SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM

K062387 · Boston Scientific · PNO · Oct 5, 2006 · Cardiovascular

Device Facts

• Record ID: K062387
• Device Name: SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
• Applicant: Boston Scientific
• Product Code: PNO · Cardiovascular
• Decision Date: Oct 5, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The small Peripheral Cutting Balloon catheters are indicated for percutaneous transluminal angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

Device Story

Small Peripheral Cutting Balloon (PCB) with Monorail delivery system; conventional angioplasty catheter integrated with microsurgical capabilities. Balloon features 3 or 4 longitudinal atherotomes (microsurgical blades) on outer surface. Device inserted over guidewire to target lesion; inflation causes atherotomes to score plaque, creating initiation sites for crack propagation. Allows lesion dilatation at lower pressures, minimizing barotrauma. Used by clinicians in interventional settings for dialysis fistula maintenance.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics.

Technological Characteristics

PTA catheter with balloon featuring 3-4 longitudinal atherotomes (microsurgical blades). Monorail delivery system. Mechanical dilation mechanism. No software or electronic components.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty to treat obstructive lesions in synthetic or native arteriovenous dialysis fistulae.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Small Peripheral Cutting Balloon with Monorail Delivery System (K052038)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white 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. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.

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

My 31, 2016

Boston Scientific Corporation c/o Mr. Joseph Ostendorf Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

Re: K062387

Small Peripheral Cutting Balloon Monorail Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: PNO Dated: September 25, 2006 Received: September 26, 2006

Dear Mr. Ostendorf:

This letter corrects our substantially equivalent letter of October 5, 2006.

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 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. We remind you, however, 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 or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Joseph Ostendorf

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 device-related 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Misti L. Malone -S

for 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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Boston Scientific Corporation

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4. Indications for Use Statement

510(k) Number:

K062387

Device Name: System

small Peripheral Cutting Balloon with Monorail Delivery

Indications for Use:

The Small Peripheral Cutting Balloon catheters are indicated for percutaneous transluminal angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

Prescription Use × (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)

Duna R. Jachus
(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_Ko 6238 7

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## Boston Scientific Corporation

## 5. 510(k) Summary

| Submitter's Name<br>and Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and<br>Information | Angie Byland<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared | August 14, 2006 |
| Proprietary<br>Name(s) | Small Peripheral Cutting Balloon™ |
| Common Name | PTA Catheter |
| Product Code | LIT |
| Classification of<br>Device | Class II, 21 CFR Part 870.1250 |
| Predicate Device | Small Peripheral Cutting Balloon™<br>with Monorail<br>Delivery System<br>K052038 August 16, 2005 |
| Device<br>Description | The small Peripheral Cutting Balloon Catheter (PCB) with<br>Monorail (MR) delivery system has features of a<br>conventional angioplasty catheter with advanced<br>microsurgical capabilities. The sPCB features a balloon<br>with 3 or 4 atherotomes (microsurgical blades) mounted<br>longitudinally on its outer surface. The device is inserted<br>over a guidewire and delivered to the target lesion. When<br>the PCB device is inflated, the atherotomes score the<br>plaque, creating initiation sites for crack propagation.<br>Percutaneous Angioplasty (PTA) with the PCB device<br>allows dilatation of the target lesion with less pressure,<br>minimizing barotrauma. |
| Intended Use of<br>Device | The small Peripheral Cutting Balloon catheters are indicated<br>for percutaneous transluminal angioplasty of obstructive<br>lesions of synthetic or native arteriovenous dialysis fistulae. |
| Support of<br>Substantial<br>Equivalence | The small Peripheral Cutting Balloon Catheter with Monorail<br>delivery system with the modified port weld is the same<br>indication, design, composition, and function as the<br>Peripheral Cutting Balloon Catheter, small Monorail<br>(K052038), cleared August 16, 2005. |

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## Boston Scientific Corporation

| Conclusion | Based on the indications for use and the technological<br>characteristics, the small Peripheral Cutting Balloon with<br>Monorail delivery system has been shown to be equivalent<br>in intended use and is considered to be substantially<br>equivalent to the Small Peripheral Cutting BalloonTM with<br>Monorail delivery system (K052038, cleared June 22,<br>2005). |
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