K Number
K980390
Manufacturer
Date Cleared
1998-08-20

(199 days)

Product Code
Regulation Number
870.1250
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and is also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The PTA Balloon Catheter is a double lumen catheter with a balloon near the distal tip. The catheter features a minimally compliant balloon constructed from high density polyethylene material. The balloon is designed to expand to a specified diameter and length at a specific pressure as labeled. The balloon catheter is provided in an overall length of 135cm. The catheter will be made in four balloon diameters of 2.5mm, 3.0mm, 3.5mm and 4.0mm. Balloon lengths will be 1.5cm, 2.0cm, 3.0cm and 4.5cm. The catheter is compatible with 0.014-inch standard PTA wire guides. Two radiopaque marker bands located at the proximal and distal ends of the balloon segment facilitate fluoroscopic visualization of the balloon during use.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for a PTA Balloon Catheter. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies in the way a novel AI or diagnostic device would.

Therefore, many of the requested categories in your prompt are not applicable to this type of regulatory submission. Specifically, this document does not contain:

  • A table of acceptance criteria and reported device performance in a clinical context for AI/diagnostic devices.
  • Information on sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, or AI-related comparative effectiveness studies (MRMC or standalone performance).
  • Details about training sets or how ground truth for training sets was established.

Here's a breakdown of what can be extracted and what is not applicable, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes engineering and material performance tests rather than clinical performance or diagnostic accuracy. The "acceptance criteria" for these tests are not explicitly quantified in this document beyond the statement "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a vascular PTA balloon."

Acceptance Criteria (Implied)Reported Device Performance
Reliable design and performance under specified testing parameters for vascular PTA balloon useThe balloon catheter was subjected to and passed the following tests:
Balloon Minimum Burst Strength Test(Results indicate compliance, but specific values are not provided)
Balloon Distensibility Test(Results indicate compliance, but specific values are not provided)
Balloon Inflation/Deflation Test(Results indicate compliance, but specific values are not provided)
Balloon Fatigue Test(Results indicate compliance, but specific values are not provided)
Bond Strength Test(Results indicate compliance, but specific values are not provided)
Diameter and Profile Test(Results indicate compliance, but specific values are not provided)
Biocompatibility Test(Results indicate compliance, but specific values are not provided)

2. Sample size used for the test set and the data provenance

  • Test Set Sample Size: Not specified. The document mentions "the balloon catheter was subjected to the following tests," implying laboratory testing on device prototypes/samples, not a clinical test set with patient data.
  • Data Provenance: Not applicable. These are laboratory engineering tests, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

  • Not applicable. Ground truth for clinical data is not relevant to these engineering performance tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

  • Not applicable. This concept is for clinical data review, not engineering tests.

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 for angioplasty, not an AI or diagnostic imaging device that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

  • Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

  • Type of Ground Truth: For the engineering tests, the "ground truth" would be the established engineering specifications, standards, and performance limits for each parameter (e.g., minimum burst pressure, maximum distensibility, cycle endurance). The device's performance is compared against these predetermined specifications.

8. The sample size for the training set

  • Not applicable. This is a physical medical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

  • Not applicable. No training set is involved.

§ 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).