(183 days)
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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.
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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.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Product Requirement Testing | |
| Corrosion Resistance | Met (testing successfully completed) |
| Visual – Foreign Material and Defects | Met (testing successfully completed) |
| Visual – Butt Joint Inspection | Met (testing successfully completed) |
| Visual – Band Electrodes | Met (testing successfully completed) |
| Visual – Tip Assembly | Met (testing successfully completed) |
| Visual – Lot Number | Met (testing successfully completed) |
| Catheter Outer Diameter | Met (testing successfully completed) |
| Electrode Band Spacing | Met (testing successfully completed) |
| Working Length | Met (testing successfully completed) |
| Connector to Shaft Pull Test (Torqr) | Met (testing successfully completed) |
| Band and Tip DC Resistance | Met (testing successfully completed) |
| Connector Interface Requirements | Met (testing successfully completed) |
| Packaging Requirement Testing | |
| Packaging Configuration (Torqr) | Met (testing successfully completed) |
| Traceability | Met (testing successfully completed) |
| Material Sterilization Compatibility | Met (testing successfully completed) |
| Packaging Performance | Met (testing successfully completed) |
| Sterile Barrier Integrity | Met (testing successfully completed) |
| Seal Strength | Met (testing successfully completed) |
| Shelf Life Format | Met (testing successfully completed) |
| Lot Number Identification | Met (testing successfully completed) |
| Storage and Shipping Conditions | Met (testing successfully completed) |
| Label Legibility Testing | Met (testing successfully completed) |
| Label Durability Testing | Met (testing successfully completed) |
| Bubble Leak Testing | Met (testing successfully completed) |
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.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).