UNIPOLAR IPG GROUND CABLE, MODEL 5473

K961520 · Medtronic Vascular · LDF · Nov 13, 1996 · Cardiovascular

Device Facts

• Record ID: K961520
• Device Name: UNIPOLAR IPG GROUND CABLE, MODEL 5473
• Applicant: Medtronic Vascular
• Product Code: LDF · Cardiovascular
• Decision Date: Nov 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3680
• Device Class: Class 2

Device Story

Unipolar IPG Ground Cable, Model 5473, is a reusable surgical accessory used to provide electrical grounding for an Implantable Pulse Generator (IPG) during surgical procedures. The device features a grounding clip that attaches to the IPG. It is designed to withstand repeated use, including flash autoclave sterilization, rotational flexing, and repeated opening/closing of the grounding clip mechanism. The device ensures electrical continuity and secure mechanical attachment to the IPG throughout the surgical environment.

Clinical Evidence

Bench testing only. Sample size of 30 cable assemblies. Testing included 100 cycles of flash autoclave sterilization (270°F, 10 min, 21 psi), 250 cycles of grounding clip opening/closing (verified by 2 oz weight retention and contact resistance), and 1000 cycles of rotational flex testing. All tests passed with 90% confidence levels for reliability.

Technological Characteristics

Reusable unipolar surgical cable assembly. Features a grounding clip mechanism for IPG attachment. Designed for flash autoclave sterilization. Mechanical integrity verified through rotational flex and life cycle testing of clip mechanism. Materials have proven history in Medtronic surgical cable assemblies.

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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K96/520
MOV 13 1995
MEDTRONIC CONFIDENTIAL

# Section 7 - Performance Data Demonstrating Safety and Effectiveness

## 1. Device Integrity Testing

The following table identifies the tests which were performed to verify that the UNIPOLAR IPG GROUND CABLE, Model 5473 meets the device integrity requirements. The table includes a summary of the requirements for each test. Following the table, a summary of each test objective and method is provided.

## 2. Sample Size

A total sample size of thirty (30) cable assemblies were used for the Model 5473 performance testing. Twenty (20) cable assemblies were exposed to life cycle testing, providing a 90% confidence level with a minimum reliability of 89%. Ten (10) cable assemblies were exposed to autoclave sterilization testing, providing a 90% confidence level with a minimum reliability of 79%. Rotational flex testing required a sample size of eight (8) cable assemblies to gain a 90% confidence with a minimum reliability of 74%. Lower sample sizes for the sterilization and rotational flex testing were deemed adequate due to the proven history that these materials have in many other Medtronic surgical cable assemblies.

Table 4: Device Integrity Tests

| Test | Test Requirement | Device Tested | Test Results |
| --- | --- | --- | --- |
| Autoclave Sterilization | Devices shall remain within specification following flash autoclave sterilization. | 10 | Pass |
| Grounding Clip Life Cycling | Devices shall be capable of grasping and holding a minimum of 2 ounce weight in the vertical direction, and shall have acceptable contact resistance. | 20 | Pass |
| Rotational Flex | Devices shall be reusable | 8 | Pass |

## 3. Device Integrity Test Objectives and Methods

### A. Autoclave Sterilization

#### Objective

To verify the device can be sterilized without loss of function.

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MEDTRONIC CONFIDENTIAL

## Test Method

The samples are subjected to an initial visual inspection, a contact resistance measurement, and a grip force measurement. The samples are subjected to one hundred (100) flash autoclave sterilization at 270°F for 10 minutes at a pressure of 21 psi. After sterilization, the samples are subjected to a visual inspection, a contact resistance measurement, and a grip force measurement.

## B. Grounding Clip Life Cycling

### Objective

To verify the device can be reused without loss of function.

### Test Method

The samples are subjected to an initial visual inspection, a contact resistance measurement, and a grip force measurement. The samples are subjected to 250 cycles of opening and closing of the IPG grounding clip. After cycling, the samples are subjected to a visual inspection, a contact resistance measurement, and a grip force measurement.

## C. Rotational Flex

### Objective

To verify the device can be reused without loss of function.

### Test Method

The samples are subjected to an initial visual inspection, and a contact resistance measurement. The samples are subjected to 1000 cycles of rotational flex by clamping the IPG ground clip to a rotating platform, with a one (1) ounce weight six (6) inches from the ground clip. After cycling, the samples are again subjected to visual inspection, and a contact resistance measurement.