DUALSCREEN

K955291 · Medtronic Vascular · GZB · May 17, 1996 · Neurology

Device Facts

• Record ID: K955291
• Device Name: DUALSCREEN
• Applicant: Medtronic Vascular
• Product Code: GZB · Neurology
• Decision Date: May 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5880
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Medtronic Model 3628 Screener is indicated for use in trial screening for SCS and PNS for chronic intractable pain of the trunk or limbs, as is the Model 3627 Screener and the Model 3210 Transmitter.

Device Story

Model 3628 Screener; external device for trial screening of SCS/PNS systems; combines functionality of Model 3627 Screener and Model 3210 Transmitter into single portable unit. Patient carries device during screening period to manage stimulation parameters for chronic intractable pain. Features larger LCD for parameter display; RF transformer replaces previous antenna/receiver coil; relocated user interface controls. Physician programs device; patient uses during trial to assess therapy efficacy for pain management.

Clinical Evidence

No clinical data provided; substantial equivalence based on functional and electrical similarity to predicate devices.

Technological Characteristics

Portable external screener; RF transformer-based signal transmission; LCD interface; pushbuttons/switches for parameter control. Functionally equivalent to combined Model 3627/3210 units.

Indications for Use

Indicated for patients undergoing trial screening for spinal cord stimulation (SCS) or peripheral nerve stimulation (PNS) to manage chronic intractable pain of the trunk or limbs.

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

• Model 3627 Screener (K955291)
• Model 3210 Transmitter (K955291)

Submission Summary (Full Text)

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Medtronic

K955291

Medtronic Neurological

800 53rd Avenue NE

P.O. Box 1250

Minneapolis, MN 55440-9087

[phone]

1-800-328-0810

FAX: [phone]

MAY 17 1996

Medtronic

November 15, 1995

RE: 510(k) Notification: Medtronic Model 3628 Screener

In order to comply with the Safe Medical Devices Act of 1990, this page will provide safety and effectiveness information to interested persons.

SUMMARY OF SAFETY AND EFFECTIVENESS

The Medtronic Model 3628 Screener is indicated for use in trial screening for SCS and PNS for chronic intractable pain of the trunk or limbs, as is the Model 3627 Screener and the Model 3210 Transmitter. The Model 3628 Screener is a combination of the Model 3627 Screener and the Model 3210 Transmitter. Electrically and functionally, it is the same as the two current products combined. The new Screener allows the patient to carry one unit rather than two during the screening period.

There are only minor differences between the Model 3628 Screener and the commercially available Model 3627/3210 units, which are as follows:

1. A larger liquid crystal display (LCD); used to display parameter information.
2. The antenna and receiver coil in the current products have been replaced with a RF transformer.
3. Several items (pushbuttons, switches, etc.) have been relocated for improved ease of use.

Therefore, the Model 3628 Screener is substantially equivalent to current Model 3627/3210 units.

Sincerely,

MEDTRONIC, INC.
Neurological Division

Dennis H. Crane
Principal Regulation Manager