(248 days)
ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers. ELA Medical Stela ™ Model BJ44 and BJ45 bipolar pacing leads are intended for atrial implantation only.
Stela™ BJ44 and BJ45 models are silicone rubber, tined, J-shaped, bipolar transvenous leads that provide a permanent electrical pathway between a pacemaker and the atrium. They are similar in design and construction to other such leads in commercial distribution.
The provided text describes the Stela™ Models BJ44 and BJ45 pacing leads. Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Performance Metric | Pass/Fail Criterion | Reported Device Performance |
|---|---|---|---|
| In-Vitro Functional Testing | Stylet Insertion/Removal | Met established criterion | All test results met the established pass/fail criterion. |
| Stylet Bottoming | Met established criterion | All test results met the established pass/fail criterion. | |
| Electrical Resistance | Met established criterion | All test results met the established pass/fail criterion. | |
| IS-1 Connector Conformity | Met established criterion | All test results met the established pass/fail criterion. | |
| Leak Resistance | Met established criterion | All test results met the established pass/fail criterion. | |
| Distal Tip Electrode/Conductor Coil Tensile Strength | Met established criterion | All test results met the established pass/fail criterion. | |
| Insulation Integrity | Met established criterion | All test results met the established pass/fail criterion. | |
| Conductor Coil Fatigue | Met established criterion | All test results met the established pass/fail criterion. | |
| Tip Flexibility | Met established criterion | All test results met the established pass/fail criterion. | |
| Biocompatibility | Biocompatibility | Not applicable (successful history of materials) | Not performed due to successful history with same materials in other lead products. |
| Sterilization & Packaging | Sterilization Testing | Met established criterion | Performed, and all test results met the established pass/fail criterion. |
| Mechanical/Environmental Packaging Validation | Met established criterion | Performed, and all test results met the established pass/fail criterion. | |
| Clinical Performance | Pacing Characteristics | Appropriate pacing characteristics | Exhibit appropriate pacing characteristics. |
| Sensing Characteristics | Appropriate sensing characteristics | Exhibit appropriate sensing characteristics. | |
| Complications | No complications observed | No complications were observed. |
2. Sample Size Used for the Test Set and Data Provenance:
- In-vitro functional testing, sterilization, and packaging validation: The text states "All test results demonstrated that the established pass / fail criterion was met in all cases." However, it does not specify the sample size for these in-vitro tests.
- Clinical study: Described as a "limited clinical study." The exact sample size is not provided, only that it involved the Model BJ45 lead.
- Data Provenance:
- In-vitro tests: Likely conducted in a lab environment by the manufacturer (ELA Medical).
- Clinical study: The text indicates the device was "recently introduced into commercial distribution outside the U.S." and that "No unanticipated adverse device effects have been reported for these leads" from this OUS experience. The limited clinical study mentioned is likely related to this OUS experience or a precursor to it. It is a prospective study for the clinical data from the "limited clinical study."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not Applicable. The described studies are primarily in-vitro engineering tests and a limited clinical study evaluating device performance, not diagnostic accuracy requiring expert panel review for ground truth.
4. Adjudication Method:
- Not Applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not described. This device is a medical lead, not an imaging or diagnostic AI tool that would typically undergo an MRMC study.
6. Standalone Performance:
- Partially. The in-vitro functional testing, sterilization, and packaging validation can be considered standalone performance assessments of the device itself (algorithm only is not applicable here as it's a hardware device).
- The "limited clinical study" also assesses the device's performance in patients in a standalone manner (without another human-in-the-loop comparison).
7. Type of Ground Truth Used:
- In-vitro functional testing: The ground truth is based on engineering specifications and established pass/fail criteria for physical and electrical properties.
- Clinical study: The ground truth for pacing and sensing characteristics would be derived from physiological measurements and clinical observations in patients. The absence of complications serves as a negative ground truth.
8. Sample Size for the Training Set:
- Not Applicable. The description does not involve a "training set" in the context of machine learning or AI. This is a hardware device.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. See point 8.
§ 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.