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The MarrowStim™ Concentration Kit and the MarrowStim™ Mini Concentration Kit are intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.

The MarrowStim™ Concentration Kit and MarrowStim™ Mini Concentration Kit consist of a table-top, swinging bucket centrifuge and accessories to allow for preparation of platelet poor plasma and platelet concentrate from blood, and for preparation of a cell concentrate from bone marrow.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and FDA clearance letter for the MarrowStim™ Concentration Kit and MarrowStim™ Mini Concentration Kit, which are centrifuges. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Harvest SmartPReP2 Centrifuge System, K052925) rather than presenting new performance study data with specific acceptance criteria.

Therefore, I cannot provide the requested information. The document explicitly states:

• "Documentation is provided which demonstrated the · MarrowStim™ Concentration Kit and MarrowStim™ Mini Concentration Kit to be substantially equivalent to other legally marketed devices."
• This indicates that direct comparative performance studies against acceptance criteria for the new device were likely not the primary method of clearance, but rather a comparison to an existing, cleared device.

The FDA letter also includes a warning:

• "The safety and effectiveness of this device for in vivo indications for use has not been established." This further confirms that no clinical studies proving safety and effectiveness for in vivo use were part of this submission.

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