2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter

K151253 · Boston Scientific Limited · PNO · Jun 10, 2015 · Cardiovascular

Device Facts

• Record ID: K151253
• Device Name: 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter
• Applicant: Boston Scientific Limited
• Product Code: PNO · Cardiovascular
• Decision Date: Jun 10, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Peripheral Cutting Balloon catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

Device Story

The 2cm Peripheral Cutting Balloon (PCB) is an over-the-wire (OTW) microsurgical dilatation catheter used in radiology suites, catheterization labs, or operating rooms. It features a double-lumen design with a non-compliant balloon at the distal tip, equipped with atherotomes (blades). The device is passed over a 0.018" guidewire under fluoroscopic imaging. The outer lumen facilitates balloon inflation/deflation, while the inner lumen accommodates the guidewire. Radiopaque markers on the guidewire tubing assist in precise balloon positioning within the vessel. By inflating the balloon, the atherotomes are deployed to score or cut the obstructive lesion, facilitating dilatation. This process helps restore patency in dialysis fistulae, potentially improving blood flow and extending the functional life of the access site. The device is intended for single use.

Clinical Evidence

Bench testing only. No clinical data provided. In-vitro performance testing included balloon compliance, rated burst pressure, multiple inflation, deflation time, bond strength, crossing profile, leakage, blade attachment, guide catheter/introducer sheath compatibility, and particulate release. Extensive biocompatibility testing was performed, including cytotoxicity, sensitization, reactivity, systemic injection, pyrogenicity, mutagenicity, hemolysis, complement activation, and hemocompatibility.

Technological Characteristics

Double-lumen OTW catheter; non-compliant balloon with atherotomes; MDX 4-4159 silicone coating; radiopaque markers; compatible with 0.018" guidewires; available in 50cm, 90cm, and 135cm lengths. Materials are identical to predicate devices. Sterilization method not specified.

Indications for Use

Indicated for patients requiring Percutaneous Transluminal Angioplasty (PTA) 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

• 2cm Peripheral Cutting Balloon® Microsurgical Dilatation Catheter (K041993)
• 2cm Peripheral Cutting Balloon® Microsurgical Dilatation Catheter (K070951)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a bird in flight.

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

May 31, 2016

Boston Scientific Limited Ms. Lisa Mee Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

Re: K151253

Trade/Device Name: 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: May 8, 2015 Received: May 12, 2015

Dear Ms. Mee,

This letter corrects our substantially equivalent letter of June 10, 2015.

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 - Ms. Lisa Mee

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

#### 510(k) Number (if known) K151253

#### Device Name

2cm Peripheral Cutting Balloon® Microsurgical Dilatation Catheter

#### Indications for Use (Describe)

The Peripheral Cutting Balloon catheters are indicated for Perculaneous Transluminal Angioplasty (PTA) of obstructive lessions of synthetic or native arteriovenous dialysis fistulae.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

[] Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## 510k Summary

# Per 21 CFR §807.92

| Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name<br>and Information | Lisa Mee<br>Senior Specialist, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail]<br>Or<br>Melissa Sommerfeld<br>Principal Specialist, Regulatory Affairs<br>Phone : [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Date Prepared | 8 May 2015 |
| Proprietary<br>Name | 2cm Peripheral Cutting Balloon® Microsurgical Dilatation Catheter |
| Common Name | Percutaneous Transluminal Angioplasty Dilatation Catheter |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal |
| Classification | Class II, 21 CFR Part 870.1250 |
| Predicate<br>Device(s) | 2cm Peripheral Cutting Balloon® Microsurgical Dilatation Catheter K041993 Aug 16, 2004<br><br>2cm Peripheral Cutting Balloon® Microsurgical Dilatation Catheter K070951 June 04, 2007 |
| Device<br>Description | The 2cm PCB is an Over-The-Wire (OTW) catheter packaged as sterile and<br>intended for single use in a radiology suite/catheterization laboratory/operating<br>room in conjunction with radiologic equipment for fluoroscopic imaging.<br>The device consists of a double-lumen catheter with a non-compliant balloon<br>attached at the distal tip. One of the lumens connects the Y-Adaptor to the<br>proximal end of the outer shaft and the other connects the Y-Adaptor wire port<br>extending from the wire lumen to the distal end of the balloon. The outer<br>lumen is the balloon inflation lumen and is used to inflate and deflate the<br>balloon during the procedure. The inner lumen is used to pass the catheter<br>over a guidewire. The product is intended to pass a 0.018" (0.46 mm)<br>guidewire. The catheter useable length (effective length) is measured from the<br>distal end of the strain relief to the tip and is available in three sizes - 50 cm,<br>90 cm and 135 cm. Radiopaque markers are placed on the guidewire tubing<br>at the ends of the atherotomes to provide visual reference points for balloon<br>positioning within the vessel. The device is coated with MDX 4-4159 silicone<br>coating. |
| Intended Use of<br>Device | The Peripheral Cutting Balloon catheters are indicated for Percutaneous<br>Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native<br>arteriovenous dialysis fistulae. |

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| Indications for Use | The Peripheral Cutting Balloon catheters are indicated for Percutaneous<br>Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native<br>arteriovenous dialysis fistulae | | |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|--|
| Comparison of<br>Technological<br>Characteristics | The 2cm PCB incorporates substantially equivalent device materials, design,<br>packaging, catheter configuration, fundamental technology, manufacturing<br>processes, sterilization process, and intended use/indication for use as those<br>in the Boston Scientific predicate devices, K041993 and K070951. | | |
| Performance<br>Data | Bench testing was performed to support a determination of substantial<br>equivalence. The results of these tests provide reasonable assurance that the<br>proposed device has been designed and tested to assure conformance to the<br>requirements for its intended use. No new safety or performance issues were<br>raised during the testing and therefore, these devices may be considered<br>substantially equivalent to the predicate devices. The following in-vitro<br>performance tests were completed: | | |
| | Balloon Compliance | Freedom from Leakage | |
| | Balloon Rated Burst Pressure | Blade Attach | |
| | Balloon Multiple Inflation | Guide Catheter Compatibility | |
| | Balloon Deflation Time | Particulate Release | |
| | Introducer Sheath Compatibility | | |
| | Bond Strength | | |
| | Crossing Profile | | |
| | The following biocompatibility tests were completed: | | |
| | In Vitro Cytotoxicity | Direct Contact Hemolysis | |
| | Guinea Pig Maximization<br>Sensitization | Complement Activation C3a and<br>SC5b-9 Assay | |
| | Intracutaneous Reactivity | Indirect Extract Hemolysis | |
| | Acute Systemic Injection | Partial Thromboplastin Time | |
| | Materials Mediated Rabbit Pyrogen | In Vitro Hemocompatibility | |
| | Ames Mutagenicity | USP Physicochemical | |
| | Mouse Lymphoma Assay | Natural Rubber Latex | |
| Conclusion | Based on the indications for use, technological characteristics, and safety and<br>performance testing, the proposed 2cm PCB Dilatation Catheter has been<br>shown to be appropriate for its intended use and is considered to be<br>substantially equivalent to the Boston Scientific predicate 2cm PCB Dilatation<br>Catheter. | | |