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K Number
K070396
Device Name
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45
Manufacturer
ACUMEN MEDICAL, INC.
Date Cleared
2007-05-22

(99 days)

Product Code
DYB
Regulation Number
870.1340
Type
Special
Panel
CV
Reference & Predicate Devices
K053400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Modified Acumen Single-Lumen Delivery Sheath is intended for the introduction of various types of pacing or defibrillator leads and catheters.

Device Description

The Modified Acumen Single-Lumen Delivery Sheath is designed to aid in the introduction of various types of pacing or defibrillator leads and catheters. The sheath will be packaged with a dilator and is designed to be slittable. The Modified Acumen Single-Lumen Delivery Sheath is available in a range of inner diameters, from 4F to 6F.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called the "Modified Acumen Single-Lumen Delivery Sheath". This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data as would be found in a PMA.

Therefore, the requested information regarding acceptance criteria and performance data for an AI-powered device, involving sample sizes, expert ground truth, MRMC studies, and standalone performance, is not applicable to this 510(k) submission.

This submission is for a physical medical device (a catheter introducer sheath), not an AI/software as a medical device (SaMD). The "testing" mentioned refers to in-vitro testing of the physical device's components and does not involve AI performance metrics.

Here's a breakdown of why each requested point is not present or applicable:

  1. A table of acceptance criteria and the reported device performance: Not applicable. The document states "In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." However, it does not provide a table of these specifications or detailed performance metrics. This is typical for a 510(k) of this nature, where adherence to internal design specifications and equivalence to a predicate device are the primary focus.
  2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This refers to physical in-vitro tests, not an AI test set.
  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, as there is no AI algorithm being evaluated against expert ground truth.
  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there is no AI algorithm and no expert adjudication process 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 a physical medical device, not an AI-assisted diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is a physical medical device, not an AI algorithm.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there is no AI algorithm that requires ground truth for its evaluation as per the provided document. The "ground truth" for the device's function would be its ability to physically introduce leads and catheters, assessed through engineering and bench testing.
  8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
  9. How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

Summary from the provided documents:

  • Device Type: Catheter Introducer Sheath (physical medical device)
  • Purpose of Submission: Demonstrate substantial equivalence to a predicate device (Acumen Single-Lumen Delivery Sheath K053400).
  • Primary Evidence: In-vitro testing (details not provided beyond "met the required specifications") and comparison of materials, intended use, method of operation, and construction to the predicate device.
  • Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices.

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).