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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 Vein360 Reprocessed Visions PV .018 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 Vein360 Reprocessed Visions PV .018 Digital IVUS Catheter is designed for use as an adjunct to conventional anglographic procedures to provide an image of the vessel lumen and wall structures. The catheter is designed for use on adult patients (greater than 21 years of age).

The Vein360 Reprocessed Visions PV .018 Digital IVUS catheter (subject device) is a reprocessed single use device. After clinical use of the Visions PV .018 Digital IVUS Catheter (Manufactured by Philips), the IVUS catheter is shipped to Vein360 per established Vein360 instructions. Upon receipt, the subject device is cleaned, inspected, functionally tested, packaged and sterilized using ethylene oxide (EO) qas.

The subject device is an intravascular imaging catheter containing an ultrasound transducer located at the distal end of the catheter. This transducer utilizes a 64element 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 subject device utilizes an internal lumen that allows the catheter to track over the 0.018"(0.46mm) guide wire. The guide wire exits from the guide wire lumen approximately 31 cm proximal to the catheter tip. The subject device is introduced percutaneously or via surgical cutdown into the vascular system.

The catheter's working length is 135 cm and includes three (3) non-radiopaque positioning markers. The subject device maintains all mechanical and electrical properties of the predicate device after reprocessing operations.

The subject device may only be used with Volcano s5 Series, CORE, and IntraSight 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 device can only be reprocessed once and is permanently marked to indicate it has been reprocessed.

The provided documents describe the Vein360 Reprocessed Visions PV .018 Digital IVUS Catheter. This device is a reprocessed single-use device, and the submission's goal is to demonstrate its substantial equivalence to the original, unused version of the same product. The acceptance criteria and the study that proves the device meets these criteria are primarily focused on the reprocessing aspects and ensuring the reprocessed device performs identically to the new device.

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

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

The document details various validation studies and performance testing conducted to demonstrate that the reprocessed device maintains the same performance characteristics as the predicate device. The acceptance criteria essentially infer that the reprocessed device must pass these tests, demonstrating identical or equivalent performance to the predicate.

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

The document does not explicitly state the specific sample sizes for each test set. It mentions that "subject devices were clinically used and then soiled with artificial test soil" for cleaning validation and performance validation. This indicates a prospective approach for the testing, where devices were intentionally reprocessed and then tested. The country of origin of the data is not specified, but given the FDA submission, it implicitly aligns with U.S. regulatory standards.

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 section is not applicable as the evaluation of this medical device (a reprocessed IVUS catheter) is based on technical performance testing and validation, not on interpretations or diagnoses by medical experts to establish a "ground truth" for a diagnostic task. The "ground truth" here is the original specifications and performance of the new device.

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

This section is not applicable for the reasons stated above. Adjudication methods are typically used in clinical studies involving interpretation of medical images or data by multiple experts.

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 section is not applicable. The device is an Intravascular Ultrasound (IVUS) catheter, which is a diagnostic tool, not an AI-assisted diagnostic system. No MRMC study involving human readers and AI assistance was conducted or described in the provided text. The study focuses purely on the physical and functional performance of the reprocessed device compared to the original.

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

This section is not applicable. The device is a physical medical instrument, not an algorithm.

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

The 'ground truth' for this submission is the original design specifications and established performance characteristics of the new, unused predicate device (Visions® PV .018 Digital IVUS Catheter - K150442). The studies aimed to prove that the reprocessed device adheres to these same performance standards after reprocessing. This is evidenced by statements like: "Electro-mechanical performance testing was performed to demonstrate that the reprocessing operations did not adversely affect the predicate device's form, fit, or function."

8. The sample size for the training set

This section is not applicable. The evaluation of this device does not involve a "training set" in the context of machine learning or AI models. The testing described is for physical device validation.

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

This section is not applicable for the same reasons as point 8.

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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.

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