(102 days)
To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.
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.
This submission pertains to Axon Systems' Disposable Stimulator Probes, which are devices used to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The document provided is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance study results. As such, the requested information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) is not present in the provided text.
The 510(k) summary only states the following:
1. A table of acceptance criteria and the reported device performance: This information is not provided. The summary focuses on technological characteristics and substantial equivalence, not specific performance metrics against pre-defined acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No information on test set sample sizes or data provenance is available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): This information is not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable and not mentioned, as there is no test set or ground truth establishment process described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not applicable. The device described is a medical instrument (stimulator probe), not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as there isn't a diagnostic algorithm undergoing validation against a ground truth.
8. The sample size for the training set: Not applicable and not mentioned.
9. How the ground truth for the training set was established: Not applicable and not mentioned.
Summary of the 510(k) Conclusion:
The document concludes that "Axon Systems' Disposable Stimulator Probes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident." This equivalence is based on the description of technological characteristics, such as:
- Identical materials: "Materials used are the same as in the predicate devices."
- Similar design: Insulated probe shaft of various lengths mounted to a plastic handle, electrically connected to a "touch-proof" safety connector.
- Intended Use: "To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery," which is presumably consistent with the predicate devices.
The predicate devices mentioned are:
- Technomed Europe - Disposable Probes (K050325)
- Xomed Surgical Products - Ball Tip Monopolar stimulating probe (K992869)
In essence, the "study" proving the device meets acceptance criteria in a 510(k) submission like this is primarily a demonstration of substantial equivalence to already cleared devices, rather than a de novo clinical trial with defined acceptance criteria and performance outcomes.
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510(k) Summary
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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'sInformation: | September 29, 2006Howard BailinVice President, C.O.O.Axon Systems, Inc.400-2200 Oser AveHauppauge, NY 11788P: 631 436 5112F: 631 436 5141hbailin@axonsystems.comJAN 1 2 2007 |
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| Trade Names:Common Name:ClassificationName:Classification: | Axon Systems Disposable Stimulator ProbesStimulator ProbesStimulator, Nerve (21. CFR 874.1820)Needle Electrode (21. CFR 882.1350)Class II (Performance Standards)Panels: Ear, Nose and Throat; 874.1820Neurology; 882.1350Procodes: ETN, GXZ |
| PredicateDevices: | Technomed Europe - Disposable Probes (K050325)Xomed Surgical Products - Ball Tip Monopolar stimulating probe(K992869) |
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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.
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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
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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 spinalnerve 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
§ 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).