Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

K220568 · Cardiovascualr Systems, Inc. · MCW · Apr 27, 2022 · Cardiovascular

Device Facts

• Record ID: K220568
• Device Name: Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
• Applicant: Cardiovascualr Systems, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Apr 27, 2022
• 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 is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerosis disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS SOLID, CLASSIC and MICRO crowns support removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectorny system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty. *The 2.00 Max Crown has not been tested to support removal of stenovenous dialysis fistulae (AV shunt). The Stealth 360® Peripheral Orbital Atherectomy System 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 OAS SOLID, CLASSIC and MICRO crowns support 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. *The 2.00 Max Crown has not been tested to support removal of stenotic materiovenous dialysis fistulae (AV shunt). The Diamondback 360® Peripheral Orbital Atherectorny 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 OAS SOLID, CLASSIC and MICRO crowns support 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. *The 2.00 Max Crown has not been tested to support removal of stenovenous dialysis fistulae (AV shunt).

Device Story

Percutaneous orbital atherectomy system; removes/reduces occlusive material in peripheral arteries and AV fistulae. System components: reusable saline pump, single-use orbital atherectomy device, lubricant, guide wire. Principle: orbiting, diamond-coated, eccentrically mounted crown abrades stenotic material to restore luminal patency. Operated by physicians in clinical settings. Output: physical removal of plaque/stenotic material. Benefit: restoration of blood flow in peripheral vasculature and dialysis access sites. Modification: transition from 30-micron to 70-micron diamond coating on 2.00 Max crown to increase sanding surface exposure.

Clinical Evidence

Bench testing only. Includes biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility) and performance testing (stall, tight stenosis, life, coating integrity, tensile, orbit characterization, temperature/flow, particulate, corrosion). GLP animal testing performed to verify design specifications and safety.

Technological Characteristics

Orbital atherectomy system; diamond-coated eccentrically mounted crown; reusable saline pump; single-use components. Materials: diamond-coated crown. Energy: mechanical (orbital rotation). Connectivity: N/A. Sterilization: standard method (SAL specified).

Indications for Use

Indicated for patients with occlusive atherosclerotic disease in peripheral arteries or occluded hemodialysis grafts 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/Stealth (K203008)
• Exchangeable (K203008)

Reference Devices

• Predator (K090521)

Submission Summary (Full Text)

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April 27, 2022

Cardiovascualr Systems Inc. Kris Miller Principal Regulatory Specialist 1225 Old Highway 8 NW New Brighton, Minnesota 55112

#### Re: K220568

Trade/Device Name: Diamondback 360® Peripheral Orbital Atherectomy System, Stealth 360® Peripheral Orbital Atherectomy System, 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: February 25, 2022 Received: February 28, 2022

### Dear Kris 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.

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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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/cdrh-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

Gregory O'Connell 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

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## Indications for Use

510(k) Number (if known)

#### K220568

Device Name Diamondback 360® Peripheral Orbital Atherectomy System Stealth 360® Peripheral Orbital Atherectomy System Diamondback 360® Peripheral Orbital Atherectomy System, Exchangeable Series

Indications for Use (Describe)

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

The OAS SOLID, CLASSIC and MICRO crowns support removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectorny system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty. *The 2.00 Max Crown has not been tested to support removal of stenovenous dialysis fistulae (AV shunt).

The Stealth 360® Peripheral Orbital Atherectomy System 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 OAS SOLID, CLASSIC and MICRO crowns support 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. *The 2.00 Max Crown has not been tested to support removal of stenotic materiovenous dialysis fistulae (AV shunt).

The Diamondback 360® Peripheral Orbital Atherectorny 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 OAS SOLID, CLASSIC and MICRO crowns support 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. *The 2.00 Max Crown has not been tested to support removal of stenovenous dialysis fistulae (AV shunt).

Type of Use (Select one or both, as applicable)

| <div> <span></span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|--------------------------------------------------------------------------------|
| <div> <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/0 description: The image shows the logo for CSI. The logo consists of the letters "CSI" in a sans-serif font, with the "C" and "S" connected and the "I" standing separately. Below the letters is a curved green line, resembling a smile or an arc. The letters are in a muted gray color.

# 510(k) Summary

| Submitter: | Cardiovascular Systems Inc. (CSI)<br>1225 Old Highway 8 NW<br>St. Paul, MN 55112 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kris Miller<br>Principal Regulatory Affairs Specialist<br>Cardiovascular Systems Inc.<br>1225 Old Highway 8 NW<br>St. Paul, MN 55112<br>Phone: [phone]<br>[e-mail] |
| Date Prepared: | February 25, 2022 |
| Trade Name: | Diamondback 360® Peripheral Orbital Atherectomy System Stealth 360® Peripheral Orbital Atherectomy System Diamondback 360® Peripheral Orbital Atherectomy System Exchangeable Series |
| Common Name: | Intraluminal Artery Stripper |
| Classification: | Class II, 21 CFR 870.4875 |
| Product Code: | MCW |
| Predicate Device(s): | Diamondback/Stealth = K203008 Exchangeable = K203008 Reference Device Predator = K090521 |

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#### K220568

Image /page/4/Picture/3 description: This document describes the Diamondback [STEALTH] [Exchangeable Series] Peripheral Orbital Atherectomy Systems (OAS). The OAS is designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown. The document lists the main components of the OAS, including a reusable saline pump, a single-use orbital atherectomy device, a single-use atherectomy lubricant, and a single-use atherectomy guide wire. The document also describes the mechanism of action and indications for use of the OAS.

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Image /page/5/Picture/0 description: The image shows the logo for CSI. The logo consists of the letters "CSI" in a gray, sans-serif font. Below the letters is a curved, green shape that resembles a wave or an arc. The letters are slightly rounded, giving the logo a modern and approachable feel.

| Functional and<br>Safety Testing: | Biocompatibility Testing<br>The biocompatibility evaluation includes the following tests: |
|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Systemic Toxicity Pyrogenicity Hemocompatibility |
| Bench Testing<br>The following bench tests were conducted in accordance with<br>applicable standards and guidance. | |
| | Stall, Tight Stenosis, Life, Coating Integrity, Tensile Verification Testing Orbit Characterization Testing Temperature and Flow Verification Testing Particulate Testing Corrosion Testing GLP Animal Testing |
| | These tests performed are intended to verify that the<br>design meets all product specifications and address the<br>potential safety hazards that have been identified. |

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| | K220568 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to<br>Predicate Device: | The modified Diamondback 360® [Stealth 360®] Peripheral<br>Orbital Atherectomy System [Exchangeable Series] devices<br>are identical to the predicate devices as follows: |
| | • Same regulation number, product code and classification |
| | • Same intended use |
| | • Same vessel diameter range and anatomic location of use |
| | • Same principles of operation |
| | • Same sterilization method and SAL |
| | • Same number of uses per device (single use) |
| | • Same performance specifications |
| | The only difference between the cleared crown in the<br>predicate device and the currently marketed 2.00 Solid<br>crown is the size of the diamonds used in the crown coating.<br>The currently marketed crowns are coated with 30-micron<br>diamonds whereas the proposed crown will use 70-micron<br>diamonds. |
| | The crown diamond coating process is intended to leave<br>approximately one-third of the diamond exposed, such that<br>a 30-micron diamond has about 10-microns exposed as a<br>sanding surface. Therefore, the change from 30-micron to<br>70-micron diamonds results in an approximately 13-<br>microns in exposed diamond on the crown surface. |
| | There is a minor update to the Indications for Use statement<br>as the 2.00 Max Crown has not been tested to support<br>removal of stenotic material from artificial arteriovenous<br>dialysis fistulae (AV shunt). |
| | No other changes will be made to the devices. The current<br>2.00 Solid Crown and the proposed 2.00 Max Crown may<br>be used to treat lesions in larger vessels such as the Superior<br>Femoral Artery (SFA) or Common Femoral Artery (CFA).<br>In these larger vessels, lesions tend to be less calcified. |
| Conclusion: | The data provided supports substantial equivalence for the<br>Diamondback [STEALTH] [Exchangeable Series] 360®<br>Peripheral Orbital Atherectomy System compared to the<br>predicate device. The testing results demonstrate that the devices<br>perform as intended under the specified use conditions |