Vaccines, Blood & Biologics
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(As required by section 21 CFR 807.92(c))
Matthew R. Kyle, J.D.
Telephone: 763-577-0900/ Fax: 763-577-0903
|Date Prepared:||June 25, 2010|
|Trade Name:||Autologous Platelet Concentrator (APC)™ System|
|Regulation Number:||21 CFR 864.9245|
|Regulation Name:||Automated blood cell separator|
|Product Name:||Platelet and plasma separator for bone graft handling|
|Predicate Device:||GPS III Platelet Concentrate Separation Kit,
3650 Annapolis Lane, Suite 105
Minneapolis, MN 55447
The Circle Biologics Autologous Platelet Concentrator (APC)™ System (APC System) allows for point-of-care preparation of platelet rich plasma / platelet poor plasma through centrifugation and ultra-filtration of a fraction of autologous patient blood. The system consists of the APC centrifuge, device and accessories that aid in the preparation of platelet rich plasma / platelet poor plasma. The APC device and accessories are sterile and provided together as a single use, disposable kit. The APC centrifuge and optional centrifuge table are available separately.
Statement of Intended Use:
The Circle Biologics Autologous Platelet Concentrator (APC)™ System is indicated for the rapid preparation of autologous platelet rich plasma / platelet poor plasma from a small sample of blood at the patient's point of care. The platelet rich plasma / platelet poor plasma is mixed with autograft and/or allograft prior to application to a bony defect for improving handling characteristics.
Summary of technological characteristics in comparison to those of the predicate device.
The Circle Biologics APC System is substantially equivalent to the Biomet GPS III Platelet Concentrate Separation Kit w/ Plasma Concentrator Accessory with respect to indications / intended use, performance characteristics and fundamental scientific technology. Both devices are intended for the rapid preparation of autologous PRP from a small sample of blood at the patient's point of care. The design differences between the APC System and the predicate have been evaluated through design verification and validation testing. The results of the design verification and validation testing, and the risk assessment activities described in this 510(k) submission support substantial equivalence of the APC System.
Summary of Clinical Testing:
No additional clinical evaluations of this product for this use have been conducted.
The Circle Biologics APC System is substantially equivalent to the Biomet GPS III Platelet Concentrate Separation Kit, BK070026.