STIMPOD NMS450 NERVE STIMULATOR

K102084 · Xavant Technology (Pty), Ltd. · BXN · Dec 16, 2010 · Anesthesiology

Device Facts

• Record ID: K102084
• Device Name: STIMPOD NMS450 NERVE STIMULATOR
• Applicant: Xavant Technology (Pty), Ltd.
• Product Code: BXN · Anesthesiology
• Decision Date: Dec 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2775
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended 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) 2. Regional Anaesthesia for the purpose of nerve mapping using the non-invasive Nerve Mapping Probe (supplied) and nerve locating using invasive electrodes/needles (not supplied).

Device Story

STIMPOD NMS450 is a battery-powered peripheral nerve stimulator used by anesthetists in clinical settings. It functions as a constant current source, delivering monophasic square wave electrical pulses. Inputs include user-selected stimulation modes (Train-of-Four, Double Burst, Post-Tetanic-Count, Twitch, Tetanus) and current/pulse width parameters. Outputs are delivered via a supplied nerve mapping probe, user-supplied invasive needles, or surface electrodes. A 3D accelerometer provides feedback for neuromuscular blocking agent (NMBA) monitoring. The device assists clinicians in locating nerves for regional anesthesia and assessing the efficacy of NMBAs during general anesthesia. By providing precise electrical stimulation, it aids in nerve identification and monitoring of muscle relaxation, potentially improving the accuracy of nerve blocks and the safety of anesthesia management.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, including safety, performance, and biocompatibility validations, demonstrating that the device meets applicable international and US regulations.

Technological Characteristics

Battery-powered (4x AAA) peripheral nerve stimulator. Constant current source; monophasic square wave output. Current ranges: 0-20mA (mapping), 0-5mA (locating), 0-80mA (NMBA). Pulse widths: 0.05ms to 1ms. Features 3D accelerometer for NMBA monitoring. Dimensions: 145mm x 90mm x 30mm; Weight: 130g. Biocompatible materials.

Indications for Use

Indicated for use by anesthetists during general anesthesia to establish neuromuscular blocking agent efficacy via surface electrodes, and during regional anesthesia for nerve mapping (using supplied probe) and nerve locating (using invasive electrodes/needles).

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

• HDC Corporation, NeuroTrace III (K023342)
• Xavant Technology, STIMPOD NMS400 (K093591)
• Life Technologies Inc., EzStim II (K954505)

Submission Summary (Full Text)

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K102084

DEC 1 6 2010

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## 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 Park<br>169 Garsfontein Road<br>Ashlea Gardens 0081 |
| City: | Pretoria |
| State/Province: | Gauteng |
| Country: | South Africa |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Contact Person: | Brian Rothman |
| Contact Title: | Quality Assurance and Regulatory<br>Compliance Officer |
| Contact Email: | [e-mail] |

## 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 Stimulator<br>per 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)
- 2. 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

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- . 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 [phone] or [phone] 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). --
- 2. 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: