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K Number
K083139
Device Name
VIPERSPHERE PTA BALLOON CATHETER
Manufacturer
CARDIOVASCULAR SYSTEMS, INC.
Date Cleared
2008-11-25

(33 days)

Product Code
DQY,LIT
Regulation Number
870.1250
Type
Traditional
Panel
CV
Reference & Predicate Devices
K993913,K053116,K971010,K052791
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ViperSphere PTA balloon dilatation catheter is intended to dilate stenoses in peripheral arteries including the iliac, femoral, popliteal, and infra-popliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The Vipersphere™ PTA balloon catheter is a standard percutaneous transluminal angioplasty balloon catheter intended for use in the peripheral vessels. The Vipersphere™ PTA balloon catheter is provided in an over-the-wire configuration with a standard y-adapter on the proximal and a hydrophilic coating balloon on the distal end. The multiple balloon sizes are available with diameter of 2.0mm to 5.0mm and lengths of 10cm, 15cm and 20cm.

AI/ML Overview

This document describes a 510(k) submission for the Vipersphere™ PTA Balloon Catheter. The submission aims to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the context of AI/ML or diagnostic devices.

Therefore, the requested information elements related to AI/ML or diagnostic studies (acceptance criteria, device performance, sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and ground truth establishment methods) are not applicable to this type of regulatory submission.

The document primarily focuses on:

  • Device Description: The Vipersphere™ PTA balloon catheter is a standard percutaneous transluminal angioplasty balloon catheter for peripheral vessels, available in over-the-wire configuration with various sizes.
  • Intended Use/Indications for Use: To dilate stenoses in peripheral arteries (iliac, femoral, popliteal, infra-popliteal) and treat obstructive lesions in native or synthetic arteriovenous dialysis fistulae.
  • Substantial Equivalence: The submission claims substantial equivalence to several predicate PTA balloon catheters, listed with their 510(k) numbers.
  • Supporting Evidence: "Laboratory test data were provided to support the safety and effectiveness of the Vipersphere PTA balloon catheter." (No specifics on these tests or acceptance criteria are given in the provided text).
  • Regulatory Decision: The FDA determined the device is substantially equivalent to legally marketed predicate devices.

§ 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).