Search Results

The Vein360 Reprocessed Visions PV .035 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The Vein360 Reprocessed Visions PV .035 Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

The Vein360 Reprocessed Visions PV .035 Digital IVUS catheter is a reprocessed single use device. After clinical use of the Visions PV .035 Digital IVUS Catheter (Manufactured by Philips), the IVUS catheter is shipped to Vein360 per established Vein360 instructions. Upon receipt, the Visions PV .035 Digital IVUS catheter is cleaned, inspected, functionally tested, hydrophilic coated, packaged and sterilized using ethylene oxide (EO) gas.

The Vein360 Reprocessed Visions PV .035 Digital IVUS catheter is an over-thewire intravascular imaging catheter containing an ultrasound transducer located at the distal end of the catheter. This transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels.

The catheter is introduced percutaneously or via surgical cutdown into the peripheral vasculature. The catheter is designed to track over a maximum guidewire of 0.038" (0.97mm).

The catheter is 90cm in working length with 1cm inked markers (non-radiopaque) along the proximal shaft for length assessments during pull back. There are 25 radiopaque markers spaced 1cm apart along the distal shaft for quick length measurements under angiogram imaging. A hydrophilic coating is applied externally to the distal end of the catheter. The Vein360 Reprocessed Visions PV .035 Digital IVUS catheter maintains all mechanical and electrical properties of the predicate device after reprocessing operations.

The Vein360 Reprocessed Visions PV .035 Digital IVUS catheter may only be used with Volcano s5 Series and CORE Series imaging systems.

The Vein360 Reprocessed Visions PV.035 Digital IVUS catheter is not supplied with any accessories.

The Visions PV .035 Digital IVUS catheter can only be reprocessed once. All Vein360 Reprocessed Visions PV .035 Digital IVUS catheters are permanently marked to indicate it has been reprocessed.

The provided text describes the 510(k) summary for the Vein360 Reprocessed Visions PV .035 Digital IVUS Catheter. This device is a reprocessed single-use device, meaning it is an original device that has been cleaned, inspected, functionally tested, repackaged, and sterilized for re-use. The performance data presented focuses on demonstrating that the reprocessed device is substantially equivalent to the new, unused predicate device.

Here's an analysis based on your request, highlighting what is available and what is not in the provided document:

Acceptance Criteria and Reported Device Performance

The document doesn't provide a direct table of specific numerical acceptance criteria for various performance metrics alongside the reported results. Instead, it states that "Results of performance testing demonstrate the Vein360 Reprocessed Visions PV .035 Digital IVUS catheters are substantially equivalent to the predicate devices which are safe and effective for their intended use."

The types of tests performed indicate the areas where performance was assessed, and the conclusion of substantial equivalence implies that the reprocessed device met the necessary criteria in all these areas.

Inferred Acceptance Criteria (Implied by the tests performed) and Implied Performance:

Important Note: The document confirms that "The Vein360 Reprocessed Visions PV .035 Digital IVUS catheter is validated for one reprocessing cycle after successful completion of the above performance testing."

Study Information:

The provided document describes a bench and laboratory testing study (performance validation) to demonstrate substantial equivalence, rather than a clinical study involving human patients or a reader study typically associated with AI/CADe devices.

1. A table of acceptance criteria and the reported device performance:
   As detailed above, the document implies that acceptance criteria were met for various functional and material properties, but does not provide a specific table with numerical thresholds. The standard for a reprocessed device is typically that it performs "as well as or better than" the predicate device and that reprocessing does not adversely affect its performance, safety, or effectiveness.

2. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The document mentions that "Visions PV .035 Digital IVUS catheters were clinically used and then soiled with artificial test soil" for cleaning validation and performance validation. The exact number of catheters used for these tests is not provided.
   • Data Provenance: The studies are laboratory and bench tests on reprocessed devices, some of which were "clinically used" prior to reprocessing. The country of origin of this clinical use data (if it informs the "soiling" step) is not specified. The studies are by nature retrospective in terms of using already-used devices and then testing them.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This question is not applicable in the context of this device and study. The "ground truth" here is the performance of the predicate device (a new, unused IVUS catheter) and established engineering/performance standards for mechanical, electrical, and imaging properties. Experts would be involved in setting these standards and interpreting test results, but likely not in the typical "ground truth" establishment for image interpretation as seen in AI/CADe devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. Adjudication methods are typically used in reader studies for diagnostic devices to resolve discrepancies in expert interpretations. This submission focuses on the physical and functional properties of a reprocessed medical 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. This type of study is specifically relevant to AI/CADe devices that assist human readers in diagnosis. The Vein360 Reprocessed Visions PV .035 Digital IVUS Catheter is an imaging catheter itself, not an AI diagnostic aid.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is not an algorithm or AI device. The "performance" described is the catheter's ability to mechanically and electrically function to produce images, and the quality of those images.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The "ground truth" is primarily based on established engineering specifications and performance benchmarks of the original predicate device (Visions PV .035 Digital IVUS Catheter) and relevant industry standards for safety and performance of reprocessed medical devices. This includes:

   • Absence of residual soil/bioburden.
   • Dimensional accuracy.
   • Mechanical strength and flexibility.
   • Electrical signal integrity.
   • Image quality metrics (though specific metrics are not detailed).
   • Sterility.
   • Biocompatibility.

8. The sample size for the training set:
   Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:
   Not applicable, as there is no training set for an AI model.

Ask a specific question about this device

The Reprocessed Visions PV .035 catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The Visions PV .035 ultrasound imaging catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

The Reprocessed Visions PV .035 catheter is an over-the-wire intravascular imaging catheter with a digital ultrasound transducer at the distal end. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels.

The catheter is introduced percutaneously or via surgical cutdown into the vascular system, and it is designed to track over 0.035"-.038" (0.89-0.97mm) guide wires.

The catheter has body markers 1 cm apart along the working length. There are 25 radiopaque markers on the distal end of the catheter, starting 1cm from the imaging plane, with the 25th RO marker overlapping the distal most wide inked marker. Inked markers (non-radiopaque) continue along the shaft, spaced 1 cm apart, middle-to-middle, with wider marks indicating 5 cm intervals.

The Visions PV .035 catheters may only be used with Volcano s5 Series and CORE Series of Systems.

A hydrophilic coating is applied externally to a distal portion of the catheter.

This document is not a study that proves a device meets acceptance criteria, but rather a 510(k) Premarket Notification by Innovative Health, LLC for a reprocessed medical device, the Reprocessed Visions PV .035 Digital IVUS Catheter.

In the context of reprocessed devices, the primary goal of the 510(k) submission is to demonstrate substantial equivalence to a predicate (new) device, not to showcase novel performance or "AI" capabilities. The "acceptance criteria" here are largely related to demonstrating that the reprocessed device performs as safely and effectively as the original, new device, and that the reprocessing process itself is robust.

Therefore, many of the requested points regarding AI, MRMC studies, specific performance metrics, and training data are not applicable to this type of submission.

Here's an analysis based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" with numerical performance results in the way a new device with novel functionality might. Instead, it demonstrates substantial equivalence by confirming that the reprocessed device maintains the same functional and safety characteristics as the predicate device after reprocessing.

The "acceptance criteria" for this device would broadly be:

• Biocompatibility identical to the new device.
• Cleaning effectiveness to remove contaminants.
• Sterilization effectiveness.
• Functional performance (visual, dimensional, simulated use) equivalent to the new device.
• Mechanical characteristics equivalent to the new device.
• Hydrophilic coating integrity maintained.
• System compatibility with existing Volcano systems.
• Packaging integrity maintained.

The "reported device performance" is the successful completion of these tests, leading to the conclusion of substantial equivalence.

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

The document states: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Visions PV .035 Catheter."

• Sample Size: The specific number of reprocessed catheters used for each type of testing (biocompatibility, cleaning, sterilization, functional, mechanical, packaging) is not specified in the provided text.
• Data Provenance: The testing was conducted in a "bench and laboratory" setting, indicating controlled laboratory conditions rather than patient data. The country of origin is not specified but implicitly within the US, given the FDA submission. This is prospective testing of reprocessed devices.

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)

This question is not applicable to this submission. The "ground truth" for a reprocessed device like this is the performance and safety profile of the original, new device, and the successful validation of the reprocessing steps to ensure equivalence. This doesn't involve expert readers or diagnostic accuracy assessments in the traditional sense. The evaluations are primarily engineering and scientific tests.

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

This question is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or diagnostic decisions, and not in the bench/laboratory testing described for this reprocessed 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

This question is not applicable. This device is an Intravascular Ultrasound (IVUS) catheter, a imaging tool, and the submission is for a reprocessed version of it. It does not involve Artificial Intelligence (AI) or human-in-the-loop performance improvement.

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

This question is not applicable. The device does not contain an algorithm or AI for standalone performance assessment. It's a hardware medical device.

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

The "ground truth" for this reprocessed device is established by demonstrating that its performance and safety characteristics after reprocessing are equivalent to those of the predicate (new) device. This is assessed through:

• Physical and chemical testing: Biocompatibility, material integrity, cleaning efficacy.
• Functional testing: Visual inspection, dimensional verification, simulated use (e.g., tracking over guide wires), mechanical characteristics (e.g., tensile strength, kink resistance), hydrophilic coating performance.
• Sterilization validation: Ensuring sterility assurance level.

There is no "expert consensus" on diagnostic findings, pathology, or outcomes data involved in this specific submission for substantial equivalence of a reprocessed device.

8. The sample size for the training set

This question is not applicable. This device is a reprocessed physical medical device, not an AI/machine learning algorithm. Therefore, there is no training set in the computational sense.

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

This question is not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The Visions® PV .035 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.

The Visions® PV .035 Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

The Visions® PV .035 Digital IVUS Catheter is an over-the-wire intravascular imaging catheter with a digital ultrasound transducer at the distal end. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels.

The Visions® PV .035 Digital IVUS Catheter is introduced percutaneously or via surgical cutdown into the vascular system, and is designed to track over 0.035"-0.038" (0.89-0.97mm) guide wires.

The catheter body has markers 1 cm apart along the working length. There are 25 radiopaque (RO) markers on the distal end of the catheter, starting 1 cm from the imaging plane, with the 25th RO marker overlapping the distal-most wide inked marker. Inked markers (non-radiopaque) continue along the shaft, spaced 1 cm apart, middle-to-middle, with wider marks indicating 5 cm intervals.

A lubricious hydrophilic coating is applied externally to a distal portion of the catheter. The Visions® PV .035 Digital IVUS Catheter, catalog number 88901, may only be used with the In-Vision Imaging System, Volcano s5" Series and CORE " Series of Systems. This catheter will not operate if connected to any other imaging system.

Based on the provided text, the device in question is the Volcano Visions® PV .035 Digital IVUS Catheter.
However, the document states that "Volcano Corporation made minor revisions to the instructions for use for the Visions® PV.035 Digital IVUS Catheter. These edits include revisions to contraindication section and other editorial changes to improve and streamline the overall IFU. There is no change to the current device design, specifications, indications, and/or any other characteristics."

Therefore, the provided document does not contain information about studies to prove acceptance criteria for a new device or a modified device with changes to design or specifications. Instead, it refers to a literature search conducted to support minor modifications to the contraindication sections, implying that the device's fundamental performance characteristics were already established by a previous submission (K121273 - the predicate device).

Given this, I cannot fully complete all sections of your request as the information is not present in the provided text. I will address the parts that can be inferred or explicitly stated.

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

The document explicitly states: "There is no change to the current device design, specifications, indications, and/or any other characteristics." This indicates that the performance criteria and reported performance remain the same as the predicate device (Visions® PV .035 Digital IVUS Catheter, K121273). The current submission focuses on minor revisions to the instructions for use, specifically contraindications. Therefore, no new performance data or acceptance criteria related to device function are presented.

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. No new test set data was generated or submitted for device performance as there were no changes to device design or specifications. A "literature search was carried out to support minor modifications to the contraindication sections," but details on sample size or provenance of that literature are not provided.

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. No new test set requiring ground truth establishment was conducted for device performance. The literature search was used to evaluate contraindications, but details on expert involvement or qualifications are not given.

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

Not applicable. No new test set requiring adjudication was conducted for device performance.

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. The device is a diagnostic intravascular catheter, not an AI-assisted interpretation device. No MRMC studies or AI assistance are mentioned.

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

Not applicable. The device is a diagnostic intravascular catheter; it is used by a human operator and does not operate as a standalone algorithm for diagnosis.

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

Not applicable for device performance validation in this submission. The literature search supported modifications to contraindications, implying a review of existing medical knowledge, potentially including outcomes data or expert opinions from published studies, but this is not a "ground truth" for a new performance study.

8. The sample size for the training set

Not applicable. No new training set for an algorithm was used or described.

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

Not applicable. No new training set for an algorithm was used or described.

Ask a specific question about this device