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Disposable Reuter Tip Deflecting Wire Guides are intended for use in curving or deflecting catheter tips for pulmonary angiography, selective angiography, translumbar aortography, repositioning of central venous catheter tips and other vascular and non-vascular applications.

Reuter Tip Deflecting Wire Guides are intended for use with the Reuter Tip Deflecting Handle assembly for curving or deflecting catheter tips for pulmonary angiography, translumbar aortography, bronchography, bronchography, repositioning of central venous catheter tips and other vascular and non-vascular applications.

The Reuter Tip Deflecting Wire Guides, subject of this submission, are Class II devices according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The subject devices are available with outer diameters of 0.025 and 0.035 inches, lengths of 80 - 145 centimeters, and a curved tip.

The subject device includes two configurations indicated by prefixes TDW and DTDW. Both configurations are constructed with stainless steel mandrils, coils, and internal handles. The coils cover the entire mandril and are secured using distal and proximal anchor points. The internal handle is permanently affixed to the proximal end of the wire guide and is designed to mate with the tip deflecting handle. The internal handle of the wire guide is not patient contacting.

The Reuter Tip Deflecting Wire Guide configuration with the TDW prefix is a disposable wire guide designed to be used with the Reusable Reuter Tip Deflecting Wire Guide handle which is not subject of this submission.

The Disposable Reuter Tip Deflecting Wire Guide configuration with the DTDW prefix is designed with a deflecting handle permanently affixed to the proximal end of the wire guide. The deflecting handle is manufactured from polycarbonate and stainless steel materials.

The purpose of the handle is to operate in a retracting motion thereby causing the tip of the connected wire guide to deflect to the specified radius.

The side-arm flushing adapter (Class II 510(k) exempt under product code DTL) is supplied with the Disposable Reuter Tip Deflecting Wire Guides as an accessory. The flushing adapter may be used to flush a catheter being used with the subject device during diagnostic and interventional procedures.

The subject device is a packaged, sterile device intended for single patient use.

This document is a 510(k) summary for the Reuter Tip Deflecting Wire Guide, which is a medical device. The information provided primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of a new AI/software-based device. Therefore, many of the requested categories for AI/software studies are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the sample size for each test. It mentions "The following tests were performed...", implying a certain number of units were tested for each criterion, but the exact count is not given.
• Data Provenance: Not applicable. These are physical performance tests of a device, not data analysis tests. The testing would have been performed by Cook Incorporated or a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. The "ground truth" for these physical device tests is defined by the objective industry standards (ISO, ASTM) and the manufacturer's predetermined acceptance criteria for physical properties. No human experts are establishing "ground truth" in the context of diagnostic interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This is not an adjudication process for clinical or diagnostic data. The tests are objective measurements against defined standards.

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

• Not applicable. This document describes a physical medical device, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This document describes a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable in the AI/software context. For this medical device, the "ground truth" or reference for evaluating performance is the adherence to established international standards (ISO, ASTM) and internal engineering specifications for physical and material properties.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI model. There is no concept of a "training set."

9. How the ground truth for the training set was established

• Not applicable. This is a physical device, not an AI model.

Summary of the Study per the Document:

The document describes a series of performance tests conducted on the Reuter Tip Deflecting Wire Guide. These tests were designed to demonstrate that the modified device (with new lengths, diameter, and handle configuration) meets applicable design and performance requirements and supports a determination of substantial equivalence to its predicate device. The tests covered various aspects including:

• Biocompatibility
• Corrosion
• Flexing
• Surface Examination
• Fracture
• Tensile strength of the core wire and coil union
• Tensile strength of the handle and wire guide union
• Dimensional accuracy and catheter compatibility
• Radiopacity

For all listed tests, the document explicitly states that the "predetermined acceptance criteria were met," indicating successful completion of the studies and compliance with the specified standards. The study's conclusions support that the modifications do not raise new questions of safety or effectiveness and that the device is substantially equivalent to the predicate.

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