DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT

K082981 · Cardiovascular Systems, Inc. · MCW · Oct 31, 2008 · Cardiovascular

Device Facts

• Record ID: K082981
• Device Name: DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT
• Applicant: Cardiovascular Systems, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Oct 31, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Diamondback 360°™ Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use 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 Story

Diamondback 360° Orbital Atherectomy System is a percutaneous device used to treat peripheral artery disease and clear stenotic material from artificial arteriovenous dialysis fistulae. The system utilizes an orbital atherectomy mechanism to remove plaque or stenotic material. It is intended for use by physicians in a clinical setting. The device includes ViperSlide™ lubricant. The system functions as a mechanical tool for percutaneous transluminal atherectomy, allowing for the restoration of blood flow in diseased vessels or dialysis access sites.

Technological Characteristics

Orbital atherectomy system; includes ViperSlide™ lubricant; percutaneous delivery mechanism.

Indications for Use

Indicated for patients with occlusive atherosclerotic disease in peripheral arteries and patients requiring removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V shunts) who are candidates for percutaneous transluminal atherectomy.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

## MAR 2 3 2010

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

Re: K082981

Trade/Device Name: Diamondback 360° Orbital Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: October 3, 2008 Received: October 6, 2008

Dear Mr. Brooke:

This letter corrects our substantially equivalent letter of October 31, 2008.

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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.

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Page 2 - Mr. David D. Brooke

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 (1 wire), it may of belofen 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 i cacral agencies: - 1 od mast comp (21 CFR Part 807); labeling (21 CFR Part 801); medical minited to: reporting of medical device-related adverse events) (21 CFR 803); good device reporting (reporting or ments as set forth in the quality systems (QS) regulation (21 manafacturing practicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

In addition, we have determined that your device kit contains Liposyn III, which is subject to regulation as a drug.

Our substantially equivalent determination does not apply to the drug component of your Our Substantian'y equiread you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing this drug, we suggest you contact:

Director, Division of Drug Labeling Compliance Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 [phone]

This letter will allow you to begin marketing your device as described in your Section This letter will anow you to oegn inding of substantial equivalence of your device 510(K) prematics nothreation: "The 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1 1 5809.htm for hip?//www.ida.gov/About/D/VCchters/Clices/CDRH's) Office of Compliance. Also, the Center for Devices and ruallers group of reference to premarket notification"

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Page 3 - Mr. David D. Brooke

(21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

R. Vahner

Image /page/2/Picture/5 description: The image shows a signature next to the text "Br" and "Di". The signature is a series of connected lines that form a unique shape. The text is in a simple, sans-serif font and is aligned to the left of the signature. The image is black and white and appears to be a scan or photocopy of a document.

\ 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 Statement Section. 4

K08281 510(k) Number:

Device Name: Diamondback 360° Orbital Atherectomy System with ViperSlide™ Lubricant

Indications for Use:

The Diamondback 360°™ Orbital Atherectomy System is a percutaneous orbital The Diamondouct 500 disease in peripheral arteries and who are acceptable candidates for perculaneous transluminal atherectomy.

The Diamondback 360°™ Orbital Atherectorny 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)

Duana P. Holmes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number Ko8298 J