(89 days)
Not Found
No
The device description focuses on the physical components and intended use of a needle electrode for signal detection and stimulation, with no mention of AI or ML for data processing or interpretation.
No
The device is used for recording, monitoring, and stimulation/recording of biopotential signals and for stimulation during diagnosis. It is specifically described as an interface medium for "diagnostic or monitoring equipment." There is no indication that it directly treats or cures a disease or condition.
Yes
The product's intended use explicitly states "for stimulation during the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction." Additionally, the device description mentions its use as an "interface medium between the diagnostic or monitoring equipment and the patient" and its application in "clinical electro-diagnostic studies or intraoperative monitoring."
No
The device description clearly states it is comprised of a physical needle, lead 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 Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. This testing is done outside the body (in vitro).
- Device Function: The Axon Systems' Subdermal Needle Electrodes are used to record biopotential signals and provide electrical stimulation directly within the patient's body (subcutaneously). They are an interface between the patient and the recording/stimulation equipment.
- Intended Use: The intended use clearly states recording of signals like EEG, EMG, and nerve potentials, and stimulation during intraoperative diagnosis. These are all procedures performed on the patient, not on specimens taken from the patient.
Therefore, because the device interacts directly with the patient's body to record signals and provide stimulation, rather than analyzing specimens outside the body, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Axon Systems' Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals and for stimulation during the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.
Product codes (comma separated list FDA assigned to the subject device)
GXZ
Device Description
Axon Systems' Subdermal Needle Electrodes are disposable (for "Single Use Only"), sterile devices used to detect electro-physiological signals or provide electrical stimulation subcutaneously.
The electrodes are the interface medium between the diagnostic or monitoring equipment and the patient. The subdermal needle electrode is comprised of a small gauge stainless steel needle on one end electrically connected to lead wire and a "touch-proof" safety connector on the other end. The needle is inserted subdermally by a licensed physician or technologist under the supervision of a physician. The safety connector is connected to recording or monitoring equipment.
The safety connector is an industry standard DIN 42802 protected, "touch proof" connector and cannot be connected to an AC outlet.
Electrodes are used in clinical electro-diagnostic studies or intraoperative monitoring which may include electroencephalography (EEG), electromyography (EMG) or evoked potentials recording and electrical stimulation.
Subdermal Needle Electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician.
Axon Systems' Subdermal Needle Electrode consists of an insulated wire, of various lengths, electrically connected to a small gauge, stainless steel needle on one end, and a DIN 42802 "touch-proof" safety connector on the other end. The connector is specifically designed so that it cannot be plugged into AC power outlet. The electrode is supplied in a sterile pouch. Materials used are the same as in the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneously
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed physician or technologist 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.
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.
Not Found
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
§ 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
APR 2 6 2005
Appendix J Summary of Safety and Effectiveness
.
Page 1 of 2
11. Summary of Safety and Effectiveness
| Company Name: | Axon Systems, Inc.
400-2200 Oser Ave
Hauppauge, NY 11788 | | |
|--------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------|---------------------|
| Contact:
Phone:
Fax:
Email: | Howard Bailin
Vice President, C.O.O.
631 436 5112
631 436 5141
hbailin@axonsystems.com | | |
| Summary Date | January 17, 2005 | | |
| Proprietary Name: | Subdermal Needle Electrodes
Twisted Pair Needle Electrodes
Corkscrew (spiral) Needle Electrode | | |
| Common Name: | Subdermal Needle Electrodes | | |
| Classification: | Class II
Number:
Procodes: | (Performance Standards)
882.1350
GXZ | Needle Electrode |
| Predicate Devices | Manufacturer: Nicolet Biomedical | Trade Name: Sterile Subdermal Needle Electrodes | FDA number: K010019 |
| | Manufacturer: TechnoMed Europe | Trade Name: Various Needle Electrodes | FDA number: K990015 |
| | Manufacturer: Agram Export-Import Company | Trade Name: Spiral Electrode | FDA number: K934779 |
1
Page 2 of 2
Device Description
Axon Systems' Subdermal Needle Electrodes are disposable (for "Single Use Only"), sterile devices used to detect electro-physiological signals or provide electrical stimulation subcutaneously.
The electrodes are the interface medium between the diagnostic or monitoring equipment and the patient. The subdermal needle electrode is comprised of a small gauge stainless steel needle on one end electrically connected to lead wire and a "touch-proof" safety connector on the other end. The needle is inserted subdermally by a licensed physician or technologist under the supervision of a physician. The safety connector is connected to recording or monitoring equipment.
The safety connector is an industry standard DIN 42802 protected, "touch proof" connector and cannot be connected to an AC outlet.
Electrodes are used in clinical electro-diagnostic studies or intraoperative monitoring which may include electroencephalography (EEG), electromyography (EMG) or evoked potentials recording and electrical stimulation.
Subdermal Needle Electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician.
Intended Use
Axon Systems' Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals and for stimulation during the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.
Technological Characteristics
Axon Systems' Subdermal Needle Electrode consists of an insulated wire, of various lengths, electrically connected to a small gauge, stainless steel needle on one end, and a DIN 42802 "touch-proof" safety connector on the other end. The connector is specifically designed so that it cannot be plugged into AC power outlet. The electrode is supplied in a sterile pouch. Materials used are the same as in the predicate devices.
Conclusions
Axon Systems' Subdermal Needle Electrodes are 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Public Health Service
APR 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Howard Bailin Vice President, Chief Operating Officer Axon Systems, Inc. 400-2200 Oser Avenue Hauppauge, New York 11788
Re: K050194
Trade/Device Name: Subdermal Needle Electrodes Regulation Number: 21 CFR 882.1350 Regulation Name: Needle electrode Regulatory Class: II Product Code: GXZ Dated: April 1, 2005 Received: April 5, 2005
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 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.
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) 276-0115 . 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Miriam C. Provost
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| 510(k) Number | K050194 |
|---|---|
| Device Name | Subdermal Needle Electrodes |
| Indications for Use | Axon Systems' Subdermal Needle Electrodes are intended for use |
| with recording, monitoring and stimulation/recording equipment for | |
| the recording of biopotential signals including | |
| electroencephalograph (EEG), electromyograph (EMG) and nerve | |
| potential signals and for stimulation during the intraoperative | |
| diagnosis of acute dysfunction in corticospinal axonal conduction. |
Prescription Use _ x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1,Enive
cd Deve o
Page 1 of 1