(87 days)
This device is designed to connect an intravascular electrode to a monitor through a standard EKG patient lead for the purpose of displaying an intravascular signal in real time. Only the black pinjack is "active". The red pinjack is electrically blind and designed to isolate the proximal electrode from inadvertent stimulation.
In essence, the subject device provides an electrically safe connection between the proximal pin of an intravascular electrode and a patient EKG lead , the signal ultimately traveling retrograde along a standard EKG cable to a bedside monitor. It would be used to facilitate placement of a transvenous pacemaker or appropriately designed intravenous catheter with EKG guidance rather than the more cumbersome (and expensive) fluoroscopic approach. The device entirely consists of a pin jack (to accept the proximal pin of the electrode) connected in series via a 1000 ohm resistor to a standard EKG eyelet all encased in an appropriate housing. The snap-fit connection between the EKG lead and device eyelet completes the connection to the monitor.
The provided text does not contain information about acceptance criteria or a study that demonstrates the device meets such criteria. The document is a 510(k) summary for a "Transvenous Pacemaker Placement Assist Device" (formerly "PACER ASSIST DEVICE"), indicating FDA clearance based on substantial equivalence to predicate devices, rather than performance testing against specific acceptance criteria.
The information primarily describes:
- Device Description: An accessory to an EKG cable, consisting of a pin jack, a 1000 ohm resistor, and an EKG eyelet, encased in a housing. Its purpose is to provide an electrically safe connection between an intravascular electrode and a patient EKG lead for displaying an intravascular signal.
- Intended Use: To facilitate placement of a transvenous pacemaker or appropriately designed intravenous catheter with EKG guidance.
- Regulatory Information: Classification as Class II with product codes LDF and DRR, and the FDA's determination of substantial equivalence.
- Key Features: One "active" black pinjack for the signal and one "electrically blind" red pinjack for isolation.
Since no performance study or acceptance criteria are discussed in the provided text, I cannot complete the table or answer the specific questions about the study design, sample sizes, ground truth establishment, or multi-reader studies.
§ 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.