(87 days)
No
The document describes a passive electrode device for recording biopotential signals and makes no mention of AI or ML technology.
No
Explanation: The device is described as being used for recording, monitoring, and stimulation/recording of biopotential signals, specifically electromyograph (EMG) and nerve potential signals, for diagnostic purposes rather than direct therapeutic treatment.
Yes
Explanation: The device is intended for use with recording and monitoring equipment for the stimulation and recording of biopotential signals (like EMG and nerve potential signals), which are used for diagnostic purposes (e.g., studying nerve conduction).
No
The device description explicitly states the electrodes consist of a needle with a connector/lead wire, which are physical hardware components.
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 examine specimens outside of the body.
- Device Function: The description clearly states that these EMG electrodes are invasive and are placed in contact with nerve or muscle tissue within the patient's body. They are used to record biopotential signals directly from the tissue.
- Intended Use: The intended use is for stimulation and recording of biopotential signals from the patient, not for analyzing samples taken from the patient.
Therefore, this device falls under the category of a medical device used for physiological measurement and stimulation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Concentric, Monopolar, Hook Wire and Hypodermic EMG Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.
Product codes (comma separated list FDA assigned to the subject device)
IKT, GXZ
Device Description
EMG electrodes are applied in the study of biopotentials such as electromyograph (EMG), nerve conduction and stimulation/response. Electrodes are invasive as they are placed in contact with nerve or muscle tissue.
The electrodes consist of a needle with a connector/lead wire attached. The connector/lead wires terminate in a safety connector that cannot be connected to an AC power outlet.
The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physician.
The EMG Electrodes are provided sterile and for single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nerve or muscle tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Under the supervision of a physician.
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.
K850107, K912282, K924521, K955335, K982950, K912783
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.
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).
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SEP - 6 2001
Image /page/0/Picture/1 description: The image shows the logo for Nicolet Biomedical. The word "Nicolet" is in a large, bold, sans-serif font. Below the word "Nicolet" is a thick black line. Below the line, the word "BIOMEDICAL" is in a smaller, sans-serif font.
Summary of Safety and Effectiveness
| Company Name: | Nicolet Biomedical Incorporated
5225 Verona Road
Madison, WI 53711 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Glen Hermanson, Manager of Standards and Compliance |
| Phone: | 608 441-2065 |
| Fax: | 608 441-2007 |
| Summary Date: | June 7, 2001 |
| Trade Name: | Sterile EMG Electrodes |
| Common Name: | EMG Electrodes |
| Classification Name: | 21 CFR 890.1385, EMG Needle Electrode |
| Predicate Device(s): | |
| 510(k) Number: | K850107 |
| Manufacture: | Nicolet Biomedical Incorporated |
| Trade Name: | Concentric EMG Electrodes (non-sterile) |
| Product Code: | IKT |
| Classification: | 21 890.1385, Diagnostic Electromyograph Needle Electrode |
| 510(k) Number: | K912282, K924521, K955335, K982950 |
| Manufacture: | Chalgren, Incorporated |
| Trade Name: | Disposable Monopolar EMG Electrode, Disposable Concentric
Needle Electrode, Disposable Hypodermic Monopolar Needle,
Fine Wire Electrode (Hook Wire) |
| Product Code: | IKT |
| Classification: | 21 890.1385, Diagnostic Electromyograph Needle Electrode |
| 510(k) Number: | K912783 |
| Manufacture: | Class A Incorporated |
| Trade Name: | Disposable Monopolar Needle Electrode |
| Product Code: | GXZ |
| Classification: | 21 882.1350, Needle Electrode |
Nicolet Biomedical Inc.
Image /page/0/Picture/6 description: The image shows the ISO 9001 logo. The logo is in black and white. The letters "ISO" are stacked on top of the number "9001".
5225 Verona Road Bldg. 2 Madison, Wisconsin USA 53711-4495 Tel: 608/273-5000 Fax: 608/273-5067 Toll free: 1-800/356-0007
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BIOMEDICA
Packaging and sterilization of the EMG electrodes is equivalent to the Subdermal Needle Electrodes, described in the following Nicolet Biomedical 510(k):
510(k) Number: K010019 Manufacture: Nicolet Biomedical Subdermal Needle Electrodes Trade Name:
1.0 Description of Electrodes
EMG electrodes are applied in the study of biopotentials such as electromyograph (EMG), nerve conduction and stimulation/response. Electrodes are invasive as they are placed in contact with nerve or muscle tissue.
The electrodes consist of a needle with a connector/lead wire attached. The connector/lead wires terminate in a safety connector that cannot be connected to an AC power outlet.
The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physician.
2.0 Intended Use of Electrodes
EMG electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.
3.0 Technological Characteristics
The EMG electrodes consist of a needle with a connector or lead wire attached. The connector or lead wires terminate in a safety connector that cannot be connected to an AC power outlet. The EMG Electrodes are provided sterile and for single patient use.
Image /page/1/Picture/13 description: The image contains a handwritten number 5. The number is written in a cursive style, with a curved top and a vertical line extending downwards. The number is written in black ink on a white background. The image is simple and clear, with the number 5 being the only element present.
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Image /page/2/Picture/0 description: The image shows the logo for Nicolet Biomedical. The word "Nicolet" is in large, bold, sans-serif font. Below "Nicolet" is a thick black line, and below that is the word "BIOMEDICAL" in a smaller, sans-serif font.
4.0 Conclusions
The characteristics of the EMG Electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised.
$\sigma$
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 6 2001
Nicolet Biomedical, Inc. c/o Mr. Gary Syring Quality and Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589
Re: K011818
Trade/Device Name: Sterile EMG Electrodes Regulation Number: 890.1385, 882.1350 Regulation Name: Diagnostic electromyograph needle electrode Needle electrode Regulatory Class: II Product Code: IKT, GXZ Dated: June 8, 2001 Received: June 11, 2001
Dear Mr. Syring:
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 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). You may, therefore, market the device, subject to the general controls Costions 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 ( remailed in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 mopellish 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. Gary Syring
This letter will allow you to begin marketing your device as described in your 510(k) premarket This lotter will and it your disubstantial 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 additionally 607.10 for in 10 and stimestions 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mountacturers 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,
Susa Walker, M.D
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
5
510(k) Number (if known): K011818
Device Name: Sterile EMG Electrodes
Indications For Use:
Concentric, Monopolar, Hook Wire and Hypodermic EMG Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.
(PLEASE: DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
SV
Division Sign-Off
(Division Sign-Of (Division Sign-On)
Division of General, Restorative Division of Sources
(Optional Format 3-10-98)
510(k) Number K011818
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