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.

AI/ML Overview

The document provided is a 510(k) summary for the SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator. It describes the device, its intended use, and its substantial equivalence to a predicate device (EasyMed Instruments Co., LTD. Peripheral Nerve Stimulator, K121743).

However, the document does not contain specific acceptance criteria, reported device performance metrics, or details about a study designed to prove the device meets such criteria in the way that would typically apply to AI/ML or diagnostic devices.

The "Performance Data" section lists recognized consensus standards that the device underwent tests against, which are primarily related to electrical safety, electromagnetic compatibility, risk management, and software lifecycle processes. These are general standards for medical electrical equipment and software, not performance metrics like accuracy, sensitivity, or specificity that would be expected for an AI system or device requiring clinical performance validation.

Therefore, many of the requested details about acceptance criteria and a study proving performance cannot be extracted from this document because they are not present. This document is focused on demonstrating substantial equivalence based on technological characteristics and adherence to general safety and quality standards, not a specific clinical performance study with defined criteria and results.

Here's an attempt to answer based on the available information, with many points marked as "Not provided in the document."

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

The provided document describes the SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator, highlighting its substantial equivalence to a predicate device (K121743) based on its intended use, operating principle, basic design principle, operating modes, and stimulation parameters. The "performance data" section focuses on adherence to general safety, electromagnetic compatibility, risk management, and software lifecycle process standards, rather than specific clinical performance metrics.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Acceptance Criteria (from standards)	Reported Device Performance (from document)	Notes
Electrical Safety	Adherence to AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, Mod).	"Test results show that the modification for the new device do not affect the safety and effectiveness."	This implies compliance with the standard but no specific numerical performance is given.
Electromagnetic Compatibility (EMC)	Adherence to AAMI / ANSI / IEC 60601-1-2:2007/(R) 2012, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests (Edition 3).	"Test results show that the modification for the new device do not affect the safety and effectiveness."	This implies compliance with the standard but no specific numerical performance is given.
Risk Management	Adherence to ISO 14971: Second Edition 2007-03-01 Medical devices- Application of Risk Management To Medical Devices.	"Test results show that the modification for the new device do not affect the safety and effectiveness."	This implies compliance with the standard but no specific numerical performance is given.
Software Life Cycle Processes	Adherence to IEC 62304 First Edition 2006-05, Medical devices software- Software life cycle processes.	"Test results show that the modification for the new device do not affect the safety and effectiveness."	This implies compliance with the standard but no specific numerical performance is given.
Clinical Performance	Not provided in the document. (No specific clinical performance acceptance criteria like accuracy, sensitivity, specificity, etc., are mentioned.)	Not provided in the document.	The marketing submission focuses on substantial equivalence based on technological characteristics and safety standards, not a clinical performance study with specific metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided in the document. The testing mentioned refers to conformance with general safety and engineering standards, not a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical ground truth or expert review process for a test-set of patient data is described. The "testing" refers to engineering and quality assurance against recognized standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical data test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a peripheral nerve stimulator, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as the document describes a hardware medical device (peripheral nerve stimulator), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as the "testing" described is against engineering and safety standards, not based on clinical ground truth.

8. The sample size for the training set

Not applicable, as the document describes a hardware medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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 (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" (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 (800) 638-2041 or (301) 796-7100 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)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart G)

| 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:	+86 757 2809 1300
Fax :	+86 757 2772 7868
Official Contact:	Jeffery Wu (Wu Tingjie)
E-Mail:	jeffery@easymed.com.cn

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:

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)2012And A2:2010/(R)2012 (Consolidated Text) Medical ElectricalEquipment - Part 1: General Requirements For Basic Safety AndEssential Performance (IEC 60601-1:2005, Mod). (General I (QS/RM))
19-2	AAMI / ANSI / IEC 60601-1-2:2007/(R) 2012, Medical ElectricalEquipment - Part 1-2: General Requirements For Basic Safety AndEssential Performance - Collateral Standard: ElectromagneticCompatibility - Requirements And Tests (Edition 3). (General II(ES/EMC))
5-40	ISO 14971: Second Edition 2007-03-01 Medical devices- Application ofRisk Management To Medical Devices. (General I (QS/RM))
13-8	IEC 62304 First Edition 2006-05, Medical devices software- Softwarelife 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.

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).