(189 days)
Not Found
No
The summary describes a physical electrode device for EMG and drug delivery, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for diagnostic purposes (EMG recording, muscle stimulation for monitoring motor nerves) and drug delivery, not primarily for therapeutic treatment itself.
Yes
The intended use states it is used for "motor unit action potential recording" and "motor nerves are monitored by detecting EMG activity", which are diagnostic functions.
No
The device description clearly details a physical, disposable needle electrode made of stainless steel with a PTFE coating, a husk fitting, and a wire. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a hypodermic needle electrode used for muscle stimulation, recording electrical activity in muscles (EMG), and delivering drugs directly into the muscle. These are procedures performed in vivo (within the living body), not in vitro (in a test tube or laboratory setting).
- Intended Use: The intended uses clearly involve interacting directly with the patient's muscles for diagnostic (EMG recording) and therapeutic (stimulation, drug delivery) purposes.
Therefore, the device falls under the category of a medical device used for in vivo procedures, not an IVD.
N/A
Intended Use / Indications for Use
The disposable hypodermic EMG needle electrode is used for muscle stimulation, motor unit action potential recording and drug delivery. The motor nerves are monitored by detecting EMG activity in the muscles they innervate.
The drug used should be Botox Botilium Toxin type A.
Note: Technomed Europe does not supply any drugs with the Disposable hypodermic EMG needle electrodes nor does Technomed Europe offer for sale any form of drugs.
Product codes (comma separated list FDA assigned to the subject device)
IKT
Device Description
The disposable hypodermic EMG needle electrode is designed for single use only. It consists of a stainless steel cannula electrically insulated with a PTFE coating, except for the lancet point and the inner surface of the tube. The coating is to ensure easy skin penetration and to ensure electrical insulation on the entire cannula, except for the point. A husk fitting together with a wire with connection to an extension cable has been attached to the cannula. This cable will enable the electrical signal to be transferred to a stimulating or recording device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
muscles; motor nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Technomed Europe has been bench testing the Disposable hypodermic EMG needle electrode to confirm performance characteristics of this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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).
Not Found
§ 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
FEB 16 2007
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V
| Attachment D: | 510(k) Summary | |
|---|---|---|
| Manufacturer: | Technomed Europe | |
| Amerikalaan 71 | ||
| 6199 AE Maastricht Airport | ||
| The Netherlands | ||
| Submitted by: | Technomed Europe | |
| Amerikalaan 71 | ||
| 6199 AE Maastricht Airport | ||
| The Netherlands | ||
| Tel.: (+31) 43-408 6868 | ||
| Fax: (+31) 43-408 6888 | ||
| Contact person: | René Roncken | |
| Manager Quality Assurance | ||
| E-mail: rroncken@technomed.nl | ||
| Date: | December 22, 2006 | |
| Proprietary Name: | Diagnostic electromyography needle electrode | |
| Common/usual Name: | Disposable hypodermic EMG needle electrode | |
| Classification Name: | ||
| 890.1385) | Diagnostic electromyography needle electrode (21 CFR section | |
| Substantial Equivalence: | K973444: Teca Myoject disposable needle electrode | |
| K002992: Medtronic Disposable Hypodermic Needle | ||
| Electrode | ||
| Device description: | The disposable hypodermic EMG needle electrode is designed | |
| for single use only. It consists of a stainless steel cannula | ||
| electrically insulated with a PTFE coating, except for the lancet | ||
| point and the inner surface of the tube. The coating is to ensure | ||
| easy skin penetration and to ensure electrical insulation on the | ||
| entire cannula, except for the point. | ||
| A husk fitting together with a wire with connection to an | ||
| extension cable has been attached to the cannula. This cable | ||
| will enable the electrical signal to be transferred to a stimulating | ||
| or recording device. | ||
| Intended Use: | The disposable hypodermic EMG needle electrode is used for | |
| muscle stimulation, motor unit action potential recording and | ||
| drug delivery. | ||
| The motor nerves are monitored by detecting EMG activity in | ||
| the muscles they innervate. |
The drug used should be Botox Botilium Toxin type A.
Note: Technomed Europe does not supply any drugs with the
Disposable hypodermic EMG needle electrodes nor does
Technomed Europe offer for sale any form of drugs | |
| Page 2:2 | | |
| Comparison to predicates: | The design, materials, chemical composition, packaging and
other technological characteristics of the subject device is
equivalent to those of the predicate devices. | |
| Non-clinical data: | Technomed Europe has been bench testing the Disposable
hypodermic EMG needle electrode to confirm performance
characteristics of this device. | |
| Conclusion: | The comparison to the predicate devices demonstrate that the
Disposable hypodermic EMG needle electrode is safe and
effective and is substantially equivalent to the predicate devices. | |
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Technomed Europe % Mr. Rene Roncken Manager Quality Assurance Amerikalaan 71 6199 AE Maastricht Airport The Netherlands
FEB : 8 2007
Re: K062437
Trade/Device Name: Disposable Hypodermic EMG Needle Electrode Regulation Number: 21 CFR 890.1385 Regulation Name: Electromyograph Needle Electrode Regulatory Class: Class II Product Code: IKT Dated: January 22, 2007 Received: January 25, 2007
Dear Mr. Roncken:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. Renee Roncken
This letter will allow you to begin marketing your device as described in your Section 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 levice to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/suport/index.html.
Sincerely vours.
for D.J. Diaz
Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KO62437
Disposable hypodermic EMG needle electrode Device Name:
Indications For Use:
The disposable hypodermic EMG needle electrode is used for muscle stimulation, motor unit action potential recording and drug delivery. The motor nerves are monitored by detecting EMG activity in the muscles they innervate.
The drug used should be Botox Botilium Toxin type A.
Note: Technomed Europe does not supply any drugs with the Disposable hypodermic EMG needle electrodes nor does Technomed Europe offer for sale any form of drugs.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorativegge 1 of _1 and Neurological Devices
510(k) N