(91 days)
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 7.0 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, Lightbox Sled (referred to as Sled), the Lightbox HS Imaging Console and the Sterile Drape (accessory).
The Pantheris System and its modified version (K153460) are intended to remove plaque from partially occluded peripheral vasculature. The device uses OCT-assisted orientation as an adjunct to fluoroscopy.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and the Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in a quantitative manner that would typically be seen for diagnostic device accuracy (e.g., sensitivity, specificity, AUC). Instead, the studies performed are primarily focused on demonstrating the safety and effective function of the device's modifications and ensuring substantial equivalence to a previously cleared predicate device.
The acceptance criteria for this device seem to be implicitly defined by the successful completion of various non-clinical engineering and biological tests, and the modified device's performance matching or exceeding that of its predicate. The "reported device performance" is qualitative and indicates "meets established specifications necessary for consistent performance for its intended use."
The identified non-clinical tests and their implicit acceptance criteria are:
| Acceptance Criteria (Implied by Test Name) | Reported Device Performance (Qualitative) |
|---|---|
| Design Verification | |
| Working Length | Meets specifications |
| Catheter Flush | Meets specifications |
| OCT Image Generation and Sled Interface | Meets specifications |
| Catheter Field of View | Meets specifications |
| Distal Tip Rotation | Meets specifications |
| Guidewire compatibility | Meets specifications |
| Distal Tip Max OD | Meets specifications |
| Insertion Force | Meets specifications |
| Force to Overcome User Slide Lock | Meets specifications |
| Force to Remove Sled Bag | Meets specifications |
| Force to Remove Sled Bag ring | Meets specifications |
| Full 360° Image | Meets specifications |
| Inflation Cycles | Meets specifications |
| Cut/Pack Cycles | Meets specifications |
| Packed Position Life Cycle | Meets specifications |
| Active position Life Cycle | Meets specifications |
| Balloon Burst | Meets specifications |
| Torque Shaft Torque Proof loading | Meets specifications |
| Drive Shaft Torque Proof loading | Meets specifications |
| Inflation Luer Tensile Strength | Meets specifications |
| Flush Lumen Tensile Strength | Meets specifications |
| Distal Catheter Joints Tensile Strength | Meets specifications |
| Proximal Catheter Joints Tensile Strength | Meets specifications |
| Simulated Use (Design Validation) | |
| Setup (Ease of Use & Sterility) | Meets specifications |
| Functionality (Visualization, Flushing, Device Tracking, Target Sites, Treatment, Markings, Safety) | Meets specifications |
| Insertion/Retraction force | Meets specifications |
| Number of Insertions | Meets specifications |
| Post-Retraction (Visualization, Device Tracking, Treatment, Markings, Safety) | Meets specifications |
| Sterilization Validation | Meets specifications |
| Packaging Validation | Meets specifications |
| Product Shelf Life | Meets specifications |
| Biocompatibility | Meets specifications |
| Cytotoxicity | Meets specifications |
| Sensitization | Meets specifications |
| Intracutaneous Reactivity | Meets specifications |
| Systemic Toxicity | Meets specifications |
| Hemolysis extract | Meets specifications |
| Hemolysis direct | Meets specifications |
| Complement Activation | Meets specifications |
| Material Mediated (Rabbit) Pyrogenicity | Meets specifications |
| Preclinical Animal Testing | |
| Porcine Study (acute and chronic histopathological assessments, in vivo performance comparison) | Acceptable histopathological assessments; in vivo performance deemed comparable to predicate |
| Functionality (Radiopacity, OCT marker visibility, Insertion/Retraction, Advance to target location, Ability to orient device to a landmark) | Demonstrated |
| Minimum Effective Flow Rate (MEFR) for clear OCT imaging | Meets specifications |
| Thrombogenicity | Meets specifications |
| Safety Assessment | Acceptable safety profile |
2. Sample Size Used for the Test Set and the Data Provenance
The document mentions a "Porcine Study" as a preclinical animal test. The sample size for this study is not explicitly stated, only that it involved "acute and chronic histopathological assessments." The data provenance is from an animal model (porcine), and it is a prospective study design to evaluate the modified device. No human test set data is provided or referenced in this 510(k) summary for this specific modification. The study is a "comparison to a predicate device."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
For the preclinical porcine study, the documentation refers to "histopathological assessments." This implies that experts (likely veterinary pathologists) were involved in establishing the ground truth regarding tissue response and safety. However, the exact number of experts and their specific qualifications (e.g., "veterinary pathologist with X years of experience") are not provided in this document.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set, as it does not present a clinical study with human outcomes that would typically require independent expert adjudication. For the animal study, the pathological assessments would likely follow standard practices for veterinary pathology reporting, but no specific adjudication process (e.g., 2+1, 3+1 consensus) is detailed.
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
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor is there any discussion of AI assistance or human reader improvement. The Pantheris System (and its modification) is a medical device for atherectomy, and while it uses "OCT-assisted orientation," this is not presented as an AI-driven diagnostic aid for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This document describes a medical device rather than an algorithm. Its performance is assessed through engineering tests, biocompatibility, and preclinical animal studies. Therefore, the concept of "standalone algorithm performance" is not applicable here. The device's OCT imaging component is an "adjunct to fluoroscopy" and is part of a human-operated system for guided intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the preclinical animal study, the ground truth was primarily established through pathology (histopathological assessments). The functional aspects of the device in vivo were also evaluated. For the extensive non-clinical and design validation testing, the ground truth was based on pre-defined engineering specifications and performance standards.
8. The Sample Size for the Training Set
This document does not describe the development of an artificial intelligence or machine learning algorithm. Therefore, the concept of a "training set" in that context is not applicable. The device's design and modifications are based on engineering principles and iterative design, not on machine learning training data.
9. How the Ground Truth for the Training Set was Established
As there is no mention of an AI/ML algorithm or a training set in this document, this question is not applicable.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).