(27 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 Catheter received clearance under K153460 to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature using OCTassisted orientation. This Special 510(k) submission is intended to add Tweezers and two 3-way Stopcocks to the Pantheris Catheter packaging. The Tweezers are provided to assist in the extraction of tissue that is collected during the atherectomy procedure from the distal end of the catheter once the catheter is removed from the patient. The catheter can then be re-inserted into the vessel to continue plaque removal using the same technique. The Tweezers are not intended to come into direct contact with the patient.
The Stopcocks are standard, off the shelf accessories, used to facilitate the delivery of CO2 and saline to the catheter. The Syringes are connected to the Flush and Balloon Inflation Lumens (components on the catheter's handle assembly) via the Stopcocks. The Stopcocks are not intended to come into direct contact with the patient.
Both the Tweezers and the Stopcocks are provided in order to make readily available these commonly used accessories and for user's convenience.
Here's an analysis of the provided text regarding the Pantheris Catheter, focusing on acceptance criteria and study details.
Based on the provided document, the submission (K160827) is a Special 510(k) for adding accessories (Tweezers and 3-way Stopcocks) to an already cleared device (Pantheris Catheter, K153460). Therefore, the "device" in question for this specific submission is primarily the addition of these accessories and their impact on the overall system's safety and effectiveness, rather than a fundamental re-evaluation of the core Pantheris Catheter's performance.
The document explicitly states: "There are no modifications to the indications for use, intended use, material, design, functionality or performance of the catheter, flush fixture and syringes cleared under K153460." This means the performance of the Pantheris Catheter itself was established in a prior submission (K153460), and this current submission focuses on ensuring the accessories do not negatively impact safety or effectiveness.
Given this context, the acceptance criteria and supporting studies are framed around the accessories, not the catheter's primary function of plaque removal.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Tweezers and Stopcocks verified per ISO 10993-1:2009 and related collateral standards for patient contacting materials. |
| Packaging and Shelf-life Validation | Performed to test the packaging tray configuration in accordance with ISO 11607-1:2006 and ISO 11607-2:2006. |
| Sterilization Assurance Level (SAL) | Maintained a SAL of 10^-6 using Electron Beam sterilization per Method VDMax25, in accordance with ISO 11137-1:2006 and ISO 11137-2:2006. |
| No new questions of safety and effectiveness | The non-clinical testing collectively demonstrated that the Pantheris Catheter (with new accessories) meets established specifications, and the accessories raise no new questions of safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the traditional sense of patient data or clinical trials for evaluating the performance of the atherectomy aspect of the device. Instead, the testing described is focused on the non-clinical performance of the new accessories and their impact on the existing system.
- Sample Size for Test Set: Not applicable or not specified in terms of patient data. The non-clinical tests (biocompatibility, packaging, sterilization) would involve specific numbers of samples/units for each test, but these are not detailed in the summary.
- Data Provenance: Not applicable for clinical data. The tests are non-clinical (laboratory/bench testing) of the device components.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for biocompatibility, packaging, and sterilization standards is defined by international standards (ISO series) and accepted regulatory practices, not by expert consensus on clinical data in this context.
4. Adjudication Method for the Test Set
Not applicable. There's no indication of clinical data requiring expert adjudication in this submission. The non-clinical tests rely on meeting predefined specifications and 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 device is an atherectomy catheter, not an AI-powered diagnostic device. The submission does not mention any AI component or MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
Not applicable. This device is not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this submission's acceptance criteria primarily relies on:
- International Standards and Regulations: ISO 10993-1, ISO 11607-1, ISO 11607-2, ISO 11137-1, ISO 11137-2.
- Design Specifications: The device (with accessories) meeting its established performance specifications.
- Predicate Device Equivalence: The primary "ground truth" for the overall system's safety and effectiveness is its substantial equivalence to the previously cleared Pantheris Catheter (K153460), as no changes were made to the core functionality.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of the Document's Focus:
This FDA 510(k) submission (K160827) is a "Special 510(k)" for minor modifications (adding accessories) to an already cleared medical device. The key takeaway is that the safety and effectiveness of the original Pantheris Catheter for its intended use were established previously. This submission's purpose is to demonstrate that the addition of Tweezers and Stopcocks does not introduce new risks or modify the fundamental performance of the catheter. Therefore, the "acceptance criteria" and "studies" are focused on standard non-clinical evaluations related to these new components' biocompatibility, packaging, and sterilization, ensuring they do not compromise the system's previous clearance basis. The document explicitly states: "The performance testing conducted establishes that the addition of Tweezers and Stopcocks does not raise new questions of the safety and efficacy for the Pantheris Catheter cleared under K153460."
§ 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).