XPOD/XMAP NERVE STIMULATOR

K072092 · Xavant Technology (Pty), Ltd. · BXN · Nov 15, 2007 · Anesthesiology

Device Facts

• Record ID: K072092
• Device Name: XPOD/XMAP NERVE STIMULATOR
• Applicant: Xavant Technology (Pty), Ltd.
• Product Code: BXN · Anesthesiology
• Decision Date: Nov 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2775
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The XPOD/XMAP is a nerve stimulation device intended to be used by an anesthetist during regional anesthesia procedures wherever peripheral anesthesia is normally applied. The XMAP is intended for percutaneous nerve mapping using the non-invasive Nerve Mapping Probe (supplied). The XPOD is intended for nerve localization using invasive electrodes/needles (not supplied).

Device Story

Battery-powered peripheral nerve stimulator; generates constant current monophasic square wave pulses. XMAP model uses non-invasive cutaneous probe for nerve mapping; XPOD model uses invasive needles/electrodes for nerve localization. Device continuously checks for closed circuit at 2Hz; triggers stimulation upon detection. User adjusts current amplitude and pulse width (0.1ms or 0.3ms) via controls; LCD screen provides visual feedback. Used by anesthetists in clinical settings to assist in regional anesthesia procedures. Facilitates precise nerve identification, potentially improving anesthesia delivery and patient outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, function, and operational principles.

Technological Characteristics

Battery-powered (2x 1.5V AAAA) constant current nerve stimulator. Waveform: Monophasic square wave (2Hz). Pulse widths: 0.1ms, 0.3ms. XMap current range: 0-20mA (1mA increments). XPod current range: 0-5.0mA (0.1-0.2mA increments). Max voltage: 100V p-p. Dimensions: 80mm x 80mm x 22mm. Weight: 60g. Includes cutaneous nerve mapping probe.

Indications for Use

Indicated for use by anesthetists during regional anesthesia procedures requiring peripheral nerve mapping (XMAP model, percutaneous) or nerve localization (XPOD model, invasive).

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 CORP, Neuro-Trace III (K023342)
• Stockert GmbH, Stimuplex HNS12 (K052313)

Submission Summary (Full Text)

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# SECTION 4

K072092

#### ION 4 -- 510(k) SUMMARY SECT

NOV 1 5 2007

[As required by 21CFR807.92]

Image /page/0/Picture/5 description: The image shows the logo for Xavant Technologies. The logo features a large, bold "X" followed by the word "AVANT" in a similar bold font. Below "AVANT" is the word "TECHNOLOGIES" in a smaller, less bold font.

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

July 26, 2007

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

| Company Name: | XAVANT Technology (Pty) LTD |
|-----------------|-----------------------------------|
| Street Address: | 181 Soutpansberg Road, Rietondale |
| City: | Pretoria |
| State/Province: | Gauteng |
| Country: | South Africa |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Contact Person: | Roché van Rensburg |
| Contact Title: | Director |
| Contact Email: | [e-mail] |

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

| Trade Name: | The XPOD/XMAP 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 |

XAVANT Technology Nerve Stimulator

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# SECTION 4

### 4.4 Identification of Predicate Device(s) [21CFR807,92(a)(3)]

| PREDICATE DEVICES |
|--------------------------------|
| HDC CORP, Neuro-Trace III |
| (K023342) |
| Stockert GmbH, Stimuplex HNS12 |
| (K052313) |

There are no significant differences between the XPOD/XMAP Nerve Stimulator and the predicate devices which 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 XPod/XMap devices are battery powered peripheral nerve stimulators that can be used for

- nerve mapping using the non-invasive Nerve Mapping Probe (supplied) ﻬ
- nerve locating using invasive electrodes/needles (not supplied) ◆ ◆

The stimulus is generated by a constant current source. The waveform is a square wave with 2 options for pulse width. These are: 0.1 and 0.3 milliseconds.

The units will continuously check for a closed circuit at 2Hz. Once a closed circuit is detected, the twitches will repeat at 2Hz, until an open circuit is detected.

Visual feedback of the current amplitude as well as pulse-width is given by means of an LCD screen.

The unit is permanently attached to the anode. The anode comprises a modified ECG type pad. The cathode comprises a permanently attached nerve mapping probe, in the XMap model, and a separate nerve locating needle in the XPod model.

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

The XPOD/XMAP is a nerve stimulation device intended to be used by an anesthetist during regional anesthesia procedures wherever peripheral anesthesia is normally applied. The XMAP is intended for percutaneous nerve mapping using the non-invasive Nerve Mapping Probe (supplied). The XPOD is intended for nerve localization using invasive electrodes/needles (not supplied).

XAVANT Technology Nerve Stimulator

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# SECTION 4

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

### Stimulus Modes

Square wave, repeating at 2Hz

### Current Ranges

| Xmap: | 0 - 20mA adjustable in 1mA increments |
|--------------|--------------------------------------------|
| Pulse Width: | 0.1ms, 0.3ms |
| Xpod: | 0.0 - 1.6mA adjustable in 0.1mA increments |
| | 1.6 - 5.0mA adjustable in 0.2mA increments |
| Pulse Width: | 0.1ms, 0.3ms |

# Stimulation Voltages

| XMap: | Max 100V p-p |
|-------|--------------|
| XPod: | Max 100V p-p |

# Waveform

Constant Current Monophasic Squarewave

## Nerve Mapping Probe

Ergonomically designed cutaneous Nerve Mapping Probe

### Technical Specifications

| Power Supply | 2x 1.5V AAAA Alkaline Batteries |
|--------------|---------------------------------|
| Weight | 60g |
| Dimensions | 80mm x 80mm x 22mm |

XAVANT Technology Nerve Stimulator

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and four horizontal bars above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 5 2007

Mr. Roche Van Rensburg Director Xavant Technology Party, Limited 181 Soutpansberg Road, Rietondale Pretoria, Gauteng 0084 South Africa

Re: K072092

Trade/Device Name: XPOD/XMAP Nerve Stimulator Regulation Number: 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: II Product Code: BXN Dated: October 5, 2007 Received: October 29, 2007

Dear Mr. Rensburg:

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 such 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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Page 2 - Mr. Rensburg

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Liu, Ph.D.

Chiu Lin. Ph.D. 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):

| Device Name: |
|--------------|
|--------------|

The XPOD/XMAP Nerve Stimulator

Indications for Use:

The XPOD/XMAP is a nerve stimulation device intended to be used by an anesthetist during regional anesthesia procedures wherever peripheral anesthesia is normally applied. The XMAP is intended for percutaneous nerve mapping using the non-invasive Nerve Mapping Probe (supplied). The XPOD is intended for nerve localization using invasive electrodes/needles (not supplied).

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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