(144 days)
Not Found
No
The summary describes a reprocessed intravascular ultrasound catheter and its functional and performance characteristics. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the reprocessing process and ensuring the device maintains the properties of the predicate.
No
The device is described as an "intravascular imaging catheter" used for "evaluation of vascular morphology" and to "generate real-time images of the peripheral vessels." Its purpose is diagnostic, to provide images, rather than to treat or cure a disease.
Yes
The device is designed for "evaluating vascular morphology" and provides "cross-sectional images" and "real-time images of the peripheral vessels," which are used to assess the condition of blood vessels. Such evaluation and imaging for assessment constitute a diagnostic purpose.
No
The device description clearly details a physical catheter with an ultrasound transducer, internal lumen, and positioning markers. It also mentions reprocessing of a physical device and extensive bench and laboratory testing of physical properties. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels." This describes an imaging device used in vivo (within the body) to visualize structures.
- Device Description: The description details an "intravascular imaging catheter containing an ultrasound transducer located at the distal end of the catheter." This further confirms it's an imaging device used inside blood vessels.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices 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. This device does not perform tests on samples; it generates images of internal structures.
The device is an intravascular ultrasound (IVUS) catheter, which is a type of medical imaging device used during procedures.
N/A
Intended Use / Indications for Use
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 anqiographic procedures to provide an image of the vessel lumen and wall structures.
Product codes (comma separated list FDA assigned to the subject device)
OWO, OWQ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Blood vessels of the peripheral vasculature
Indicated Patient Age Range
adult patients (greater than 21 years of age)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 ●
- 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 ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows 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.
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
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
| Predicate
Item Number | Vein360
ltem Number | Guide Wire Compatibility | Imaging System Compatibility |
|--------------------------|------------------------|--------------------------|-------------------------------------|
| 86700 | VEN-PV-018 | 0.018" (0.46mm) | Volcano s5, CORE, IntraSight Series |
3
Indications for Use
510(k) Number (if known) K230928
Device Name
Vein360 Reprocessed Visions PV .018 Digital IVUS Catheter
Indications for Use (Describe)
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).
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, 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 .018
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 |
| 510(k) Number: | K230928 |
Predicate Devices:
| Predicate Device Trade Name | Reference
Number | Predicate
510(k) |
|----------------------------------------|---------------------|---------------------|
| Visions® PV .018 Digital IVUS Catheter | 86700 | K150442 |
5
510(k) SUMMARY
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.
The scope of this submission is as follows:
| Predicate
Item Number | Vein360
Item Number | Guide Wire Compatibility | Imaging System Compatibility |
|--------------------------|------------------------|--------------------------|-------------------------------------|
| 86700 | VEN-PV-018 | 0.018" (0.46mm) | Volcano s5, CORE, IntraSight Series |
Indications for Use:
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.
6
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 ●
7
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.