The EasyMed InstrumentsCo., LTD. Peripheral Nerve Stimulator is a battery -powered device intended for monitoring the magnitude of neuromuscular blocks in general anesthesia; by delivering an electrical stimulus near a peripheral motor nerve.

Device Description

The EasyMed Peripheral Nerve Stimulator devices are battery powered peripheral nerve stimulators which provide low electrical direct current (DC) stimulation in order to determine the level of anesthetic nerve block. The Stimulus Amplitude control dial provides variable current control (0 to 70 mA into a 2K ohm load).

The Output Stimulus Pulse Indicator flashes each time current passes through the patient. Functions include: Train-of-Four, Twitch, and 100Hz Tetanus. The device offers sufficient output to ensure supramaximal stimulation: from 0 to 70 mA.

All finished products are tested and must meet all required release specifications before distribution. Testing includes physical testing (e.g. Pulse Amplitude, Pulse Width, Pulse Frequency and Low Battery Voltage Indicator) and visual examination.

AI/ML Overview

This document describes the validation of the EasyMed Instruments Co., LTD. Peripheral Nerve Stimulator.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EasyMed Peripheral Nerve Stimulator are based on compliance with specific electromagnetic compatibility (EMC) standards. The reported device performance indicates that the device passed all these tests.

Test Type	Test Requirement	Reported Device Performance
Radiated Emission (30 MHz to 1 GHz)	EN 60601-1-2: 2007	Pass
ESD Susceptibility	EN 60601-1-2: 2007	Pass
Radiated Immunity (90 MHz to 2.5 GHz)	EN 60601-1-2: 2007	Pass
Power-frequency magnetic field immunity	EN 60601-1-2: 2007	Pass

Beyond these EMC specific tests, the document also mentions that "All finished products are tested and must meet all required release specifications before distribution. Testing includes physical testing (e.g. Pulse Amplitude, Pulse Width, Pulse Frequency and Low Battery Voltage Indicator) and visual examination." However, the specific acceptance criteria for these physical tests are not detailed in the provided text.

2. Sample Size and Data Provenance

The provided document does not specify the sample size used for the tests mentioned in the "Performance Data" section.
The provenance of the data is not explicitly stated as "country of origin of the data" or "retrospective or prospective." However, given EasyMed Instruments Co., LTD. is located in China, it's reasonable to infer that the testing likely occurred in China. The testing described appears to be prospective testing of the device itself, rather than retrospective analysis of clinical data.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This document describes performance testing for an electrical medical device (peripheral nerve stimulator) against engineering standards (e.g., electromagnetic compatibility). The nature of this testing does not involve establishing ground truth based on expert review of medical images or clinical cases.

4. Adjudication Method for the Test Set

Not applicable. As the testing described is for engineering performance rather than clinical data interpretation, there is no adjudication method involved. The results are binary (Pass/Fail) based on predefined technical standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. This validation is for a medical device (a peripheral nerve stimulator), not an AI algorithm.

6. Standalone (Algorithm Only) Performance

Not applicable. This document describes the validation of a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the tests described is the established technical requirements and limits defined by the international standards (e.g., EN 60601-1-2, EN 55011, EN 61000-4-2, EN 61000-4-3, EN 61000-4-8). The device's performance is measured against these objective, verifiable criteria.

8. Sample Size for the Training Set

Not applicable. This device is hardware, not a machine learning model, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set, there is no ground truth for a training set to be established.

Summary

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i21743

MAR 28 2013

EasyMed Instruments Co., LTD.

5/F - 6/F, block A, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Daliang, Shunde, Foshan, CHINA 528300

Phone: +86 757 2809 1300

510(k) SUMMARY 21 CFR 807.92(c)

SUBMITTER INFORMATION

510k Owner:

Company Address:

EasyMed Instruments Co., LTD.

+86 757 2809 1300

Wu Tingjie/ Owner

April 17, 2012

March 27, 2013

5/F ~ 6/F, block A, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Daliang, Shunde, Foshan, CHINA 528300

Company Phone:

Contact Person:

Date Summary Prepared:

Date of Updated Summary:

DEVICE INFORMATION

Trade/Proprietary Name:

Common/Usual Names:

Classification Name:

Product Code:

EasyMed Instruments Co., LTD. Peripheral Nerve Stimulator

Peripheral Nerve Stimulator Battery-Powered Nerve Stimulator

Electrical Peripheral Nerve Stimulator 21 CFR 868.2775

BXN

EasyMed Instruments Co., LTD. Peripheral Nerve Stimulator 510(k) Premarket Notification

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IDENTIFICATION OF PREDICATE DEVICE

Company	Device	510k No.
Life-Tech Intl., Inc.	MiniStim	K913184

DEVICE DESCRIPTION

INTENDED USE

EasyMed Instruments Co., LTD. Peripheral Nerve Stimulator is a battery-powered device intended for monitoring the magnitude of neuromuscular blocks in general anesthesia, by delivering an electrical stimuls near a peripheral motor nerve.

TECHNOLOGICAL CHARACTERISTICS

The technical characteristics of the EasyMed Peripheral Nerve Stimulators are similar to those of the predicate device in design, energy source, intended use and function. Like the predicate device, the EasyMed Peripheral Nerve Stimulators are devices used to apply an electric current to a patient to test the level of pharmacological effect of anesthetic drugs and gases. A comparative summary of the EasyMed device to the predicate device is provided in Section 12.0, Table 1.

EasyMed Instruments Co., LTD. Peripheral Nerve Stimulator 510(k) Premarket Notification

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PERFORMANCE DATA (e.g. non-clinical testing)

The EasyMed Peripheral Nerve Stimulator underwent the tests noted in the below table and results are indicated as well. The full test report can be found in Section 21.0 Appendix -Appendix VIII.

Test	Test Requirement	Test Method	Result
ElectromagneticInterference -Radiated Emission(30 MHz to 1 GHz)	EN 60601-1-2: 2007	EN 55011: 2009+ A1: 2010	Pass
ElectromagneticSusceptibility - ESD	EN 60601-1-2: 2007	EN 61000-4-2: 2009	Pass
ElectromagneticSusceptibility -Radiated Immunity (90MHz to 2.5 GHz)	EN 60601-1-2: 2007	EN 61000-4-3: 2006+ A1: 2008+ A2: 2010	Pass
ElectromagneticSusceptibility -Power-frequency magneticfield immunity	EN 60601-1-2: 2007	EN 61000-4-8:1993+ A1: 2001	Pass

BASIS OF SUBSTANTIAL EQUIVALENCE/CONCLUSION

EasyMed Peripheral Nerve Stimulators have been tested and found to perform as intended. EasyMed Peripheral Nerve Stimulators have been compared to legally cleared predicate device and found to be substantially equivalent. Substantial equivalence testing results can be found in section 12.0.

The EasyMed Peripheral Nerve Stimulator and Stimulator Plus models have the same functions with the following exceptions: the Peripheral Nerve Stimulator functions do not include double burst and 2 tetanus options (50 Hz and 100 Hz).

STANDARDS

ISO 14971:2007 Medical Devices - Application of Risk Management to Medical . Devices

. EN 60601-1-2: 2007 (Second edition, 2001), Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance- Collateral Standard: Electromagnetic Compatibility - Requirements and Tests

EasyMed Instruments Co., LTD. Peripheral Nerve Stimulator 510(k) Premarket Notification

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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March 28, 2013

SunMed Limited Liability Company C/O Mr. Wu Tingjie EasyMed Instruments Company, Limited 5/F - 6/F, Block A, Gupo Gongmao Building Fengxin Road, Fengxiang Industrial District Daliang, Shunde, Foshan China 528300

Re: K121743

Trade/Device Name: Peripheral Nerve Stimulator Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: II Product Code: BXN Dated: February 22, 2013 Received: February 25, 2013

Dear Mr. Tingjie:

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.

Public Health Service

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

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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 (2) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 vours.

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for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Peripheral Nerve Stimulator

K121743

Indications for Use:

Prescription Use ਮ (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)

Lester W. Schultheis Jr 2013.03.27 12:42:42:44:204'00'

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hosphal
Division of Anesthesiology, General Devices Division of Allestheolorology.
Infection Control, Dental Devices

Kreizer

510(k) Number:_

Regulation Number and Section

§ 868.2775 Electrical peripheral nerve stimulator.

(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).