(288 days)
Not Found
No
The document describes a simple electrical stimulator with basic functions and no mention of AI/ML terms or capabilities.
Yes
The device is used for monitoring neuromuscular blocks, which is a diagnostic function rather than a direct therapeutic intervention.
Yes
The device is intended for "monitoring the magnitude of neuromuscular blocks in general anesthesia" and "to determine the level of anesthetic nerve block," which falls under the definition of diagnosing or monitoring a physiological state.
No
The device description explicitly states it is a "battery powered device" that "deliver[s] an electrical stimulus" and has a "Stimulus Amplitude control dial," indicating it is a hardware device that performs electrical stimulation, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for monitoring the magnitude of neuromuscular blocks in general anesthesia; by delivering an electrical stimulus near a peripheral motor nerve." This describes a device that interacts directly with the patient's body (in vivo) to assess a physiological state.
- Device Description: The device delivers electrical stimulation to the patient. This is an in vivo action, not an in vitro (outside the body) test.
- IVD Definition: In Vitro Diagnostics are medical devices intended to perform tests on specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This device does not perform tests on such specimens.
The device is a therapeutic and monitoring device that applies electrical stimulation to the patient's nerve.
N/A
Intended Use / Indications for Use
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.
Product codes
BXN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral motor nerve
Indicated Patient Age Range
Not Found
Intended User / Care Setting
general anesthesia
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)
| Test | Test Requirement | Test Method | Result |
|---|---|---|---|
| Electromagnetic Interference - Radiated Emission (30 MHz to 1 GHz) | EN 60601-1-2: 2007 | EN 55011: 2009 + A1: 2010 | Pass |
| Electromagnetic Susceptibility - ESD | EN 60601-1-2: 2007 | EN 61000-4-2: 2009 | Pass |
| Electromagnetic Susceptibility - Radiated Immunity (90 MHz to 2.5 GHz) | EN 60601-1-2: 2007 | EN 61000-4-3: 2006 + A1: 2008 + A2: 2010 | Pass |
| Electromagnetic Susceptibility - Power-frequency magnetic field immunity | EN 60601-1-2: 2007 | EN 61000-4-8:1993 + A1: 2001 | Pass |
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
§ 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).
0
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
1
IDENTIFICATION OF PREDICATE DEVICE
| Company | Device | 510k No. |
|---|---|---|
| Life-Tech Intl., Inc. | MiniStim | K913184 |
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.
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
2
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 |
|---|---|---|---|
| Electromagnetic | |||
| Interference - | |||
| Radiated Emission | |||
| (30 MHz to 1 GHz) | EN 60601-1-2: 2007 | EN 55011: 2009 |
- A1: 2010 | Pass |
| Electromagnetic
Susceptibility - ESD | EN 60601-1-2: 2007 | EN 61000-4-2: 2009 | Pass |
| Electromagnetic
Susceptibility -
Radiated Immunity (90
MHz to 2.5 GHz) | EN 60601-1-2: 2007 | EN 61000-4-3: 2006 - A1: 2008
- A2: 2010 | Pass |
| Electromagnetic
Susceptibility -
Power-frequency magnetic
field 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
3
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
4
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
5
Indications for Use
510(k) Number (if known):
Device Name:
Peripheral Nerve Stimulator
Indications for Use:
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.
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:_