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 Description

The DIAMONDBACK 360 Peripheral Orbital Atherectomy System (OAS) Exchangeable Series is designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown. The DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series consists of the following main components:

Reusable Saline Pump (provided non-sterile)
Single-use Orbital Atherectomy Device (OAD) (provided sterile). The Exchangeable Series OAD consists of a physician-operated handle and an interchangeable crown cartridge.
Single-use Atherectomy lubricant (provided sterile)
Single-use Atherectomy guide wire (provided sterile)

AI/ML Overview

This document describes the Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series (K182397) and its acceptance criteria as proven by a study.

Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific, quantifiable acceptance criteria values or a direct table comparing them to reported device performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K152694) through a series of performance/bench tests and biocompatibility tests. The conclusion states that the data supports "no new questions of safety or effectiveness...compared to the predicate device" and that "the mechanical testing results demonstrate that the device should perform as intended in the specified use conditions."

Therefore, the acceptance criteria implicitly involve the device successfully passing all listed performance and biocompatibility tests, demonstrating performance comparable to the predicate device, and not raising new safety or effectiveness concerns.

Given the information, a table of acceptance criteria and reported device performance would be structured as follows, with the "Reported Device Performance" reflecting the successful completion of these tests:

Acceptance Criteria Category	Specific Test/Criterion	Reported Device Performance
Biocompatibility	Cytotoxicity	Passed
	Sensitization	Passed
	Irritation/Intracutaneous Reactivity	Passed
	Systemic Toxicity	Passed
	Pyrogenicity	Passed
	Hemolysis Study	Passed
Device Performance/Bench Testing	Track Verification Testing	Passed
	Stall / Life and Tight Stenosis Verification Testing	Passed
	Device Pre-Conditioning Verification Testing	Passed
	Handle Potting and Switch Mount Base and Process Updates	Verified/Passed
	Handle Life Verification Testing	Passed
	Tensile Verification Testing	Passed
	Temperature and Saline Flow Life Verification Testing	Passed
	Dimensional and Weight Verification Testing	Passed
	Glide Start Up Life Verification Testing	Passed
	Orbit Characterization Testing	Passed
	Switch Logic Verification Testing	Passed
	Miscellaneous Verification Testing: Traverse Force, Knob Lock Force, Exchange Durability, Guidewire Back Loading	Passed
	Usability/human factors Testing	Passed

Study Information

The document describes performance (bench) testing and biocompatibility testing to demonstrate substantial equivalence, rather than a clinical study with human subjects.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of devices. For bench testing, typically multiple units are tested to ensure consistency and robustness, but the exact quantity is not detailed in this summary. For biocompatibility tests, samples of materials from the device are used.
- Data Provenance: The document does not specify the country of origin for the data directly, but the submission is from "Cardiovascular Systems Inc." located in "St. Paul, MN, USA". The testing is described as "bench tests" and "biocompatibility evaluation," indicating laboratory-based studies, not retrospective or prospective human subject data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This question is not applicable in the context of this submission. The "ground truth" for demonstrating substantial equivalence of a medical device like this relies on objective engineering and scientific principles, validated test methods, and compliance with applicable standards and guidance (e.g., ISO standards for biocompatibility). There are no "experts" establishing a subjective ground truth for a test set in the way one might for diagnostic imaging.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are typically used in clinical trials involving human endpoints or expert interpretation of data. For bench and biocompatibility testing, the results are typically objectively measured and evaluated against predetermined pass/fail criteria, not adjudicated by a panel of experts.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable. MRMC studies are specific to diagnostic imaging devices where human readers interpret medical images. This submission is for an atherectomy system, not an imaging device with AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The Diamondback 360 Peripheral Orbital Atherectomy System is a physical medical device for performing a surgical procedure, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this submission is based on objective engineering measurements and scientific principles, verified through standardized bench testing and biocompatibility assessments, and evaluated against established performance specifications and regulatory standards. The goal is to demonstrate that the device performs equivalently to the predicate device in terms of safety and effectiveness, based on its physical and biological properties.
The sample size for the training set:
- This is not applicable. There is no mention of a "training set" as this is not an artificial intelligence/machine learning device. The device itself is subject to performance testing, not trained on data.
How the ground truth for the training set was established:
- This is not applicable, as there is no training set mentioned in the context of this device.

Summary

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

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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510(k) Summary / Statement

510k Number	K182397
Submitter:	Cardiovascular Systems Inc.1225 Old Highway 8 NWSt. Paul, MN 55112
Contact Person:	Kris MillerSr. Regulatory Affairs SpecialistCardiovascular Systems Inc.1225 Old Highway 8 NWSt. Paul, MN 55112USAPhone: 651-259-1656Fax: 651-259-2094kmiller@csi360.com
Date Prepared:	August 31, 2018
Trade Name:	Diamondback 360® Peripheral Orbital Atherectomy SystemExchangeable Series
Common Name:	Intraluminal Artery Stripper
Classification:	Class II, 21 CFR 870.4875
Product Code:	MCW
Predicate Device:	K152694 - Diamondback 360® Peripheral Orbital AtherectomySystem (Cardiovascular Systems, Inc.)
Device Description:	The DIAMONDBACK 360 Peripheral Orbital AtherectomySystem (OAS) Exchangeable Series is designed to remove orreduce occlusive material and restore luminal patency by usingan orbiting, diamond-coated, eccentrically mounted crown.The DIAMONDBACK 360 Peripheral Orbital AtherectomySystem Exchangeable Series consists of the following maincomponents:
	1. Reusable Saline Pump (provided non-sterile)2. Single-use Orbital Atherectomy Device (OAD)(provided sterile). The Exchangeable Series OADconsists of a physician-operated handle and aninterchangeable crown cartridge.3. Single-use Atherectomy lubricant (provided sterile)4. Single-use Atherectomy guide wire (provided sterile)Mechanism of Action
	The Exchangeable Series mechanism of action is identical to thepredicate device and defined by:
	• Centrifugal force• Orbital rotation• Differential sanding• Bi-directional sanding
	The rapidly rotating eccentric crown creates a centrifugal forcethat presses the diamond-coated crown against the calcifiedplaque. With each pass of the crown, plaque is reduced and thediameter of the orbit increases.
Indications for Use:	The Diamondback 360 Peripheral Orbital Atherectomy SystemExchangeable Series is a percutaneous orbital atherectomysystem indicated for use as therapy in patients with occlusiveatherosclerotic disease in peripheral arteries and who areacceptable candidates for percutaneous transluminalatherectomy.The Exchangeable Series OAS supports removal of stenoticmaterial from artificial arteriovenous dialysis fistulae (AVshunt). The system is a percutaneous orbital atherectomy systemindicated as a therapy in patients with occluded hemodialysisgrafts who are acceptable candidates for percutaneoustransluminal angioplasty.
Comparison withPredicate Device:	The Exchangeable Series OAS has the same intended use,mechanism of action and indications for use as the predicatedevice.All Exchangeable OADs use the same base handle to which acrown cartridge is attached. The only differences between thevarious crown cartridges are the length of the drive shaft and thesize and style of the crown on each model. With theExchangeable Series OAS, up to 3 crowns can be used with asingle handle.An additional length of drive shaft has been added to theDIAMONDBACK 360 Peripheral Orbital Atherectomy System(OAS) Exchangeable Series. The 75cm drive shaft materials andconstruction are identical to the currently cleared CSI drive shaftdevices.
	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:	Biocompatibility Testing
	The biocompatibility evaluation for the Exchangeable OAD
	device included the following tests:
	● Cytotoxicity
	● Sensitization
	● Irritation/Intracutaneous Reactivity
	● Systemic Toxicity
	● Pyrogenicity
	● Hemolysis Study

	Performance/Bench Testing
	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 OrbitalAtherectomy System Exchangeable Series compared to thepredicate device. The mechanical testing results demonstrate thatthe device should perform as intended in the specified useconditions.

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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).