Barkey GmbH & Co. KG

During an inspection of your firm Barkey GmbH & Co. KG, located at Gewerbestr. 8, Leopoldshohe, North Rhine-Westphalia, 33818, Germany, conducted between October 31, 2022 and November 4, 2022, the United States Food and Drug Administration (FDA) documented that your firm manufactures the Barkey plasmatherm and Barkey plasmatherm V. As reflected in the Instructions for Use collected during the inspection, the Barkey plasmatherm and the Barkey plasmatherm V are intended for thawing or warming certain fluids, including thawing fresh frozen plasma (FFP) and warming whole blood and red blood cells (RBCs), prior to transfusion. Under section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h)(1), each of these products is a device because it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

Your firm currently holds a 510(k) clearance for the Barkey plasmatherm device (BK100063), which was issued on November 17, 2011. However, your firm introduced a new version of this device, the Barkey plasmatherm V, in August 2021 without submitting a new premarket notification to FDA. Based on our review of the materials FDA collected during the inspection as well as your website, barkey-us.com/us/ (last reviewed January 2024), the Barkey plasmatherm V includes significant changes or modifications in design, components, method of manufacture, or intended use within the meaning of 21 CFR 807.81(a)(3). For example, your firm has changed the device in multiple ways to reduce thawing time. Specifically, you changed from a single, rubber “Disc” paddle for the Barkey plasmatherm to a larger, wire “Smart Motion” paddle with a different shape for the Barkey plasmatherm V. In addition, the Barkey plasmatherm V paddle moves laterally driven by a stepper motor, instead of the up-and-down motion driven by a gear motor used for the Barkey plasmatherm device. According to materials on your firm’s website, the Barkey plasmathem V can thaw 1 bag of FFP in 9 minutes compared to a 14-minute thaw time for the “standard Barkey plasmatherm.” The changes to the paddle movement could increase the risk of hemolysis of RBC products during thawing and the more rapid rise in temperature could affect the quality of some clotting factors in plasma. Because these changes or modifications to the device could significantly affect its safety or effectiveness, your firm was required to submit a new premarket notification for the Barkey plasmatherm V pursuant to section 510(k) of the Act, 21 U.S.C. § 360(k), to FDA at least 90 days before your firm proposed to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of the device. See 21 CFR 807.81(a)(3). FDA has not received such a 510(k).

Accordingly, the Barkey plasmatherm V is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g), for the changed device. The device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the changed device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3).

For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency (21 CFR 807.81(b)). The kind of information needed to obtain approval or clearance for a device is described on FDA’s website at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm.

This inspection also revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at 21 CFR 820. These deficiencies include, but are not limited to, the following:

Your firm failed to conduct an adequate risk analysis as part of design validation, as required by 21 CFR 820.30(g). For example, your firm implemented a design change to reduce the thawing time of a new version of the device (i.e., the Barkey plasmatherm V), which included changes to the design of the paddle as described above. However, the risk management plan and risk management file your firm provided to the FDA investigator did not include a risk analysis of the specific design changes implemented to reduce the thawing time.

We acknowledge receipt of your correspondences dated November 17, 2022, February 7, 2023, and March 1, 2023, written in response to the Form FDA-483, List of Inspectional Observations, issued at the conclusion of the inspection. Your response did not include sufficient information to demonstrate that the above-referenced deficiency has been corrected. For example, your response does not include documentation showing a risk analysis specific to the design changes to reduce thawing time of the Barkey plasmatherm V. Further, your response fails to address how the changes described above could not significantly affect the safety or effectiveness of the device. Your response also did not include plans to submit a new 510(k).

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure and injunction.

Your response should be sent to the following address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 71, Silver Spring, MD 20993. In addition, you may also email a copy of your response to CBERDCMRecommendations@fda.hhs.gov. If you have any questions regarding this letter, please contact the Division of Case Management, CBER at (240) 402-9156.