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 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.

AI/ML Overview

This document describes the premarket notification for Bio Protech, Inc.'s Disposable Concentric Needle Electrodes, Disposable Monopolar Needle Electrodes, Disposable EP Needle Electrodes, and Disposable Hypodermic Needle Electrodes. The submission seeks to demonstrate substantial equivalence to legally marketed predicate devices.

Acceptance Criteria and Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it relies on demonstrating similar performance characteristics to predicate devices and adherence to relevant standards. The "Substantial Equivalence Chart" (Pages 5-7) directly compares the new device with predicate devices across various characteristics.

For "Performance", the report states:

Acceptance Criteria (Implied): Equivalent penetration and friction force to predicate devices, and electrical properties conforming to DIN 13097. Assurance of functionality during the shelf life through aging tests. Optimal bevel and burr for sharpening, and electrical continuity and isolation of all poles.
Reported Device Performance:
- 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."
- Disposable Hypodermic Needle electrodes (under the "Performance" row for Concentric, but appears to relate to Hypodermic based on context within the table): "Sharpening; Camera visual examination with special attention to bevel and burrs; Electrical continuity and isolation of all poles;"
- Disposable Monopolar Needle electrodes / EP Needle electrodes: "Sharpening; Camera visual examination with special attention to bevel and burrs; Electrical continuity and isolation of all poles;"

The overall conclusion states: "The result of testing shows that the electrodes are as safe, effective and perform at least as the legally marketed device."

Summary of Studies and Information:

Table of Acceptance Criteria and Reported Device Performance:

Feature/Test	Acceptance Criteria (Implied/Predicate Match)	Reported Device Performance (Bio Protech Needle Electrodes)
Penetration and Friction Force	Equivalent to predicate devices (according to DIN 13097 for Concentric/Hypodermic, unknown for Monopolar/EP as predicate performance is "Unknown")	Tested for penetration and friction force according to DIN 13097. Results show the electrodes are "as safe, effective and perform at least as the legally marketed device."
Electrical Properties	Conforms to DIN 13097 (for Concentric). Electrical continuity and isolation of all poles (for Hypodermic/Monopolar/EP).	Tested for electrical properties (according to DIN 13097) for Concentric. Sharpening; Camera visual examination with special attention to bevel and burrs; Electrical continuity and isolation of all poles for Hypodermic/Monopolar/EP.
Shelf-Life	Functionality during shelf life (implied by predicate's aging tests). Specific duration for predicates: 60 months (BIONEN Concentric), Unknown (Technomed, Axon).	Accelerated aging testing conducted according to ASTM F 1980. Test results indicate a shelf-life of 3 years.
Sterility	EO sterilization or Gamma irradiation (predicate dependent).	EO sterilization. Passed EO residual testing per ISO 10993-7: 2008.
Biocompatibility	Appropriate levels of biocompatibility (based on ISO 10993-1).	Evaluations performed for cytotoxicity (ISO MEM elution), intracutaneous reactivity, Guinea pig maximization sensitization, acute systemic toxicity, material-mediated pyrogenicity (rabbit), and hemolysis (based on ISO 10993-1).
Electrical Safety	"Touch-proof" safety connector, not pluggable into AC power outlet, cannot contact hazardous voltage.	The "touch-proof" safety connector is specifically designed so that it cannot be plugged into an 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.
Materials	(Matches predicate materials: Stainless Steel, Silver/Platinum/Stainless Steel sensor, ABS/PE Hub, Epoxy Insulator, PELD Plastic protector, etc.)	Stainless Steel cannula, silver, ABS Hub, Epoxy Insulator, PELD Plastic protector, Stainless steel / gold plated connection (Concentric). Stainless steel cannula, ABS Hub, PELD Plastic protector, stainless steel/gold plated connection, lead wire (Hypodermic). Stainless Steel (Monopolar/EP).
Dimensions	(Similar to predicate dimensions)	Concentric: Diameter 0.30/0.45/0.36/0.65mm, L=25-30-38-50-75mm. Hypodermic: Diameter 0.30/0.40/0.45/0.65mm, L=25-37-40-50-75mm. Monopolar/EP: Diameter 0.36/0.45mm, L=25-37-50-75mm; Diameter 0.40mm, L=12mm.
Indications for Use / Anatomical Sites / Where Used	Functionally equivalent to predicates.	Demonstrated to be equivalent to BIONEN s.a.s. (K092973), Technomed Europe (K130136), and Axon System, Inc. (K050194) for their respective types of needle electrodes.

Sample size used for the test set and the data provenance:
- The document does not specify the sample sizes used for the bench testing (penetration, friction force, electrical properties, aging, EO residual, biocompatibility).
- Data Provenance: The accelerated aging testing was conducted by KTR (Korea Testing and Research Institute). Biocompatibility evaluations were performed for manufactured and sterilized Bio Protech electrodes. The provenance of the specific test samples (e.g., country of manufacture) is not detailed beyond the company's location in Republic of Korea. All testing appears to be prospective testing of the Bio Protech device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the studies are bench performance and material characterization tests, not studies requiring expert interpretation of medical images or patient data to establish ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable as the studies are bench performance and material characterization tests, not studies requiring adjudication of medical interpretations.
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:
- No MRMC or comparative effectiveness study involving human readers or AI assistance was conducted or described in this document. This device is a disposable needle electrode, not an imaging or diagnostic AI device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was conducted. This device is a physical medical device (needle electrodes), not an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance testing, the "ground truth" or reference was based on established industry standards (e.g., DIN 13097 for mechanical and electrical properties, ASTM F 1980 for aging, ISO 10993 for biocompatibility, ISO 10993-7 for EO residuals) and direct comparison to the performance characteristics of the legally marketed predicate devices.
The sample size for the training set:
- This question is not applicable as there is no mention of a training set or an algorithm in this submission.
How the ground truth for the training set was established:
- This question is not applicable as there is no mention of a training set or an algorithm in this submission.

Summary

{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.

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 needleelectrodes	K130136
Axon System, Inc.	Subdermal Needle Electrodes, Twisted Pair NeedleElectrodes, 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:

{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
Indicationsfor use	DisposableConcentricneedleelectrodes	Disposable Concentric Needleelectrodes are sterile electrodesindicated for recording muscleactivity for Electromyography(EMG) applications. Theelectrodes are for single patientuse only	The BIONEN DisposableConcentric Needle electrodesare sterile electrodes indicatedfor recording muscle activity forElectromyography (EMG)applications. The electrodes arefor single patient use only.
	DisposableHypodermicNeedleelectrodes	Disposable Hypodermic Needleelectrodes are sterile electrodesindicated for injection ofBotulium Toxin while recordingmuscle activity withElectromyography (EMG)applications. The electrodes arefor single patient use only.	The BIONEN DisposableMonopolar Needle electrodesare sterile electrodes indicatedfor injection of Botulium Toxinwhile recording muscle activitywith Electromyography (EMG)applications. The electrodes arefor single patient use only.
Anatomicalsites	DisposableConcentricneedleelectrodes	Subdermal, muscle or nervetissue	Subdermal, muscle or nervetissue
	HypodermicNeedleelectrodes	Muscle	Muscle
Whereused(hospital,home,ambulance, etc)	DisposableConcentricneedleelectrodes	Electrode preparation andapplication should be supervisedby a qualified healthcareprofessional.	Electrode preparation andapplication should be supervisedby a qualified healthcareprofessional.
	DisposableHypodermicNeedleelectrodes	Electrode preparation andapplication should be supervisedby a qualified healthcareprofessional. The specific Botox®type to be injected must bechosen by the physician.	Electrode preparation andapplication should be supervisedby a qualified healthcareprofessional. The specific Botox®type to be injected must bechosen by the physician.
Design	DisposableConcentricneedleelectrodes	Ergonomic connector andgeometric sharper tip. Color-coded hub	Ergonomic connector andgeometric sharper tip. Color-coded hub
Product characteristics		Needle electrodes	Needle electrodes
	Manufacturer	Bio Protech Inc.	BIONEN s.a.s.
	DisposableHypodermicNeedleelectrodes	Ergonomic connector andgeometric sharper tip. Thedisposable Monopolar Needleelectrode consists of a stainlesssteel cannula electricallyinsulated with a PTFE coating,except for the lancet point andthe inner surface of the tube.The coating is to ensure easyskin penetration and to ensureelectrical insulation on the entirecannula, except for the point. Ahusk fitting together with a wirewith connection to an extensioncable has been attached to thecannula. This cable will enablethe electrical signal to betransferred to a stimulating orrecording device.	Ergonomic connector andgeometric sharper tip. Thedisposable Monopolar Needleelectrode consists of a stainlesssteel cannula electricallyinsulated with a PTFE coating,except for the lancet point andthe inner surface of the tube.The coating is to ensure easyskin penetration and to ensureelectrical insulation on the entirecannula, except for the point. Ahusk fitting together with a wirewith connection to an extensioncable has been attached to thecannula. This cable will enablethe electrical signal to betransferred to a stimulating orrecording device.
	DisposableConcentricneedleelectrodes	Tested for penetration andfriction force and electricalproperties (according to DIN13097). Ageing tests areperformed to verify and ensurethe functionality during the shelflife of the product.	Tested for penetration andfriction force and electricalproperties (according to DIN13097). Ageing tests areperformed to verify and ensurethe functionality during the shelflife of the product.
	DisposableHypodermicNeedleelectrodes	Sharpening; Camera visualexamination with specialattention to bevel and burrs;Electrical continuity and isolationof all poles;	Sharpening; Camera visualexamination with specialattention to bevel and burrs;Electrical continuity and isolationof all poles;
Standards met		IEC 60601-1ISO 10993-1ISO 10993-10ISO 10993-5ISO 11137ISO 11607-1(compliable withUNI EN 11607-1)ASTM F88(compliable with UNIEN 868-5)	IEC 60601-1ISO 10993-1ISO 10993-10ISO 10993-5ISO 11137UNI EN 11607-1UNI EN 868-5
Materials	DisposableConcentricNeedleelectrode	Stainless Steel cannula, silver,ABS Hub, Epoxy Insulator,PELD Plastic protector, Stainlesssteel / gold plated connection	Stainless Steel cannula,Platinum / Stainless Steelsensor, Polyethylene(PE) Hub,Epoxy Insulator, PELD Plasticprotector, Stainless steel / goldplated connection
	DisposableHypodermicNeedleelectrode	Stainless steel cannula, ABSHub, PELD Plastic protector,stainless steel/gold platedconnection, lead wire	Stainless steel cannula,polyethylene (PE) Hub, PELDPlastic protector, stainlesssteel/gold plated connection,lead wire
Dimensions	DisposableConcentricNeedleelectrode	Diameter0.30/0.45/0.36/0.65mmL=25-30-38-50-75mm	Diameter = 0.45/0.35mmL=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.
DisposableHypodermicNeedleelectrode	Diameter0.30/0.40/0.45/0.65mmL=25-37-40-50-75mm	Diameter = 0.50mmL=20-30-40-50-60mm
RecordingareaDisposableConcentricNeedleelectrode	0.02-0.07mm²	0.02-0.07mm²
ConnectorcableDisposableConcentricNeedleelectrode	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	DisposableNeedle electrodes / EPelectrodes(CorkscrewNeedle electrode)	Disposablemonopolarand subdermalneedle electrodes	SubdermalElectrodes,Twisted PairElectrodesCorkscrew(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	Disposablemonopolarneedleelectrode,disposablesubdermalneedle electrode	Subdermalelectrode
Regulation number	882.1350 / 890.1385	882.1350 / 890.1385	882.1350
Product characteristics	Disposable MonopolarNeedle electrodes / EPNeedle electrodes(CorkscrewNeedle electrode)(spiral)	Disposable monopolarand subdermal needleelectrodes	Subdermal NeedleElectrodes,Twisted Pair NeedleElectrodesCorkscrew(spiral)Needle Electrode
Manufacturer	Bio Protech Inc.	Technomed Europe	Axon System, Inc.
Indications for use	Disposable MonopolarNeedle electrodes / EPNeedle electrodes aresterile electrodes indicatedfor recording muscleactivity forElectromyography (EMG)and/orElectroencephalography(EEG) applications. Theelectrodes are for singlepatient use only.	Disposable Monopolar andSubdermal Needles areintended for use withrecording, monitoring andstimulation/recordingequipment for thestimulation/recording ofbiopotential signalsincludingelectromyography(EMG)and nerve potential signals	Axon System/s SubdermalNeedle Electrodes areintended for use withrecording, monitoring andstimulation/recordingequipment for therecording of biopotentialsignals includingelectroencephalograph(EEG),electromyography(EMG)and nerve potential signalsand for stimulation duringthe intraoperativediagnosis of acutedysfuction in corticospinalaxonal conduction
Anatomical sites	Subdermal, muscle ornerve tissue	Peripheral nerves andmuscle	Subdermal
Where used(hospital, home,ambulance, etc)	Electrode preparation andapplication should besupervised by a qualifiedhealthcare professional.	Hospital	Use by a licensedphysician or technologistunder the supervision of aphysician.
Design	Ergonomic connector andgeometric sharper tip.Color-coded hub	UnknownTip Geometry: Front beveland pencil tip	Unknown
Performance	Sharpening; Cameravisual examination withspecial attention to beveland burrs; Electricalcontinuity and isolation ofall poles;	Unknown	Unknown
Standards met	IEC 60601-1ISO 10993-1ISO 10993-10ISO 10993-5ISO 11137ISO 11607-1(compliablewith UNI EN 11607-1)ASTM F88(compliablewith UNI EN 868-5)	Unknown	Unknown
Materials	Stainless Steel	Stainless Steel, Pt/Ir	Stainless steel needle
Dimensions	Diameter = 0.36/0.45mmL=25-37-50-75mDiameter = 0.40mmL=12mm	Diameter = 0.30~~0.65mmL=25~~75mm(monopolar))7~20mm(subdermal)23mm(corkscrew)Diameter = 0.40mmL=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 ElectrodesCorkscrew 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.

Regulation Number and Section

§ 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).