The Diamondback 360° ™ Orbital Atherectomy System (OAS) is intended for use in treatment of artificial ateriovenous dialysis fistula stenosis. An artificial arteriovenous dialysis fistula (A-V shunt) is placed sub-dermal to support kidney dialysis. A consequence of the body's reaction to the foreign material of the A-V shunt is to form clots and neointimal stenosis of the A-V Shunt. The most common location for the A-V shunt stenosis is at the shunt to vein anastomosis. It is this region that the Cardiovascular Systems, Inc. Orbital Atherectomy System (CSI OAS) is applied to remove neointimal tissue causing a stenosis in the A-V shunt.

AI/ML Overview

Here's an analysis of the provided text regarding the Diamondback 360°™ Orbital Atherectomy System, focusing on acceptance criteria and the supporting study information:

Based on the provided snippets (K071427), it appears this submission is for a premarket notification (510(k)) that relies on substantial equivalence to a predicate device, not on a new clinical study with specific performance acceptance criteria. Therefore, the device performance is demonstrated through comparison to the predicate, and a traditional "study proving the device meets acceptance criteria" as might be seen for devices requiring clinical efficacy data is not explicitly detailed.

Here's what can be inferred and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from 510(k) Scope)	Reported Device Performance
Functional and Performance Requirements Met	Device underwent mechanical testing and biocompatibility in accordance with ISO 10993 to verify design met requirements.
Material Equivalence	Uses similar materials to predicate device (K041630).
Technology Equivalence	Employs similar technology to predicate device (K041630).
Principles of Operation Equivalence	Operates on similar principles to predicate device (K041630).
Indications for Use Equivalence	Intended for use in treatment of artificial arteriovenous dialysis fistula stenosis, which is equivalent to the predicate device's indications.

Explanation: In a 510(k) for substantial equivalence, the "acceptance criteria" are primarily met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. The primary "performance" shown here is the successful completion of functional, mechanical, and biocompatibility testing, and the conclusion that these, along with similarities in design, materials, and intended use, establish equivalence.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not specified in the provided documents. The submission emphasizes mechanical testing and biocompatibility rather than a clinical human trial.
Data Provenance: Not applicable in the context of a human clinical test set. The functional and safety testing would have been conducted internally by Cardiovascular Systems, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided as the submission does not detail a clinical study requiring expert-established ground truth. The "ground truth" for functional and safety testing would be based on engineering specifications and recognized standards (like ISO 10993).

4. Adjudication method for the test set

Not applicable. There is no indication of a clinical test set requiring adjudication in these documents.

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

Not applicable. This device is an atherectomy system (a physical device for removing plaque), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related metrics are irrelevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

For the functional and safety testing (mechanical, biocompatibility), the ground truth is based on engineering specifications, standardized test methods (e.g., ISO 10993), and regulatory requirements for medical devices. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth in a clinical study context for this specific 510(k) submission.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As above, no training set for an algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this 510(k) context is primarily the pre-clinical functional and safety testing combined with the comparative analysis against the predicate device (K041630).

Study Design: The submission indicates that "representative samples of the device underwent mechanical testing and biocompatibility in accordance with ISO 10993." This constitutes the primary evidence base presented.
Purpose: To verify that the device design met its functional and performance requirements and to demonstrate substantial equivalence to the predicate device in terms of principles of operation, technology, materials, and indications for use.
Conclusion: The sponsor concluded that the Diamondback 360°™ Orbital Atherectomy System is equivalent to the predicate device (K041630) based on these similarities and the successful completion of the pre-clinical testing. The FDA's issuance of the 510(k) clearance signifies agreement with this conclusion, deeming the device as safe and effective as the predicate.

This 510(k) summary focuses on demonstrating that the new device is "substantially equivalent" to an already legally marketed device – a common pathway for medical device clearance when significant new safety or effectiveness questions are not raised. Clinical efficacy data, detailed human study designs, or AI performance metrics are typically not required for such submissions unless the device introduces new technology or indications that fundamentally alter its risk/benefit profile compared to existing devices.

Summary

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K071427
2 of 1

AUG 3 0 2007

Section 5 – 510(k) Summary

Submitter:	Cardiovascular Systems, Inc651 Campus Drive, St. Paul, MN 55112
Contact Person:	Cindy Setum, Ph.D., Vice President, Clinical Affairsphone: 651-259-1650, fax: 651-259-1697
Date Prepared:	May 22, 2007
Trade Name:	Diamondback 360° ™ Orbital Atherectomy System for Treatment of A-V Shunt Stenosis
Classification:	Class IIPeripheral Atherectomy Catheter21 CFR §870.4875
Product Code:	MCW
Predicate Device(s):	The subject device is equivalent to the following device: K041630,Orbital Atherectomy System for Treatment of A-V Shunt Stenosis
Device Description:	The Diamondback 360° ™ Orbital Atherectomy System (OAS) isintended for use in treatment of artificial ateriovenous dialysis fistulastenosis. An artificial arteriovenous dialysis fistula (A-V shunt) isplaced sub-dermal to support kidney dialysis. A consequence of thebody's reaction to the foreign material of the A-V shunt is to form clotsand neointimal stenosis of the A-V Shunt. The most common locationfor the A-V shunt stenosis is at the shunt to vein anastomosis. It is thisregion that the Cardiovascular Systems, Inc. Orbital AtherectomySystem (CSI OAS) is applied to remove neointimal tissue causing astenosis in the A-V shunt.
Intended Use:	The Orbital Atherectomy System supports removal of stenotic materialfrom artificial arteriovenous dialysis fistulae (A-V Shunts).
Functional and SafetyTesting:	To verify that device design met its functional and performancerequirements, representative sample of the device underwentmechanical testing and biocompatibility in accordance with ISO10993.
Conclusion:	Cardiovascular Systems, Inc. considers the Diamondback 360° ™Orbital Atherectomy System to be equivalent to the predicate devicelisted above. This conclusion is based upon the devices' similarities inprinciples of operation, technology, materials and indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 0 2007

Cardiovascular Systems, Inc. c/o Michael J. Kallok, Ph.D. Chief Scientific Officer 651 Campus Drive St. Paul, MN 55112-3495

Re: K071427

Diamondback 360°TM Orbital Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II (Two) Product Code: MCW Dated: August 3, 2007 Received: August 6, 2007

Dear Dr. Kallok:

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 - Michael J. Kallok, Ph.D.

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 Biometric's (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,

Duna R. Vachner

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

510(k) Number (if known): KO7 | 4 27

Device Name: Diamondback 360° ™ Orbitial Atherectomy System for Treatment of A-V Shunt Stenosis

Indications for Use:

The Orbital Atherectomy System supports 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 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. de hnes

vision of Cardiovascular Devices

510(k) Number K071427

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).