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510(k) Data Aggregation
(77 days)
Pacing leads are intended for use with implantable cardiac pulse generators for long-term pacing of the heart. The indications for ventricular pacing include, but are not limited to: Sick sinus syndrome, sinus bradycardia, complete heart block, and certain conditions of asymptomatic second-degree block.
In the presence of normal A-V conduction the indications for atrial pacing include, but are not limited to: Sinus arrest, sick sinus syndrome, sinus bradycardia and conditions requiring increased cardiac efficiency, enhanced cardiac output or the overdrive of certain cardiac arrhythmias.
In the absence of normal A-V conduction, an atrial lead may be used with a ventricular lead in a dual-chamber pacing system to restore A-V synchrony.
Active fixation leads are specifically indicated for use in cases where passivefixation leads provide unsatisfactory positional stability in either the atrium or the ventricle, or in cases where the atrial appendage has been sacrificed due to open-heart surgery or is abnormal because of congenital or acquired heart disease.
The Intermedics Models 430-07, 432-03, 436-02, 436-07, 438-05, and 438-07 endocardial pacing leads are designed for use with implantable cardiac generators for long term cardiac pacing. With the exception of the solution used during the manufacturing process, the listed pacing leads manufactured with the CFC-free process are identically configured to the commercially available Intermedics pacing leads with the same model numbers. The general characteristics of the pacing leads include electrodes, lead body, tip fixation, and connector assembly.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Intermedics pacing leads, specifically focusing on the new CFC-free manufacturing process.
It’s important to note that this 510(k) summary, typical for medical devices in 1996, focuses heavily on demonstrating equivalence to a predicate device rather than establishing novel safety and effectiveness from scratch. Therefore, many of the performance metrics and study designs common in modern AI/ML device submissions are not directly applicable or present.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Material Biocompatibility | Absence of toxic liability under physiological conditions; continued biocompatibility after manufacturing process change. | Hemolysis Test: No toxic liability found. |
| MEM Elution Cytology: No toxic liability found. | ||
| Ames Mutagenicity: No toxic liability found. | ||
| USP Class V: No toxic liability found. | ||
| Intramuscular Implantation Test: No toxic liability found. | ||
| Maximization Sensitization Test: No toxic liability found. | ||
| USP Pyrogen Test: No toxic liability found. | ||
| Repeated for IPA/heptane cleaned materials (Silicone, 80A Polyurethane, 55D Polyurethane): Results indicate continued biocompatibility. | ||
| Manufacturing Process Safety | Maintain biocompatibility of materials after switching to IPA/heptane cleaning. | Demonstrated by repeated hemolysis and cytotoxicity tests on materials cleaned with the new IPA/heptane blend. |
| Pacing Lead Performance Equivalence | Expected performance equivalent to commercially available Freon-TMS manufactured leads. | Qualification testing on model 430-07 (representative of process changes) demonstrated that performance is expected to be equivalent. The document indicates "similarity in design and materials" (with the exception of the cleaning agent) as a basis for expecting comparable efficacy. |
| Clinical Performance (Long-Term) | Low incidence of clinical complications; effective performance in human implantation. | The predicate devices (commercially available leads manufactured with Freon-TMS) had an "extremely low incidence of clinical complications, demonstrating its effective performance in human implantation." The new CFC-free leads are expected to perform with comparable efficacy due to favorable biocompatibility and qualification test results. |
| Sterilization Efficacy | Sterilization methods meet AAMI guidelines for ethylene oxide sterilization. | Intermedics sterilization procedures utilize EO sterilizers set for specific parameters derived using methods described in the 1988 AAMI guideline. |
2. Sample Size Used for the Test Set and the Data Provenance
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Test Set Sample Size:
- Biocompatibility: Not explicitly stated as a "sample size" in terms of number of devices. However, the tests were performed on "all of the tissue/fluid contacting materials" and specific material types (silicone, 80A polyurethane, 55D polyurethane) after the manufacturing change. The individual tests (e.g., animal tests for implantation, in vitro tests) would have their own sample sizes, which are not detailed here. For the repeated tests on IPA/heptane cleaned materials, these were performed on "the following materials," implying a material-level test rather than a full product-level "test set."
- Qualification Testing: Performed on a single lead model: Model 430-07. This model was selected as "representative of the changes in the manufacturing processes."
- Clinical Data: No new clinical test set was used for the CFC-free leads. The clinical performance claim relies on the "clinical experience of the commercially available Intermedics pacing leads" (predicate devices).
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Data Provenance: The biocompatibility and qualification testing data are prospective, generated specifically for this 510(k) submission. The clinical performance data for predicate devices is retrospective, based on prior commercialization and post-market experience. The country of origin of the data is not specified, but Intermedics Inc. is based in Angleton, TX, USA, suggesting testing was likely conducted in the US or by its chosen test laboratories.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not applicable to this submission. The device is a physical medical device (pacing lead) and not an AI/ML diagnostic or predictive tool that relies on expert interpretation for ground truth establishment. The "performance" being evaluated is material biocompatibility, physical and electrical function, and manufacturing process validation, not diagnostic accuracy against a clinical ground truth established by experts.
4. Adjudication Method for the Test Set
- This information is not applicable as the evaluation is not based on expert interpretation of results that would require adjudication. Test results for biocompatibility and qualification would be interpreted against predefined pass/fail criteria.
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. This is a submission for a physical medical device (pacing lead), not an AI-assisted diagnostic or decision support system. Therefore, no MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable. This is not an algorithm or software-only device.
7. The Type of Ground Truth Used
- For Biocompatibility: The "ground truth" is established by standard, validated biological and chemical test methodologies (e.g., ISO standards or USP monographs for hemolysis, cytotoxicity, implantation tests, pyrogen tests, etc.). The expected outcome (e.g., "no toxic liability") serves as the ground truth.
- For Qualification Testing: The "ground truth" is the established performance characteristics of the predicate device (Freon-TMS manufactured leads). The new leads are tested to ensure their performance (e.g., electrical properties, mechanical strength if tested) is equivalent to these established characteristics.
- For Clinical Performance: The "ground truth" for clinical effectiveness and safety is derived from the established long-term clinical outcomes and low complication rates of the predicate devices.
8. The Sample Size for the Training Set
- This information is not applicable. This is not an AI/Machine Learning device that requires a training set. The "training" for this device would be the manufacturing process development and optimization, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no "training set" in the context of an AI/ML device.
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