MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD

K962036 · Medtronic Vascular · DTB · Aug 22, 1996 · Cardiovascular

Device Facts

• Record ID: K962036
• Device Name: MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD
• Applicant: Medtronic Vascular
• Product Code: DTB · Cardiovascular
• Decision Date: Aug 22, 1996
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.3680
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The model 5058 screw-in lead is indicated for pacing and sensing applications in either the atrium or the ventricle. This lead has application where implantable permanent atrial or ventricular, single chamber or dual chamber pacing systems are indicated. This permanent pacemaker lead is used to provide channeled electrically conductive pathways between the pulse generator and the heart.

Device Story

Medtronic model 5058 is a transvenous, bipolar, screw-in pacing lead for permanent cardiac pacing. Device features a helical platinum-alloy tip electrode for active endocardial fixation; helix extension/retraction is controlled by rotating the lead connector pin via a fixation tool. Lead includes a proximal ring electrode and an IS-1 bipolar connector. Conductors consist of MP35N nickel-alloy coils; insulation is silicone rubber. Device is implanted by a physician in a clinical setting to provide an electrically conductive pathway between an implanted pulse generator and the heart. Output is the delivery of pacing pulses to the myocardium and sensing of cardiac electrical activity. Benefits include stable fixation and reliable electrical conduction for cardiac rhythm management.

Clinical Evidence

Bench testing only. Testing included environmental conditioning (EtO sterilization, thermal shock), mechanical testing (helix extension/retraction, connector mating, tip pressure, leak, pull/torsional strength, flex, stylet insertion), electrical testing (resistance, impedance), and tip-to-ring spacer testing. In-vivo canine electrical performance testing was also conducted. Biocompatibility and insulation biostability were supported by reference to previously cleared Medtronic lead models.

Technological Characteristics

Transvenous bipolar pacing lead. Materials: Platinum-iridium electrodes, MP35N nickel-alloy conductor coils, silicone rubber insulation. Features: Extendible/retractable helical tip electrode, IS-1 bipolar connector (ISO 5841-3:1992[E]). Dimensions: Compatible with 9 French introducers. Sterilization: EtO.

Indications for Use

Indicated for patients requiring permanent atrial or ventricular pacing and sensing, including single or dual chamber pacing systems.

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

• Medtronic model 4558M Bipolar, Implantable, Screw-In, Atrial, Transvenous Lead (K940703)
• Medtronic model 4058M Bipolar, Implantable, Screw-In, Ventricular/Atrial, Transvenous Lead (K883743)

Reference Devices

• Medtronic model 5024/5524 (P950089/S9)
• Medtronic model 5023/5523 (P850089/S6)
• Medtronic model 5024M (P850089/S15)
• Medtronic model 5524M (P850089/S16)
• Medtronic model 4057/4557 (K882452)
• Medtronic model 4058 (K883743)
• Medtronic model 5028 (K933731)

Submission Summary (Full Text)

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MED TRONIC CONFIDENTIAL

AUG 22 1996

K962036

## II.510(K) SUMMARY

### A. General Information

Submitter's Name Todd A. Fonseca, RAC

Company Name and Address Medtronic, Inc.
7000 Central Avenue N.E.
Minneapolis, MN 55432

Submission Date 5/8/96

### B. Device Name and Classification

Device Generic Name Transvenous screw-in pacing lead

Device Trade Name Medtronic model 5058 Bipolar, Implantable, Screw-In, Ventricular/Atrial, Transvenous Lead

Classification Name and Number Permanent Pacemaker Electrode
21 CFR, Part 870.3680

### C. Predicate Devices

| Device | 510(k) Number / Approval Date |
| --- | --- |
| Medtronic model 4558M Bipolar, Implantable, Screw-In, Atrial, Transvenous Lead | K940703 / November 1994 |
| Medtronic model 4058M Bipolar, Implantable, Screw-In, Ventricular/Atrial, Transvenous Lead | K883743 / January 1989 |

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MEDTRONIC CONFIDENTIAL

## D. Device Description

The Medtronic model 5058 transvenous screw-in pacing lead has a helical tip electrode made of platinum alloy that can be actively fixed in the endocardium. The helix can be extended or retracted by rotating the lead connector pin with a fixation tool. This lead also has a second, larger electrode proximal to the tip electrode and an IS-1 Bipolar connector with one terminal pin. It features MP35N nickel-alloy coil conductors and silicone rubber insulation.

## E. Intended Use

The model 5058 screw-in lead is indicated for pacing and sensing applications in either the atrium or the ventricle. This lead has application where implantable permanent atrial or ventricular, single chamber or dual chamber pacing systems are indicated. This permanent pacemaker lead is used to provide channeled electrically conductive pathways between the pulse generator and the heart.

## F. Technology Comparison

The new model 5058 lead and the currently available model 4558M and 4058M leads all have extendible/retractable helix electrode lead tips. These tips act as the cathode electrodes for all three bipolar leads. The anodes for these leads consist of ring electrodes proximal to the helix. All electrodes for all leads are made of the same material, Platinum -Iridium (Pt-Ir).

The cathodes and anodes for all three leads are connected to conductor coils made of MP35N nickel-alloy. The MP35N conductor coils for the model 4558M and 4058M leads are platinum sputtered whereas the coils for the model 5058 lead are not sputtered.

The reason the model 5058 coils are not sputtered is because the inner and outer insulation material for the model 5058 lead is silicone rubber. The insulation material for the model 4558M and 4058M leads is polyurethane.

The conductor coils for all three leads terminate at the proximal end of the leads in the standard bipolar IS-1 (International Connector Standard ISO 5841-3:1992[E]) configuration. Furthermore, all three leads utilize 9 French introducers for access into the venous system.

## G. Summary of Studies

Mechanical, electrical and canine testing was performed to evaluate the model 5058 lead. Testing previously provided for the models 5024/5524 (P950089/S9) regarding the surface treatment of the silicone insulation and the biostability of the insulation, is considered relevant to the 5058. Additionally, testing previously provided on the lead models identified below, regarding biocompatibility, is also considered relevant to the model 5058 lead:

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MEDTRONIC CONFIDENTIAL

| Lead Model Number | Document Control Number | Approval Date |
| --- | --- | --- |
| 5023/5523 | P850089/S6 | November 1988 |
| 5024/5524 | P850089/S9 | December, 1989 |
| 5024M | P850089/S15 | December, 1990 |
| 5524M | P850089/S16 | December, 1991 |
| 4057/4557 | K882452 | August, 1988 |
| 4058 | K883743 | January, 1989 |
| 4558M | K940703 | November, 1994 |
| 5028 | K933731 | March, 1994 |

Testing performed on the model 5058 included:

I. Environmental Conditioning
1. EtO sterilization,
2. Thermal shock,

II. Mechanical Testing
1. Helix electrode extension/retraction testing,
2. Connector mating,
3. Tip pressure testing,
4. Leak testing,
5. Joint and composite pull strength,
6. Composite torsional strength,
7. Anchoring sleeve suture test,
8. Flex testing,
9. Stylet insertion/withdrawal testing,

III. Electrical Testing
1. Resistance,
2. IS-1 offset block/AC impedance testing,

IV. Tip-to-ring Spacer Testing

V. In-vivo (canine) electrical performance testing

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MEDTRONIC CONFIDENTIAL

All of the testing performed on the model 5058 lead, and previously submitted testing on the model 5024/5524, and the lead models identified above for biocompatibility testing, demonstrate that the model 5058 will perform to Medtronic specifications.

## H. Conclusion

The bench testing presented herein, along with the testing provided previously on the lead models identified above, provide reasonable assurance that the Medtronic model 5058 lead will perform as intended when used in accordance with its labeling. Additionally, based on similarities in design, materials, in vitro test data and *in vivo* electrical performance, the model 5058 is considered substantially equivalent to the model 4558M and model 4058M leads.