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Used for the delivery of PTCA balloons and other various types of interventional cardiology devices. They are intended for use by physicians trained and experienced in PTCA and interventional cardiology techniques. Not intended for cerebral vascular use.

The Envy™ Guiding Catheter is manufactured using an inner layer of nylon tubing with stainless steel braiding and laminated with an outer layer of TFE tubing. This tubing is coated with a hydrophilic coating to enhance lubricity. This catheter is available in 4.0, 7.0 and 8.0 French outer diameter, various lengths and various curves to accommodate interventional cardiology procedures. This device can also be used with an inner catheter used for introduction. The inner catheter is manufactured using polyethylene tubing tapered to an .038-inch endhole with a hydrophilic coated distal tip. The length of the inner catheter corresponds to the guiding catheter length. The inner catheter is designed to introduce the guiding catheter over an 0.038-inch wire guide or through an appropriately sized sheath introducer.

This filing pertains to a Special 510(k) Premarket Notification for the Envy™ Guiding Catheter, specifically the 4.0, 7.0, and 8.0 French sizes. The submission indicates that these new sizes are substantially equivalent to the previously cleared Envy™ Guiding Catheter, 6.0 French (K974774). As a Special 510(k), it relies on substantial equivalence and does not typically include new independent studies with acceptance criteria or detailed performance data beyond what's needed to demonstrate equivalence.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly available or applicable in the provided document, which focuses on demonstrating substantial equivalence rather than presenting an independent performance study.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or detailed performance data for the Envy™ Guiding Catheter (4.0, 7.0, 8.0 French). The basis for clearance is substantial equivalence to an existing predicate device (Envy™ Guiding Catheter, 6.0 French). The "performance" in this context is the assertion that the new sizes have the "same intended use, materials of construction, and technological characteristics" as the predicate device.

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

Not applicable. This is a Special 510(k) based on substantial equivalence, not a new performance study requiring a dedicated test set with patients/data. The "test set" implicitly refers to the design and material evaluations performed to demonstrate similarity to the predicate, but these details are not provided in this regulatory summary.

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

Not applicable. There is no specific "ground truth" establishment process described for a test set in this substantial equivalence submission.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring expert adjudication is described in this filing.

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 device is a guiding catheter, not an AI-powered diagnostic or interpretive device. Therefore, a MRMC study involving human readers and AI assistance is irrelevant.

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

Not applicable. This device is a guiding catheter, a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used:

Not applicable. The "ground truth" in this context is the established safety and effectiveness of the existing predicate device, backed by its prior clearance (K974774), and the manufacturer's assertion of equivalence in design, materials, and intended use.

8. The Sample Size for the Training Set:

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

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

Not applicable. There is no training set for this device.

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Used for the delivery of PTCA balloons and other various types of interventional cardiology devices. They are intended for use by physicians trained and experienced in PTCA and interventional cardiology techniques. Supplied sterile in peel-open packages. Intended for single procedure use.

The EnvyTM Guiding Catheter is used as a support catheter for interventional intracoronary devices. The device will be constructed of nylon and TFE with stainless steel braiding. The EnvyTM Guiding Catheter outside diameter is 6.0 French and will be available in various lengths and various distal curves. It will be supplied sterile, intended for one-time use.

The provided text is a 510(k) Premarket Notification for the Envy™ Guiding Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from a clinical study with detailed acceptance criteria.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria. The FDA's letter explicitly states that the review determined the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for market clearance for a 510(k) submission.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set or training set.
• Data provenance.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness study results or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for a training set was established.

The "Safety and Effectiveness Information" section primarily focuses on stating the device's intended use, materials, and technological characteristics as being similar to the predicate device, the COOK Coronary Guiding Catheter. Substantial equivalence is established based on these similarities and compliance with manufacturing and quality assurance programs, not typically through a clinical study demonstrating specific performance metrics against pre-defined acceptance criteria as would be expected for novel AI/ML devices.

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