BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION

K964604 · Biotronik, Inc. · DTB · Mar 10, 1997 · Cardiovascular

Device Facts

• Record ID: K964604
• Device Name: BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION
• Applicant: Biotronik, Inc.
• Product Code: DTB · Cardiovascular
• Decision Date: Mar 10, 1997
• Decision: PT
• Submission Type: Traditional
• Regulation: 21 CFR 870.3680
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The BIOTRONIK PX-BP and PX-JBP pacing leads are safe and effective bipolar, transvenous, implantable, endocardial leads used with implantable cardiac pacemakers.

Device Story

Bipolar, transvenous, implantable endocardial pacing leads; used with implantable cardiac pacemakers. Lead body: NuSil silicone rubber; conductor: quadrafilar MP35N. Electrode tip: titanium with Physical Vapor Deposition (PVD) iridium fractal-surfaced microstructure; ring electrode: platinum/iridium with fractal iridium surface. Passive fixation via four flexible silicone rubber tines. PX-JBP model pre-formed into 'J' shape for atrial positioning. IS-1 connection system (ISO 5841.3:1992). Physician-implanted in clinical setting. Provides electrical connection between pulse generator and heart tissue for pacing/sensing. Benefits: long-term pacing stability, biocompatibility, and durability.

Clinical Evidence

Bench testing only; no clinical trial data provided. Evidence includes qualification testing (crimp/weld strength, fatigue, DC resistance, environmental resistance, stylet performance, sterilization validation) and biocompatibility studies (acute/chronic, long-term implantation, corrosion studies). Field clinical experience from 1400+ leads sold internationally cited as supporting evidence.

Technological Characteristics

Materials: NuSil silicone rubber, quadrafilar MP35N, titanium, platinum/iridium. Surface: PVD iridium fractal microstructure. Connection: IS-1 (ISO 5841.3:1992). Form factor: Bipolar, transvenous, endocardial lead; PX-JBP 'J' shape. Sterilization: Validated process.

Indications for Use

Indicated for patients requiring permanent cardiac pacing via implantable pacemakers. Used for endocardial stimulation and sensing.

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.

Submission Summary (Full Text)

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POLYROX PX-BP/PX-JBP Leads - 510(k)

MAR 10 1997 K964604

# 1.4 Safety And Effectiveness Summary

The BIOTRONIK PX-BP and PX-JBP pacing leads are safe and effective bipolar, transvenous, implantable, endocardial leads used with implantable cardiac pacemakers. The lead body insulation of all PX-BP/PX-JBP endocardial leads is NuSil silicone rubber tubing, with the conductor of quadrafilar MP35N.

The PX-BP/PX-JBP endocardial leads provide long-term safe and effective pacing due to the surface structure of the lenticular electrode tip. The tip has undergone a Physical Vapor Deposition (PVD) treatment of iridium over titanium, creating a fractal-surfaced ball-like microstructure. Passive fixation in the heart's trabeculae is provided by four flexible silicone rubber tines. The ring electrode (anode) of the bipolar lead is made of platinum/iridium, also with a fractal iridium surface treatment. The IS-1 connection system of PX-BP/PX-JBP leads complies with the International Standard ISO 5841.3:1992: Low Profile Connectors. The PX-JBP lead is pre-formed into a “J” shape for optimal positioning in the atrium.

The materials used to manufacture the PX-BP/PX-JBP leads which come into contact with the patient were tested for biocompatibility. Acute and chronic biocompatibility tests were performed, as well as long term implantation studies. Corrosion studies were completed to address both long-term toxicity and durability of the tip and ring iridium material. The testing conducted for biocompatibility as well as extensive clinical experience confirms that iridium is safe for use as an implantable material. Literature has been published illustrating this conclusion. The long term corrosion testing results substantiate that iridium is a non-toxic and durable material for use in implantable devices.

Qualification testing results validate the safety and effectiveness of the lead design and materials used. The PX-BP and PX-JBP leads are tested for crimp and weld strength of connections, fatigue strength, DC resistance, environmental resistance, adherence to IS-1 standards, stylet performance, packaging and transportation durability, lead tip testing, and sterilization validation. All test results were within specifications. An overview of non-clinical testing is found in this premarket notification.

Field clinical experience, the in-vitro and qualification testing performed on the PX-BP/PX-JBP leads show that the risk to the patient in using these leads is the same as that of any implantable endocardial lead.

Potential complications resulting from the use of endocardial leads include, but are not limited to: thrombosis, embolism, body rejection phenomena, cardiac tamponade, muscle/nerve stimulation, valve damage, fibrillation, and infection. Lead perforation through the myocardium has been rarely observed. The table below summarizes some of the potential symptoms indicating a complication and possible corrective actions:

BIOTRONIK, November 15, 1996

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POLYROX PX-BP/PX-JBP Leads - 510(k)

## Lead Complications

| SYMPTOM | POTENTIAL COMPLICATION | POTENTIAL CORRECTIVE ACTION |
| --- | --- | --- |
| Loss of pacing or sensing | Electrode displacement
Lead fracture
Setscrew penetration
Improper lead to pacemaker connection | Reposition lead
Replace lead
Replace lead
Reconnect lead to pacemaker |
| Increase or decrease in threshold | Fibrotic tissue formation | Adjust pulse generator output;
Reposition lead |

The PX-BP/PX-JBP was introduced into the European market in 1996. The lead body design and the size of the tip and the ring (where applicable) is the same for all PX-BP/PX-JBP leads, now representing over 1400 leads sold outside of the United States, as of October 1, 1996.

BIOTRONIK, November 15, 1996