AD-TECH'S SPINAL ELECTRODE

K973454 · Ad-Tech Medical Instrument Corp · GZL · Jun 10, 1998 · Neurology

Device Facts

• Record ID: K973454
• Device Name: AD-TECH'S SPINAL ELECTRODE
• Applicant: Ad-Tech Medical Instrument Corp
• Product Code: GZL · Neurology
• Decision Date: Jun 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2

Intended Use

Ad-Tech's Spinal Electrode is intended for measurement of muscle MEP (Motor Evoked Potential) type monitoring during spinal surgery.

Device Story

Ad-Tech Spinal Electrode is an epidural electrode used for intraoperative monitoring of Motor Evoked Potentials (MEP) during spinal surgery. The device is placed epidurally by a physician to record electrical signals from the spinal cord/nerves. These signals are transmitted to external monitoring equipment to assess neural integrity. The output allows the surgeon or neurophysiologist to monitor spinal cord function in real-time, potentially preventing neurological injury during surgical manipulation. The device is a passive electrode component used within a clinical surgical environment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Epidural electrode for MEP monitoring. Materials, technological characteristics, and sterilization procedures are identical to the Ad-Tech Depth Electrode (K891920B). Passive sensing device.

Indications for Use

Indicated for patients undergoing spinal surgery requiring intraoperative monitoring of muscle Motor Evoked Potentials (MEP).

Regulatory Classification

Identification

A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.

Predicate Devices

• Nicolet Epidural Spinal Electrode (K882053)

Reference Devices

• Ad-Tech Depth Electrode (K891920B)

Submission Summary (Full Text)

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JUN 1 0 1998

K973454

AD-TECH MEDICAL INSTRUMENT CORPORATION

## 510(k) Summary April 20, 1998

#### General Information L

Contact Name and Manufacturing Address:

Curtis Van Allen II Ad-Tech Medical Instrument Corp. 1901 William Street Racine, WI 53404 Tel. [phone] Fax. [phone]

Device Trade Name:

Common Name:

Classification:

Intended Use:

Predicate Device:

Product Code / Classification:

Establishment Registration Number:

Ad-Tech's Spinal Electrode

Electrode, Cortical

Class II 882.1310 Cortical Electrode

Ad-Tech's Spinal Electrode is intended for measurement of muscle MEP (Motor Evoked Potential) type monitoring during spinal surgery.

Nicolet Epidural Spinal Electrode (K882053)

84GYC

2183456

#### Safety and Effectiveness Information Supporting the Substantial Equivalence II. Determination

A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.

> 1901 WILLIAM STREET RACINE, WISCONSIN 53404, U.S.A. TELEPHONE [phone] TELEFAX 414-634-5668

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### General Safety and Effectiveness Concerns

Ad-Tech Spinal Electrode labeling contains instructions for the proper use of this product. It includes a description of the product, directions for use and applicable safety information. These instructions promote safe and effective use of the device when followed by a physician.

### Description of the Device and Basis for Substantial Equivalence

The Ad-Tech Spinal Electrode addressed in this premarket notification has identical materials, technological characteristics, sterilization procedures and packaging as the commercially available Ad-Tech Depth Electrode (K891920B). The device has similar intended use, materials and technological characteristics to the commercially available Nicolet Epidural Spinal Electrode (K882053). Like this device, the Ad-Tech Spinal Electrode is to be placed epidurally for monitoring evoked potentials. Ad-Tech believes that the information provided in this premarket notification clearly demonstrate that it is safe and equivalent to the mentioned commercially marketed predicate device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes, with a pair of wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 1998

Mr. Curtis Van Allen II Vice President Director of Marketing and Planning Ad-Tech Medical Instrument Corporation 1901 William Street Racine, Wisconsin 53404

K973454 Re: Ad-Tech's Spinal Electrode Trade Name: Requlatory Class: II Product Codes: GZL, GWF, and JXE Dated: April 24, 1998 May 11, 1998 Received:

Dear Mr. Allen:

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. ਕੇ 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 requlations.

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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 [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,

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

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# Indications for Use

510K Number:

Device Name: Ad-Tech's Spinal Electrode

Indications for Use: Ad-Tech's Spinal Electrode is intended for measurement of muscle MEP (Motor Evoked Potential) type monitoring during spinal surgery.

Prescription Use
(Per 21 CFR 801.109)

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Division Sign-Off) (Division of General Restorative Devices 11-973454 510(k) Number

File Name: FDA no. 5.doc

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