(237 days)
Not Found
No
The device description explicitly states "There is no software / firmware in the device." and there are no mentions of AI, ML, or related concepts in the summary. The temperature monitoring and adjustment appear to be based on a fixed set point and safety mechanisms, not adaptive learning.
Yes
Explanation: The device is intended to deliver warm blood, blood products, and liquids to patients via intravenous administration in a hospital setting, which directly aligns with the definition of a therapeutic device as it is used in the treatment or management of a patient's condition.
No
This device is a fluid warming system, not a diagnostic device. It delivers warmed fluids for administration, and its functionality involves temperature monitoring and adjustment, not the identification or assessment of medical conditions.
No
The device description explicitly states "There is no software / firmware in the device." and describes a hardware-based blood/fluid warming system.
Based on the provided information, the Barkey S-Line blood / fluid warming system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to warm blood, blood products, and liquids for intravenous administration to patients. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The device warms fluids that are already prepared and intended for direct infusion into the patient's bloodstream. It does not analyze or test biological samples in vitro (outside the body) to provide diagnostic information.
- Lack of Diagnostic Function: The device's function is purely to regulate the temperature of the fluid being administered. It does not perform any tests, measurements, or analyses on the fluid or the patient's sample to aid in diagnosis or monitoring.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Barkey S-Line does not fit this description.
N/A
Intended Use / Indications for Use
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.
Product codes
LGZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients.
Intended User / Care Setting
hospitals and clinical settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
Indications for Use
510(k) Number (if known)
K213191
Device Name
Barkey S-Line
Indications for Use (Describe)
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.
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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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
3
| Date Prepared: | 24-Apr-22 |
|---|---|
| Applicant | Barkey GmbH & Co. KG |
| Gewerbestr. 8 | |
| 33818 Leopoldshoehe Germany | |
| Tel - +49(0)5202-9801-0 | |
| Sponsor Contact: | Thomas Barkey, CEO |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| Proprietary or Trade Name: | |
| Common/Usual Name: | |
| Classification Name: | |
| Product Classification: | |
| CFR: | S-line |
| Warmer, Thermal, Infusion Fluid | |
| Warmer, Thermal, Infusion Fluid | |
| LGZ | |
| Unclassified | |
| Predicate Device: | |
| Tradename: | |
| Classification Name: | |
| Product Classification: | |
| CFR: | K121198 |
| Biegler BW685S | |
| Warmer, Thermal, Infusion Fluid | |
| LGZ | |
| Unclassified |
Accessory
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.
4
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:
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.
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,
5
510(k) Summary Page 3 of 6
| Table 1 – Comparison – Subject vs. Predicate | |||
|---|---|---|---|
| Attribute | Biegler GmbH | ||
| BW685S | |||
| 510(k) K121198 | Barkey S-line | ||
| 510(k) TBD | Equivalency to at least one or | ||
| both devices | |||
| Product | |||
| Classification | LGZ | LGZ | |
| Indications for | |||
| Use | The BW685/S blood / fluid warming system is | ||
| intended to deliver warm blood, blood products, and | |||
| liquids to adult and pediatric patients. | 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. | Similar | ||
| Environments of | |||
| use | Hospital | Hospitals and clinical settings where warmed IV | |
| fluids are required. | Similar | ||
| Principle of | |||
| operation | 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 fluid | ||
| temperature of 20°C | |||
| 1.7 ml/mn, 37°C | |||
| 25 ml/mn, 37.5°C | |||
| 100 ml/mn – 36°C | Set at fixed temperature of 39°C and fluid | ||
| temperature of 20°C | |||
| 1.7 ml/mn, 37°C | |||
| 25 ml/mn, 29°C | |||
| 100 ml/mn – N/A | |||
| Ingress Protection | IPX4 | IPX2 | Barkey S-line provides adequate |
| ingress protection | |||
| Degree of | |||
| protection against | |||
| electric 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 patient | |||
| reusable | Used with user supplied cleared IV sets | Used with user supplied FDA cleared IV sets | Similar |
| Attribute | Biegler GmbH | ||
| BW685S | |||
| 510(k) K121198 | Barkey S-line | ||
| 510(k) TBD | Equivalency to at least one or | ||
| both devices | |||
| Accessories | 3 extension sets (K954769) | 2 extension sets from Biegler (K954769) | |
| Model Length (cm) | |||
| 35000 350 | |||
| 46000 460 | K954769 and K121198 these | ||
| extensions sets have been cleared | |||
| for use with fluid warmers | |||
| Heating | |||
| Mechanism | The system includes a main unit and then the | ||
| warming tube, Autoline. The Autoline wraps | |||
| around the extension set. |
This Autoline, also referred to as the TubeFlow is
manufactured by Barkey. It uses a heat exchanger
method with the Autoline / TubeFlow wrapped
around the IV line to keep it warm. | The system included a main unit which attaches to a
warming Tube, S-line. The S-line wraps around the
extension set.
The S-line has embedded heating element which
heat and keep warm the fluids. The principle is a
heat exchanger method. | Similar technology of heat
exchanger. Instead of heating inside
the unit like the predicate the
subject device heats the line from
the controller to the patient. This
does not raise different risk
concerns. |
| Fluid Contact
materials | The controller and Autolone do not contact the
patient. The accessory Extension sets does contact
the fluid | No fluid contact contacting materials as the subject
device does not provide the IV sets but there are
recommended compatible extension sets which have
been cleared for use with fluid warmers. | The subject device has no fluid
contacting materials. |
| Temperature
Control | 3 sensors: 1 monitored by software, two hardware | Integrated overtemperature protector in the warming
section of the S-line while there is monitoring of the
temperature in the control unit | Similar in performance and safety |
| Alarm | Audio/ Visual | Audio/ Visual | Similar |
| Alarm Conditions | Audible and Visual
Low temperature (42.0C) | Audible and Visual
Overtemperature
Fault | Similar |
| Operation | 110/220 VAC with AC power | 100 - 240 VAC, 50/60 Hz | Similar |
| Electronics | Microprocessor Control | No microprocessor
The temperature regulation is realized by hardware
comparator circuit. | Similar |
| Infusion
Temperature | User selectable between 37 to 41°C at increments of
0.5° Default 38.5°C | Fixed 39°C | Similar, within the temperature
heating range of the predicate |
Table 1 - Comparison - Subject vs Predicate
6
510(k) Summary Page 4 of 6
7
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.