2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS

K070951 · Boston Scientific · PNO · Jun 4, 2007 · Cardiovascular

Device Facts

• Record ID: K070951
• Device Name: 2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS
• Applicant: Boston Scientific
• Product Code: PNO · Cardiovascular
• Decision Date: Jun 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Peripheral Cutting Balloon (PCB) catheter; conventional angioplasty catheter with microsurgical capabilities. Features balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on outer surface. Device inserted over guidewire to target lesion. Inflation causes atherotomes to score plaque, creating initiation sites for crack propagation. Allows dilatation of target lesion with less pressure, minimizing barotrauma. Used by clinicians in clinical settings for dialysis fistula treatment.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, technological characteristics, and intended use compared to predicate devices.

Technological Characteristics

PTA catheter featuring balloon with 3 or 4 longitudinal atherotomes (microsurgical blades). Monorail or Over-the-Wire delivery system options. Class II device.

Indications for Use

Indicated for percutaneous transluminal angioplasty of 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

• 2cm Peripheral Cutting Balloon (K041993)
• 2cm Peripheral Cutting Balloon (K051254)
• small Peripheral Cutting Balloon with Monorail Delivery System (K052038)
• small Peripheral Cutting Balloon with Monorail Delivery System (K062387)
• small Peripheral Cutting Balloon with Over-the-Wire Delivery System (K052038)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The logo is black and white.

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

May 31, 2016

Boston Scientific Corporation c/o Mr. Brian Park Principal Regulatory Affairs Specialist 3574 Ruffin Road San Diego, CA 92123

Re: K070951

Trade/Device Name: Peripheral Cutting Balloon Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: April 3, 2007 Received: April 4, 2007

Dear Mr. Park:

This letter corrects our substantially equivalent letter of June 4, 2007.

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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

Page 2 - Mr. Brian Park

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

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

## ll. INDICATIONS FOR USE STATEMENT

Kozo95) 510(k) Number:

Device Names: 2cm Peripheral Cutting Balloon® small Peripheral Cutting Balloon® with Monorail Delivery System small Peripheral Cutting Balloon® with Over-the-Wire Delivery System

Indications for Use:

The 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)

L

(Division of Cardio)
Division of Cardiovasc
510(k) Number K070695

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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

## 510(k) SUMMARY lll.

JUN -- 4 2007

| Submitter's Name<br>and Address | Boston Scientific Corporation<br>3574 Ruffin Road<br>San Diego, CA 92123 | | | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|------------------------------------|-----------------|
| Contact Name and<br>Information | Brian Park<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] | | | |
| Date Prepared | April 3, 2007 | | | |
| Proprietary<br>Names | 2cm Peripheral Cutting Balloon®<br>small Peripheral Cutting Balloon® with Monorail Delivery System<br>small Peripheral Cutting Balloon® with Over-the-Wire Delivery System | | | |
| Common Name | PTA Catheter | | | |
| Product Code | LIT | | | |
| Classification of<br>Device | Class II, 21 CFR Part 870.1250 | | | |
| Predicate Device | 2cm Peripheral Cutting<br>Balloon® | K041993<br>K051254 | August 16, 2004<br>June 22, 2005 | |
| | Small Peripheral Cutting<br>Balloon® with Monorail Delivery<br>System | K052038<br>K062387 | August 16, 2005<br>October 5, 2006 | |
| | Small Peripheral Cutting<br>Balloon® with Over-the-Wire<br>Delivery System | K052038 | August 16, 2005 | |
| Device<br>Description | The family of Peripheral Cutting Balloon (PCB) Catheters has<br>features of a conventional angioplasty catheter with advanced<br>microsurgical capabilities. The PCB family features a balloon with<br>3 or 4 atherotomes (microsurgical blades) mounted longitudinally<br>on its outer surface. The device is inserted over a guidewire and<br>delivered to the target lesion. When the PCB device is inflated,<br>the atherotomes score the plaque, creating initiation sites for crack<br>propagation. Percutaneous Angioplasty (PTA) with the PCB<br>device allows dilatation of the target lesion with less pressure,<br>minimizing barotrauma. | | | |
| Intended Use of<br>Device | PCB catheters are indicated for percutaneous transluminal<br>angioplasty of obstructive lesions of synthetic or native<br>arteriovenous dialysis fistulae. | | | |
| Support of<br>Substantial<br>Equivalence | There are no changes in design, composition, function or indication<br>of any of the proposed PCB devices compared to their respective<br>predicates: | | | |
| | Proposed Device | Predicate Device | 510(k) | Clearance Date |
| | 2cm PCB | 2cm PCB | K041993 | August 16, 2004 |
| | | | K051254 | June 22, 2005 |
| | small PCB with<br>Monorail Delivery<br>System | small PCB with<br>Monorail Delivery<br>System | K052038 | August 16, 2005 |
| | | | K062387 | October 5, 2006 |
| | small PCB with<br>OTW Delivery<br>System | small PCB with<br>OTW Delivery<br>System | K052038 | August 16, 2005 |
| | The only change being proposed is adding a new contraindication<br>and a new warning in the DFU. | | | |
| Conclusion | Based on the indications for use and the technological<br>characteristics, the PCB has been shown to be equivalent in<br>intended use and is considered to be substantially equivalent to<br>their respective predicate PCBs (K041993, cleared August 16,<br>2004; K051254, cleared June 22, 2005; K052038, cleared August<br>16, 2005; and K062387, cleared October 5, 2006.) | | | |

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

.

.