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.

Device Description

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.

AI/ML Overview

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:

Acceptance Criterion (Inferred from Test Goals)	Reported Device Performance (Implied)
Sufficient removal of physical soil after cleaning	Cleaning operation was validated with a high degree of confidence by objectively demonstrating removal of all physical soil.
Functional performance maintained after reprocessing	Performance validation studies demonstrated the reprocessed catheters maintained form, fit, and function.
Dimensional integrity maintained	Demonstrated (successful completion of bench and laboratory testing).
Mechanical integrity maintained	Demonstrated (successful completion of bench and laboratory testing).
Electrical integrity maintained	Demonstrated (successful completion of bench and laboratory testing).
Electrical safety maintained	Demonstrated (successful completion of bench and laboratory testing).
Hydrophilic coating integrity maintained	Demonstrated (successful completion of bench and laboratory testing).
Acoustic output maintained	Demonstrated (successful completion of bench and laboratory testing).
Image quality maintained	Demonstrated (successful completion of bench and laboratory testing).
System compatibility maintained	Demonstrated (successful completion of bench and laboratory testing).
Sterility achieved and maintained	Sterilization Validation was successfully completed.
Endotoxin levels within acceptable limits	Endotoxin Test Method Validation was successfully completed.
Biocompatibility maintained	Biocompatibility testing was successfully completed.
Packaging integrity maintained	Packaging Validation was successfully completed.

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.

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.
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.
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.
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.
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.
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.
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.
The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI model.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 6, 2023

Vein 360 LLC Suzanne Meyer CEO 4460 Lake Forest Dr Suite 230 Blue Ash, Ohio 45242-3741

Re: K230584

Trade/Device Name: Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: OWO Dated: May 11, 2023 Received: May 12, 2023

Dear Suzanne Meyer:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Aneesh S. Deoras -S

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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K230584 - Suzanne Meyer

The reprocessed devices included in the scope of the submission are as follows:

Description	ItemNumber	French Size	Guide Wire	MinimumSheath	Length (cm)
Vein360 ReprocessedVisions PV .035 DigitalIVUS Catheter	88901	7	0.035"-0.038"	8.5 F	90

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Indications for Use

510(k) Number (if known) K230584

Device Name

Vein360 Reprocessed Visions PV .035 Digital IVUS Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/2 description: The image shows the logo for Vein 360. The word "VEIN" is written in large, bold, black letters at the top of the logo. Below "VEIN" is the number "360" in a similar font. A curved arrow wraps around the number 360. The arrow starts in blue on the left side and transitions to teal on the right side.

Date of Preparation: March 1st, 2023

Company Name / Contact:

Company:	Vein360, LLC
	4460 Lake Forest Drive
	Suite 230
	Blue Ash, OH 45242

Contact: Suzanne Meyer CEO Phone: (513) 554-1300

Device Identification:

Proprietary Name:	Vein360 Reprocessed Visions PV .035Digital IVUS Catheter
Common Name:	Diagnostic Intravascular Catheter
Classification Reference:	21 CFR 870.1200
Classification Panel:	Cardiovascular
Device Product Code:	OWQ
Regulatory Class:	Class II

Predicate Devices:

Predicate Device Trade Name	ReferenceNumber	Predicate510(k)
Visions® PV .035 Digital IVUS Catheter	88901	K153094

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SECTION 5: 510(k) SUMMARY

Device Description:

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 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.

Description	ReferenceNumber	FrenchSize	Guidewire	MinimumSheath	WorkingLength
Vein360 ReprocessedVisions PV .035 DigitalIVUS Catheter	88901	7	0.035" — 0.038"	8.5 F	90 cm

The scope of this submission is as follows:

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Indications for Use:

Substantial Equivalence Information:

The Vein360 Reprocessed Visions PV .035 Digital IVUS catheter is substantially equivalent to the new, unused device of the same product currently marketed by the device's original equipment manufacturer (OEM) and described herein with respect to intended use, design, materials, performance, and function. As a reprocessed SUD, there are no changes to the clinical applications, patient population, or method of operation.

Vein360 Reprocessed Visions PV .035 Digital IVUS Catheter
Feature	Predicate Device	Subject Device
Hydrophilic Coating Length	30cm	Identical
Working Length	90cm	Identical
Working Length Diameter	7.0 F	Identical
Transducer Diameter	8.2 F	Identical
Guidewire Compatibility	0.035" (0.89mm) - 0.038"(0.97mm)	Identical
Sterilization Method	Ethylene Oxide (EO) gas	Identical
Markers	Inked and RO markers spaced1cm apart along the shaft	Identical
Shelf Life	2 years	13 months
Uses	Single patient use	Identical
Accessories	None	Identical

Performance Data:

With respect to SUD reprocessing, comprehensive cleaning validation studies were performed ensuring Visions PV .035 Digital IVUS catheters were clinically used and then soiled with artificial test soil. The cleaning operation was validated with a high degree of confidence by objectively demonstrating removal of all physical soil under minimum operating conditions. The body of this submission includes all data related to the cleaning process and validation.

Performance validation studies were performed after ensuring Visions PV .035 Digital IVUS catheters were clinically used and then soiled with artificial test soils. The cleaning process was conducted using maximum operating conditions in order to challenge functional performance of the device. Electro-mechanical performance

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SECTION 5: 510(k) SUMMARY

testing was performed to demonstrate that the reprocessing operations did not adversely affect the predicate device's form, fit, or function.

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. Substantial equivalence determination was concluded through successful completion of bench and laboratory testing, which included:

Cleaning Validation ●
Drying Validation ●
Sterilization Validation ●
Endotoxin Test Method Validation
Biocompatibility ●
Performance Validation ●
- Simulated Use o
- Dimensional Integrity o
- Mechanical integrity O
- Electrical Integrity о
- Electrical Safety о
- Hydrophilic Coating Integrity O
- Acoustic Output o
- Image Quality O
- System Compatibility o
Packaging Validation

The Vein360 Reprocessed Visions PV .035 Digital IVUS catheter is validated for one reprocessing cycle after successful completion of the above performance testing. All Vein360 Reprocessed Visions PV .035 Digital IVUS catheters are permanently marked and tracked via OEM label during reprocessing. Vein360 Reprocessed Visions PV .035 Digital IVUS catheters are taken out of service and rejected from further reprocessing once the maximum number of cycles have been reached. Further, Vein360 restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.

Conclusion:

Vein360 concludes the Vein360 Reprocessed Visions PV .035 Digital IVUS catheter is as safe, as effective, and performs as well as or better than the predicate device.

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).