(108 days)
CDO™ System: The CDO™ System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, platelet-rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.
Graft Preparation System: The Graft Preparation System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, platelet-rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.
CDO™ System: The CDO™ System consists of a curved delivery cannula, a modified syringe, a flexible plunger and an optional syringe adaptor tip.
Graft Preparation System: The Graft Preparation System consists of a modified syringe with a check valve, plunger, nozzle cap and end cap.
The provided document is a 510(k) premarket notification for the Biomet Biologics, Inc. Curved Delivery Option (CDO™ System) and Graft Preparation System. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a standalone study with acceptance criteria and performance metrics for a novel technology.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets.
- Data provenance.
- Number and qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets.
- How ground truth for training sets was established.
Instead, the document states:
- Non-Clinical Testing: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use."
- Clinical Testing: "None provided as a basis for substantial equivalence."
This indicates that the submission relied solely on non-clinical (i.e., benchtop or in vitro) testing to support functional equivalence to predicate devices, and no human factors or clinical performance studies with specific acceptance criteria or expert-adjudicated ground truth were conducted or reported in this 510(k) submission.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).