The Thrombinator System for use with Arthrex PRP Systems (Arthrex Angel concentrated Platelet Rich Plasma cPRP System or Arthrex Double Syringe (ACP) System or Arthrex ACP Max™ Platelet-Rich Plasma (PRP) System) is designed for the preparation of autologous serum from anticoagulated or non-anticoagulated peripheral blood, platelet poor plasma, or platelet rich plasma (PRP) that is to be mixed with PRP and autograft or allograft bone prior to application to a bony defect for improving handling characteristics.
Device Story
System comprises sterile, single-use Thrombinator tube construct and filter; used to prepare autologous thrombin serum from peripheral blood, platelet poor plasma, or PRP. Device operates in conjunction with Arthrex PRP systems (Angel cPRP, ACP, or ACP Max). Prepared serum mixed with PRP and bone graft material by clinician to improve graft handling properties before application to bony defects. System facilitates autologous thrombin production for surgical site use.
Clinical Evidence
Bench testing only. Performance testing evaluated thrombin activity and bone graft cohesive strength to confirm substantial equivalence to the predicate device.
Technological Characteristics
Sterile, single-use tube construct and filter. Mechanical separation/preparation system. No electronic components, software, or energy sources.
Indications for Use
Indicated for preparation of autologous serum from peripheral blood, platelet poor plasma, or platelet rich plasma (PRP) for mixing with PRP and bone graft (autograft/allograft) to improve handling characteristics during application to bony defects.
Regulatory Classification
Identification
An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to automatically withdraw whole blood from a donor, separate the whole blood into blood components, collect one or more of the blood components, and return to the donor the remainder of the whole blood and blood components. The automated blood cell separator device is intended for routine collection of blood and blood components for transfusion or further manufacturing use.
Special Controls
*Classification.* Class II (special controls). The special control for this device is a guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.”
Arthrex ACP Max™ Platelet-Rich Plasma (PRP) System (BK210655)
Submission Summary (Full Text)
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# 510(k) Summary
| ***Date Prepared*** | March 22, 2024 |
| --- | --- |
| ***Submitter*** | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 |
| ***Contact Person*** | Name: Emmarie Halteman Title: Senior Regulatory Affairs Specialist Phone: 1-239-643-5553 Email: emmarie.halteman@arthrex.com |
| ***Trade Name*** | Arthrex Thrombinator System |
| ***Common Name*** | Platelet and plasma separator for bone graft handling |
| ***Product Code*** | ORG |
| ***Classification Name*** | 21 CFR 864.9245 – Automated blood cell separator |
| ***Regulatory Class*** | II |
| ***Primary Predicate Device*** | BK180299 – Arthrex Thrombinator System |
| ***Purpose of Submission*** | This Special 510(k) premarket notification is submitted to obtain clearance for the Arthrex Thrombinator System cleared via K180299 to include the addition of a third Arthrex PRP System, Arthrex ACP Max™ Platelet-Rich Plasma (PRP) System cleared via BK210655, to the Indication for Use. The proposed addition of the Arthrex ACP Max™ PRP System for use with the Arthrex Thrombinator System is to allow for a third Arthrex PRP System source. |
| ***Device Description*** | The Arthrex Thrombinator System includes a sterile, single-use device (i.e., Thrombinator tube construct) and a separate filter that aid in the preparation of autologous thrombin serum. Additional equipment used for blood draw and processing is available and sold separately and to be supplied by the end-user in order to operate the device as intended. |
| ***Indications for Use*** | The Thrombinator System for use with Arthrex PRP Systems (Arthrex Angel concentrated Platelet Rich Plasma cPRP System or Arthrex Double Syringe (ACP) System or Arthrex ACP Max™ Platelet-Rich Plasma (PRP) System) is designed for the preparation of autologous |
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| | serum from anticoagulated or non-anticoagulated peripheral blood, platelet poor plasma, or platelet rich plasma (PRP) that is to be mixed with PRP and autograft or allograft bone prior to application to a bony defect for improving handling characteristics. |
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| ***Performance Data*** | Performance testing, inclusive of thrombin activity and bone graft cohesive strength, was performed to demonstrate that the Arthrex Thrombinator System is substantially equivalent to the predicate device (BK180299). |
| ***Technological Comparison*** | The Arthrex Thrombinator System is substantially equivalent to the predicate device cleared under BK180299 in which the intended use, device material, technological characteristics, fundamental scientific technology, sterility, and shelf-life is identical. The Arthrex Thrombinator System will include the addition of a third Arthrex PRP System, Arthrex ACP Max™ Platelet-Rich Plasma (PRP) System cleared via BK210655 to the indication for use. Any differences between the Arthrex Thrombinator System and the predicate device are considered minor and do not raise new or different questions concerning safety or effectiveness. |
| ***Conclusion*** | The Arthrex Thrombinator System is substantially equivalent to the predicate device in which the basic design features and intended use are the same. Any differences between the proposed Arthrex Thrombinator System and the predicate device are considered minor and do not result in new or different questions of safety or effectiveness. Based on the intended use, technological characteristics, and the summary of data submitted, Arthrex, Inc. has determined that proposed device is substantially equivalent to the currently marketed device. |
