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K Number
K093139
Device Name
BANTAM,48XXXXXX, 50XXXXXX
Manufacturer
CLEAR STREAM TECHNOLOGIES, LTD.
Date Cleared
2009-12-30

(86 days)

Product Code
LIT,DQY
Regulation Number
870.1250
Type
Special
Panel
CV
Reference & Predicate Devices
K072947
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.

Device Description

The Bantam and Bantam & PTA Catheters are standard over-the-wire PTA catheters. The co-axial catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the internal lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.018" and 0.014"). The balloon expands to a known diameter at specific pressure.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (PTA Catheters) and does not describe acceptance criteria, a study proving device meeting acceptance criteria, or any of the specific details requested in the prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance).

Instead, it focuses on:

  • Applicant Information: ClearStream Technologies Ltd, contact details.
  • Device Information: Trade name (Bantam and Bantam α PTA Catheter), common name, classification, product code.
  • Predicate Device: Savvy Long PTA Catheter (K072947).
  • Device Description: Standard over-the-wire PTA catheters with a balloon for inflation and a lumen for guidewire insertion.
  • Intended Use: Balloon dilatation of femoral, popliteal, and infra-popliteal arteries (excluding coronary arteries).
  • Comparison to Predicate Device: Stated as "substantially equivalent."
  • Test Data: Mentions safety and effectiveness demonstrated through "non-clinical design verification and design validation tests and analyses," but provides no details on these tests, their results, or acceptance criteria.
  • FDA Correspondence: Official letter from FDA granting marketing clearance based on substantial equivalence to the predicate device.
  • Indications for Use Form: Reiterates the intended use.

Therefore, I cannot provide the requested information based on the input document. The document primarily serves as a regulatory submission and clearance notice, not a detailed scientific study report.

§ 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).