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K Number
K173385
Device Name
Graft Delivery, DePuy Synthes
Manufacturer
Micromedics, Inc. (d/b/a Nordson MEDICAL)
Date Cleared
2017-11-30

(31 days)

Product Code
FMF
Regulation Number
880.5860
Type
Special
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Graft Preparation and Delivery Device is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as I.V. fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a medical device called "Graft Delivery, DePuy Synthes." It is a regulatory letter that grants clearance for the device to be marketed.

This document does not contain the information requested in your prompt. The prompt asks for details about acceptance criteria and a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information.

The provided FDA letter focuses on:

  • Regulatory clearance: Stating that the device is substantially equivalent to legally marketed predicate devices.
  • Indications for Use: Describing what the device is intended for (delivery and premixing of bone graft materials).
  • General controls and regulations: Reminding the manufacturer of their obligations under the Federal Food, Drug, and Cosmetic Act.

The letter does not include any performance data, study designs, or analytical results that would describe acceptance criteria or how the device met them. Such information would typically be found in the 510(k) submission itself (which is not provided here), not the final clearance letter.

§ 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).