(30 days)
The Chandler Transluminal V-Pacing Probe is indicated for temporary ventricular pacing when used with a Swan-Ganz Paceport or A-V Paceport catheter, and can be inserted with or without the aid of fluoroscopy. The probe can also be used for intraventricular ECG detection (during placement).
The Flex-Tip Transluminal A-Pacing Probe is indicated for temporary emergency atrial pacing or sequential A-V pacing when used with a Swan-Ganz A-V Paceport catheter, and can be inserted with or without the aid of fluoroscopy. The probe can also be used for intraatrial ECG detection (during placement).
The Chandler Transluminal V-Pacing Probe and the Flex-Tip Transluminal A-Pacing Probe are 2.4F probes indicated for temporary emergency pacing of either the ventricle or atrium.
The Chandler Transluminal V-Pacing probe is a 2.4F pacing probe with a straight distal electrode tip for emergency temporary ventricular pacing when connected to an external pulse generator.
The Flex-Tip Transluminal A-Pacing probe is a 2.4F pacing probe with a 'J' tip distal electrode for emergency temporary atrial or A-V sequential pacing when connected to an external pulse generator.
The provided document describes the Chandler Transluminal V-Pacing Probe and the Flex-Tip Transluminal A-Pacing Probe. It outlines a comparison to a predicate device and states that the new devices successfully passed functional-performance and biocompatibility testing. However, it does not provide specific acceptance criteria or detailed results of a study as typically performed for diagnostic or AI-based devices.
Therefore, many of the requested elements cannot be extracted from this document, as it focuses on the substantial equivalence of pacing probes rather than the performance of a diagnostic algorithm or device with measurable performance metrics against a defined ground truth.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for the pacing probes. Instead, the "acceptance criteria" are implied by successful completion of various tests showing "substantial equivalence" to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material biocompatibility in compliance with ISO 10993 standards | Successfully passed |
| Functional-performance testing | Successfully passed |
| Safety testing | Successfully passed |
| Substantial equivalence to predicate device (K813521) | Shown to be substantially equivalent for intended use |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "material biocompatibility testing" and "functional-performance testing" but does not specify sample sizes or data provenance for these tests. For a pacing probe, this usually involves lab testing or animal studies, not a "test set" in the context of diagnostic data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The ground truth for a pacing probe's performance would be established by engineering and physiological standards, not expert consensus on diagnostic images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically used for establishing ground truth in diagnostic studies involving interpretation, which is not the nature of the testing described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/provided. This type of study relates to AI-assisted diagnostic tools, not pacing probes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This device is a pacing probe, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the testing of these pacing probes would be established by engineering specifications, physiological compatibility, and material science standards. This is inferred from the mention of "applicable ISO 10993 requirements" and "functional-performance testing."
8. The sample size for the training set
This information is not applicable/provided. There is no "training set" for a physical device like a pacing probe.
9. How the ground truth for the training set was established
This information is not applicable/provided. As above, there is no "training set."
Summary of the Study:
The study described is a comparative analysis to demonstrate substantial equivalence of the Chandler Transluminal V-Pacing Probe and the Flex-Tip Transluminal A-Pacing Probe to the predicate device K813521 Transluminal™ BiPolar Pacing Probe. This was achieved through:
- Material biocompatibility testing: In compliance with applicable ISO 10993 requirements.
- Functional-performance testing: To assess the device's operational capabilities.
- Safety testing: To ensure the device is safe for its intended use.
The document states that these tests were successfully passed, indicating that the fundamental scientific technology remains unchanged and the devices are safe, effective, and substantially equivalent to the predicate device. The nature of this submission is not for a diagnostic device, particularly one involving AI or interpretation of data, but rather for a physical medical device.
§ 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.