(403 days)
The ELC xx-UP epicardial sutureless screw-in lead is indicated for unipolar pacing and sensing in the ventricle when an epicardial lead is preferred, or when a transvenous lead cannot provide satisfactory results or is contraindicated. Epicardial leads are well suited for situations where open heart surgery is being performed, or based upon the patient's age or heart condition (e.g., in young patients who have not reached full physical maturity and in patients with congenital heart disease). Epicardial leads are also indicated in situations where transvenous access is not available or is contraindicated.
The BIOTRONIK ELC xx-UP epicardial sutureless active fixation lead is a safe and effective unipolar lead used with implantable cardiac pacemakers when an epicardial lead is preferred, or when a transvenous lead cannot provide satisfactory results or is contraindicated. The lead body insulation of all ELC epicardial leads is NuSil MED-4750 silicone rubber tubing, with a conductor of quadrafilar MP35N wire. These leads provide long-term safe and effective pacing through overall quality of design, manufacture and the surface structure of the active-fixation electrode tip. This tip is a single helically-wound fixation wire ("fixation screw") composed of 70% platinum and 30% iridium which has undergone a Physical Vapor Deposition (PVD) treatment, creating a fractal-surfaced, ball-like microstructure. The IS-1 (3.2 mm) connection system of the ELC lead complies with the International Standard ISO 5841.3:1992.
Here's an analysis based on the provided text, structured according to your request. It's important to note that the document is a 510(k) clearance letter for a medical device and not a detailed clinical study report, so some of the requested information (especially regarding specific statistical acceptance criteria or detailed study methodologies) is not explicitly present.
Acceptance Criteria and Study for BIOTRONIK ELC xx-UP Epicardial Sutureless Active Fixation Lead
The provided document (K965106) is a 510(k) premarket notification clearance letter from the FDA, asserting substantial equivalence to previously marketed devices. It describes the device's safety and effectiveness based on various tests and clinical experience. However, it does not present a formal, statistically powered clinical study with pre-defined hard acceptance criteria and corresponding reported performance metrics in the way a modern, randomized controlled trial might.
The "acceptance criteria" can be inferred from the reported lack of failures and the successful functioning of leads in clinical experience, as well as satisfactory performance in various in-vitro and qualification tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility: Safe for human implantation. | Materials (NuSil MED-4750 silicone rubber, MP35N wire, Pt-Ir alloy) commonly used in market-released leads. Acute and chronic biocompatibility tests performed. Long-term implantation studies conducted. Corrosion studies completed for PVD iridium treatment, confirming it is non-toxic and durable. Extensive clinical experience confirms iridium safety. |
| Mechanical/Electrical Integrity & Durability: Maintain structural and electrical function over time. | Weld strength, fatigue strength, DC resistance, environmental resistance, electrical integrity, sterilization tested. All test results were within specifications. |
| Adherence to Standards: Compliance with industry standards. | IS-1 (3.2 mm) connection system complies with International Standard ISO 5841.3:1992. Adherence to IS-1 standards tested. |
| Packaging & Transportation Durability: Device remains intact and functional after handling. | Packaging and transportation durability tested. All test results were within specifications. |
| Clinical Performance (outside US): No reported device failures or complaints in commercial use. | Over 2000 leads sold worldwide outside the United States (since March 1994, CE Mark), including 426 in 1996 (excluding December). No reported device failures or complaints. |
| Clinical Performance (US Trial): Functioning normally with acceptable adverse events. | As of Dec 5, 1996, 18 leads implanted in a US clinical trial (IDE #G960045). All leads functioning normally, with the exception of one anticipated adverse event (failing to yield consistent ventricular capture, potentially due to lead dislodgement). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical - OUS): Over 2000 leads sold worldwide outside the United States since March 1994, with 426 sold in 1996 (excluding December).
- Sample Size (Clinical - US Trial): 18 leads implanted in the United States as part of a clinical trial for the Physios CTM 01 Cardiac Transplant Monitoring System (IDE #G960045).
- Data Provenance:
- Outside US: Primarily from countries within the European Economic Community (EEC) and other international markets, following CE Mark approval in March 1994. This data is retrospective, based on commercial sales and complaint monitoring.
- United States: Prospective, from a dedicated clinical trial (IDE #G960045).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the "number of experts" or their "qualifications" in the context of establishing ground truth for a test set.
- For the OUS commercial experience, "ground truth" would be derived from reported adverse events or device failures, likely identified by implanting physicians, patients, or other healthcare professionals, and reported to the manufacturer. No specific expert panel is described for this.
- For the US clinical trial, "ground truth" for the performance of the 18 leads would have been established by the clinical investigators involved in the trial. While their qualifications are not detailed, by definition, they would be medical professionals (e.g., cardiologists, cardiac surgeons) experienced in implanting and monitoring pacing leads, adhering to the IDE protocol. However, no specific number of experts or detailed qualifications are provided in this regulatory summary.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (like 2+1 or 3+1) for evaluating device performance or adverse events.
- For the OUS commercial experience, adverse events and complaints would typically be recorded and evaluated by the manufacturer's quality and regulatory departments based on received reports.
- For the US clinical trial, adverse events (like the noted lead dislodgement) would be identified and reported by the clinical investigators as part of the study protocol for IDE #G960045. The "adjudication" would largely rest with the clinical site and potentially a study monitor or data safety monitoring board, but no specific multi-expert adjudication method is detailed in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, ...
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This document pertains to a physical medical device (a cardiac lead) and its safety and effectiveness, not an AI or imaging diagnostic tool that would typically involve MRMC studies to compare human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a physical cardiac lead, not an algorithm, so the concept of a "standalone algorithm" performance does not apply. The device's performance is inherently "standalone" in the sense that its physical and electrical properties are evaluated directly.
7. The Type of Ground Truth Used
The "ground truth" for assessing the device's safety and effectiveness comes from a combination of:
- In-vitro/Laboratory Testing: This forms the "ground truth" for material properties, weld strength, fatigue strength, electrical integrity, environmental resistance, and adherence to ISO standards.
- Biocompatibility Testing: Dedicated animal and/or in-vitro tests established the "ground truth" for biocompatibility and corrosion resistance.
- Clinical Experience/Outcomes Data:
- Commercial (OUS): "No reported device failures or complaints" from over 2000 leads represents an aggregated form of outcomes data/clinical experience.
- Clinical Trial (US): The observation that "All leads are functioning normally" with one anticipated adverse event represents direct clinical outcomes data from a prospective study setting. This provides "ground truth" regarding real-world performance, including the occurrence of complications like lead dislodgement.
8. The Sample Size for the Training Set
The concept of a "training set" is usually applicable to machine learning algorithms. Since this is a physical medical device, there isn't a "training set" in that sense. The "training" for the device's design and manufacturing comes from:
- Design and Materials Expertise: Utilizing commonly used, biocompatible materials and established design principles for epicardial leads.
- Extensive Prior Knowledge: Leveraging "extensive clinical experience" with iridium and other implantable materials.
- Iteration and Testing: The various qualification and in-vitro tests (weld strength, fatigue, etc.) would be part of a design verification and validation process, which could be informally considered as "training" in an engineering sense, but not for a machine learning algorithm.
Therefore, a specific "sample size for the training set" is not relevant or provided in this context.
9. How the Ground Truth for the Training Set Was Established
As explained above, there isn't a "training set" in the machine learning sense. The "ground truth" for the device's development and validation (analogous to how a training set might inform an algorithm) was established through:
- Engineering Specifications: Setting performance targets and design requirements based on the intended use and existing medical device standards.
- Bench Testing & In-vitro Studies: Establishing "ground truth" for physical, mechanical, and electrical properties under controlled laboratory conditions.
- Biocompatibility Studies: Using recognized standards and expert evaluation for toxicology and biocompatibility.
- Prior Clinical Knowledge: Drawing upon the established safety and effectiveness of similar materials and designs that are "commonly used in market-released leads" and published in "technical journals."
§ 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.