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K Number
K073326
Device Name
NRG TRANSSEPTAL NEEDLE
Manufacturer
BAYLIS MEDICAL CO., INC.
Date Cleared
2008-05-28

(183 days)

Product Code
DXF
Regulation Number
870.5175
Type
Traditional
Panel
CV
Reference & Predicate Devices
K031949,K011727
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Creation of an atrial septal defect in the heart. Secondary applications include transseptal heart access, monitoring intracardiac pressures, sampling blood, and infusing solutions.

Device Description

The NRG Transseptal Needle is a sterile, single-use device that delivers radiofrequency (RF) energy to create an atrial septal defect in the heart.

AI/ML Overview

The provided text describes a medical device, the NRG Transseptal Needle, and its 510(k) summary for FDA clearance. However, it does not contain information about acceptance criteria, device performance, or any study involving AI or human readers.

The key points from the document regarding the device and its clearance are:

  • Device Name: NRG Transseptal Needle
  • Intended Use: Creation of an atrial septal defect in the heart. Secondary applications include transseptal heart access, monitoring intracardiac pressures, sampling blood, and infusing solutions.
  • Predicate Devices: Toronto RF Septostomy Catheter (K031949) and Transseptal Needle/Trocar (K011727).
  • Substantial Equivalence: The device was deemed substantially equivalent to the predicate devices based on identical indications for use and similar fundamental scientific technology.
  • Device Testing: The document states that the NRG Transseptal Needle "has been subjected to mechanical, electrical and simulated use bench testing to verify compliance with safety and performance requirements." It also notes that the device "will be validated for biocompatibility, sterilization and packaging."

Since the input text is a 510(k) summary for a traditional medical device (not an AI/ML powered device), the following requested information cannot be extracted:

  • A table of acceptance criteria and the reported device performance.
  • Sample size used for the test set and data provenance.
  • Number of experts used to establish ground truth.
  • Adjudication method.
  • Multi-reader multi-case (MRMC) comparative effectiveness study.
  • Standalone (algorithm only) performance.
  • Type of ground truth used (expert consensus, pathology, outcomes data, etc).
  • Sample size for the training set.
  • How ground truth for the training set was established.

§ 870.5175 Septostomy catheter.

(a)
Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.(b)
Classification. Class II (performance standards).