SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL

K972512 · Boston Scientific Scimed, Inc. · LIT · Feb 12, 1998 · Cardiovascular

Device Facts

• Record ID: K972512
• Device Name: SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL
• Applicant: Boston Scientific Scimed, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Feb 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter is recommended for use in percutaneous dilatation of the iliac, femoral, popliteal, tibial, renal, and tibioperoneal vessels in whose lumens are obstructed by atherosclerotic plaque. This catheter is not intended for use in the coronary arteries. Any other use than those indicated is not recommended.

Device Story

Smash™ PTA Catheter is a bilumen catheter with a controlled-compliance balloon at the distal tip; used for percutaneous dilatation of peripheral vessels (iliac, femoral, popliteal, tibial, renal, tibioperoneal) obstructed by atherosclerotic plaque. Physician operates device in clinical setting. Balloon inflated/deflated via side port to specific diameter/pressure; second lumen allows guidewire insertion, pressure monitoring, and contrast media infusion. Two marker bands aid placement. Device benefits patients by restoring vessel patency. Non-clinical performance testing (burst strength, compliance, fatigue, bond strength, trackability) confirms safety and efficacy.

Clinical Evidence

Bench testing only. Testing followed FDA guidance for Interventional Cardiology Devices (May 1994). Evaluated balloon burst strength, compliance, inflation/deflation performance, fatigue, bond strength, catheter profile, and body burst pressure. Additional evaluations included resistance through stenosis, pull-back resistance, and trackability. Biocompatibility testing was performed and found acceptable.

Technological Characteristics

Bilumen catheter; Nylon balloon and shaft; ABS manifold. Two gold marker bands. Rated burst pressure 7-15 atm. Compatible with 0.035-inch guidewires. Shaft length 60-120 cm; balloon diameter 3-12 mm. Mechanical device; no energy source or software.

Indications for Use

Indicated for percutaneous dilation of iliac, femoral, popliteal, tibial, renal, and tibioperoneal vessels obstructed by atherosclerotic plaque. Not for use in coronary arteries.

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

• Match-35TM Percutaneous Transluminal Angioplasty (PTA) Catheter (K913297, K926271)

Submission Summary (Full Text)

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Premarket Notification for - Smash™ PTA Catheter

# FEB 1 2 1998

## 16. 510(k) Summary

| Date Prepared | June 30, 1997 |
|--------------------------------|---------------------------------------------------------------------------------------|
| Submitter | |
| Address: | Schneider (USA) Inc<br>5905 Nathan Lane<br>Minneapolis, MN 55442 |
| Phone : | [phone] |
| Fax : | [phone] |
| Contact Person | |
| | Ronald W. Bennett<br>Senior Regulatory Affairs Specialist |
| Device Name and Classification | |
| Trade Name | Smash™ Percutaneous Transluminal Angioplasty<br>(PTA) Catheter |
| Common Name | Percutaneous Transluminal Angioplasty (PTA)<br>Catheter |
| Classification | Class II |
| Predicate Device | Match-35TM Percutaneous Transluminal<br>Angioplasty (PTA) Catheter - K913297, K926271 |

#### Device Description

The Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter consists of a bilumen 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. The second lumen allows access to the distal tip of the catheter for guidewire insertion, pressure monitoring and infusion of contrast media. Two marker bands are positioned under the balloon at the proximal and distal tapers to aid in accurate placement.

and K942154

### Intended Use

The Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter is recommended for use in percutaneous dilatation of the iliac, femoral, popliteal, tibial, renal, and tibioperoneal vessels in whose lumens are obstructed by atherosclerotic plaque. This catheter is not intended for use in the coronary arteries. Any other use than those indicated is not recommended.

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# Technical Characteristic Comparison to Predicate

The Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter has the same intended use and basic construction as the predicate device, the Match-35™ Percutaneous Transluminal Angioplasty (PTA) Catheter. The following table compares the technical characteristics of the two devices:

| Feature | Match-35™ Percutaneous<br>Transluminal Angioplasty<br>(PTA) Catheter | Smash™ Percutaneous<br>Transluminal Angioplasty<br>(PTA) Catheter |
|----------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------|
| Configuration | Bilumen | Bilumen |
| Shaft Length (cm) | 40-200 | 60-120 |
| Shaft French Size | 5 | 5 |
| Balloon Length (mm) | 20-100 | 20-80 |
| Balloon Diameter (mm) | 3-12 | 3-12 |
| Rated Burst Pressure (atm) | 7-12 | 7-15 |
| Guidewire Size (inches) | 0.035 | 0.035 |
| Balloon Markers | 2 (Gold / Tantalum) | 2 (Gold) |
| Balloon Material | Polyethylene Terephthalate | Nylon |
| Manifold Material | Polycarbonate | ABS |
| Shaft Material | Polyester | Nylon |

## Performance Data

The Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter had non-clinical performance testing as did the predicate device, the Match-35TM Percutaneous Transluminal Angioplasty (PTA) Catheter.

Testing of the Smash™ 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 by Schneider (USA):

Resistance through Stenosis Pull Back Resistance into Introducer Trackability Catheter Prep Time

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

#### Summary

In summary, Schneider (USA) Inc has demonstrated the Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter is substantially equivalent to the Match-35TM Percutaneous Transluminal Angioplasty (PTA) Catheter based on design, test results, and indications for use and is therefore acceptable for commercialization.

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Image /page/3/Picture/2 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

FEB 1 2 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ronald W. Bennett Senior Regulatory Affairs Specialist Schneider (USA) Inc. Pfizer Hospital Products Group 5905 Nathan Lane Minneapolis, MN 55442

K972512 Re: Smash™ Percutaneous Transluminal Angioplasty (PTA) Regulatory Class: II (two) Product Code: 74 LIT Dated: January 16, 1998 Received: January 20, 1998

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 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 requlation 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 regulations.

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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 (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. reference to premarket notification" (21 CFR 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/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Cállahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification for Smash™ PTA Catheter

Page of

510(k) Number (if known):

Device Name:

Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter

Indications for Use:

The Smash™ Percutaneous Transluminal Angioplasty (PTA) Catheter is recommended for use in percutaneous dilation of the iliac, femoral, popliteal, tibial, renal, and tibioperoneal vessels in whose lumens are obstructed by atherosclerotic plaque. This catheter is not intended for use in the coronary arteries. Any other use than those indicated is not recommended.

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

| | | Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| | | <table><tr><td>(Division Sign-Off)</td></tr><tr><td>Division of Cardiovascular, Respiratory,</td></tr><tr><td>and Neurological Devices</td></tr></table> | (Division Sign-Off) | Division of Cardiovascular, Respiratory, | and Neurological Devices |
|------------------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|------------------------------------------|--------------------------|
| (Division Sign-Off) | | | | | |
| Division of Cardiovascular, Respiratory, | | | | | |
| and Neurological Devices | | | | | |

| 510(k) Number | K972512 |
|---------------|---------|
|---------------|---------|

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
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(Optional Format 1-2-96)