MEDTRONIC MODEL 7495 EXTENSION KIT

K990104 · Medtronic Vascular · GZB · Feb 9, 1999 · Neurology

Device Facts

• Record ID: K990104
• Device Name: MEDTRONIC MODEL 7495 EXTENSION KIT
• Applicant: Medtronic Vascular
• Product Code: GZB · Neurology
• Decision Date: Feb 9, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic Model 7495 Extension Kit is intended for use with implanted spinal cord or peripheral nerve stimulation systems for the treatment of chronic, intractable pain.

Device Story

Model 7495 extension kit serves as electrical conduit between implanted neurostimulator and stimulation lead; facilitates delivery of electrical stimulation to target site in spinal cord or peripheral nerves. Used in conjunction with externally powered (RF) neurostimulation systems. Implanted surgically by physicians. Kit includes tunneling accessories (large wedge tip, dual carrier tip) and connector boots with radiopaque material and Roman Numeral identification. Device provides passive electrical path; no active processing or software components.

Clinical Evidence

No clinical data. Bench testing not applicable due to lack of significant design changes; biocompatibility testing performed on added connector boot material.

Technological Characteristics

Passive electrical extension cable for neurostimulation systems. Includes tunneling accessories and connector boots. Connector boots modified with radiopaque material. Biocompatible materials used. No energy source, software, or active electronics.

Indications for Use

Indicated for patients requiring surgically implanted spinal cord or peripheral nerve stimulation systems to treat chronic, intractable pain.

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

• Medtronic Model 7495 extension kit (currently in commercial distribution)

Reference Devices

• Medtronic Model 7498 extension kit

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the date 2/9/99 at the top. Below the date is the Medtronic logo. The logo consists of the word "Medtronic" in bold, sans-serif font, followed by a square symbol containing a stylized image.

K 9940104

800 53rd Avenue Minneapolis, MN 55421-1200 nternet: www.medtronic.com elephone: [phone] Toll-free: 1-800-328-0810 FAX: [phone]

### 510(k) SUMMARY

#### SUBMITTER I.

Name and Address:

Medtronic, Inc. Neurological Division 800 53rd Avenue NE Minneapolis, MN 55421

Lisa L. Pritchard Contact Person:

January 11, 1999 Date of Summary Preparation:

Establishment Registration Number: 2182207

#### II. DEVICE NAME

Extension for Spinal Cord and Device Common or Usual Name: Peripheral Nerve Stimulators Device Trade Name: Medtronic Model 7495 Extension Kit

#### III. PREDICATE DEVICE

Extensions for Implanted spinal Cord Stimulation (SCS) and/or Peripheral Nerve Stimulation (PNS) for the treatment of chronic intractable pain.

#### IV. DEVICE DESCRIPTION

The Medtronic Model 7495 extension kit is used with spinal cord and peripheral nerve stimulation systems to connect stimulation leads to the implanted receiver of externally powered (RF) systems. The extension provides an electrical path to allow stimulation to be delivered to the target site.

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

# Medtronic &

Medtronic Neurological 800 53rd Avenue NE Minneapolis, MN 55440-9087 Internet: www.medtronic.com Telephone: [phone] Toll Free: 1-800-328-0810 FAX: [phone]

#### V. INDICATION FOR USE

The Model 7495 extension kit with revised accessories has the same intended use as the current Model 7495 extension kit. These extensions are intended to be surgically implanted as part of a neurostimulation system to treat chronic, intractable pain.

#### VI. COMPARISON TO PREDICATE DEVICE

The Medtronic Model 7495 extension kit with revised accessories is substantially equivalent to the Medtronic Model 7495 extension kit that is currently in commercial distribution.

#### a. Intended Use

These extensions are intended to be surgically implanted as part of a neurostimulation system to treat chronic, intractable pain.

#### b. Principles of Operation

The design and principle of operation of the extension in the revised kit is identical to the currently available Model 7495 extension. The extension provides an electrical path between the neurostimulator and the lead to allow stimulation to be delivered to the target site.

#### Device Performance C.

Performance of the Model 7495 extension is not affected by the modifications in accessories provided with the extension kit. The design of the extension remains unchanged. Design of the large wedge tip and dual carrier tip tunneling accessories also remains unchanged (these accessories are currently packaged with the Model 7498 extension kit). Changes to the connector boots to add Roman Numeral identification and radiopaque material do not change the performance or use of the connector boot.

#### d. Bench Testing

Because there is no significant change to the design of the accessory components, mechanical testing is not applicable. The material added to the connector boot has undergone extensive biocompatibility testing and has been determined to be biocompatible.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 1999

Ms. Lisa L. Pritchard Principal Product Regulation Manager Medtronic Neurological 800 53rd Avenue NE Minneapolis, Minnesota 55440-9087

Re: K990104 Medtronic Model 7495 Extension Kit Trade Name: Regulatory Class: II Product Codes: GZB and GZF Dated: January 11, 1999 Received: January 12, 1999

Dear Ms. Pritchard:

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 able beach in the 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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.

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

Page 2 - Ms. Lisa L. Pritchard

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberroom in your tial equivalence of your device to a legally marketed predicate device results in a classification for your marketed produced or mits 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 che promocion and liance 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

Enclosure

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

### APPENDIX 2

## INDICATIONS FOR USE STATEMENT

510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________

Device Name: Model 7495 Extension Kit

Indications For Use:

The Medtronic Model 7495 Extension Kit is intended for use with implanted spinal cord or peripheral nerve stimulation systems for the treatment of chronic, intractable pain.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The Counter Use OR Prescription Use (Per 21 CFR 801.109)

Special 510(k) for Model 7495 Extension Kit Medtronic Neurological January 11, 1999

Page 10