(238 days)
Not Found
No
The device description and intended use focus solely on the physical characteristics and function of disposable needle electrodes for recording biopotentials. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
No.
The devices are indicated for recording muscle activity or biopotentials, not for treating a disease or condition. The hypodermic needle electrode is indicated for injection, but the device itself is not providing the therapy.
Yes
The devices are electrodes intended for recording muscle activity (EMG) and/or brain activity (EEG), which are diagnostic applications used to assess the function of the neuromuscular system or brain. Additionally, one type of electrode mentions its use for "recording muscle activity for Electromyography (EMG) applications" while another explicitly states "examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles", both of which are diagnostic processes.
No
The device description clearly details physical hardware components (stainless steel cannula, inner conductor, insulation layer, lead wire, safety connector, hypodermic needle) and their function in recording biopotential signals. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The described electrodes are inserted into the body (subdermal, muscle, or nerve tissue) to record electrical activity (EMG and/or EEG) or for the injection of medication while recording activity. This is an in vivo (within the living body) application, not an in vitro application.
- Intended Use: The intended uses clearly state recording muscle activity for EMG and/or EEG applications, and for injecting medication while recording EMG. These are all procedures performed directly on the patient.
The device is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / 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 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.
Product codes
IKT, GXZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Subdermal, muscle or nerve tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Electrode preparation and application should be supervised by a qualified healthcare professional.
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
Performance Testing Bench: Needle electrodes of Bio Protech are tested for verifying the substantial equivalence of penetration and friction force according to DIN 13097. Bio Protech Needle electrodes were tested for comparing the penetration and friction force performance of the Bio Protech Needle electrodes against the predicate devices.
The result of testing shows that the electrodes are as safe, effective and perform at least as the legally marketed device.
Performance Testing Animal: Animal testing is not required for this device.
Performance Testing Clinical testing is not required for this device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.1385 Diagnostic electromyograph needle electrode.
(a)
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).(b)
Classification. Class II (performance standards).
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 = 0.300.65mm75mm
L=25
(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 |
8
9
Technological Characteristics
Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor that can be 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 Electrode has a plastic (ABS) ergonomic hub.
Disposable Monopolar Needle Electrode / EP Needle Electrode consist of a formed stainless steel needle with a lead wire attached and Disposable Monopolar Needle Electrode (Non-wired model) can be connected with dettachable cable for use. The lead wire terminates in a safety connector that cannot be connected to an AC power outlet.
Disposable Hypodermic Needle Electrode consists of a hypodermic stainless steel needle with an open lumen and a lead wire attached. The Stainless steel cannula is coated by Teflon (PTFE) for low friction. The lead wire terminates in a safety connector that cannot be connected in a AC power outlet.
10
Sterility and Shelf Life Testing:
The typical samples passed accelerated aging testing conducted by KTR (Korea Testing and Research Institute) according to ASTM F 1980, "Accelerated aging of sterile barrier systems for medical devices"; FDA recognition number 14-355. The test results indicate the products conducted reliability of shelf-life of 3 years.
The method of sterilization for Needle Electrodes is EO sterilization.
Accelerated aging tests were conducted according to ASTM F 1980, "Accelerated aging of sterile barrier systems for medical devices." The test results indicate the Needle Electrodes has a shelf-life of 3 years.
The Needle Electrodes passed EO residual testing performed according to ISO 10993-7: 2008 Ethylene Oxide Residuals.
Biocompatibility Testing:
Biocompatibility evaluations of manufactured and sterilized Bio Protech electrodes were performed for cytotoxicity (ISO MEM elution), intracutaneous reactivity, Guinea pig maximization sensitization, acute systemic toxicity, material-mediated pyrogenicity (rabbit), and hemolysis.
Safety and Effectiveness Testing:
Performance Testing Bench:
Needle electrodes of Bio Protech are tested for verifying the substantial equivalence of penetration and friction force according to DIN 13097. Bio Protech Needle electrodes were tested for comparing the penetration and friction force performance of the Bio Protech Needle electrodes against the predicate devices.
The result of testing shows that the electrodes are as safe, effective and perform at least as the legally marketed device.
Performance Testing Animal: Animal testing is not required for this device.
Performance Testing Clinical testing is not required for this device.
Conclusion:
Needle electrodes of Bio Protech are substantially equivalent to the predicate devices in indications for use, materials and design. The Needle electrodes can be considered the adequate needle electrodes in regard to safety and effectiveness.