(237 days)
The Barkey S-Line blood / fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients. It delivers the fluid via intravenous (IV) administration in hospitals and clinical settings where warmed intravenous fluids are required.
The Barkey S-line is a blood and infusion fluid warmer. The infused fluid flows through a standard IV set. The IV line is inserted into a groove in a warming sleeve, referred to as the Sline. The warming sleeve is made of silicon with embedded heating wires. There is no direct contact between the heat exchanging tube and the fluids. The fluid only contacts the off-the-shelf 510(k) I.V. extension set. There is no software / firmware in the device. The S-line operates on 100 - 240 VAC. 50/60 Hz powering an IEC 60601-1 compliant internal power supply. The set temperature is set to 39 ℃ which is not user selectable. The fluid is warmed to approximately 39 ℃ as it travels a path through the heating sleeve. The temperature is constantly monitored and adjusted. The temperature is measured at the end of the extension set, where it leaves the heated sleeve prior to delivery to the patient. The S-line unit weighs approximately 1.3 kg and is equipped with a knob clamp at the back of the devices for attachment to an I.V. pole, the S-line may also be clamped to a bedrail. Independent overtemperature protector monitors the temperature in the warming section. In case of a fault, there is a second overtemperature safety feature which if a temperature of 43°C +/- 1°C is reached, the warming section's heater is switched off, the luminous ring in the display and control panel shows yellow and an acoustic alarm sounds.
The provided text is a 510(k) Premarket Notification for the Barkey S-Line blood/fluid warming system. This document is a submission to the FDA demonstrating that a new medical device is substantially equivalent to a legally marketed predicate device.
Crucially, this document does not describe a clinical study or a study proving the device meets acceptance criteria in the context of typical AI/ML medical device performance studies. Instead, it describes non-clinical testing (electrical/EMC and performance testing) to demonstrate the device's basic functionality and safety, and compares its specifications to a predicate device to establish substantial equivalence.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, MRMC study, ground truth for training set) are not applicable to the type of device and submission described in this document. The Barkey S-Line device is a fluid warmer, not a diagnostic AI/ML system that would typically undergo such a rigorous performance validation involving human experts and clinical datasets.
However, I can extract the "acceptance criteria" in a broad sense from the non-clinical testing sections and the comparison to the predicate.
Non-Applicable Information for this Device/Submission Type:
- Sample sized used for the test set and the data provenance: Not a clinical study involving a test set of patient data.
- Number of experts used to establish the ground truth: Not applicable, no ground truth based on expert review of medical images/data.
- Qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI/ML diagnostic device requiring an MRMC study.
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there's no complex algorithm. The "electronics" section explicitly states "No microprocessor" and "The temperature regulation is realized by hardware comparator circuit."
- The type of ground truth used: Not applicable in the sense of clinical ground truth (e.g., pathology, expert consensus). The "ground truth" here is the physical measurement of temperature and electrical properties against specified ranges.
- The sample size for the training set: Not applicable; there is no machine learning model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Acceptance Criteria and Reported Device "Performance" (as per the non-clinical testing and comparison):
Based on the nature of this 510(k) submission for a fluid warmer, the "acceptance criteria" are derived from relevant electrical/safety standards and the device's ability to maintain a target temperature within specified limits, similar to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicitly Derived) | Reported Device Performance/Comparison |
|---|---|
| Electrical Safety / EMC Compliance: Adherence to recognized national and international standards for medical electrical equipment. | Met: "AAMI ANSI ES 60601-1: 2005 + A1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" and "IEC 60601-1-2: 2014 Collateral standard: Electromagnetic Disturbances Requirements and Tests." |
| Temperature Management (Accuracy & Overheating Prevention): Ability to warm fluids to a target temperature without exceeding safe limits, and maintain accuracy. | Met: "Performance testing to support accuracy and prevention of over heating" per "ASTM F2172: 2002 (R2011): Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers Temperature management." Specifically, it states the fluid is warmed to "approximately 39 ℃" and has an "independent overtemperature protector" that switches off heating at "43°C +/- 1°C." The target temperature is "Fixed 39°C" (compared to predicate's user-selectable 37-41°C). |
| Warm-up Time: Acceptable time to reach operational temperature. | 62-66 seconds (compared to predicate's 45-55 seconds). Considered "Similar" within the context of substantial equivalence. |
| Flow Rates vs. Temperature Maintenance: Ability to maintain warmed fluid temperature across a range of flow rates. | Demonstrated at fixed temperature of 39°C and fluid temperature of 20°C: |
- 1.7 ml/min, 37°C
- 25 ml/min, 29°C
- 100 ml/min – N/A
(Compared to predicate's performance at max 41°C: 1.7 ml/min, 37°C; 25 ml/min, 37.5°C; 100 ml/min, 36°C). Despite differences in specific performance values for flow rates, these are typically considered sufficient for the stated indications when compared for substantial equivalence. The document doesn't explicitly state the thresholds for "acceptable" performance for each flow rate but implied sufficiency. |
| Ingress Protection (Water/Particulate): Adequate protection against ingress of foreign objects and water. | IPX2 (compared to predicate's IPX4). Deemed "adequate ingress protection" given the device's design and intended use. |
| Protection Against Electric Shock: Classification of protection against electric shock. | Type BF (Similar to predicate). |
| Alarm Functionality: Timely and appropriate audible/visual alerts for fault conditions (e.g., overtemperature). | Audible and Visual alarms for "Overtemperature" and "Fault" conditions. (Similar to predicate's Audible and Visual alarms for Low temp (42.0C)). |
| Compatibility with Accessories: Proper function with specified IV sets. | "Used with user supplied FDA cleared IV sets" from Biegler (K954769), which are cleared for use with fluid warmers. (Similar to predicate). |
| Dimensions: Appropriate physical size for intended use (implied, not a direct safety/performance criterion but part of equivalence). | 90 x 60 x 160 mm ("Dimensions not critical" compared to predicate's 228 x 278 x 132mm, as long as it functions). |
| Operational Power Requirements: Compatibility with standard hospital power supply. | 100 - 240 VAC, 50/60 Hz (Similar to predicate's 110/220 VAC). |
| Indications for Use, Patient Population, Environments of Use: Alignment with the predicate device and appropriate for intended context. | "Similar" in all these aspects to the predicate device. |
| Fundamental Warming Methodology & Principle of Operation: Maintain a similar, safe approach to fluid warming. | "Similar technology of heat exchanger." The difference (heating within the controller vs. heating the line) "does not raise different risk concerns." |
| Fluid Contact Materials: (Crucial for patient safety) Ensuring no hazardous materials in contact with fluids or that proper clearances exist for compatible accessories. | "The subject device has no fluid contacting materials" as it heats the IV line, which is an FDA-cleared accessory. (Predicate uses accessory extension sets that contact fluid). This is a design difference but deemed safe and equivalent. |
2. Sample Size and Data Provenance:
- Sample Size: This document does not specify a "sample size" in the context of clinical data for an AI/ML device. The "testing" involves internal non-clinical validation of the device's physical and electrical properties. The number of units tested for electrical safety, temperature accuracy, or flow rate performance is not explicitly stated but would be part of a quality management system.
- Data Provenance: Not applicable in the context of clinical data. The performance claims are based on non-clinical testing performed internally by the manufacturer (Barkey GmbH & Co. KG), presumably in Germany given their address. The testing reports (e.g., electrical, performance testing) would be available internally.
3. Number of Experts and Qualifications:
- Not applicable. This device does not rely on expert interpretation of medical data for its function or validation for regulatory submission. The "experts" involved would be engineers and quality assurance personnel performing the non-clinical tests.
4. Adjudication Method:
- Not applicable.
5. MRMC Comparative Effectiveness Study:
- No. This type of study is for evaluating the impact of AI on human reader performance, which is not relevant for a fluid warming device.
6. Standalone Performance:
- Yes, in a very literal sense. The device's performance in heating fluids and its safety features (e.g., overtemperature cutoff, alarms) are evaluated as a standalone product against engineering specifications and relevant standards. There is no AI/ML component or complex algorithm, it's a hardware-based direct warming device.
7. Type of Ground Truth Used:
- The "ground truth" for this device's performance relies on physical measurements against engineering specifications and regulatory standards. For example:
- Temperature: Measured temperature must fall within a specified range (e.g., 39°C +/- tolerance) and safety cutoffs (e.g., 43°C +/- 1°C).
- Electrical Safety: Electrical parameters (e.g., leakage current, insulation resistance) must meet the limits specified by IEC 60601-1.
- Flow Rate vs. Temperature: Measured output fluid temperature at various input fluid temperatures and flow rates.
- This is not "expert consensus," "pathology," or "outcomes data."
8. Sample Size for the Training Set:
- Not applicable. There is no training set as there is no machine learning component. The device's temperature regulation is achieved through a "hardware comparator circuit" rather than a software algorithm.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).