ULTRA-SOFT SV BALLOON DILATATION CATHETER

K050389 · Boston Scientific Corp · DQY · May 25, 2005 · Cardiovascular

Device Facts

• Record ID: K050389
• Device Name: ULTRA-SOFT SV BALLOON DILATATION CATHETER
• Applicant: Boston Scientific Corp
• Product Code: DQY · Cardiovascular
• Decision Date: May 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed Ultra-soft™ SV Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of the carotid, iliac, femoral, ilio-femoral, popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

Monorail balloon dilatation catheter; distal segment dual-lumen coaxial design; balloon near distal tip provides inflatable segment of known diameter/length. Wire lumen accommodates guidewires (≤0.018 in) for advancement to/through stenosis. Used by physicians in clinical settings for PTA procedures; facilitates dilation of obstructive lesions in peripheral arteries and dialysis fistulae. Output is mechanical dilation of vessel/fistula via balloon inflation at recommended pressures. Benefits patient by restoring blood flow through stenotic regions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Monorail catheter; dual-lumen coaxial distal segment; balloon dilatation mechanism; compatible with guidewires ≤0.018 in; various lengths (90cm/150cm) and diameters (4.0mm-7.0mm).

Indications for Use

Indicated for percutaneous transluminal angioplasty (PTA) of carotid, iliac, femoral, ilio-femoral, popliteal, and renal arteries, and treatment of obstructive lesions in native or 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

• Ultra-soft™ SV Balloon Dilatation Catheter (K021735)

Submission Summary (Full Text)

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K050389 Lof2

# 510(k) Summary

# (as required per 21 CFR 807.92)

## General Provisions

| Submitter's Name<br>and Address | Boston Scientific Corporation<br>Two Scimed Place<br>Maple Grove, Minnesota 55311 |
|---------------------------------|-----------------------------------------------------------------------------------------------|
| Contact Person | Angela Byland<br>Manager, Regulatory Affairs<br>[phone] |
| Classification Name | Percutaneous Transluminal Angioplasty<br>Balloon Dilatation Catheter<br>(21CFR Part 870.1250) |
| Classification | Class II |
| Common or Usual Name | Balloon Dilatation Catheter |
| Proprietary Name | Boston Scientific Ultra-soft™ SV Balloon<br>Dilatation Catheter |

#### Predicate Device

Boston Scientific Corporation Ultra-soft™ SV Balloon Dilatation Catheter (K021735; cleared August 8, 2002)

#### Device Description

The Ultra-soft™ SV Balloon Dilatation Catheter is a Monorail™ catheter with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The distal segment of the balloon catheter is dual lumen and coaxial. The outer lumen is used for inflation of the balloon. The wire lumen permits the use of guidewires (≤0.018 in / 0,46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The Ultra-soft™ SV Balloon Dilatation Catheter will be available in the sizes summarized in Table 1.

> Ultra-soft SV™ Balloon Dilatation Catheter Traditional 510(k) Premarket Notification

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Section 4

# Summary of Safety and Effectiveness

# Device Description (continued)

| Length<br>Balloon/Catheter | 4.0mm | 4.5mm | 5.0mm | 5.5mm | 6.0mm | 6.5mm | 7.0mm |
|----------------------------|-------|-------|-------|-------|-------|-------|-------|
| 15 mm/90 cm | X | X | X | X | X | X | X |
| 15 mm/150 cm | X | X | X | X | X | X | X |
| 20 mm/90 cm | X | X | X | X | X | X | X |
| 20 mm/ 150 cm | X | X | X | X | X | X | X |

# Table 1: Ultra-soft™ SV Size Matrix

## Intended Use

The proposed Ultra-soft™ SV Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of the carotid, iliac, femoral, ilio-femoral, popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

## Technological Characteristics

The Ultra-soft™ SV Balloon Dilatation Catheter is substantially equivalent in design, packaging, fundamental technology, manufacturing, sterilization and intended use as compared to the predicate Boston Scientific Ultra-soft™ SV Balloon Dilatation Catheter.

## Conclusion

Based on the Indications for Use, technological characteristics, and safety and performance testing, the Ultra-soft™ SV Balloon Dilatation Catheter has been shown to be acceptable for its intended use and is considered to be substantially equivalent to the Ultra-soft™ Balloon Dilatation Catheter (K021735; cleared August 8, 2002)

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird with three stylized wings or feathers.

MAY 2 5 2005

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corporation c/o Ms. Angela Byland Manager, Regulatory Affairs Two Scimed Place Maple Grove, MN 55311-1566

Re: K050389

Ultra-Soft SV Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: May 11, 2005 Received: May 12, 2005

Dear Ms. Byland:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the Clerosule) to regarly mannent date of the Medical Device American Case of Drug commerce proof to May 20, 1976, the ensordance with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval application (PMA). allu Cosmetic Act (71ct) market the device, subject to the general controls provisions of the Act. The You may, therefore, market the devices, books of the virements for annual registration. Iisting of general controls provisions of the fret merade comments of and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (IPMA). it If your device is classified (500 above) the existing major regulations afficcting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obacements concerning your device in the Federal Register.

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Page 2 - Ms. Angela Byland

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase of advisou that I Draination that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must of any I catal statutes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K I all 607); adoling (21 CFR Part 820); and if applicable, the electronic form in the quarty bybeline (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of to begin marketing your device as described in your Section 510(k) I mis lotter with and not your finding of substantial equivalence of your device to a legally prematice notification: "The President 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), please rr you desire specific at no 10-12-1 at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

e Mdl.

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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# Indications for Use

510(k) Number (if known): KO 50389

Ultra-soft™ SV Balloon Dilatation Catheter Device Name:

Indications For Use:

The Ultra-soft™ SV Balloon Dilatation Catheters are indicated for percutaneous The Oltra-Solt - OV Balloon Bilatthe carotid, iliac, femoral, illio-femoral, popliteal, transfulnimal angloplatiy (r 1) treatment of obstructive lesions of native or synthetic 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)

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rdisvascular Devices K050389 510fk1 Number