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K Number
K083674
Device Name
PK-141 PATIENT CABLE
Manufacturer
BIOTRONIK, INC.
Date Cleared
2009-04-01

(111 days)

Product Code
DTC,KRG
Regulation Number
870.3630
Type
Traditional
Panel
CV
Reference & Predicate Devices
K022360
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The PK-141 patient cable is an accessory indicated for use with external equipment from BIOTRONIK and is used for the transmission of sensing signals and pacing pulses for diagnostics and therapy in the context of intracardiac examinations including the following activities:

  • Temporary External Pacing Provides temporary stimulation during implantable pacemaker procedures or physician evaluations.
  • Lead Threshold Determination Determines in situ lead characteristics of impedance, capture threshold. P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time.
  • Pacemaker Function Test Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude and width, AV delay, and rate/interval.
Device Description

The PK-141 patient cable is compatible with the following BIOTRONIK external equipment: ICS 3000 Implant Control System, EDP 20/30 B External Pacemakers, and ERA 300/3000 Pacing System Analyzers. The PK-141 is intended to connect to the patient's sensing and pacing leads. The PK-141 is connected to the Redel connector provided by the external equipment and the alligator clips connect to the electrode. The PK-141 is made up of a 2.8m cable with four touch-proof alligator clips. The alligator clips are clamped directly to the tip or the contact ring of the leads. During its use, the cable is in the sterile field; therefore it must be sterile itself. Skin contact with the patient is not anticipated.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria for the PK-141 Patient Cable. The document is a 510(k) premarket notification summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device and outlining the device's indications for use.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

§ 870.3630 Pacemaker generator function analyzer.

(a)
Identification. A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.(b)
Classification. Class II (performance standards).