ViperCath XC Peripheral Exchange Catheter

K183000 · Cardiovascular Systems, Inc. · DQY · Dec 29, 2018 · Cardiovascular

Device Facts

• Record ID: K183000
• Device Name: ViperCath XC Peripheral Exchange Catheter
• Applicant: Cardiovascular Systems, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 29, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The ViperCath™ XC Peripheral Exchange Catheter is intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

Device Story

ViperCath XC is a percutaneous exchange catheter used in peripheral vascular interventions. It facilitates vascular access, guidewire support, and guidewire exchanges; provides a conduit for saline or diagnostic contrast agent delivery. Device features 200 cm length for radial access; straight or angled tip options; radiopaque marker bands at 1 cm and 5 cm from distal tip; printed markers at 120 cm and 150 cm for placement aid. Operated by physicians in clinical settings. Device is inserted into vasculature to track over a 0.035" guidewire. Output is physical support for wire navigation and a lumen for fluid delivery. Benefits include improved procedural efficiency during wire exchanges and access in peripheral vasculature.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, thrombogenicity, pyrogenicity) and bench performance (dimensional verification, bond strengths, tracking, guidewire exchange, radiopacity, wrap/kink, torque transfer, torque to failure, fluid flow, burst pressure, leakage).

Technological Characteristics

Braid-reinforced catheter shaft; 200 cm length; straight or angled tip; radiopaque marker bands; 0.035" guidewire compatibility; 600 psi max injection pressure; non-hydrophilic; sterile; single-use. Testing performed per FDA Class II Special Controls Guidance for PTCA Catheters.

Indications for Use

Indicated for patients undergoing peripheral vascular intervention procedures requiring vascular access, guidewire support, guidewire exchange, or delivery of saline/diagnostic contrast agents.

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

• NaviCross™ Support Catheter (K110540)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 29, 2018

Cardiovascular Systems, Inc. Erika Huffman Regulatory Affairs Manager 1225 Old Highway 8 NW St. Paul, Minnesota 55112

Re: K183000

Trade/Device Name: ViperCath XC Peripheral Exchange Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: October 29, 2018 Received: October 30, 2018

Dear Erika Huffman:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Michael John -S 2018.12.29 19:57:01 -05'00'

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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### Indications for Use

510(k) Number (if known) K183000

Device Name

ViperCath XC Exchange Catheter, 035-XC-200-0; ViperCath XC Exchange Catheter, 035-XC-200-1

Indications for Use (Describe)

The ViperCath XC Peripheral Exchange Catheter is intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

| 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) |

Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary / Statement

| Submitter: | Cardiovascular Systems, Inc.<br>1225 Old Highway 8 NW<br>Saint Paul, MN 55112 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Erika Huffman, MS, RAC<br>Regulatory Affairs Manager<br>Cardiovascular Systems, Inc.<br>1225 Old Highway 8 NW<br>St. Paul, MN 55112<br>Ph: 651-259-1608<br>[e-mail] |
| Date Prepared: | October 30, 2018 |
| Trade Name: | ViperCath™ XC Peripheral Exchange Catheter |
| Common Name: | Percutaneous Catheter, 21 CFR 870.1250 |
| Classification: | Class II |
| Product Code: | DQY |
| Predicate Device(s): | K110540 - NaviCross™ Support Catheter |
| Device Description: | The ViperCath XC Exchange Catheter (ViperCath XC) is<br>intended to be used to facilitate vascular access and guidewire<br>exchanges during peripheral vascular intervention procedures. It<br>is provided in a 200 cm length, to facilitate the radial access<br>approach, with either a straight or angled tip. There are no<br>accessories for this device.<br>The catheter shaft has radiopaque marker bands at distances of 1<br>cm and 5 cm from the distal tip. Two additional printed markers<br>are located 120 cm and 150 cm from the distal tip and are<br>provided to aid with placement. |
| Intended Use: | The ViperCath™ XC Peripheral Exchange Catheter is intended<br>to guide and support a guide wire during access of the<br>vasculature, allow for wire exchanges and provide a conduit for<br>the delivery of saline or diagnostic contrast agents. |

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| Comparison to<br>Predicate: | | ViperCath™ XC<br>Peripheral<br>Exchange Catheter<br>(subject device) | Terumo<br>NaviCross™<br>Support Catheter<br>(predicate device) |
|-----------------------------------|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| | Effective<br>Length(s) | 200 cm | 65, 90, 135, 150 cm |
| | Recommended<br>Guide Catheter | 5 Fr | 4 Fr |
| | Shaft Design | Braid-reinforced | Braid-reinforced |
| | Tip Shape | Straight, Angled | Straight, Angled |
| | Maximum<br>Injection Pressure | 600 psi | 750 psi |
| | Guidewire<br>Compatibility | 0.035" | 0.035" |
| | Hydrophilic<br>Coating | No | Yes |
| | Sterile | Yes | Yes |
| | Single Use | Yes | Yes |
| Functional and<br>Safety Testing: | | Testing was performed in accordance with applicable standards<br>and guidance, including FDA Class II Special Controls<br>Guidance Document for Certain Percutaneous Transluminal<br>Coronary Angioplasty (PTCA) Catheters (September 2010). | |
| | | <b>Biocompatibility Testing:</b> | |
| | | ● Cytotoxicity | |
| | | ● Sensitization | |
| | | ● Irritation/Intracutaneous Reactivity | |
| | | ● Acute Systemic Toxicity | |
| | | ● Hemocompatibility | |
| | | ● Thrombogenicity | |
| | | ● Pyrogenicity | |
| | | <b>Bench Testing</b> | |
| | | ● Dimensional verification – luer, shaft, tip | |
| | | ● Bond strengths | |
| | | ● Tracking | |
| | | ● Guidewire Exchange | |
| | | ● Radiopacity | |
| | | ● Wrap/Kink | |
| | | ● Torque Transfer | |
| | | ● Torque to Failure | |
| | | ● Fluid flow | |
| | | ● Burst Pressure | |
| | | ● Leakage | |

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| <b>Conclusion:</b> | The ViperCath XC Exchange Catheter data supports that no new questions of safety or effectiveness were identified compared to the predicate device. |
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