(182 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Disposable Monopolar and Subdermal Needle Electrodes (K130136), based on the provided 510(k) summary:
This device is a Class II medical device (Needle Electrode, product codes GXZ and IKT) and its approval is based on establishing Substantial Equivalence (SE) to predicate devices, rather than a clinical effectiveness study with strict acceptance criteria often seen in AI/algorithm-driven devices. Therefore, the "acceptance criteria" here refer to meeting the characteristics and performance of the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (based on predicate K990015 and K072276) | Reported Device Performance (K130136) |
|---|---|---|
| Intended Use | Recording, monitoring equipment for the recording of biopotential signals (EEG, EMG, nerve potential signals), and stimulation/recording with stimulation/recording equipment for EMG and nerve potential signals. (Combined from K990015 and K072276, and narrowed down for K112034) | Same as the combined predicate intended uses, specifically: "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." |
| Device Class | Class II | Same (Class II) |
| Product Code | IKT and GXZ (from K990015) and GXZ (from K072276), IKT (from K112034) | Same (IKT and GXZ) |
| Device Type | Disposable needle electrode, disposable subdermal needle electrode, disposable concentric needle. | Disposable monopolar needle electrode, Disposable subdermal needle electrode. (Encompasses types from predicates) |
| Target Population | All patients | Same (All patients) |
| Anatomical Sites | Peripheral nerves and muscles | Same (Peripheral nerves and muscles) |
| Where Used | Hospital | Same (Hospital) |
| Needle Diameters | Monopolar: 0.30mm to 0.60mm (from K990015), Subdermal: 0.4mm and 0.6mm (from K072276) | Diameters: 0.30mm to 0.60mm (matches K990015 and covers K072276) |
| Needle Lengths | Monopolar: 25 to 75mm (from K990015), Subdermal: 13mm (from K990015 and K072276), corkscrew: 23mm (from K072276) | Lengths: 25 to 75mm (monopolar). 7 to 20 mm (subdermal). 23 mm (corkscrew) (covers and falls within range of predicates, with a slight adjustment for subdermal from 13mm to 7-20mm) |
| Tip Geometry | Front bevel and pencil tip (from K990015), Front bevel (from K072276) | Same (Front bevel and pencil tip) |
| Recording/Stim Area | 0.42mm² - 44.5mm² (from K990015), 16.3mm² - 44.5mm² (from K072276) | Same as K990015 (0.42mm² - 44.5mm²) |
| Electrode Materials | Stainless steel (from K990015, K072276), Pt/Ir or W (from K112034) | Stainless steel, Pt/Ir (matches and encompasses predicate materials, excluding W from K112034 which is not critical for SE) |
| Coatings | PTFE (from K990015) | Same as K990015 (PTFE) |
| Cables | PVC insulated tin plated copper lead wire (from K990015, K072276) | Same as K990015 (PVC insulated tin plated copper lead wire) |
| Connectors | DIN 42802 1.5mm touch proof (from K990015), DIN 42802 Touch proof connector (from K072276) | Same as K990015 and K072276 (DIN 42802 1.5mm touch proof) |
| Electrical Insulation | Electrical insulation on all surfaces not intended to provide electrical contact with the patient and connection (from K990015, K072276) | Same (Electrical insulation on all surfaces not intended to provide electrical contact with the patient and connection) |
| Impedance | <200kΩ (from K990015), <300kΩ (from K112034) | Same as K990015 (<200kΩ) |
| Sterilization Method | EO ethylene oxide (from K990015, K072276, K112034) | Same (EO ethylene oxide) |
| Sterility Assurance Level (SAL) | 10⁻⁶ (from K990015, K112034) | Same as K990015 (10⁻⁶) |
| Biocompatibility | Identical to predicate in formulation, processing, sterilization, no other chemicals (for monopolar); identical to predicate in material (for subdermal). | Met: "The stainless steel monopolar needle with the polytetrafluoroethylene coating is identical to the Technomed Europe disposable hypodermic needles (K062437) in formulation, processing, sterilization, and no other chemicals have been added... The stainless steel or the platinum/iridium material used in the subdermal needle is identical to that of the Technomed Europe needle electrodes (K990015)." |
| Electrical Safety | Verified, including impedance testing consistent with predicates. | Met: "Electrical safety and compatibility was verified, including impedance testing." (Reported as compliant with predicate K990015's <200kΩ) |
| Sterilization Validation | Complies with requirements (for K050325 standard). | Met: "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." (Reported as 10⁻⁶ SAL, same as K990015) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of evaluating statistical performance on a test set of data. This submission is for a physical medical device, not an AI/software algorithm.
- Data Provenance: Not applicable. Performance was demonstrated through engineering and manufacturing testing, and comparison of physical and functional characteristics to legally marketed predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The approval is based on substantial equivalence to existing devices through direct comparison of features and performance tests, not on expert consensus or clinical evaluation of diagnostic interpretations.
4. Adjudication method for the test set:
- Not applicable.
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:
- Not applicable. This device is a passive electrode, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- The "ground truth" in this context is the established safety and effectiveness of the predicate devices (K990015, K050325, K062437, K112034, K072276). The new device is substantially equivalent if its characteristics and performance fall within acceptable limits or are identical to those predicates. This "ground truth" is established through:
- Direct comparison of technical specifications: Dimensions, materials, coatings, electrical properties, sterilization methods.
- Performance testing: Electrical safety, impedance, and sterilization validation (demonstrating it works as intended and is sterile).
- Biocompatibility assessment: Justification based on identical materials and manufacturing processes to already approved devices.
8. The sample size for the training set:
- Not applicable. This is not an AI/algorithm-driven device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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| 510(k) Summary | |
|---|---|
| Manufacturer: | Technomed EuropeAmerikalaan 716199 AE Maastricht AirportThe NetherlandsJUL 1 9 2013 |
| Submitted by: | Technomed EuropeAmerikalaan 716199 AE Maastricht AirportThe NetherlandsTel.: (+31) 43-408 6868Fax: (+31) 43-408 6888 |
| Contact person: | Mr. Pierre VreulsManager Regulatory Affairs and Quality AssuranceE-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 CFRsection 882.1350 product code GXZ and section 890.1385product code IKT (diagnostic electromyograph needleelectrode). |
| Legally MarketedPredicate Devices: | K990015: Technomed Europe Needle ElectrodesK050325: Technomed Europe Disposable Concentric Probe.Disposable Bipolar Probe, Disposable Monopolar ProbeK062437: Technomed Europe Disposable HypodermicEMG Needle ElectrodeK112034: Carefusion 209. Inc. TECA™ ELITE DisposableConcentric NeedlesK072276: Xian Friendship Electronics Co., Ltd., SubdermalNeedle Electrodes |
| Device description: | Needle Electrodes are passive devices used for recording,monitoring and stimulation during EEG, EMG, nerveconducting studies and IONM. The Needle Electrodes have |
.......
510(k) Summary
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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 devicedisposable needleelectrode EEG / EMG[K990015] | Predicate deviceSubdermal NeedleElectrodes[K072276] | Predicate devicedisposable concentricneedles [K112034] | Disposable monopolarand subdermal needleelectrodes[K130136] |
|---|---|---|---|---|
| Name | Technomed EEG /EMG needle electrodes | Xian FriendshipSubdermal NeedleElectrodes | Carefusion 209, Inc.TECA™ ELITEDisposable ConcentricNeedles | Disposable monopolarneedle electrode.Disposable subdermalneedle electrode |
| Device class | Class II | Class II | Class II | Same |
| Product code | IKT and GXZ | GXZ | IKT | IKT and GXZ |
| Device type | Disposable needleelectrode | Disposable subdermalneedle electrode | Disposable concentricneedle | Disposable monopolarneedle electrode.Disposable subdermalneedle electrode |
Comparison to predicates:
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| Indications for use | Technomed Europediagnostic needleelectrodes are intendedto be inserted in thesubdermal muscle ornerve tissue only tosense bio-electric,EMG or EEG, signalsdistally, and willproximal be connectedto:Electromyography/electroencephalogramrecording equipment | Subdermal NeedleElectrodes are intendedfor use with recording,monitoring andstimulation/recordingequipment for therecording ofbiopotential signals,includingelectroencephalograph(EEG),electromyograph(EMG) andnervepotential signalsand for stimulationduring theintraoperativediagnosis of acutedysfunction incorticospinal axonalconduction. Theelectrodes are sterileand forsingle patient use only. | Disposable ConcentricNeedles are intendedfor use with recording,monitoring andstimulation/recordingequipment for thestimulation/recordingof biopotential signalsIncludingelectromyography(EMG) and nervepotential signals. | Disposable Monopolarand Subdermal Needlesare intended for usewith recording,monitoring andstimulation/recordingequipment for thestimulation/recordingof biopotential signalsIncludingelectromyography(EMG) and nervepotential signals. |
|---|---|---|---|---|
| Targetpopulation | All patients | All patients | All patients | Same |
| Anatomicalsites | Peripheral nerves andmuscles | Peripheral nerves andmuscles | Peripheral nerves andmuscles | Same |
| Where used | Hospital | Hospital | Hospital | Same |
| Device design• Diameters• Lengths | Diameters: 0.30mm to0.60mmLengths:25 to 75mm(monopolar), 13 mm(straight subdermal) | Diameter: 0.4mm and0.6mmLength: 13mm(subdermal) and 23mm(corkscrew) | Diameters: 0.30mm to0.60mmLengths: 25mm to75mm | Diameters: 0.30mm to0.60mmLengths: 25 to 75mm(monopolar). 7 to 20mm (subdermal). 23mm (corkscrew) |
| • Tipgeometry | Tip geometry: frontbevel and pencil tip | Tip geometry: frontbevel | Tip geometry: backbevel | Tip geometry: frontbevel 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 |
| Electrodematerials | Stainless steel | Stainless steel | Stainless steel, Pt/Ir orW | Stainless steel, Pt/Ir |
| Coatings | PTFE | n/a | Polyesterimide and lowfriction lubricant | Same as K990015 |
| Cables | PVC insulated tinplated copper lead wire | PVC insulated tinplated copper lead wire | Detachable reusablecable | Same as K990015 |
| Connectors | DIN 42802 1.5mmtouch proof | DIN 42802 Touchproof connector | 5 pole DIN | Same as K990015 andK072276 |
| Electricalinsulation | Electrical insulation onall surfaces notintended to provideelectrical contact withthe patient andconnection | Electrical insulation onall surfaces notintended to provideelectrical contact withthe patient andconnection | Electrical insulation onall surfaces notintended to provideelectrical contact withthe patient andconnection | Same |
| Impedance | <200kΩ | Unknown | <300kΩ | Same as K990015 |
.
:
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| Sterilizationmethod | EO ethylene oxide | EO ethylene oxide | EO ethylene oxide | EO ethylene oxide |
|---|---|---|---|---|
| Sterilityassurance level(SAL) | $10^{-6}$ | Unknown | $10^{-6}$ | Same as K990015 |
| Manufacturers | Technomed Europe | Xian Friendship | CareFusion | Technomed Europe |
Biocompatibility: The stainless steel monopolar needle with the polytetrafluoroethylene coating is identical to the Technomed Europe disposable hypodermic needles (K062437) in formulation, processing, sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents). No further biocompatibility testing with the final finished device was determined to be necessary.
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.
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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
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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
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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
Page 1 of 1
§ 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).