STEALTH 360 ORBITAL PAD SYSTEM

K122987 · Cardiovascular Systems, Inc. · MCW · Oct 25, 2012 · Cardiovascular

Device Facts

• Record ID: K122987
• Device Name: STEALTH 360 ORBITAL PAD SYSTEM
• Applicant: Cardiovascular Systems, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Oct 25, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stealth 360° Orbital PAD 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 OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectorny system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

Device Story

Percutaneous orbital atherectomy system (OAS) for removal of stenotic material from peripheral arteries and AV dialysis grafts. System components: orbital atherectomy device (OAD), guide wire, saline pump, and lubricant. Principle of operation: electrically driven shaft rotates a diamond-coated crown eccentrically to ablate stenotic tissue; resulting particles are small enough for bodily absorption. Used in clinical settings by physicians. Output is physical removal of stenosis; healthcare provider monitors procedure via standard imaging/clinical assessment. Benefits: minimally invasive treatment of occlusive disease.

Clinical Evidence

Bench testing only. Performance evaluated via life/stall testing and orbit testing to compare the modified molded crown design against the predicate machined crown design.

Technological Characteristics

Orbital atherectomy system; electrically driven shaft; diamond-coated rotating crown; saline-cooled. Crown blanks are molded. System includes OAD, guide wire, saline pump, and lubricant. Class II device (21 CFR 870.4875).

Indications for Use

Indicated for patients with occlusive atherosclerotic disease in peripheral arteries or occluded hemodialysis grafts (AV shunts) who are candidates for percutaneous transluminal atherectomy or angioplasty.

Regulatory Classification

Identification

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

Predicate Devices

• Stealth 360º® Orbital PAD System (K110389)

Reference Devices

• K071350
• Predator 360° (K090521)

Submission Summary (Full Text)

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K122987

### 510(k) Summary Section. 6

OCT 2 5 2012 Company Name: Cardiovascular Systems, Inc. 651 Campus Drive Saint Paul, MN 55112 Contact: Maureen McDonnell Phone: [phone] Fax: [phone] September 25, 2012 Summary Date: Trade Name: Stealth 360°® Orbital PAD System Common Name: Peripheral Atherectomy Device Classification Name: Peripheral Atherectomy Catheter (21 CFR 870.4875; Product Code: MCW) Predicate Device:

> 510(k) Number: K110389 Manufacturer: Cardiovascular Systems, Inc. Trade Name: Stealth 360º® Orbital PAD System

### 6.1 Description of Device

The Stealth 360° Orbital PAD System is an orbital atherectomy system (OAS) that is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Stealth 360° uses an electrically driven shaft to apply a diamond coated, eccentrically rotating surface to ablate stenotic material. The stenotic particles that are removed are small enough to be absorbed by the body.

The Stealth 360° Orbital PAD System consists of the following components:

- 1) Orbital atherectomy device (OAD)
- 2) Atherectomy guide wire
- 3) Externally operated saline pump
- 4) Atherectomy Lubricant (e.g. ViperSlide)

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### Intended Use 6.2

The Stealth 360° Orbital PAD 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 OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

#### 6.3 Technology

The Stealth 360° Orbital PAD System provides a method of removing occlusive atherosclerotic or stenotic material. The OAS applies a diamond coated, eccentrically rotating sanding surface to ablate stenotic tissue. The stenotic particles that are removed are small enough to be absorbed by the body. This same technology was cleared to market for use in 510(k) K110389, 510(k) K071350, and Predator 360° (originally cleared as 3X) per K090521.

The device crowns are comprised of blanks that are plated and diamond coated. The primary difference between the device that is the subject of this submission and the predicate device is that the current solid crown blanks are machined and the crown blanks for the modified device will be molded. Molding blanks is intended to be another method for producing a crown of the same material composition as the current blank. The plating and diamond coating processes will be exactly the same for both blanks.

#### 6.4 Performance Data

The modified Stealth 360° Orbital PAD System was evaluated using the following performance bench testing to confirm the performance characteristics as compared to the predicate device.

- Life/Stall Testing .
- Orbit Testing .

#### 6.5 Conclusions

The Stealth 360° Orbital PAD System with the molded crown is substantially equivalent to the predicate device. Design verification testing was performed to support the safety profile of the modified Stealth 360° Orbital PAD System. Testing results demonstrate that the modified Stealth 360° Orbital PAD System is as safe and effective as the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of an eagle.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT
2 5 2012

Cardiovascular Systems, Inc. c/o Maureen McDonnell Senior Regulatory Affairs Specialist 651 Campus Drive St. Paul, MN 55112

Re: K122987

Trade/Device Name: Stealth 360° Orbital PAD System Regulation Number: 21 CFR 870.4875 Regulation Name: Peripheral Atherectomy Catheter Regulatory Class: Class II Product Code: MCW Dated: September 25, 2012 Received: September 26, 2012

Dear Ms. McDonnell:

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. Please note: CDRH does not evaluate information related to contract liability warranties. However, we remind you that device labeling must be truthful and not misleading.

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 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.

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

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Page 2 - Ms. Maureen McDonnell

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

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/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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,

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

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### Indications for Use Statement Section. 5

K122987 510(k) Number:

Device Name: Stealth 360°@ Orbital PAD System

## Indications for Use:

The Stealth 360° Orbital PAD 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 OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectorny system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Numb