.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS

K111295 · Boston Scientific Corporation · LIT · May 31, 2011 · Cardiovascular

Device Facts

• Record ID: K111295
• Device Name: .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
• Applicant: Boston Scientific Corporation
• Product Code: LIT · Cardiovascular
• Decision Date: May 31, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

.014 PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, infrapopliteal, popliteal, renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

The .014 PTA Balloon Dilatation Catheter is a peripheral vascular device featuring a coaxial shaft design; it utilizes a guidewire (0.014 in) to navigate to and through stenotic lesions. The device includes an inflatable balloon segment of defined diameter and length, and a tapered tip to facilitate advancement. Operated by physicians in clinical settings, the catheter is inflated to recommended pressures to dilate obstructive lesions in the peripheral vasculature or dialysis fistulae. The device provides mechanical dilation of vessels, improving blood flow and potentially benefiting patients by resolving obstructive vascular conditions.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (cytotoxicity, sensitization, reactivity, systemic toxicity, pyrogenicity, hemolysis, complement activation, hemocompatibility) and in-vitro performance (balloon inflation, compliance, burst pressure, bond tensile, shaft profile, flexibility, kink resistance, crossing profile, particulate evaluation, radiopacity, and sheath compatibility).

Technological Characteristics

Coaxial shaft design; 0.014 inch guidewire compatibility; balloon segment with defined diameter/length; tapered tip. Materials and manufacturing processes are substantially equivalent to predicate devices. Sterilization via established methods with consistent Sterility Assurance Level (SAL).

Indications for Use

Indicated for patients requiring Percutaneous Transluminal Angioplasty (PTA) in peripheral vasculature (iliac, femoral, infrapopliteal, popliteal, renal arteries) or treatment of obstructive lesions in native/synthetic 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

• Sterling ES Monorail and OTW PTA Balloon Dilatation Catheters (K080982, K093636)
• Sterling SL Monorail and OTW PTA Balloon Dilatation Catheters (K093720)

Submission Summary (Full Text)

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K111295 page 1 of 4

MAY 3 1 2011

## 510(k) Summary

| Submitter: | Boston Scientific Corporation<br>One Scimed Place Maple Grove, MN 55311 |
|------------------------|-------------------------------------------------------------------------|
| Contact Person: | Mark Murphy |
| Phone Number: | 763-494-2377 |
| Fax Number: | 763-494-2222 |
| Date Prepared: | May 6, 2011 |
| Device Trade Name: | .014 Monorail and OTW PTA Balloon Dilatation Catheters |
| Common Name: | Percutaneous Transluminal Angioplasty Dilatation Catheter |
| Device Classification: | Class II, 21 CFR 870.1250 Product Code: LIT |

## Predicate Devices

Sterling SL Monorail and OTW PTA Balloon Dilatation Catheters and Sterling ES Monorail and OTW PTA Catheters.

#### Device Description

The .014 PTA Balloon Dilatation Catheters have a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014 in (0.36 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The catheter includes a tapered tip to facilitate advancement of the catheter. The working lengths of the balloon catheter are 90 cm and 150 cm.

#### Indications for Use

The .014 Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, infrapopliteal, renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

#### Substantial Equivalence

The .014 PTA Balloon Dilatation Catheters design, materials, manufacturing process and intended use are substantially equivalent to predicate devices Sterling ES (K080982 and K093636), and Sterling SL Monorail and OTW (K093720) PTA Catheters.

## Comparison of Technological Characteristics

The .014 PTA Balloon Dilatation Catheter incorporates substantially equivalent device materials and design, packaging materials and design, fundamental technology, manufacturing processes, sterilization processes and intended use as those featured in the Boston Scientific predicate devices, Sterling ES PTA Balloon Dilatation Catheter (K080982 and K093636) and Sterling SL PTA Balloon Dilatation Catheter (K093720).

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| Characteristic | Sterling ES (MR/OTW) | Sterling SL (MR/OTW) |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Manifold | Same material. Different colorant.<br>Same design with minor<br>dimensional differences but serving<br>same function | OTW Same material. MR different<br>material. Same design with minor<br>dimensional differences but<br>serving same function |
| Strain Relief | MR has different material. OTW has<br>same material. Similar designs with<br>serving same function | Same material, different colorant,<br>different designs but serving same<br>function |
| Catheter Proximal Shaft /<br>Distal Outer | MR different material. OTW similar<br>material. Both designs serving<br>same function | Similar material and design serving<br>same function |
| Catheter Inner Shaft | Same material, different colorants<br>and serving same function | Similar material, same colorants<br>and serving same function |
| Bumper Tip | Different material, same colorant<br>but serving same function | Different material, different<br>colorant but serving same function |
| Balloon | Difference in balloon material and<br>design but serving same function<br>and fundamental technology | Difference in balloon material and<br>design but serving same function<br>and fundamental technology |
| Balloon Bonding Method | Same bonding method and<br>function | Same bonding method and<br>function |
| Balloon Forming<br>Process | Same forming method and function | Same forming method and function |
| Marker Bands | Similar component serving same<br>function | Different component serving same<br>function |
| Coating | Same coating serving same<br>function | Same coating serving same<br>function |
| Balloon Protector | Same material and similar design<br>both serving same function. | Same material and similar design<br>both serving same function |
| Proximal Shaft Outer<br>Diameter | Similar shaft outer diameters | Similar shaft outer diameters |

·

## Comparison to Predicate Devices in Materials and Manufacturing

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| Characteristic | Sterling ES (MR/OTW) | Sterling SL (MR/OTW) |
|---------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------|
| Balloon Diameters | Similar balloon diameter range<br>serving same function | Same balloon diameter range<br>serving same function |
| Balloon Lengths | Shorter balloon length ranges<br>serving same function | Similar balloon length ranges<br>serving same function |
| Rated Burst Pressure<br>(RBP) | Similar rated burst pressure | Same rated burst pressure |
| Catheter Length | Similar catheter length ranges<br>serving same function | Same catheter length ranges<br>serving same function |
| Recommended<br>Introducer Sheath<br>Compatibility | Similar ranges and compatibilities | Same ranges and compatibilities |
| Recommended<br>Guidewire | Same compatibility. | Same compatibility. |
| Sterilization Method | Same method. | Same method. |
| SAL | Same level of assurance | Same level of assurance |
| Packaging Material<br>and Configuration | Same design and function | Same design and function |

## Performance Data

Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing.

The following biocompatibility tests were completed on the .014 PTA Balloon Dilatation Catheter:

| MEM Elution / Cytotoxicity | Hemolysis / Direct Contact |
|---------------------------------------|-----------------------------|
| Guinea Pig Maximization Sensitization | Complement Activation |
| Intracutaneous Reactivity | Partial Thromboplastin Time |
| Acute Systemic Toxicity | In Vitro Hemocompatibility |
| Materials Mediated Rabbit Pyrogen | |

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K111295 page 4 of 4

The following in-vitro performance tests were completed for the .014 PTA Balloon Dilatation Catheter:

| Balloon Multiple Inflation | Distal Shaft Profile |
|--------------------------------------|---------------------------------------|
| Balloon Compliance (Distension) | Flexibility and Kink Test |
| Balloon Diameter at Nominal Pressure | Folded Balloon Crossing Profile |
| Balloon Length Dimensions (mm) | Particulates Evaluation |
| Balloon Rated Burst Pressure | Proximal Shaft Profile MR |
| Bond Tensile | Proximal Shaft Profile OTW |
| Burst Mode | Radiopacity |
| Catheter Length Dimensions | Sheath Insertion and Withdrawal Force |
| | Distal Inner Shaft ID |

## Conclusion

Based on the indications for use, technological characteristics, and safety and performance testing, the .014 PTA Balloon Dilatation Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Boston Scientific Sterling ES PTA Balloon Dilatation Catheter (K080982 and K0936336) and the Sterling SL PTA Balloon Dilatation Catheter (K093720).

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a caduceus-like symbol with three parallel lines that curve and converge, representing health and human services.

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

MAY 3 1 2011

Boston Scientific Corporation c/o Mr. Mark Murphy One Scimed Place Maple Grove, MN 55311-1566

Re: K111295

Trade/Device Name: .014 Monorail and Over-The-Wire PTA Balloon Dilatation Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutancous catheter Regulatory Class: Class II (two) Product Code: LIT, DQY Dated: May 6, 2011 Received: May 9, 2011

Dear Mr. Murphy:

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. 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.

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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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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/Resourcesfor You/Industry/default.htm.

érely vou

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

Enclosure

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| Indications for Use Statement | | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k) Number<br>(if known) | K111295 | |
| Device Name | .014 MR & OTW PTA Balloon Dilatation Catheters | |
| Indications for<br>Use | .014 PTA Balloon Dilatation Catheter is indicated for Percutaneous<br>Transluminal Angioplasty (PTA) in the peripheral vasculature, including<br>iliac, femoral, infrapopliteal, popliteal, renal arteries, and for the treatment o<br>obstructive lesions of native or synthetic arteriovenous dialysis fistulae. | |

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Cardioyascular Devices 510(k) Nui ાંાણા 295

Prescription Use ___X (Per 21 CFR 801.109 OR

Over-The-Counter Use___________________________________________________________________________________________________________________________________________________________________________