Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

K182397 · Cardiovascular Systems, Inc. · MCW · Dec 13, 2018 · Cardiovascular

Device Facts

• Record ID: K182397
• Device Name: Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
• Applicant: Cardiovascular Systems, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Dec 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Percutaneous orbital atherectomy system for removal of stenotic material in peripheral arteries and AV dialysis fistulae. System comprises reusable saline pump, single-use handle, interchangeable crown cartridges, lubricant, and guide wire. Physician-operated; utilizes centrifugal force, orbital rotation, and differential/bi-directional sanding. Rapidly rotating eccentric diamond-coated crown presses against calcified plaque; plaque reduction increases orbit diameter with each pass. Enables use of up to three different crowns with a single handle. Benefits include restoration of luminal patency in occluded vessels/grafts.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis) and extensive performance verification (track, stall/life, tight stenosis, pre-conditioning, handle life, tensile, temperature/saline flow, dimensional/weight, glide start-up, orbit characterization, switch logic, traverse force, knob lock force, exchange durability, guidewire back loading, and usability/human factors).

Technological Characteristics

System consists of a reusable saline pump and single-use orbital atherectomy device (handle and interchangeable crown cartridges). Features diamond-coated, eccentrically mounted rotating crown. Driven by centrifugal force. Includes single-use lubricant and guide wire. Materials and construction for the 75cm drive shaft are identical to previously cleared devices. Sterilization applies to single-use components.

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

• Diamondback 360 Peripheral Orbital Atherectomy System (K152694)

Submission Summary (Full Text)

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December 13, 2018

Cardiovascular Systems Inc. Kris Miller Sr. Regulatory Specialist 1225 Old Highway 8 NW St. Paul, Minnesota 55112

## Re: K182397

Trade/Device Name: Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: November 6, 2018 Received: November 7, 2018

Dear Ms. Miller:

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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 medical devices and radiation-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,

Gregory O'Connell 2018.12.13 14:39:01 -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) K182397

Device Name

Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

Indications for Use (Describe)

The Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The Exchangeable Series OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system 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) |
|-------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary / Statement

| 510k Number | K182397 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Cardiovascular Systems Inc.<br>1225 Old Highway 8 NW<br>St. Paul, MN 55112 |
| Contact Person: | Kris Miller<br>Sr. Regulatory Affairs Specialist<br>Cardiovascular Systems Inc.<br>1225 Old Highway 8 NW<br>St. Paul, MN 55112<br>USA<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | August 31, 2018 |
| Trade Name: | Diamondback 360® Peripheral Orbital Atherectomy System<br>Exchangeable Series |
| Common Name: | Intraluminal Artery Stripper |
| Classification: | Class II, 21 CFR 870.4875 |
| Product Code: | MCW |
| Predicate Device: | K152694 - Diamondback 360® Peripheral Orbital Atherectomy<br>System (Cardiovascular Systems, Inc.) |
| Device Description: | The DIAMONDBACK 360 Peripheral Orbital Atherectomy<br>System (OAS) Exchangeable Series is designed to remove or<br>reduce occlusive material and restore luminal patency by using<br>an orbiting, diamond-coated, eccentrically mounted crown.<br>The DIAMONDBACK 360 Peripheral Orbital Atherectomy<br>System Exchangeable Series consists of the following main<br>components: |
| | 1. Reusable Saline Pump (provided non-sterile)<br>2. Single-use Orbital Atherectomy Device (OAD)<br>(provided sterile). The Exchangeable Series OAD<br>consists of a physician-operated handle and an<br>interchangeable crown cartridge.<br>3. Single-use Atherectomy lubricant (provided sterile)<br>4. Single-use Atherectomy guide wire (provided sterile)<br>Mechanism of Action |
| | The Exchangeable Series mechanism of action is identical to the<br>predicate device and defined by: |
| | • Centrifugal force<br>• Orbital rotation<br>• Differential sanding<br>• Bi-directional sanding |
| | The rapidly rotating eccentric crown creates a centrifugal force<br>that presses the diamond-coated crown against the calcified<br>plaque. With each pass of the crown, plaque is reduced and the<br>diameter of the orbit increases. |
| Indications for Use: | The Diamondback 360 Peripheral Orbital Atherectomy System<br>Exchangeable Series is a percutaneous orbital atherectomy<br>system indicated for use as therapy in patients with occlusive<br>atherosclerotic disease in peripheral arteries and who are<br>acceptable candidates for percutaneous transluminal<br>atherectomy.<br><br>The Exchangeable Series OAS supports removal of stenotic<br>material from artificial arteriovenous dialysis fistulae (AV<br>shunt). The system is a percutaneous orbital atherectomy system<br>indicated as a therapy in patients with occluded hemodialysis<br>grafts who are acceptable candidates for percutaneous<br>transluminal angioplasty. |
| Comparison with<br>Predicate Device: | The Exchangeable Series OAS has the same intended use,<br>mechanism of action and indications for use as the predicate<br>device.<br><br>All Exchangeable OADs use the same base handle to which a<br>crown cartridge is attached. The only differences between the<br>various crown cartridges are the length of the drive shaft and the<br>size and style of the crown on each model. With the<br>Exchangeable Series OAS, up to 3 crowns can be used with a<br>single handle.<br><br>An additional length of drive shaft has been added to the<br>DIAMONDBACK 360 Peripheral Orbital Atherectomy System<br>(OAS) Exchangeable Series. The 75cm drive shaft materials and<br>construction are identical to the currently cleared CSI drive shaft<br>devices. |
| | There has been a change in materials that are in the indirect |
| | patient contact pathway. These new components are located |
| | inside the cartridge housing. |
| | |
| Performance Data: | <b>Biocompatibility Testing</b> |
| | The biocompatibility evaluation for the Exchangeable OAD |
| | device included the following tests: |
| | ● Cytotoxicity |
| | ● Sensitization |
| | ● Irritation/Intracutaneous Reactivity |
| | ● Systemic Toxicity |
| | ● Pyrogenicity |
| | ● Hemolysis Study |
| | |
| | <b>Performance/Bench Testing</b> |
| | The following bench tests on the Diamondback 360 Peripheral |
| | Orbital Atherectomy System Exchangeable Series were |
| | conducted in accordance with applicable standards and |
| | guidance. |
| | ● Track Verification Testing |
| | ● Stall / Life and Tight Stenosis Verification Testing |
| | ● Device Pre-Conditioning Verification Testing |
| | ● Handle Potting and Switch Mount Base and Process |
| | Updates |
| | ● Handle Life Verification Testing |
| | ● Tensile Verification Testing |
| | ● Temperature and Saline Flow Life Verification Testing |
| | ● Dimensional and Weight Verification Testing |
| | ● Glide Start Up Life Verification Testing |
| | ● Orbit Characterization Testing |
| | ● Switch Logic Verification Testing |
| | ● Miscellaneous Verification Testing: Includes the |
| | following tests: |
| | Ο Traverse Force |
| | Ο Knob Lock Force |
| | Ο Exchange Durability |
| | Ο Guidewire Back Loading |
| | ● Usability/human factors Testing |
| | These tests performed are intended to verify that the design |
| | meets all product specifications and address the potential safety |
| | hazards that have been identified. |
| | |
| Conclusion: | The data provided supports no new questions of safety or effectiveness of the Diamondback 360 Peripheral Orbital<br>Atherectomy System Exchangeable Series compared to the<br>predicate device. The mechanical testing results demonstrate that<br>the device should perform as intended in the specified use<br>conditions. |

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