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K Number
K043172
Device Name
TRUGRAFT BGS SYRINGE, MODEL 600-041
Manufacturer
OSTEOBIOLOGICS, INC.
Date Cleared
2005-01-07

(52 days)

Product Code
FMF,MQV
Regulation Number
880.5860
Type
Traditional
Panel
HO
Reference & Predicate Devices
K030288,K033707,K011087,K030208,K032130
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

TruGraft™ BGS Syringe is indicated for the aspiration of fluids, such as autologous blood, plasma or other blood components with preloaded bone graft substitute.

Device Description

The TruGraft™ BGS Syringe is a device that can be filled with OsteoBiologics, Inc. products: PolyGraft® BGS or PolyGraft® TCP (K030288 and K033707 respectively) or other bone graft substitute. The TruGrafTM BGS Syringe can be provided as a kit configuration. The convenience kit provides the TruGrafTM BGS Syringe loaded (filled) with a variety of bone graft substitutes.

The TruGrafi™ BGS Syringe is a standard piston syringe that consists of a barrel, plunger and removable end cap. The distal end of the barrel is threaded to allow connection to adapters. While without the attachment, the open end allows for filling of the bone graft material. A cap is available to seal the end of the barrel, enclosing the syringe contents. The piston/plunger assembly is used to expel contents or facilitate in the collection into the barrel of the syringe.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, or a study that proves the device meets specific criteria. The document is a 510(k) summary for a medical device (TruGraft™ BGS Syringe) seeking substantial equivalence to predicate devices, not a performance study.

The text describes:

  • The device's intended use and components.
  • Its classification and product codes.
  • The predicate devices it claims substantial equivalence to.
  • Correspondence from the FDA confirming the 510(k) clearance.

It does not contain the following information typically found in a performance study:

  1. Acceptance criteria and reported device performance table: No specific performance metrics or thresholds are mentioned.
  2. Sample size, data provenance: No test sets, training sets, or data origin (country, retrospective/prospective) are discussed.
  3. Number/qualifications of experts for ground truth: There's no mention of experts or ground truth establishment.
  4. Adjudication method: Not applicable as no ground truth creation is described.
  5. MRMC comparative effectiveness study: No such study is mentioned or implied.
  6. Standalone (algorithm-only) performance: The device is a physical syringe, not an algorithm, so this is not applicable.
  7. Type of ground truth: Not applicable as no ground truth is discussed.
  8. Sample size for training set: No training set is mentioned.
  9. How ground truth for the training set was established: Not applicable.

§ 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).