USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING

K955712 · C.R. Bard, Inc. · LDF · Oct 11, 1996 · Cardiovascular

Device Facts

• Record ID: K955712
• Device Name: USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING
• Applicant: C.R. Bard, Inc.
• Product Code: LDF · Cardiovascular
• Decision Date: Oct 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The USCI® Balloon Bipolar Pacing Electrodes and USCI® Special Care Electrodes (temporary pacing leads) are used to transmit an electrical stimulus from the pulse generator to the heart and/or to transmit an electrical signal from the heart to a recording device.

Device Story

Flexible, insulated temporary transvenous pacing leads; constructed of woven filament, polyurethane base, and stainless steel electrodes; coated with Benzalkonium Heparin (BH). Used by clinicians to transmit electrical stimuli from pulse generators to the heart or transmit cardiac signals to recording devices. Packaged with needle cannula, EKG clip, and syringe. Sterile, single-use device.

Clinical Evidence

Bench testing only. Electrical continuity tests confirmed pacing capability; inflated balloon diameter tests confirmed performance within specifications.

Technological Characteristics

Materials: polyurethane shaft, latex balloon, stainless steel electrodes. Surface: Benzalkonium Heparin (BH) coating. Form factor: flexible, insulated temporary transvenous pacing lead. Sterilization: sterile, single-use.

Indications for Use

Indicated for patients requiring temporary transvenous cardiac pacing or cardiac signal monitoring.

Regulatory Classification

Identification

Temporary pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. Permanent pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

Predicate Devices

• USCI® Bipolar Balloon Pacing Electrode (K800298)

Reference Devices

• USCI® Safe-T-Cath Thermodilution catheter (K791873)
• USCI® Temporary Atrio-Ventricular Electrode (K830094)

Submission Summary (Full Text)

{0}

OCT 11 1996
K955712
USCI

USCI Division
C.R. Bard, Inc.
Clinical and Regulatory Affairs
1200 Technology Park Drive
P.O. Box 7025
Billerica, MA 01821
[phone]
FAX: [phone]

6.0 510(k) SUMMARY FOR THE USCI® BIPOLAR PACING ELECTRODE

As required under Section 12, part (a)(i)(3A) of the Safe Medical Device Act of 1990, an adequate summary of any information respecting safety and effectiveness follows.

6.1 General Information

♦ Name and address of submitter:
USCI, Div. of C.R. Bard,Inc.
1200 Technology Park Drive
Billerica, MA 01821
Tel #: [phone]
Fax #: [phone]
Contact Person: Robert Miragliuolo
Date of Preparation: December 11, 1995

♦ Device Names:

Trade Name(s):
USCI® Bipolar Balloon Pacing Electrode
USCI® Special Care Electrode

Common Name:
Temporary Transvenous Pacing Electrode

Classification Name:
Temporary Pacemaker Electrode

♦ Predicate Device Name:

Trade Name:
USCI® Bipolar Balloon Pacing Electrode

BARD

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6.1 General Information con't

- Device Description and Intended Use:

The USCI® Balloon Bipolar Pacing Electrodes and USCI® Special Care Electrodes (temporary pacing leads) are flexible, insulated conductors, constructed of a woven filament and a polyurethane base with Benzalkonium Heparin coating and stainless steel electrodes.

The USCI® Balloon Bipolar Pacing Electrodes and the USCI® Special Care Electrodes are used to transmit an electrical stimulus from the pulse generator to the heart and/or to transmit an electrical signal from the heart to a recording device. These devices are sold sterile and are for one time use only. In addition to the pacing electrode with BH coating, each catheter is packaged with a needle cannula, an EKG clip, and a syringe to assist in the use of the pacing electrode.

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## 6.2 Summary of Similarities and Differences

The coated USCI Bipolar Pacing Electrode is substantially equivalent to the uncoated USCI® Bipolar Balloon Pacing Electrode (covered under #K800298).

The similarities between the current devices, the USCI Bipolar Pacing Electrodes and the predicate device, the USCI® Bipolar Balloon Pacing Electrode, include identical materials: a latex balloon, a polyurethane shaft, and stainless steel electrodes.

The difference between the two devices is that the current USCI® Bipolar Pacing Electrode has been coated with benzalkonium heparin, which is identical to the coating used on the USCI® Safe-T-Cath Thermodilution catheter (#K791873), and the USCI® Temporary Atrio-Ventricular Electrode, (#K830094).

Results from bench test data demonstrate that the BH coated USCI Bipolar Pacing Electrodes perform similar to the predicate device, the uncoated USCI® Bipolar Balloon Pacing Electrode. Electrical continuity tests demonstrated that the BH coated Bipolar Pacing Electrodes does not affect the ability of the catheter to pace. The inflated balloon diameter test confirms that the BH coated Bipolar Pacing Electrode is within the recommended diameter range.

In conclusion, results from all the bench test data demonstrate that the BH coated Bipolar Pacing Electrodes perform similar to the predicate device, the uncoated Bipolar Balloon Pacing Electrode, therefore, a determination of substantial equivalence can be claimed.