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The Vein360 Reprocessed Visions® PV .014P RX (85910P), Visions® PV.014P RX (014R), Eagle Eye Platinum RX, and Eagle Eve Platinum ST RX Digital IVUS catheters are all designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. These devices are not currently indicated for use in the cerebral vessels.

The Vein360 Reprocessed Visions® PV .014P RX (85910P), Visions® PV.014p RX (014R), Eagle Eye Platinum RX, and Eagle Eye Platinum ST RX RX Digital IVUS catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The subject devices are reprocessed single use devices. After clinical use of the predicate devices (Manufactured by Philips), the devices are shipped to Vein360 per established Vein360 instructions. Upon receipt, the subject devices are cleaned, inspected, hydrophilic coated, functionally tested, packaged, and sterilized using ethylene oxide (EO) gas.

The subject devices are rapid exchange intravascular imaging catheters 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 coronary and peripheral vessels.

The subject devices utilize an internal lumen that allows the catheter to track over the 0.014" (0.36mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The subject devices are introduced percutaneously or via surgical cutdown into the vascular system.

Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge, starting 10 mm from the proximal edge of the portion of the scanner marker tube normally visible under fluoroscopy.

The subject devices may only be used with Volcano s5 Series or CORE Series imaging systems.

The subject device is packaged with a flushing tool that is equivalent to the predicate and is used for flushing the device's lumen with heparinized normal saline.

The subject devices are reprocessed once and permanently marked to indicate it has been reprocessed by Vein360.

This document describes the Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (85910P, 014R), and Vein360 Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter, and Vein360 Reprocessed Eagle Eye Platinum ST RX Digital IVUS Catheter. This device is a reprocessed single-use intravascular imaging catheter.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" for each performance test in a quantitative manner. Instead, it states that "results of performance testing demonstrate the subject devices are substantially equivalent to the predicate devices which are safe and effective for their intended use." This implies that the acceptance criteria for each test was to match or not degrade from the performance of the original predicate devices.

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

The document does not explicitly state the sample sizes used for each specific test set. It mentions "subject devices were clinically used and then soiled with artificial test soil" for cleaning and performance validation. However, the number of devices, cases, or specific data points for these tests is not provided.

• Data Provenance: The devices are "reprocessed single use devices" that were "after clinical use of the predicate devices (Manufactured by Philips)". This indicates that the initial data (the predicate devices themselves) came from clinical use, and then the reprocessed devices were subjected to further testing. The geographical origin of the initial clinical use data is not specified, but the reprocessing company is based in the US (Ohio). The tests conducted are prospective in the sense that they are performed on reprocessed devices to demonstrate their continued performance.

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

The document does not mention the use of experts to establish ground truth for a test set. The evaluation seems to be focused on physical, electrical, and imaging characteristics compared to baseline (predicate device) performance, rather than an interpretation of medical images by human experts.

4. Adjudication Method:

Since no experts were mentioned for establishing ground truth, there is no adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is more common for AI-powered diagnostic tools where human interpretation is a key component. This submission relates to the reprocessing of physical medical devices.

6. Standalone (Algorithm Only) Performance:

No, a standalone (algorithm only) performance study was not done. This device is an IVUS catheter, a physical device that generates images, not an AI algorithm itself. The imaging system (Volcano s5 Series or CORE Series) has its own algorithms, but the study focuses on the reprocessed catheter's ability to produce comparable images.

7. Type of Ground Truth Used:

The ground truth used for assessing the reprocessed device's performance is the original performance and specifications of the predicate (unreprocessed) devices. The studies aimed to demonstrate that the reprocessed devices maintained "form, fit, or function" comparable to the new predicate devices. This includes:

• Physical measurements (dimensional integrity, mechanical integrity)
• Functional performance (simulated use, cross/re-cross, electrical integrity, acoustic output, image quality)
• Safety parameters (cleaning efficacy, sterility, endotoxin levels, biocompatibility, electrical safety)

For cleaning validation, the "ground truth" was the absence of physical soil, demonstrated objectively.

8. Sample Size for the Training Set:

This is not applicable as the device is a physical, reprocessed IVUS catheter, not an AI algorithm that requires a training set.

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

This is not applicable, as there is no mention of a training set for an AI algorithm.

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The NES Reprocessed Visions PV .014P RX Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The NES Reprocessed .014P RX 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.

The NES Reprocessed Visions PV .014P RX Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array. The array 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 coronary and peripheral vessels.

The NES Reprocessed Visions PV .014P RX Digital IVUS Catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 mm) guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The catheter is introduced percutaneously or via surgical cutdown into the vascular system.

Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge, starting 10 mm from the proximal edge of the scanner marker tube normally visible under fluoroscopy.

The VISIONS PV .014P catheter may only be used with the Volcano s5 Series or CORE Series of Systems Operator's Manual. This catheter will not operate if connected to any other imaging system.

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

This document is a 510(k) premarket notification for a reprocessed medical device, specifically an Intravascular Ultrasound (IVUS) Catheter. The primary objective of this submission is to demonstrate substantial equivalence to a predicate device, not to prove the device meets new acceptance criteria for a novel technology through a clinical study with AI components.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device or a device with new performance claims are not applicable to this specific 510(k) submission.

This submission focuses on demonstrating that the reprocessed device maintains the same safety and effectiveness as the original, new device (predicate device). The "proof" relies on bench and laboratory testing, not on a clinical effectiveness study with human readers or AI.

Here's a breakdown of the requested information and why most of it is not explicitly addressed in this 510(k) summary:

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

   • Acceptance Criteria: Not presented in a tabular format with specific numerical thresholds for clinical performance. The acceptance criteria for this reprocessed device revolve around demonstrating that its functional and safety characteristics are equivalent to the predicate device after reprocessing. This is shown through various tests of physical and functional integrity.
   • Reported Device Performance: The document states that "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the NES Reprocessed Visions PV .014P RX Digital IVUS Catheter." A list of tests is provided (e.g., Cleaning Validation, Sterilization Validation, Visual Inspection, Dimensional Verification, Simulated Use, Mechanical Characteristics, Hydrophilic Coating, System Compatibility, Drying Validation, Packaging Validation, Biocompatibility). However, the specific numerical results of these tests and their direct comparison to pre-defined numerical acceptance criteria are not detailed in this summary. The conclusion is that the reprocessed device is "as safe and effective" as the predicate based on these tests.

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

   • Sample Size: Not explicitly stated for each test. The testing involves reprocessed units of the IVUS catheter.
   • Data Provenance: Not applicable in the context of clinical data for performance evaluation. The data comes from internal lab testing conducted by Northeast Scientific, Inc. It is not clinical patient data, therefore, retrospective/prospective or country of origin of data is not relevant here.

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: This is not a study requiring expert readers to establish ground truth for clinical cases (e.g., image interpretation). The "ground truth" for this submission is established through validated engineering and biological testing methodologies (e.g., confirming sterility, dimensional accuracy, mechanical integrity).

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

   • Not Applicable: As above, this applies to studies with human readers interpreting data, which is not the nature of the testing described in this 510(k) summary.

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 is not a study assessing the effectiveness of an AI component or the improvement of human readers. This device is an IVUS catheter, an imaging tool; there is no mention of an associated AI component to assist readers.

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

   • Not Applicable: There is no algorithm or AI component discussed for standalone performance.

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

   • Ground Truth: The "ground truth" for this submission is derived from benchmarks and specifications of the original new device and validated test methods (e.g., sterility testing, dimensional measurements, mechanical force testing). The reprocessed device is tested to ensure it meets these established engineering and biological standards, demonstrating equivalence to the predicate.

8. The sample size for the training set:

   • Not Applicable: This is not a machine learning/AI device, so there is no "training set."

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

   • Not Applicable: No training set exists for this device.

In summary, for this particular 510(k) submission for a reprocessed IVUS catheter, the "acceptance criteria" and "proof" primarily revolve around demonstrating that the reprocessed device performs equivalently to the original, new device through a battery of non-clinical, benchtop, and laboratory tests. The summary provided does not contain the detailed numerical results or specific sample sizes for these tests, but merely lists the categories of testing performed to support the claim of substantial equivalence. The questions regarding AI, human readers, and clinical ground truth are not relevant to this type of device submission.

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The Visions® PV.014P RX Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in the cerebral vessels.

The Visions® PV.014P RX 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.

The PV . 014P RX Catheter incorporates a cylindrical ultrasound transducer array located near the distal tip of the Catheter. The array radiates acoustic energy into the surrounding tissue and detects the subsequent ultrasonic echoes. The information from the echoes is used to generate real-time images of the coronary or peripheral vessels.

The term RX has been added to the PV.014P Catheter to identify it as a rapid exchange catheter. The rapid exchange feature has not changed from the currently marketed PV.014P Catheter. Volcano is adding the term RX to the name to clearly identify the catheter as rapid exchange.

The PV . 014P RX Catheter utilizes an internal lumen that allows the catheter to track over a 0.014" (0.36 mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the Catheter tip. The device is introduced either percutaneously or via surgical cut down into the vascular system.

The PV . 014P RX Catheter may be used with the Volcano s5™. Volcano CORE Mobile, and Volcano CORE imaging systems. The device is designed to work with Volcano VH IVUS system software v1.2 or higher. This catheter will not operate if connected to any other imaging system.

The modified PV.014P Catheter (PV.014P RX) has a stiffer core to help improve device deliverability. The stiffer core wire provides increased "pushability" while maintaining the same trackability as the currently marketed PV.014P Catheter. In order to increase "pushability", the size of the core within the proximal shaft of the catheter was made with a larger OD. The proximal end was increased while keeping the distal end diameter the same. The modified PV.014P Catheter (PV.014P RX) with stiffer core utilizes the same current manufacturing processes, equipment and materials as the currently marketed device.

The provided document is a 510(k) summary for the Volcano Visions® PV.014P RX Digital IVUS Catheter. This device is an intravascular ultrasound (IVUS) catheter, which is a diagnostic tool used to visualize the internal structure of blood vessels.

The 510(k) in question is for a modification to an existing device (Visions® PV.014P Catheter) specifically, "The modified PV.014P Catheter (PV.014P RX) has a stiffer core to help improve device deliverability." Therefore, the "study" described is primarily focused on demonstrating that this modification does not negatively impact the safety or effectiveness of the device compared to the predicate device, rather than proving the device meets novel acceptance criteria for a new type of device.

Given this context, some of the requested information (like expert consensus for ground truth on images, MRMC studies, or training set details for an AI algorithm) are not applicable to this type of device modification submission. The "acceptance criteria" here are largely related to bench testing performance to ensure functional equivalence and safety.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing to ensure the modified device is substantially equivalent to the predicate. The "acceptance criteria" are implied by the successful completion of these tests and demonstrating no statistically significant difference or acceptable performance compared to known standards or product specifications.

2. Sample Size and Data Provenance

• Sample size used for the test set: Not explicitly stated for each test (Cross/Re-Cross, Insertion/Recovery, Buckling, Signal Processing). The language "The results demonstrated..." suggests sufficient testing was performed, but specific numbers are not provided in this summary.
• Data Provenance: The tests are non-clinical bench tests. The data is generated internally by the manufacturer (Volcano Corporation) in a controlled laboratory environment. The country of origin of the data is implied to be the US, where Volcano Corporation is based. The data is prospective, generated specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth

• Number of experts: Not applicable. For this type of device modification, the ground truth is established through physical measurements and comparisons against engineering specifications and the predicate device's performance, not human expert consensus on images.
• Qualifications of experts: Not applicable in the context of image interpretation. The "experts" would be the engineers and quality control personnel performing the bench tests.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. This is not a study involving subjective human interpretation that would require an adjudication process. It's a series of objective physical and performance measurements.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• MRMC study: No, an MRMC comparative effectiveness study was not conducted. This is not an AI-assisted diagnostic device where human reader performance is being evaluated. The device is purely a diagnostic imaging catheter whose modification impacts physical properties (stiffness, deliverability), not directly human diagnostic accuracy.

6. Standalone (Algorithm Only) Performance

• Standalone performance: Not applicable. This is not a software algorithm, but a physical medical device. The "performance data" refers to its mechanical and imaging capabilities.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this submission is based on:
  • Engineering specifications and standards: e.g., acceptable rigidity for buckling according to FDA guidance.
  • Bench test measurements: Direct quantitative measurements of forces, dimensions, and image characteristics.
  • Comparison to predicate device: The key "ground truth" is that the modified device's performance metrics are either statistically equivalent to the predicate or meet established safety thresholds.

8. Sample Size for the Training Set

• Training set size: Not applicable. This is not a machine learning or AI device that requires a training set.

9. How Ground Truth for the Training Set was Established

• Ground truth for training set: Not applicable (as above).

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