(30 days)
Arox and Merox bipolar, passive-fixation, endocardial pacing leads are intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator.
The BIOTRONIK Arox and Merox leads are bipolar, passive-fixation, endocardial pacing leads available in straight and "J"-shaped configurations, for placement in the ventricle or atrium. The Arox and Merox xx-JBP models have a permanent bend proximal to both lead electrodes, resulting in the distal portion of the lead body having what is commonly referred to as a "U" or "J" shape. This lead shape facilitates placement in the right atrial appendage. The device modification only applies to the atrial Arox xx-JBP bipolar, passive-fixation, endocardial, pacing leads. The modification consists of an exact specification for the J-shape of the leads.
The presented document is a 510(k) premarket notification for a medical device (Arox and Merox Leads), not a study report or clinical trial. Therefore, it does not contain the detailed information typically found in a study that proves a device meets acceptance criteria. The submission is for a "Special 510(k)" due to a device modification – specifically, the precise specification of the J-shape for the atrial Arox xx-JBP leads.
Based on the provided text, here's an analysis of what information is available and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the document. A 510(k) summary typically focuses on substantial equivalence to a predicate device rather than detailed acceptance criteria and performance data from a specific study for the modification. The modification is described as an "exact specification for the J-shape of the leads," implying a design control change, likely validated through engineering and bench testing, rather than a clinical performance study.
2. Sample Size Used for the Test Set and Data Provenance
This information is not present. No test set or study data is described in this regulatory submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not present. No ground truth establishment is described, as it's not a diagnostic AI device or a study requiring expert consensus.
4. Adjudication Method
This information is not present. No adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not present. The device is a pacing lead, not an AI-assisted diagnostic tool. An MRMC study would be irrelevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This information is not present. The device is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
This information is not present. No ground truth is mentioned. The modification is a design specification for a physical characteristic.
8. Sample Size for the Training Set
This information is not present. Since this is a physical device modification, not an AI algorithm, there would be no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not present. As above, there is no training set mentioned.
Summary of Device and Modification relevance to Acceptance Criteria:
The core of this 510(k) submission is a "Special 510(k)" for a modification to existing, previously approved pacemaker leads (Arox and Merox). The modification is:
- Device Modification: "The modification consists of an exact specification for the J-shape of the leads. Previously, BIOTRONIK did not specify the precise J-shape of the leads."
For such a modification, acceptance criteria would typically revolve around:
- Dimensional Accuracy: Does the new manufacturing process consistently produce the J-shape within the specified tolerances? This would be verified through manufacturing quality control and possibly bench testing.
- Mechanical Integrity/Performance: Does the precisely defined J-shape maintain the lead's mechanical properties (e.g., flexibility, durability, resistance to kinking, ability to be positioned as intended)? This would involve bench testing for fatigue, tensile strength, and simulated use.
- Biocompatibility: (Likely unchanged, as materials are not mentioned as being modified).
- Electrical Performance: (Likely unchanged if electrodes and insulation are not modified).
The current document only states that the FDA reviewed the submission and found the device to be "substantially equivalent" to predicate devices, subject to general controls. This implies that the modification was deemed not to raise new questions of safety or effectiveness. The specific evidence (e.g., engineering reports, bench test results) demonstrating that the modified J-shape meets the internal design and performance specifications (the "acceptance criteria" for this specific change) would have been part of the full 510(k) submission to the FDA, but it is not provided in this summary document.
§ 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.