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 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.

Device Description

The Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Diamondback 360 uses an eccentrically orbiting sanding surface (crown) to remove stenotic material on the vessel wall. The stenotic particles that are removed are small enough to be absorbed by the body.

The Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components:

Orbital Atherectomy Device (OAD)
Atherectomy Guide Wire (e.g., ViperWire Advance)
Saline Pump (OAS Pump)
Atherectomy Lubricant (e.g., ViperSlide)

Additional 1.25 Solid, 1.50 Solid, and 1.75 Solid Diamondback 360 Peripheral Orbital Atherectomy Devices (OADs) with increased drive shaft lengths of 180 cm and 200 cm are proposed as additional length options to accommodate patient vessel anatomy and physicians preferred access methodology, for example radial access. The proposed OADs are designed to maintain 5Fr compatibility. Additional accessories to accommodate the increased drive shaft lengths were necessitated such as additional saline sheaths with increased lengths and additional lengths of ViperWire Advance Peripheral guide wires to accommodate the working length of the proposed OADs. The proposed 0.014 in core guide wires are 475 cm in length and compatible with the 180 cm and 200 cm length drive shafts. The proposed 0.014 in core guide wires are designed with a 0.014 in or 0.018 in distal spring tip options. The proposed dimensions of the 1.75 Solid crown are configured to accommodate the smaller diameter drive shaft while maintaining 5Fr compatibility. Packaging dimensions were increased in comparison to that of the predicate packaging to accommodate for the increased OAD and guide wire lengths.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, the Diamondback 360® Peripheral Orbital Atherectomy System. This submission is for modifications to an already cleared predicate device, specifically offering additional lengths for the Orbital Atherectomy Devices (OADs) and guide wires.

Since this is a submission for modifications to an existing device, and not a de novo review for a novel AI device, the information typically requested for AI-powered diagnostic or comparative effectiveness studies (like sample sizes for test/training sets, expert qualifications for ground truth, MRMC studies, or standalone algorithm performance) is not directly applicable or present in this document. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than clinical study outcomes.

Therefore, for aspects related to AI performance metrics, ground truth establishment, or clinical study designs (MRMC, standalone), the document would state "Not Applicable" or "Information Not Provided in Document" because these are not within the scope of a 510(k) for device modifications confirmed by bench testing.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria	Reported Device Performance
System Life Testing (including guide wire)	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Stall Testing	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Introducer Compatibility Testing	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Switch Logic Testing	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Dimensional Analysis	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Tactile Feedback	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Temperature Testing	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Tensile Testing	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Flexibility Testing	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Delivered Torque Testing	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Orbit Testing	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Guide Wire Brake Testing	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Saline Flow Testing	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Track Testing	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Packaging/Simulated Distribution Testing for Guide Wire	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Guide Wire Tip Flexibility	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Guide Wire Trackability	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Guide Wire Torque Transfer	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Guide Wire Torque Strength	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Particulate Inspection	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Effluent Particulate Analysis	Met established specifications necessary for consistent performance during its intended use.	The device met all established specifications.
Overall Conclusion	Met all predetermined acceptance criteria of design verification and validation testing.	All test results demonstrate that the materials, manufacturing process, and design utilized...met the established specifications necessary for consistent performance during its intended use.

Description of the Study:

The study conducted was a series of performance bench tests designed to confirm that the modified Diamondback 360 Peripheral Orbital Atherectomy System (with increased drive shaft lengths) met its established specifications and was substantially equivalent to the predicate device. The tests evaluated various mechanical, physical, and operational characteristics of the device and its components (OADs and guide wires).

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not specified in the provided document. The document refers to "bench testing" which typically involves a number of units tested to satisfy engineering specifications and statistical requirements for device validation, but the exact number is not included here.
Data Provenance: Not applicable in the context of clinical data. This refers to laboratory and bench testing results conducted by the manufacturer, Cardiovascular Systems, Inc.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Number of Experts: Not applicable. Ground truth, in this context, would be defined by engineering specifications and objective measurements from the bench tests, not by expert clinical interpretation.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. The tests are objective measurements against predefined specifications.

5. 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:

MRMC Study: No, an MRMC comparative effectiveness study was not done.
Effect Size: Not applicable. This document does not describe an AI-powered diagnostic device or a study involving human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done:

Standalone Study: No, a standalone algorithm performance study was not done.
This device is a mechanical medical device, not an AI algorithm.

7. The Type of Ground Truth Used:

Type of Ground Truth: The ground truth for this device's performance is based on pre-established engineering specifications, material properties, and functional performance requirements as demonstrated through bench testing. These specifications ensure the device operates as intended and is safe and effective.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This document does not describe an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

How Ground Truth for Training Set Was Established: Not applicable. This document does not describe an AI algorithm that requires a training set.

Summary

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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

June 9, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Cardiovascular Systems, Inc. Ms. Kara Cutshall Regulatory Affairs Specialist 1225 Old Highway 8 NW Saint Paul, Minnesota 55112

Re: K170792

Trade/Device Name: Diamondback 360 Peripheral Orbital Atherectomy System Regulation Number: 21 CFR 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: May 10, 2017 Received: May 12, 2017

Dear Ms. Cutshall:

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. 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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Fernando
Aguel-S

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) K170792

Device Name

Diamondback 360 Peripheral Orbital Atherectomy System

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

Company Name:	Cardiovascular Systems, Inc.1225 Old Highway 8 NWSaint Paul, MN 55112
Contact:	Kara Cutshall
Phone:	(651) 202-4886
Summary Date:	March 15, 2017
Trade Name:	Diamondback 360® Peripheral Orbital Atherectomy System
Product Code:	MCW-Catheter, Peripheral, Atherectomy
Classification Regulation:		21 CFR 870.4875—Intraluminal Artery Stripper
Classification:	II
Predicate Devices:	510(k) Number:Manufacturer:Trade Name:	K152694Cardiovascular Systems, Inc.Diamondback 360® Peripheral OrbitalAtherectomy System

6.1 Description of Device

The Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

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The Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components:

1. Orbital Atherectomy Device (OAD)
1. Atherectomy Guide Wire (e.g., ViperWire Advance)
1. Saline Pump (OAS Pump)
1. Atherectomy Lubricant (e.g., ViperSlide)

6.2 Description of Proposed

6.3 Indications for Use

The Intended Use has not changed from the predicate/current Diamondback 360 Peripheral Orbital Atherectomy System.

6.4 Technology

The Diamondback 360 Peripheral Orbital Atherectomy System provides a method of removing or reducing occlusive atherosclerotic or stenotic material. The OAS applies a diamond coated, eccentrically rotating sanding surface to reduce or remove stenotic

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material on the vessel wall. The stenotic particles are small enough to be absorbed by the body. The proposed OADs and guide wires have the same mechanism of operation, materials, chemical composition, and energy source characteristics that were cleared to market for use in the peripheral arteries for Diamondback 360 Peripheral OAS in 510(k) K152694. The proposed OADs and guide wires have increased lengths as options to accommodate patient vessel anatomy and physicians preferred access methodology.

Characteristic	PredicateOADs and Guide Wires	ProposedOADs and Guide Wires
Manufacturer	OAD	CSI	Same
Guide Wires	CSI	Same
Indication for Use	The Diamondback 360Peripheral OrbitalAtherectomy System is apercutaneous orbitalatherectomy systemindicated for use as atherapy in patients withocclusive atheroscleroticdisease in peripheralarteries and who areacceptable candidates forpercutaneoustransluminalAtherectomy.The OAS supportsremoval of stenoticmaterial from artificialarteriovenous dialysisfistulae (AV shunt). Thesystem is a percutaneousorbital atherectomysystem indicated as atherapy in patients withoccluded hemodialysisgrafts who are acceptablecandidates forpercutaneoustransluminal angioplasty.	Same
Characteristic		PredicateOADs and Guide Wires	ProposedOADs and Guide Wires
Orbital Atherectomy Device Platform		Electrically driven, diamond crown, atherectomy catheter	Same
Design/Construction	CrownAssembly	Eccentric crown assembly bonded to a concentric drive shaft	Same
	DriveMechanism	Brushless DC Electric Motor	Same
	Guide Wire	0.014 in atherectomy guide wire designs compatible with 145 cm drive shaft lengths	0.014 in atherectomy guide wire designs compatible with 180 cm and 200 cm drive shaft lengths
Materials	OAD	Drive Shaft: 304V Stainless Steel Saline Sheath: Nylon body and Pebax distal end	Same
	Guide Wire	Core Material: 304V Stainless Steel Support Coil: 304V Stainless Steel	Same
Packaging	OAD	1 unit per package	Same Increase in length of drive shaft dispenser coil to accommodate the 180 cm and 200 cm length drive shafts
	Guide Wire	5 units packaged per shelf carton	Same Increase in the dimensions of the guide wire dispenser coil, guide wire pouch, shelf carton, and shipper box to accommodate the 475 cm guide wires Increase in the density of the shelf carton
Characteristic		Predicate	Proposed
			OADs and Guide Wires OADs and Guide Wires
	Drive Shaft	· Length: 145 cm	Length: 180 cm and
		• OD: 0.029 in; 0.031 in	200 cm
		ID: 0.0156 in; 0.019●	OD: 0.029 in
		in	ID: 0.017 in●
Specifications	SalineSheath	Introducer Size●	Introducer Size●
		Compatibility: 4 Fr; 5	Compatibility: 5Fr
		Fr; 6 Fr	· Length: 70.92 in;
		Length: 57.26 in;●	78.75 in
		57.35 in	• OD: 0.063 in
		· OD: 0.052 in;	ID: 0.049 in
		0.063 in
		ID: 0.041 in; 0.049 in
	Guide Wire	Core: 0.014 in	Core: Same
		Spring Tip: 0.014 in;	Spring Tip: 0.014 in;●
		0.017 in	0.018 in
		Length: 335 cm	Length: 475 cm
Sterilization		Ethylene oxide	Same

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6.5 Performance Data

The Diamondback 360 Peripheral Orbital Atherectomy System was evaluated using the following performance bench testing to confirm the performance characteristics as compared to the predicate device.

System Life Testing including guide wire ●
. Stall Testing
Introducer Compatibility Testing .
. Switch Logic Testing
Dimensional Analysis .
Tactile Feedback ●
Temperature Testing .
Tensile Testing ●
Flexibility Testing .
Delivered Torque Testing .
Orbit Testing .
Guide Wire Brake Testing .
Saline Flow Testing ●
Track Testing ●
Packaging/Simulated Distribution Testing for Guide Wire ●

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Guide Wire Tip Flexibility
Guide Wire Trackability
Guide Wire Torque Transfer
Guide Wire Torque Strength .
. Particulate Inspection
Effluent Particulate Analysis .

All test results demonstrate that the materials, manufacturing process, and design utilized for the Diamondback 360 Peripheral Orbital Atherectomy System met the established specifications necessary for consistent performance during its intended use.

Conclusions 6.6

The Diamondback 360 Peripheral Orbital Atherectomy System met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs. Testing results demonstrate that the Diamondback 360 Peripheral Orbital Atherectomy System is substantially equivalent to the legally marketed predicate devices and does not raise any new safety or effectiveness questions.

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).