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K Number
K971577
Device Name
FOCUS-PV BALLOON DILATATION CATHETER
Manufacturer
CARDIOVASCULAR DYNAMICS, INC.
Date Cleared
1997-06-18

(58 days)

Product Code
LIT
Regulation Number
870.1250
Type
Traditional
Panel
CV
Reference & Predicate Devices
K944016,K952064,K954313
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

FOCUS™-PV Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the large vessels of the renal, femoral, popliteal, tibial, peroneal, iliac and profunda arteries and for treatment of obstructive lesions of native or synthetic arterovenous dialysis fistulae.

Device Description

Not Found

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the FOCUS™-PV Balloon Dilatation Catheter. A 510(k) submission is primarily for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a formal study with detailed performance metrics as one might find in a de novo application or a clinical trial for a novel device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets them in the way clinical trials or performance studies for novel devices typically would.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

  1. A table of acceptance criteria and the reported device performance: This document focuses on comparing the new device's specifications and intended use to predicate devices, not on setting and meeting specific performance acceptance criteria from a study.
  2. Sample size used for the test set and the data provenance: No test set is described. The 510(k) primarily relies on substantial equivalence to existing devices rather than new performance data.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such test set or ground truth establishment is mentioned.
  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. This is a medical device (balloon catheter), not an AI-powered diagnostic tool.
  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.

Explanation based on the provided text:

The document is a 510(k) summary for the FOCUS™-PV Balloon Dilatation Catheter. The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a predicate device already legally marketed. This means the device has:

  • The same intended use as a predicate device.
  • The same technological characteristics as a predicate device; OR
  • Different technological characteristics from a predicate device but does not raise different questions of safety and effectiveness, and the new device is as safe and effective as the predicate device.

The provided text details:

  • Intended Use: The FOCUS™-PV Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty of large vessels in various arteries and for treatment of obstructive lesions in arteriovenous dialysis fistulae. This is compared to the intended uses of several predicate devices, demonstrating similarity.
  • Comparison of Characteristics: A detailed table (TABLE 1) compares the physical and material characteristics of the FOCUS™-PV catheter with several predicate PTA catheters (Schneider Match 35™, Schneider Total Cross™, Medi-tech MS Classique™, Medi-tech Ultra-Thin™, and previous versions of CardioVascular Dynamics' FOCUS™). This comparison highlights similarities in balloon size ranges, lengths, shaft sizes, materials, and guidewire compatibility.

The FDA's letter states that they "determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified..." This "substantial equivalence" determination is the "acceptance criteria" met in the context of a 510(k) process, rather than specific performance metrics from a dedicated clinical study.

§ 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).