RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR

K032561 · Medtronic Vascular · GZB · Sep 11, 2003 · Neurology

Device Facts

• Record ID: K032561
• Device Name: RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR
• Applicant: Medtronic Vascular
• Product Code: GZB · Neurology
• Decision Date: Sep 11, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Resume II Model 3587A and Resume TL Model 3986A are indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs. They are also indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain. On-Point Model 3987A is indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain. SymMix Model 3982A is indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs.

Device Story

Quadripolar implantable neurostimulation surgical leads with in-line connectors; designed for spinal cord or peripheral nerve stimulation. Leads deliver electrical stimulation to nerves to manage chronic intractable pain. Used by physicians in surgical settings for implantation. Output consists of electrical pulses to target nerves; clinical benefit is relief of severe intractable pain. Device functions as part of a neurostimulation system.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing.

Technological Characteristics

Quadripolar implantable neurostimulation leads; in-line connector design; intended for spinal cord and peripheral nerve stimulation; Class II devices.

Indications for Use

Indicated for patients with chronic intractable pain of the trunk and/or limbs requiring spinal cord stimulation or peripheral nerve stimulation to relieve severe 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

• Resume II 3587A (K904507)
• Resume TL 3986 (K904507)
• SymMix 3982 (K913993)
• On-Point (K920567)

Submission Summary (Full Text)

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SEP. 11 2003

## 510(k) Summary Medtronic In-Line Surgical Leads for Neurostimulation (as required by 21 CFR 807.92)

K032561

### Submitter Information A.

| Submitter's Name: | Medtronic Neurological |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 710 Medtronic Parkway NE<br>Minneapolis, Minnesota 55432.5604 U.S.A. |
| Telephone Number: | 763.505.1465 |
| Contact Person: | Lucy Tan |
| Date Submission Prepared: | August 19, 2003 |
| B. Device Information | |
| Device Trade Name: | In-Line Surgical Leads for Neurostimulation |
| Common or usual Name: | Spinal Cord Stimulation Lead<br>Peripheral Nerve Stimulation Lead |
| Classification Name: | Spinal Cord Stimulators (21 CFR Part 882.5880)<br>Peripheral Nerve Stimulators (21 CFR Part<br>882.5870) |
| Classification Code: | GZB - Spinal Cord Stimulators<br>GZF - Peripheral Nerve Stimulators |
| Predicate Device: | Resume II 3587A – K904507<br>Resume TL 3986 - K904507<br>SymMix 3982 - K913993<br>On-Point - K920567 |
| Device Description: | Quadripolar implantable neurostimulation surgical<br>leads with in-line connector. |
| Indications for Use: | Resume II Model 3587A and Resume TL Model<br>3986A are indicated for Spinal Cord Stimulation<br>and Peripheral Nerve Stimulation to aid in the<br>management of chronic intractable pain of the trunk<br>and/or limbs. The peripheral nerve stimulators are<br>used to stimulate electrically a peripheral nerve in<br>patients to relieve severe intractable pain.<br><br>On-Point Model 3987A is indicated for Peripheral<br>Nerve Stimulation to aid in the management of |

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chronic intractable pain of the trunk and/or limbs. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.

SymMix Model 3982A is indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs.

#### Comparison of Required Technological Characteristics C.

The technological characteristics of the proposed ILS leads for neurostimulation are substantially equivalent to the noted predicate devices.

#### Performance Data D.

Performance data that supports the safety and effectiveness of the ILS leads for neurostimulation are included in this 510(k) premarket notification.

#### E. Conclusion

Medtronic neurostimulation ILS leads (Resume II 3587A, Resume TL 3986A, SymMix 3982A, and On-Point 3987A) are substantially equivalent to the noted predicate devices based on the similarities of technological characteristics, the identical indications for use and the results of the testing.

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Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo contains the symbol of the Department of Health and Human Services, which is an abstract representation of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.

Public Health Service

SEP 1 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lucy Tan, RAC Senior Regulatory Affairs Specialist Medtronic, Inc. 710 Medtronic Parkway Minneapolis, Minnesota 55432

Re: K032561

Trade/Device Name: Resume II Model 3587A Regulation Number: 21 CFR 882.5880 and 21 CFR 882.5870 Regulation Name: Implanted spinal cord stimulator for pain relief and Implanted peripheral nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZB and GZF

Trade/Device Name: Resume TL Model 3986A Regulation Number: 21 CFR 882.5880 and 21 CFR 882.5870 Regulation Name: Implanted spinal cord stimulator for pain relief and Implanted peripheral nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZB and GZF

Trade/Device Name: On-Point Model 3987A Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted peripheral nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZF

Trade/Device Name: SymMix Model 3982A Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted spinal cord stimulator for pain relief Regulatory Class: Class II Product Code: GZB

Dated: August 19, 2003 Received: August 20, 2003

Dear Ms. Tan:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate

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Page 2 - Ms. Lucy Tan, RAC

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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Miriam C. Provost

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

Enclosure

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# Indications for Use Statement

Page 1

510(k) Number (if known): K032561

| Device Name: | Resume II In-Line Surgical Lead |
|--------------|---------------------------------|
| | Resume TL In-Line Surgical Lead |
| | SymMix In-Line Surgical Lead |
| | On-Point In-Line Surgical Lead |

## Indications for Use:

Resume II Model 3587A and Resume TL Model 3986A are indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs. They are also indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.

On-Point Model 3987A is indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.

SymMix Model 3982A is indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs.

(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 (Optional Format 1-2-96)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

OR

510(k) Number K03256/