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The Pantheris System is intended to remove plaque (atherectomy) from partially occluded native or restenotic vessels, including in-stent restenosis (ISR), in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies. The Pantheris system is not intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

The Pantheris System consists of a Pantheris atherectomy catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and a Lightbox HS Imaging Console (referred to as "Lightbox"). The Pantheris atherectomy catheter is a 7 French device with a working length of 110 cm. It incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCT-guided atherectomy during the procedure with its connection to the Lightbox via the Sled accessory.

The following provides an analysis of the acceptance criteria and study findings for the Pantheris System, based on the provided FDA 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

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The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0mm to 7.0mm, using OCT-assisted orientation and imaging. The system is as an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies. The Pantheris System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

The Pantheris System combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular atherectomy capabilities. The Pantheris System consists of the Pantheris catheter, Lightbox Sled with integrated Umbilical (referred to as "Sled") and the Lightbox HS Imaging Console (referred to as "Lightbox"). The Pantheris Catheter has a working length of 110 cm and is a sterile, single-use device that is compatible with 7 and 8F sheaths and 0.014" guidewires. The Pantheris Catheter incorporates an optical fiber that allows for real-time OCT-guided directional atherectomy during the procedure. The Pantheris catheter is connected to the Lightbox via the Sled. The Lightbox is an optical transceiver, transmitting light to the intraluminal environment through the optical fiber on the Pantheris Catheter and receiving and interpreting the signal from the tissue using a PCbased processing system. The Lightbox provides a visualization platform for the real-time OCT-assisted directional atherectomy. The Lightbox consists of a cart with two monitors, a PC-based processing system, software, an isolation transformer, and an OCT system.

The Pantheris System described in K173862 is an updated version of a previously cleared device (K172236). Therefore, the acceptance criteria and performance data provided focus on demonstrating that the modifications to the device do not raise new questions of safety and effectiveness, and that the updated device remains substantially equivalent to its predicate.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for modifications to an already cleared device, the "acceptance criteria" are implicitly that the modified device performs comparably to the predicate device and does not introduce new safety or effectiveness concerns. The "reported device performance" is largely demonstrating mechanical equivalence and biocompatibility, as well as satisfactory performance in an animal model.

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

The provided text primarily details non-clinical testing.

• Biocompatibility: The sample sizes for each specific biocompatibility test are not explicitly stated, but standard protocols are typically followed (e.g., multiple replicates per material, positive/negative controls).
• Mechanical Testing: Specific sample sizes for each mechanical test are not provided. These are generally performed on a sufficient number of units to establish statistical confidence or engineering acceptance, often following ISO or ASTM standards.
• Animal Study: Two female Yorkshire swine were enrolled (one for acute assessment, one for chronic assessment).
  • Provenance: This was an animal study, not human data. The location of the GLP animal study is not specified, but it's likely a controlled laboratory setting.

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

Experts are primarily mentioned in the context of the animal study:

• Animal Study: "the physician conducting the study" (singular).
  • Qualifications: Likely a veterinarian or interventionalist with expertise in animal models and vascular procedures, though specific qualifications (e.g., years of experience, board certification) are not detailed. This physician made the clinical judgment on the significance of the minor perforation.

For other tests (biocompatibility, mechanical), "ground truth" is established by adherence to recognized standards and validated test methods, rather than human expert consensus.

4. Adjudication Method for the Test Set

• Animal Study: The text mentions "the physician conducting the study" made a determination regarding the clinical significance of an adverse event. This implies a single expert's judgment rather than a formal multi-expert adjudication method (e.g., 2+1, 3+1).
• Other Testing: Not applicable; acceptance is based on objective measurements against engineering specifications or standard pass/fail criteria.

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 MRMC study or AI assistance is mentioned. The Pantheris System is an atherectomy device with OCT imaging, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not applicable to the provided information.

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

• Not applicable. The device is a surgical atherectomy system with integrated imaging, not a standalone algorithm. The imaging component (OCT) is meant to be used real-time by a human operator (physician) for guidance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Biocompatibility: Established by adherence to ISO standards and validated test methods (e.g., specific cell responses for cytotoxicity, immune responses for sensitization).
• Mechanical Testing: Based on engineering specifications, design requirements, and validated test methods (e.g., force measurements, cycle counts, dimensional tolerances).
• Animal Study:
  • Direct Observation: For trackability, advancement, OCT image clarity, orientation, and MEFR, which were ranked as "good" to "excellent."
  • Pathological/Clinical Assessment: For adverse events (minor perforation) and its clinical significance by the study physician. While not explicitly stated, post-mortem pathological examination is standard for chronic animal studies to confirm tissue response and healing.

8. The Sample Size for the Training Set

• Not applicable. This device is a medical instrument, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development.

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

• Not applicable, as there is no training set for this type of device.

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The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation as an adjunct to fluoroscopy. The Pantheris System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

The Pantheris System consists of the Pantheris Catheter (packaged with the Flush Fixture), Lightbox Sled (referred to as Sled), the Lightbox HS Imaging Console, the Lightbox Umbilical (referred to as Umbilical), Sterile Drape (accessory) and the Occlusion Sheath (optional accessory). The Pantheris System combines the use of Avinger's Optical Coherence Tomography (OCT) technology with peripheral vascular atherectomy capabilities.

The Pantheris Catheter has a working length of 130 cm and is a sterile, singleuse device that is compatible with 8F sheaths and 0.014" guidewires. The Pantheris Catheter consists of an imaging assembly, a rotating cutter, an apposition mechanism (balloon) and a flexible, tiltable nosecone. It also incorporates an Optical Fiber that allows for real-time OCT guided directional atherectomy during the procedure. The Pantheris Catheter and optional Occlusion Sheath accessory are provided sterile and are intended for single-use only.

The Pantheris Catheter is connected to the Lightbox HS Imaging Console via the Sled and the Umbilical. The Sled provides optical and rotational power to the Pantheris Catheter. The Umbilical is a 3-meter long optical and electrical extension cable that connects the Sled to the Lightbox HS Imaging Console.

The Lightbox HS Imaging Console is an optical transceiver, transmitting light to the intraluminal environment through the optical fiber on the Pantheris Catheter and receiving and interpreting the signal from the tissue using a PC-based processing system. The Lightbox provides a visualization platform that allows for real-time OCT-assisted directional atherectomy. The Lightbox HS Imaging Console consists of a cart with two monitors; a PC based processing system, an isolation transformer and an OCT system.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Pantheris System (Intraluminal Artery Stripper)

1. Table of Acceptance Criteria and Reported Device Performance

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