(29 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:
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.
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. Certain catheters may incorporate a lumen for balloon inflation.
Some products may be packaged with accessories such as a needle / cannula, an ECG adapter, or a balloon inflation syringe. All Bard® Temporary Catheter devices are packaged with safety adapters, are intended for prescription use only, and are for single use only.
Needle / Cannula (Introducer):
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 The needle is then withdrawn, leaving in place the cannula, through which the Bard® Temporary Pacing Electrode Catheter can be advanced through the vessel and into the desired placement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 FDA 510(k) clearance letter and summary describe the Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer). The submission is a "Special 510(k)" primarily focused on removing a warning label related to unknown electromagnetic compatibility (EMC) with low-frequency emissions.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The core of this Special 510(k) is the demonstration of electromagnetic compatibility, specifically concerning immunity to proximity magnetic fields, to justify the removal of a previous warning label.
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 (Edition 4.1): 2020 Compliance | Met EMC requirements as defined in IEC 60601-1-2 Clause 8.11 for Immunity to Proximity Magnetic Fields. |
| - IEC 60601-1-2 Clause 8.11 (Immunity to Proximity Magnetic Fields): Tested using methods specified in IEC 61000-4-39 (2017) per applicable specifications in Table 11 of IEC 60601-1-2. | - Demonstrated electromagnetic compatibility with electronics capable of generating low-frequency emissions. | |
| Functional Performance (Implicit) | The device, when used as a system with representative external pulse generator equipment, should maintain its essential performance (transmitting electrical signals for pacing/monitoring) without degradation or disruption in the presence of low-frequency electromagnetic interference. The acceptance criteria were the same as the acceptance criteria utilized for other IEC 60601-1-2 immunity testing performed as part of the predicate (K241334) clearance, implying that the device's basic safety and essential performance were maintained. | Testing confirmed that the device met EMC requirements, indicating its functional performance was not negatively impacted by the tested electromagnetic fields. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state a numerical sample size (e.g., "N=X devices were tested"). It refers to "representative external pulse generator equipment and the sample Temporary Pacing Electrode devices." This typically implies a limited number of devices/systems sufficient to represent the product line for EMC testing as per regulatory guidelines for in-vitro/bench testing.
- Data Provenance: The study was a bench (in-vitro) test performed to a recognized international standard (IEC 60601-1-2). There is no patient data involved, so there is no country of origin or retrospective/prospective distinction.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This was a bench-top engineering test evaluating electromagnetic compatibility against a defined international standard (IEC 60601-1-2). "Ground truth" in the clinical sense (e.g., diagnosis by experts) is not relevant here. The "ground truth" is the established test methodology and performance limits defined by the IEC standard.
4. Adjudication Method for the Test Set
Not applicable. As a bench test against objective standards, there is no expert adjudication process like those used in clinical studies for diagnostic accuracy. The results are objectively measured against the specified limits of the IEC standard.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a passive pacing electrode catheter and introducer, not an AI-powered diagnostic or therapeutic tool with a human-in-the-loop component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a medical hardware component, not an algorithm. The testing focused on the physical and electrical compatibility of the hardware with relevant external equipment.
7. The Type of Ground Truth Used
The "ground truth" for this study is compliance with international consensus standards for electromagnetic compatibility, specifically IEC 60601-1-2 (Edition 4.1): 2020, with particular focus on Clause 8.11 and the methods specified in IEC 61000-4-39 (2017). This standard defines objective tests and acceptance limits for device performance under various electromagnetic conditions.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.