(50 days)
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Not Found
No
The summary describes a physical electrode for sensing bioelectrical signals and does not mention any AI or ML components or functions.
No
The device is an accessory to an electromyography (EMG) machine, used for sensing bioelectrical signals to assess skeletal muscles. It is a diagnostic tool, not a therapeutic one that treats a condition.
Yes
Explanation: The device is an accessory to an electromyography machine used for "assessing a series of skeletal muscles" by sensing bioelectrical signals, which directly implies a diagnostic purpose.
No
The device description clearly states it is a "Detachable Monopolar EMG Needle Electrode," which is a physical hardware component. The intended use also describes placement into muscle or nerve tissue, indicating a physical interaction.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "sense bioelectrical signals" by being placed into muscle or nerve tissue. This is a direct measurement of physiological signals within the body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside of the body (in vitro).
- Device Description: The device is a needle electrode, which is used for direct insertion into tissue.
The device is an accessory to an electromyography machine, which is a diagnostic tool, but the needle electrode itself is a device for in vivo (within the living body) measurement, not in vitro testing of samples.
N/A
Intended Use / Indications for Use
Electromyographic (EMG) needle electrodes are intended to be placed into the muscle or nerve tissue to sense bioelectrical signals. This monopolar needle is an accessory to the electromyography recording machine, which is used for assessing the electrical activity of skeletal muscles. EMG electrodes are for professional use, only. This device is to be used under the supervision of a licensed physician and intended for single patient use, only.
Product codes
GXZ
Device Description
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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
muscle or nerve tissue
Indicated Patient Age Range
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Intended User / Care Setting
professional use, only. This device is to be used under the supervision of a licensed physician
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.
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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.
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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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§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping shapes suggesting multiple individuals or a sense of community.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Samantha L. Draper Quality Assurance Manager Class A Enterprises, Inc. P.O. Box 401964 16039 Walnut Street, Ste. C Hesperia, CA 92340
MAY 2 8 2002
Re: K021118
Trade/Device Name: Detachable Monopolar EMG Needle Electrode Regulation Number: 882.1350 Regulation Name: Needle electrode Regulatory Class: II Product Code: GXZ Dated: May 8, 2002 Received: May 13, 2002
Dear Ms. Draper:
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.
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Page 2 - Ms. Samantha L. Draper
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 device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). regaration on information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
fur Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) NUMBER: K021118
DEVICE NAME: Detachable Monopolar EMG Needle Electrode
INDICATIONS FOR USE: Electromyographic (EMG) needle electrodes are INDICATIONS FOR OOL. Elooking ographis (into the muscle or nerve tissue to monopolar necules inconded to be mice is an accessory to the electromygraphy sense bloelectrical agrials: "This dothor with electromyography studies (recording machine, whiler to for ass eries of skeletal muscles). EMG electrodes are the inthinsto oloothour propertion of a licensed physician and intended for single patient use, only.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Miriam C. Provost
Division Sign. Off Division of General, Restorative and Neurological Device
510(k) Number K021118