DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE

K050325 · Technomed Europe · GXZ · May 5, 2005 · Neurology

Device Facts

• Record ID: K050325
• Device Name: DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE
• Applicant: Technomed Europe
• Product Code: GXZ · Neurology
• Decision Date: May 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1350
• Device Class: Class 2

Intended Use

The stimulating probe is used: - to locate and identify cranial motor nerves during ENT and intra-cranial procedures - to locate and identify cranial and peripheral motor nerves during surgery, including spinal nerve roots - to locate, identify and monitor cranial motor nerves during surgery - The motor nerves are monitored by detecting EMG activity in the muscles they innervate

Device Story

Disposable probes (Concentric, Bipolar, Monopolar) used by surgeons during ENT, intra-cranial, and spinal surgeries to locate, identify, and monitor motor nerves. Concentric probe (1mm diameter) provides precise stimulation for cranial nerves and fine fibers. Bipolar probe features integrated active/return electrodes for localized stimulation in skull-base and peripheral nerve surgery. Monopolar probe requires a remote return electrode and is used for broader stimulation of tumor masses. Probes deliver electrical stimulation to tissue; nerve location is confirmed by detecting EMG activity in innervated muscles via external monitoring equipment. Devices facilitate nerve preservation during complex surgical procedures.

Clinical Evidence

No clinical data. Substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Disposable stimulating probes available in Concentric, Bipolar, and Monopolar configurations. Monopolar probe features 2mm tip-free insulation for precise stimulation. Devices function as passive electrodes for electrical nerve stimulation and EMG signal acquisition. Materials and construction are stated to be equivalent to predicate devices.

Indications for Use

Indicated for locating, identifying, and monitoring cranial and peripheral motor nerves (including spinal nerve roots) during ENT, intra-cranial, and other surgical procedures by detecting EMG activity in innervated muscles.

Regulatory Classification

Identification

A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

Predicate Devices

• Neurosign 400, 4 channel motor nerve monitor (K991583)
• Neurosign 800, 8 channel motor nerve monitor (K980148)
• Neurosign 800, 8 channel motor nerve monitor (K964869)

Submission Summary (Full Text)

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## 510(k) Summary

| Manufacturer: | Technomed Europe<br>Amerikalaan 71<br>6199 AE Maastricht Airport<br>The Netherlands |
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| Submitted by: | Technomed Europe<br>Amerikalaan 71<br>6199 AE Maastricht Airport<br>The Netherlands |
| Contact person: | René Roncken<br>Manager Quality Assurance<br>Tel.: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date: | February 7, 2005 |
| Proprietary Name: | Needle electrodes |
| Common/usual Name: | Disposable probe |
| Classification Name: | Needle electrode (21 CFR section 882.1350) |
| Substantial Equivalence: | K991583: Neurosign 400, 4 channel motor nerve monitor<br>K980148: Neurosign 800, 8 channel motor nerve monitor<br>K964869: Neurosign 800, 8 channel motor nerve monitor |
| Device description: | There are three types of disposable probes: Concentric, Bipolar and Monopolar <p>Disposable Concentric probe The Concentric probe is very precise and has a diameter of only 1 mm. They are especially useful when working with the microscope, and allow the surgeon to differentiate between cranial nerves, to stimulate within the Internal Auditory Canal, or to stimulate fine fibers of the extra-cranial nerve without stimulating surrounding tissue.</p> <p>Disposable Bipolar probe The Bipolar probe has both the active and return electrode builds in to the probe. Both tips of the Bipolar probe must come into contact with tissue in order for the stimulation current to flow. The Bipolar probe will stimulate through a small amount of tissue. The Bipolar probe may be used in skull-base surgery and those involving peripheral motor nerves.</p> |

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Disposable Monopolar probe

The Monopolar probe has a single active electrode, but must have a remote return electrode connected to the patient.

જીરુ

The Monopolar probe is insulated to a tip free coating length of 2 mm, so it is capable of very precise stimulation. The probe should be touched onto the tissue until the nerve is located. The Monopolar probe is designed to be used to stimulate the tumor mass or when a large spread is required.

Intended Use:

The stimulating probe is used:

- to locate and identify cranial motor nerves during ENT and intra-cranial procedures
- to locate and identify cranial and peripheral motor nerves during surgery, including spinal nerve roots
- to locate, identify and monitor cranial motor nerves during surgery -

The motor nerves are monitored by detecting EMG activity in the muscles they innervate

Technological characteristics:

The design, materials, chemical composition, packaging and other technological characteristics of the subject devices are considered to be the equivalent of the predicated devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, representing the department's focus on health-related matters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2005

Ms. René Roncken Manager Quality Assurance Technomed Europe Amerikalaan 71 6199 AE Maastricht Airport The Netherlands

Re: K050325

Trade/Device Name: Disposable probe Regulation Number: 21 CFR 882.1350 Regulation Name: Needle electrode Regulatory Class: II Product Code: GXZ Dated: March 22, 2005 Received: March 25, 2005

Dear Ms. Roncken:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your we your we determined the device is substantially equivalent (for the indications ferenced about and in sure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conniner of the 1125 2019 11:31 accordance with the provisions of the Federal Food, Drug, de vices that have been receasined require approval of a premarket approval application (PMA). and Cosmetic Her (11ct) that to novice, subject to the general controls provisions of the Act. The r out may, mercere, maines of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 your device is classified (655 and controls. Existing major regulations affecting your device it may be subject to sam additions, Title 21, Parts 800 to 898. In addition, FDA ean or found in the announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 lease of advisou that i Drivination that your device complies with other requirements of the Act that I DA has made a send regulations administered by other Federal agencies. You must or any i catal statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fatt 6077, adoling (21 CFR regulation (21 CFR Part 820); and if applicable, the electronic form in the quanty bytellio (QS) reggly style of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. René Roncken

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to cegm maning of substantial equivalence of your device to a legally premation notification - ' e 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 If you desire specific at noviance at [phone] . Also, please note the regulation entitled, Colliation of Company of Company of Court (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Eun C. Oh

_ 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

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## Indications for Use

510(k) Number (if known): K050325

Device Name: Disposable probe

Indications For Use:

The disposable probe is used:

- to locate and identify cranial motor nerves during ENT and intra-cranial procedures
- to locate and identify cranial and peripheral motor nerves during surgery, including spinal nerve roots
- to locate, identify and monitor cranial motor nerves during surgery

The motor nerves are monitored by detecting EMG activity in the muscles they innervate.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

MORTGAGE COMPANY DESIGNEE

Ko 50325

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