MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER

K992320 · Boston Scientific Corp · LIT · May 18, 2000 · Cardiovascular

Device Facts

• Record ID: K992320
• Device Name: MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
• Applicant: Boston Scientific Corp
• Product Code: LIT · Cardiovascular
• Decision Date: May 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Megabello Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty (PTA) of the iliac and femoral vessels whose lumens are obstructed by atherosclerotic plaque. Megabello catheters are not indicated for use in coronary arteries nor in the neurovasculature. Any other use than those indicated is not recommended.

Device Story

Multilumen catheter with distal controlled-compliance balloon; used for percutaneous transluminal angioplasty (PTA) of iliac and femoral vessels. Physician inserts guidewire through secondary lumen; positions catheter using two radiopaque marker bands. Balloon inflated/deflated via side port to dilate atherosclerotic plaque. Device provides mechanical expansion of obstructed vessel lumens. Used in clinical settings by physicians. Benefits include restoration of blood flow in peripheral vessels.

Clinical Evidence

Bench testing only. Performance testing followed FDA guidance for interventional cardiology devices, including balloon burst strength, compliance, inflation/deflation performance, fatigue, bond strength, catheter diameter/profile, and sheath removal profile. Biocompatibility testing was also performed.

Technological Characteristics

Multilumen catheter; balloon material: Nylon; manifold material: Pebax; shaft material: Pebax 6333; markers: 90/10 Platinum/Iridium; guidewire compatibility: 0.035 inches; rated burst pressure: 7 atm. Mechanical device; no software or energy source.

Indications for Use

Indicated for percutaneous transluminal angioplasty (PTA) of iliac and femoral vessels obstructed by atherosclerotic plaque. Contraindicated for use in coronary arteries and neurovasculature.

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

• SMASH TM Percutaneous Transluminal Angioplasty (PTA) Catheter (K972512)

Submission Summary (Full Text)

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# MAY 1 8 2000

K992320

| 510(k) Summary |
|----------------|
|----------------|

Date Prepared

February 18, 2000

Submitter

| Submitter | Address: | Boston Scientific Corporation<br>Schneider (USA) Inc<br>5905 Nathan Lane<br>Minneapolis, MN 55442 |
|----------------|--------------------------------|---------------------------------------------------------------------------------------------------|
| | Phone :<br>Fax : | [phone]<br>[phone] |
| Contact Person | | Ronald W. Bennett<br>Regulatory Affairs Project Manager |
| | Device Name and Classification | |
| | Trade Name | Megabello Percutaneous Transluminal Angioplasty<br>(PTA) Catheter |

Catheter

Class II

#### Device Description

Predicate Device

Common Name

Classification

The Megabello Percutaneous Transluminal Angioplasty (PTA) Catheter consists of a multilumen catheter with a controlled-compliance balloon mounted at the distal tip. The balloon is designed to inflate to a known diameter and length at a specific pressure and is inflated and deflated via the side port. A second lumen allows access to the distal tip of the catheter for guidewire insertion. Two marker bands are positioned under the balloon at the proximal and distal tapers to aid in accurate placement.

Percutaneous Transluminal Angioplasty (PTA)

SMASH TM Percutaneous Transluminal

Angioplasty (PTA) Catheter - K972512

#### Intended Use

Megabello Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty (PTA) of the iliac and femoral vessels whose lumens are obstructed by atherosclerotic plaque. Megabello catheters are not indicated for use in coronary arteries nor in the neurovasculature. Any other use than those indicated is not recommended.

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### Technical Characteristic Comparison to Predicate

The Megabello Percutaneous Transluminal Angioplasty (PTA) Catheter has the same intended use and basic construction as the predicate device, the SMASH™ Percutaneous Transluminal Angioplasty (PTA) Catheter. The following table compares the technical characteristics of the two devices:

| Feature | MEGABELLO<br>Percutaneous Transluminal<br>Angioplasty (PTA) Catheter | Smash™ Percutaneous<br>Transluminal Angioplasty<br>(PTA) Catheter |
|----------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------|
| Configuration | Multilumen | Multilumen |
| Shaft Length (cm) | 75-120 | 60-120 |
| Shaft French Size | 7 | 5 |
| Balloon Length (mm) | 20-40 | 20-80 |
| Balloon Diameter (mm) | 12, 14 | 3-12 |
| Rated Burst Pressure (atm) | 7 | 7-15 |
| Guidewire Size (inches) | 0.035 | 0.035 |
| Balloon Markers | 2 (90/10 Platinum/ Iridium) | 2 (Gold) |
| Balloon Material | Nylon | Nylon |
| Manifold Material | Pebax | ABS |
| Shaft Material | Pebax 6333 | Nylon |

### Performance Data

The Megabello Percutaneous Transluminal Angioplasty (PTA) Catheter had non-clinical performance testing, as did the predicate device, the SMASH™M Percutaneous Transluminal Angioplasty (PTA) Catheter.

Testing of the Megabello Percutaneous Transluminal Angioplasty (PTA) Catheter generally followed the PTCA Balloon Catheters section in Part II of the "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices", May 1994. The following types of tests were performed similar to those in the guidance:

Balloon Minimum Burst Strength Balloon Compliance (Distensibility) Balloon Inflation/Deflation Performance Balloon Fatigue (Repeated Balloon Inflation) Bond Strength Catheter Diameter and Balloon Profile Catheter Body Burst Pressure

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The following additional evaluations were also performed:

Sheath Removal Profile

The biocompatibility of the catheter was also tested and found acceptable.

## Summary

In summary, Boston Scientific Corporation has demonstrated the Megabello Percutaneous Transluminal Angioplasty (PTA) Catheter is substantially equivalent to the SMASHIM Percutaneous Transluminal Angioplasty (PTA) Catheter based on design and test results for the indications for use given, and is therefore acceptable for commercialization.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 8 2000

Mr. Ronald W. Bennett Regulatory Affairs Project Manager Boston Scientific Corporation Scneider (USA) Inc. 5905 Nathan Lane Minneapolis, MN 55442

K992320 Re: Megabello Balloon Dilatation Catheter Regulatory Class: II (two) Product Code: LIT February 18, 2000 Dated: February 22, 2000 Received:

Dear Mr. Bennett:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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#### Page 2 - Mr. Ronald W. Bennett

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Bin E. Hawr
James E. Dillard III

Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:

Megabello Percutaneous Transluminal Angioplasty (PTA) Catheter

Indications for Use:

Megabello Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty (PTA) of the iliac and femoral vessels whose lumens are obstructed by atherosclerotic plaque. Megabello catheters are not indicated for use in coronary arteries nor in the neurovasculature. Any other use than those indicated is not recommended.

Tom E. Harvey

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(Division Sign-Off)
Division of Cardiovascular, Respiratory,
5/11/10

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

and Neurological Devi

510(k) Number

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Over-The-Counter Use