(305 days)
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Not Found
No
The summary describes a passive electrode and needle assembly for EMG recording, with no mention of data processing, analysis, or any computational capabilities that would suggest AI/ML.
No
Explanation: The device is explicitly described as being for "EMG diagnostic tests" and designed to "record electrical activity in muscle tissue," indicating its use for diagnosis rather than therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "connected to an EMG instrument for electromyographic (EMG) diagnostic tests." This indicates its purpose is for diagnosis.
No
The device description explicitly mentions physical components like fine wire electrodes, a needle assembly, and an adaptor cable, which are hardware.
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 performed outside the body (in vitro).
- Device Function: This device is used to record electrical activity within human muscle tissue in vivo (within the living body). It is a diagnostic tool used directly on the patient.
Therefore, this device falls under the category of a medical device used for in vivo diagnostic testing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Fine wire electrodes are supplied preloaded into a needle assembly. The needle is inserted into human muscle tissue and then removed, leaving the fine wires implanted for a short term. An adaptor cable is attached to the fine wires and then connected to an EMG instrument for electromyographic (EMG) diagnostic tests.
This device is intended for use by licensed physicians. Physicians using this device are well trained in the use of EMG electrodes, their placement, and proper use of related EMG instruments.
The fine wire electrodes are designed to record electrical activity in muscle tissue. As recording electrodes, there is no risk of damage to the tissue from electrical current.
Fine wire electrodes allow for multiple tests without additional needle sticks.
Product codes
IKT
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
human muscle tissue
Indicated Patient Age Range
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Intended User / Care Setting
licensed physicians
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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§ 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
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 22 1999
Mr. Richard Kaiser Chief Executive Officer Chalgren Enterprises, Inc. 8021 Carmel Street Gilroy, California 95020
Re: K982950 Regulatory Class: II Product Code: IKT Dated: March 24, 1999 Received: March 26, 1999
Dear Mr. Kaiser:
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 (OS) 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.
1
Page 2 - Mr. Richard Kaiser
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 vour 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,
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 1 of 1
K982950 510(k) Number (if known):
Device Name: FINE WIRE ELECTRODE
Indications For Use:
Fine wire electrodes are supplied preloaded into a needle The needle is inserted into human muscle tissue and then assembly. removed, leaving the fine wires implanted for a short term. An adaptor cable is attached to the fine wires and then connected to an EMG instrument for electromyographic (EMG) diagnostic tests.
This device is intended for use by licensed physicians. Physicians using this device are well trained in the use of EMG electrodes, their placement, and proper use of related EMG instruments.
The fine wire electrodes are designed to record electrical activity in muscle tissue. As recording electrodes, there is no risk of damage to the tissue from electrical current.
Fine wire electrodes allow for multiple tests without additional needle sticks.
K. Harris
Richard Kaiser, CEO 3-24-99
:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pcolle
(Diviside Sign Off)
Divi... (eral Restorative Devices
510(k) Number K982950
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)