SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator

K153045 · Easy Med Instrument Co., Ltd. · BXN · May 13, 2016 · Anesthesiology

Device Facts

• Record ID: K153045
• Device Name: SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
• Applicant: Easy Med Instrument Co., Ltd.
• Product Code: BXN · Anesthesiology
• Decision Date: May 13, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.2775
• Device Class: Class 2

Intended Use

SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator are a battery-powered device intended for monitoring the magnitude of neuromuscular block in general anesthesia, by delivering an electrical stimulus near a peripheral motor nerve.

Device Story

Battery-powered peripheral nerve stimulator; delivers low electrical direct current (DC) stimulation near peripheral motor nerves to assess anesthetic nerve block levels. Clinician-operated in clinical settings. Features variable current control (0-70 mA into 2K ohm load). Output modes include Twitch, Train-of-Four, 100Hz Tetanus; SunStim Plus adds Double Burst and 50Hz Tetanus. Device includes an output pulse indicator. Uses an 8-bit MCU for timing control to replace logic circuits found in predicate. Output stimulus pulse indicator provides visual feedback to clinician. Enables assessment of pharmacological effect of anesthetic drugs/gases; assists in clinical decision-making regarding neuromuscular blockade management.

Clinical Evidence

Bench testing only. Testing included compliance with AAMI/ANSI ES60601-1 (general safety), AAMI/ANSI/IEC 60601-1-2 (EMC), ISO 14971 (risk management), and IEC 62304 (software life cycle).

Technological Characteristics

Battery-powered; 8-bit MCU for timing control; voltage generator for stimulation output. Output: 0-70 mA into 2K ohm load. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 14971, IEC 62304. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for monitoring neuromuscular block magnitude in patients undergoing general anesthesia by delivering electrical stimulation near peripheral motor nerves.

Regulatory Classification

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.

Predicate Devices

• Microstim Peripheral Nerve Stimulator (K121743)

Submission Summary (Full Text)

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

May 13, 2016

EasyMed Instrument Co., Ltd. Jeffery Wu (Tingjie Wu) General Manager 5/F-6/F, Block A, Gupo Gongmao Building Fengxin Road, Fengxiang Industrial District Daliang, 528300 Shunde, Foshan, Guangdong, China

Re: K153045

Trade/Device Name: SunStim™ Peripheral Nerve Stimulator/SunStim™ Plus Peripheral Nerve Stimulator Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: Class II Product Code: BXN Dated: February 18, 2016 Received: April 08, 2016

Dear Jeffery Wu:

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

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related 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (21 CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

*Tejashri Purohit-Sheth, M.D.*

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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) K153045

#### Device Name

SunStim Peripheral Nerve Stimulator / SunStim Plus Peripheral Nerve Stimulator

#### Indications for Use (Describe)

SunStim Peripheral Nerve Stimulator and SunStim Plus Peripheral Nerve Stimulator are a battery-powered device intended for monitoring the magnitude of neuromuscular block in general anesthesia, by delivering an electrical stimulus near a peripheral motor nerve.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"> <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
| <div style="display:flex; align-items:center;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart G) </div> |

| X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 6.0 510(k) Summary

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# 510(k) Summary

Date of submission prepared: 12 May 2016

| Submitter: | EasyMed Instruments Co., Ltd. |
|-------------------|----------------------------------------------------------------|
| Address: | 5/F – 6/F, Block A, Gupo Gongmao Building, Fengxin Road, |
| | Fengxiang Industrial District, Daliang, 528300 Shunde, Foshan, |
| | Guangdong, CHINA |
| Tel: | [phone] |
| Fax : | [phone] |
| Official Contact: | Jeffery Wu (Wu Tingjie) |
| E-Mail: | [e-mail] |

Address of the manufacturing facility: The same as above

# SUBMITTED DEVICE:

| Proprietary or Trade Name: | SunStim™ Peripheral Nerve Stimulator / |
|----------------------------|-------------------------------------------|
| | SunStim™ Plus Peripheral Nerve Stimulator |
| Common/Usual Name: | Peripheral Nerve Stimulator |
| | Battery-Powered Nerve Stimulator |
| Classification Name: | Electrical Peripheral Nerve Stimulator |
| | 21 CFR 868.2775 |
| Product Code: | BXN |
| Device Panel: | Anesthesiology |
| Device Classification: | Class II |
| Prior submission: | No |

# PREDICATE DEVICE:

| Device Name: | EasyMed Instruments Co., LTD. Peripheral Nerve Stimulator |
|----------------|-----------------------------------------------------------|
| Manufacturer: | EasyMed Instruments Co., Ltd. |
| 510(k) Number: | K121743 |
| Product Code: | BXN |
| Trade name: | Microstim Peripheral Nerve Stimulator |

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### INTENDED USE:

SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator are a battery-powered device intended for monitoring the magnitude of neuromuscular block in general anesthesia, by delivering an electrical stimulus near a peripheral motor nerve.

## DEVICE DESCRIPTION:

SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator 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: Double Burst (DBS), Train-of-Four, Twitch, and 100Hz Tetanus. The device offers sufficient output to ensure supramaximal stimulation: from 0 to 70 mA. SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator models have the same functions with the following exceptions: the SunStim™ Peripheral Nerve Stimulator functions do not include Double Burst and the 50 Hz Tetanus option.

## TECHNOLOGICAL CHARACTERISTICS

The technical characteristics of the modified Peripheral Nerve Stimulators (i.e. SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator) are the same as those of the original legally marketed Peripheral Nerve Stimulators (K121743) in energy source, intended use and functions. Like the predicate device, SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator are devices used to apply an electric current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.

The devices, both the predicated ones and modified ones, can be divided into two parts:

- 1. The timing control
This part can be considered to be simplified as a switch controlling the device high voltage output on or off.

In our original design this part uses a simple logical circuit; in our modified design this part uses a simple 8 bits MCU (Micro Control Unit) so that the circuitry can be simplified.

### 2. The voltage generator

This part generates voltage to the setting level, and output the stimulating signal at the time when the output of timing control part is set to on.

This part is not changed in this modification.

The design principle and operational principle of the modified Peripheral Nerve Stimulators (i.e.

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SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator) are the same as those of original legally marketed Peripheral Nerve Stimulators (K121743). The difference is an MCU is used inside the modified Peripheral Nerve Stimulators to take the place of timing control part of the predicate device.

This modification does not affect the device's intended use or alter the device's fundamental scientific technology.

# PERFORMANCE DATA (e.g. non-clinical tests)

The SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator underwent the tests and recognized consensus standards noted in the below table.

| FDA recognition No. | Standard Title |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-5 | AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012<br>And A2:2010/(R)2012 (Consolidated Text) Medical Electrical<br>Equipment - Part 1: General Requirements For Basic Safety And<br>Essential Performance (IEC 60601-1:2005, Mod). (General I (QS/RM)) |
| 19-2 | AAMI / ANSI / IEC 60601-1-2:2007/(R) 2012, Medical Electrical<br>Equipment - Part 1-2: General Requirements For Basic Safety And<br>Essential Performance - Collateral Standard: Electromagnetic<br>Compatibility - Requirements And Tests (Edition 3). (General II<br>(ES/EMC)) |
| 5-40 | ISO 14971: Second Edition 2007-03-01 Medical devices- Application of<br>Risk Management To Medical Devices. (General I (QS/RM)) |
| 13-8 | IEC 62304 First Edition 2006-05, Medical devices software- Software<br>life cycle processes (Software/ Informatics) |

Test results show that the modification for the new device do not affect the safety and effectiveness.

# SUBSTANTIAL EQUIVALENCE CONCLUSION

The modified Peripheral Nerve Stimulators (i.e. SunStim™ Peripheral Nerve Stimulator and SunStim" Plus Peripheral Nerve Stimulator) are of the following similarities to the original legally marketed Peripheral Nerve Stimulators (K121743)

- . The same intended use;
- . Use the same operating principle;

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- Incorporate the same basic design principle; .
- The same operating modes; ●
- . The same stimulation parameters

The modified Peripheral Nerve Stimulators (i.e. SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator) have the same intended use and similar technological characteristics to the original legally marketed Peripheral Nerve Stimulators (K121743). Thus, the modified Peripheral Nerve Stimulators (i.e. SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator) are substantially equivalent to the predicate device.

The modifications do not affect the device's intended use or alter the device's fundamental scientific technology. The modified devices are as safe, as effective and are substantially equivalent to the predicated device.