RENEW LEAD EXTENSION

K991784 · Advanced Neuromodulation Systems · GZB · Jun 24, 1999 · Neurology

Device Facts

• Record ID: K991784
• Device Name: RENEW LEAD EXTENSION
• Applicant: Advanced Neuromodulation Systems
• Product Code: GZB · Neurology
• Decision Date: Jun 24, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5880
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

ANS Renew Lead Extensions are indicated for the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. Lead extensions are intended to be used with Advanced Neuromodulation Systems, leads, receivers, transmitters, and antennae.

Device Story

Renew Lead Extensions are implantable accessories designed to increase the length of spinal cord stimulation leads. The device consists of a silicone connector body, Platinum/Iridium contacts, and a braided wire cable within a polyurethane sheath. It is used to connect a lead to a receiver or to externalize the connection for a trial stimulation period (up to 30 days). The device is implanted by a physician; it functions as a passive electrical conduit to facilitate signal transmission from the stimulator system to the spinal cord. By extending the reach of the lead, it allows for flexible placement of the receiver or external trial components, aiding in the management of chronic pain.

Clinical Evidence

Bench testing only. Verification testing included insulation resistance, conductor resistance, system impedance, dielectric strength, accelerated contact resistance, connector pull test, lead body flex life, strain relief flex life, stiffness, and setscrew block retention. All acceptance criteria were met.

Technological Characteristics

Materials: Platinum/Iridium contacts, polyurethane sheath, silicone connector body. Design: Braided wire cable, 10-30 cm length. Connectivity: Passive electrical extension for spinal cord stimulation leads. Sterilization: 100% ETO (SAL 1x10^-6).

Indications for Use

Indicated for patients with chronic pain of the trunk and limbs requiring spinal cord stimulation, either as a primary therapy or as an adjunct in a multidisciplinary approach.

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

• One Step Connect™ Leads (K960728)
• Octrode Neurostim Receiver (K930536)

Submission Summary (Full Text)

{0}------------------------------------------------

JUN 2 4 1999

Image /page/0/Picture/1 description: The image shows the logo "ANS" in bold, black letters. To the left of the letters is a square grid pattern, also in black. The grid is made up of small squares arranged in a 6x6 pattern. The letters are large and fill most of the horizontal space in the image.

.

K991784

Page 1 of 3

# 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: | May 21, 1999 |
|----------------|-----------------------------------------------------------------------------------------|
| Company: | Advanced Neuromodulation Systems, Inc.<br>One Allentown Parkway<br>Allen, TX 75002-4211 |
| Contact: | Katryna Warren |
| Phone Number: | 972-390-9800 Ext. 332 or<br>972-309-8000 |
| Fax Number: | 972-390-2881 or [phone] |

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for ANS, which is a professional organization for people in the nuclear industry. The logo consists of a grid of small squares on the left, followed by the letters "ANS" in a bold, sans-serif font. The grid of squares is likely meant to represent a nuclear reactor core, while the letters "ANS" stand for the American Nuclear Society.

K991784

Page 2 of 3

## Lead Extension 510(k) Summary of Safety and Effectiveness

#### Device Information:

| Trade Names: | Renew Lead Extension Model 3382<br>Renew Lead Extension Model 3383<br>Renew Dual Lead Extension Model 3341<br>Renew Dual Lead Extension Model 3342<br>Renew Dual Lead Extension Model 3343 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Spinal Cord Stimulator |
| Classification Name:<br>Relief | Implanted Spinal Cord Stimulator for Pain |

#### Predicate Device:

Advanced Neuromodulation Systems, Inc., currently markets One Step Connect™ Leads under 510(k) # K960728 and Octrode Neurostim Receiver under 510(k) # K930536.

#### Device Description:

The Renew Lead Extension consists of a silicone connector body, with Platinum/Iridium contacts, and braided wire cable inside a polyurethane sheath. Lead extensions are designed to be implanted to add additional length to the lead for connection to a receiver or externalized for use during a trial stimulation period not to exceed 30 days.

#### Intended Use:

ANS Renew Lead Extensions are indicated for the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. Lead extensions are intended to be used with Advanced Neuromodulation Systems, leads, receivers, transmitters, and antennae.

#### Comparison To Predicate Device:

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

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the letters 'ANS' in a bold, sans-serif font. To the left of the letters is a square grid pattern composed of smaller filled squares. The letters and the grid pattern are all in black, contrasting with the white background.

Page 3 of 3

| | ANS Predicate Device<br>510(k) K960728, K930536 | ANS Modified Device<br>K# Under Review |
|---------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Intended Use: | Stimulation of spinal cord for<br>treatment of chronic pain of<br>the trunk and limbs | Stimulation of spinal cord for<br>treatment of chronic pain of<br>the trunk and limbs |
| Materials: | | |
| • Electrode: | Platinum/Iridium | N/A |
| • Contact Terminal: | Stainless Steel 304 | Platinum/Iridium |
| • Insulator: | Polyurethane | Polyurethane |
| • Connector Coating | Silicone<br>(K930536) | Silicone |
| Design Features: | Braided Wire Cable | Braided Wire Cable |
| | 4,8,or 16 electrodes | N/A – The extension<br>connects with the terminal<br>end of the lead |
| | Percutaneous Introduction | Percutaneous<br>Introduction/<br>External Use |
| Dimensions: | | |
| • Length: | 58 - 80 cm | 10 - 30 cm |
| Sterilization | 100% ETO | 100% ETO |
| | Sterility Assurance Level<br>(SAL) 1x 10-6 | Sterility Assurance Level<br>(SAL) 1x 10-6 |
| Packaging: | Tray w/ Tyvek Lid | Tray w/ Tyvek Lid |
| Labeling: | Labeled as sterile,<br>prescription device | Labeled as sterile,<br>prescription device |

#### Non-clinical Testing:

The biocompatible materials used to construct the lead extension are the same type as those used for predicate devices with the same classification regulation, for the same intended use. The addition of this extension raises no significant safety or effectiveness questions.

Verification testing was performed as required by the risk analysis for this modification. The results demonstrated that the acceptance criteria were met for the following tests: Insulation Resistance, Conductor Resistance System Impedance, Dielectric Strength, Accelerated Contact Resistance, Connector Pull Test, Lead Body Flex Life, Strain Relief Flex Life, Stiffness, and Setscrew Block Retention.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human profiles facing to the right, arranged in a way that they resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 1999

Ms. Katryna Warren Advanced Neuromodulation Systems One Allentown Parkway Allen, Texas 75002-4211

K991784 Re: Trade Name: Renew TM Lead Extension Regulatory Class: II Product Code: GZB Dated: May 21, 1999 Received: May 25, 1999

Dear Ms. Warren:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

Page 2 - Ms. Katryna Warren

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

{5}------------------------------------------------

Page 1of 1

510(k) Number (if known): K 99/787

Device Name: Lead Extension

Indications For Use:

ANS Lead Extensions are indicated for the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. Lead extensions are intended to be used with Advanced Neuromodulation Systems', leads, receivers, transmitters, and antennae.

### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

les

eral Restorative Devices

0000000