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510(k) Data Aggregation
(154 days)
The Pantheris LV System is indicated 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, 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 LV System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.
The Pantheris LV catheter combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular atherectomy capabilities. The Pantheris LV System consists of the Pantheris LV catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox Imaging Console (referred to as "Lightbox"). The Pantheris LV catheter is a 7 French device with a working length of 110 cm. It is comprised of two components-an outer support catheter and an inner assembly or drive shaft. It is provided sterile and is a single-use device compatible with 5 Fr vascular sheaths. The Pantheris LV catheter 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.
This document is a 510(k) summary for the Pantheris LV Atherectomy Catheter. It outlines the device's indications for use, compares it to predicate and reference devices, and describes the performance data used to demonstrate substantial equivalence.
Based on the provided text, the Pantheris LV Atherectomy Catheter is not an AI/ML enabled device. This conclusion is drawn from the following observations:
- Absence of AI/ML terminology: The document does not mention any terms typically associated with AI or machine learning, such as "algorithm," "model," "deep learning," "neural network," "AI assistance," "inference," "training data," "validation data," "ground truth establishment" for algorithms, or "performance metrics" relevant to AI (e.g., sensitivity, specificity, AUC for an AI-driven diagnostic).
- Focus on mechanical and optical characteristics: The device description and performance data sections primarily detail mechanical properties, optical coherence tomography (OCT) imaging capabilities (which are optical imaging not AI-driven image interpretation), electrical safety, electromagnetic compatibility, and biocompatibility.
- Comparison to existing devices based on physical design: The substantial equivalence argument relies heavily on comparing the Pantheris LV's physical design attributes (e.g., catheter size, tip length, working length, mechanism of atherectomy) and shared operational characteristics with existing cleared devices, rather than any advanced computational functionalities.
- Nature of the device: The device is described as an "atherectomy catheter" used to "remove plaque." Its functionality involves physical plaque removal assisted by OCT imaging for guidance, not AI-driven diagnosis, interpretation, or decision-making. The OCT is explicitly stated as "OCT-assisted orientation and imaging" and "an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies," referring to human interpretation of these images, not AI analysis of them.
- Lack of AI-specific study types: The "Performance Data" section details mechanical, electrical, and biocompatibility testing. There is no mention of studies that would be typical for an AI/ML device, such as those evaluating diagnostic accuracy (e.g., standalone performance, MRMC studies, reader studies). The sections on "Animal Testing" and "Clinical Studies" explicitly state they "were not necessary" for this particular submission, further indicating the absence of complex data-driven (AI) performance validation.
Therefore, the request to describe acceptance criteria and study data for an AI/ML device is not applicable to the Pantheris LV Atherectomy Catheter based on this document. The provided text does not contain information related to AI/ML acceptance criteria or studies.
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(53 days)
The Tigereye ST System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the perior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures.
The Tigereye ST System combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular chronic total occlusion (CTO) crossing capabilities. The Tigereye ST System consists of the Tigereye ST CTO-crossing catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox Imaging Console (referred to as "Lightbox"). The Tigereye ST CTO-crossing catheter is a coaxial 5 French device with a working length of 140 cm. It is comprised of two components-an outer support catheter and an inner assembly or drive shaft. It is provided sterile and is a single-use device compatible with 5 Fr vascular sheaths. The Tigereye ST CTO-crossing head incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCTguided CTO crossing during the procedure with its connection to an optical Sled and Lightbox.
The provided text is a 510(k) summary for the Tigereye ST CTO-Crossing Catheter. It focuses on demonstrating substantial equivalence to a predicate device (Tigereye CTO-Crossing Catheter K201330) based on similarities in indications for use, technological characteristics, and performance data from bench and biocompatibility testing.
However, the document does not contain information regarding a study involving AI/algorithm performance, human reader studies (MRMC), or details about acceptance criteria for such a study, sample sizes for test/training sets, expert adjudication, or ground truth establishment for an AI device.
Therefore, I cannot provide a detailed response to your request, as the necessary information is not present in the provided text. The device described is a medical instrument (catheter with OCT imaging), not an AI/algorithm-based diagnostic or assistive device that would typically undergo the type of performance evaluation criteria you are asking about (e.g., acceptance criteria for diagnostic accuracy, standalone algorithm performance, or human-in-the-loop improvement with AI).
The "Software Verification and Validation Testing" section mentions that the software of the Lightbox component has not been changed since a previous clearance (K212468) and is considered "moderate" level of concern, but this does not imply AI-driven diagnostic or assistive capabilities requiring the kind of study details you've requested.
In summary, the provided document is a 510(k) for a physical medical device and does not contain information about an AI/algorithm study.
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(153 days)
The Tigereye System 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 using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. The Tigereye System is contraindicated for use in the iliac, coronary, cerebral, renal, or carotid vasculature.
The Tigereye System combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular chronic total occlusion (CTO) crossing capabilities. The Tigereye System consists of the Tigereye CTO-crossing catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox 3 Imaging Console (referred to as "Lightbox 3" or "L300").
The subject device of this submission is a line extension of the Tigereve System reviewed and cleared earlier under K201330.
The Tigereye CTO-crossing catheter is a coaxial 5 French device with a working length of 140 cm. It is comprised of two components-an outer support catheter and an inner assembly or drive shaft. It is provided sterile and is a single-use device compatible with 5 Fr vascular sheaths. The Tigereye CTO-crossing head incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCT-guided CTO crossing during the procedure with its connection to an optical Sled and Lightbox 3 imaging console.
The Lightbox 3 console is comprised of a PC and an OCT engine, all contained within a casing. The operator monitor has a touchscreen that allows the user to interact with the console software for controlling the console, monitoring the procedure, and facilitating data input before, during, and after the procedure. The Lightbox 3 console is an optical transceiver, transmitting light to the intraluminal environment through an optical fiber in the catheter and receiving and interpreting the signal from the tissue using a PC-based processing system. The resulting OCT image is displayed on the monitor and provides a qualitative view of the vessel's structure inside traversed vessels as an adjunct to standard imaging techniques (e.g., fluoroscopy) during percutaneous peripheral vascular procedures.
The software of the Lightbox 3 console has been updated to version 1.0.300, which builds on version 4.6.0 that was reviewed and cleared under K201330.
The Tigereye catheter is to be used in a healthcare facility, such as a cardiac catheter lab or a hospital. It is to be used and in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible.
This Traditional 510(k) is focused solely on the updates to the software and design of the Lightbox 3 imaging console component of the Tigereye System. The Tigereye CTOcrossing catheter and the Sled in this submission are exactly the same as the catheter and Sled that were cleared in K201330.
Here's a breakdown of the acceptance criteria and study information for the Tigereye CTO-Crossing Catheter, based on the provided FDA 510(k) summary:
The provided document is a 510(k) summary for a medical device (Tigereye CTO-Crossing Catheter) seeking clearance for a software and console update, not a device proving its initial efficacy or diagnostic performance. Therefore, many of the typical acceptance criteria related to diagnostic accuracy, sensitivity, specificity, and expert adjudication are not present in this document.
The focus of this submission is to demonstrate that the updated device (Tigereye System with Lightbox 3 imaging console) remains substantially equivalent to its predicate device (Tigereye System cleared under K201330) and that the changes do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a software/console update and not an initial efficacy study, the "acceptance criteria" are primarily related to meeting performance standards for the modified components and showing equivalence to the predicate.
| Acceptance Criteria / Performance Aspect | Reported Device Performance (Tigereye System with Lightbox 3) | Justification/Reference |
|---|---|---|
| Biocompatibility | Catheter passed all biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Pyrogenicity, Hemocompatibility). Lightbox 3 console does not contact the patient, so no testing was necessary. | Reviewed in K201330; no changes to catheter or materials. |
| Electrical Safety | Complies with IEC 60601-1:2005 AMD1:2012. | Met standard. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2014. | Met standard. |
| Laser Safety | Complies with IEC 60825-1:2014 and 21 CFR Part 1040. | Met standard. |
| Software Verification & Validation | Performed for Lightbox 3 (v1.0.300), including regression testing. Documentation provided as recommended by FDA guidance. Software "Moderate" Level of Concern. | Testing conducted. |
| Mechanical Testing (Catheter) | No new mechanical testing for the catheter. The catheter itself is identical to the predicate device cleared in K201330. | K201330 mechanical testing deemed sufficient. |
| Mechanical Testing (Lightbox 3 Console) | Hipot testing, OCT engine laser power, OCT image accuracy, Console verification, Console validation, EMC, Laser safety, Electrical safety, Software verification, Software validation. | All performed successfully. |
| Effect on Safety & Effectiveness | No new questions of safety and effectiveness were raised by the changes. Substantially equivalent to predicate. | Conclusion of 510(k) review. |
| Indications for Use | Remains the same as the predicate (facilitate guidewire placement beyond stenotic lesions in peripheral vasculature using OCT-assisted orientation and imaging, as an adjunct to fluoroscopy). | Confirmed. |
| Contraindications | Remains the same as the predicate (iliac, coronary, cerebral, renal, or carotid vasculature). | Confirmed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of an efficacy study. This submission is for a software/console upgrade of an already cleared device. The performance data for the mechanical and electrical components likely involved a small number of test units (e.g., a few consoles and catheters) for engineering verification and validation.
- Data Provenance: Not explicitly stated as real-world patient data. The tests described are primarily bench testing, electrical safety, EMC, and software testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. This submission does not involve clinical studies or expert consensus for diagnostic ground truth. The "ground truth" for the engineering performance tests would be established by validated test methods, reference standards, and specifications.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no expert adjudication for a test set in this 510(k) submission.
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 MRMC comparative effectiveness study was done or reported in this 510(k) summary. This device is an imaging-assisted crossing catheter, not an AI-driven diagnostic system that assists human readers in interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is an imaging system providing real-time OCT images to a clinician during a procedure. It is inherently a human-in-the-loop device, not a standalone algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the mechanical, electrical, and software performance tests, the "ground truth" is based on engineering specifications, validated test methods, and compliance with recognized industry standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1). For example, "OCT image accuracy" would be compared against a known, accurate reference.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document does not describe the development of a machine learning or AI model, thus there is no "training set." The software updates are likely traditional software enhancements and bug fixes, verified and validated through standard software engineering practices.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for a machine learning model described here.
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(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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(114 days)
The Tigereye System 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 using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. The Tigereye system is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
The Tigereye System combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular chronic total occlusion (CTO) crossing capabilities. The Tigereye System consists of the Tigereye CTO-crossing catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox HS Imaging Console (referred to as "Lightbox"). The Tigereye CTO-crossing catheter is a coaxial 5 French device with a working length of 140 cm. It is comprised of two components-an outer support catheter and an inner assembly or drive shaft. It is provided sterile and is a single-use device compatible with 5 Fr vascular sheaths. The Tigereye CTO-crossing head incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCT-guided CTO crossing during the procedure with its connection to an optical Sled and Lightbox. The software of the Lightbox has been updated to version 4.6.0, which builds on version 4.4.0 that was reviewed and cleared under K182341.
The provided text does not describe a study involving an AI/Machine Learning device. Instead, it is a 510(k) summary for the Tigereye CTO-Crossing Catheter, a medical device used for crossing chronic total occlusions in peripheral vasculature. The device utilizes Optical Coherence Tomography (OCT) for imaging and orientation, but this is a physical imaging technology, not an AI/ML algorithm.
Therefore, many of the requested elements, such as acceptance criteria for AI performance (e.g., sensitivity, specificity), ground truth establishment for AI models, sample sizes for training/test sets for AI, MRMC studies, or standalone algorithm performance, are not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device (Ocelot PIXL CTO-Crossing Catheter) and a reference device (Pantheris SV Catheter) through:
- Comparison of Technological Characteristics: Highlighting similarities in intended use, imaging modality (OCT), safety standards, materials, and operational characteristics.
- Performance Data: This section details engineering and biocompatibility tests, not clinical or AI performance. These include:
- Biocompatibility testing (cytotoxicity, sensitization, hemocompatibility, etc.)
- Electrical safety and electromagnetic compatibility (EMC)
- Software verification and validation (for the Lightbox component, which houses the control software, not an AI for image analysis)
- Mechanical testing (e.g., catheter length, flow rate, tip rotation, force to cross occlusion, torque, tensile strength).
The conclusion states that the data "raises no new questions of safety and effectiveness and that the Tigereye catheter is substantially equivalent to the predicate device."
In summary, based on the provided text, it's impossible to fill out the requested table or answer most of the questions, as they pertain to the evaluation of an AI/Machine Learning device, which the Tigereye CTO-Crossing Catheter is not.
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(224 days)
The Pantheris SV is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 2.0 mm to 4.0 mm, using OCTassisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies. The Pantheris SV is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.
The Pantheris SV catheter is a monorail (rapid exchange) device with a working length of 144 cm, compatible with a 6 French sheath and an 0.014" guidewire. It consists of a lubricious coated torque shaft with a proximal handle assembly and an atraumatic distal assembly. The distal assembly of the catheter consists of an imaging assembly, a rotating cutter, and a flexible, tiltable nosecone. The catheter is sterilized by electron beam radiation and is intended for single use only. The Pantheris SV is to be used in a healthcare facility, such as a cardiac catheter lab or a hospital. It is to be used and in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible.
This document is a 510(k) summary for the Pantheris SV atherectomy catheter. It describes the device, its intended use, and compares it to a predicate device and a reference device. It also details the non-clinical performance data supporting the device's substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a tabular format for each test. Instead, it states that the device "passed all tests" or that parameters were "ranked from 'good' to 'excellent'." No specific quantitative acceptance values are provided, as this is a 510(k) submission focused on substantial equivalence rather than a detailed performance study with pre-defined statistical endpoints for a new technology.
However, based on the Mechanical Testing and Animal Testing sections, we can infer some performance indicators:
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Biocompatibility standards met | Passed all ISO 10993 tests (Cytotoxicity, Sensitization, Irritation, Material-mediated pyrogenicity, Systemic toxicity, Complement activation, Partial thromboplastin time, Platelet and leukocyte count, Hemolysis extract, Hemolysis direct) |
| Electrical safety standards met | Complies with IEC 60601-1 |
| Electromagnetic compatibility (EMC) standards met | Complies with IEC 60601-1-2 |
| Software Verification & Validation | Successfully upgraded to version 4.4.0 (for Lightbox console) |
| Mechanical integrity (e.g., Simulated use, working length, flush & leak, image generation, rotation, guidewire compatibility, insertion force, retraction force, cutter exposure, full 360° image, cut/pack cycles, coating integrity, life cycle, torque-proof loading, tensile strengths, functionality performance) | All mechanical tests performed at time 0 and 3 months. Implied successful completion as no issues are reported. |
| Animal study safety | No significant procedural adverse events, no evidence of acute vessel trauma, no evidence of thrombus, no tissue reaction (gross necropsy and histopathology). |
| Animal study performance (tracking, advancement, OCT clarity, orientation, MEFR) | All treatment evaluation parameters and MEFR evaluations ranked from "good" to "excellent." No thrombus visualized, no device failures. |
2. Sample Size Used for the Test Set and Data Provenance
- Mechanical Testing: The document does not specify the exact sample size (number of catheters/units) used for each mechanical test. It lists the types of tests conducted.
- Animal Testing: Two pigs were enrolled in this study.
- Data Provenance: The study was a GLP (Good Laboratory Practice) animal study. While the country isn't explicitly stated, GLP studies are typically highly regulated, and the context of an FDA submission suggests it was conducted under U.S. or comparable international standards. It is a prospective study for the purpose of demonstrating safety and performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For the animal study, the document mentions "gross necropsy and histopathology" which would typically involve qualified veterinary pathologists. However, the number of experts or their specific qualifications (e.g., board-certified veterinary pathologist with X years of experience) are not specified in this summary. The ranking of treatment evaluation parameters from "good" to "excellent" implies expert assessment, but the details are missing.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the animal study or mechanical testing. Given the summary's content, it's likely that a single expert or a team within the company assessed the results of the animal study, but no formal adjudication process (like 2+1 or 3+1 consensus) is outlined.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical testing of the subject device was necessary." The testing involved mechanical and animal studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The Pantheris SV catheter incorporates Optical Coherence Tomography (OCT) for imaging, and the "Lightbox Console" has software (version 4.4.0). The device is characterized as "OCT-assisted orientation and imaging" with the system acting "as an adjunct to fluoroscopy." This implies human interaction/interpretation of the OCT images for directional atherectomy. Therefore, a purely standalone algorithm without human-in-the-loop performance cannot be definitively inferred from this document as the primary mode of operation. The "Imaging Capabilities" section describes the system as one to "facilitate atherectomy" and "identify clinically relevant morphologies," which suggests human interpretation of the images provided by the device.
7. The Type of Ground Truth Used
- Mechanical Testing: Ground truth is established by engineering specifications, standardized test methods (e.g., BS EN 1707:1997, ISO 10555-1:2013), and direct physical measurement/observation against those specifications.
- Animal Testing: Ground truth for safety was established by gross necropsy and histopathology performed by veterinary professionals (implied, though not explicitly stated as "experts"). Ground truth for performance was based on direct observation during the procedure and subsequent evaluation/ranking by the study team.
8. The Sample Size for the Training Set
This document describes a 510(k) submission for a medical device (atherectomy catheter with OCT imaging). It is not an AI/Machine Learning submission where a training set of data for an algorithm would be used in the conventional sense. The "Software Verification and Validation Testing" refers to the Lightbox component's software, but this typically involves testing the software against functional requirements and software design specifications, not training an AI model with a data set. Therefore, a "training set" as understood in AI systems is not applicable to this submission.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, a "training set" for an AI model is not applicable to this submission. The "ground truth" for the device's functional software would be its adherence to documented software requirements and design specifications, established through V&V activities.
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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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(97 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, 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 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 comes in both a 7Fr and an 8Fr size. Both sizes have a working length of 110 cm and are sterile, single-use devices that are compatible with 7 and 8F sheaths (respectively) 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 provided document is a 510(k) Summary for the Pantheris System, which describes modifications to an already cleared device. This submission focuses on demonstrating that these modifications do not impact the safety and effectiveness of the device compared to its predicate. Therefore, the "acceptance criteria" and "device performance" primarily revolve around showing equivalence to the predicate and passing various safety and performance tests.
Here's the information extracted and organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | No changes in patient-contacting materials; accessories (tweezers) without direct patient contact must pass: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity. | Patient-contacting materials unchanged. Stainless steel tweezers (accessory) passed Cytotoxicity, Sensitization, Irritation, and Systemic Toxicity tests. |
| Electrical Safety | Compliance with IEC 60601-1 standard for safety. | Complies with IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 standard for EMC. | Complies with IEC 60601-1-2. |
| Software | Verification and validation testing, including regression testing, conducted per FDA Guidance for Medical Device Software (Moderate Level of Concern). | Software V&V and regression testing conducted, documentation provided per FDA guidance. Device software determined to be "moderate" level of concern. |
| Mechanical Testing | Device modifications must not negatively impact mechanical performance. Tests include: Sheath insertion cycle, Destructive balloon burst, Torque capacity, Leak evaluation, Bond joint tensile strength, Life-cycle tests (8-month accelerated shelf life, simulated use), Corrosion, Heat generation, Rotational speed, Dimensional verification, Balloon inflation/deflation cycle, Plaque removal efficiency, Flushing tool capacity. | All listed mechanical tests were performed. (Specific pass/fail results for each test are not detailed in the summary, but the conclusion states "these modifications do not impact the safety and effectiveness"). |
| Plaque Removal Efficiency | Maintain equivalent plaque removal efficiency to the predicate device. | Testing for "Plaque removal efficiency" was performed. |
| Clinical Equivalence | The modifications should not raise new questions of safety and effectiveness, maintaining substantial equivalence to the predicate (K163264). | "The information submitted... confirms that the minor modifications... raise no new questions of safety and effectiveness and that the device is substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each mechanical or biocompatibility test. It mentions that "Testing was performed to demonstrate that these changes do not impact the safety and effectiveness of the final device."
- Test Set Sample Sizes: Not explicitly stated for each test.
- Data Provenance: The studies are described as "Performance Data" from various tests (Biocompatibility, Electrical Safety, EMC, Software, Mechanical). These are laboratory-based, non-clinical tests conducted by the manufacturer to demonstrate compliance with standards and equivalence. There is no mention of country of origin for the data or if it's retrospective or prospective, as these are device performance tests, not clinical studies on patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable (N/A) to this 510(k) submission. The submission describes a device with mechanical, electrical, and software components, not an AI or diagnostic application requiring expert review for ground truth in a test set. The performance tests (e.g., destructive balloon burst, torque capacity) rely on engineering specifications and physical measurements, not expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable (N/A) for the reasons stated above. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers interpreting medical data, not for engineering performance tests of a physical device.
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, an MRMC comparative effectiveness study was not done, and this type of study is not applicable (N/A) to this 510(k) submission. This submission is for modifications to an atherectomy system that includes OCT imaging as an adjunctive visualization tool, not an AI-powered diagnostic system requiring human reader performance evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable (N/A). While the device contains software and OCT imaging, it is an interventional atherectomy system. The OCT provides real-time, surgeon-guided visualization, it's not a standalone diagnostic algorithm that would typically undergo "algorithm-only" performance testing in the context of a 510(k) for an AI device. The software update specifically mentioned is an attenuation of the laser when the drive is not rotating, a safety feature, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed is based on engineering specifications, established physical properties, and compliance with recognized standards. For example:
- Biocompatibility: Adherence to ISO standards for material compatibility.
- Electrical/EMC Safety: Compliance with IEC standards (e.g., IEC 60601-1).
- Mechanical Testing: Meeting specified tensile strengths, torque capacities, leak rates, burst pressures, cycle counts, dimensional accuracies, and plaque removal efficiency based on defined test methods.
- Software Validation: Successful execution of test cases against documented requirements and expected outcomes.
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these device modification performance tests.
8. The Sample Size for the Training Set
This information is not applicable (N/A) as the device functionality described does not involve a "training set" in the context of machine learning or AI algorithms requiring such a dataset. The software update mentioned is a safety feature for laser attenuation, not a complex algorithm dependent on a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable (N/A) for the same reason as point 8.
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(30 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 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 (cleared under K162326) 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 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 PC-based 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. This Special 510(k) introduces an optional vessel measurement feature to the Pantheris System software in the Lightbox HS Imaging Console.
This document is a 510(k) premarket notification for a medical device called the Pantheris System, specifically focusing on a software modification that introduces an optional vessel measurement feature. It's important to note that this document is not a clinical study report but rather a regulatory submission demonstrating substantial equivalence to a previously cleared device. Therefore, it does not contain extensive clinical trial data or detailed performance metrics as one might find in a full clinical study publication. However, it does discuss verification and accuracy testing for the new feature.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "the accuracy of the measurement feature was assessed and found to be within the specified acceptance criteria." However, it does not explicitly list the acceptance criteria or the specific reported device performance values for the measurement feature. It only broadly states they were met.
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "software verification and measurement accuracy testing." This testing appears to be non-clinical in nature, as stated in the section "Non-Clinical Test Data." It does not mention a specific test set of patient data, but rather testing of the software's ability to measure simulated or in-vitro data. There is no information provided on the sample size for this test set, nor on data provenance (country of origin, retrospective/prospective), as it's not a clinical study involving patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Given that the testing was described as "non-clinical" and focused on software verification and measurement accuracy, it's highly unlikely that human experts were used to establish ground truth in the traditional sense of clinical image interpretation. The ground truth would likely be established by known physical dimensions in simulated or in-vitro models. Therefore, this information is not applicable in the context of this document.
4. Adjudication Method for the Test Set:
As no human experts or patient data are described for the test set, an adjudication method is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
The document does not describe an MRMC comparative effectiveness study, nor does it mention any human reader performance or improvements with AI assistance. The modification is described as providing "an optional confirmation of their initial vessel diameter/size assessment" and "additional information." It's not presented as an AI-powered diagnostic tool that directly aids human readers in their primary diagnosis.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The document describes "measurement accuracy testing" for the new vessel measurement feature as part of "software verification." This implies a standalone performance evaluation of the algorithm's measurement accuracy against known values (ground truth) in a non-clinical setting. The results are summarized as "found to be within the specified acceptance criteria," though the criteria and specific numbers are not provided.
7. The Type of Ground Truth Used:
For the "measurement accuracy testing," the ground truth would have been established by known physical dimensions or precisely measured values in the non-clinical test environment (e.g., phantoms, simulated vessels, or in-vitro models). The document doesn't explicitly state the type of ground truth but implies it's a quantitative comparison to a known standard.
8. The Sample Size for the Training Set:
This document describes a software modification to an existing device, not a new algorithm developed from scratch. Therefore, it does not provide information on a training set sample size. The focus is on verifying and validating the new feature's performance, not on a machine learning model's training process.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set, there is no information on how its ground truth would have been established.
In summary:
This 510(k) submission addresses a minor software modification (addition of a vessel measurement feature) to an already cleared device. The "study" described is a non-clinical software verification and measurement accuracy testing. It demonstrates that the new feature meets its internal specifications and acceptance criteria, without raising new safety or effectiveness concerns. It is not a clinical trial and thus lacks the detailed clinical performance metrics (e.g., sensitivity, specificity, reader performance) typically associated with such studies.
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(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."
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