E-Shield Multi-paired Subdermal Needle Electrodes are intended for use with recording and monitoring equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.

Device Description

E-Shield Multi-paired Subdermal Needle Electrodes are single use, disposable, monopolar, non-pyrogenic and sterilized stainless steel subdermal needle electrodes. Electrodes are applied in the study of biopotentials such as electroencephalograph (EEG), electromyography (EMG). Electrodes are invasive as they are placed subcutaneously or in contact with nerve or muscle tissue. The subdermal needle electrodes can be used to record variety of types of neurological and neurophysiological evoked potentials, including but not limited to electroencephalogram (EEG), electromyogram (EMG) in hospital and clinical setting. It is highly recommended to be used of intra-operative neuromonitoring (IOM). The electrodes consist of a stainless steel needle with a lead wire attached and the lead wires terminate in a safety connector. The electrodes are used under the supervision of a physician. Each sterilized PET box contains 2 sets of 5-paired subdermal needle electrodes and a safety shield attached to each set. The safety shield is used to cover the needle sharps and the multi-paired lead wires are designed in group for easy organizing. Grouped wire cable can be separated into 5 paired lead wires to reach different recording sites of a patient over desired length. For instance, it can be used for the recording in one limb muscle groups.

AI/ML Overview

The manufacturer, NeuroInvent Inc., established acceptance criteria and conducted non-clinical testing to demonstrate that "E-Shield Multi-paired Subdermal Needle Electrodes" meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

Testing Item	Acceptance Criteria (Standard Applied)	Reported Device Performance
Biocompatibility	ISO 10993-5:2009 (Tests for in vitro cytotoxicity) ISO 10993-10:2010 (Tests for irritation and skin sensitization) ISO 10993-11:2009 (Tests for systemic toxicity) ISO 10993-12:2012 (Sample preparation and reference material) ASTM F756-08 (Standard Practice For Assessment Hemolytic Properties Of Materials) USP 35-NF30:2012, <151> Pyrogen Test (USP Rabbit Test) ASTM F750-87 (Reapproved 2012) (Standard Practice For Evaluating Material Extracts By Systemic Injection In The Mouse)	All test results demonstrate the device meets the requirements of its pre-defined acceptance criteria and intended uses.
Sterilization	ISO 10993-7:2008 (Ethylene Oxide sterilization residuals) ISO 11135-1:2007 (Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices) ISO 11135-2:2008 (Ethylene oxide -- Guidance on the application of ISO 11135-1) ISO 11737-1:2006 (Sterilization of Medical Devices - Microbiological Method - Part I: Determination of a population of microorganisms on products) ISO 11737-2:2009 (Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process)	All test results demonstrate the device meets the requirements of its pre-defined acceptance criteria and intended uses.
Shelf Life	ASTM F1980-07 (Standard Guide for Accelerated Aging of Sterile Medical Device Packages) ASTM F88/F88M-09 (Standard Test Method for Seal Strength of Flexible Barrier Materials) ASTM F1140-13 (Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications) ASTM F1929-12 (Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration) ASTM D4332:2001 (Standard practice conditioning containers, packages or packaging components for testing) ASTM F1608 (Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)) ASTM D4169-09 (Standard Practice For Performance Testing Of Shipping Containers And Systems) ISO 11607-1 (Packaging For Terminally Sterilized Medical Devices - Part 1: Requirements For Materials, Sterile Barrier Systems And Packaging Systems) ISO 11607-2 (Packaging For Terminally Sterilized Medical Devices - Part 2: Validation Requirements For Forming, Sealing And Assembly Processes) ASTM F2096-11 (Standard Test Method For Detecting Gross Leaks In Packaging By Internal Pressurization (Bubble Test)) The International Safe Transit Association (ISTA) Procedure 1A	All test results demonstrate the device meets the requirements of its pre-defined acceptance criteria and intended uses.
Electromagnetic Compatibility & Electrical Safety	IEC 60601-1 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance)	All test results demonstrate the device meets the requirements of its pre-defined acceptance criteria and intended uses.
Performance	ISO 9626 First Edition 1991-09-01, Amendment 1 2001-06-01 (Stainless Steel Needle Tubing For The Manufacture Of Medical Devices) ASTM B193-87(1992) (Standard Test Method for Resistivity of Electrical Conductor Materials) IEC 60028 (1925) (International standard of resistance for copper) GB/T 3048.2-2007 (TEST method for electrical properties of electric cables and wire-part2: Test of electrical resistivity of metallic materials)	All test results demonstrate the device meets the requirements of its pre-defined acceptance criteria and intended uses.

2. Sample size used for the test set and the data provenance:

The document does not specify the exact sample sizes for each non-clinical test (e.g., how many electrodes were tested for biocompatibility, sterility, etc.). It only lists the standards to which the tests were conducted.

The data provenance is from non-clinical testing performed by NeuroInvent Inc. There is no mention of patient data or specific geographic origin for the test materials beyond the product being manufactured by a company based in Mountain View, CA, with contact information in Taiwan.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the study involved non-clinical, bench testing rather than studies requiring expert interpretation of patient data to establish ground truth. The acceptance criteria were based on recognized international and national standards for medical devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable as the study involved non-clinical, bench testing. Adjudication methods are typically employed in clinical studies or studies involving human readers to resolve discrepancies in interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical test data was used to support the decision of safety and effectiveness." The device is a physical medical electrode, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The device is a physical medical electrode, not a standalone algorithm. The non-clinical testing evaluated the physical and material properties of the electrodes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the non-clinical testing was established by adherence to established international and national standards and regulations for medical devices (e.g., ISO, ASTM, USP, IEC, GB/T). The tests performed according to these standards (e.g., cytotoxicity tests, pyrogen tests, seal strength tests, electrical resistivity tests) provide the "ground truth" for the device's physical and material properties.

8. The sample size for the training set:

This information is not applicable. There was no training set, as the study involved non-clinical, bench testing of the physical device to meet predefined standards, not machine learning model training.

9. How the ground truth for the training set was established:

This information is not applicable as there was no training set.

Summary

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JUL 1 8 2014

NeuroInvent Inc. 510(k) Notification. K140200

E-Shield Multi-paired . Subdermal Needle Electrodes

510(k) Summary

5.1	Type of Submission:	Traditional
5.2	Preparation Date:	20th January 2014
5.3	Submitter:	NeuroInvent Inc.
	Address:	211 Hope Street, Ste 390082
		Mountain View, CA 94039, U.S.A.
	Phone:	+001-917-915-3568
	Fax:	+001-650-353-9398
	Contact:	Chao-Shent Chao
		(kuo-tai-hospitals@hotmail.com)

5.4 Identification of the Device:

Trade name:	E-Shield Multi-paired Subdermal NeedleElectrodes
Classification Name:	Needle Electrode
Device Classification:	II
Regulation Number:	882.1350
Panel:	Neurology
Product Code:	GXZ

5.5 Identification of the Predicate Device:

Predicate Device Name:	Rhythmlink International SubdermalNeedle Electrodes
Manufacturer:	Rhythmlink International, LLC
Product Code:	GXZ
510(k) Number:	K022914

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E-Shield Multi-paired Subdermal Needle Electrodes

5.6 Intended Use

5.7 Device Description

The subdermal needle electrodes can be used to record variety of types of neurological and neurophysiological evoked potentials, including but not limited to electroencephalogram (EEG), electromyogram (EMG) in hospital and clinical setting. It is highly recommended to be used of intra-operative neuromonitoring (IOM).

The electrodes consist of a stainless steel needle with a lead wire attached and the lead wires terminate in a safety connector. The electrodes are used under the supervision of a physician. Each sterilized PET box contains 2 sets of 5-paired subdermal needle electrodes and a safety shield attached to each set. The safety shield is used to cover the needle sharps and the multi-paired lead wires are designed in group for easy organizing. Grouped wire cable can be separated into 5 paired lead wires to reach different recording sites of a patient over desired length. For instance, it can be used for the recording in one limb muscle groups.

5.8 Non-clinical Testing

A series of safety tests were performed to assess the safety and effectiveness of the E-Shield Multi-paired Subdermal Needle Electrodes.

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Subdermal Needle Multi-paired

Subdermal Needle Electrodes

Testing Item	Standard and regulations applied
Biocompatibility	ISO 10993-5:2009 Biological evaluation of medical devices -
	Part 5: Tests for in vitro cytotoxicity
	ISO 10993-10:2010 Biological evaluation of medical devices -
	Part 10: Tests for irritation and skin sensitization
	ISO 10993-11:2009 Biological evaluation of medical devices -
	Part 11: Tests for systemic toxicity
	ISO 10993-12:2012 Biological evaluation of medical devices -
	Part 12: Sample preparation and reference material
	ASTM F756-08, Standard Practice For AssessmentOl
	Hemolytic Properties Of Materials.(Biocompatibility)
	USP 35-NF30:2012, <151> Pyrogen Test (USPRabbit
	Test).(Sterility)
	ASTM F750-87 (Reapproved 2012), Standard Practice For
	Evaluating Material Extracts By Systemic Injection In The
	Mouse. (Biocompatibility)
Sterilization	ISO 10993-7:2008 Biological evaluation of medical device
	-Part 7: Ethylene Oxide sterilization residuals
	ISO 11135-1 2007 Sterilization of health care products -
	Ethylene oxide - Requirements for development, validation and
	routine control of a sterilization process for medical devices
	ISO 11135-2 2008 Sterilization of health care products -
	Ethylene oxide -- Guidance on the application of ISO 11135-1
	ISO 11737-1: 2006 Sterilization of Medical Devices
	Microbiological Method - Part I: Determination ofਨ
	population of microorganisms on products
	ISO 11737-2: 2009 Sterilization of medical devices
	Microbiological methods - Part 2: Tests of sterility performed
	in the definition, validation and maintenance of a sterilization
	process
Shelf life	ASTM F1980-07 Standard Guide for Accelerated Aging of
	Sterile Medical Device Packages.
	ASTM F88/F88M-09 Standard Test Method for Seal Strengthof Flexible Barrier Materials
	ASTM F1140-13 Standard Test Methods for InternalPressurization Failure Resistance of Unrestrained Packages forMedical Applications.
	ASTM F1929-12 Standard Test Method for Detecting SealLeaks in Porous Medical Packaging by Dye Penetration.
	ASTM D4332: 2001 Standard practice conditioning containers,packages or packaging components for testing.
	ASTM F1608 Standard Test Method for Microbial Ranking ofPorous Packaging Materials (Exposure Chamber Method).
	ASTM D4169-09, Standard Practice For Performance TestingOf Shipping Containers And Systems. (Sterility)
	ISO 11607-1 Packaging For Terminally Sterilized MedicalDevices - Part 1: Requirements For Materials, Sterile BarrierSystems And Packaging Systems. (Sterility)
	ISO 11607-2 Packaging For Terminally Sterilized MedicalDevices - Part 2: Validation Requirements For Forming,Sealing And Assembly Processes. (Sterility)
	ASTM F2096-11, Standard Test Method For Detecting GrossLeaks In Packaging By Internal Pressurization (Bubble Test).(Sterility)
	The International Safe Transit Association (ISTA) Procedure1A
ElectromagneticCompatibility &Electrical Safety	IEC 60601-1 Medical electrical equipment Part 1: Generalrequirements for basic safety and essential performance
Performance	ISO 9626 First Edition 1991-09-01, Amendment 1 2001-06-01Stainless Steel Needle Tubing For The Manufacture Of MedicalDevices. (General Plastic Surgery/General Hospital)
	ASTM B193-87(1992): Standard Test Method for Resistivity ofElectrical Conductor Materials
IEC 60028 (1925): International standard of resistance forcopper
GB/T 3048.2-2007: TEST method for electrical properties ofelectric cables and wire-part2: Test of electrical resistivity ofmetallic materials

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. .

Subdermal Needle Electrodes

. .

・

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All the test results demonstrate E-Shield Multi-paired Subdermal Needle Electrodes meet the requirements of its pre-defined acceptance criteria and intended uses.

5.9 Clinical Testing

No clinical test data was used to support the decision of safety and effectiveness.

5.10 Substantial Equivalence Determination

E-Shield Multi-paired Subdermal Needle Electrodes has similar intended use, fundamental scientific technology and technological characteristics with the predicate device, Rhythmlink International Subdermal Needle Electrodes. Information described below can demonstrate the E-Shield Multi-paired Subdermal Needle Electrodes is substantial equivalent to the predicate device.

	Proposed Device	Predicate Device
Item	E-Shield Multi-pairedSubdermal Needle Electrodes	Rhythmlink InternationalSubdermal Needle Electrodes
Classification	II	II
Regulation No.	882.1350	882.1350
Product Code	GXZ	GXZ
Intended Use	E-Shield Multi-pairedSubdermal Needle Electrodesare intended for use withrecording and monitoringequipment for the purpose ofrecording of biopotentialsignals. Examples include:Electromyography (EMG),	Rhythmlink InternationalSubdermal Needle Electrodesare intended for use withrecording, monitoring andstimulation equipment for thepurpose of recording ofbiopotential signals.Examples include:

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E-Shield Multi-paired Subdermal Needle Electrodes

	Electroencephagraph (EEG)and Nerve potential signals.The electrodes are sterile andfor single patient use only.	Electromyography (EMG),Electroencephagraph (EEG)and Nerve potential signals.The electrodes are sterile andfor single patient use only.
Design	Monopolar	Monopolar
Anatomical sites	Subdermal, nerve or muscle	Subdermal, nerve or muscle
	tissue	tissue
Materials	Stainless steel needle with	Stainless steel needle with
	lead wire attached.	lead wire attached
Sterility	EO	unknown
Shelf life	3 years	unknown
Mechanical safety	Packaged needle coveredwith a needle cover	unknown

5.11 Similarity and differences

The only difference between the subject device and predicate device is the proposed device is designed in 5-paired subdermal needle electrodes and a safety shield attached to each set. The safety shield is used to cover the needle sharps and the multi-paired lead wires are designed in group for easy organizing. Grouped wire cable can be separated into 5 paired lead wires to reach different recording sites of a patient over desired length. The subject device has tested on safety and performance tests and the test results were complied with the test requests. Therefore, the difference of subject device and predicate device didn't raise any problems of safety or effectiveness. The proposed device is substantially equivalent to the predicate device in design, operation, intended use and performance claims.

5.12 Conclusion

After analyzing bench tests and safety testing data, it can be concluded that E-Shield Multi-paired Subdermal Needle Electrodes is as safe and effective as the predicate device.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 18, 2014

Neuroinvent, Inc. c/o Chao-Shent Chao Kuo Tai Hospitals Management & Consultant Co. Ltd. 5F. No. 123 anMei St. Neihu District, Taipei City, 11484 Taiwan

Re: K140200

Trade/Device Name: E-Shield Multi-paired Subdermal Needle Electrodes Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: II Product Code: GXZ Dated: June 16, 2014 Received: June 17, 2014

Dear Mr. Chao-Shent Chao:

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

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Page 2 - Mr. Chao-Shent Chao

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of 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.

Felipe Aquel -S

Carlos L. Peña, Ph.D., M.S. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140200

Device Name E-Shield Multi-paired Subdermal Needle Electrodes

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

ം Date: 2014.07.18 13:32:49

13:32:49 0 -04'00'

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*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:

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Regulation Number and Section

§ 882.1350 Needle electrode.

(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).