nerve mapping using the non-invasive Nerve Mapping Probe (supplied)
nerve locating using invasive electrodes/needles (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 a permanently attached nerve mapping probe (supplied), and/or a separate nerve locating needle (not supplied), depending on the mode of the unit.

AI/ML Overview

The provided text (K093591) is a 510(k) summary for a medical device (STIMPOD NMS400 Nerve Stimulator). It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on establishing "substantial equivalence" to predicate devices, which is a regulatory pathway for clearance in the US. This process typically involves demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, and that any differences do not raise new questions of safety or effectiveness.

Therefore, I cannot provide the requested information. The sections you asked for, such as sample size for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are typically part of a comprehensive clinical study report, which is not included in this 510(k) summary.

In summary, based on the provided text, the device's acceptance criteria and any study demonstrating their fulfillment are not described.

Summary

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KC093591

SECTION 4 DEC - 3 2009

ﺎ

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 an orbital path around it, followed by the text "AVANT" in bold, uppercase letters. Below "AVANT" is the word "TECHNOLOGY" in a smaller, uppercase font.

4.1 Date Prepared [21CFR807.92(a)(1)] May 11, 2009

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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 NMS400 Nerve Stimulator Common Name: Classification Name: per 21 CFR § 868.2775 Device Class:

Product Code:

Battery Powered Peripheral Nerve Stimulator Battery Powered Nerve Stimulator Class II BXN

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SECTION 4

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

Image /page/1/Figure/2 description: The image shows a list of predicate devices. The first device is the HDC Corporation, NeuroTrace III (K023342). The second device is the Xavant Technology, XPOD/XMAP Nerve Stimulator (K072092). The third device is the Stockert GmbH, Stimuplex HNS12 (K052313).

There are no significant differences between the STIMPOD NMS400 Nerve Stimulator and the predicate devices that would adverselv affect 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 NMS400 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)

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 a permanently attached nerve mapping probe (supplied), and/or a separate nerve locating needle (not supplied), 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 regional anesthesia for the purpose of

1. nerve mapping using the non-invasive Nerve Mapping Probe (supplied) and
1. nerve locating using invasive electrodes/needles (not supplied)

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SECTION 4 4.7 Technological Characteristics [21CFR807.92(a)(6)]

Stimulus Modes

11 ﺷ

Monophasic Square wave, repeating at 1Hz or 2Hz

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

Stimulation Voltages

Nerve Mapping:	Max 300V p-p
Nerve Locating:	Max 100V p-p

Waveform

· Constant Current Monophasic Squarewave

Nerve Mapping Probe

Nerve Mapping Probe designed for non-invasive nerve mapping

Technical Specifications

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

STIMPOD NMS400 Nerve Stimulator Doc No: XAV-510k-02 Ver 2.00

Page 4-3 XAVANT TECHNOLOGY

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text reading "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is an abstract symbol resembling an eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Xavant Technology Party, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 NW Lake Road Camas, Washington 98607-5926

DEC - 3 2009

Re: K093591

Trade/Device Name: STIMPOD NMS400 Nerve Stimulator Regulation Number: 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: II Product Code: BXN Dated: October 26, 2009 Received: November 19, 2009

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 misbranding and adulteration.

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.

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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 (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 (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.ida.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1]15809.htm forthe 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting 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

510(k) Number (if known): KC99359)

Device Name:

ﺋ

STIMPOD NMS400 Nerve Stimulator

Indications for Use:

This product is a nerve stimulation device designed to be used by an anesthetist during regional anesthesia for the purpose of

nerve mapping using the non-invasive Nerve Mapping Probe (supplied) and
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)

Schultheis

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

510(k) Number: K093591

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).