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K Number
K152947
Device Name
Disposable Temporary Pacing Cable
Manufacturer
TIGER MEDICAL PRODUCTS
Date Cleared
2016-04-05

(182 days)

Product Code
DSA
Regulation Number
870.2900
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
K971968
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The PXT701 Disposable Temporary Pacing Cable is designed to connect a pacing system analyzer (PSA) or temporary pacemaker to a cardiac lead.

Device Description

The Disposable Temporary Pacing Cable is an electrical extension cable used to transmit signal from, or power or excitation signal to patient-connected electrodes. The cable is bipolar, with alligator clips at the end of the cable that will be attached to the patient leads, and a safety plug instrument connector at the other end that allows electrical connection to a pacing system analyzer or to an external pacing system (temporary pacemaker). The alligator clips are color coded (red = positive; black = negative). The cable is approximately 2.5 meters (8 feet) long, and is supplied sterile. The cable is a disposable, single-patient use device.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Disposable Temporary Pacing Cable, K152947). It details the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence.

However, the document does not contain the information requested regarding acceptance criteria in the context of an AI/ML powered device, nor does it describe a study involving:

  • A test set sample size or provenance.
  • The number or qualifications of experts for ground truth establishment.
  • Adjudication methods.
  • A multi-reader multi-case (MRMC) comparative effectiveness study.
  • A standalone algorithm performance study.
  • The type of ground truth used (e.g., pathology, outcomes data).
  • Training set sample size or ground truth establishment for a training set.

This document describes a traditional medical device (a cable) and its performance is evaluated through physical and electrical integrity tests against a recognized standard (ANSI/AAMI EC53:2013). It focuses on demonstrating that the new device performs similarly to a legally marketed predicate device, rather than on the performance of a diagnostic or predictive algorithm.

Therefore, I cannot populate the requested tables or information, as the provided text does not contain any details related to AI/ML device performance studies. The core concept of the 510(k) summary is based on direct physical and electrical testing of a simple medical device, not on the complex evaluation of an AI model's diagnostic accuracy.

§ 870.2900 Patient transducer and electrode cable (including connector).

(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).