(182 days)
None
No
The device description and intended use clearly define the device as passive needle electrodes for recording and stimulating biopotential signals. There is no mention of AI, ML, or any computational processing of the signals beyond basic recording and stimulation.
No
The device is described as being used for "recording, monitoring, and stimulation" of biopotential signals (EEG, EMG, nerve potentials). While stimulation might be considered therapeutic in some contexts, the primary stated uses relate to diagnostics and monitoring, not directly treating a disease or condition. The text focuses on data acquisition for assessment rather than interventional therapy.
Yes
The device is used for recording biopotential signals (EEG, EMG, nerve potentials) and for stimulation/recording in EMG and nerve potential studies, which are diagnostic procedures to assess physiological functions.
No
The device description clearly outlines physical components (needles, lead wires, connectors) and their materials (stainless steel, platinum alloy, PTFE coating). It also describes the device as passive and disposable, requiring sterilization, all of which are characteristics of hardware, 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The description clearly states that these Needle Electrodes are used for recording, monitoring, and stimulation of biopotential signals (EEG, EMG, nerve potentials) within the body (subcutaneously). They are invasive devices used directly on the patient.
- Intended Use: The intended use is for neurological purposes, specifically for recording and stimulating electrical activity in nerves and muscles. This is a direct interaction with the patient's physiology, not an analysis of a sample taken from the patient.
Therefore, the function and intended use of these Needle Electrodes fall outside the scope of In Vitro Diagnostics. They are considered medical devices used for physiological measurement and stimulation.
N/A
Intended Use / Indications for Use
Needle Electrodes for Neurological purposes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.
Product codes (comma separated list FDA assigned to the subject device)
GXZ, IKT
Device Description
Needle Electrodes are passive devices used for recording, monitoring and stimulation during EEG, EMG, nerve conducting studies and IONM. The Needle Electrodes have different tip shapes for performing different recording and stimulating procedures.
The Needle Electrodes are disposable and designed for single use and are labeled accordingly. The disposable Needle Electrodes are delivered sterile and can be used after opening of the sterile package.
The needles are comprised of a stainless steel or platinum alloy needle, electrically connected to a lead wire. or with a connector for connection to a separate lead wire. Monopolar needles are coated with a polytetrafluoroethylene coating. In case of a pre-connected lead wire the other end is a regular industry standard DIN 42802 safety connector.
The needles are invasive as they are used subcutaneously. Positioning and use is under supervision of a licensed physician.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral nerves and muscles
Indicated Patient Age Range
All patients
Intended User / Care Setting
licensed physician, Hospital
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)
Performance testing: Electrical safety and compatibility was verified, including impedance testing. Sterilization validation was confirmed to comply equally as for Technomed Europe devices already released to be legally marketed under K050325, and to conform to all requirements.
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.
K990015, K050325, K062437, K112034, K072276
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
| 510(k) Summary | |
|---|---|
| Manufacturer: | Technomed Europe |
| Amerikalaan 71 | |
| 6199 AE Maastricht Airport | |
| The Netherlands | |
| JUL 1 9 2013 | |
| Submitted by: | Technomed Europe |
| Amerikalaan 71 | |
| 6199 AE Maastricht Airport | |
| The Netherlands | |
| Tel.: (+31) 43-408 6868 | |
| Fax: (+31) 43-408 6888 | |
| Contact person: | Mr. Pierre Vreuls |
| Manager Regulatory Affairs and Quality Assurance | |
| E-mail: pvreuls@technomed.nl | |
| Date: | June 6, 2013 |
| Proprietary Name: | Disposable Monopolar and Subdermal Needle Electrodes |
| Common/usual Name: | Needle Electrode |
| Classification Name: | Needle electrodes are classified as class II per 21 CFR |
| section 882.1350 product code GXZ and section 890.1385 | |
| product code IKT (diagnostic electromyograph needle | |
| electrode). | |
| Legally Marketed | |
| Predicate Devices: | K990015: Technomed Europe Needle Electrodes |
| K050325: Technomed Europe Disposable Concentric Probe. | |
| Disposable Bipolar Probe, Disposable Monopolar Probe | |
| K062437: Technomed Europe Disposable Hypodermic | |
| EMG Needle Electrode | |
| K112034: Carefusion 209. Inc. TECA™ ELITE Disposable | |
| Concentric Needles | |
| K072276: Xian Friendship Electronics Co., Ltd., Subdermal | |
| Needle Electrodes | |
| Device description: | Needle Electrodes are passive devices used for recording, |
| monitoring and stimulation during EEG, EMG, nerve | |
| conducting studies and IONM. The Needle Electrodes have |
.......
510(k) Summary
1
different tip shapes for performing different recording and stimulating procedures.
The Needle Electrodes are disposable and designed for single use and are labeled accordingly. The disposable Needle Electrodes are delivered sterile and can be used after opening of the sterile package.
The needles are comprised of a stainless steel or platinum alloy needle, electrically connected to a lead wire. or with a connector for connection to a separate lead wire. Monopolar needles are coated with a polytetrafluoroethylene coating. In case of a pre-connected lead wire the other end is a regular industry standard DIN 42802 safety connector.
The needles are invasive as they are used subcutaneously. Positioning and use is under supervision of a licensed physician.
Intended Use:
Needle Electrodes for Neurological purposes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyography (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.
| Characteristic | Predicate device
disposable needle
electrode EEG / EMG
[K990015] | Predicate device
Subdermal Needle
Electrodes[K072276] | Predicate device
disposable concentric
needles [K112034] | Disposable monopolar
and subdermal needle
electrodes[K130136] |
|----------------|---------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Name | Technomed EEG /
EMG needle electrodes | Xian Friendship
Subdermal Needle
Electrodes | Carefusion 209, Inc.
TECA™ ELITE
Disposable Concentric
Needles | Disposable monopolar
needle electrode.
Disposable subdermal
needle electrode |
| Device class | Class II | Class II | Class II | Same |
| Product code | IKT and GXZ | GXZ | IKT | IKT and GXZ |
| Device type | Disposable needle
electrode | Disposable subdermal
needle electrode | Disposable concentric
needle | Disposable monopolar
needle electrode.
Disposable subdermal
needle electrode |
Comparison to predicates:
2
| Indications for use | Technomed Europe
diagnostic needle
electrodes are intended
to be inserted in the
subdermal muscle or
nerve tissue only to
sense bio-electric,
EMG or EEG, signals
distally, and will
proximal be connected
to:
Electromyography/electroencephalogram
recording equipment | 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
nervepotential signals
and for stimulation
during the
intraoperative
diagnosis of acute
dysfunction in
corticospinal axonal
conduction. The
electrodes are sterile
and for
single patient use only. | Disposable Concentric
Needles are intended
for use with recording,
monitoring and
stimulation/recording
equipment for the
stimulation/recording
of biopotential signals
Including
electromyography
(EMG) and nerve
potential signals. | Disposable Monopolar
and Subdermal Needles
are intended for use
with recording,
monitoring and
stimulation/recording
equipment for the
stimulation/recording
of biopotential signals
Including
electromyography
(EMG) and nerve
potential signals. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Target
population | All patients | All patients | All patients | Same |
| Anatomical
sites | Peripheral nerves and
muscles | Peripheral nerves and
muscles | Peripheral nerves and
muscles | Same |
| Where used | Hospital | Hospital | Hospital | Same |
| Device design
• Diameters
• Lengths | Diameters: 0.30mm to
0.60mm
Lengths:25 to 75mm
(monopolar), 13 mm
(straight subdermal) | Diameter: 0.4mm and
0.6mm
Length: 13mm
(subdermal) and 23mm
(corkscrew) | Diameters: 0.30mm to
0.60mm
Lengths: 25mm to
75mm | Diameters: 0.30mm to
0.60mm
Lengths: 25 to 75mm
(monopolar). 7 to 20
mm (subdermal). 23
mm (corkscrew) |
| • Tip
geometry | Tip geometry: front
bevel and pencil tip | Tip geometry: front
bevel | Tip geometry: back
bevel | Tip geometry: front
bevel and pencil tip |
| Recording /
stimulation area | $0.42mm^2$ - $44.5mm^2$ | $16.3mm^2$ - $44.5 mm^2$ | $0.025mm^2$ - $0.068mm^2$ | Same as K990015 |
| Electrode
materials | Stainless steel | Stainless steel | Stainless steel, Pt/Ir or
W | Stainless steel, Pt/Ir |
| Coatings | PTFE | n/a | Polyesterimide and low
friction lubricant | Same as K990015 |
| Cables | PVC insulated tin
plated copper lead wire | PVC insulated tin
plated copper lead wire | Detachable reusable
cable | Same as K990015 |
| Connectors | DIN 42802 1.5mm
touch proof | DIN 42802 Touch
proof connector | 5 pole DIN | Same as K990015 and
K072276 |
| Electrical
insulation | Electrical insulation on
all surfaces not
intended to provide
electrical contact with
the patient and
connection | Electrical insulation on
all surfaces not
intended to provide
electrical contact with
the patient and
connection | Electrical insulation on
all surfaces not
intended to provide
electrical contact with
the patient and
connection | Same |
| Impedance | The stainless steel or the platinum/iridium material used in the subdermal needle is identical to that of the Technomed Europe needle electrodes (K990015). No further biocompatibility testing with the final finished device was determined to be necessary.
Performance testing: Electrical safety and compatibility was verified, including impedance testing. Sterilization validation was confirmed to comply equally as for Technomed Europe devices already released to be legally marketed under K050325, and to conform to all requirements.
Conclusion:
The comparison to the predicate devices demonstrates that the Needle Electrodes are safe and effective for its intended use and are substantially equivalent to the predicate devices.
4
Image /page/4/Picture/0 description: The image shows a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design that resembles an abstract bird or wave-like form.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
July 19, 2013
Technomed Europe c/o Mr. Pierre Vreuls Amerikalaan 71 6199 AE Maastricht Airport The Netherlands
Re: K130136
Trade/Device Name: Disposable Monopolar Needle Electrode and Disposable Subdermal Needle Electrode Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ and IKT Dated: June 6, 2013 Received: June 12, 2013
Dear Mr. Vreuls
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Mr. Pierre Vreuls
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Victor Krauthamer -S
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): _ K130136
Device Name: Disposable Monopolar Needle Electrode and Disposable Subdermal Needle Electrode
Indications For Use:
Needle Electrodes for Neurological purposes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.
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)
Victor Krauthamer -S 2013.07.18 18:26:51 -04'00'
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number _ K130136
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