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510(k) Data Aggregation
(139 days)
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
| Endpoint | Acceptance Criteria (Performance Goal) | Reported Device Performance (Pantheris System) |
|---|---|---|
| Primary Safety: Freedom from Major Adverse Events (MAE) at 30 days | MAEs occurring in < 20% of subjects | 97% freedom from MAEs (3% experienced MAE); 95% one-sided upper confidence bound of 6.5%. Met. |
| Secondary Safety: Absence of new or worsening stent fracture | Not established with a sample size requirement; extremely low incidence expected | 1% (1 out of 97 procedures) inadvertently made contact with a stent. Met (due to low incidence and subsequent physician retraining efficacy). |
| Primary Effectiveness: Technical Success (residual stenosis ≤ 50% post-Pantheris alone) | > 79% | 89% (86 out of 97 subjects) had <50% residual stenosis; 95% one-sided upper confidence bound of 95% and lower confidence bound of 82%. Met. |
| Secondary Effectiveness (Powered): Freedom from Target Lesion Revascularization (TLR) at 6 months | > 61% | 93% (79 out of 85 subjects) freedom from TLR; 95% one-sided upper confidence bound of 98% and lower bound of 87%. Met. |
| Secondary Effectiveness: Procedural Success (residual stenosis ≤ 30% post-Pantheris + adjunctive therapy) | Not explicitly defined as a performance goal with a specific threshold. | 80% (78 out of 97 subjects) had residual stenosis < 30%; mean stenosis of 15% ± 10.1%. |
| Secondary Effectiveness: Change in Ankle-Brachial Index (ABI) | Not explicitly defined as a performance goal with a specific threshold. | ABI improved 39% from baseline at 6 months. |
| Secondary Effectiveness: Change in Rutherford Classes | Not explicitly defined as a performance goal with a specific threshold. | Rutherford Classification improved 71% at 6 months. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A total of 97 subjects were enrolled in the INSIGHT trial.
- Data Provenance: The study was a prospective, multi-center trial conducted across 17 investigational sites in the USA (n=15) and EU (n=2). Therefore, the data is prospective and from both the US and Europe.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document specified that the primary safety endpoint (freedom from MAEs) was adjudicated by an independent Clinical Events Committee (CEC).
- The primary effectiveness endpoint (technical success) and secondary effectiveness endpoint (procedural success) involving residual diameter stenosis were assessed by an independent angiographic core laboratory.
- The specific number or qualifications of experts within the CEC or the core laboratory are not detailed in this summary.
4. Adjudication Method for the Test Set
- For the primary safety endpoint (MAEs), an independent Clinical Events Committee (CEC) was used for adjudication. The specific method (e.g., 2+1, 3+1) is not provided, but the independence suggests a standardized, expert-driven review process.
- For effectiveness endpoints related to stenosis, an independent angiographic core laboratory assessed the outcomes. This implies multiple expert readers are likely involved in standardized image analysis, but the exact adjudication method is not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was reported. The study focused on the performance of the Pantheris System itself, a medical device for atherectomy, not an AI-assisted diagnostic or interpretative system.
6. Standalone Performance
- The study was a "single-arm trial" to determine the safety and performance outcomes of the Pantheris System.
- The primary effectiveness endpoint specifically refers to "residual diameter stenosis ≤ 50% after use of the Pantheris device alone," indicating that standalone performance (algorithm only without human-in-the-loop performance) was assessed for this specific aspect of effectiveness, meaning the intervention of the device itself.
- The "algorithm" in this context refers to the device's mechanism of action, as it's an atherectomy system, not a software-based AI algorithm.
7. Type of Ground Truth Used
- Clinical Outcomes: The ground truth relied on direct clinical outcomes assessed during the study, including:
- Occurrence of Major Adverse Events (MAEs).
- Angiographic measurements of residual stenosis (assessed by an independent core lab).
- Target Lesion Revascularization (TLR) rates.
- Changes in physiological markers (ABI) and clinical classification (Rutherford Classes).
- Expert Adjudication: For MAEs and angiographic assessments, the "ground truth" was established by expert adjudication (independent CEC and independent angiographic core laboratory).
- Histopathology/Pathology: For preclinical animal studies, pathology (light microscopy, radiography, and SEM) was used to assess acute treatment effects on arteries and stents.
8. Sample Size for the Training Set
- The document describes a clinical trial (INSIGHT Trial) which is a clinical validation study for expanded indications, not a training set for an AI algorithm.
- No training set for an AI algorithm is mentioned as the device is a physical atherectomy system, not an AI diagnostic tool.
9. How the Ground Truth for the Training Set Was Established
- As the device is an atherectomy system and not an AI algorithm, there is no mention of a "training set" or "ground truth for a training set" in the context of machine learning. The clinical trial data serves as validation for the device's performance against pre-defined clinical endpoints.
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(153 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 7.0mm, 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.
| Acceptance Criteria Category | Specific Criteria (Implicit for equivalence) | Reported Device Performance and Supporting Studies |
|---|---|---|
| Biocompatibility | No new or increased biocompatibility risks due to material changes in the torque shaft and balloon. Device materials must be safe for patient contact. | Passed all tests: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity (acute), Pyrogenicity, Complement Activation, Hemolysis (extract and direct), In Vivo Thrombogenicity. (Details of specific pass/fail values not provided, but stated as "passed all tests.") |
| Electrical Safety | Maintain compliance with electrical safety standards. | Complies with IEC 60601-1 standard for safety. |
| EMC | Maintain compliance with electromagnetic compatibility standards. | Complies with IEC 60601-1-2 standard for EMC. |
| Software Functionality | No change in software functionality, ensuring continued safety and effectiveness of the software. | No change to the software with the subject device. (Implies existing verification and validation remain valid.) |
| Mechanical Performance | Modified components (stiffer shaft, modified cutter, longer nosecone, single balloon, depth markings) must maintain or improve mechanical performance, durability, and functionality relative to the predicate without compromising safety. Aspects like device advancement, cutting efficiency, imaging, etc., must be satisfactory. | Extensive Mechanical Testing performed: 3-month accelerated aging and package performance, Simulated use, Working length, Catheter flush and leak, OCT image generation and Sled interface, Catheter field of view, Distal tip rotation, Guidewire compatibility and insertion force, Catheter-Sheath insertion cycles, various insertion/retraction forces, Cutter exposure, Full 360° image, Balloon inflation cycles, Balloon burst, Cut/Pack cycles, Catheter Sled insertion cycles, Packed/Active position life cycle, Torque shaft torque-proof, Driveshaft torque-proof, Proximal section torque shaft torque, Luer tensile strength tests, Catheter functionality, compatibility, insertion, retraction, and post-procedure checks, Visualization with a single balloon, Cutter corrosion/heat/rotational speed/dimensional verification, Plaque removal efficiency. (All tests implicitly met their respective criteria to support substantial equivalence.) |
| Safety & Performance in vivo | Modified device performs safely and effectively in a living system, demonstrating adequate trackability, OCT imaging clarity, and directed atherectomy without significant adverse events, especially in target vessel diameters. | GLP Animal Study: Two female Yorkshire swine (one acute, one chronic) were used. The v1.4 Pantheris catheter (test device) and v1.3 Pantheris catheter (control device) were assessed for: trackability, advancement through vascular sheath, clarity of OCT imaging, orientation towards landmark, and minimum effective flow rate (MEFR) for acceptable OCT images across 3.0-7.0 mm vessel lumen diameters. Results: All treatment evaluation parameters and MEFR evaluations ranked "good" to "excellent." Only adverse event: minor perforation during MEFR assessment in one animal, deemed clinically insignificant and self-resolving. Conclusion: No new questions of safety and effectiveness were produced. |
| Clinical Effectiveness | No new clinical concerns introduced by the modifications. | No clinical testing of the modifications was deemed necessary, indicating that existing clinical data for the predicate device is considered applicable. |
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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(63 days)
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
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Effectiveness | Technical success: Percent of target lesions with residual diameter stenosis < 50% post Pantheris device alone. Performance Goal: 92.13% with a lower 95% confidence bound of >= 87%. | 96% (158/164) of lesions treated achieved residual diameter stenosis < 50% post-Pantheris device alone. This met the performance goal of 92.13% with a lower 95% confidence bound of 87%. |
| Primary Safety | Freedom from a composite of major adverse events (MAEs) through 6-Month follow-up. Performance Goal: 35.3% (meaning a maximum MAE rate of 35.3% was acceptable). | Overall safety event rate of 21.5% (20/93) in the per protocol population (78.5% event free). This met the safety performance goal of 35.3% with a 95% 1-sided upper confidence bound of 43.2% (meaning the observed MAE rate was well below the acceptable threshold). |
| Secondary Effectiveness | Procedural success: Percent of target lesions with residual diameter stenosis ≤ 30% post-Pantheris and/or any other adjunctive therapy. | Achieved in 79.3% of lesions. |
| Secondary Safety | Freedom from MAEs through 30 days. | Further confirmed clinical improvement in subjects' clinical status over time. (Specific numerical rate not explicitly provided, but stated as confirming improvement). |
| Secondary Safety | Freedom from procedural related emboli (through 30 days). | Further confirmed clinical improvement in subjects' clinical status over time. (Specific numerical rate not explicitly provided, but stated as confirming improvement). |
| Secondary Safety | Freedom from target vessel revascularization (TVR) through 30 days and 6 months. | Further confirmed clinical improvement in subjects' clinical status over time. (Specific numerical rate not explicitly provided, but stated as confirming improvement). |
2. Sample Size Used for the Test Set and Data Provenance
- Total Subjects Enrolled: 162
- Intention-To-Treat (ITT) Cohort: 134 subjects
- Roll-In Cohort: 28 subjects
- Per Protocol Cohort (primary focus for atherectomy performance): 130 subjects (This is the primary test set for effectiveness)
- Safety Population (for primary safety endpoint): 93 subjects (This is the primary test set for safety, likely a subset of the per-protocol cohort or ITT cohort after accounting for censoring/follow-up).
- Data Provenance: The study is described as a "prospective, multi-center" study. While the specific countries are not mentioned, the context of an FDA submission for a US company suggests it likely included US sites, and potentially international sites given "multi-center" can imply broader geographic inclusion.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Primary Effectiveness (Angiographic assessment): An "independent Angiographic Core Laboratory" assessed residual diameter stenosis. The number of individual experts or their specific qualifications (e.g., years of experience, specific certifications) are not specified in the provided text, only that it was an "independent" lab.
- Primary Safety (Adjudication of MAEs): An "independent Clinical Events Committee (CEC)" adjudicated major adverse events. The number of experts or their specific qualifications are not specified in the provided text.
4. Adjudication Method for the Test Set
- Angiographic Assessment (Effectiveness): Performed by an "independent Angiographic Core Laboratory." The specific method of consensus (e.g., 2+1, 3+1) or if multiple readers were used and averaged/adjudicated is not specified.
- Safety Events (MAEs): Adjudicated by an "independent Clinical Events Committee (CEC)." The specific adjudication method (e.g., consensus, majority rule, specific tie-breaking) is not specified.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not explicitly described. The study evaluates the Pantheris System's standalone safety and effectiveness against pre-defined performance goals, not in comparison to human readers with or without AI assistance.
- The study design focuses on the device's technical success and safety outcomes in patients, not on observer performance or diagnostic accuracy improved by an AI component per se. The OCT-assisted orientation is a feature of the device itself, not a separate AI system augmenting human interpretation of other imaging modalities.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
- Yes, a standalone performance evaluation of the device as a whole was performed. The study primarily assessed the performance of the Pantheris System (which includes OCT-assisted orientation as an inherent part of its mechanism) in removing plaque and its associated safety outcomes. The "algorithm" here is the device's overall function, including its OCT guidance technology, rather than a separate AI diagnostic algorithm. The primary effectiveness endpoint was based on a post-procedure angiogram read by an independent lab, directly assessing the device's effect.
7. The Type of Ground Truth Used
- Effectiveness Ground Truth: The primary effectiveness endpoint (residual diameter stenosis < 50%) was assessed by an "independent Angiographic Core Laboratory" based on angiographic imaging. While angiography is a clinical imaging modality, for this study, the core lab's interpretation of these images served as the ground truth for measuring the device's efficacy.
- Safety Ground Truth: The primary safety endpoint (Major Adverse Events) was adjudicated by an "independent Clinical Events Committee (CEC)" based on clinical events and outcomes data. This would typically involve review of patient records, clinical notes, and potentially other diagnostic reports.
8. The Sample Size for the Training Set
- The provided document describes a clinical trial (VISION Study), which is typically designed to evaluate the safety and effectiveness of a device on a patient population. It is not a study describing the training of an AI algorithm. Therefore, there is no mention of a training set sample size in the context of machine learning model development. The 162 subjects are the studied patient cohort for evaluating the device's performance.
9. How the Ground Truth for the Training Set was Established
- As this is a clinical trial evaluating a medical device rather than an AI or machine learning algorithm, the concept of a "training set ground truth" as typically understood in AI development does not apply here. The study gathered clinical data and patient outcomes to validate the device's performance against pre-defined clinical endpoints.
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