ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS

K041630 · Cardiovascular Systems Incorporated · MCW · Jan 31, 2005 · Cardiovascular

Device Facts

• Record ID: K041630
• Device Name: ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
• Applicant: Cardiovascular Systems Incorporated
• Product Code: MCW · Cardiovascular
• Decision Date: Jan 31, 2005
• Decision: SESE
• Submission Type: Abbreviated
• 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

The Orbital Atherectomy System (OAS) is a peripheral atherectomy device used to treat neointimal stenosis in artificial arteriovenous (A-V) dialysis fistulae. The device utilizes a diamond-coated, eccentrically rotating cutting surface to ablate stenotic tissue. The mechanical action of the rotating head reduces the tissue into small particles that are absorbed by the body. The system is intended for use by clinicians to clear obstructions at the shunt-to-vein anastomosis, thereby maintaining fistula patency for dialysis access.

Clinical Evidence

No clinical data provided. Safety and effectiveness were supported by laboratory and animal testing.

Technological Characteristics

The device features a diamond-coated, eccentrically rotating cutting head. It is a mechanical atherectomy catheter designed for peripheral use. No specific materials, energy sources, or software/connectivity details are provided beyond the mechanical ablation principle.

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

• Arrow-Trerotola PTD (K970080)
• Rotablator Orbital Atherectomy System - Peripheral Use (K901206)
• Blue Max® 20™ Balloon Catheter (K972357)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Cardiovascular Systems, Inc. The logo features the letters "CSI" in a stylized font, with a curved line above the letters. Below the letters, the words "CARDIOVASCULAR SYSTEMS, INC." are written in a smaller, sans-serif font. The logo is simple and professional, and it effectively communicates the company's name and focus.

K041630

# Summary of Safety and Effectiveness

JAN 3 1 2005

Company Name: Cardiovascular Systems, Inc. 2715 Nevada Avenue North New Hope (Minneapolis), MN 55427

Contact: Michael J. Kallok, Ph.D. President and CEO

Phone: [phone]

Fax: [phone]

Summary Date: June 10, 2004

Trade Name: Cardiovascular Systems, Inc. Orbital Atherectomy System (CSI OAS) for Treatment of A-V Shunt Stenosis

Common Name: Peripheral Atherectomy Device

Classification Name: 21 CFR 870.4875, Peripheral Atherectomy Catheter

Predicate Device:

| 510(k) Number: | K970080 |
|----------------|----------------------------------------------------------|
| Manufacture: | Arrow |
| Trade Name: | Arrow-Trerotola PTD |
| | |
| 510(k) Number: | K901206 |
| Manufacture: | Boston Scientific (Acquired from Heart Technology, Inc.) |
| Trade Name: | Rotablator Orbital Atherectomy System - Peripheral Use |
| | |
| 510(k) Number: | K972357 |
| Manufacture: | Boston Scientific |
| Trade Name: | Blue Max® 20™ Balloon Catheter |

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

#### 1.0 Description of Device

The Orbital Atherectomy System (OAS) is intended for use in treatment of artificial arteriovenous 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

2715 Nevada Avenue North ● New Hope, MN 55427 ● Tel. [phone]

{1}------------------------------------------------

of the A-V shunt. The most common location for A-V shut stenosis is at the shunt to vein anastomosis. It is this region that the Cardiovascular Systems, Inc. (CSI) Orbital Atherectomy System is applied to remove neointimal tissue causing a stenosis in the A-V shunt.

### 2.0 Intended Use

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

### 3.0 Technology

The Orbital Atherectomy System (OAS) provides a method of removing occlusive neointimal tissue. The OAS applies a diamond coated, eccentrically rotating cutting surface to ablate neointimal tissue. The resulting particles of removed neointimal tissue are very small and can be absorbed by the body.

#### 4.0 Conclusions

The OAS is substantially equivalent to the predicate devices. Laboratory and animal data were provided to support the safety of the OAS for use in the treatment of A-V shunt stenosis. No new questions of safety or effectiveness are raised.

{2}------------------------------------------------

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle-like emblem with three stylized lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 1 2005

Cardiovascular Systems, Inc. c/o Mr. Gary Syring Principal Consultant Quality and Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589

Re: K041630

Trade Name: Orbital Atherectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Catheter, Peripheral, Atherectomy Regulatory Class: Class II Product Code: MCW Dated: December 23, 2004 Received: December 27, 2004

Dear Mr. Syring:

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.

{3}------------------------------------------------

Page 2 - Mr. Gary Syring

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a substition with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decemination that your as rout of receral agencies. You must or any Federal Statules and regulations daminister on thot limited to: registration and listing (21 comply with all the Act s requirements, mercesses annufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 801), good and the may of any and and one of any of the electronic
forth in the quality systems (QS) regulation (21 CFR Party) (2001) 105 form in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Deceible 501 - 10 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - I his letter will anow you to begin marketing your avence of your devreits your device to a legally premarket notification. THE PDA miding of backannal volume 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 If you desire specific advice ior your as [phone]. Also, please note the regulation entitled, Colliact the Office of Complance at (217) 21 CFR Part 807.97). You may obtain "Misbranding by reference to premance notificanses in the Act from the Division of Small other general information on your responsible at its toll-free number (800) 638-204, or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duana P. Vochner

Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): K 04 | 6 30

Device Name: Orbital 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duana R. Wilmer

Page 1 of 1

(Division Sign-Off)
Division of Cardiovascular Devices

**510(k) Number** K041630