(266 days)
Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.
The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature.
Bard® Temporary Pacing Electrode Catheters are constructed of insulated electrical wires encased within a woven shaft, which is then coated with various blends of radiopaque polyurethane-based materials. All Temporary Pacing Electrode Catheters are bipolar and include two stainless steel electrodes - one located along the shaft and one at the catheter distal tip. The proximal end of the devices includes the two electrical leads which have shrouded jacks and are used to establish electrical connections with an external pulse generator or monitoring device.
Some products may be packaged with accessories such as a needle / cannula, an ECG adapter, or a balloon inflation syringe. All Bard® Temporary Pacing Catheter devices are packaged with safety adapters, are intended for prescription use only, and are for single use only.
The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature. The Needle / Cannula (Introducer) is not sold separately by C. R. Bard, Inc. and this accessory is only included with certain Bard® Temporary Pacing Electrode Catheter kits. The devices are provided in two different French size / length variants, dependent on size / type of the accompanying Bard® Temporary Pacing Electrode Catheter.
The Needle / Cannula (Introducer) includes a needle and a cannula. The two components of the Introducer are inserted into the vein simultaneously. The needle in then withdrawn, leaving in place the cannula, through which the Bard® Temporary Pacing Electrode Catheter can be advanced through the vessel and into the desired placement location. The device is intended for prescription use only and is for single use only.
The provided text is a 510(k) Summary for a medical device (Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)). It describes the device, its intended use, and comparability to predicate devices. However, this document does not contain acceptance criteria or detailed study results in the format requested.
The text focuses on demonstrating substantial equivalence to a predicate device through:
- Comparison of Technological Characteristics: Tables comparing the subject device and the predicate device in terms of design, materials, and dimensions.
- Performance Data Summary: A list of various performance tests conducted (e.g., biocompatibility, electrical safety, mechanical tests, functional testing to standards like ISO 10555-1, IEC 60601-1, ISO 80369 series, ISO 11070). The document states that the devices met the requirements of the above standards and performance endpoints.
Therefore, I cannot provide the specific details requested in your prompt (a detailed table of acceptance criteria and reported device performance with numerical values, sample sizes for test sets, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment).
The document explicitly states that the device "met the requirements of the above standards and performance endpoints," implying that the acceptance criteria are defined by these referenced standards and internal specifications, but the specific numerical acceptance criteria and the quantitative results are not disclosed in this summary.
If you have a document that contains the detailed study results and acceptance criteria, please provide it.
§ 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.