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. There are three specifications for E-Shield Multi-paired Subdermal Needle Electrodes, 7mm, 13mm and 19mm. The sterilized PET box contains 2 sets of 5-paired, 2 sets of 4-paired or 1 set of single 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 multi-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 provided text describes the regulatory submission for the E-Shield Multi-paired Subdermal Needle Electrodes (K142470) and its substantial equivalence to a predicate device (K140200). It focuses heavily on non-clinical testing for safety and effectiveness rather than a clinical study evaluating diagnostic or prognostic performance.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies, especially in the context of efficacy for a diagnostic or prognostic medical AI device, is largely not applicable to this submission as it pertains to a needle electrode, not an AI device.

Let's break down what can be extracted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes non-clinical testing categories and the standards applied. The "performance" here refers to meeting these safety and manufacturing standards, not analytical or clinical performance in the sense of accuracy, sensitivity, or specificity commonly associated with AI/diagnostic devices.

Testing Item	Standard and Regulations Applied (Acceptance Criteria)	Reported Device Performance
Sterilization	ISO 10993-7:2008, ISO 11135-1:2007, ISO 11135-2:2008, ISO 11737-1:2006, ISO 11737-2:2009	Met requirements of pre-defined acceptance criteria
Shelf Life/Packaging	ASTM F88/F88M-09, F1140-13, F1929-12, D4332, F1608, ISO 11607-1, 11607-2, ASTM D4169-09, ISTA 1A, ASTM F2096-11	Met requirements of pre-defined acceptance criteria
Biocompatibility	ISO 10993-5:2009, 10993-10:2010, 10993-11:2009, 10993-12:2012, ASTM F756-08, USP 35-NF30:2012 <151>, ASTM F750-87, USP <85>, USP <161>	Met requirements of pre-defined acceptance criteria
Electromagnetic Compatibility & Electrical Safety	IEC 60601-1	Met requirements of pre-defined acceptance criteria
Performance (Material)	ISO 9626:1991, ASTM B193-87(1992), IEC 60028 (1925), GB/T 3048.2-2007	Met requirements of pre-defined acceptance criteria

The overall reported performance is: "All the test results demonstrate E-Shield Multi-paired Subdermal Needle Electrodes meet the requirements of its pre-defined acceptance criteria and intended uses."

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

This section is Not Applicable in the context of an "AI device" test set. The testing performed was non-clinical for safety, sterility, biocompatibility, and material properties. Sample sizes for these types of engineering and materials tests are typically determined by relevant ISO/ASTM standards and Good Manufacturing Practices (GMP) for device validation, not by patient data samples. The data provenance is from laboratory and manufacturing validation processes, not country of origin of patient data or retrospective/prospective studies.

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

This is Not Applicable. Ground truth, in the context of expert consensus, is relevant for diagnostic performance evaluation. The "ground truth" for this device's testing was established by adherence to the specified international and national standards by qualified testing facilities and personnel.

4. Adjudication method for the test set

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human experts when establishing ground truth for diagnostic tasks. This device underwent non-clinical testing against established standards.

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

Not Applicable. This device is a needle electrode, a hardware medical device for signal acquisition, not an AI algorithm designed to assist human readers in interpreting medical data. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not Applicable. This is a physical medical device (needle electrode), not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's regulatory clearance is compliance with the detailed standards and regulations listed for sterilization, shelf life, biocompatibility, electromagnetic compatibility, electrical safety, and material performance (e.g., ISO, ASTM, USP, IEC standards).

8. The sample size for the training set

Not Applicable. This is a physical medical device. It does not involve a "training set" in the context of machine learning or AI.

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

Not Applicable. As above, this is a physical medical device, not an AI algorithm requiring a training set with established ground truth.

Summary for the provided document:

The regulatory submission for the E-Shield Multi-paired Subdermal Needle Electrodes demonstrates its safety and effectiveness through non-clinical testing against a comprehensive set of national and international standards. These tests cover sterilization, shelf life, biocompatibility, electromagnetic compatibility, electrical safety, and material performance. The device was found to meet all pre-defined acceptance criteria derived from these standards. No clinical trial data or AI/algorithm performance studies were conducted or required, as the device is a needle electrode and not a diagnostic or AI-driven system. The substantial equivalence argument relies on comparing the device's intended use, design, technological characteristics, and materials to a legally marketed predicate device, with the only difference being the addition of a new needle length specification and revised product categories, which did not raise new safety or effectiveness concerns after testing.

Summary

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

November 5, 2014

NeuroInvent Inc. Chao-Shent Chao Manager and Contact Window of Taiwan NeuroInvent Inc. 19925 Stevens Creek Blvd. Suite 100 Cupertino, CA 95014-2358

Re: K142470

Trade/Device Name: E-Shield Multi-paired Subdermal Needle Electrodes Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ Dated: September 30, 2014 Received: October 6, 2014

Dear Mr. 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 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

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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/Resourcesfor You/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,

Michael J. Hoffmann -S

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

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NeuroInvent Inc. 510(k) Notification

E-Shield Multi-paired Subdermal Needle Electrodes

Indications for Use

510(k) Number (if known):

E-Shield Multi-paired Subdermal Needle Electrodes Device Name:

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Michael J. Hoffmann -S 2014.11.05 10:09:39 -05'00'

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NeuroInvent Inc. 510(k) Notification, K142470/S001

E-Shield Multi-paired Subdermal Needle Electrodes

510(k) Summary

5.1	Type of Submission:	Special
5.2	Preparation Date:	22th August, 2014
5.3	Submitter:	NeuroInvent Inc.
	Address:	19925 Stevens Creek Blvd., Suite 100,Cupertino, CA 95014-2358, U.S.A.
	Phone:	+1 (917) 915 - 3568
	Fax:	+1 (408) 973 - 7287
	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:	E-Shield Multi-paired Subdermal Needle
	Electrodes
Manufacturer:	NeuroInvent Inc.
Product Code:	GXZ
510(k) Number:	K140200

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5.6 Intended Use

5.7 Device Description

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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.

Testing Item	Standard and regulations applied
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 androutine 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 DevicesMicrobiological Method – Part 1: Determination of apopulation of microorganisms on products.
	ISO 11737-2: 2009 Sterilization of medical devices –Microbiological methods – Part 2: Tests of sterility performedin the definition, validation and maintenance of a sterilizationprocess.
	Shelf life
		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)
		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 D4169-09, Standard Practice For Performance TestingOf Shipping Containers And Systems. (Sterility)
	The International Safe Transit Association (ISTA) Procedure1A
	ASTM F2096-11 Standard Test Method for Detecting GrossLeaks in Packaging by Internal Pressurization (Bubble Test)
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 Assessment OfHemolytic Properties Of Materials. (Biocompatibility)
	USP 35-NF30:2012, <151> Pyrogen Test (USP RabbitTest). (Sterility)
	ASTM F750-87 (Reapproved 2012), Standard Practice ForEvaluating Material Extracts By Systemic Injection In TheMouse. (Biocompatibility)
	USP <85>, Bacterial endotoxin test. Chapter 85, USP version36.
	USP <161>, Transfusion and infusion assembles and similarMedical devices. Chapter 161, USP version 36.
Electromagnetic	IEC 60601-1 Medical electrical equipment Part 1: General
Compatibility &Electrical Safety	requirements 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 Resistivityof Electrical 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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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 the same intended use, fundamental scientific technology and technological characteristics as the predicate device, E-Shield Multi-paired Subdermal Needle Electrodes (K140200). 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	E-Shield Multi-pairedSubdermal Needle Electrodes(K140200)
Classification	II	II
Regulation No.	882.1350	882.1350

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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),Electroencephagraph (EEG)and Nerve potential signals.The electrodes are sterile andfor single patient use only.	E-Shield Multi-pairedSubdermal Needle Electrodesare intended for use withrecording and monitoringequipment for the purpose ofrecording of biopotentialsignals. Examples include: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 muscletissue	Subdermal, nerve or muscletissue
Materials	Stainless steel needle withlead wire attached.	Stainless steel needle withlead wire attached.
Sterility	EO	EO
Shelf life	3 years	3 years
Mechanicalsafety	Packaged needle coveredwith a needle cover	Packaged needle coveredwith a needle cover
Specification-Needle Length	7mm, 13mm and 19mm	13mm and 19mm
Specification-category	> 2 sets of 4 or 5-pairedsubdermal needle electrodesfor 7mm, 13mm and 19mm> 5, 7 or 9-Single SubdemalNeedle Electrodes for 13mm	> 2 sets of 5-pairedsubdermal needle electrodesfor 13mm and 19mm

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5.11 Similarity and differences

The proposed device is the same in intended use, design, technological characteristics and materials as the predicate device. The only difference between the proposed device and the predicate device is the specification. The proposed device added 7mm - Needle Length as new specification and revised codes of products. The category was modified as well. There are 2 sets of 4 or 5-paired subdermal needle electrodes and 1 set of single Subdemal Needle Electrodes for proposed device. The predicate device only contains 2 sets of 5-paired subdermal needle electrodes.

The proposed device has tested on safety and performance tests and the test results were complied with the test requests. Therefore, the difference of proposed device and predicate device did not raise any problems of safety or effectiveness. The proposed device is substantially equivalent to the predicate device in intended use, design 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.

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).