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K Number
K132022
Device Name
LEMAITRE 8F OCCLUSION CATHETER
Manufacturer
LEMAITRE VASCULAR, INC.
Date Cleared
2013-11-06

(128 days)

Product Code
MJN
Regulation Number
870.4450
Type
Traditional
Panel
CV
Reference & Predicate Devices
K093911
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The LeMaitre 8F Occlusion Catheter is indicated for temporary vessel occlusion.

Device Description

The 8F Occlusion Catheters is offered in two balloon sizes; 28 mm or 45mm. It is a single lumen catheter with a latex balloon specifically designed and sized for use in the outlined general procedures. The single lumen (inflation lumen indicated by the white stopcock) is used for balloon inflation. The stop-cock is to maintain balloon inflation level throughout the procedure. The device has radiopaque marker bands at the proximal and distal ends of the balloon to enhance visibility of the balloon location when used under fluoroscopy.

AI/ML Overview

The provided text describes a medical device, the LeMaitre 8F Occlusion Catheter, and its 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. However, it does not contain information about a study that establishes acceptance criteria and then proves the device meets those criteria, especially in the context of an AI/algorithm-driven device.

The document outlines functional and safety testing, but these tests are for the physical catheter's performance (e.g., inflation volume, burst volume) rather than for an AI algorithm's diagnostic or predictive capabilities.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it describes a physical medical device clearance, not an AI/algorithm-based one:

  1. A table of acceptance criteria and the reported device performance: The document only lists types of tests, not specific acceptance criteria (e.g., a minimum inflation pressure value) or detailed performance results that would be typically found for an AI system (e.g., sensitivity, specificity, AUC).
  2. Sample size used for the test set and the data provenance: No test set information for an algorithm is provided.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no algorithm test set.
  4. Adjudication method for the test set: Not applicable.
  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.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
  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.
  9. How the ground truth for the training set was established: Not applicable.

The document focuses on:

  • Device Description: Physical characteristics of the LeMaitre 8F Occlusion Catheter.
  • Intended Use: Temporary vessel occlusion.
  • Predicate Device: Fogarty Occlusion Catheter (K093911).
  • Substantial Equivalence: Claiming similar intended use and fundamental scientific technology as the predicate.
  • Functional/Safety Testing: Mentioning tests like "Volume Required to Inflate Balloon to IFU Indicated Diameter," "Inflation Pressure," "Radial Force," "Contact Area," "Inflation Time," "Deflation Time," and "Burst Volume." These are physical device performance tests.
  • Sterilization and Biocompatibility: Confirming compliance with relevant standards.

To summarize, the provided text does not contain the type of AI/algorithm performance study details you are asking for.

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).