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 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.

AI/ML Overview

The provided document is a 510(k) summary for the Renew Lead Extension, a medical device. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions several tests and states that "The results demonstrated that the acceptance criteria were met for the following tests." However, it does not explicitly list the specific acceptance criteria values or the reported performance values for each test. It only provides the names of the tests performed.

Test Name	Acceptance Criteria	Reported Device Performance
Insulation Resistance	Not specified	Met acceptance criteria
Conductor Resistance System Impedance	Not specified	Met acceptance criteria
Dielectric Strength	Not specified	Met acceptance criteria
Accelerated Contact Resistance	Not specified	Met acceptance criteria
Connector Pull Test	Not specified	Met acceptance criteria
Lead Body Flex Life	Not specified	Met acceptance criteria
Strain Relief Flex Life	Not specified	Met acceptance criteria
Stiffness	Not specified	Met acceptance criteria
Setscrew Block Retention	Not specified	Met acceptance criteria

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not specify the sample size used for the described non-clinical tests. It also does not provide information about data provenance (e.g., country of origin, retrospective or prospective) as these are non-clinical (engineering) bench tests, not clinical studies involving patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This is not applicable. The "test set" in this context refers to physical devices undergoing engineering tests, not a dataset requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication methods are typically used in studies where multiple human readers interpret data, not for objective engineering tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. This document describes non-clinical engineering testing for a medical device's components and materials, not a study evaluating human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a "standalone" study in the context of an algorithm's performance was not done. This device is a physical lead extension, not an algorithm.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" would be established by the engineering specifications and test standards for each specific parameter (e.g., a specific resistance value, a minimum pull force). The document doesn't explicitly state these specific ground truths but implies adherence to established engineering standards for medical devices.

8. The Sample Size for the Training Set:

This is not applicable. This document describes the testing of a physical medical device. There is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable, as there is no training set for this type of device testing.

Summary

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JUN 2 4 1999

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K991784

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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.One Allentown ParkwayAllen, TX 75002-4211
Contact:	Katryna Warren
Phone Number:	972-390-9800 Ext. 332 or972-309-8000
Fax Number:	972-390-2881 or (972) 309-8150

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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

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Lead Extension 510(k) Summary of Safety and Effectiveness

Device Information:

Trade Names:	Renew Lead Extension Model 3382Renew Lead Extension Model 3383Renew Dual Lead Extension Model 3341Renew Dual Lead Extension Model 3342Renew Dual Lead Extension Model 3343
Common Name:	Spinal Cord Stimulator
Classification Name: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:

Intended Use:

Comparison To Predicate Device:

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

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	ANS Predicate Device510(k) K960728, K930536	ANS Modified DeviceK# Under Review
Intended Use:	Stimulation of spinal cord fortreatment of chronic pain ofthe trunk and limbs	Stimulation of spinal cord fortreatment of chronic pain ofthe trunk and limbs
Materials:
• Electrode:	Platinum/Iridium	N/A
• Contact Terminal:	Stainless Steel 304	Platinum/Iridium
• Insulator:	Polyurethane	Polyurethane
• Connector Coating	Silicone(K930536)	Silicone
Design Features:	Braided Wire Cable	Braided Wire Cable
	4,8,or 16 electrodes	N/A – The extensionconnects with the terminalend of the lead
	Percutaneous Introduction	PercutaneousIntroduction/External Use
Dimensions:
• Length:	58 - 80 cm	10 - 30 cm
Sterilization	100% ETO	100% ETO
	Sterility Assurance Level(SAL) 1x 10-6	Sterility Assurance Level(SAL) 1x 10-6
Packaging:	Tray w/ Tyvek Lid	Tray w/ Tyvek Lid
Labeling:	Labeled as sterile,prescription device	Labeled as sterile,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.

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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.

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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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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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)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

les

eral Restorative Devices

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Regulation Number and Section

§ 882.5880 Implanted spinal cord stimulator for pain relief.

(a)
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.(b)
Classification. Class II (performance standards).