General Anaesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes (not supplied).
Regional Anaesthesia for the purpose of
a. Nerve mapping using the non-invasive Nerve Mapping Probe (supplied).
b. Nerve locating using invasive electrodes/needles (not supplied).

Device Description

The STIMPOD NMS450 is a battery powered peripheral nerve stimulators that can be used for

nerve mapping using the non-invasive Nerve Mapping Probe (supplied)
nerve locating using invasive electrodes/needles (not supplied)
general anesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes (not supplied)
The stimulus is generated by a constant current source. The waveform is a square wave with various pulse width options.
The anode comprises of an ECG electrode (not supplied). The cathode comprises of
a permanently attached nerve mapping probe (supplied) for nerve mapping,
and/or a separate nerve locating needle (not supplied) for nerve locating,
and/or another ECG electrode (not supplied) for NMBA monitoring, depending on the mode of the unit.

AI/ML Overview

The provided text is a 510(k) summary for the STIMPOD NMS450 Nerve Stimulator. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing de novo acceptance criteria and proving independent device performance against those criteria through a new study.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies, is not present in this 510(k) summary.

The document states:

"There are no significant differences between the STIMPOD NMS450 Nerve Stimulator and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use."
"The STIMPOD NMS450 has been subjected to extensive safety, performance and product validations prior to release." (However, no details of these validations or their acceptance criteria are provided in the public summary).
The conclusion emphasizes substantial equivalence based on "clinical use, technical and biological considerations" to predicate devices, and that it "does not raise any new questions of safety and effectiveness."

In the context of a 510(k) submission for substantial equivalence, a manufacturer generally demonstrates that their new device is as safe and effective as a legally marketed predicate device. This often involves showing that the technical characteristics, intended use, and performance are similar or identical, rather than conducting a new clinical study to establish and meet novel acceptance criteria for a new device type.

Summary

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K102084

DEC 1 6 2010

SECTION 4 - 510(k) SUMMARY

[As required by 21CFR807.92]

Image /page/0/Picture/5 description: The image shows the logo for Xavant Technology. The logo features a stylized "X" with a circular orbit and dot to the left, followed by the text "AVANT" in a bold, sans-serif font. Below the "AVANT" text, the word "TECHNOLOGY" is written in a smaller, sans-serif font.

4.1 Date Prepared [21CFR807.92(a)(1)]

January 28, 2010

4.2 Submitter's Information [21CFR807.92(a)(1)]

Company Name:	XAVANT TECHNOLOGY (PTY) LTD
Street Address:	Ravello 1st Floor, Delmondo Office Park169 Garsfontein RoadAshlea Gardens 0081
City:	Pretoria
State/Province:	Gauteng
Country:	South Africa
Telephone:	+27(0) 12 755 9491
Facsimile:	+27(0) 86 547 0026
Contact Person:	Brian Rothman
Contact Title:	Quality Assurance and RegulatoryCompliance Officer
Contact Email:	brian@xavant.com

4.3 Trade Name, Common Name, Classification [21CFR807.92(a)(2)]

Trade Name:	STIMPOD NMS450 Nerve Stimulator
Common Name:	Battery Powered Peripheral Nerve Stimulator
Classification Name:	Battery Powered Nerve Stimulatorper 21 CFR § 868.2775
Device Class:	Class II
Product Code:	BXN

STIMPOD NMS450 Nerve Stimulator
Doc No: XAV-510k-03 Ver 3.00

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4.4 Identification of Predicate Device(s) [21CFR807.92(a)(3){

PREDICATE DEVICES

HDC Corporation. NeuroTrace III (K023342)

Xavant Technology, STIMPOD NMS400 (K093591)

Life Technologies Inc. EzStim II (K954505)

There are no significant differences between the STIMPOD NMS450 Nerve Stimulator and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use.

4.5 Description of the Device [21CFR807.92(a)(4)]

The STIMPOD NMS450 is a battery powered peripheral nerve stimulators that can be used for

nerve mapping using the non-invasive Nerve Mapping Probe (supplied) �
nerve locating using invasive electrodes/needles (not supplied) �
general anesthesia, for the purpose of establishing the efficacy of a Neuromuscular � Blocking Agent using non-invasive surface electrodes (not supplied)

The stimulus is generated by a constant current source. The waveform is a square wave with various pulse width options.

The anode comprises of an ECG electrode (not supplied). The cathode comprises of

a permanently attached nerve mapping probe (supplied) for nerve mapping, .
. and/or a separate nerve locating needle (not supplied) for nerve locating,
and/or another ECG electrode (not supplied) for NMBA monitoring, depending on . the mode of the unit.

4.6 Intended Use [21CFR807.92(a)(5)]

This product is a nerve stimulation device designed to be used by an anesthetist during

1. General Anaesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes (not supplied)
1. Regional Anaesthesia for the purpose of
- nerve mapping using the non-invasive Nerve Mapping Probe (supplied) and a.
- nerve locating using invasive electrodes/needles (not supplied) b.

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4.7 Technological Characteristics [21CFR807.92(a)(6)]

Stimulus Modes

Monophasic Square wave, repeating at 1Hz, 2Hz, 5Hz, 50Hz, 100Hz Stimulation patterns: Train-of-Four, Double Burst, Post-Tetanic-Count, Twitch, Tetanus

Current Ranges

Current Ranges
Nerve mapping:	0 – 20mA
Pulse Width:	0.05ms, 0.1ms, 0.3ms, 0.5ms, 1ms
Nerve Locating:	0.0 - 5.0mA
Pulse Width:	0.05ms, 0.1ms, 0.3ms, 0.5ms, 1ms
NMBA Mode:	0.0 - 80.0mA
Pulse Width:	0.2ms

Stimulation Voltages

Nerve Mapping:	Max 400V p-p
Nerve Locating:	Max 100V p-p
NMBA Mode:	Max 400V p-p

Waveform

Constant Current

i Monophasic
Squarewave

Nerve Mapping Probe

Nerve Mapping Probe designed for non-invasive nerve mapping

Three-Dimensional Accelerometer

Three-dimensional accelerometer designed to provide feedback for NMBA monitoring

Technical Specifications

STIMPOD NMS450 Nerve Stimulator Doc No: XAV-510k-03 Ver 3.00

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Power Supply	4 x AAA Alkaline Batteries
Weight	130g
Dimensions	145mm x 90mm x 30mm

The STIMPOD NMS450 Peripheral Nerve Stimulator is equivalent to the identified

predicates in technical properties, design and utilized materials of construction of the

currently marketed predicate devices.

4.8 Product Similarities with the predicates

The similarities between the subject device and cited predicate nerve stimulator product are summarized below:

System components	Equivalent
Indications for Use	Equivalent
Principles of Operation	Equivalent
Required Labeling	Equivalent
Contraindications	Equivalent
Materials	Equivalent
Electrical Performance	Equivalent

The STIMPOD NMS450 has the similar technological characteristics as the predicate device, device design, appearance, materials and indication for use.

The STIMPOD NMS450 has the similar technical properties as the predicate device; waveform and current settings, pulse width setting, current settings in NMBA.

The STIMPOD NMS450 has been subjected to extensive safety, performance and product validations prior to release. Safety testing including biocompatibility test has been performed to ensure that the devices comply with the applicable international and US regulations.

4.9 Conclusion

Clinical Use

Each of the above devices:

. used for the same clinical condition or purpose;
have similar relevant critical performance according to expected clinical effect for . specific intended use.

Technical Characteristics

Each of the above devices:
used under similar conditions of use; .
have similar specifications and properties; ●
are of similar design; .

STIMPOD NMS450 Nerve Stimulator Doc No: XAV-510k-03 Ver 3.00

{4}------------------------------------------------

. use similar deployment methods;
. have similar principles of operation; and
have similar electrical performance. .

Biological Characteristics

Each of the above devices has:

no known biocompatibility issues; and .
no known effect on the environment, or to other devices. .

Based upon the above clinical use, technical and biological considerations the manufacturer believes that the STIMPOD NMS450 Peripheral Nerve Stimulators are substantially equivalent to the identified predicate devices, and does not raise any new questions of safety and effectiveness.

Xavant Technology, will update and include in this summary any other information deemed reasonably necessary by the FDA.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the bird's body and wings. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Xavant Technology (PTY) Limited C/O Mr. Marc M. Mouser Responsible Third Part Official Underwriters Laboratories, Incorporated 2600 NW Lake Road Camas, Washington 98607-9526

DEC 16 2010

Re: K102084

Trade/Device Name: STIMPOD NMS450 Nerve Stimulator Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator | Regulatory Class: II Product Code: BXN Dated: November 29, 2010 Received: December 2, 2010

Dear Mr. Mouser:

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 misting 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 misley ware

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, This 21, and 800 lo 898. In
Register Register.

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Page 2- Mr. Mouser

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 Fequirements.
You must comply with all the active 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-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 (21 CFR Part 820)
and if applicable, the electronic product radiation control provisions (Sections 531the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to please go to

http://www.fda.gov/AboutFDA/CentersQffices/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 yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

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INDICATIONS FOR USE

.. K102084

510(k) Number (if known):

DEC 16 2010

ﺮ ، ﻓﻬﺎ

Device Name: STIMPOD NMS450 Nerve Stimulator

Indications for Use:

This product is a nerve stimulation device designed to be used by an anesthetist during

1. General Anaesthesia, for the purpose of establishing the efficacy of a
Neuromuscular Blocking Agent using non-invasive surface electrodes (not supplied). --
1. Regional Anaesthesia for the purpose of
- a. Nerve mapping using the non-invasive Nerve Mapping Probe (supplied).
- b. Nerve locating using invasive electrodes/needles (not supplied).

Prescription Use X (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)

L. Schullto

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

11/2084 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).