(172 days)
No
The device description focuses solely on the physical characteristics and intended use of subdermal needle electrodes for recording biopotential signals. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No
The document states the device is used for the recording of biopotential signals for monitoring and diagnosis, not for therapeutic intervention.
No.
The device is an electrode intended for recording biopotential signals, not for providing a diagnosis itself.
No
The device description clearly states it is a physical, invasive electrode made of stainless steel with lead wires and a connector, intended for recording biopotential signals. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The E-Shield Multi-paired Subdermal Needle Electrodes are used to record biopotential signals directly from the body (subdermally, nerve, or muscle tissue). This is an in vivo measurement, meaning it's taken within a living organism.
- Intended Use: The intended use is for recording signals like EMG, EEG, and nerve potentials, which are physiological measurements, not diagnostic tests performed on samples outside the body.
Therefore, the device's function and intended use clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
GXZ
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), electromyogram (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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Subdermal, nerve or muscle tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital and clinical setting, under the supervision of a physician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of safety tests were performed to assess the safety and effectiveness of the E-Shield Multi-paired Subdermal Needle Electrodes. All the test results demonstrate E-Shield Multi-paired Subdermal Needle Electrodes meet the requirements of its pre-defined acceptance criteria and intended uses. No clinical test data was used to support the decision of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 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: | Rhythmlink International Subdermal
Needle Electrodes |
|------------------------|---------------------------------------------------------|
| Manufacturer: | Rhythmlink International, LLC |
| Product Code: | GXZ |
| 510(k) Number: | K022914 |
1
E-Shield Multi-paired 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. 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.
2
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 Assessment | |
| Ol | |
| Hemolytic Properties Of Materials.(Biocompatibility) | |
| USP 35-NF30:2012, Pyrogen Test (USP | |
| Rabbit | |
| 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 of | |
| ਨ | |
| 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). | |
| ASTM D4169-09, Standard Practice For Performance Testing | |
| Of Shipping Containers And Systems. (Sterility) | |
| 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 F2096-11, Standard Test Method For Detecting Gross | |
| Leaks In Packaging By Internal Pressurization (Bubble Test). | |
| (Sterility) | |
| The International Safe Transit Association (ISTA) Procedure | |
| 1A | |
| Electromagnetic | |
| Compatibility & | |
| Electrical Safety | IEC 60601-1 Medical electrical equipment Part 1: General |
| requirements for basic safety and essential performance | |
| 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 |
.
3
.
.
. .
.
,
·
Subdermal Needle Electrodes
:
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・
:
4
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-paired | |
| Subdermal Needle Electrodes | Rhythmlink International | |
| Subdermal Needle Electrodes | ||
| Classification | II | II |
| Regulation No. | 882.1350 | 882.1350 |
| Product Code | GXZ | GXZ |
| 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), | Rhythmlink International | |
| Subdermal Needle Electrodes | ||
| are intended for use with | ||
| recording, monitoring and | ||
| stimulation equipment for the | ||
| purpose of recording of | ||
| biopotential signals. | ||
| Examples include: |
5
E-Shield Multi-paired Subdermal Needle Electrodes
| | Electroencephagraph (EEG)
and Nerve potential signals.
The electrodes are sterile and
for single patient use only. | Electromyography (EMG),
Electroencephagraph (EEG)
and Nerve potential signals.
The electrodes are sterile and
for 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 covered
with 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.
6
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
7
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
8
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)
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.
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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