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

Q: Who is the manufacturer of DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System?

Cardiovascular Systems, Inc. filed the 510(k) submission for DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System (K203008).

Q: What is the FDA product code for DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System?

MCW. It is classified under 21 CFR 870.4875 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K203008 · Cardiovascular Systems, Inc. · MCW · Nov 19, 2020 · Cardiovascular

Device Facts

Record ID	K203008
Device Name	DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
Applicant	Cardiovascular Systems, Inc.
Product Code	MCW · Cardiovascular
Decision Date	Nov 19, 2020
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 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 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 Stealth 360® Peripheral Orbital Atherectorny 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 supports 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 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; removes/reduces occlusive material in peripheral arteries and AV dialysis fistulae. Components: reusable saline pump, single-use orbital atherectomy device (OAD) with physician-operated handle and interchangeable crown cartridge, lubricant, and guide wire. Mechanism: centrifugal force, orbital rotation, differential sanding, and bi-directional sanding via diamond-coated, eccentrically mounted crown. Used in clinical settings by physicians to restore luminal patency. Benefits: removal of stenotic material to improve blood flow.

Clinical Evidence

Bench testing only. Testing included biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, complement activation, platelet/leukocyte counts, PTT) and bench performance (corrosion resistance, orbit characterization, particulate testing, radiopacity, tensile verification).

Technological Characteristics

Orbital atherectomy system; diamond-coated, eccentrically mounted crown; centrifugal force/orbital rotation mechanism. Components: reusable saline pump, single-use OAD, lubricant, guide wire. Crown styles: solid, classic, micro; sizes: 1.25-2.00mm; driveshaft lengths: 75-200cm. Sterile, single-use.

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® and Stealth 360® Peripheral Orbital Atherectomy Systems (K190634)
DIAMONDBACK 360® Peripheral Orbital Atherectomy System Exchangeable Series (K182397)

Related Devices

K220109 — DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System · Cardiovascular Systems, Inc. · Mar 1, 2022
K210586 — Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system · Cardiovascular Systems, Inc. · Sep 14, 2021
K190634 — Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System · Cardiovascular Systems, Inc. · Jul 2, 2019
K152694 — Diamondback 360 Peripheral Orbital Atherectomy System · Cardiovascular Systems, Inc. · Oct 21, 2015
K151260 — ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD · Cardiovascular System, Inc. · Jun 10, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. November 19, 2020 Cardiovascular Systems Inc. Nikita Basandra Principal Regulatory Affairs Specialist 1225 Old Highway 8 NW Saint Paul, Minnesota 55112 ### Re: K203008 Trade/Device Name: DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: September 30, 2020 Received: October 7, 2020 Dear Nikita Basandra: 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 {1}------------------------------------------------ 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 medical devices and radiation-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, 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K203008 #### Device Name Diamondback 360® Peripheral Orbital Atherectomy System Diamondback 360® Peripheral Orbital Atherectomy System. Exchangeable Series Stealth 360® Peripheral Orbital Atherectomy System #### 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 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 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 Stealth 360® Peripheral Orbital Atherectorny 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 supports 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 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) | |-------------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) | #### 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 PRAStaff(@fda.hhs.gov "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}------------------------------------------------ # 510(k) Summary | Submitter: | Cardiovascular Systems, Inc. 1225 Old Highway 8 NW Saint Paul, MN 55112 | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Nikita Basandra Principal Regulatory Affairs Specialist Cardiovascular Systems, Inc. 1225 Old Highway 8 NW Saint Paul, MN 55112 Ph: 651-259-8206 nbasandra@csi360.com | | Date Prepared: | September 30, 2020 | | Trade Name: | • DIAMONDBACK 360 Peripheral Orbital Atherectomy System • DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series • Stealth 360 Peripheral Orbital Atherectomy System | | Common Name: | Intraluminal Artery Stripper | | Classificatio n: | Class II, 21 CFR 870.4875 | | Product Code: | MCW | | Predicate Device(s): | • K190634 - DIAMONDBACK 360® and Stealth 360® Peripheral Orbital Atherectomy Systems (Cardiovascular Systems, Inc.) • K182397 - DIAMONDBACK 360® Peripheral Orbital Atherectomy System Exchangeable Series | {4}------------------------------------------------ | Device Description: | The DIAMONDBACK 360 Peripheral OAS, Stealth 360 Peripheral OAS, and DIAMONDBACK 360 OAS Exchangeable Series are designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown. Each OAS consists of the following main components: 1. Reusable Saline Pump (provided non-sterile) 2. Single-use Orbital Atherectomy Device (OAD) (provided sterile). The Exchangeable Series OAD consists of a physician-operated handle and an interchangeable crown cartridge. 3. Single-use Atherectomy lubricant (provided sterile) 4. Single-use Atherectomy guide wire (provided sterile) Mechanism of Action The Diamondback, Stealth, and Exchangeable Series OAS mechanism of action is identical to the predicate device and is defined by: • Centrifugal force • Orbital rotation • Differential sanding • Bi-directional sanding The proposed device has the same intended use, mechanism of action, and indications for use as the predicate. The proposed device differs in manufacturing process and supplier of a device component. | |-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use: | The Diamondback 360® [Stealth 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. | {5}------------------------------------------------ | Comparison to Predicate: | | DIAMONDBACK 360 Peripheral OAS (Predicate Device) | DIAMONDBACK 360 Peripheral OAS, Stealth 360 Peripheral OAS, and DIAMONDBACK 360 OAS Exchangeable Series (Subject Device) | |-----------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | | Indications for Use | The OAS 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 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. | Same | | | Crown Styles | Solid Classic Micro | Same | | | Crown Sizes (mm) | 1.25 1.50 1.75 2.00 | Same | | | OAD driveshaft lengths (cm) | 75 145 180 200 | Same | | | Sterile | Yes | Same | | | Single Use | Yes | Same | | | Principles of Operation | Same | Same | | | Operation | Yes | Same | | | Used in conjunction with • OAS Pump • CSI Peripheral Guide Wires • ViperSlide Lubricant | | | {6}------------------------------------------------ | Performance Data: | Biocompatibility Testing The biocompatibility evaluation for the DIAMONDBACK 360 Peripheral OAS, Stealth 360 Peripheral OAS, and DIAMONDBACK 360 OAS Exchangeable Series included the following tests: Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Systemic Toxicity Pyrogenicity Hemolysis Study Complement Activation Assay Platelet and Leukocyte Counts Partial Thromboplastin Time | |-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Bench Testing The following bench tests were conducted in accordance with applicable standards and guidance. Corrosion Resistance Testing Orbit Characterization Testing Particulate Testing Radiopacity Assessment Tensile Verification 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 for the DIAMONDBACK 360 Peripheral Orbital Atherectomy System, the Stealth 360 Peripheral Orbital Atherectomy System, and the DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series compared to the predicate device. The testing results demonstrate that the devices should perform as intended under the specified use conditions. |