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510(k) Data Aggregation
(87 days)
The Model 2188 coronary sinus lead is designed for atrial pacing and sensing in the coronary sinus. The lead has application where permanent atrial or dual-chamber pacing systems are indicated.
The Model 2188 coronary sinus lead is a bipolar coaxial polyurethane lead with an IS-1 connector and a porous tip electrode which is canted toward the lead body. The distal portion of the lead is pre-shaped at a 45° angle. The conductor coils utilize a platinum sputtered MP35N nickel-alloy material.
This document describes the testing and acceptance criteria for the Medtronic Model 2188 Coronary Sinus Lead.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of acceptance criteria with specific numerical thresholds for each test. Instead, it states that the device "passed all of the in vitro bench test requirements" and that the in vivo canine testing "demonstrated that the pacing and sensing thresholds produced by the Model 2188 coronary sinus lead is substantially equivalent to the Model 6992A coronary sinus lead."
To create a table, we must infer the acceptance criteria from the descriptions.
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Criteria (Inferred from Text) | Reported Device Performance |
|---|---|---|---|
| In Vitro/Bench Testing | Environmental Conditioning | Pass all requirements (implies meeting predefined standards for durability, integrity under various environmental stresses) | Passed all in vitro bench test requirements. |
| Mechanical Testing | Pass all requirements (implies meeting predefined standards for strength, flexibility, resistance to damage) | Passed all in vitro bench test requirements. | |
| Electrical Testing | Pass all requirements (implies meeting predefined standards for conductivity, insulation integrity, impedance) | Passed all in vitro bench test requirements. | |
| In Vivo Testing (Animal) | Pacing Thresholds | Substantially equivalent to Model 6992A coronary sinus lead | Demonstrated substantial equivalence to Model 6992A coronary sinus lead. |
| Sensing Thresholds | Substantially equivalent to Model 6992A coronary sinus lead | Demonstrated substantial equivalence to Model 6992A coronary sinus lead. | |
| Package Qualification | Ethylene Oxide (EtO) Sterilization Conditioning/Testing | Suitability for sterilization and maintenance of sterile barrier (implies resistance to EtO effects) | Demonstrated suitability of the new package. |
| Visual Inspection Testing | No significant defects affecting product integrity or usability | Demonstrated suitability of the new package. | |
| Packaging Conditioning/Testing | Maintain integrity and protection of lead under various conditions | Demonstrated suitability of the new package. | |
| Lead Mechanical Testing (within package) | Lead remains undamaged and functional after packaging stress tests | Demonstrated suitability of the new package. | |
| Lead Electrical Testing (within package) | Lead remains electrically functional after packaging stress tests | Demonstrated suitability of the new package. | |
| Shelf Life Testing | Maintain product integrity and sterility over specified shelf life | Demonstrated suitability of the new package. | |
| Biocompatibility | Lead Materials | Approved for use with Medtronic CapSure SP Model 4524 (implying non-toxic, non-allergenic, non-irritating) | Materials were approved for use with Medtronic CapSure SP Model 4524. |
| Uncoated PETG Package | Approved for use with Medtronic pulse generators (PMA Supplements P850051/S44, P850051/S49 and P890003/S30) | Approved for use with Medtronic pulse generators. | |
| Silicone-coated PETG Package | Proven biocompatible (implying non-toxic, non-allergenic, non-irritating) | Proved to be biocompatible. | |
| Sterilization Validation | EtO Sterilization Process | Validated as appropriate for sterilizing the Model 2188 lead (implies achieving sterility assurance level) | A process appropriate for sterilizing the Model 2188 coronary sinus lead was validated. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the "in vivo canine testing." It simply states "The data generated as a result of this testing..."
- Data Provenance: The in vivo testing was conducted using canine subjects, meaning it was animal-based (not human). It was conducted prospectively as part of the device development and validation. The country of origin is not explicitly stated but is implied to be within Medtronic's operational regions, likely the USA, given the submission context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided. For animal studies, "ground truth" would typically be derived from physiological measurements and observations by veterinary specialists and animal researchers, but their number and specific qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of a device performance study in animals, "adjudication" in the sense of expert consensus on human clinical outcomes is less applicable. Performance metrics (pacing/sensing thresholds) would be measured objectively.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is for a medical device (pacing lead), not an AI diagnostic or interpretive system. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, this question is not applicable. The Model 2188 is a physical pacing lead, not an algorithm.
7. The Type of Ground Truth Used
For the in vivo canine testing, the ground truth was based on physiological measurements (pacing and sensing thresholds) directly obtained from the animals. These are objective, quantitative measurements reflecting the lead's electrical performance in a living system.
8. The Sample Size for the Training Set
This product is a physical medical device, not a machine learning model. Therefore, the concepts of a "training set" and "sample size for a training set" as typically understood in AI/ML are not applicable. The device's design was informed by Medtronic's extensive experience and previous models (e.g., Model 6992A, 4524, 4582, 6990, 6991A), which could be considered an analogous form of "prior data" or "design input" but not a formal training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated in point 8.
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