FOCUS PV BALLOON DILATATION CATHETER

K963688 · Cardiovascular Dynamics, Inc. · LIT · Mar 28, 1997 · Cardiovascular

Device Facts

• Record ID: K963688
• Device Name: FOCUS PV BALLOON DILATATION CATHETER
• Applicant: Cardiovascular Dynamics, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Mar 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The FOCUS™-PV Balloon Dilatation Catheter is a balloon dilatation catheter intended for use in percutaneous transluminal balloon dilatation (PTA) of large vessels of the peripheral vasculature.

Device Story

FOCUS™-PV is a double-lumen balloon dilatation catheter used for peripheral transluminal angioplasty. Operates via hydraulic pressurization of a distal balloon to exert radial force on narrowed vessel segments. Designed for use in peripheral vascular procedures; operated by clinicians. Modifications from previous FOCUS models include larger balloon sizes, reduced balloon compliance, transition from double-layer polyethylene/PET to single-layer PET balloon, adhesive bonding to nylon shaft, and shift from side-by-side to coaxial shaft configuration. Device provides mechanical dilatation to improve blood flow in peripheral vessels.

Clinical Evidence

Bench testing only. Testing included balloon burst, balloon cycle, radiopacity, tensile strength (connector to shaft and distal end), profile measurements, and biocompatibility. All tests met design specifications with no failures reported.

Technological Characteristics

Double-lumen catheter with distal balloon. Materials: Single-layer polyethylene terephthalate (PET) balloon, nylon shaft. Configuration: Coaxial tubing. Dimensions: 4.0-8.0 mm balloon diameter, 75-150 cm shaft length. Compatible with 0.018/0.035 inch guidewires. Mechanical operation via hydraulic pressurization.

Indications for Use

Indicated for percutaneous transluminal balloon dilatation (PTA) of large vessels of the peripheral vasculature.

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 35™ PTA Balloon Catheters (Schneider)
• Total Cross™ Balloon Dilatation Catheter (Schneider)
• MS Classique™ Balloon Dilatation Catheter (Medi-tech)
• Ultra-Thin™ Balloon Dilatation Catheter (Medi-tech)
• FOCUS™ Balloon Dilatation Catheter (K944016)
• FOCUS™ Balloon Dilatation Catheter (K952064)
• FOCUS™ Balloon Dilatation Catheter (K954313)

Submission Summary (Full Text)

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CardioVascular Dynamics, Inc.
510(k) Notification
FOCUS™-PV Balloon Dilatation Catheter
September 13, 1996

# SECTION 2 - 510(k) SUMMARY

K963688
march 28, 1997

## Submitted By:

CardioVascular Dynamics Incorporated (CVD)
13900 Alton Parkway, Suite 122
Irvine, CA 92618
714-457-9546
Contact: Michael Crocker

## Summary Preparation:
September 13, 1996

## Device:
FOCUS™-PV Balloon Dilatation Catheter

## Classification Name:
Catheter, Peripheral, Balloon Type

## Predicate Device:
PTA Catheters:

Match 35™ PTA Balloon Catheters
Schneider

Total Cross™ Balloon Dilatation Catheter
Schneider

MS Classique™ Balloon Dilatation Catheter
Medi-tech

Ultra-Thin™ Balloon Dilatation Catheter
Medi-tech

FOCUS™ Balloon Dilatation Catheter
CardioVascular Dynamics, Inc.
510(k) K944016
SE Date: December 20, 1994

FOCUS™ Balloon Dilatation Catheter
CardioVascular Dynamics, Inc.
510(k) K952064
SE Date: June 21, 1995

FOCUS™ Balloon Dilatation Catheter
CardioVascular Dynamics, Inc.
510(k) K954313
SE Date: December 1, 1995

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CardioVascular Dynamics, Inc.
510(k) Notification
FOCUS™-PV Balloon Dilatation Catheter
September 13, 1996

The FOCUS™-PV Balloon Dilatation Catheter is a balloon dilatation catheter intended for use in percutaneous transluminal balloon dilatation (PTA) of large vessels of the peripheral vasculature.

The FOCUS™-PV Balloon Dilatation Catheter, styled after the Gruntzig technique, is a double lumen catheter with a balloon mounted at the distal tip. Dilatation Balloon catheters are used to exert radial force to dilate narrow vessel segments, based on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end of a catheter.

There are many commercially available catheters indicated for peripheral transluminal balloon angioplasty which were marketed prior to promulgation of the Act (May 28, 1976) or have been found substantially equivalent to pre-enactment devices. The FOCUS™-PV device is intended for use in exactly the same manner. In particular, the FOCUS™-PV Balloon Dilatation Catheter is equivalent in indications and intended use to the listed predicate devices in the table below.

All catheters are manufactured from similar biocompatible materials. They are all preformed plastic tubes with luer fittings.

The FOCUS™-PV Balloon Dilatation Catheter is a peripheral balloon dilatation catheter. The FOCUS™-PV Balloon Dilatation Catheter is substantially equivalent to existing balloon dilation catheters.

The FOCUS™-PV Balloon Dilatation Catheter is designed for use during peripheral vascular balloon dilatation. Numerous catheters are available in a large range of sizes for use in this manner. The comparison table lists several commercially available devices. Comparisons are made based on the size, construction, materials and use.

This 510(k) is for modifications to existing devices, 510(k) number K944016, substantial equivalence December 20, 1994, 510(k) number K952064, substantial equivalence June 21, 1995, 510(k) number K954313, substantial equivalence December 1, 1995. Modifications include larger balloon sizes and reduced balloon compliance. The balloon changes from a double layer polyethylene with polyethylene terephalate to a single layer polyethylene terephalate balloon. The balloon is bonded with an adhesive to a nylon shaft instead of heat sealed to a polyethylene shaft. The catheter shaft tubing changes from a side by side tubing configuration to a coaxial tubing configuration.

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CardioVascular Dynamics, Inc.
510(k) Notification
FOCUS™-PV Balloon Dilatation Catheter
September 13, 1996

# COMPARISON OF FOCUS™-PV WITH CURRENTLY MARKETED PTA CATHETERS

| MANUFACTURER | CardioVascular Dynamics | CardioVascular Dynamics | Schneider | Schneider | Medi-tech | Medi-tech |
| --- | --- | --- | --- | --- | --- | --- |
| Product Name | FOCUS Balloon Dilatation Catheter | FOCUS™-PV Balloon Dilatation Catheter | Match 35 PTA Balloon Dilatation Catheter | Total Cross PTA Balloon Dilatation Catheter | MS Classique Balloon Dilatation Catheter | MS Ultra-Thin Balloon Dilatation Catheter |
| Balloon Size | 2.5 - 4.0 mm (0.5 incr.) | 4.0/5.0-7.0/8.0 mm (1.0 incr) | 3.0 - 10.0 mm | 2.0 - 8.0 mm | 4.0 - 10.0 mm | 4.0 - 10.0 mm |
| Balloon Length | 20, 25 mm | 25, 30, 40 mm | 20, 40, 80, 100 mm | 20, 40, 80 mm | 25, 40, 80, 100 mm | 20, 40, 80, 100 mm |
| Shaft Size | 3.5 F proximal 3.0 F distal | 4.3F/5.0F | 4.3F/5.0 F | 4.3F | 4.8F and 5.2F | 5.0F |
| Shaft Length | 135 cm | 75 - 150 cm | 75 - 150 cm | 95 - 150 cm | 75 - 120 cm | 75 - 150 cm |
| Materials | | | | | | |
| Balloon | Polyethylene/ PET | Polyethylene Terephalate (PET) | Polyethylene Terephalate (PET) | Polyethylene/ PET | Polyethylene Terephalate (PET) | Polyethylene Terephalate (PET) |
| Shaft | Polyethylene | Nylon | Polyester | Polyester | Polyester | Polyester |
| Guidewire Size (Max) | 0.014 in. | 0.018/0.035 in. | 0.035 in. | 0.021 in. | 0.035 in. | 0.035 in. |

Testing of the FOCUS™-PV Balloon Dilatation Catheter included balloon burst, balloon cycle, radiopacity, tensile strength of connector to catheter shaft, catheter distal end tensile strength, profile measurements, and biocompatibility. These tests demonstrated the balloons meet or exceed specification as well as catheter tip profiles were within specification tolerances. Tensile strength of the catheter shaft and catheter tip as well as torsion strength of the catheter tip met design specifications. There were no failures during these tests.

Overall, all testing demonstrated that the FOCUS™-PV Balloon Dilatation Catheter is safe and effective.

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