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K Number
K092361
Device Name
REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER
Manufacturer
INVATEC S.P.A.
Date Cleared
2009-10-29

(86 days)

Product Code
LIT,DQY
Regulation Number
870.1250
Type
Traditional
Panel
CV
Reference & Predicate Devices
K062809,K032737
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The REEF HP 0.035" OTW PTA Balloon Dilatation Catheters are intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The Reef HP 0.035"OTW PTA Balloon Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter consisting of a proximal hub, dual lumen shaft, and a distal non-compliant dilatation balloon. The REEF HP 0.035" OTW PTA Balloon Dilatation Catheter is compatible with guidewires with a maximum diameter of 0.035" and with 5, 6 or 7 FR introducer sheaths, depending on the diameter/length of the dilatation balloon. The catheter is provided in useable catheter lengths of 50 cm, 80cm and 120 cm.

AI/ML Overview

The provided documentation is a 510(k) summary for a medical device (REEF HP 0.035" OTW PTA Balloon Dilatation Catheter), not a study evaluating an AI/ML powered device. Therefore, it does not contain the specific information requested in the prompt regarding acceptance criteria, study design parameters (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies typically associated with AI/ML device evaluations.

The document states:

  • Performance Data: "Bench testing of the REEF HP 0.035" OTW PTA Balloon Dilatation Catheter demonstrated that the device met the bench test acceptance criteria."
  • Biocompatibility: "Biocompatibility testing was performed in accordance with ISO 10993-Part 1."

However, it does not provide:

  1. A table of acceptance criteria or reported device performance metrics and their values.
  2. Details about sample sizes for test sets, data provenance, or anything related to "test sets" in the context of an AI/ML algorithm.
  3. Information on experts, ground truth establishment (beyond general bench testing), or adjudication methods, as these are not relevant to the traditional medical device being described.
  4. Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study.
  5. Any mention of a standalone algorithm performance study.
  6. The type of ground truth used (e.g., pathology, expert consensus) for algorithm training or testing.
  7. Sample size for a training set.
  8. How ground truth for a training set was established.

This document is a regulatory submission for a conventional medical device (a balloon catheter), focusing on its substantial equivalence to predicate devices based on design, materials, technological characteristics, and bench performance, rather than an AI/ML diagnostic or assistive device.

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).