DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS

K071427 · Cardiovascular Systems, Inc. · MCW · Aug 30, 2007 · Cardiovascular

Device Facts

• Record ID: K071427
• Device Name: DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
• Applicant: Cardiovascular Systems, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Aug 30, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Orbital Atherectomy System supports removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V Shunts).

Device Story

Diamondback 360° Orbital Atherectomy System (OAS) is a catheter-based device designed to remove neointimal tissue causing stenosis in artificial arteriovenous (A-V) dialysis fistulae. The system operates via an orbital mechanism to ablate stenotic material. It is intended for use by clinicians in a clinical setting. By removing obstructive tissue, the device restores patency to the A-V shunt, facilitating continued hemodialysis access for patients with kidney disease.

Clinical Evidence

Bench testing only. The device underwent mechanical testing and biocompatibility testing in accordance with ISO 10993 to verify that design requirements were met.

Technological Characteristics

Orbital atherectomy catheter system. Materials evaluated for biocompatibility per ISO 10993. Mechanical design utilizes orbital motion for tissue removal. Class II device under 21 CFR 870.4875.

Indications for Use

Indicated for the removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V Shunts) in patients requiring dialysis.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• Orbital Atherectomy System for Treatment of A-V Shunt Stenosis (K041630)

Submission Summary (Full Text)

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K071427
2 of 1

AUG 3 0 2007

# Section 5 – 510(k) Summary

| Submitter: | Cardiovascular Systems, Inc<br>651 Campus Drive, St. Paul, MN 55112 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Cindy Setum, Ph.D., Vice President, Clinical Affairs<br>phone: [phone], fax: [phone] |
| Date Prepared: | May 22, 2007 |
| Trade Name: | Diamondback 360° ™ Orbital Atherectomy System for Treatment of A-<br>V Shunt Stenosis |
| Classification: | Class II<br>Peripheral Atherectomy Catheter<br>21 CFR §870.4875 |
| Product Code: | MCW |
| Predicate Device(s): | The subject device is equivalent to the following device: K041630,<br>Orbital Atherectomy System for Treatment of A-V Shunt Stenosis |
| Device Description: | The Diamondback 360° ™ Orbital Atherectomy System (OAS) is<br>intended for use in treatment of artificial ateriovenous dialysis fistula<br>stenosis. An artificial arteriovenous dialysis fistula (A-V shunt) is<br>placed sub-dermal to support kidney dialysis. A consequence of the<br>body's reaction to the foreign material of the A-V shunt is to form clots<br>and neointimal stenosis of the A-V Shunt. The most common location<br>for the A-V shunt stenosis is at the shunt to vein anastomosis. It is this<br>region that the Cardiovascular Systems, Inc. Orbital Atherectomy<br>System (CSI OAS) is applied to remove neointimal tissue causing a<br>stenosis in the A-V shunt. |
| Intended Use: | The Orbital Atherectomy System supports removal of stenotic material<br>from artificial arteriovenous dialysis fistulae (A-V Shunts). |
| Functional and Safety<br>Testing: | To verify that device design met its functional and performance<br>requirements, representative sample of the device underwent<br>mechanical testing and biocompatibility in accordance with ISO<br>10993. |
| Conclusion: | Cardiovascular Systems, Inc. considers the Diamondback 360° ™<br>Orbital Atherectomy System to be equivalent to the predicate device<br>listed above. This conclusion is based upon the devices' similarities in<br>principles 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 [phone]. 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 [phone] or [phone] 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