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K Number
K113773
Device Name
ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL
Manufacturer
ST. JUDE MEDICAL
Date Cleared
2012-01-18

(27 days)

Product Code
KRA
Regulation Number
870.1210
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The IS4 Flushing/Funneling Tool is to provide a means of flushing the lead and facilitate the insertion of either a guidewire or stylet into the connector pin of the over the wire left heart lead with an IS4 connector

Device Description

The St. Jude Medical IS4 Flushing/funneling tool Accessory kit Model DS0A002 is an individually packaged accessory kit containing one IS4 flushing/funneling tool.

AI/ML Overview

This submission document pertains to the St. Jude Medical IS4 Flushing/Funneling Tool Accessory Kit. The information provided heavily emphasizes the substantial equivalence to a predicate device and does not describe a study involving detailed acceptance criteria and performance metrics typically associated with new or significantly modified medical devices that would involve AI or advanced analytical capabilities.

Based on the provided text, there is no mention of an AI-powered device, acceptance criteria, or a study that evaluates device performance against specific metrics.

The document is a 510(k) summary for a Class II medical device (Continuous Flush Catheter, product code KRA) that is an accessory kit. The core of the submission is to demonstrate substantial equivalence to a previously approved predicate device.

Here's how the requested information relates to the provided text:

  1. A table of acceptance criteria and the reported device performance: This information is not present. The submission focuses on substantial equivalence to a predicate device, implying that the new device meets the same performance standards as the predicate, but these standards are not explicitly detailed here.
  2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance information is provided as this is a substantial equivalence claim for an accessory kit, not a performance study as described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. No ground truth establishment or expert involvement in this context is mentioned.
  4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication process is described.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-powered device, nor is it a comparative effectiveness study involving human readers.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but a physical accessory kit.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
  8. The sample size for the training set: Not applicable. This is not a machine learning model.
  9. How the ground truth for the training set was established: Not applicable.

Summary of the document's content:

  • Device: St. Jude Medical IS4 Flushing/Funneling Tool Accessory Kit (Model DS0A002).
  • Intended Use: To provide a means of flushing the lead and facilitate the insertion of a guidewire or stylet into the connector pin of an over-the-wire left heart lead with an IS4 connector.
  • Classification: Class II, regulated under 21 CFR 870.1210 (Continuous Flush Catheter).
  • Predicate Device: St. Jude Medical IS4 Flushing/Funneling tool (approved under P030054/S173).
  • Conclusion: The device is considered substantially equivalent to the predicate device based on similarities in design, technological characteristics, principle of operation, materials, and indications for use.

In essence, the provided text describes a regulatory submission for a medical device accessory kit, where the primary justification for market approval is its substantial equivalence to an already approved product, rather than presenting a performance study against specific acceptance criteria.

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).