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1. The Medtronic Torqr catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

2. The Medtronic Soloist catheter is intended for use in diagnostic electrophysiologic procedures. The catherer is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Medtronic diagnostic catheters are flexible radiopaque catheters constructed of extruded polymer over a stainless-steel braid. The catheters contain platinum-iridium sensing band electrodes and are designed for intracardiac recording or stimulation.

This premarket notification covers changes impacting Medtronic diagnostic catheters, including labeling updates packaging design and packaging material changes, and product requirement updates.

This FDA 510(k) summary (K190132) is for the Medtronic Torqr Intracardiac Electrode Catheter and Soloist Intracardiac Electrode Catheter. It is a submission for modifications to existing devices, specifically concerning labeling, packaging design and materials, and product requirement specifications. There are no changes to the finished diagnostic catheter designs or materials, or their fundamental scientific technology, intended use, or indications for use. Therefore, the device performance information in this document relates to confirming that these modifications do not negatively impact the existing performance and safety of the devices.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a quantitative manner as one might expect for a new AI/software device with specific performance metrics (e.g., sensitivity, specificity thresholds). Instead, it focuses on verifying that the proposed changes (labeling, packaging, product requirements) do not compromise the established safety and effectiveness of the already cleared predicate devices. The "acceptance criteria" are implied to be meeting all applicable proposed product requirements after the changes, and the "device performance" is reported as successful completion of performance testing (bench) demonstrating this.

Study Proving Acceptance Criteria is Met:

The study proving the acceptance criteria is met is the performance testing (bench) completed in support of the proposed modifications. The document states: "The results of the design verification testing completed in support of the proposed changes demonstrate that all diagnostic catheters in scope of this premarket notification meet all applicable proposed product requirements."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each test in the "test set" (i.e., the units exposed to accelerated aging and then tested). It states that tests were performed "on test samples exposed to accelerated aging conditions equivalent to the product shelf life of 2 years." The provenance of the data is prospective bench testing conducted by the manufacturer, Medtronic, in the United States (Mounds View, Minnesota).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this submission. The tests are bench tests verifying physical, electrical, and packaging integrity/performance. They do not involve clinical interpretation or human expert "ground truth" establishment in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

This information is not applicable. As these are bench tests for physical and performance characteristics, there is no adjudication process involving human observers for discrepancies or ground truth.

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 done. This submission is for modifications to existing physical medical devices (catheters), not an AI or software device that assists human readers.

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 AI device.

7. The Type of Ground Truth Used

The "ground truth" used for this type of submission is based on engineering and physical performance specifications, material properties, and regulatory standards. For example, the "ground truth" for "corrosion resistance" would be the absence of corrosion after specific exposure, and for "electrical resistance," it would be measurement within a predefined range. These are objective, measurable parameters.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this traditional medical device modification submission. AI models are not being developed or refined here.

9. How the Ground Truth for the Training Set was Established

This information is not applicable. Since there is no training set, there is no ground truth establishment process for a training set.

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