Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical components and actions (sheathed catheter, struts, blades, actuators, pull-back). There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies described are bench testing and biological safety, not algorithm validation.

Therapeutic

Yes
The device is indicated for facilitating dilation and treatment of stenoses and obstructive lesions, which are therapeutic actions aimed at improving patient health.

Diagnostic

No

The device description clearly states its purpose is to "facilitate dilation of stenoses" and "treatment of obstructive lesions" by creating "controlled-depth microincisions." This is an interventional/treatment device, not one for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical catheter with mechanical components (struts, blades, actuators, shaft) and mentions bench testing of physical and performance specifications, biological safety testing, and environmental conditioning. There is no mention of software as a component or function of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device used within the body to physically modify blood vessels (facilitate dilation of stenoses, treat obstructive lesions, treat in-stent restenosis). This is an interventional procedure, not a diagnostic test performed on samples taken from the body.
Device Description: The description details a catheter with a treatment element designed to create microincisions within the vessel. This is a therapeutic action, not a diagnostic one.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The FLEX Vessel Prep™ System performs a physical intervention within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The FLEX Vessel Prep™ System is indicated for use with percutaneous transluminal angioplasty (PTA) catheters to facilitate dilation of stenoses in the femoral and popliteal arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature.

Product codes

PNO

Device Description

The FLEX Vessel Prep System™ is an over-the-wire sheathed catheter with a three-strut treatment element near the distal tip.

The FLEX Vessel Prep™ System is advanced over a 0.014" or 0.018" quidewire until distal to the lesion to be treated. The Treatment Element is unsheathed and expanded. The Treatment Element consists of three independent flexible struts, each with a precision blade, mounted on the proximal end. As the device is pulled back in a retrograde fashion through the target lesion, the Treatment Element "flexes" providing continuous engagement along the lesion to create controlled-depth microincisions.

The Flex Vessel Prep™ System is available in 2 lengths, 120cm and 40cm. The device has a 2mm crossing profile and is compatible with 6 French introducer sheaths. It is recommended to use a 150 cm+ guidewire with the 40cm product and a 300cm guidewire with the 120cm product.

The device consists of three integrated components. The Control Handle, which contains a Guidewire Port for quidewire insertion, a Flush Port to flush with saline to remove air from the device, the Sheath Actuator and Treatment Element Actuator.

The Sheath Actuator is located on the flat surface of the handle below the word FLEX. When the Sheath Actuator is pulled back and held in place, the sheath covering the Treatment Element is retracted and the Treatment Element is exposed. A click verifies the sheath is fully retracted.

The Treatment Element Actuator is located on the curved aspect of the handle, above the word FLEX. When the Treatment Element Actuator is pulled back and held in place, the Treatment Element expands the 3 flexible struts of the Treatment Element.

The Reinforced Braided Shaft, which is enclosed within a clear polymer sheath, provides strength to enhance deliverability and torque performance of the device.

The distal end of the device contains a radiopaque marker to aid in positioning the catheter and the Treatment Element.

The Treatment Element consists of three precision blades. 10 thousandths of an inch (0.010") in height and mounted on the proximal end of each of the three independent flexible struts. The expansion of the Treatment Element allows the three precision blades to independently engage the lesion.

During the retrograde pull-back of the device, each strut of the protective Treatment "flexes" independently to provide continuous engagement along and through complex lesions to create controlled-depth micro-incisions along the lesion. These micro-incisions modify the plaque in the lesion and enable dilatation of the target lesion using percutaneous angioplasty balloons at lower inflation pressures, minimizing barotrauma to the vessel.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

femoral and popliteal arteries, native or synthetic arteriovenous dialysis fistulae, 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

The FLEX Vessel Prep™ System has been tested and meets all its physical and performance specifications for treatment element protective strut material change and in-stent use. Bench testing was performed in accordance with applicable FDA guidance, ASTM and ISO standards.

The testing demonstrated that the device meets specifications before and after distribution and aging indicating that the device is substantially equivalent to the predicate device.

Testing included: Biological Safety Testing

Cytotoxicity
Sensitization ●
Irritation or Intracutaneous Reactivity ●
Acute Systemic Toxicity ●
Pyrogenicity
Hemocompatibility
Chemical Characterization with Toxicological Risk Assessment .

Environmental Conditioning & Distribution Performance Specifications Testing Simulated Use Testing Physical & Dimensional Testing Packaging & Labeling Testing

Key Metrics

Not Found

Predicate Device(s)

K152789

Reference Device(s)

K182713

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

September 11, 2020

VentureMed Group, Inc. Ms. Jill Schweiger Vice President of Clinical, Regulatory, and Quality Assurance 2800 Campus Drive, Suite 50 Plymouth, Minnesota 55441

Re: K202187

Trade/Device Name: FLEX Vessel Prep System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: PNO Dated: August 3, 2020 Received: August 4, 2020

Dear Ms. Schweiger:

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 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

1

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,

For

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

Device Name FLEX Vessel Prep™ System

Indications for Use (Describe)

The FLEX Vessel Prep™ System is indicated for use with percutaneous transluminal angioplasty (PTA) catheters to facilitate dilation of stenoses in the femoral and poplited arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature.

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/3/Picture/0 description: The image contains the VentureMed logo. The logo features a red abstract human figure with outstretched arms and legs, positioned to the left of the text "VentureMed". The text is in a bold, sans-serif font, with the "Med" portion slightly smaller and raised. A registered trademark symbol is present to the right of "VentureMed".

510(K) SUMMARY

This 510(k) Summary is submitted in accordance with 21 CFR 807.92(c).

ADMINISTRATIVE INFORMATION

| 510(k) Owner's name, address, phone,
and fax numbers: | VentureMed Group, Inc.
2800 Campus Drive, Suite 50
Plymouth, MN 55441, USA
Phone: 763.951.0280
Fax: 419-558-4171 |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Submission Contact: | Jill Schweiger
Vice President, Clinical, Regulatory, and Quality Assurance
VentureMed Group, Inc.
2800 Campus Drive, Suite 50
Plymouth, MN 55441, USA
Cell Phone: 612-385-4090
Email: jschweiger@venturemedgroup.com |
| Secondary Submission Contact: | Sara Petrie
Director of Quality Assurance and Regulatory
VentureMed Group, Inc.
2800 Campus Drive, Suite 50
Plymouth, MN 55441, USA
Cell Phone: 612.396.9849
Email: spetrie@venturemedgroup.com |
| Date Summary Prepared: | 31 August 2020 |
| Trade Name: | FLEX Vessel Prep™ System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Percutaneous, Cutting/Scoring |
| Classification Regulation | 21 CFR 870.1250 |
| Class | II |
| Panel | Cardiovascular |
| Classification Product Code | PNO |

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Image /page/4/Picture/0 description: The image shows the VentureMed logo. The logo consists of a red abstract figure of a person with outstretched arms and legs, followed by the word "VentureMed" in a bold, sans-serif font. A registered trademark symbol is present to the right of the word "VentureMed".

Predicate Device

The subject device is equivalent to the following device: K152789 – FLEX Vessel Prep™ System

REFERENCE DEVICE

K182713 – Scoreflex PTA Scoring Balloon Catheter.