Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes

Q: Who is the manufacturer of Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes?

Bio Protech, Inc. filed the 510(k) submission for Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes (K152984).

Q: What is the FDA product code for Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes?

IKT. It is classified under 21 CFR 890.1385 as a Class 2 device in the Physical Medicine panel.

Q: What is the regulatory pathway for Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes?

Disposable Concentric Needle electrodes (K092973); Disposable Monopolar Needle electrodes / Subdermal Needle electrodes (K092973); Disposable Monopolar Needle electrodes (K092973); Disposable monopolar and subdermal needle electrodes (K130136); Subdermal Needle Electrodes, Twisted Pair Needle Electrodes, Corkscrew (spiral) Needle Electrode (K050194).

Q: Who can help prepare an FDA 510(k) submission like Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K152984 · Bio Protech, Inc. · IKT · Jun 3, 2016 · Physical Medicine

Device Facts

Record ID	K152984
Device Name	Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
Applicant	Bio Protech, Inc.
Product Code	IKT · Physical Medicine
Decision Date	Jun 3, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.1385
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electromyography (EMG) applications. The electrodes are for single patient use only. Disposable Monopolar Needle electrodes / EP Needle electrodes indicated for recording muscle activity for Electromyography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only. Disposable Hypodermic Needle electrodes indicated for injection of Botulium Toxin while recording muscle activity with Electromyography (EMG) applications. The electrodes are for single patient use only.

Device Story

Needle electrodes (concentric, monopolar, EP, hypodermic) function as passive sensors for biopotential signals; inputs are electrical signals from muscle or nerve tissue; device transmits signals via lead wires to external EMG/EEG recording equipment; hypodermic variant includes lumen for Botulinum Toxin injection; used in clinical settings by qualified healthcare professionals; output is raw electrical signal displayed on recording equipment; aids clinicians in neuromuscular system examination or targeted toxin delivery; benefits include diagnostic data acquisition and precise therapeutic injection.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via penetration and friction force testing per DIN 13097. Biocompatibility testing performed per ISO 10993 (cytotoxicity, sensitization, systemic toxicity, pyrogenicity, hemolysis). Sterility validated per ISO 11137 and EO residuals per ISO 10993-7. Shelf-life of 3 years validated via accelerated aging per ASTM F1980.

Technological Characteristics

Stainless steel cannula; silver inner conductor (concentric); PTFE coating (hypodermic); ABS hub; epoxy insulator. Connectivity via lead wires with DIN 42802 touch-proof safety connectors. EO sterilization. Standards: IEC 60601-1, ISO 10993, ASTM F88, DIN 13097.

Indications for Use

Indicated for patients requiring EMG or EEG recording, or Botulinum Toxin injection with EMG monitoring. Used for recording muscle activity or biopotential signals from subdermal, muscle, or nerve tissue. Single patient use only.

Regulatory Classification

Identification

A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).

Predicate Devices

Disposable Concentric Needle electrodes (K092973)
Disposable Monopolar Needle electrodes / Subdermal Needle electrodes (K092973)
Disposable Monopolar Needle electrodes (K092973)
Disposable monopolar and subdermal needle electrodes (K130136)
Subdermal Needle Electrodes, Twisted Pair Needle Electrodes, Corkscrew (spiral) Needle Electrode (K050194)

Related Devices

K091410 — DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, · Spes Medica Srl · Aug 11, 2009
K092973 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE · Bionen S.A.S. · Oct 7, 2010
K973444 — TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES · Medelec, Inc. D.B.A. Teca Corp. · Nov 20, 1997
K232581 — Medical Disposable Sterile Needle Electrode · Suzhou Haishen Medical Device Associates Co., Ltd. · Dec 4, 2023
K062437 — DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED · Technomed Europe · Feb 16, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with a flowing design element below them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 3, 2016 Bio Protech, Inc. % Kevin Han Manager Bio Protech Usa, Inc. 2601 Walnut Ave Tustin, California 92780 Re: K152984 Trade/Device Name: Disposable Concentric Needle Electrodes, Disposable Monopolar Needle Electrodes, Disposable EP Needle Electrodes, Disposable Hypodermic Needle Electrodes Regulation Number: 21 CFR 890.1385 Regulation Name: Diagnostic electromyograph needle electrode Regulatory Class: Class II Product Code: IKT, GXZ Dated: October 8, 2015 Received: October 9, 2015 Dear Mr. Han: 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 {1}------------------------------------------------ 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 (reporting of medical devicerelated adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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, Michael J. Hoffmann -A for Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K152984 Device Name Disposable Concentric Needle electrodes, Disposable Hypodermic Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes #### Indications for Use (Describe) Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electromyography (EMG) applications. The electrodes are for single patient use only. Disposable Monopolar Needle electrodes / EP Needle electrodes indicated for recording muscle activity for Electromyography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only. Disposable Hypodermic Needle electrodes indicated for injection of Botulium Toxin while recording muscle activity with Electromyography (EMG) applications. The electrodes are for single patient use only. Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## SECTION 10 - 510(k) Summary ### SPONSOR: Bio Protech, Inc. Donghwa Medical Instrument Complex, 151-3, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, 200-801, Republic of Korea Company Contact Person: Kevin Han Official Correspondent: Judy Burton, Advena USA Telephone: (972) 243-5105 Date Summary Prepared: April 7, 2016 ### NEW DEVICE: ### Proprietary/Trade Name: Disposable Concentric Needle electrodes / Disposable Hypodermic Needle electrodes Disposable Monopolar Needle electrodes / Disposable EP Needle electrodes Common/Usual Name: Needle Electrodes #### Classification Name: Electrode, Needle, Diagnostic Electromyograph (21 CFR 890.1385, Product Code: IKT) Electrode, Needle (21 CFR 882.1350, Product Code: GXZ) Device Class: Class II #### PREDICATE DEVICES: | Manufacturer | Trade Name or Model Name | 510(k) Number | |-------------------|-----------------------------------------------------------------------------------------------------|---------------| | Bionen S.A.S | Disposable Concentric Needle electrodes | K092973 | | | Disposable Monopolar Needle electrodes / Subdermal Needle electrodes | | | | Disposable Monopolar Needle electrodes | | | Technomed Europe | Disposable monopolar and subdermal needle electrodes | K130136 | | Axon System, Inc. | Subdermal Needle Electrodes, Twisted Pair Needle Electrodes, Corkscrew (spiral) Needle Electrode | K050194 | {4}------------------------------------------------ ### Indications for Use: Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electromyography (EMG) applications. The electrodes are for single patient use only. Disposable Monopolar Needle electrodes / EP Needle electrodes are sterile electrodes indicated for recording muscle activity for Electromyography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only. Disposable Hypodermic Needle electrodes are sterile electrodes indicated for injection of Botulium Toxin while recording muscle activity with Electromyography (EMG) applications. The electrodes are for single patient use only. ### Device Description: The Bio Protech Disposable Concentric Needle Electrode is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles. Bio Protech Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor of silver. Between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction lubricant. The Bio Protech Disposable Monopolar / EP Needle Electrode is intended to be inserted in the subdermal, muscle or nerve tissue for use with recording equipment for the recording of biopotentials signals, EEG or EMG, and proximally connected to electromyography / Electroencephalogram recording equipment. The electrodes consist of a formed stainless steel needle with a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage. The Bio Protech Disposable Hypodermic Needle Electrode is intended to be inserted in the muscle while recording electromyography activity, and proximally connected to electromyography recording equipment. The electrodes consist of an hypodermic stainless steel needle with an open lumen and a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage. {5}------------------------------------------------ ## Substantial Equivalence Chart: Compared to the predicate, the subject devices have intended use, similar physical and performance characteristics and manufactured using similar process. | Product characteristics | | Needle electrodes | Needle electrodes | |-------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | | Bio Protech Inc. | BIONEN s.a.s. | | 510k number | | K152984 | K092973 | | Device class | | Class II | Class II | | Product code | | IKT, GXZ | IKT, GXZ | | Device type | | Needle electrode | Needle electrode | | Regulation number | | 882.1350 / 890.1385 | 882.1350 / 890.1385 | | Indications for use | Disposable Concentric needle electrodes | Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electromyography (EMG) applications. The electrodes are for single patient use only | The BIONEN Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electromyography (EMG) applications. The electrodes are for single patient use only. | | | Disposable Hypodermic Needle electrodes | Disposable Hypodermic Needle electrodes are sterile electrodes indicated for injection of Botulium Toxin while recording muscle activity with Electromyography (EMG) applications. The electrodes are for single patient use only. | The BIONEN Disposable Monopolar Needle electrodes are sterile electrodes indicated for injection of Botulium Toxin while recording muscle activity with Electromyography (EMG) applications. The electrodes are for single patient use only. | | Anatomical sites | Disposable Concentric needle electrodes | Subdermal, muscle or nerve tissue | Subdermal, muscle or nerve tissue | | | Hypodermic Needle electrodes | Muscle | Muscle | | Where used (hospital, home, ambulance , etc) | Disposable Concentric needle electrodes | Electrode preparation and application should be supervised by a qualified healthcare professional. | Electrode preparation and application should be supervised by a qualified healthcare professional. | | | Disposable Hypodermic Needle electrodes | Electrode preparation and application should be supervised by a qualified healthcare professional. The specific Botox® type to be injected must be chosen by the physician. | Electrode preparation and application should be supervised by a qualified healthcare professional. The specific Botox® type to be injected must be chosen by the physician. | | Design | Disposable Concentric needle electrodes | Ergonomic connector and geometric sharper tip. Color- coded hub | Ergonomic connector and geometric sharper tip. Color- coded hub | | Product characteristics | | Needle electrodes | Needle electrodes | | | Manufacturer | Bio Protech Inc. | BIONEN s.a.s. | | | Disposable Hypodermic Needle electrodes | Ergonomic connector and geometric sharper tip. The disposable Monopolar Needle electrode consists of a stainless steel cannula electrically insulated with a PTFE coating, except for the lancet point and the inner surface of the tube. The coating is to ensure easy skin penetration and to ensure electrical insulation on the entire cannula, except for the point. A husk fitting together with a wire with connection to an extension cable has been attached to the cannula. This cable will enable the electrical signal to be transferred to a stimulating or recording device. | Ergonomic connector and geometric sharper tip. The disposable Monopolar Needle electrode consists of a stainless steel cannula electrically insulated with a PTFE coating, except for the lancet point and the inner surface of the tube. The coating is to ensure easy skin penetration and to ensure electrical insulation on the entire cannula, except for the point. A husk fitting together with a wire with connection to an extension cable has been attached to the cannula. This cable will enable the electrical signal to be transferred to a stimulating or recording device. | | | Disposable Concentric needle electrodes | Tested for penetration and friction force and electrical properties (according to DIN 13097). Ageing tests are performed to verify and ensure the functionality during the shelf life of the product. | Tested for penetration and friction force and electrical properties (according to DIN 13097). Ageing tests are performed to verify and ensure the functionality during the shelf life of the product. | | | Disposable Hypodermic Needle electrodes | Sharpening; Camera visual examination with special attention to bevel and burrs; Electrical continuity and isolation of all poles; | Sharpening; Camera visual examination with special attention to bevel and burrs; Electrical continuity and isolation of all poles; | | Standards met | | IEC 60601-1 ISO 10993-1 ISO 10993-10 ISO 10993-5 ISO 11137 ISO 11607-1(compliable with UNI EN 11607-1) ASTM F88(compliable with UNI EN 868-5) | IEC 60601-1 ISO 10993-1 ISO 10993-10 ISO 10993-5 ISO 11137 UNI EN 11607-1 UNI EN 868-5 | | Materials | Disposable Concentric Needle electrode | Stainless Steel cannula, silver, ABS Hub, Epoxy Insulator, PELD Plastic protector, Stainless steel / gold plated connection | Stainless Steel cannula, Platinum / Stainless Steel sensor, Polyethylene(PE) Hub, Epoxy Insulator, PELD Plastic protector, Stainless steel / gold plated connection | | | Disposable Hypodermic Needle electrode | Stainless steel cannula, ABS Hub, PELD Plastic protector, stainless steel/gold plated connection, lead wire | Stainless steel cannula, polyethylene (PE) Hub, PELD Plastic protector, stainless steel/gold plated connection, lead wire | | Dimensions | Disposable Concentric Needle electrode | Diameter 0.30/0.45/0.36/0.65mm L=25-30-38-50-75mm | Diameter = 0.45/0.35mm L=25-30-35-40-45-50-65mm | Disposable Concentric Needle electrodes & Disposable Hypodermic Needle electrodes {6}------------------------------------------------ {7}------------------------------------------------ | Product characteristics | Needle electrodes | Needle electrodes | |-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Bio Protech Inc. | BIONEN s.a.s. | | Disposable Hypodermic Needle electrode | Diameter 0.30/0.40/0.45/0.65mm L=25-37-40-50-75mm | Diameter = 0.50mm L=20-30-40-50-60mm | | Recording area Disposable Concentric Needle electrode | 0.02-0.07mm² | 0.02-0.07mm² | | Connector cable Disposable Concentric Needle electrode | DIN 5 poles | DIN 5 poles | | Biocompatibility | Selection of materials, which demonstrate appropriate levels of biocompatibility. Tests on basis of ISO 10993-1 | Selection of materials, which demonstrate appropriate levels of biocompatibility. Tests on basis of ISO 10993-1 | | Compatibility with the environment and other devices | Compatibility is achieved through the connecting cable to EMG/EEG machines or similar physiological recording devices. | Compatibility is achieved through the connecting cable to EMG/EEG machines or similar physiological recording devices. | | Sterility | EO sterilization | Gamma irradiation | | Shelf life | 3 years | 60 months | | Electrical safety | The “touch-proof” safety connector is specifically designed so that is cannot the plugged into AC power outlet and cannot get in touch with possible hazardous voltage | The “touch-proof” safety connector is specifically designed so that is cannot the plugged into AC power outlet and cannot get in touch with possible hazardous voltage | | Mechanical safety | Packaged needle covered with a needle cover. | Packaged needle covered with a needle cover. | | Chemical safety | Not applicable | Not applicable | | Thermal safety | Not applicable | Not applicable | | Radiation safety | Not applicable | Not applicable | # Disposable Monopolar Needle electrodes / EP Needle electrodes | Product characteristics | Disposable Needle electrodes / EP electrodes (Corkscrew Needle electrode) | Disposable monopolar and subdermal needle electrodes | Subdermal Electrodes, Twisted Pair Electrodes Corkscrew (spiral) Needle Electrode | |------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Bio Protech Inc. | Technomed Europe | Axon System, Inc. | | 510k number | K152984 | K130136 | K050194 | | Device class | Class II | Class II | Class II | | Product code | IKT, GXZ | IKT, GXZ | IKT, GXZ | | Device type | Needle electrode | Disposable monopolar needle electrode, disposable subdermal needle electrode | Subdermal electrode | | Regulation number | 882.1350 / 890.1385 | 882.1350 / 890.1385 | 882.1350 | | Product characteristics | Disposable Monopolar Needle electrodes / EP Needle electrodes (Corkscrew Needle electrode) (spiral) | Disposable monopolar and subdermal needle electrodes | Subdermal Needle Electrodes, Twisted Pair Needle Electrodes Corkscrew (spiral) Needle Electrode | | Manufacturer | Bio Protech Inc. | Technomed Europe | Axon System, Inc. | | Indications for use | Disposable Monopolar Needle electrodes / EP Needle electrodes are sterile electrodes indicated for recording muscle activity for Electromyography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only. | 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 | Axon System/s Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the recording of biopotential signals including electroencephalograph(EE G), electromyography(EMG) and nerve potential signals and for stimulation during the intraoperative diagnosis of acute dysfuction in corticospinal axonal conduction | | Anatomical sites | Subdermal, muscle or nerve tissue | Peripheral nerves and muscle | Subdermal | | Where used (hospital, home, ambulance, etc) | Electrode preparation and application should be supervised by a qualified healthcare professional. | Hospital | Use by a licensed physician or technologist under the supervision of a physician. | | Design | Ergonomic connector and geometric sharper tip. Color-coded hub | Unknown Tip Geometry: Front bevel and pencil tip | Unknown | | Performance | Sharpening; Camera visual examination with special attention to bevel and burrs; Electrical continuity and isolation of all poles; | Unknown | Unknown | | Standards met | IEC 60601-1 ISO 10993-1 ISO 10993-10 ISO 10993-5 ISO 11137 ISO 11607-1(compliable with UNI EN 11607-1) ASTM F88(compliable with UNI EN 868-5) | Unknown | Unknown | | Materials | Stainless Steel | Stainless Steel, Pt/Ir | Stainless steel needle | | Dimensions | Diameter = 0.36/0.45mm L=25-37-50-75m Diameter = 0.40mm L=12mm | Diameter = 0.30~0.65mm L=25~75mm (monopolar)) 7~20mm(subdermal) 23mm(corkscrew) Diameter = 0.40mm L=12mm | Diameter = 0.40mm | | Product characteristics | Disposable Monopolar Needle electrodes / EP Needle electrodes (Corkscrew Needle electrode) (spiral) | Disposable monopolar and subdermal needle electrodes | Subdermal Needle Electrodes, Twisted Pair Needle Electrodes Corkscrew Needle Electrode (spiral) | | Manufacturer | Bio Protech Inc. | Technomed Europe | Axon System, Inc. | | Biocompatibility | Selection of materials, which demonstrate appropriate levels of biocompatibility. Tests on basis of ISO 10993-1 | No further biocompatibility testing was determined to be necessary. | Unknown | | Compatibility with the environment and other devices | Compatibility is achieved through the connecting cable to EMG/EEG machines or similar physiological recording devices. | Unknown | Unknown | | Sterility | EO sterilization | EO sterilization | Unknown | | Shelf life | 3 years | Unknown | Unknown | | Electrical safety | The "touch-proof" safety connector is specifically designed so that is cannot the plugged into AC power outlet and cannot get in touch with possible hazardous voltage | Electrical insulation on all surfaces not all surfaces not intended to provide electrical contact with the patient and connection DIN 42802 1.5mm touch proof | The DIN 42802 safety connector is specifically designed so that is cannot the plugged into AC power outlet | | Mechanical safety | Packaged needle covered with a needle cover. | Unknown | Packaged needle covered with a needle cover. | | Chemical safety | Not applicable | Not applicable | Not applicable | | Thermal safety | Not applicable | Not applicable | Not applicable | | Radiation safety | Not applicable | Not applicable | Not applicable…