ViperCross Support Catheters

K211240 · Cardiovascular Systems, Inc. · DQY · Aug 26, 2021 · Cardiovascular

Device Facts

• Record ID: K211240
• Device Name: ViperCross Support Catheters
• Applicant: Cardiovascular Systems, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The ViperCross™ Support Catheters may be used to facilitate placement and exchange of guidewires and other interventional devices and to selectively infuse/deliver diagnostic and therapeutic agents.

Device Story

ViperCross Support Catheters are single-lumen, percutaneous catheters used in peripheral and/or coronary vasculature. Input: steerable guidewires. Operation: catheter tracks over guidewire to access target vasculature; provides support for guidewire exchange; serves as conduit for diagnostic/therapeutic agent infusion. Output: physical access to distal vasculature. Used in clinical settings by physicians. Benefits: facilitates navigation of complex vasculature and device exchange. Features hydrophilic coating for deliverability, radiopaque marker for visualization, and luer-lock for flushing.

Clinical Evidence

Bench testing only. Testing included mechanical performance (working length, OD/ID, radiopacity, leak resistance, trackability, torque, kink resistance, tensile strength, luer fitting) and biocompatibility per ISO 10993-1 for limited (<24 hour) blood-contacting devices (hemolysis, PTT, cytotoxicity, systemic toxicity, sensitization, pyrogenicity). All tests passed.

Technological Characteristics

Single-lumen, coiled-shaft percutaneous catheter. Materials: hydrophilic coating on distal shaft. Dimensions: 0.014", 0.018", 0.035" guidewire compatibility; various lengths (40cm-150cm). Radiopaque marker band at distal tip. Sterilization: Ethylene Oxide. No software or electronic components.

Indications for Use

Indicated for use in conjunction with steerable guidewires to access discrete regions of the peripheral and/or coronary vasculature (0.014" model) or peripheral vasculature (0.018" & 0.035" models). Used to facilitate placement/exchange of guidewires and interventional devices and to sub-selectively infuse/deliver diagnostic and therapeutic 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

• SuperCross Microcatheter (K101659)
• Quick-Cross Extreme & Quick-Cross Select (K082561)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

August 26, 2021

Cardiovascular Systems, Inc. Jonathan Holmes Regulatory Affairs Manager 6030 W. Harold Gatty Dr. Salt Lake City, Utah 84116

Re: K211240

Trade/Device Name: ViperCross Support Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 28, 2021 Received: July 29, 2021

Dear Jonathan Holmes:

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 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

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 (OS) 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/cdrl-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Lydia Glaw 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) K211240

Device Name ViperCross™ Support Catheters

Indications for Use (Describe)

0.014"

The ViperCross™ Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse/deliver diagnostic and therapeutic agents.

0.018" & 0.035"

The ViperCross™ Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse / deliver diagnostic and therapeutic agents.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------|------------------------------------------------------------------|
| <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Cardiovascular Systems, Inc. The logo consists of the letters "CSI" in a stylized font, with a green arc underneath. The address "1225 Old Highway 8 NW, Saint Paul, MN 55112" is printed below the logo.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) K211240

#### Submitter:

Cardiovascular Systems, Inc. 1225 Old Highway 8 NW Saint Paul, MN 55112

### Correspondent:

Jonathan Holmes 6030 W Harold Gatty Dr. Salt Lake City, UT 84116 Phone: [phone] Email: jholmes(@biomerics.com

#### Manufacturer:

Cardiovascular Systems, Inc. 1225 Old Highway 8 NW Saint Paul, MN 55112

### DATE PREPARED: 22 April 2021

### NAME OF MEDICAL DEVICE:

ViperCross™ Support Catheters Proprietary Name: Common/Usual Name: Percutaneous Catheter Classification Name: Catheter, Percutaneous

## DEVICE CLASSIFICATION:

| Classification Panel: | Cardiovascular |
|-----------------------|-----------------|
| Regulatory Class: | 2 |
| Product Code: | DQY |
| Regulation Number: | 21 CFR 870.1250 |

### PREDICATE DEVICE 1 (014):

| Proprietary Name: | SuperCross Microcatheter |
|----------------------|--------------------------|
| Common/Usual Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Percutaneous |
| 510(k) Number: | K101659 |

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Cardiovascular Systems, Inc. The logo consists of the letters "CSI" in a stylized, sans-serif font, with a green arc underneath. To the right of the letters is a vertical line, followed by the words "CARDIOVASCULAR SYSTEMS, INC." in a smaller, sans-serif font. The overall design is clean and modern.

### PREDICATE DEVICE 2 (018 & 035):

| Proprietary Name: | Quick-Cross Extreme & Quick-Cross Select |
|----------------------|------------------------------------------|
| Common/Usual Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Percutaneous |
| 510(k) Number: | K082561 |

### DEVICE DESCRIPTION:

014: The ViperCross™ Support Catheter is a single lumen catheter designed for use in the peripheral and/or coronary vasculature. The ViperCross™ Support Catheter provides guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The ViperCross™ Support Catheters have a hydrophilic coating on the distal 90cm or 70cm dependent on model length to enhance deliverability to the target vasculature.

The ViperCross™ Support Catheters have a single radiopaque marker band located 0.040" / 1.02mm from the distal tip. The catheters have white positioning marks located at 100cm and 110cm from the distal tip. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing.

018/035: The ViperCross™ Support Catheter is a single lumen catheter designed for use in the peripheral vasculature. The ViperCross™ Support Catheter provides guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The ViperCross™ Support Catheters have a hydrophilic coating on the distal 90cm, 70cm, or 40cm dependent on model length to enhance deliverability to the target vasculature.

The ViperCross™ Support Catheters have a single radiopaque marker band located 0.040" / 1.02mm from the distal tip. The 135cm catheters have white positioning marks located at 100cm and 110cm from the distal tip. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing.

The ViperCross™ Support Catheters have been sterilized with ethylene oxide.

# INTENDED USE/INDICATION FOR USE:

Intended Use: The ViperCross™ Support Catheters may be used to facilitate placement and exchange of guidewires and other interventional devices and to selectively infuse/deliver diagnostic and therapeutic agents.

014 Indications for Use: The ViperCross™ Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse/deliver diagnostic and therapeutic agents.

018/035 Indications for Use: The ViperCross™ Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Cardiovascular Systems, Inc. The logo consists of the letters "CSI" in a gray, rounded font, with a green arc underneath. To the right of the letters is a vertical line, followed by the words "CARDIOVASCULAR SYSTEMS, INC." in a smaller, gray font.

interventional devices and to sub-selectively infuse/deliver diagnostic and therapeutic agents.

# TECNOLOGICAL COMPARISION TO PREDICATE DEVICE:

Technologically the ViperCross™ Support Catheter is substantially equivalent to the SuperCross Microcatheter, (K101659) and Quick-Cross Extreme & Quick-Cross Select, (K082561) in terms of design, materials, technology and performance.

The ViperCross™ Support Catheter uses the same technology and has a similar intended use, fundamental technology and performance as the predicate device.

| Characteristic | ViperCross™<br>Support Catheters<br>(Subject Device) | SuperCross™<br>Microcatheter<br>(Predicate for 014<br>Straight Model) | Quick-Cross<br>Extreme & Quick-<br>Cross Select<br>(Predicate for 018<br>Straight & 035<br>Straight/Angled<br>Models) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ViperCross™<br>Support Catheter may<br>be used to facilitate<br>placement and exchange<br>of guidewires and other<br>interventional devices<br>and to selectively<br>infuse/deliver diagnostic<br>and therapeutic agents. | The SuperCross<br>Microcatheter is<br>intended to be used in<br>conjunction with<br>steerable guidewires to<br>access discrete regions<br>of the coronary and/or<br>peripheral vasculature.<br>It may be used to<br>facilitate placement and<br>exchange of guidewires<br>and other interventional<br>devices and to<br>subselectively<br>infuse/deliver diagnostic<br>and therapeutic agents. | Quick-Cross Extreme<br>and Quick-Cross Select<br>support catheters are<br>intended to guide and<br>support a guidewire<br>during access of the<br>coronary or peripheral<br>vasculature, allow for<br>wire exchanges and<br>provide a conduit for<br>the delivery of saline<br>solutions or diagnostic<br>contrast agents. |
| Indications for<br>use | 014<br>The ViperCross™<br>Support Catheter is<br>intended to be used in<br>conjunction with<br>steerable guidewires to<br>access discrete regions<br>of the peripheral and/or<br>coronary vasculature. It<br>may be used to facilitate<br>placement and exchange<br>of guidewires and other | The SuperCross<br>Microcatheter is<br>intended to be used in<br>conjunction with<br>steerable guidewires to<br>access discrete regions<br>of the coronary and/or<br>peripheral vasculature.<br>It may be used to<br>facilitate placement and<br>exchange of guidewires<br>and other interventional | Quick-Cross Extreme<br>and Quick-Cross Select<br>support catheters are<br>intended to guide and<br>support a guidewire<br>during access of the<br>coronary or peripheral<br>vasculature, allow for<br>wire exchanges and<br>provide a conduit for<br>the delivery of saline |
| Characteristic | ViperCross™™<br>Support Catheters<br>(Subject Device) | SuperCross™<br>Microcatheter<br>(Predicate for 014<br>Straight Model) | Quick-Cross<br>Extreme & Quick-<br>Cross Select<br>(Predicate for 018<br>Straight & 035<br>Straight/Angled<br>Models) |
| | interventional devices<br>and to sub-selectively<br>infuse/deliver diagnostic<br>and therapeutic agents. | devices and to<br>subselectively<br>infuse/deliver diagnostic<br>and therapeutic agents. | solutions or diagnostic<br>contrast agents. |
| | <b>018/035</b><br>The ViperCross™™<br>Support Catheter is<br>intended to be used in<br>conjunction with<br>steerable guidewires to<br>access discrete regions<br>of the peripheral<br>vasculature. It may be<br>used to facilitate<br>placement and exchange<br>of guidewires and other<br>interventional devices<br>and to sub-selectively<br>infuse/deliver diagnostic<br>and therapeutic agents. | | |
| Technology | | | |
| | Max. Guidewire<br>Diameter: | Max. Guidewire<br>Diameter: | Max. Guidewire<br>Diameter: |
| Dimensions | 014: 0.014" / 0.36mm | 0.014" / 0.36mm | Extreme 018: 0.018" /<br>0.46mm |
| | 018: 0.018" / 0.46mm | Working Length:<br>130cm & 150cm | Extreme 035 Straight:<br>0.035" / 0.89mm |
| | 035 Straight & Angled:<br>0.035" / 0.89mm | Distal Tip OD:<br>0.024" / 0.61mm | Select 035 Angled:<br>0.035" / 0.89mm |
| | Working Length:<br>014: 135cm & 150cm | Proximal Shaft OD:<br>0.033" / 0.84mm | Working Length: |
| | 018: 135cm | Min. Guide Catheter<br>ID:<br>0.042" / 1.07mm | Extreme 018: 135cm |
| | 035 Straight & Angled:<br>90cm & 135cm | | Extreme 035 Straight:<br>90cm & 135cm |
| Characteristic | ViperCross™™<br>Support Catheters<br>(Subject Device) | SuperCross™<br>Microcatheter<br>(Predicate for 014<br>Straight Model) | Quick-Cross<br>Extreme & Quick-<br>Cross Select<br>(Predicate for 018<br>Straight & 035<br>Straight/Angled<br>Models) |
| | Distal Tip OD: | | Select 035 Angled:<br>90cm & 135cm |
| | 014: 0.021" / 0.53mm | | Distal Tip OD: |
| | 018: 0.025" / 0.63mm | | Extreme 018: 0.038" |
| | 035 Straight & Angled:<br>0.45" / 1.14mm | | Extreme 035 Straight:<br>0.052" |
| | Proximal Shaft OD: | | Select 035 Angled:<br>0.052" |
| | 014: 0.375" / 0.95mm | | Proximal Shaft OD: |
| | 018: 0.0375" / 0.95mm | | Extreme 018: 0.044" |
| | 035 Straight & Angled:<br>0.056" / 1.42mm | | Extreme 035 Straight:<br>0.059" |
| | Min Guide Catheter<br>ID: | | Select 035 Angled:<br>0.059" |
| | 014: 0.042" / 1.07mm | | Min. Guide Catheter<br>ID: |
| | 018: 0.042" / 1.07mm | | Extreme 018: 0.049" /<br>1.24mm |
| | 035 Straight & Angled:<br>0.061" / 1.55mm | | Extreme 035 Straight:<br>0.064" / 1.63mm |
| | | | Select 035 Angled:<br>0.064" / 1.63mm |
| Distal Tip<br>Angulation | 014: N/A | N/A | Extreme 018: N/A |
| | 018: N/A | | Extreme 035 Straight:<br>N/A |
| | 035 Straight: N/A | | Select 035 Angled: 45° |
| | 035 Angled: 30° | | |
| Angled Tip<br>Length | 014: N/A | N/A | Extreme 018: N/A |
| | 018: N/A | | Extreme 035 Straight:<br>N/A |
| | 035 Straight: N/A | | |
| Characteristic | ViperCross™<br>Support Catheters<br>(Subject Device) | SuperCross™<br>Microcatheter<br>(Predicate for 014<br>Straight Model) | Quick-Cross<br>Extreme & Quick-<br>Cross Select<br>(Predicate for 018<br>Straight & 035<br>Straight/Angled<br>Models) |
| | 035 Angled: 1.2cm | | Select 035 Angled:<br>7mm |
| Shaft<br>Construction | Coiled | Coiled | Coiled |
| Packaging | Mylar / Tyvek Pouch | Tyvek Pouch | Tyvek Pouch |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for CSI, which is a company that provides software and technology solutions for the financial industry. The logo consists of the letters "CSI" in a stylized font, with a green arc underneath. The letters are gray, and the arc is green. The logo is simple and modern, and it conveys a sense of innovation and technology.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for CSI. The logo consists of the letters "CSI" in a sans-serif font, with the letters in gray. Underneath the letters is a green curved line. To the right of the letter "I" is a registered trademark symbol.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Cardiovascular Systems, Inc. The logo consists of the letters "CSI" in a gray sans-serif font, with a green arc underneath. To the right of the letters is a vertical line, followed by the words "CARDIOVASCULAR SYSTEMS, INC." in a smaller, gray sans-serif font. The logo is simple and modern, and the use of green suggests a connection to health and wellness.

The ViperCross™ Support Catheter is substantially equivalent to the predicate device, SuperCross Microcatheter, (K101659) and Quick-Cross Extreme Support Catheter, (K082561). The ViperCross™ Support Catheter, SuperCross Microcatheter, and the Quick-Cross Extreme Support Catheter provide in conjunction with a steerable guidewire, provide access to discrete regions of the coronary and/or peripheral vasculature.

## PERFORMANCE TESTING

The ViperCross™ Support Catheter was thoroughly tested and verifies that it performs as designed and is suitable for it intended use.

Performance Testing included the following:

- · Working length
- · Overall length
- Distal shaft outer diameter
- Proximal shaft outer diameter
- Inner diameter
- Radiopacity of tip
- · Contrast injection
- Leak test air aspiration
- · Liquid leak resistance
- · High pressure leak test
- · Surface finish
- · Particulate
- · Corrosion resistance
- Trackability / simulated use
- · Torque transmission
- Kink resistance
- · Tip flexibility

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for Cardiovascular Systems, Inc. The logo consists of the letters "CSI" in a gray, sans-serif font, with a green arc underneath. To the right of the letters, separated by a vertical line, is the text "CARDIOVASCULAR SYSTEMS, INC." also in gray.

- · Tensile strength
- Luer hub fitting
- 035 only Tip Angle

Biocompatibility per ISO 10993-1 for an external communicating device, limited (<24 hour) blood contacting device.

- · ASTM Hemolysis assay
- · Heparinized blood platelet and leukocyte count assay
- · Partial thromboplastin Time (PTT) assay
- · Complement activation assay
- · MEM Elution cytotoxicity assay
- · Material meditated pyrogenicity test
- · Acute systemic toxicity test
- · Intracutaneous reactivity test
- · Guinea pig maximization test
- · In-vitro blood loop assay with comparison article

All testing met the requirements and passed. There are no new questions raised regarding safety or efficacy of the ViperCross™ Support Catheter.

## CONCLUSION:

The ViperCross™ Support Catheter is substantially equivalent in design, materials, sterilization, principles of operation, performance and indications for use to the cited predicate.