(140 days)
No
The description focuses solely on the physical components and intended use of surface electrodes for electrophysiological recording and stimulation. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No
The device is described as being for "recording of electrophysiological activity and for peripheral nerve electrical stimulation," and is used with "electrodiagnostic or neurological monitoring equipment." Its function is to facilitate the detection of signals or provide electrical stimulation, not to directly treat a condition. While stimulation can be therapeutic, the context here is for diagnostic/monitoring equipment, not a therapeutic device itself.
Yes.
The "Intended Use / Indications for Use" states that the electrodes are "intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity". The "Device Description" further clarifies their use in "electro-diagnostic clinical studies".
No
The device description clearly details physical components like electrodes, leads, connectors, and materials (polyester fabric, polyethylene foam, carbon, Ag/AgCl, hydrogel). It is a hardware device used to interface with other equipment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Axon Systems' Pre-gelled Surface Electrodes are used to record electrophysiological activity and for peripheral nerve electrical stimulation by being placed on the skin or muscle surface. They are an interface between the patient and electrodiagnostic/neurological monitoring equipment.
- Lack of Specimen Analysis: The device does not involve the collection or analysis of any specimens from the human body. It directly interacts with the body's electrical signals.
Therefore, the intended use and function of this device clearly fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Axon Systems' Pre-gelled Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for peripheral nerve electrical stimulation. The electrodes are non-sterile and for single patient use only.
Product codes
GXZ
Device Description
Electrodes are the interface medium between neurodiagnostic or neuromonitoring equipment and the patient. Electrodes are used in electro-diagnostic clinical studies or during intraoperative monitoring for electroencephalography (EEG), electromyography (EMG) or evoked potentials recording and electrical stimulation.
The electrodes used to detect electro-physiological signals or provide electrical stimulation cutaneously. The electrodes are non-sterile and are designed to be disposable, for single use only. Pre-gelled Surface Electrodes are noninvasive as they are placed cutaneously or in contact with the skin or muscle surface and are used under the supervision of a licensed physician. Axon Systems' Pre-gelled Surface Electrodes (PGSE) are supplied with leads or with snap connector. The leaded electrodes are comprised of a laminated, flexible structure composed of polyester fabric or polyethylene foam and use conductive carbon coated with Aq/AqCl and activated carbon mesh material and conductive hydrogel on one side as the coupling medium to the skin. No other adhesive is used. The active conductor is electrically connected to flexible, copper or carbon fiber lead wire and an industry standard DIN 42802 "touch proof" safety connector on the other end. The safety connector is connected to the recording input or electrical stimulator output of the neurodiagnostic or neuromonitoring equipment. The snap connector electrode is comprised of a polyethylene foam substrate with medical grade adhesive and uses Ag/AgCl pellet(s) as the conductive element. The active surface of the pellet is coated with conductive hydrogel to form the coupling medium to the skin. The pellet is attached to a male snap which is used to connect the electrode directly to the recording amplifier.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin or muscle surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed 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)
The Pre-gelled Surface Electrodes were tested functionally using accepted laboratory test procedures.
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
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
062198
DEC 1 9 2006
14. 510(k) Summary
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of CFR 807.92.
| Summary Date: | July 10, 2006 |
|---|---|
| Submitter's | |
| Information: | Howard Bailin |
| Vice President, C.O.O. | |
| Axon Systems, Inc. | |
| 400-2200 Oser Ave | |
| Hauppauge, NY 11788 | |
| P: 631 436 5112 | |
| F: 631 436 5141 | |
| hbailin@axonsystems.com | |
| Trade Name: | Pre-gelled Disposable Surface Electrodes; Sunspots Pre-gelled |
| Surface Electrodes | |
| Common Name: | Pre-gelled Surface Electrodes |
| Classification | |
| Name: | Surface Electrode |
| Classification: | Number: 882.1320 Surface Electrode |
| Product Codes: | GXZ |
| Predicate | |
| Devices: | Manufacturer: Nicolet Biomedical |
| Trade Name: Pre-gelled Surface Electrodes | |
| FDA number: K971914 |
Manufacturer: Medicotest, Inc.
Trade Name: Surface Electrodes
FDA number: K931030
Manufacturer: Tyco Health Kendall (Graphic Controls)
Trade Name: Medi-Trace 133 ECG Pellet Electrodes
FDA number: K821137 |
| Description: | Electrodes are the interface medium between neurodiagnostic or
neuromonitoring equipment and the patient. Electrodes are used in
electro-diagnostic clinical studies or during intraoperative monitoring
for electroencephalography (EEG), electromyography (EMG) or
evoked potentials recording and electrical stimulation.
The electrodes used to detect electro-physiological signals or
provide electrical stimulation cutaneously. The electrodes are non- |
1
sterile and are designed to be disposable, for single use only. Pre-gelled Surface Electrodes are noninvasive as they are placed cutaneously or in contact with the skin or muscle surface and are used under the supervision of a licensed physician. Axon Systems' Pre-gelled Surface Electrodes (PGSE) are supplied with leads or with snap connector. The leaded electrodes are comprised of a laminated, flexible structure composed of polyester fabric or polyethylene foam and use conductive carbon coated with Aq/AqCl and activated carbon mesh material and conductive hydrogel on one side as the coupling medium to the skin. No other adhesive is used. The active conductor is electrically connected to flexible, copper or carbon fiber lead wire and an industry standard DIN 42802 "touch proof" safety connector on the other end. The safety connector is connected to the recording input or electrical stimulator output of the neurodiagnostic or neuromonitoring equipment. The snap connector electrode is comprised of a polyethylene foam substrate with medical grade adhesive and uses Ag/AgCl pellet(s) as the conductive element. The active surface of the pellet is coated with conductive hydrogel to form the coupling medium to the skin. The pellet is attached to a male snap which is used to connect the electrode directly to the recording amplifier. Intended Use: Axon Systems' Pre-gelled Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for peripheral nerve electrical stimulation. The electrodes are non-sterile and for single patient use only. Technologically, the Pre-gelled Surface Electrodes are similar to the Technological predicate devices. The exceptions are in physical dimensions only. Comparison: No new technology or basic materials are used in these designs. The Pre-gelled Surface Electrodes were tested functionally using accepted laboratory test procedures. Conclusions: Based on the technical information provided and the safety and effectiveness criteria of the design and development process, we claim the Pre-gelled Surface Electrodes to be safe, effective and substantially equivalent to the predicate device(s) noted.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wings, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Howard Bailin VP, Chief Operating Officer Axon Systems, Inc. 400-2200 Oser Ave. Hauppauge, NY 11788
DEC 1 9 2006
Re: K062198
Trade/Device Name: Pre-gelled Surface Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: November 7, 2006 Received: November 9, 2006
Dear Mr. Bailin:
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 Cometic 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. To ameral controls provisions of the Act include requirements for annual registration, listing of devines, 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 a vice your 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 Ramp); 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 and giam control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Howard Bailin
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), please contact the Office of Compliance at (240) 276-0120. 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 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,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number
Device Name
Pre-gelled surface electrodes
Indications for Use
Axon Systems' Pre-gelled Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for peripheral nerve electrical stimulation. The electrodes are non-sterile and for single patient use only.
Prescription Use
(Part 21 CFR 801 part D) AND/OR
vision Sign-Off)
motive
3-2
Over-The-Counter Use (21 CFR 807 Subpart C)
510(k) Number
Division of Occal Devices
(Division )
(Division Sign-Old)
Division of General, Restorative,
Division of General, Devices