FLEX SCORING CATHETER

K152789 · Venturemed Group · PNO · May 25, 2016 · Cardiovascular

Device Facts

• Record ID: K152789
• Device Name: FLEX SCORING CATHETER
• Applicant: Venturemed Group
• Product Code: PNO · Cardiovascular
• Decision Date: May 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FLEX Scoring Catheter 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 or synthetic arteriovenous dialysis fistulae.

Device Story

FLEX Scoring Catheter is a sterile, single-use, disposable percutaneous catheter; 120cm working length; features three distal scoring elements, atraumatic tip, and radiopaque marker band. Used in clinical settings by physicians to facilitate dilation of stenoses in femoral/popliteal arteries and AV fistulae. Operation: device is inserted over 0.18" guidewire; unsheathed to expand scoring elements; retracted to score plaque; then exchanged for a standard PTA balloon catheter for final dilation. Scoring elements provide controlled depth of plaque scoring. Benefits include improved plaque modification prior to balloon angioplasty, potentially reducing vessel trauma or improving dilation outcomes.

Clinical Evidence

Evidence includes bench testing (ISO 10555-1, ISO 10993-1, ISO 11135-1), simulated use testing, GLP animal studies, and cadaveric studies. No human clinical trial data provided in summary.

Technological Characteristics

Sterile, single-use, disposable percutaneous catheter. Features three scoring elements with 0.010" height and 5mm expanded size. Includes radiopaque marker band for visualization. Compatible with 0.18" guidewires. Sterilized via Ethylene Oxide. Mechanical expansion mechanism controlled by operator.

Indications for Use

Indicated for patients requiring dilation of stenoses in femoral and popliteal arteries or treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae.

Regulatory Classification

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.

Predicate Devices

• SplitWire Percutaneous Transluminal Angioplasty Scoring Device (K113103)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 25,2016

VentureMed Group Ms. Tiffini Diage, MPH Regulatory Affairs Consultant 5855 Monroe St, Suite 220 A Sylvania, OH 43560

Re: K152789

Trade/Device Name: Flex Scoring Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: April 21, 2016 Received: April 25, 2016

Dear Ms. Diage,

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K152789

Device Name FLEX Scoring Catheter

#### Indications for Use (Describe)

The FLEX Scoring Catheter 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 or synthetic arteriovenous dialysis fistulae.

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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### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary

| Submitter: | VentureMed Group, Ltd<br>5855 Monroe St, Suite 200<br>Sylvania, OH 43560 | |
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| Contact Person: | Tiffini Diage<br>Regulatory Affairs Consultant<br>Phone: [phone]<br>E-mail: [e-mail] | |
| Date Prepared: | 5/17/2016 | |
| Trade Name: | FLEXTM Scoring Catheter | |
| Common Name: | Percutaneous Catheter | |
| Classification: | Class II | |
| Product Code: | PNO - 21 CFR 870.1250 | |
| Predicate Device(s): | The subject device is equivalent to the following devices:<br>K113103 - SplitWire Percutaneous Transluminal Angioplasty Scoring Device | |
| Device Description: | The FLEXTM Scoring Catheter is a sterile, single use, disposable device designed to facilitate the dilation of stenoses. The device has a working length of 120cm and is comprised of three scoring elements at the distal end. The distal end also contains an atraumatic tip and radiopaque maker band to aid in proper placement of the catheter. When the device is unsheathed the scoring elements are expanded to contact the plaque. The device scores the plaque as it is retracted. Once the desired plaque is scored the device is exchanged for a PTA balloon.<br>The device is compatible with0.18" guidewires. | |
| Technical Comparison Table | | |
| | FLEX TM Scoring Catheter<br>(Subject Device) | SplitWire Percutaneous<br>Transluminal Angioplasty<br>Scoring Device<br>(Predicate Device) |
| 510(k) Number | K152789 | K113103 |
| Decision Date | | |
| Manufacturer | VentureMed Group Ltd | Rex Medical |
| Classification | Class II | Class II |
| Regulation | 21 CFR 870.1250 | 21 CFR 870.1250 |
| Indications for Use | indicated for use with percutaneous<br>transluminal angioplasty (PTA)<br>catheters to facilitate dilation of<br>stenoses in the femoral and<br>popliteal arteries and treatment of<br>obstructive lesions of native or<br>synthetic arteriovenous dialysis<br>fistulae. | indicated for use with percutaneous<br>transluminal angioplasty (PTA)<br>catheters to facilitate dilation of<br>stenosis in the iliac, femoral, ilio-<br>femoral, popliteal, infra-popliteal,<br>and renal arteries and treatment of<br>obstructive lesions of native or<br>synthetic arteriovenous dialysis<br>fistulae. |
| Intended Use | Same | To facilitate the dilation of stenotic<br>vessels |
| Overall Device Length | 120cm | 90cm, 180cm, 260cm |
| Balloon Compatibility | Not applicable – device not in<br>vessel at same time as balloon | 20 – 80mm |
| Integrated Balloon | No | No |
| Visibility | Radiopaque markerband at distal<br>tip | Radiopaque coil at distal tip, plus 2<br>markerbands for balloon placement |
| Expansion Mechanism | Operator expanded | Balloon expanded |
| Scoring Member | 3 | 1 |
| Scoring Member Height | 0.010" | 0.014" |
| Scoring Member<br>Expanded Size | 5 mm | Dependent on inflated balloon<br>diameter |
| Scoring Member Depth<br>Control | Yes | No |
| Deflection | Yes < 1ATM | Yes 3ATM |
| Scoring Member Fixed<br>to Balloon | No | No |
| Sterilization | Same | Ethylene Oxide |
| Single Use Only | Same | Yes |

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| Functional and<br>Safety Testing to<br>Determine<br>Substantial<br>Equivalence: | To verify that the device design meets its functional and<br>performance requirements, representative samples of the device<br>underwent bench testing. Testing included:<br>General Requirements for Intravascular Catheters - ISO 10555-1 Biocompatibility Testing - ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Sterilization Validation Testing - ISO-11135-1 Sterilization of Health Care Products. Ethylene Oxide Sterilization Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices Simulated Use Testing<br>In Vivo GLP animal testing, cadaveric studies, and clinical evaluations were also performed and demonstrated the FLEX device meets user needs and intended use. | |
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| Conclusion: | VentureMed Group considers the FLEX™ Scoring Catheter to be substantially equivalent to the predicate device listed above.<br>The subject device has the same intended use, principles of operation, and similar design features. Bench testing and pre-clinical animal studies demonstrate that none of the technical differences raise any new questions of safety and effectiveness. | |