission designed to demonstrate that hardware and software updates to the epoc Host component of the epoc® Blood Analysis System do not alter the safety or effectiveness of the device and thus maintain substantial equivalence to the previously cleared predicate device.
The "study" or evidence provided to meet acceptance criteria consists of:
- Verification and Validation Activities: "All software, hardware and usability verification and validation activities were performed in accordance to relevant standards, established plans and protocols and Design Control procedures."
- Meeting Acceptance Criteria: "Testing verified all acceptance criteria were met." (These are acceptance criteria related to software, hardware function, and usability for the new host component, ensuring it performs its intended role without impacting the core analytical performance).
- Risk Management: A risk management process compliant with EN ISO 14971:2012 and ISO 14971:2007 was performed, concluding that "the overall residual risk of the epoc System with the epoc NXS host is acceptable."
- Cybersecurity Information: Cybersecurity design inputs were established, risks assessed, and controls designed within the software.
The core argument for meeting acceptance criteria (by proving substantial equivalence) is that:
- There is no change to the intended use or indications for use.
- There is no change to the fundamental scientific technology (the epoc Reader and Test Card, which contain the sensors, remain unchanged).
- There is no change to labeled performance claims.
- There is no change to the principle of operation.
- There is no change to cartridge (test card) calibrator formulation and technology.
Therefore, the "acceptance criteria" here are implicitly that the new epoc NXS Host component, through its verification and validation, functions correctly, safely, and does not introduce new risks, thereby maintaining the established performance and safety profile of the predicate device.
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.