(85 days)
Not Found
No
The description focuses on the physical characteristics and function of disposable probes for nerve stimulation and EMG detection, with no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.
No
The device is used to locate, identify, and monitor motor nerves during surgery by detecting EMG activity, which is a diagnostic/monitoring function, not a therapeutic one.
Yes
The device is used to "locate and identify cranial motor nerves" and "monitor cranial motor nerves by detecting EMG activity," which are diagnostic functions. The predicates are also "motor nerve monitor" devices.
No
The device description explicitly details three types of physical, disposable probes (Concentric, Bipolar, and Monopolar) which are hardware components used to interact with the patient's tissue.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device is a surgical probe used during surgery to locate, identify, and monitor motor nerves by detecting electrical activity (EMG). It interacts directly with the patient's tissues in vivo, not with samples in vitro.
- Intended Use: The intended use clearly describes surgical procedures and the stimulation and monitoring of nerves within the body.
- Device Description: The description details the physical characteristics and how the probes are used to apply electrical stimulation and detect responses in vivo.
Therefore, this device falls under the category of a surgical instrument or a nerve monitoring device used during surgery, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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
Product codes
GXZ
Device Description
There are three types of disposable probes: Concentric, Bipolar and Monopolar
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.
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.
Disposable Monopolar probe
The Monopolar probe has a single active electrode, but must have a remote return electrode connected to the patient.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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).
0
112
| Attachment D: | |
|---|---|
| --------------- | -- |
510(k) Summary
| Manufacturer: | Technomed Europe
Amerikalaan 71
6199 AE Maastricht Airport
The Netherlands |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by: | Technomed Europe
Amerikalaan 71
6199 AE Maastricht Airport
The Netherlands |
| Contact person: | René Roncken
Manager Quality Assurance
Tel.: (+31) 43-408 6868
Fax: (+31) 43-408 6888
E-mail: rroncken@technomed.nl |
| 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
K980148: Neurosign 800, 8 channel motor nerve monitor
K964869: Neurosign 800, 8 channel motor nerve monitor |
| Device description: | There are three types of disposable probes: Concentric, Bipolar and Monopolar 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. 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. |
.
1
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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.
2
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.
3
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 (240) 276-0115 . 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 (800) 638-2041 or (301) 443-6597 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
4
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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