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

Q: Who is the manufacturer of Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System?

Cardiovascular Systems, Inc. filed the 510(k) submission for Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System (K190634).

Q: What is the FDA product code for Diamondback 360 Peripheral Orbital Atherectomy System, 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, 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, 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.

K190634 · Cardiovascular Systems, Inc. · MCW · Jul 2, 2019 · Cardiovascular

Device Facts

Record ID	K190634
Device Name	Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System
Applicant	Cardiovascular Systems, Inc.
Product Code	MCW · Cardiovascular
Decision Date	Jul 2, 2019
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 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.

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), lubricant, guide wire. Operation: rapidly rotating eccentric diamond-coated crown creates centrifugal force; presses crown against calcified plaque; differential/bi-directional sanding reduces plaque; orbit diameter increases with each pass. Used in clinical settings by physicians. Output: restored luminal patency. Benefits: plaque reduction; improved blood flow in peripheral arteries and dialysis access sites.

Clinical Evidence

Bench testing only. Conducted in accordance with standards/guidance: track verification, stall/life and tight stenosis verification, pre-conditioning, tensile, temperature/saline flow, glide start-up, software verification, electromagnetic compatibility, and electrical safety. No clinical data presented.

Technological Characteristics

Orbital atherectomy system; diamond-coated eccentric crown; saline-cooled. Rotational speeds: 60k, 90k, 120k, 140k RPM. Components: reusable saline pump, single-use OAD, guide wire, lubricant. Sheath sizes: 4 Fr to 6 Fr. Software-controlled operation. Sterilized, single-use OAD.

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 360® Peripheral Orbital Atherectomy System (K152694)

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
K203008 — DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System · Cardiovascular Systems, Inc. · Nov 19, 2020
K220568 — Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series · Cardiovascualr Systems, Inc. · Apr 27, 2022
K152694 — Diamondback 360 Peripheral Orbital Atherectomy System · Cardiovascular Systems, Inc. · Oct 21, 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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 2, 2019 Cardiovascular Systems Inc. Kris Miller Sr. Regulatory Specialist 1225 Old Highway 8 NW St. Paul, MN 55112 Re: K190634 Trade/Device Name: Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System Regulation Number: 21 CFR 840.4875 Regulation Name: Intramural Artery Stripper Regulatory Class: Class II Product Code: MCW Received: May 29, 2019 Dated: May 28, 2019 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 {1}------------------------------------------------ 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 (OS) 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, For Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) #### K190634 Device Name Diamondback 360® Peripheral Orbital Atherectomy System 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 atherectorny system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty. 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 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) | |-------------------------------------------------| |-------------------------------------------------| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------| | <input type="checkbox"/> 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for CSI. The logo is in gray and green. The letters "CSI" are in gray, and there is a green arc below the letters. # 510(k) Summary | Submitter: | Cardiovascular Systems Inc. (CSI) 1225 Old Highway 8 NW St. Paul, MN 55112 | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Kris Miller Sr. Regulatory Affairs Specialist Cardiovascular Systems Inc. 1225 Old Highway 8 NW St. Paul, MN 55112 Phone: 651-259-1656 Fax: 651-259-2094 kmiller@csi360.com | | Date Prepared: | March 8, 2019 | | 510(k) Number: | K190634 | | Trade Name: | Diamondback 360® Peripheral Orbital Atherectomy System Stealth 360® Peripheral Orbital Atherectomy System | | Common Name: | Intraluminal Artery Stripper | | Classification: | Class II, 21 CFR 870.4875 | | Product Code: | MCW | | Predicate Device: | K152694 - Diamondback 360® Peripheral Orbital Atherectomy System (Cardiovascular Systems, Inc.) | | Device Description: | The Diamondback 360 and Stealth 360 Peripheral Orbital Atherectomy Systems (OAS) are designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown. The OAS consists of the following main components: 1. Reusable Saline Pump (provided non-sterile) 2. Single-use Orbital Atherectomy Device (OAD) (provided sterile) 3. Single-use Atherectomy lubricant (provided sterile) 4. Single-use Atherectomy guide wire (provided sterile) | | | Mechanism of Action | | | Traditional 510(k) Pre-market Notification Diamondback 360 and Stealth 360 OAS | | | The Diamondback and Stealth OAS mechanism of action is identical to the predicate device and is defined by: • Centrifugal force • Orbital rotation • Differential sanding • Bi-directional sanding The rapidly rotating eccentric crown creates a centrifugal force that presses the diamond-coated crown against the calcified plaque. With each pass of the crown, plaque is reduced, and the diameter of the orbit increases. | | Indications for Use: | The Diamondback 360® [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 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. | {4}------------------------------------------------ # Technologic Characteristic Comparison: | | DiamondBack (Predicate Device) K152694 | Proposed Device DiamondBack OAS | Proposed Device Stealth OAS | Impact of Difference on Safety and Effectiveness | | |-----------------------------------|--------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--| | Crown Styles | Micro Solid Classic | Same as predicate | 1.25 Micro crown is new to Stealth. Solid and Classic are same as predicate | No Impact to Safety and Effectiveness as this crown style is identical to the predicate device. | | | Crown Sizes (mm) | 1.25 1.50 1.75 2.00 | Same as predicate | 1.25 Micro crown is new to Stealth. All other sizes are the same as predicate. | No Impact to Safety and Effectiveness as this crown size is identical to the predicate device. | | | | DiamondBack (Predicate Device) K152694 | Proposed Device DiamondBack OAS | Proposed Device Stealth OAS | Impact of Difference on Safety and Effectiveness | | | OAD driveshaft lengths (mm) | 145 180 200 | Same as predicate | Same as predicate | NA - No difference | | | OAD driveshaft diameter (in.) | .0285 | Same as predicate | New to Stealth (same as predicate) | No Impact to Safety and Effectiveness as this is comparable to the currently marketed 1.25MICRO145 | | | 1.25Solid145 | .029 | Same as predicate | Same as predicate | NA - No difference | | | 1.50Solid145 | .029 | Same as predicate | Same as predicate | NA - No difference | | | 2.00Solid145 | .031 | Same as predicate | Same as predicate | NA - No difference | | | 1.50Classic145 | .0335 | Same as predicate | Same as predicate | NA - No difference | | | 2.00Classic145 | .0335 | Same as predicate | Same as predicate | NA - No difference | | | 1.25Solid200 | .029 | Same as predicate | Same as predicate | NA - No difference | | | 1.50Solid200 | .029 | Same as predicate | Same as predicate | NA - No difference | | | 1.75Solid180 | .029 | Same as predicate | Same as predicate | NA - No difference | | | Sheath Size | 4 Fr | Same as predicate | Same as predicate | No Impact to Safety and Effectiveness as this is comparable to the currently marketed 1.25MICRO145 | | | 1.25Solid145 | 4 Fr | Same as predicate | 6 Fr | The Stealth sheath size is unchanged from | | | | DiamondBack (Predicate Device) K152694 | Proposed Device DiamondBack OAS | Proposed Device Stealth OAS | Impact of Difference on Safety and Effectiveness | | | 1.50Solid145 | 5 Fr | Same as predicate | 6 Fr | the currently cleared device. The Stealth sheath size is unchanged from the currently cleared device. | | | 2.00Solid145 | 5 Fr | Same as predicate | 6 Fr | The Stealth sheath size is unchanged from the currently cleared device. | | | 1.50Classic145 | 5 Fr | Same as predicate | 6 Fr | The Stealth sheath size is unchanged from the currently cleared device. | | | 2.00Classic145 | 5 Fr | Same as predicate | 6 Fr | The Stealth sheath size is unchanged from the currently cleared device. | | | 1.25Solid200 | 5 Fr | Same as predicate | Same as predicate | NA - No difference | | | 1.50Solid200 | 5 Fr | Same as predicate | Same as predicate | NA – No difference | | | 1.75Solid180 | 5 Fr | Same as predicate | Same as predicate | NA - No difference | | | | Filar Count(x) and Wire Diameter | | | | | | 1.25Micro145 | 3x.0061 | Same as predicate | Same as predicate | NA – No difference | | | 1.25Solid145 | 3x.0067 | Same as predicate | Same as predicate | NA – No difference | | | 1.50Solid145 | 3x.0067 | Same as predicate | Same as predicate | NA – No difference | | | 2.00Solid145 | 6x.0060 | Same as predicate | Same as predicate | NA – No difference | | | 1.50Classic145 | 3x.0070 | Same as predicate | Same as predicate | NA – No difference | | | 2.00Classic145 | 3x.0070 | Same as predicate | Same as predicate | NA – No difference | | | | DiamondBack (Predicate Device) K152694 | Proposed Device DiamondBack OAS | Proposed Device Stealth OAS | Impact of Difference on Safety and Effectiveness | | | 1.25Solid200 | 7x.0060 | Same as predicate | Same as predicate | NA – No difference | | | 1.50Solid200 | 7x.0060 | Same as predicate | Same as predicate | NA – No difference | | | 1.75Solid180 | 7x.0060 | Same as predicate | Same as predicate | NA – No difference | | | Rotational Speed Range | Low (60 kRPM) Medium (90 kRPM) High (120 kRPM) High (140 kRPM - classic crowns only) | Same as predicate | Same as predicate | NA – No difference | | | GllideAssist | (cleared in K182397) | Same as predicate | 1.25MICRO145 only | No impact. This function was cleared in K182397. | | | Sterile | Yes | Same as predicate | Same as predicate | NA – No difference | | | Single Use | Yes | Same as predicate | Same as predicate | NA – No difference | | | Used in conjunction with | • OAS Saline Pump • CSI Peripheral Guide Wires • ViperSlide Lubricant | Same as predicate | Same as predicate | NA – No difference | | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for CSI. The logo consists of the letters "CSI" in a gray, rounded font. Below the letters is a green, curved line. The logo is simple and modern. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for CSI. The logo consists of the letters "CSI" in a gray, rounded font. Below the letters is a green curved line. The letters are spaced apart, and the "I" has a small trademark symbol next to it. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for CSI. The letters "CSI" are in a gray, sans-serif font. A green arc is below the letters. The letters are slightly rounded. Performance Data: Bench Testing The following bench tests were conducted in accordance with applicable standards and guidance. - Track Verification Testing . - Stall / Life and Tight Stenosis Verification Testing ● - Device Pre-Conditioning Verification Testing - Tensile Verification Testing ● - Temperature and Saline Flow Verification Testing ● - Glide Start Up Verification Testing - Software Verification ● - Electromagnetic Compatibility ● - Electrical Safety ● {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for CSI. The logo consists of the letters "CSI" in a rounded, sans-serif font. The letters are gray. Below the letters is a green arc. The arc is curved upwards, suggesting a smile or a rising line. Performance data and software verification was collected and verified that the design meets all product specifications and address the potential safety hazards that have been identified. The Diamondback 360 Peripheral Orbital Atherectomy System and Conclusion: the Stealth 360 Peripheral Orbital Atherectomy System have the same indications for use and the same technological characteristics as the predicate device. The testing results demonstrate that the devices perform as intended under the specified use conditions. Based on this and data provided in this pre-market notification, the subject and predicate devices have been shown to be substantially equivalent.