ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System

K180416 · Cardiovascular Systems, Inc. · MCW · Apr 17, 2018 · Cardiovascular

Device Facts

• Record ID: K180416
• Device Name: ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
• Applicant: Cardiovascular Systems, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Apr 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

Device Story

ViperWire Advance Flex Tip Peripheral Guide Wire is a component of the Diamondback 360 and Stealth 360 Orbital Atherectomy Systems (OAS). The guide wire provides a center of rotation and positioning for the device's eccentrically rotating diamond-coated crown. During procedure, the crown removes stenotic material from peripheral arteries or AV shunts; particles are small enough for bodily absorption. The system includes an Orbital Atherectomy Device (OAD), saline infusion pump, and lubricant. Used in clinical settings by physicians to treat peripheral artery disease and graft occlusions. The guide wire ensures precise crown placement within the vessel. Benefits include removal of stenotic material to restore blood flow.

Clinical Evidence

Bench testing only. Evaluations included manual track, torque transfer/strength, life, orbit, tensile (ISO 11070), tip flexibility, transfer force, corrosion/flex/fracture (ISO 11070), particulate (USP 788), biocompatibility (ISO 10993), OAS flow, OAS pump functional tests, and EMC (IEC 60601-1-2:2014). Results met all predetermined acceptance criteria.

Technological Characteristics

Guide wire: stainless steel core, silicone coating, radiopaque platinum/tungsten distal spring tip. Lengths: 335 cm and 475 cm. Diameter: .014" and .018". Sensing/actuation: mechanical rotation of diamond-coated crown. Connectivity: standalone system. Sterilization: not specified. Software: OAS pump updated for IEC 60601-1-2:2014 compliance.

Indications for Use

Indicated for patients with occlusive atherosclerotic disease in peripheral arteries or occluded hemodialysis grafts (AV shunts) who are candidates for percutaneous transluminal atherectomy or angioplasty.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• Stealth 360 PAD System and Diamondback 360 Peripheral Orbital Atherectomy System (K151260)
• Diamondback 360 Peripheral Orbital Atherectomy System (K170792)

Submission Summary (Full Text)

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

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

April 17, 2018

Cardiovascular Systems, Inc. Ms. Susan Wolf Regulatory Affairs Manager 1225 Old Highway 8 NW Saint Paul, Minnesota 55112

#### Re: K180416

Trade/Device Name: ViperWire Advance Flex Tip Peripheral Guide Wire (OAS component of: Diamondback 360 Peripheral Orbital Atherectomy System and Stealth 360 PAD System) Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: February 14, 2018 Received: February 15, 2018

Dear Ms. Wolf:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

M.A. Hillemann

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

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K180416

#### Device Name

ViperWire Advance Flex Tip Peripheral Guide Wire

(OAS component of: Diamondback 360 Peripheral Orbital Atherectomy System and Stealth 360 PAD System)

#### Indications for Use (Describe)

The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:12px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size:12px">☐ 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 [e-mail]

"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/1 description: The image shows the logo for Cardiovascular Systems, Inc. The logo consists of the letters "CSI" in a bold, 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.

# 510(K) SUMMARY

| Company Name: | Cardiovascular Systems, Inc.<br>1225 Old Highway 8 NW<br>Saint Paul, MN 55112 | | |
|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--|
| Contact: | Susan Wolf, RAC | | |
| Phone: | [phone] | | |
| Fax: | [phone] | | |
| Summary Date: | April 16, 2018 | | |
| Trade Name: | ViperWire Advance Flex Tip Peripheral Guide Wire<br>(OAS component of: Diamondback 360® Peripheral Orbital<br>Atherectomy System and Stealth 360® PAD System) | | |
| Product Code:<br>Classification Regulation:<br>Stripper Classification:<br>Primary Predicate: | MCW—Catheter, Peripheral, Atherectomy<br>21 CFR 870.4875—Intraluminal Artery<br>II | | |
| | 510(k) Number:<br>Manufacturer:<br>Trade Name: | K151260<br>Cardiovascular Systems, Inc.<br>Stealth 360® PAD System and Diamondback<br>360® Peripheral Orbital Atherectomy System | |

Additional Reference Predicate:

| 510(k) Number: | K170792 |
|----------------|-----------------------------------------------------------|
| Manufacturer: | Cardiovascular Systems, Inc. |
| Trade Name: | Diamondback 360® Peripheral Orbital<br>Atherectomy System |

## Description of Device

The atherectomy guide wire is a component that is part of the Stealth 360 Orbital PAD System and Diamondback 360 Peripheral Orbital Atherectomy System. The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System (OAS) are intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Stealth 360 and the Diamondback 360 use an eccentrically rotating surface (crown) to remove stenotic material on the vessel wall. The stenotic particles that are removed are small enough to be absorbed by the body. In addition to the atherectomy guide wire, the

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

Stealth 360® Orbital PAD System and the Diamondback 360® Peripheral Orbital Atherectomy System consists of the following components: Orbital Atherectomy Device (OAD), Saline Infusion Pump, and Atherectomy Lubricant (e.g., ViperSlide).

#### Description of Change

Guide wire component modification and additional guidewire lengths and updates to the OAS pump to comply with IEC 60601-1-2:2014 (4th edition).

# Indications For Use

The Stealth 360® Orbital PAD System and the Diamondback 360® Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

# Technology

The Stealth 360® Orbital PAD System and the Diamondback 360® Peripheral Orbital Atherectomy System provide a method of removing or reducing occlusive atherosclerotic or stenotic material. The OAS applies a diamond coated, eccentrically rotating sanding surface to remove stenotic material on the vessel wall. The stenotic particles that are removed are small enough to be absorbed by the body. The ViperWire Advance FlexTip Guide Wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the device crown within peripheral arteries and provides a center of rotation for the device drive shaft. These extended length guide wires use the same technology as the previously cleared Stealth 360® Orbital PAD.

| Specifications | | | | |
|---------------------------------------------|-----------------------|-----------------------|-----------------------|-----------------------|
| | | | VPR-GW-ELFT14 | VPR-GW-ELFT18 |
| VIPERWIRE ADVANCE Guide Wire Specifications | | | | |
| Guidewire Length | 335 cm | 335 cm | 475 cm | 475 cm |
| Guidewire Coating | Silicone | Silicone | Silicone | Silicone |
| Core wire diameter | .014" | .014" | .014" | .014" |
| Core wire material | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel |
| Spring Tip Length | 3 cm | 3 cm | 3 cm | 3 cm |
| Spring Tip | .014" | .018" | .014" | .018" |
| Diameter | | | | |
| Spring Tip Material | Platinum/<br>Tungsten | Platinum/<br>Tungsten | Platinum/<br>Tungsten | Platinum/<br>Tungsten |
| Spring Tip Shape | Straight | Straight | Straight | Straight |

# Snecifications

## Performance Data

The ViperWire Advance FlexTip Guide Wire was evaluated using the following performance bench testing to confirm the performance characteristics as compared to the predicate device.

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

- Manual Track Testing ●
- Torque Transfer Testing
- Torque Strength Testing ●
- Life Testing
- Orbit Testing
- Tensile Testing ISO 11070
- Tip Flexibility Testing
- Transfer Force Test ●
- ISO Corrosion, Flex, and Fracture Test ISO 11070
- Particulate USP <788>
- Biocompatibility ISO 10993
- . OAS Flow Tests
- OAS Pump Functional Tests
- IEC 60601-1-2:2014 (4th edition) ●

All test results demonstrate that the materials chosen, the manufacturing processes, and the design utilized for the ViperWire Advance FlexTip Guide Wire and OAS pump met the established specifications necessary for consistent performance during its intended use.

## Conclusion

The ViperWire Advance Flex Tip Guide Wire and OAS pump met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs. Testing results demonstrate that the ViperWire AdvanceFlex Tip Guide Wire and OAS pump used with the Stealth 360® Orbital PAD System and Diamondback 360® Peripheral Orbital Atherectomy System is substantially equivalent to the legally marketed predicate device, does not raise any new safety or effectiveness questions, and performs as well as the predicate device.