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K Number
K111632
Device Name
INFILL GRAFT DELIVERY SYSTEM
Manufacturer
PINNACLE SPINE GROUP, LLC
Date Cleared
2011-08-11

(59 days)

Product Code
FMF
Regulation Number
880.5860
Type
Traditional
Panel
HO
Reference & Predicate Devices
K023088,K100754
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The InFill™ Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site.

Device Description

The InFill™ Graft Delivery System is comprised of a commercially available disposable medical piston syringe (syringe barrel w/female luer, plunger) and a cannulated applicator tip. The InFill™ Graft Delivery System is provided sterile, for single use only.

AI/ML Overview

The provided text describes a 510(k) summary for the "InFill™ Graft Delivery System" and a letter from the FDA. It does not include information about acceptance criteria, device performance metrics, or study results related to clinical efficacy or accuracy.

The document primarily focuses on establishing substantial equivalence to predicate devices based on:

  • Intended Use: Delivering hydrated bone graft material to an orthopedic surgical site.
  • Technological Characteristics: Overall design, materials, principle of operation, and configuration.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or MRMC studies, as these details are not present in the provided text.

The closest relevant information is:

  • Device Name: InFill™ Graft Delivery System
  • Intended Use: "The InFill™ Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site."
  • Basis for Substantial Equivalence: Comparison of intended use, design, materials, principle of operation, and overall technological characteristics to predicate devices (Wright Medical Bone Graft Syringe, K023088; FibirJet Graft Delivery System K100754).

For all other requested points, the information is not provided in the given text.

§ 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).