The 3X Solid Crown Diamondback 360°™ 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°TM Orbital Atherectomy System (OAS) with 3X Solid Crown is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. OAS applies a diamond coated, eccentrically rotating sanding surface to ablate stenotic material. The resulting particles of removed stenotic material are very small and can be absorbed by the body.

The Diamondback 360° Orbital Atherectomy System consists of the following three significant components:

1. Orbital atherectomy device
1. Orbital atherectomy controller, and
1. Atherectomy guidewire.

This 510/k) is for the same device with modifications to the crown ,shaft and guidewire for improved sanding efficiency.

AI/ML Overview

The provided text is a 510(k) summary for the 3X Solid Crown Diamondback 360°™ Orbital Atherectomy System. This document does not describe a study involving acceptance criteria for device performance in the context of an AI/algorithm-driven medical device, nor does it contain information about AI performance metrics, sample sizes for test or training sets, expert adjudication, or MRMC studies.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for regulatory approval. The "study" mentioned is laboratory and animal tests performed to support the safety profile of modifications made to an existing device, not a performance study as typically understood for AI-driven devices.

Here's how the requested information maps to the provided text:

A table of acceptance criteria and the reported device performance:
- Not applicable. The document does not define specific performance acceptance criteria or report device performance in a quantitative manner (e.g., sensitivity, specificity, accuracy) that would be relevant for an AI/algorithm. The "performance" assessment is based on demonstrating that the modified device's safety profile is consistent with earlier versions and predicate devices.
Sample sizes used for the test set and the data provenance:
- Not applicable. No test sets for algorithm performance are mentioned. The document refers to "laboratory and animal tests" but does not specify sample sizes or data provenance for these engineering/biological validation tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of AI device performance is not relevant to this document. The "ground truth" for this regulatory submission is established through engineering principles, preclinical testing (lab and animal), and comparison to existing, cleared devices.
Adjudication method for the test set:
- Not applicable. No adjudication method for a test set is mentioned.
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:
- Not applicable. No MRMC study is mentioned. This device is a physical medical instrument, not an AI-assisted diagnostic or therapeutic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device. It is a physical atherectomy system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI context. For this physical device, the "ground truth" for its safety and effectiveness is established through engineering design, material properties testing, bench testing, and animal studies to confirm its ability to ablate stenotic material without adverse effects and its substantial equivalence to predicate devices.
The sample size for the training set:
- Not applicable. No training set for an algorithm is mentioned.
How the ground truth for the training set was established:
- Not applicable. No training set ground truth is mentioned.

In summary, the provided text is a regulatory submission demonstrating substantial equivalence for a physical medical device (an atherectomy system), not a performance study for an AI-driven device. Therefore, most of the requested information regarding AI acceptance criteria and studies is not present.

Summary

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K090521

Section. 5 510(k) Summary

Company Name:	Cardiovascular Systems, Inc.651 Campus DriveSt. Paul, MN 55112
Contact:	David D. Brooke
Phone:	(651) 259-2061
Fax:	(651) 259-1696
Summary Date:	February 25, 2009
Trade Name:	3X Solid Crown Diamondback 360°™ Orbital Atherectomy System
Common Name:	Peripheral Atherectomy Device
Classification Name:	Peripheral Atherectomy Catheter (21 CFR 870.4875; Product Code: MCW)
Predicate Device:	510(k) Number:	K072748
	Manufacture:	Cardiovascular Systems, Inc.
	Trade Name:	Diamondback 360°™ Orbital Atherectomy System
	510(k) Number:	K071350
	Manufacture:	Cardiovascular Systems, Inc.
	Trade Name:	Diamondback 360°™ Orbital Atherectomy System
	510(k) Number:	K081944
	Manufacture:	Cardiovascular Systems, Inc.
	Trade Name:	Sidewinder Diamondback 360°™ Orbital

5.1 Description of Device

The Diamondback 360°TM Orbital Atherectomy System (OAS) with 3X Solid Crown is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. OAS applies a diamond coated, eccentrically rotating sanding surface to ablate

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stenotic material. The resulting particles of removed stenotic material are very small and can be absorbed by the body.

The Diamondback 360° Orbital Atherectomy System consists of the following three significant components:

1. Orbital atherectomy device
1. Orbital atherectomy controller, and
1. Atherectomy guidewire.

This 510/k) is for the same device with modifications to the crown ,shaft and guidewire for improved sanding efficiency.

5.2 Intended Use

5.3 Technology

The 3X Solid Crown Diamondback 360°™ Orbital Atherectomy System provides a method of removing occlusive atherosclerotic or stenotic material. The OAS applies a diamond coated, eccentrically rotating sanding surface to ablate stenotic tissue. The resulting particles of removed stenotic tissue are very small and can be absorbed by the body. This same technology was cleared to market for use in peripheral arteries in 510(k) K071350, A-V grafts per K071427, Solid Crown per K072748, and Solid Crown with Sidewinder Shaft per K081944.

5.4 Conclusions

The 3X Solid Crown Diamondback 360°™ Orbital Atherectomy System is substantially equivalent to the predicate devices. Laboratory and animal tests were performed to support the safety profile of the modification to the Diamondback 360°™ Orbital Atherectomy System. No new questions of safety or effectiveness were raised.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardiovascular Systems, Inc. c/o Mr. David Brooke Senior Regulatory Manager 651 Campus Drive St. Paul, MN 55112

MAR 2 0 2009

Re: K090521

3X Solid Crown Diamondback 360° Orbital Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: February 25, 2009 Received: February 26, 2009

Dear Mr. Brooke:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. David Brooke

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(ls) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

ina R. b. h. h.

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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Section. 4 Indications For Use Statement

K090521 510(k) Number:

Device Name: 3X Solid Crown Diamondback 360° Orbital Atherectomy System

Indications for Use:

The Diamondback 360°™ 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dura R. V. Auser
38

sion of Cardiovascular Devices

510(k) Number_ko 9052

Diamondback 360°TM OAS.

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).