MEDAMICUS EPIDURAL INTRODUCER

K994097 · Medamicus, Inc. · GZB · Mar 1, 2000 · Neurology

Device Facts

• Record ID: K994097
• Device Name: MEDAMICUS EPIDURAL INTRODUCER
• Applicant: Medamicus, Inc.
• Product Code: GZB · Neurology
• Decision Date: Mar 1, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5880
• Device Class: Class 2

Intended Use

The MedAmicus Epidural Introducer is intended to be used in the same manner as the ANS (Neuromed) Introde INT-8 cleared by the FDA under K930242 and in a similar manner to the Coaxial Dilator manufactured by MedAmicus, Inc. and cleared by the FDA under K990705. The intended use of these introducers is for percutaneous introduction, manipulation, and removal of epidural stimulation leads.

Device Story

The MedAmicus Epidural Introducer is a percutaneous device used by clinicians to facilitate the placement, adjustment, and extraction of epidural stimulation leads. It functions as an introducer sheath, providing a pathway for lead delivery into the epidural space. The device is used in a clinical setting; it is a mechanical tool without electronic or software components. It serves as a procedural aid to assist physicians in lead positioning, thereby supporting the implantation of neurostimulation systems.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use comparison to predicate devices.

Technological Characteristics

Percutaneous introducer sheath. Mechanical device; no energy source, software, or connectivity. Materials and manufacturing methods are stated to be equivalent to predicate devices.

Indications for Use

Indicated for percutaneous introduction, manipulation, and removal of epidural stimulation leads. No specific patient population or contraindications stated.

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

• Coaxial Dilator from MedAmicus, Inc. (K990705)
• Introde INT-8 from ANS (Neuromed), Inc. (K930242)

Submission Summary (Full Text)

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#### CONFIDENTIAL

Medamicus Inc.

510 (k) Submission

Epidural Introducer

MAR - 1 2000

# 510(k) Summary

K 994097

# MedAmicus Epidural Introducer

Date of Preparation: October 29, 1999

### General Information

| Trade Name | MedAmicus Epidural Introducer |
|---------------------|-----------------------------------------------------------------------------------------------------------------|
| Classification Name | Introducer, Percutaneous §870.1340 |
| Common Name | Percutaneous Introducer |
| Submitter | MedAmicus, Inc.<br>15301 Highway 55 West<br>Minneapolis, MN 55447 |
| Contact | Dennis S. Madison<br>Vice President, Quality<br>Assurance/Regulatory Affairs<br>612-559-2613, Fax: [phone] |

#### Predicate Devices

Coaxial Dilator from MedAmicus, Inc. (K990705) Introde INT-8 from ANS (Neuromed), Inc. (K930242) ·

### Device Description Information

### Intended Use

The MedAmicus Epidural Introducer is intended to be used in the same manner as the ANS (Neuromed) Introde INT-8 cleared by the FDA under K930242 and in a similar manner to the Coaxial Dilator manufactured by MedAmicus, Inc. and cleared by the FDA under K990705. The intended use of these introducers is for percutaneous introduction, manipulation, and removal of epidural stimulation leads.

### Conclusion

MedAmicus believes the MedAmicus Epidural Introducer is safe and effective based on substantial equivalence to the predicate MedAmicus and ANS Introducer Sheaths. The intended use, materials, labeling, method of operation and manufacturing methods are substantially equivalent.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR - 1 2000

Mr. Dennis S. Madison Vice President, Quality Assurance and Regulatory Affairs MedAmicus. Inc. 15301 Highway 55 West Minneapolis, Minnesota 55447

K994097 Re:

> Trade Name: MedAmicus Epidural Introducer Regulatory Class: II Product Code: GZB Dated: November 29, 1999 Received: December 3, 1999

Dear Mr. Madison:

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.

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.

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#### Page 2 – Mr. Dennis S. Madison

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,

Theodore Sayre

So- James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Medamicus Inc.

510 (k) Submission

Epidural Introducer

## Statement of Indications for Use

K 994097

For percutaneous introduction, manipulation, and removal of epidural stimulation leads.

## Contraindications

None

Russell Page

(Division Sign-Off) Division of General Restorative Devices 510(k) Number -16954097

Prescription Use
(Per 21 CFR 801.109)