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K Number
K963073
Device Name
HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
Manufacturer
HARMAC MEDICAL PRODUCTS, INC.
Date Cleared
1997-08-14

(412 days)

Product Code
LDF
Regulation Number
870.3680
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Bipolar Temporary Pacing Catheter with Stylet is indicated for use in temporary transvenous cardiac pacing when impulse formation or conduction is impaired.

Device Description

Harmac Temporary Pacing Catheter with Stylet

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device, the Harmac Temporary Pacing Catheter with Stylet. It is not a study report or a technical performance document for an AI/ML powered device. As such, it does not contain the requested information regarding acceptance criteria or a study proving device performance against such criteria.

The letter primarily states that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976, and outlines the regulatory framework for its marketing.

Specifically, the requested information cannot be found in this document:

  1. A table of acceptance criteria and the reported device performance: Not present. This document only includes the Indications for Use.
  2. Sample size used for the test set and the data provenance: Not present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
  4. Adjudication method for the test set: Not present.
  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 present. This is a traditional medical device, not an AI/ML device.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This is a traditional medical device, not an AI/ML device.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
  8. The sample size for the training set: Not present.
  9. How the ground truth for the training set was established: Not present.

§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.

(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.