DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

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
Page 2 – Chao-Shent Chao

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, sMisbranding by reference to premarket notifications (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
NeuroInvent Inc. E-Shield Multi-paired
510(k) Notification Subdermal Needle Electrodes

Indications for Use

510(k) Number (if known):

Device Name: E-Shield Multi-paired Subdermal Needle Electrodes
Indications for Use:
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.

Prescription Use X AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D) (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'

лк
NeuroInvent Inc. E-Shield Multi-paired
510(k) Notification, K142470/S001 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 Needle
Electrodes
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
NeuroInvent Inc. E-Shield Multi-paired
510(k) Notification, K142470/S001 Subdermal Needle Electrodes

5.6 Intended Use

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.

5.7 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.
NeuroInvent Inc. E-Shield Multi-paired
510(k) Notification, K142470/S001 Subdermal Needle Electrodes

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 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 1: 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.
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).
NeuroInvent Inc. E-Shield Multi-paired
510(k) Notification, K142470/S001 Subdermal Needle Electrodes

ISO 11607-1 Packaging For Terminally Sterilized Medical

Devices - Part 1: Requirements For Materials, Sterile Barrier
Systems And Packaging Systems. (Sterility)
ISO 11607-2 Packaging For Terminally Sterilized Medical
Devices - Part 2: Validation Requirements For Forming,
Sealing And Assembly Processes. (Sterility)
ASTM D4169-09, Standard Practice For Performance Testing
Of Shipping Containers And Systems. (Sterility)
The International Safe Transit Association (ISTA) Procedure
1A
ASTM F2096-11 Standard Test Method for Detecting Gross
Leaks 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 Of
Hemolytic Properties Of Materials. (Biocompatibility)
USP 35-NF30:2012, <151> Pyrogen Test (USP Rabbit
Test). (Sterility)
ASTM F750-87 (Reapproved 2012), Standard Practice For
Evaluating Material Extracts By Systemic Injection In The
Mouse. (Biocompatibility)
USP <85>, Bacterial endotoxin test. Chapter 85, USP version
36.
USP <161>, Transfusion and infusion assembles and similar
Medical devices. Chapter 161, USP version 36.
Electromagnetic IEC 60601-1 Medical electrical equipment Part 1: General
NeuroInvent Inc. E-Shield Multi-paired
510(k) Notification, K142470/S001 Subdermal Needle Electrodes

Compatibility & requirements for basic safety and essential performance.

Electrical Safety
Performance ISO 9626 First Edition 1991-09-01, Amendment 1 2001-06-01
Stainless Steel Needle Tubing For The Manufacture Of Medical
Devices. (General Plastic Surgery/General Hospital)
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 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-paired E-Shield Multi-paired
Subdermal Needle Electrodes Subdermal Needle Electrodes
(K140200)
Classification II II
Regulation No. 882.1350 882.1350
NeuroInvent Inc. E-Shield Multi-paired
510(k) Notification, K142470/S001 Subdermal Needle Electrodes

Product Code GXZ GXZ

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

Stainless steel needle with Stainless steel needle with

Materials
lead wire attached. lead wire attached.

Sterility EO EO
Shelf life 3 years 3 years
Mechanical Packaged needle covered Packaged needle covered
safety with a needle cover with a needle cover
Specification-
7mm, 13mm and 19mm 13mm and 19mm
Needle Length
¾ 2 sets of 4 or 5-paired
subdermal needle electrodes ¾ 2 sets of 5-paired
Specification-
for 7mm, 13mm and 19mm subdermal needle electrodes
category
¾ 5, 7 or 9-Single Subdemal for 13mm and 19mm
Needle Electrodes for 13mm
NeuroInvent Inc. E-Shield Multi-paired
510(k) Notification, K142470/S001 Subdermal Needle Electrodes

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.