ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)

K960728 · Neuromed, Inc. · GZB · May 22, 1996 · Neurology

Device Facts

• Record ID: K960728
• Device Name: ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)
• Applicant: Neuromed, Inc.
• Product Code: GZB · Neurology
• Decision Date: May 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Neuromed, Inc.’s One-Step Connect™ Leads are intended to be used with Neuromed trial extensions and/or receivers, transmitters, and antennae to electrically stimulate spinal cord fiber tracts for treatment of chronic pain of the extremities and/or trunk.

Device Story

Implantable percutaneous leads; consist of spaced platinum/iridium electrodes connected by wires within polyurethane sheath. Introduced into epidural space superior to spinal segment responsible for pain transmission; connected to external RF receiver or pulse generator. Used by physicians for chronic pain management; provides electrical stimulation to spinal cord fiber tracts to modulate pain signals. Modification involves transition from polyethylene to polyurethane insulators for improved durability and bond strength.

Clinical Evidence

Bench testing only. Biostability testing (Stokes method), comparative fatigue strength testing, and comparative tensile strength testing performed to validate polyurethane material change.

Technological Characteristics

Implantable percutaneous leads; 4, 7, or 8 stainless steel contact terminals; platinum/iridium electrodes; polyurethane insulator; 4 Fr catheter size; 58-66 cm length. Sterilized, prescription-only device.

Indications for Use

Indicated for patients suffering from chronic pain of the extremities and/or trunk requiring electrical stimulation of spinal cord fiber tracts.

Regulatory Classification

Identification

An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

Predicate Devices

• Neuromed spinal cord stimulator systems (K810182A)
• Neuromed spinal cord stimulator systems (K860158A)

Submission Summary (Full Text)

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NEUROMED
K960728
MAY 22 1996

# 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: February 21, 1996

Company: Neuromed, Inc., a wholly owned subsidiary of Quest Medical, Inc.
One Allentown Parkway
Allen, TX 75002-4211

Contact: Krista Oakes
Phone Number: 214-390-9800
Fax Number: 214-390-2881

QUEST Medical, Inc.
100000000000000000000000000000000000000000000000000

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# Implanted Spinal Cord Stimulator Lead
## 510(k) Summary of Safety and Effectiveness

## Device Information:

**Trade Names:**
Quattrode Plus™ One Step Connect™ Lead
Octrode Plus™ One Step Connect™ Lead
Cervitrode Plus™ One Step Connect™ Lead

**Common Name:**
Spinal Cord Stimulator

**Classification Name:**
Implanted Spinal Cord Stimulator for Pain Relief

## Predicate Device:

Neuromed, Inc., currently markets spinal cord stimulator systems with polyethylene lead insulators under 510(k) # K810182A and K860158A.

## Device Description:

Neuromed, Inc.’s One-Step Connect™ Leads are implantable devices consisting of spaced electrodes connected by wires within a cover sheath. These percutaneous leads are introduced into the epidural space superior to the spinal segment responsible for pain impulse transmission, and connected to a radio-frequency (RF) receiver or pulse generator.

## Intended Use:

Neuromed, Inc.’s One-Step Connect™ Leads are intended to be used with Neuromed trial extensions and/or receivers, transmitters, and antennae to electrically stimulate spinal cord fiber tracts for treatment of chronic pain of the extremities and/or trunk. The proposed device modification does not affect the original intended use of the legally marketed device.

## Comparison To Predicate Device:

The following table illustrates the comparison between the modified device and the original, legally marketed device.

| | Predicate Device 510(k) K810182A, K860158A | Modified Device |
| --- | --- | --- |
| Intended Use: | Stimulation of spinal cord for treatment of chronic pain | Stimulation of spinal cord for treatment of chronic pain |
| Materials:
• Electrode:
• Contact Terminal:
• Insulator: | Platinum/Iridium
Stainless Steel 304
Polyethylene
Multi-electrode | Platinum/Iridium
Stainless Steel 304
Polyurethane
Multi-electrode |

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| | Catheter | Catheter |
| --- | --- | --- |
| | Braided Wire Cable | Braided Wire Cable |
| | Platinum/Iridium Electrode | Platinum/Iridium Electrode |
| | 4 or 8 Stainless Steel Contact Terminals | 4, 7, or 8 Stainless Steel Contact Terminals |
| | Percutaneous Introduction | Percutaneous Introduction |
| | | |
| Dimensions: | 66 cm | 58 - 66 cm |
| • Length: | | |
| • Catheter Size: | 4 Fr. | 4 Fr |
| Packaging: | Tray w/ Tyvek Lid | Tray w/ Tyvek Lid |
| Labeling: | Labeled as sterile, prescription device | Labeled as sterile, prescription device |

## Non-clinical Testing:

Biostability testing of the polyurethane material using the Stokes method is provided in the manufacturer’s Master File.

Comparative testing of product fatigue strength indicates that the polyurethane lead insulators have equivalent or better durability than the original polyethylene insulators.

Comparative tensile strength testing of the original polyethylene lead insulators and the proposed new polyurethane lead insulators demonstrates an equivalent or better bond strength between the polyurethane insulator material and the electrodes.

Master File biocompatibility information, combined with supplemental testing performed by Neuromed, Inc., demonstrates that the change from polyethylene to polyurethane raises no significant safety or effectiveness questions relating to biocompatibility.