(90 days)
Not Found
No
The summary describes a physical needle electrode for recording EMG signals and injecting Botulinum Toxin. There is no mention of any software processing or analysis of the signals using AI or ML.
No.
The device is primarily described as a diagnostic electromyography needle electrode used for recording muscle activity (EMG) and sensing bioelectrical signals, which are diagnostic functions, even though it can be used during a Botulinum Toxin injection.
Yes
The "Device Description" explicitly states, "A diagnostic electromyography needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals." The "Intended Use / Indications for Use" also describes recording muscle activity for Electromyography (EMG) applications, which is a diagnostic procedure.
No
The device description explicitly states it is a "diagnostic electromyography needle electrode," which is a physical hardware component intended for insertion into tissue.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: This device is a needle electrode used for in vivo (within the living body) recording of electrical activity in muscles and nerves (Electromyography - EMG). It is also used for injecting Botulinum Toxin directly into muscle tissue.
- Specimen Examination: The device does not examine specimens derived from the body in a laboratory setting. It directly interacts with and measures electrical signals within the body.
The device is clearly described as a diagnostic tool used for Electromyography (EMG), which is a procedure performed on a living patient to assess the health of muscles and the nerve cells that control them.
Therefore, it falls under the category of in vivo diagnostic devices rather than in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
Recording muscle activity for Electromyography (EMG) applications. For single patient use only.
The disposable hypodermic needle is inteded to be used for iniection of the Botulinum Toxin into a muscle. while recording electromyography activity. The electrode has an open lumen and is designed for muscle stimulation, motor unit action, potential recording and Botulinum Toxin injection.
Product codes (comma separated list FDA assigned to the subject device)
IKT
Device Description
A diagnostic electromyography 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). The needle electrodes are for single patient only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
muscle or nerve tissue
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)
Not Found
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.
K973529, K983597, K001869, K071186, K071185, K961013, K973442, K973444, K931966, K062437
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
510 (k) Summary of safety and effectiveness
AUG 11 2009
SUBMITTER INFORMATION
ﯿ
| A. | Company Name: | Spes Medica s.r.l. |
|---|---|---|
| B. | Company Address: | Via Europa - Zona Industriale |
| Battipaglia SA, Italy 84091 | ||
| C. | Company Phone: | +39 0828 614191 |
| Company Fax: | +39 0828 341788 | |
| D. | Contact Person: | Alfredo Spadavecchia |
| Quality Assurance Assistant | ||
| Spes Medica s.r.l. | ||
| E-mail: a.spadavecchia@spesmedica.com | ||
| E. | Date Summary Prepared: | May 11, 2009 |
DEVICE IDENTIFICATION
| A. | Device name: | Disposable EMG Needle Electrodes |
|---|---|---|
| B. | Trade/Proprietary Name: | Disposable EMG Needle Electrodes, Myoline, Myobot |
| C. | Classification name: | Electrode, Needle, Diagnostic Electromyograph (21 CFR §890.1385) |
| D. | Product Code: | IKT |
LEGALLY MARKETED DEVICES (PREDICATE DEVICES)
- -MEDICOTEST A/S: Neuroline, Disposable Concentric Needle Electrodes, Neuroline, Disposable Monopolar Needle Electrodes, Diagnostic Electromyography Needle Electrode, Disposable Hypodermic Needle, K973529, K983597, K001869
- -AMBU A/S: Neuroline Concentric Needle Electrode, Neuroline, Disposable Monopolar Needle Electrode, K071186, K071185
- MEDELEC: Disposable Needle Electrode, Teca Disposable Monopolar Needle -Electrodes, Teca Myoject Disposable Needle Electrodes K961013, K973442, K973444
- DANTEC MEDICAL, INC .: Dantec Disposable Concentric Needle, K931966 ・
- -TECHNOMED EUROPE: Disposable Hypodermic EMG Needle Electrode K062437
1
DESCRIPTION OF THE DEVICE
A diagnostic electromyography 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). The needle electrodes are for single patient only.
INTENDED USE
Recording muscle activity for Electromyography (EMG) applications. For single patient use only.
The disposable hypodermic needle is inteded to be used for injection of the Botulinum Toxin into a muscle, while recording electromyography activity. The electrode has an open lumen and is designed for muscle stimulation, motor unit action, potential recording and Botulinum Toxin injection.
Spes Medica does not supply any drugs with the needle electrodes nor does Spes Medica offer for sale any form of drugs.
SUBSTANTIAL EQUIVALENCE
The Disposable EMG Needle Electrodes and the predicate devices are similar in design, materials, packaging and other technological characteristics to the predicate devices. In further support of a substantial equivalence determination, Section 6 provides a comparison chart of the Disposable EMG Needle Electrodes and the predicate devices.
Based on the available 510(k) summaries, the marketing literature and the information provided herein, we conclude that the Disposable EMG Needle Electrodes are substantially equivalent to the existing legally marketed devices under Federal Food. Drug and Cosmetic Act
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Spes Medica S.r.l. c/o Alfredo Spadavecchia Quality Assurance Assistant Via Europa - Zona Industriale 84091 Battipaglia (SA) Italy
AUG 11 2009
Re: K091410
Trade/Device Name: Disposable EMG Needle Electrodes Regulation Number: 21 CFR 890.1385 Regulation Name: Diagnostic Electromyograph Needle Electrode Regulatory Class: II Product Code: IKT Dated: May 11, 2009 Received: May 13, 2009
Dear Mr. Spadavecchia:
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. Iisting 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/support/index.html.
Sincerely yours.
Ratha m t
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
KOGJ410
510(k) Number (if known):
Device Name: .
Disposable EMG Needle Electrodes
Indications for Use:
Recording muscle activity for Electromyography (EMG) applications. For single patient use only.
The disposable hypodermic needle is inteded to be used for iniection of the Botulinum Toxin into a muscle. while recording electromyography activity. The electrode has an open lumen and is designed for muscle stimulation, motor unit action, potential recording and Botulinum Toxin injection.
Prescription Use × (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Urths
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K091410