LogoFDA 510(k) Search
K Number
K061092
Device Name
BAXTER DUPLOSPRAY MIS APPLICATOR
Manufacturer
MICROMEDICS, INC.
Date Cleared
2006-09-13

(147 days)

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

This device is for the application of Tisseel® Fibrin Sealant.

Device Description

Not Found

AI/ML Overview

This is a 510(k) clearance letter for the Baxter DuploSpray MIS Applicator, a Piston Syringe. The letter indicates that the device is substantially equivalent to legally marketed predicate devices. This type of regulatory document typically does not contain the kind of detailed study data, acceptance criteria, or ground truth information you're asking for regarding AI-driven device performance.

Therefore,Based on the provided document, the requested information regarding acceptance criteria and study details for device performance cannot be extracted. The document is a 510(k) clearance letter for a medical device (Baxter DuploSpray MIS Applicator), not a study report or a detailed technical specification with performance metrics.

Specifically, the document does not contain:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for a test set, data provenance, or details about retrospective/prospective studies.
  3. Number and qualifications of experts used to establish ground truth.
  4. Adjudication method for a test set.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, including human reader improvement with/without AI assistance.
  6. Results of a standalone (algorithm only) performance study.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
  8. The sample size for a training set.
  9. How the ground truth for a training set was established.

This document serves as regulatory clearance based on substantial equivalence to existing devices, implying that its safety and effectiveness are comparable, but it doesn't detail specific performance studies with quantitative metrics or AI components.

§ 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).