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.

The Diamondback 360°™ Orbital Atherectomy System is also indicated for removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V shunts).

Device Description

The Diamondback 360°™ Orbital Atherectomy System (OAS) with Sidewinder Shaft is intended for use in the treatment of peripheral artery and A-V shunt stenosis.

OAS provides a method of removing stenotic material from peripheral arteries and A-V shunts. OAS applies a diamond coated, eccentrically rotating cutting 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, with biased shaft
1. Orbital atherectomy controller, and
1. Atherectomy guidewire.

This 510(k) is for the same device with modifications to the shaft configuration of the orbital atherectomy device for improved sanding efficiency.

AI/ML Overview

The provided document describes a medical device, the Diamondback 360°™ Orbital Atherectomy System with Sidewinder Shaft, and its clearance process through a 510(k) submission. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a full-scale clinical study with defined endpoints.

Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the way envisioned by the prompt. Instead, it focuses on demonstrating safety and effectiveness through comparison to existing, legally marketed devices.

Here's an analysis based on the information available in the provided text, while highlighting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided document. A 510(k) summary for a substantial equivalence claim typically focuses on comparing new device features to predicate devices and outlining the tests performed to ensure the modifications do not raise new safety or effectiveness concerns. It does not present specific acceptance criteria with corresponding performance data. The document states: "Laboratory and animal tests were performed to support the safety profile of the modification to the Orbital Atherectomy System. No new questions of safety or effectiveness are raised." This is a general conclusion, not a detailed performance report against specific criteria.

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

This information is not available in the provided document. The document mentions "Laboratory and animal tests," but it does not specify the sample sizes for these tests or the provenance of any data (e.g., country of origin, retrospective/prospective human data).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

This information is not available in the provided document. Ground truth establishment with experts is typically associated with studies evaluating diagnostic or predictive devices, which is not the primary focus of this submission for an atherectomy system that removes stenotic material.

4. Adjudication Method for the Test Set:

This information is not available in the provided document. Adjudication methods are relevant in studies where expert consensus is needed to establish ground truth or resolve discrepancies, which is not detailed here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size:

This information is not available in the provided document. MRMC studies are typically used for evaluating the effectiveness of diagnostic tools where multiple human readers interpret cases. This device is an interventional therapeutic tool, not a diagnostic one.

6. Standalone (Algorithm Only) Performance Study:

This information is not available in the provided document. The device is a physical, mechanical system (orbital atherectomy system), not a software algorithm that would perform in a standalone manner.

7. Type of Ground Truth Used:

This information is not explicitly stated in the provided document in the context of device performance. For the "Laboratory and animal tests" mentioned, the "ground truth" would likely refer to established physiological or anatomical measures, but these are not detailed.

8. Sample Size for the Training Set:

This information is not available in the provided document. The concept of a "training set" is relevant for machine learning algorithms, which is not applicable to the physical atherectomy device described.

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

This information is not applicable as there is no "training set" for this type of device.

Summary based on the document:

The provided document is a 510(k) summary for the Diamondback 360°™ Orbital Atherectomy System with Sidewinder Shaft. It states that the device is substantially equivalent to predicate devices (K072748, K071350, K071427). The modifications involved "modifications to the shaft configuration of the orbital atherectomy device for improved sanding efficiency."

The evidence provided to support this claim of substantial equivalence and safety/effectiveness consisted of:

"Laboratory and animal tests" to support the "safety profile of the modification."

The conclusion is that "No new questions of safety or effectiveness are raised."

This type of submission relies on demonstrating that the modified device is as safe and effective as a legally marketed predicate, rather than meeting novel acceptance criteria established for a new technology. Therefore, the specific details requested in the prompt regarding acceptance criteria, study design parameters, expert involvement, and ground truth establishment are not typically included or required in a 510(k) summary of this nature and are absent from the provided text.

Summary

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KCEI """"

Section. 5 510(k) Summary

AUG 1 4 2008

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:	July 7, 2008
Trade Name:	Diamondback 360°™ Orbital Atherectomy System with Sidewinder Shaft
Common Name:	Peripheral Atherectomy Device
Classification Name:	Peripheral Atherectomy Catheter (21 CFR 870.4875; Product Code:MCW)
Predicate Device:	510(k) Number:Manufacture:Trade Name:	K072748Cardiovascular Systems, Inc.Diamondback 360°™ Orbital Atherectomy System
	510(k) Number:Manufacture:Trade Name:	K071350Cardiovascular Systems, Inc.Diamondback 360°™ Orbital Atherectomy System

5.1 Description of Device

The Diamondback 360°™ Orbital Atherectomy System (OAS) with Sidewinder Shaft is intended for use in the treatment of peripheral artery and A-V shunt stenosis.

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

1. Orbital atherectomy device, with biased shaft
1. Orbital atherectomy controller, and

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Atherectomy guidewire.

This 510(k) is for the same device with modifications to the shaft configuration of the orbital atherectomy device for improved sanding efficiency.

5.2 Intended Use

The Diamondback 360°TM 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 Diamondback 360°™ Orbital Atherectomy System is also indicated for removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V shunts).

5.3 Technology

The Diamondback 360°™ Orbital Atherectomy System with Sidewinder Shaft provides a method of removing occlusive atherosclerotic or stenotic material. This OAS applies a diamond coated, eccentrically rotating cutting surface mounted on a bias-formed shaft 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, for use in A-V shunts in 510(k) K071427 and for a solid crown configuration per K072748.

5.4 Conclusions

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

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2008

Cardiovascular Systems, Inc. c/o Mr. David Brooke Sr. Regulatory Manager 651 Campus Drive Saint Paul, MN 55343

Re: K081944

Diamondback 360° Orbital Atherectomy Device System with Sidewinder Shaft Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II (two) Product Code: MCW Dated: August 7, 2008 Received: August 8, 2008

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(k) 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 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,

ccemel

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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prik /:1

Indications For Use Statement Section. 4

510(k) Number: K061942

Device Name: Diamondback 360° Orbital Atherectomy System with Sidewinder Shaft

Indications for Use:

The Diamondback 360°™ Orbital Atherectomy System is also indicated for removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V Shunts).

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)

Qmel

510(k) Numb

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).