ELECTRODE NEEDLES

K990015 · Technomed Europe · IKT · May 27, 1999 · Physical Medicine

Device Facts

• Record ID: K990015
• Device Name: ELECTRODE NEEDLES
• Applicant: Technomed Europe
• Product Code: IKT · Physical Medicine
• Decision Date: May 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1385
• Device Class: Class 2

Intended Use

Technomed Europe diagnostic needle electrodes are intended to be inserted in the subdermal, muscle or nerve tissue to sense bio-electric, EMG or EEG, signals distally, and are intended to be proximal be connected to electromyography / electroencephalogram recording equipment.

Device Story

Technomed Europe needle electrodes are invasive diagnostic tools used to sense bio-electric signals (EMG/EEG) from subdermal, muscle, or nerve tissue. The needles are inserted into the patient by a clinician and connected proximally to external electromyography or electroencephalogram recording equipment. The device acts as a passive transducer, capturing electrical activity from the tissue and transmitting it to the recording system for analysis by a healthcare provider. This data assists in the diagnosis of neurological or muscular conditions. The device is intended for clinical use in diagnostic environments.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparison to legally marketed predicate devices.

Technological Characteristics

Needle electrodes for bio-electric sensing. Design, materials, and chemical composition are stated to be equivalent to predicate devices. Passive sensing principle; no internal energy source or active components. Form factor consists of needle electrodes for subdermal, muscle, or nerve insertion.

Indications for Use

Indicated for patients requiring bio-electric signal monitoring (EMG or EEG) via subdermal, muscle, or nerve tissue insertion. For use by trained clinicians in diagnostic settings.

Regulatory Classification

Identification

A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).

Predicate Devices

• SLE Electrodes and accessories (K981004)
• Neuroline disposable concentric needle electrode (K973529)
• Electrode Needle diagnostic EMG (K961013)
• Re-useable Bipolar Concentric needle (K960591)
• Disposable hypodermic monopolar needle recording (K955335)
• Re-useable Concentric Needle electrode (K953887)
• Reusable monopolar Needle (K953886)
• Monopolar EMG needle electrode (K933806)
• EEG Needle Electrode (K933796)
• Electrode Needle diagnostic EMG (K912283)
• Detachable Disposable monopolar Needle Electrode (K912283)
• Disposable Monopolar Needle electrode (K912282)
• Disposable EEG Needle Electrodes (K901280)
• Monopolar needle electrode (K900098)
• Concentric Needle electrodes various sizes (K850107)

Submission Summary (Full Text)

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MAY 2 7 1000

## 510(K) SUMMARY

| A) Manufacturer: | Technomed Europe<br>Stationstraat 122<br>6191BG BEEK<br>The Netherlands |
|--------------------------------------------------------|-------------------------------------------------------------------------|
| B) Submitted by: | Technomed Europe<br>Stationstraat 122<br>6191BG BEEK<br>The Netherlands |
| C) Contact information: | phone, [phone]<br>Fax, [phone] |
| D) Classification name: | Needle Electrode (21 CFR 882.1350) |
| E) Common/usual name: | Needle electrode EEG / EMG |
| F) Proprietary name: | Technomed EEG / EMG needle electrodes |
| G) Classification number: | 89 IKT |
| H) Substantial Equivalence: | |
| SLE Electrodes and accessories | K981004 |
| Neuroline disposable concentric needle electrode | K973529 |
| Electrode Needle diagnostic EMG | K961013 |
| Re-useable Bipolar Concentric needle | K960591 |
| Disposable hypodermic monopolar needle recording | K955335 |
| Re-useable Concentric Needle electrode | K953887 |
| Reusable monopolar Needle | K953886 |
| Monopolar EMG needle electrode, | K933806 |
| EEG Needle Electrode, | K933796 |
| Electrode Needle diagnostic EMG | K912283 |
| Detachable Disposable monopolar Needle Electrode | K912283 |
| Disposable Monopolar Needle electrode , various models | K912282 |
| Disposable EEG Needle Electrodes, | K901280 |
| Monopolar needle electrode | K900098 |
| Concentric Needle electrodes various sizes | K850107 |
| and,...and... many more | |

I) Device description: Technomed Europe Needle electrode's and accessories consist of a variety of needle electrode's and accessories to be used for bioelectric sensing in the diagnostic field of EEG or EMG.

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J) Intended use:

Technomed Europe diagnostic needle electrode's are intended to be inserted in the subdermal, muscle or nerve tissue only to sense bio-electric, EMG or EEG, signals distally, and will proximal be connected to: Electromyography/electroencephalogram recording equipment

K) Technological Characteristics: The design, materials, chemical composition, packaging and other technological characteristics of the subject devices are considered to be the equivalent of the predicated devices.

This section is intentionally left blank, and is concluding the summary statement.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of what appears to be an eagle or other bird-like figure with three horizontal lines above it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 27 1999

Mr. Harry Knuth Manager of Operations and Regulatory Affairs Technomed Europe Medical Diagnostic Accessories Stationstraat 122 P.O. Box 239 6191BG Beek The Netherlands

Re: K990015

Trade Name: Electrode Needles Regulatory Class: II Product Code: IKT and GXZ Dated: February 19, 1999 Received: February 26, 1999

Dear Mr. Knuth:

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.

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Page 2 - Mr. Harry Knuth

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,

Colin M. Wittmer, Ph.D., M.D.

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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Page of

510(k) NUMBER (IF KNOWN): `K990015`
DEVICE NAME: `ELECTRODE NEEDLES

INDICATIONS FOR USE:

Technomed Europe diagnostic needle electrodes are intended to be inserted in the subdermal, muscle or nerve tissue to sense bio-electric, EMG or EEG, signals distally, and are intended to be proximal be connected to electromyography / electroencephalogram recording equipment.

The intended use of the Technomed devices are consistent with Code of Federal Regulations title 21, volume 8 part 882.1350.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✗ OR Over-The-Counter-Use
(Per 21 CFR 801.100) (Optional Format 1

(Division \$ign-Off)
Division of General Restorative Devices
510(k) Number K990015