(72 days)
Not Found
No
The device description focuses on the physical components and function of a needle electrode for biopotential recording, with no mention of software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is described as being used for "monitoring, recording and electrical stimulation" and "recording of biopotential signals from electroencephalography (EEG), electromyography (EMG) and nerve potential studies". Its purpose is to act as a "conduit between the monitoring equipment and a patient", rather than to provide therapy.
Yes
Explanation: The device is used to record biopotential signals from EEG, EMG, and nerve potential studies, which are diagnostic procedures used to assess neurological and muscular function.
No
The device description clearly states it is a physical electrode with a needle, wire, and connector, which are 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 outside of the body.
- Device Function: The ISurg Disposable Subdermal Needle Electrodes are described as being placed subcutaneously in or near nerve and muscle tissue. They are a conduit for recording biopotential signals from within the body.
- Intended Use: The intended use is for monitoring, recording, and electrical stimulation related to EEG, EMG, and nerve potential studies, all of which involve measuring electrical activity within the body.
Therefore, because the device is used within the body to measure physiological signals, it falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
ISurg Disposable Subdermal Needle Electrodes are intended for use with monitoring, recording and stimulation equipment specifically designed for the recording of biopotential signals from electroencephalography (EEG), electromyography (EMG) and nerve potentials studies. ISurg Disposable Subdermal Needle Electrodes are "Rx Only", intended for "Single Use Only" and "Sterile".
Product codes
GXZ
Device Description
ISurg Disposable Subdermal Needle Electrodes are the conduit between the monitoring equipment and a patient. The electrode has a small gauge stainless steel needle on one end (which is subdermally positioned by a licensed physician or technologist under his (which is subcoman) pointener on the other (a safety connector which is connected to the monitoring equipment) with a small gauge wire connecting the two. The safety connector is an industry standard DIN 42802 protected connector and cannot be connected to an AC outlet.
ISurg Disposable Subdermal Needle Electrodes are used in the study of biopotentials such 13ang Disposable Daoublik (FG), electromyography (EMG), nerve conduction and evoked as crootials. They are "Rx Only", disposable (for "Single Use Only"), sterile and invasive as they are placed subcutaneously in or near nerve and muscle tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous in or near nerve and muscle tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed physician or technologist
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
ISurgicul
26625 Countryside Lake Drive Countryside Lake, IL 60000
MAY 2 1 2004
847-040-0-44 ()Ticc × | -- 9 | 9 -- 4 > 14 lis Mobile VM, 847-727-2167 isurereal a aol com
510(k) SUMMARY
March 3, 2004
12.1 Summary Date:
12.2 Company Name:
ISurgical 26625 Countryside Lake Drive
Mundelein, IL 60060
| 12.3 Contact: | Ken Leiser, Owner |
|---|---|
| 12.4 Phone: | 847-949-9744 |
| 12.5 Fax: | 847-949-4934 |
12.6 Device Identification:
Proprietary Name: ISurg Disposable Subdermal Needle Electrodes Common Name: Needle Electrodes Classification Name: Electrode, Needle (per 21 CFR section 882.1350) Class II Class: Product Code: GXZ
12.7 Predicate Devices:
K990015 510(k) Number: Technomed Europe Manufacturer: Trade Name: Technomed EEG/EMG Needle Electrodes Product Code: GXZ
510(k) Number: Manufacturer: Trade Name: Product Code:
510(k) Number: Manufacturer: Trade Name: Product Code:
K010019 Nicolet Biomedical, Incorporated Sterile Subdermal Needle Electrodes GXZ
K022914 Rhythmlink International, LLC Rhythmlink International Subdermal Needle Electrodes GXZ
•
12.0
1
12.8 Description:
1Surg Disposable Subdermal Needle Electrodes are the conduit between the monitoring equipment and a patient. The electrode has a small gauge stainless steel needle on one end (which is subdermally positioned by a licensed physician or technologist under his (which is subcoman) pointener on the other (a safety connector which is connected to the monitoring equipment) with a small gauge wire connecting the two. The safety connector is an industry standard DIN 42802 protected connector and cannot be connected to an AC outlet.
1Surg Disposable Subdermal Needle Electrodes are used in the study of biopotentials such 13ang Disposable Daoublik (FG), electromyography (EMG), nerve conduction and evoked as crootials. They are "Rx Only", disposable (for "Single Use Only"), sterile and invasive as they are placed subcutaneously in or near nerve and muscle tissue.
12.9 Intended Use:
ISurg Disposable Subdermal Necdle Electrodes are intended for use with monitoring, recording and stimulation equipment specifically designed for the recording of biopotential signals from electroencephalography (EEG), electromyography (EMG) and nerve potentials studies. ISurg Disposable Subdermal Needle Electrodes are "Rx Only", intended for "Single Use Only" and "Sterile".
- 12.10 Technological Charactcristics:
The ISurg Disposable Subdermal Needle Electrode consists of an insulated wire with a small gauge stainless stccl needle on one end, and a safety connector on the other that cannot be plugged into an AC power outlet.
The matcrials are substantially equivalent to those used in the predicate devices; however, ISurgical injection molds the needle-wire bond to insulate and provide a strong, tight seal around the needle and wire for strength and fluid occlusion. The DIN 42802 safety connector is molded to provide industry standard connectivity, insulate the terminal and provide wire stress relief by design.
- 12.11 Conclusions
The ISurg Disposable Subdermal Needle Electrode is substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 2004
Mr. Ken Leiser ISurgical 26625 Countryside Lake Drive Countryside Lake, Illinois 60060
Re: K040639
Trade/Device Name: ISurg Disposable Subdermal Needle Electrodes Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: II Product Code: GXZ Dated: March 8, 2004 Received: March 12, 2004
Dear Mr. Lciser:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatinent date of the Medical Device Amendments, or to conninered pror to may 20, 1977) 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 1 ou may, merceroro, market of the Act include requirements for annual registration, listing of general controls pro resuring 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 If your device is clussified (600 a00 rop of ols. Existing major regulations affecting your device can may be subject to sater additions, 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 I toase be deviloed that I Drimination that your device complies with other requirements of the Act that I DT has made a and regulations administered by other Federal agencies. You must or any I caeral statues and equirements, including, but not limited to: registration and listing (21 Compry with an the Ace 31equirements 01); good manufacturing practice requirements as set CI It fart 6077; fanomic (2 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quant) bywells (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Ken Leiser
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and in your of substantial equivalence of your device to a legally premits to the are 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), please it you dome of Compliance at (301) 594-4659. 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 other general 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,
Muriam C. Provost
for Cclia M. Witton, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known) // 040639
INDICATIONS FOR USE 4.0
ISurg Disposable Subdermal Needle Electrodes Device Name: Indications For Use: ISurg Disposable Subdermal Needle Electrodes are intended for use with monitoring, recording and electrical stimulation equipment with monitoring, roosraing of biopotential signals from specifically dosignivy (EEG), electromyography (EMG) and nerve ciconvential studies. ISurg Disposable Subdermal Needle Electrodes potential boars, intended for "Single Use Only" and "Sterile".
イ Prescription Use Only ________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Section 4 0, Page 1
510(k) Number_________________________________________________________________________________________________________________________________________________________________