(38 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the FLEX Vessel Prep System, based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device. This type of document is intended to demonstrate substantial equivalence to a predicate device, not necessarily to present a full clinical study with specific acceptance criteria and performance metrics against those criteria in the way a clinical trial report would. Therefore, much of the requested information (like specific quantitative acceptance criteria, human reader improvement from AI, exact sample sizes for training/test sets with ground truth details, etc.) is not explicitly available in this document. The focus here is on bench testing and material safety.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) summary focusing on substantial equivalence and bench testing, "acceptance criteria" are implied by the various tests conducted to ensure the device meets its specifications and safe performance. Exact quantitative acceptance criteria, in terms of specific percentages or thresholds for clinical outcomes, are not explicitly listed in the document for the new indication (in-stent restenosis) or material change. The performance reported is that the device "meets all its physical and performance specifications."
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Material Safety & Biocompatibility | Device meets specifications; Passed all tests: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility, Chemical Characterization with Toxicological Risk Assessment. |
| Physical & Performance Specifications | Device meets specifications before and after distribution and aging, indicating substantial equivalence. |
| Environmental Conditioning | Device maintains performance after environmental conditioning. |
| Distribution Performance | Device maintains performance after distribution. |
| Simulated Use Testing | Successfully performed. |
| Physical & Dimensional Testing | Device meets specifications. |
| Packaging & Labeling Testing | Device meets specifications. |
| Substantial Equivalence | Demonstrated to be substantially equivalent to the predicate device (K152789) for the expanded in-stent use indication and material change. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "bench testing," which implies a set of test articles (devices) were used, but the specific number is not provided.
- Data Provenance: The testing was "bench testing" and focused on physical, functional, and safety attributes of the device itself, rather than patient data. Therefore, notions of country of origin or retrospective/prospective data do not apply in the context of this 510(k) summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This document describes bench testing and material characterization, not studies involving expert evaluation of clinical data for ground truth.
4. Adjudication Method
- Not applicable. This document describes bench testing and material characterization, not studies requiring adjudication of clinical outcomes or images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The device described is a physical medical device, not an AI or imaging diagnostic tool.
6. Standalone (Algorithm Only) Performance
- No, standalone algorithm performance was not done. This device is a physical medical instrument, not an algorithm.
7. Type of Ground Truth Used
- The "ground truth" for the testing described here is based on engineering specifications, material science standards, and established biocompatibility testing protocols. For example, the "ground truth" for cytotoxicity is a standardized test result indicating non-toxicity, rather than human expert consensus or pathology on a biological sample from a patient. The "ground truth" for physical dimensions would be the engineering drawing specifications.
8. Sample Size for the Training Set
- Not applicable. This document describes bench testing of a physical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for an AI/ML model.
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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
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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
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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 50Plymouth, MN 55441, USAPhone: 763.951.0280Fax: 419-558-4171 |
|---|---|
| Primary Submission Contact: | Jill SchweigerVice President, Clinical, Regulatory, and Quality AssuranceVentureMed Group, Inc.2800 Campus Drive, Suite 50Plymouth, MN 55441, USACell Phone: 612-385-4090Email: jschweiger@venturemedgroup.com |
| Secondary Submission Contact: | Sara PetrieDirector of Quality Assurance and RegulatoryVentureMed Group, Inc.2800 Campus Drive, Suite 50Plymouth, MN 55441, USACell Phone: 612.396.9849Email: 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.
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.
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Image /page/5/Picture/0 description: The image contains the VentureMed logo. The logo consists of a red abstract figure of a person with outstretched arms and legs, positioned to the left of the company name. The text "VentureMed" is written in a bold, sans-serif font, with the "V" capitalized and slightly larger than the rest of the letters.
Indications for Use / Intended 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.
Technological Characteristics
At a high level, the subject, reference, and predicate devices are based on the same technological elements.
| FLEX Vessel Prep™ System | FLEX Vessel Prep™ System | Scoreflex PTA Scoring Balloon Catheter | |
|---|---|---|---|
| 510(k) Number | K202187 | K152789 | K182713 |
| Manufacturer | VentureMed Group, Inc. | VentureMed Group, Inc. | OrbusNeich Medical Trading, Inc. |
| Classification | Class II | Class II | Class II Same |
| Product Code | PNO | PNO | PNO Same |
| Regulation | 21 CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1250 Same |
| Item | FLEX Vessel Prep™ System | FLEX Vessel Prep™ System | Similar | Scoreflex PTA Scoring Balloon Catheter | Similar |
|---|---|---|---|---|---|
| Indications for Use/Intended 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. | 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. | Addition of ISR indication | The Scoreflex PTA Scoring Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. | (Predicate is also indicated for iliac, ilio-femoral, infra-popliteal, and renal arteries.) |
| Guidewire compatibility | 0.014" or 0.018" | 0.014" or 0.018" | Same | 0.014" and 0.018" | Same |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same | Ethylene Oxide | Same |
| Single Use Only | Yes | Yes | Same | Yes | Same |
| Scoring Member (Treatment Element) | 3Independent precision blades for controlled depth | 3Independent precision blades for controlled depth | Same | 21 (one) Nitinol Integrated Wire and1 (one) 0.018" loose guidewire | Different |
| Mechanism of Action | Retrograde pull-back of the treatment elements through lesion creates controlled microincisions | Retrograde pull-back of the treatment elements through lesion creates controlled microincisions | Same | Focal force of wires against lesion. | Different |
| Micro-incision Depth | $0.010" \pm 0.002"$ | $0.010" \pm 0.002"$ | Same | 0.018" Guidewire and0.014"Uses Nitinol Integral Wire | Different |
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Image /page/6/Picture/0 description: The image contains the VentureMed logo. The logo features a red abstract figure of a person with outstretched arms and legs, positioned to the left of the company name. The text "VentureMed" is written in a bold, sans-serif font, with the registered trademark symbol appearing to the upper right of the word "Med".
| Item | FLEX Vessel Prep™ System | FLEX Vessel Prep™ System | Scoreflex PTA Scoring Balloon Catheter | |
|---|---|---|---|---|
| Scoring MemberDepth Control | Yes | Yes | No | Different |
| Visibility | Radiopaque marker band atdistal end | Radiopaque marker bandat distal end | Two radiopaqueplatinum/iridium markersbands are located onscoring wire and alignedwith the balloon shoulders | Different |
| Integrated Balloon | No | No | Yes | Different |
| ExpansionMechanism | Operator expanded | Operator expanded | Balloon Expanding | Different |
| Scoring MemberExpanded Size | 120cm device – 4mm ± 1mm40cm device - 6mm ± 1mm | 120cm device - 4mm ± 1mm40cm device - 6mm ± 1mm | Dependent upon inflatedballoon diameter | Different |
| Overall DeviceLength | 40cm, 120cm | 40cm, 120cm | 40cm, 90cm, 150cm | Different |
| TreatmentElementProtective Struts | Stainless steel (nickel-free/high nitrogen stainlesssteel alloy) | Stainless steel | Not Applicable | Different |
Performance Data
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
SUBSTANTIAL EQUIVALENCE
The subject device is equivalent to the predicate device.
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Image /page/7/Picture/0 description: The image shows the VentureMed logo. The logo consists of a red abstract human figure on the left and the text "VentureMed" in black on the right. The human figure is made up of interconnected lines and circles, and the text is in a bold, sans-serif font. There is a registered trademark symbol next to the word "Med".
Conclusion
VentureMed considers the FLEX Vessel Prep™ System to be substantially equivalent to the predicate device listed above for the treatment element protective strut material change and in-stent use indication. The subject devices has the same intended use, principles of operation, and similar design features. Bench testing demonstrate that none of the technical differences raise any new questions of safety and effectiveness.
§ 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).