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The Pathway PVTM Atherectomy System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Pathway PV Atherectomy System is an atherectomy catheter system designed with an expandable cutting tip for use in debulking and treating vascular disease in the peripheral vasculature. Separate lumens within the Catheter allow for continuous aspiration and infusion during device use. Excised tissue, thrombus, and fluid are aspirated from the peripheral treatment site through ports in the Catheter tip to a collection bag located on the Console. The distal portion of the Catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure.

The Pathway PV Atherectorny System consists of two primary components: (1) a Catheter and Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows:

• Catheter and Control Pod: A sterile, single-use unit consisting of an electrically . driven Catheter and Control Pod. The Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities. The Control Pod provides a user interface with keypad controls. The unit, its electrical connectors, tubing, and aspirant collection bag are packaged in a double-pouched tray.
• A reusable compact Console, with two (2) peristaltic pumps for . Console: aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.

This 510(k) is for the same device with modifications to the Console to add a check of the Control Pod's parameter settings at the time of device use.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary (K082664) for the Jetstream™ Pathway PVT™ Atherectomy System does not contain explicit acceptance criteria or details of a study proving the device meets specific performance criteria in the way you might expect for an AI/algorithm-based device.

Instead, this 510(k) is for a modification to an existing, already cleared device (K081328, K082186). The primary claim for this submission is substantial equivalence to the predicate device.

The document states:

• "This 510(k) is for the same device with modifications to the Console to add a check of the Control Pod's parameter settings at the time of device use."
• "The Pathway PV Atherectomy System is substantially equivalent to the specified predicate device. The device has the identical indications for use and the same technological characteristics. Bench testing was completed and provided to support the safety and effectiveness of the modifications that were the subject of this 510(k) for the Pathway PV Atherectomy System."

This indicates that the "study" was focused on demonstrating the safety and effectiveness of the modification (the Console's parameter check) through bench testing, rather than a full-scale clinical performance study with predefined acceptance criteria for a new device.

Therefore, for many of your requested points, the answer is that the information is not applicable or not provided in this type of 510(k) submission, which focuses on substantial equivalence for a physical device modification.

Detailed Breakdown of Requested Information:

1. A table of acceptance criteria and the reported device performance

   • Not provided. The document does not list quantitative acceptance criteria or specific performance metrics. The "performance" demonstrated was that the modified console's parameter check maintained the safety and effectiveness established by the predicate device through bench testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable / Not provided. Since the study involved bench testing for a physical modification, there isn't a "test set" of patient data in the typical sense for algorithms.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable / Not provided. Ground truth, in the context of expert review of images or clinical outcomes, is not relevant for this type of bench testing study for a physical device modification.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. See point 3.

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. This device is a physical atherectomy system, not an AI/algorithm for image analysis or diagnosis. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • No. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not applicable / Not provided. For the bench testing mentioned, "ground truth" would likely relate to engineering specifications, mechanical performance, or functional checks, rather than clinical ground truth types. The document only states "Bench testing was completed and provided to support the safety and effectiveness of the modifications."

8. The sample size for the training set

   • Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

   • Not applicable. See point 8.

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The Pathway PVTM Atherectomy System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Pathway PV Atherectomy System is an atherectomy catheter system designed with an expandable cutting tip for use in debulking and treating vascular disease in the peripheral vasculature. Separate lumens within the Catheter allow for continuous aspiration and infusion during device use. Excised tissue, thrombus, and fluid are aspirated from the peripheral treatment site through ports in the Catheter tip to a collection bag located on the Console. The distal portion of the Catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure. The Pathway PV Atherectomy System consists of two primary components: (I) a Catheter and Control Pod and (2) a Console, which are packaged separately.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study information:

Analysis of Acceptance Criteria and Study Information for Pathway PV Atherectomy System (K082186)

The provided 510(k) summary for the Pathway PV Atherectomy System (K082186) focuses on demonstrating substantial equivalence to a predicate device after modifications to improve manufacturability, ergonomics, and ease of use. It explicitly states that the device has "identical indications for use and the same technological characteristics" as its predicate.

Crucially, this 510(k) summary does not detail specific acceptance criteria for performance, nor does it describe a clinical study or a standalone algorithm performance study with a test set, ground truth, or expert involvement. The documentation primarily relies on bench and laboratory testing to support the safety and effectiveness of the modifications to the device.

Therefore, many of the requested details regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment are not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document.

The document states: "Bench and laboratory testing was completed and provided to support the safety and effectiveness of the modifications that were the subject of this 510(k) for the Pathway PV Atherectomy System." However, it does not specify what parameters were tested, what the acceptance criteria for those tests were, or the quantitative results of those tests. These details would typically be found in the comprehensive testing reports submitted to the FDA, but they are not part of this summary.

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

Not available concerning clinical data or a test set for performance assessment.

The "bench and laboratory testing" mentioned would have involved a certain number of test units or trials, but the sample sizes for these engineering tests are not disclosed. There is no mention of a clinical "test set" in terms of patient data.

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

Not applicable/available.

Since there is no described clinical "test set" and no ground truth establishment process involving expert review for performance, this information is not provided. The 510(k) pathway for this device focused on demonstrating equivalence through engineering modifications, not on a new clinical efficacy study.

4. Adjudication Method for the Test Set

Not applicable/available.

No test set for performance requiring adjudication is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done.

This type of study is relevant for diagnostic imaging AI devices, comparing human performance with and without AI assistance. The Pathway PV Atherectomy System is a mechanical atherectomy device, not a diagnostic AI system, so an MRMC study would not be applicable or expected.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done.

The device is an electromechanical system for atherectomy, not an AI algorithm. Therefore, "standalone" algorithm performance is not applicable.

7. The Type of Ground Truth Used

Not applicable/available.

Without a clinical or diagnostic performance study described, there is no mention of ground truth types (e.g., pathology, outcomes data, expert consensus). The "ground truth" for the engineering changes would have been the established performance specifications of the predicate device and relevant industry standards.

8. The Sample Size for the Training Set

Not applicable/available.

The device is not an AI/ML system that utilizes a training set in the conventional sense.

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

Not applicable/available.

As the device is not an AI/ML system, there is no training set or associated ground truth establishment process.

Summary Limitations:

The provided 510(k) summary is typical for a device with minor modifications where substantial equivalence is demonstrated primarily through engineering verification and validation (bench and lab testing) rather than new clinical trials. It confirms that the modifications did not alter the safety, effectiveness, or indications for use compared to the predicate device. Therefore, the detailed information requested about clinical acceptance criteria, expert reviews, and AI-specific study designs is not within the scope of this particular document.

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The Pathway PVTM Atherectomy System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Pathway PV Atherectomy System consists of two primary components: {1} a PV Catheter and Control Pod and (2) a PV Console, which are packaged separately. Each of these system components is described generally as follows:

• PV Catheter and Control Pod: A sterile, single-use unit consisting of an . electrically driven PV Catheter and Control Pod. The PV Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities. The Control Pod provides a user interface with keypad controls and LED indicators for device operational status. The unit, its electrical connectors, tubing. and aspirant collection bag are packaged in a double pouched tray.
• Console: A reusable compact PV Console, with two (2) peristaltic pumps for . aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The PV Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.
  The Pathway PV Atherectomy System is compatible with 8F sheaths and exchange length (300cm or longer) 0.014" diameter guidewires.

The provided text is a Fragmented 510(k) Summary. It includes general device information, predicate device comparison, and FDA's substantial equivalence letter for the Pathway PV™ Atherectomy System. However, it does not contain specific details about acceptance criteria or a study that proves the device meets such criteria.

The document states that "Performance testing of the Pathway PV Atherectomy System included in vitro performance, biocompatibility, packaging, sterilization, electrical/EMC, animal, and clinical study." but does not provide results for these studies or define specific acceptance criteria.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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