Search Results

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.

Ask a specific question about this device

The NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheters are 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 Eagle Eye Platinum 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 Eagle Eye Platinum 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 Eagle Eye Platinum 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 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 Eagle Eye 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.

The provided document describes the FDA 510(k) clearance for the NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter. The document details the device, its intended use, and the testing conducted to demonstrate substantial equivalence to predicate devices.

However, the information provided does not include acceptance criteria or a study directly proving the device meets specific performance metrics in terms of diagnostic accuracy or clinical effectiveness in the way a typical AI/ML medical device would. This is because the device described is an intravascular ultrasound (IVUS) catheter, which is a hardware device used to acquire images, not an algorithm that interprets images or makes diagnoses.

The "studies" mentioned are primarily bench and laboratory testing to demonstrate the functionality, safety, and effectiveness of the reprocessed catheter, ensuring it performs identically to a new, original catheter. These tests focus on aspects like cleaning, sterilization, mechanical characteristics, system compatibility, and biocompatibility, which are typical for reprocessed medical devices.

Therefore, many of the requested categories (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance of an algorithm, and training set details) are not applicable to this type of device and its regulatory submission.

Here's a breakdown based on the available information, with explanations for why certain categories are not present:

Acceptance Criteria and Device Performance (Based on available information)

Study Details and Data Provenance (Not Applicable in the typical sense for an AI/ML device)

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

   • Not applicable for diagnostic performance as an algorithm. The "test set" here refers to the actual reprocessed catheters undergoing quality control. The document does not specify exact numbers of catheters tested for each validation section, but states "bench and laboratory testing was conducted," implying a sufficient sample size for these validation types. Data provenance is internal to Northeast Scientific, Inc.'s reprocessing and testing procedures.

2. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. Ground truth for a diagnostic algorithm is not generally established in this context. The "ground truth" for these tests would be established by validated test methods, reference standards, and specifications (e.g., a specific tensile strength, a certain level of microbial reduction, or successful image acquisition when connected to a compatible system). These are typically verified by qualified engineers and technicians, not clinical experts for diagnostic accuracy.

3. Adjudication method for the test set:

   • Not applicable. Not a diagnostic study requiring expert adjudication. Test results are compared against predetermined specifications and validated methods.

4. 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 IVUS catheter, not an AI or imaging interpretation algorithm. Therefore, no MRMC study, AI assistance performance, or human reader improvement metric is relevant.

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

   • Not applicable. This is a hardware device; there is no standalone algorithm performance to evaluate.

6. The type of ground truth used:

   • The "ground truth" for the reprocessed catheter's performance is its functional equivalence to the original, new device and compliance with established performance specifications. This is demonstrated through various engineering, mechanical, material, and biological tests (e.g., cleaning efficacy, tensile strength, sterility, biocompatibility standards), not clinical diagnostic ground truth like pathology or outcomes data.

7. The sample size for the training set:

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

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

   • Not applicable. No training set is involved.

In summary: The submission for the NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter focuses on demonstrating that the reprocessed device is as safe and effective as the original predicate device through rigorous bench and laboratory testing. The criteria and studies are designed to prove manufacturing and functional equivalence of a reprocessed medical device, rather than the diagnostic interpretive performance of an AI/ML system.

Ask a specific question about this device

The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheters are 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 Reprocessed Eagle Eye Platinum RX Digitial 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 Reprocessed Eagle Eye Platinum 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 Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter utilizes an internal lumen that allows the catheter to track over the 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 catheter is introduced percutaneously or via surgical cut down 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 Eagle Eye Platinum RX Digital IVUS Catheters are exclusive use with Volcano s5 Series and CORE Series of Systems. 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 is a medical device submission, specifically a 510(k) premarket notification for a reprocessed intravascular ultrasound (IVUS) catheter. The document details the device, its intended use, and substantial equivalence to predicate devices. However, it does not contain detailed information about acceptance criteria for a study or the results of such a study proving the device meets those criteria in a way that allows for the extraction of the requested information regarding AI device performance, sample sizes, expert ground truth, adjudication methods, or MRMC studies.

The document focuses on demonstrating that the reprocessed device is substantially equivalent to legally marketed predicate devices, a requirement for 510(k) clearance. The testing mentioned in this document (biocompatibility, cleaning validation, sterilization validation, functional testing, etc.) are standard tests for reprocessed medical devices to ensure they are safe and effective after reprocessing, not necessarily a clinical study to evaluate diagnostic performance against a specific set of acceptance criteria for an AI algorithm.

Therefore, for most of your specific questions, the information is not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

Information Not Available in the Provided Text:

• A table of acceptance criteria and the reported device performance (in the context of an AI device or a diagnostic performance study): The document lists functional and safety testing for a reprocessed physical device, not an AI or diagnostic performance study with specific criteria like sensitivity, specificity, or AUC.
• Sample size used for the test set and the data provenance: Not applicable as no diagnostic performance study of an AI device is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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 an AI device submission.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable for a diagnostic performance study.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Information that can be partially inferred or is directly stated (though not in the context of an AI study):

• Device Name: Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
• Device Type: Intravascular Ultrasound (IVUS) Catheter (a physical medical device, not an AI algorithm)
• Purpose: Evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image.
• Testing Conducted (Functional and Safety, not diagnostic performance):
  • Biocompatibility
  • Cleaning Validation
  • Sterilization Validation
  • Functional testing (Visual Inspection, Dimensional Verification, Simulated Use, Mechanical Characteristics, Hydrophilic Coating, System Compatibility)
  • Drying Validation
  • Packaging Validation
• Conclusion from the document: Innovative Health concludes that the Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is as safe and effective as the predicate devices described herein, based on the functional and safety testing for a reprocessed device.

In summary, this document is a 510(k) submission for a reprocessed medical device (an IVUS catheter) and does not describe the evaluation of an AI-powered diagnostic device or a study with "acceptance criteria" in the sense of diagnostic performance metrics for an algorithm.

Ask a specific question about this device