Search Results

The SterilMed Reprocessed Electrophysiological Diagnostic Catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and stimulation. They also provide temporary pacing for the evaluation of cardiac arrhythmias, and are used for electrophysiology mapping of cardiac structures during these evaluations.

The device consists of a reprocessed catheter that has a high-torque shaft with a handle at the proximal end, and is steerable. These catheters have an outer diameter of 5F to 7F, a length ranging from 80 to 115 cm, with 4-10 platinum, radiopaque electrodes along the tip shaft and a variety of inter-electrode spacings and curve styles at the tip. The tip is deflectable. Specific cables, as recommended by the original manufacturer, connect to the handle and interface between the catheter and an external stimulator and/or an electrophysiologic recorder. It should be noted that this submission pertains to the catheter only. It does not include any other components in a system such as connector cables, external stimulators, or electrophysiologic recorders.

The provided text describes a 510(k) summary for SterilMed Reprocessed Deflectable Electrophysiology Diagnostic Catheters. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the requested information elements related to acceptance criteria, detailed study design, ground truth, sample sizes for training/test sets, expert qualifications, and specific performance effect sizes (like MRMC) are not fully available or directly applicable in this type of submission document.

However, I can extract information about the functional and safety testing that was performed to support the substantial equivalence claim.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum leakage current, etc.) and corresponding reported device performance values. Instead, it broadly states that "Representative samples... underwent design testing to demonstrate appropriate functional characteristics, and biocompatibility testing to demonstrate compatibility of the device materials."

The "reported device performance" is implicitly that the device performs equivalently to the predicate devices, allowing for the conclusion of "substantial equivalence."

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Representative samples" were used for testing without specifying the number of units or lot sizes.
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by SterilMed, Inc. (Minneapolis, MN, USA).
• Retrospective or Prospective: Not applicable. The testing described is functional and safety testing of the reprocessed devices themselves, not a clinical study on patient data.

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

• Number of Experts: Not applicable. Ground truth as typically defined for AI/diagnostic studies (e.g., expert consensus on images) is not relevant here. The "ground truth" for the device's functionality would be established by engineering specifications and objective test methods.
• Qualifications of Experts: Not applicable. The testing would have been conducted by qualified engineers and technicians, but their specific qualifications are not detailed.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. This concept (e.g., 2+1, 3+1) is typically used for resolving discrepancies in expert interpretations in AI/diagnostic studies. For functional device testing, methods would involve comparing test results against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating human reader performance with and without AI assistance, which is not the scope of this device (a reprocessed electrophysiology catheter).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

• Standalone Study: Not applicable. This device is a physical catheter, not an algorithm. The "standalone" performance here refers to the device's direct functional testing in isolation from human use, which was indeed performed as "design testing."

7. The Type of Ground Truth Used:

The "ground truth" for this medical device (reprocessed catheter) is based on established engineering specifications, performance standards, and comparison to the characteristics of the original (new) predicate devices.

Specifically from the text:

• "Functional characteristics" (e.g., torque, steerability, electrode function).
• "Biocompatibility" (compatibility of materials with the body).
• "Cleaning and sterilization procedures" (validated to eliminate contaminants and ensure sterility).
• "Manufacturing process includes visual and functional testing of all products produced."

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that uses a "training set." The training for the manufacturing process would refer to employee training, not data-based model training.

9. How the Ground Truth for the Training Set Was Established:

• Ground Truth for Training Set: Not applicable, as there is no "training set" in the context of an AI model for this device. The "ground truth" for the manufacturing process quality would be based on validated process parameters and established quality control standards.

Summary of Available Information from the Document:

The study proving the device meets the (unspecified quantitative) acceptance criteria is described as "Functional and Safety Testing."

• Acceptance Criteria (General): Appropriate functional characteristics, biocompatibility, validated cleaning/sterilization, and packaging integrity. The overall acceptance criterion is "substantial equivalence" to the predicate devices.
• Reported Device Performance: The device performs equivalently to the predicate devices, as stated in the conclusion: "These devices are identical to the predicate devices in terms of their design, materials, indications for use, and construction."
• Sample Size & Data Provenance: "Representative samples" were used. No specific numbers or geographic origin are given for the testing. Testing is of the physical device, not patient data.
• Experts / Ground Truth for Testing: Functional and safety testing would be against engineering specifications and industry standards. No explicit "expert consensus" or "pathology" ground truth as defined for diagnostic studies is relevant.
• Adjudication / MRMC: Not applicable to this type of device submission.
• Standalone Testing: Yes, "design testing" was performed on the reprocessed catheters themselves.
• Ground Truth for Testing: Established engineering specifications, performance standards, and the characteristics of the predicate devices.
• Training Set: Not applicable.

This 510(k) submission establishes substantial equivalence through a combination of design review, functional testing, biocompatibility testing, and validation of reprocessing procedures, rather than a clinical trial or AI performance study typically associated with the detailed questions provided.

Ask a specific question about this device