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 Description

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.

AI/ML Overview

The provided text (K220568 510(k) Summary) describes a medical device, the Diamondback 360® Peripheral Orbital Atherectomy System, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria related to AI or algorithmic performance.

The document outlines:

Device Description: A percutaneous orbital atherectomy system designed to remove occlusive material from peripheral arteries and arteriovenous dialysis fistulae.
Comparison to Predicate Device: The current device is "identical" to the predicate device in terms of indication for use, vessel diameter range, principles of operation, sterilization methods, single-use nature, and performance specifications. The only described difference is a change in the diamond size used in the crown coating (from 30-micron to 70-micron diamonds). A minor update to the Indications for Use is mentioned, stating that the 2.00 Max Crown has not been tested for removal of stenotic material from AV shunts.
Testing Conducted: Biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility) and bench testing (stall, tight stenosis, life, coating integrity, tensile verification, orbit characterization, temperature and flow verification, particulate testing, corrosion testing, GLP animal testing). These tests are stated to "verify that the design meets all product specifications and address the potential safety hazards."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving algorithmic performance because the document does not discuss:

Acceptance criteria for an AI/algorithmic medical device.
A test set, training set, or data provenance for an AI/algorithmic study.
Expert involvement for ground truth establishment or adjudication for an AI/algorithmic study.
MRMC comparative effectiveness studies or standalone algorithm performance.
The type of ground truth used in the context of AI/algorithmic performance.

The document is a 510(k) submission for a physical medical device (atherectomy system) that functions mechanically, not through an AI/algorithmic component. The testing described is typical for a mechanical medical device to demonstrate safety and effectiveness and substantial equivalence to a predicate device.

Summary

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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 on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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 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)

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

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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)1225 Old Highway 8 NWSt. Paul, MN 55112
Contact Person:	Kris MillerPrincipal Regulatory Affairs SpecialistCardiovascular Systems Inc.1225 Old Highway 8 NWSt. Paul, MN 55112Phone: 612-999-3749kmiller@csi360.com
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 andSafety Testing:	Biocompatibility TestingThe biocompatibility evaluation includes the following tests:
	Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Systemic Toxicity Pyrogenicity Hemocompatibility
Bench TestingThe following bench tests were conducted in accordance withapplicable 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 thedesign meets all product specifications and address thepotential safety hazards that have been identified.

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	K220568
Comparison toPredicate Device:	The modified Diamondback 360® [Stealth 360®] PeripheralOrbital Atherectomy System [Exchangeable Series] devicesare 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 thepredicate device and the currently marketed 2.00 Solidcrown is the size of the diamonds used in the crown coating.The currently marketed crowns are coated with 30-microndiamonds whereas the proposed crown will use 70-microndiamonds.
	The crown diamond coating process is intended to leaveapproximately one-third of the diamond exposed, such thata 30-micron diamond has about 10-microns exposed as asanding surface. Therefore, the change from 30-micron to70-micron diamonds results in an approximately 13-microns in exposed diamond on the crown surface.
	There is a minor update to the Indications for Use statementas the 2.00 Max Crown has not been tested to supportremoval of stenotic material from artificial arteriovenousdialysis fistulae (AV shunt).
	No other changes will be made to the devices. The current2.00 Solid Crown and the proposed 2.00 Max Crown maybe used to treat lesions in larger vessels such as the SuperiorFemoral Artery (SFA) or Common Femoral Artery (CFA).In these larger vessels, lesions tend to be less calcified.
Conclusion:	The data provided supports substantial equivalence for theDiamondback [STEALTH] [Exchangeable Series] 360®Peripheral Orbital Atherectomy System compared to thepredicate device. The testing results demonstrate that the devicesperform as intended under the specified use conditions

Regulation Number and Section

§ 870.4875 Intraluminal artery stripper.

(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).