(102 days)
No
The device description focuses on electrical stimulation and physical probes, with no mention of AI/ML terms or functionalities.
No
The device is used to locate, identify, and monitor nerves, suggesting a diagnostic or monitoring function rather than a therapeutic one. It delivers electrical stimulation for assessment, not treatment.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is used "To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery." The "Device Description" further elaborates that the probes are used "to locate and identify motor nerves and spinal nerve roots and to assess nerve function," and also "to record nerve action potentials directly from the nerve." These are all activities aimed at gaining information about the patient's condition for medical purposes, which is the definition of a diagnostic device.
No
The device description explicitly details physical components like "Stimulator probes," "flexible lead wire(s)," "touch-proof' safety connector(s)," "plastic handle," and "stainless steel active electrode shaft." These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is used during surgery to directly stimulate nerves and assess their function in real-time. It does not analyze samples taken from the body.
- Intended Use: The intended use is to "locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery." This is an in-vivo (within the living body) application, not an in-vitro (in glass/outside the body) application.
The device is a surgical tool used for intraoperative neurological monitoring, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.
Product codes
ETN, GXZ
Device Description
Stimulator probes are used as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The probes are available in various monopolar and bipolar configurations according to the required application. The probes are supplied sterile and are for single use only.
The probes are connected to an electrical stimulator using a flexible lead wire(s) and a "touch-proof" safety connector(s) on the distal end. Monopolar electrodes require a separate stimulator return electrode
Stimulator probes are used by the surgeon to locate and identify motor nerves and spinal nerve roots and to assess nerve function. Bipolar probes may also be used to record nerve action potentials directly from the nerve.
The probes are designed with a plastic handle and stainless steel active electrode shaft insulated to the tip. The probe shaft may be bent to allow viewing access under a microscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial motor nerves, peripheral nerves and spinal nerve roots
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, intraoperative neurological monitoring
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).
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510(k) Summary
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:
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:
:
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of CFR 807.92.
| Summary Date:
Submitter's
Information: | September 29, 2006
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
JAN 1 2 2007 |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Names:
Common Name:
Classification
Name:
Classification: | Axon Systems Disposable Stimulator Probes
Stimulator Probes
Stimulator, Nerve (21. CFR 874.1820)
Needle Electrode (21. CFR 882.1350)
Class II (Performance Standards)
Panels: Ear, Nose and Throat; 874.1820
Neurology; 882.1350
Procodes: ETN, GXZ |
| Predicate
Devices: | Technomed Europe - Disposable Probes (K050325)
Xomed Surgical Products - Ball Tip Monopolar stimulating probe
(K992869) |
1
Summary:
Description
Stimulator probes are used as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The probes are available in various monopolar and bipolar configurations according to the required application. The probes are supplied sterile and are for single use only.
The probes are connected to an electrical stimulator using a flexible lead wire(s) and a "touch-proof" safety connector(s) on the distal end. Monopolar electrodes require a separate stimulator return electrode
Stimulator probes are used by the surgeon to locate and identify motor nerves and spinal nerve roots and to assess nerve function. Bipolar probes may also be used to record nerve action potentials directly from the nerve.
The probes are designed with a plastic handle and stainless steel active electrode shaft insulated to the tip. The probe shaft may be bent to allow viewing access under a microscope.
Intended Use
To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.
Technological Characteristics
Axon Systems' Disposable Stimulator Probes consist of an insulated probe shaft of various lengths mounted to plastic handle. The probe shaft is electrically connected to a DIN 42802 "touch-proof" safety connector on the other end. The electrode is supplied in a sterile pouch. Materials used are the same as in the predicate devices.
Conclusions
Axon Systems' Disposable Stimulator Probes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Axon Systems, Inc. % Mr. Howard Bailin Vice President, COO 400-2200 Oser Avenue Hauppauge, New York 11788
JAN 1 2 2007
Re: K062996
Trade/Device Name: Disposable monopolar and bipolar stimulator probes Regulation Number: 21 CFR 882.1350 Regulation Name: Needle electrode Regulatory Class: II Product Code: GXZ Dated: November 29, 2006 Received: November 30, 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 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 (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
| 510(k) Number (if known): | K062996 |
|---|---|
| Device Name: | Disposable monopolar and bipolar stimulator probes |
| Indications For Use: | To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal |
| nerve roots during surgery. |
Prescription Use X (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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of
510(k) Number_I062996