(66 days)
The Guidant SYNCRUS™ Internal Cardioversion System is indicated for use in post-operative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion.
The Syncrus System consists of three components:
- Three temporary heart wires sutured onto the heart during open-heart surgery. The wires include a unipolar defibrillation heart wire (left atrium), a bipolar pacing/sensing heart wire (right or left ventricle) and a tripolar defibrillation and pacing and sensing heart wire (right atrium).
- An attenuator box (External Defibrillator Interface Module EDIM). The EDIM attenuates the delivered energy from a standard, low energy defibrillator by 97% (50 - 360 Joules to 1.3 - 11.5 Joules).
- A cardioversion extension cable, which connects the defibrillation heart wires to the EDIM.
The user must supply an external, low-energy defibrillator that is capable of synchronized cardioversion, an external pacemaker, and temporary patient cables to connect the pacemaker to the patient. The Syncrus System is designed to perform the following cardiac rhythm management functions: - Atrial pacing and electrocardiogram sensing
- Ventricular pacing and electrocardiogram sensing
- Atrial defibrillation using low energy, synchronized cardioversion.
The provided text is a 510(k) summary for the Guidant Syncrus Internal Cardioversion System. It details an acceptance of a Special 510(k) application, which typically focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than explicit acceptance criteria and performance studies in the same way a de novo or PMA application might.
Based on the document, here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) or numerical thresholds that the device had to meet to be deemed acceptable. Instead, the focus of this Special 510(k) is on demonstrating substantial equivalence to a predicate device (Syncrus System K020701).
The "device performance" reported is that the device "met specified requirements" in bench testing, confirming its compatibility with a biphasic defibrillator. However, these "specified requirements" are not detailed in the document.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compatibility with biphasic defibrillator (implied) | All bench testing results met specified requirements. The system may be used with a biphasic defibrillator. The EDIM attenuates energy by 97% (50-360 Joules to 1.3-11.5 Joules). |
| Substantial equivalence to predicate device (K020701) | The subject device is substantially equivalent to the predicate device with regard to intended use, indications, device characteristics, method of use, labeling, materials, and safety features. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "bench testing" was performed. This typically refers to laboratory testing, not human or animal studies with a "test set" in the context of clinical data. Therefore, information about a "sample size" for a test set (e.g., number of patients, cases) or its "data provenance" (country of origin, retrospective/prospective) is not applicable or not provided in this type of submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
As the evaluation was based on bench testing and comparison to a predicate device, there was no "ground truth" to be established by human experts in a clinical context for a "test set" of cases. Therefore, this information is not applicable or not provided.
4. Adjudication Method for the Test Set
Again, given the nature of bench testing and substantial equivalence, a formal "adjudication method" in the clinical sense (e.g., 2+1, 3+1 for resolving discrepancies in expert opinions) for a clinical "test set" is not applicable or not provided.
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
This question is entirely not applicable. The device described is a medical hardware system (internal cardioversion system), not an AI algorithm designed to assist human readers (e.g., in medical image interpretation). Therefore, an MRMC study or an assessment of AI assistance is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is also entirely not applicable for the same reasons as point 5. The device is a hardware system, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission was primarily established through:
- Bench Testing Results: Verifying the electrical and functional performance of the device components, such as the energy attenuation of the EDIM and compatibility with biphasic defibrillators. The "ground truth" here is the physical and electrical measurements obtained during testing against predefined engineering specifications.
- Substantial Equivalence to a Predicate Device: The primary "ground truth" for regulatory approval in a 510(k) is the demonstration that the new device is as safe and effective as a legally marketed predicate device. This involves comparing intended use, indications, device characteristics, method of use, labeling, materials, and safety features.
There was no "expert consensus, pathology, or outcomes data" used to establish ground truth in the context of a clinical study for this 510(k) submission.
8. The Sample Size for the Training Set
Since this involves bench testing and substantial equivalence to a predicate device, there is no "training set" in the context of machine learning. Therefore, the sample size is not applicable or not provided.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this information is not applicable or not provided.
§ 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.