OPTI-PLAST XL 5.5 F PTA CATHETER

K970725 · Vas-Cath, Inc. · LIT · May 9, 1997 · Cardiovascular

Device Facts

• Record ID: K970725
• Device Name: OPTI-PLAST XL 5.5 F PTA CATHETER
• Applicant: Vas-Cath, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: May 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Opti-Plast® XL 5.5 F PTA Catheter is recommended for use in the Percutaneous Transluminal Angioplasty of the Iliac and Femoral vessels. This catheter is not for use in coronary arteries. The device is indicated for single use only and indicated not to be resterilized nor reused.

Device Story

Dual-lumen catheter with distal balloon; designed for use with 0.035-inch guidewire. One lumen for guidewire insertion; second lumen for balloon inflation/deflation using contrast media. Features two radiopaque tantalum marker bands for positioning. Operates at 5 atmospheres; balloon inflates to labeled diameter/length. Used by clinicians in peripheral vascular procedures to dilate iliac and femoral vessels. Device provides mechanical vessel dilation to improve blood flow; single-use design prevents cross-contamination.

Clinical Evidence

Bench testing only. Evaluated balloon burst strength, distensibility, inflation/deflation time, fatigue, joint/material integrity, catheter shaft/balloon profile, introducer sheath compatibility, flow/pressure, trackability, and tip torque. Results demonstrate performance equivalent to predicate devices.

Technological Characteristics

Dual-lumen catheter; nylon balloon and shaft; 5.5 French diameter; 75, 100, 120 cm lengths. Tantalum radiopaque marker bands. 0.035-inch guidewire compatibility. 5 atm operating pressure; 8 atm rated burst pressure. Mechanical dilation principle.

Indications for Use

Indicated for percutaneous transluminal angioplasty (PTA) of iliac and femoral vessels. Contraindicated for use in coronary arteries. Single use only.

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

• Opti-Plast® PTA Catheter (K933483)
• Medi-tech® XXL™ Balloon Dilatation Catheter (K952063)

Submission Summary (Full Text)

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K970725

MAY -9 1997

2380 Tedlo Street
Mississauga, Ontario
Canada, L5A 3V3

Tel. [phone]
Fax [phone]

# 510(k) SUMMARY STATEMENT of SAFETY AND EFFECTIVENESS

## FOR THE

### OPTI-PLAST® XL 5.5F PTA CATHETER

| A. Submitter Information: | Vas-Cath Incorporated
2380 Tedlo Street
Mississauga, Ontario L5Z 3V3
Canada |
| --- | --- |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Contact Person: | Dolores McGirr |
| Date of Preparation: | January 24, 1997 |
| B. Device Name: | Opti-Plast® XL 5.5 F PTA Catheter XL (Xtra-Large) |
| --- | --- |
| Common/Usual Name: | Peripheral Angioplasty Catheter |
| Classification Name: | Surgical Vessel Dilator |
| C. Predicate Device : | Opti-Plast® PTA Catheter (K933483) |
| --- | --- |
| Trade Name: | Opti-Plast |
| Predicate Device for the Indications for Use: Medi-tech® XXL™ Balloon Dilatation Catheter (K952063) | |

D. Device Description:

The Vas-Cath Opti-Plast® XL 5.5 F PTA Catheter is a dual lumen catheter with a balloon mounted on its distal end. One lumen accommodates the insertion guidewire and the other provides a channel for inflation and deflation of the balloon with contrast media. The catheters were designed to be used in conjunction with a 0.035 inch diameter guidewire. There are two radiopaque marker bands secured on the catheter body to indicate the position of the balloon within the vasculature. The balloon inflates to the labelled diameter and length at a 5 atmosphere operating pressure.

E. Indicated Use:

The Opti-Plast® XL 5.5 F PTA Catheter is recommended for use in the Percutaneous Transluminal Angioplasty of the Iliac and Femoral vessels. This catheter is not for use in coronary arteries. The device is indicated for single use only and indicated not to be resterilized nor reused.

F. Technological Characteristics Summary: Summarized in Table 6.1.

Opti-Plast® XL PTA Catheter 510(k) Summary Page 1

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TABLE 6.1 : Technological Characteristics Summary

| Features | Proposed Vas-Cath Opti-Plast® XL 5.5 F PTA Catheter | Vas-Cath Opti-Plast® PTA Catheter (K933483) | Medi-tech® XXL™ Balloon Dilatation Catheter (K952063) |
| --- | --- | --- | --- |
| Indicated Use | PTA of Iliac and Femoral vessels | PTA of vessels of the peripheral vascular system | PTA of the Iliac and Femoral arteries in the peripheral vasculature |
| Balloon Material | Nylon | Nylon | NA |
| Inflated Balloon Diameters | 12 mm | 10 mm* | 12, 14 mm |
| Inflated Balloon Length | 4 cm | 4 cm* | 2, 4, 6 cm |
| Recommended Operating Pressure | 5 atmospheres | 6 atmospheres* | NA |
| Rated Burst Pressure | 8 atmospheres | 8 atmospheres* | 8 atmospheres |
| Catheter Shaft Material | Nylon | Nylon | NA |
| Radiopaque | Yes | Yes | NA |
| Shaft Diameter | 5.5 French | 5.5 French | 5.8 French |
| Shaft Length | 75, 100, 120 cm | 75, 100, 120 cm | 75, 120cm |
| Shaft configuration | Double lumen | Double lumen | Double lumen |
| Marker Bands | Yes, Tantalum | Yes, Tantalum | Yes |
| Tip Length | 5 mm | 5 mm | 5 mm |
| Tip Inner Diameter | 0.037 inch | 0.037 inch | 0.037 inch |
| Guidewire Capability | 0.035 inch diameter | 0.035 inch diameter | 0.035 inch diameter |

NA- Not available from promotional literature
* Note that there are many other sizes of balloons in this product line. However, the comparison here is made with the 10 mm x 4 cm balloon since this is the closest size to the proposed catheter.

## G. Performance Data

Bench testing was conducted for the following characteristics: balloon burst strength, balloon distensibility, balloon inflation/deflation time, balloon fatigue, joints and material test, catheter shaft and balloon profile, introducer sheath compatibility, catheter flow/maximum pressure, trackability/ deflatability, and tip torque. The test results indicate that the proposed Opti-Plast® XL 5.5 F PTA Catheter is substantially equivalent to the current Opti-Plast® PTA Catheter marketed under 510(k) concurrence K933483. There are no new safety or effectiveness issues.

Opti-Plast® XL PTA Catheter 510(k) Summary Page 6.2