(143 days)
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No
The document describes a passive electrode device for sensing bio-electric signals and makes no mention of AI or ML capabilities.
No
The device is described as being used to "sense bio-electric, EMG or EEG, signals" for diagnostic purposes, not for treating any condition. The intended use is clearly stated as diagnostic sensing and recording.
Yes
The "Intended Use / Indications for Use" section explicitly states that the electrodes are "intended to be inserted...to sense bio-electric, EMG or EEG, signals...and are intended to be proximal be connected to electromyography / electroencephalogram recording equipment." It also mentions "bioelectric sensing in the diagnostic field of EEG or EMG" in the "Device Description."
No
The device description explicitly states it consists of "needle electrode's and accessories," which are physical hardware components used for sensing bioelectric signals.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "sensing bio-electric, EMG or EEG, signals distally" by being inserted into "subdermal, muscle or nerve tissue". This is a direct measurement of electrical activity within the body, not an analysis of samples taken from the body (like blood, urine, or tissue samples).
- Device Description: The description reinforces this by stating the electrodes are used for "bioelectric sensing".
- Code of Federal Regulations: The reference to 21 CFR 882.1350 is for "Needle electrode, diagnostic, electromyograph". This regulation falls under Part 882 - Neurological Devices, not the parts of the CFR that cover IVD devices (which are typically in Part 864 - Hematology and Pathology Devices, Part 866 - Immunology and Microbiology Devices, etc.).
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is directly interacting with the body to measure electrical signals.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
IKT and GXZ
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
subdermal, muscle or nerve tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K981004, K973529, K961013, K960591, K955335, K953887, K953886, K933806, K933796, K912283, K912283, K912282, K901280, K900098, K850107
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 890.1385 Diagnostic electromyograph needle electrode.
(a)
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).(b)
Classification. Class II (performance standards).
0
MAY 2 7 1000
510(K) SUMMARY
| A) Manufacturer: | Technomed Europe
Stationstraat 122
6191BG BEEK
The Netherlands |
|--------------------------------------------------------|-------------------------------------------------------------------------|
| B) Submitted by: | Technomed Europe
Stationstraat 122
6191BG BEEK
The Netherlands |
| C) Contact information: | phone, +31 46 4 370 371
Fax, +31 46 4 379 697 |
| 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.
1
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.
2
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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](https://510k.innolitics.com/search/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