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The Wildcat Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the garipheral vasculature prior to further percutaneous intervention. The Wildcat Catheter pontraindicated for use in the illiac, coronary, cerebral or carotid vasculature.

The Juicebox is an optional accessory that may be used to facilitate catheter tip rotation when using a compatible Avinger Wildcat catheter.

The Wildcat Catheter is a sterile, single-use, disposable catheter designed to cross chronic total occlusions (CTOs) and to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions in the peripheral vasculature. The Wildcat Catheter consists of the distal tip, catheter shaft, and proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. The catheter is 6F guide compatible, 110 cm long, and intended for use with 0.035" guidewires. Two key elements of the device define the treatment modality - the distal tip and the bilateral wedges. Both elements are visible through fluoroscopy and allow for CTO crossing and facilitation of guidewire placement.

Juicebox is an optional accessory used to provide assisted distal tip rotation when using a compatible Avinger catheter. It consists of a handle with a rotation toggle switch and a release button. Juicebox is designed to be placed over the catheter handle. This accessory is provided separately, irradiated for sterility, and intended for single use only.

Here's an analysis of the provided text regarding the Avinger Wildcat Catheter and Juicebox, breaking down the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or reported device performance metrics for the Wildcat Catheter and Juicebox. Instead, it relies on a determination of "substantial equivalence" to predicate devices based on non-clinical testing. The conclusion reached is that the device "performs according to the stated intended use and raises no new issues of safety or effectiveness."

Therefore, the table would look like this:

"non-clinical testing demonstrated that the Wildcat Catheter used with the Juicebox is substantially equivalent to the predicate devices for its intended use." |
| Functionality (e.g., ability to cross CTOs, facilitate guidewire placement, rotation with Juicebox) | "performs according to the stated intended use" (as described in the "Intended Use" section: "facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature") |

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

The document only mentions "non-clinical testing" and does not specify a "test set" in the context of patient data or clinical trials. The evaluation appears to be based on engineering and bench-top testing.

• Sample Size for Test Set: Not applicable/Not specified, as no human or biological 'test set' is described.
• Data Provenance: Not applicable/Not specified, as the testing is non-clinical.

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

• Number of Experts: Not applicable/Not specified.
• Qualifications of Experts: Not applicable/Not specified.

This type of information is typically relevant for clinical studies involving interpretation of medical images or patient outcomes, which is not the case for this non-clinical submission.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not specified.

This is relevant for clinical studies where expert disagreement on ground truth needs to be resolved.

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

• MRMC Study: No, an MRMC study was not done.
• Effect Size with AI assistance: Not applicable.

This submission is for a physical medical device (catheter and accessory), not an AI imaging or diagnostic algorithm.

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

• Standalone Performance Study: Not applicable.

This is not an AI algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc)

The "ground truth" for this device's performance is established through engineering specifications and bench-top test results against established standards and the performance of predicate devices. The non-clinical testing validates that the device's physical and functional characteristics meet its intended use.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified.

This concept is primarily relevant for machine learning algorithms, not for the non-clinical testing of a physical medical device.

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

• Ground Truth Establishment for Training Set: Not applicable/Not specified.

Again, this pertains to AI/ML development, which is not the subject of this 510(k) submission.

Summary of Key Takeaways from the Document:

The 510(k) submission for the Avinger Wildcat Catheter and Juicebox focuses on demonstrating substantial equivalence to previously cleared predicate devices (K111338 and K111704). This is achieved primarily through:

• Comparative analysis of technological characteristics, device design, packaging, procedural steps, and safety. The document explicitly states the subject device is "identical in design, manufacturing, operation, and material composition as its FDA-cleared predicates."
• Non-clinical performance testing. While the specific tests are listed (e.g., Biocompatibility, Sterilization, Dimensional Analysis, Mechanical Strength, etc.), the document does not provide the quantitative results or specific acceptance criteria for these tests. Instead, it concludes that the "collective results...confirmed that the Wildcat Catheter performs according to the stated intended use and raises no new issues of safety or effectiveness."

The framework for this submission is based on verifying that the new device shares the same fundamental characteristics and performs comparably to devices already on the market, thereby proving it meets the same safety and effectiveness standards. It is not an evaluation of a novel technology or a clinical performance study with patient data.

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The Wildcat Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Wildcat Catheter is contraindicated for use in the iliac, coronary, cerebral or carotid vasculature.

The Wildcat Catheter is a sterile, single-use, disposable catheter designed to cross chronic total occlusions (CTOs) and to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions in the peripheral vasculature.

The Wildcat Catheter consists of the distal tip, catheter shaft, and proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. The catheter is 6F guide compatible, 110 cm long, and intended for use with 0.035" guidewires. Two key elements of the device define the treatment modality - the distal tip and the bilateral wedges. Both elements are visible through fluoroscopy and allow for CTO crossing and facilitation of guidewire placement.

Subsequent to conventional guidewire placement, atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit.

The provided text describes the acceptance criteria and a clinical study (CONNECT Study) for the Wildcat Catheter. However, it focuses on the safety and effectiveness of a medical device, not an AI/ML powered device. Therefore, several of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable or cannot be extracted directly from this document.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

• No further sequelae reported prior to discharge.
• No occurrences of MAEs (0.0%).
• No unanticipated adverse events.
  Conclusion: Primary safety endpoint was met. |
  | Primary Effectiveness Endpoint: Successful CTO crossing by the Wildcat Catheter and subsequent guidewire positioning through the distal true lumen (confirmed by angiography) | Achieved in 89.3% of subjects.
  Conclusion: Primary effectiveness endpoint was met. |

2. Sample size used for the test set and the data provenance:

• Sample Size: 84 subjects.
• Data Provenance: Multi-center, prospective, non-randomized study conducted at 15 sites in the United States.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The text mentions "independent angiographic reviewers" for assessing primary safety and effectiveness endpoints. However, the number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not specified.

4. Adjudication method for the test set:

• The text states "Primary safety and effectiveness endpoints were based on independent angiographic reviewers." It does not specify the adjudication method (e.g., 2+1, 3+1, none) used by these reviewers.

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:

• No. This was a clinical study evaluating a medical device (catheter), not an AI/ML powered device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

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

• Not applicable. This device is a catheter, used in a human-in-the-loop procedure. It is not an algorithm.

7. The type of ground truth used:

• Expert Consensus / Angiography: The ground truth for both safety and effectiveness endpoints was established through the assessment of "independent angiographic reviewers" and confirmed by angiography.

8. The sample size for the training set:

• Not applicable. This document describes a clinical study for a traditional medical device (catheter), not an AI/ML model that requires a training set.

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

• Not applicable. As above, no training set for an AI/ML model was involved.

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