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).

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria Category	Reported Device Performance (Summary)
Cleaning Validation	All physical soil removed under minimum operating conditions.
Drying Validation	Successful completion (implied to meet predefined standards for dryness).
Sterilization Validation	Successful completion (implied to achieve sterility assurance level).
Endotoxin Test Method Validation	Successful validation (implied to ensure no pyrogenic contaminants).
Biocompatibility	Successful completion (implied to meet biocompatibility standards for patient contact).
Performance Validation	All tests (Simulated Use, Dimensional Integrity, Mechanical Integrity, Electrical Integrity, Electrical Safety, Acoustic Output, Image Quality, System Compatibility) successfully completed. The reprocessed device demonstrated to be substantially equivalent to the predicate device in terms of form, fit, and function.
Packaging Validation	Successful completion (implied to ensure product integrity and sterility until use).
Reprocessing Cycle Limit	Validated for one reprocessing cycle. Devices taken out of service after maximum cycles or if reprocessed by others.

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.

Summary

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August 25, 2023

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

Re: K230928

Trade/Device Name: Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWO Dated: March 31, 2023 Received: April 3, 2023

Dear Suzanne Meyer:

We have reviewed your 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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PredicateItem Number	Vein360ltem Number	Guide Wire Compatibility	Imaging System Compatibility
86700	VEN-PV-018	0.018" (0.46mm)	Volcano s5, CORE, IntraSight Series

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Indications for Use

510(k) Number (if known) K230928

Device Name

Vein360 Reprocessed Visions PV .018 Digital IVUS Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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/1 description: The image shows the logo for Vein 360. The logo has the word "VEIN" on the top line, and the number "360" on the second line. There is a curved arrow that starts on the left side of the logo and goes around the number 360. The arrow is blue on the left side and transitions to green on the right side.

Date of Preparation: August 16, 2023

Company Name / Contact:

Company:	Vein360, LLC4460 Lake Forest DriveSuite 230Blue Ash, OH 45242
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Contact: Suzanne Meyer CEO Phone: (513) 554-1300

Device Identification:

Proprietary Name:	Vein360 Reprocessed Visions PV .018Digital IVUS Catheter
Common Name:	Diagnostic Intravascular Catheter
Classification Reference:	21 CFR 870.1200
Classification Panel:	Cardiovascular
Device Product Code:	OWQ
Regulatory Class:	Class II
510(k) Number:	K230928

Predicate Devices:

Predicate Device Trade Name	ReferenceNumber	Predicate510(k)
Visions® PV .018 Digital IVUS Catheter	86700	K150442

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510(k) SUMMARY

Device Description:

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 scope of this submission is as follows:

PredicateItem Number	Vein360Item Number	Guide Wire Compatibility	Imaging System Compatibility
86700	VEN-PV-018	0.018" (0.46mm)	Volcano s5, CORE, IntraSight Series

Indications for Use:

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510(k) SUMMARY

The Vein360 Reprocessed Visions PV .018 Digital IVUS Catheter is designed for use as an adjunct to conventional anqiographic procedures to provide an image of the vessel lumen and wall structures.

Substantial Equivalence Information:

The subject device 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 .018 Digital IVUS Catheter
Feature	Predicate Device (K150442)	Subject Device (K230928)
Working Length	135cm	Identical
Working Length Diameter	3.4 F	Identical
Transducer Diameter	3.5 F	Identical
Guidewire Compatibility	0.018"	Identical
Sterilization Method	Ethylene Oxide (EO) gas	Identical
Markers	3 non-radiopaque markers	Identical
Shelf Life	2 years	13 months
Uses	Single patient use	Identical
Accessories	Flushing tool	Equivalent

Performance Data:

With respect to SUD reprocessing, comprehensive cleaning validation studies were performed ensuring subject devices 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 subject devices 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 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 subject device is 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 ●

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510(k) SUMMARY

Biocompatibility
. Performance Validation
- Simulated Use O
- Dimensional Integrity O
- Mechanical integrity o
- O Electrical Integrity
- Electrical Safety o
- o Acoustic Output
- o Image Quality
- System Compatibility o
Packaging Validation ●

The subject device is validated for one reprocessing cycle after successful completion of the above performance testing. All subject devices are permanently marked and tracked via OEM label during reprocessing. Subject devices 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 .018 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).