(90 days)
This device is intended for use in the delivery of allograft and autograft bone materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood components as deemed necessary by the clinical use requirements.
The Graft Delivery System will be configured using the following components. See Exhibit 1 for drawings and supplier catalog Information.
- . Two commercially available disposable medical piston syringes
- Applicator tips .
This Graft Delivery System will be sold in coniunction with CelSep® Centrifuge System (K994148), CelSep® Centrifuge System (K994148) that consists of a compact bench top centrifuge designed for multi-purpose use in medical, industrial, and scientific laboratories, that includes a single-use processing disposable.
The provided text describes a 510(k) premarket notification for a "Graft Delivery System" (piston syringe). This submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for a new, standalone device.
Therefore, the requested information (acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) cannot be extracted from the provided document.
The document states:
- "No performance standards have been developed for this type of device." (Page 1)
- The primary method for clearance is establishing "Substantial Equivalence" to existing predicate devices (Page 2).
The core of the submission is a comparison table showing that the "Graft Delivery System" has the "Same" intended use, components, sterility, and principle of operation as its predicate devices (DePuy/AcroMed Symphony and Harvest Technologies SmartJet). The only difference noted for Osseous Technologies and DePuy AcroMed is the specific centrifuge system with which they are commercially available/labeled.
This type of submission focuses on demonstrating that the new device is as safe and effective as already legally marketed devices, rather than providing detailed performance studies against defined acceptance criteria.
§ 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).