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.

Device Description

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.

AI/ML Overview

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 (<36.5C) and High 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.

Summary

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May 24, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out to the right of the square.

Barkey GmbH & Co. KG % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg. Florida 33704

Re: K213191

Trade/Device Name: S-Line Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: April 24, 2022 Received: April 26, 2022

Dear Paul Dryden:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Courtney H. Lias, Ph.D. Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K213191

Device Name

Barkey S-Line

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

XX Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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Date Prepared:	24-Apr-22
Applicant	Barkey GmbH & Co. KGGewerbestr. 833818 Leopoldshoehe GermanyTel - +49(0)5202-9801-0
Sponsor Contact:	Thomas Barkey, CEO
Submission Correspondent:	Paul DrydenProMedic, LLC
Proprietary or Trade Name:Common/Usual Name:Classification Name:Product Classification:CFR:	S-lineWarmer, Thermal, Infusion FluidWarmer, Thermal, Infusion FluidLGZUnclassified
Predicate Device:Tradename:Classification Name:Product Classification:CFR:	K121198Biegler BW685SWarmer, Thermal, Infusion FluidLGZUnclassified

Accessory

Device Description:

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.

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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.

Principle of Operation:

The infused fluid flows through a compatible IV extension set. This tube is inserted into a groove in a warming sleeve. The warming sleeve is made of silicon and is heated to a set temperature by an embedded heating wire. All heating is done within the warming sleeve.

Indications for Use:

Patient Population:

Patients where warming of fluids to be infused is necessitated.

Environments of use:

Hospitals and clinical settings where warmed IV fluids are required.

We present the proposed device vs. the predicate in Table 1.

As part of the comparison we will present and discuss the:

Indications for Use ●
Technology and Principle of Operation
Performance and Specifications ●

Table 1 is a comparison - Subject Device vs. the Predicate,

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510(k) Summary Page 3 of 6

Table 1 – Comparison – Subject vs. Predicate
Attribute	Biegler GmbHBW685S510(k) K121198	Barkey S-line510(k) TBD	Equivalency to at least one orboth devices
ProductClassification	LGZ	LGZ
Indications forUse	The BW685/S blood / fluid warming system isintended to deliver warm blood, blood products, andliquids to adult and pediatric patients.	The Barkey S-Line blood / fluid warming system isintended to deliver warm blood, blood products, andliquids to adult and pediatric patients. It delivers thefluid via intravenous (IV) administration in hospitalsand clinical settings where warmed intravenousfluids are required.	Similar
Environments ofuse	Hospital	Hospitals and clinical settings where warmed IVfluids are required.	Similar
Principle ofoperation	Continuous flow electrically powered warmer	Continuous flow electrically powered warmer	Similar
Warm up time	45-55 seconds	62-66 seconds	Similar
Flow rates	Set at maximum temperature of 41°C and fluidtemperature of 20°C1.7 ml/mn, 37°C25 ml/mn, 37.5°C100 ml/mn – 36°C	Set at fixed temperature of 39°C and fluidtemperature of 20°C1.7 ml/mn, 37°C25 ml/mn, 29°C100 ml/mn – N/A
Ingress Protection	IPX4	IPX2	Barkey S-line provides adequateingress protection
Degree ofprotection againstelectric shock	Type BF	Type BF	Similar
Dimensions	228 x 278 x 132mm	90 x 60 x 160 mm	Dimensions not critical
Prescriptive	Yes	Yes	Similar
Patient population	adult and pediatric	adult and pediatric	Similar
Single patientreusable	Used with user supplied cleared IV sets	Used with user supplied FDA cleared IV sets	Similar
Attribute	Biegler GmbHBW685S510(k) K121198	Barkey S-line510(k) TBD	Equivalency to at least one orboth devices
Accessories	3 extension sets (K954769)	2 extension sets from Biegler (K954769)Model Length (cm)35000 35046000 460	K954769 and K121198 theseextensions sets have been clearedfor use with fluid warmers
HeatingMechanism	The system includes a main unit and then thewarming tube, Autoline. The Autoline wrapsaround the extension set.This Autoline, also referred to as the TubeFlow ismanufactured by Barkey. It uses a heat exchangermethod with the Autoline / TubeFlow wrappedaround the IV line to keep it warm.	The system included a main unit which attaches to awarming Tube, S-line. The S-line wraps around theextension set.The S-line has embedded heating element whichheat and keep warm the fluids. The principle is aheat exchanger method.	Similar technology of heatexchanger. Instead of heating insidethe unit like the predicate thesubject device heats the line fromthe controller to the patient. Thisdoes not raise different riskconcerns.
Fluid Contactmaterials	The controller and Autolone do not contact thepatient. The accessory Extension sets does contactthe fluid	No fluid contact contacting materials as the subjectdevice does not provide the IV sets but there arerecommended compatible extension sets which havebeen cleared for use with fluid warmers.	The subject device has no fluidcontacting materials.
TemperatureControl	3 sensors: 1 monitored by software, two hardware	Integrated overtemperature protector in the warmingsection of the S-line while there is monitoring of thetemperature in the control unit	Similar in performance and safety
Alarm	Audio/ Visual	Audio/ Visual	Similar
Alarm Conditions	Audible and VisualLow temperature (<36.5C)High Temperature (>42.0C)	Audible and VisualOvertemperatureFault	Similar
Operation	110/220 VAC with AC power	100 - 240 VAC, 50/60 Hz	Similar
Electronics	Microprocessor Control	No microprocessorThe temperature regulation is realized by hardwarecomparator circuit.	Similar
InfusionTemperature	User selectable between 37 to 41°C at increments of0.5° Default 38.5°C	Fixed 39°C	Similar, within the temperatureheating range of the predicate

Table 1 - Comparison - Subject vs Predicate

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510(k) Summary Page 4 of 6

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Substantial Equivalence Discussion

The fundamental warming methodology as a heat exchanger is similar between the subject device and the predicate. The concept of heating within the controller as done in the predicate vs. heating the IV tubing within the S-line sleeve is still the of the S-line is similar to the predicate Biegler TubeFlow.

The fluid contact extension sets used with the S-line are FDA cleared IV-set which fits into the sleeve warmer (warming jacket) of the S-line.

Indications - Equivalent to the predicate

Technology - The technology is similar

Principal of Operation - The principal of operation is similar.

Operating specifications - Similar

Environment of Use - Similar

Patient Population - Similar

Non-clinical Testing

Performance testing demonstrated that the subject device met its acceptance criteria. Testing included:

Electrical / EMC

. AAMI ANSI ES 60601-1: 2005 + A1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: 2014 Collateral standard: Electromagnetic Disturbances Requirements . and Tests

Performance testing to support accuracy and prevention of over heating

ASTM F2172: 2002 (R2011): Standard Specification for Blood/Intravenous ● Fluid/Irrigation Fluid Warmers Temperature management
Comparative testing against the predicate including:
Temperature vs. flow rates .

Substantial Equivalence Conclusion

We have performed a comparison of specifications in the above table and found the proposed models to be equivalent.

Regulation Number and Section

§ 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).