(96 days)
Not Found
No
The summary describes a reprocessed intravascular ultrasound catheter and its physical and electrical properties. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the reprocessing process and ensuring the device maintains the properties of the predicate device.
No.
The "Intended Use / Indications for Use" section states that the device is "designed for use in the evaluation of vascular morphology" and "as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image." This indicates it is a diagnostic imaging device, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device 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" and "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." This indicates its purpose is to provide information for diagnosis or assessment.
No
The device is a physical catheter with an ultrasound transducer, designed for insertion into blood vessels. It is a hardware device, not software-only.
Based on the provided information, the Vein360 Reprocessed Visions PV .035 Digital IVUS Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to evaluate vascular morphology in blood vessels by providing a cross-sectional image. This is a direct imaging procedure performed in vivo (within the living body).
- Device Description: The device is an intravascular imaging catheter with an ultrasound transducer. It is introduced into the peripheral vasculature. This is a medical device used for imaging within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices and accessories used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
The Vein360 Reprocessed Visions PV .035 Digital IVUS Catheter does not perform tests on samples taken from the body. It is an imaging device used directly within the body.
N/A
Intended Use / Indications for Use
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.
Product codes
OWO
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) qas.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Cleaning Validation, Drying Validation, Sterilization Validation, Endotoxin Test Method Validation, Biocompatibility, Performance Validation (Simulated Use, Dimensional Integrity, Mechanical integrity, Electrical Integrity, Electrical Safety, Hydrophilic Coating Integrity, Acoustic Output, Image Quality, System Compatibility), and Packaging Validation.
The Vein360 Reprocessed Visions PV .035 Digital IVUS catheter is validated for one reprocessing cycle.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
K230584 - Suzanne Meyer
The reprocessed devices included in the scope of the submission are as follows:
| Description | Item
Number | French Size | Guide Wire | Minimum
Sheath | Length (cm) |
|-----------------------------------------------------------------|----------------|-------------|---------------|-------------------|-------------|
| Vein360 Reprocessed
Visions PV .035 Digital
IVUS Catheter | 88901 | 7 | 0.035"-0.038" | 8.5 F | 90 |
3
Indications for Use
510(k) Number (if known) K230584
Device Name
Vein360 Reprocessed Visions PV .035 Digital IVUS Catheter
Indications for Use (Describe)
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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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 .035
Digital 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 | Reference
Number | Predicate
510(k) |
|----------------------------------------|---------------------|---------------------|
| Visions® PV .035 Digital IVUS Catheter | 88901 | K153094 |
5
SECTION 5: 510(k) SUMMARY
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) qas.
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.
| Description | Reference
Number | French
Size | Guidewire | Minimum
Sheath | Working
Length |
|-----------------------------------------------------------------|---------------------|----------------|-----------------|-------------------|-------------------|
| Vein360 Reprocessed
Visions PV .035 Digital
IVUS Catheter | 88901 | 7 | 0.035" — 0.038" | 8.5 F | 90 cm |
The scope of this submission is as follows:
6
Indications for Use:
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.
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 spaced | |
| 1cm 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
7
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.