STIMPOD ST2-3010 NERVE STIMULATOR

K140853 · Xavant Technology (Pty), Ltd. · BXN · Nov 6, 2014 · Anesthesiology

Device Facts

• Record ID: K140853
• Device Name: STIMPOD ST2-3010 NERVE STIMULATOR
• Applicant: Xavant Technology (Pty), Ltd.
• Product Code: BXN · Anesthesiology
• Decision Date: Nov 6, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.2775
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The STIMPOD ST2-3010 is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied)

Device Story

Battery-powered peripheral nerve stimulator; used by anesthetists for nerve localization. Device connects to conducting needles (not supplied) to deliver electrical stimulation to specific neural pathways. Constant current source generates monophasic square wave pulses (0.1, 0.2, 0.3 ms pulse widths; 20, 50, 100 Hz frequencies). Unit continuously monitors circuit impedance; delivers stimulus only when closed circuit detected. Visual (LED) and audible (buzzer) feedback provided to clinician. Device operates via tactile membrane keypad and capacitive sensing wheel. Output helps clinician identify nerve proximity during regional anesthesia procedures, potentially improving needle placement accuracy and patient outcomes.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (3rd ed), IEC 60601-1-2 (EMC), and IEC 60601-2-10 (nerve/muscle stimulator safety) demonstrated. No clinical data provided.

Technological Characteristics

Battery-powered (4x AAA) peripheral nerve stimulator. ABS enclosure; 145mm x 90mm x 30mm; 130g. Constant current monophasic square wave output (0-10mA, 0.1-0.3ms pulse width). Class IIa, Type BF. Connectivity: wired stimulation cable. Software: C-language, microprocessor-controlled. Cleaning: soap/water or ethyl alcohol-based disinfectant.

Indications for Use

Indicated for nerve locating using invasive electrodes or needles in patients requiring regional anesthesia.

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

• Stimpod NMS450 (K102084)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a simple, line-art style.

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

November 6, 2014

Xavant Technology (Pty) Limited Mr. Roche van Rensburg Chairman Ravello 1st Floor, Delmondo Office Park 169 Garsfontein Road Ashlea Gardens Pretoria, Gauteng 0081 SOUTH AFRICA

Re: K140853

Trade/Device Name: Stimpod ST2-3010 Nerve Stimulator Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: II Product Code: BXN Dated: October 1, 2014 Received: October 10, 2014

Dear Mr. Rothman:

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.

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Page 2 - Mr. Rothman

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,

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

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# ATTACHMENT 2

# INDICATIONS FOR USE

510(k) Number (if known):

K140853

Device Name: STIMPOD ST2-3010 nerve stimulator

Indications for Use:

The STIMPOD ST2-3010 is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied)

X Prescription Use (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)

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# ATTACHMENT 4

# 510(k) SUMMARY

[As required by 21CFR807.92]

Image /page/3/Picture/3 description: The image is a logo for Xavant Technology. The logo features a stylized blue "X" with a gray orbital path and dot, followed by the word "AVANT" in red, block letters. Below "AVANT" is the word "TECHNOLOGY" in a smaller, gray, sans-serif font.

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

July 28, 2014

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

| Company Name: | XAVANT Technology (Pty) LTD |
|-----------------|------------------------------------------|
| Street Address: | Ravello, 1st Floor. Delmondo Office Park |
| | 169 Garstfontein Road |
| | Ashlea Gardens |
| City: | Pretoria |
| State/Province: | Gauteng |
| Country: | South Africa |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Contact Person: | Brian Rothman |
| Contact Title: | Quality Assurance and Regulatory |
| | Compliance Officer |
| Contact Email: | [e-mail] |

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

| Trade Name: | STIMPOD ST2-3010 nerve stimulator |
|----------------------|---------------------------------------------|
| Common Name: | Battery Powered Peripheral Nerve Stimulator |
| Classification Name: | Anesthesiology<br>per 21 CFR § 868.2775 |
| Device Class: | Class II |
| Product Code: | BXN |

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

#### PREDICATE DEVICES

Xavant Technology, STIMPOD NMS450 (K102084)

There are no significant differences between the STIMPOD ST2-3010 Nerve Stimulator and the predicate devices which would adversely affect the use of the product. It is substantially equivalent to the device in design, function, materials, operational principles and intended use.

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

- general anesthesia, for the purpose of establishing the efficacy of a � Neuromuscular Blocking Agent using non-invasive surface electrodes (not supplied)
- 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 units will continuously check for a closed circuit. Once a closed circuit is detected, the unit will deliver a stimulus until an open circuit is detected.

Once operational the unit will flash an LED when the circuit with the patient is a closed circuit and the stimulation was successfully delivered. In the case that the circuit with the patient is an open circuit, a stimulus will not be delivered.

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), and/or an ECG electrode (not supplied), depending on the mode of the unit

This product is a nerve stimulation device designed to be used by an anaesthetist. durina

- 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) and
- b) nerve locating using invasive electrodes/needles (not supplied)

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

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The STIMPOD ST2-3010 device is a battery powered peripheral nerve stimulator that can be used for

- the purpose of nerve locating using invasive electrodes or needles (not supplied) .
The STIMPOD ST2-3010 is a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle.

The stimulus is generated by a constant current source. The waveform is a monophasic square wave with 3 options for pulse width. These are: 0.1, 0.2 and 0.3 milliseconds.

The unit dimensions are 145mm x 90mm x 30mm with a weight of 130 g

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

This product is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied).

The difference in intended use is not critical to its use and does not affect the safety and efficacy of the subject device. Both subject and predicate device are nerve stimulators. Where as the predicate device has three (3) indications for use, the subject device has only one. This is to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied). The predicate device has this use listed and already has clearance.

The intended use of the subject device is limited to within the currently cleared indications of the predicate device.

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

#### Operating Modes:

| Current Range: | 0.00 – 10.00mA ±5%<br>adjustable in 0.1mA increments. |
|------------------------|-------------------------------------------------------|
| Pulse Width Options: | 100µs, 200µs, 300µs |
| Stimulus: | Monophasic square wave |
| Stimulating Frequency: | 20Hz, 50Hz and 100Hz |

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## Waveform:

Constant Current Monophasic Square wave

#### Technical Specifications

| Device Classification: | Class Ila, Type BF |
|------------------------------------|------------------------------|
| Power Supply: | 4x AAA alkaline batteries |
| Power Consumption: | 18mA |
| Maximum Stimulation Voltage: | 70V |
| Weight: | 130g |
| Dimensions: | 145mm x 90mm x 30mm |
| Load Impedance: | 0 kOhm – 7 kOhm |
| Operating Temperature: | 10 - 40 Degrees Celsius (°C) |
| Storage and Transport Temperature: | 0 - 50 Degrees Celsius (°C) |
| Operating Humidity: | 90% Relative Humidity |

Summary of technical characteristics between predicate device (STIMPOD NMS450) and new device (STIMPOD ST2-3010)

| Device Name: | STIMPOD ST2-3010 | STIMPOD NMS450 | Affects<br>Indications<br>for Use /<br>Technology | Comments |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Product<br>Components: | 1. Nerve Stimulator<br>2. Stimulation Cable<br>3. IFU | 1. Nerve Stimulator<br>2. Nerve Locating Cable<br>3. Nerve Mapping/Locating Cable<br>4. NMBA Monitoring Cable<br>5. IFU | NO (e) | Both contain a nerve stimulator and a cable.<br>The NMS450 has additional cables for additional functions |
| Indications for<br>Use: | This product is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied) | This product is a nerve stimulation device designed to be used by an anesthetist during<br>1. general anesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes | NO - In this case, the indications for use are limited to within the cleared indications for use of the predicate device (a) (c) | Essentially, both devices are for nerve localization using invasive electrodes/needles (not supplied) |
| Device Name: | STIMPOD ST2-3010 | STIMPOD NMS450 | Affects Indications for Use / Technology | Comments |
| | | (not supplied<br>2. regional anesthesia<br>for the purpose of<br>a. nerve mapping<br>using the non-<br>invasive Nerve<br>Mapping Probe<br>(supplied) and<br>b. nerve locating<br>using invasive<br>electrodes/need<br>les (not<br>supplied) | | |
| Current Ranges | 0 -10mA | Nerve Locating: 0-5mA<br>Nerve mapping: 0-20mA<br>NMBA Mode: 0-80mA | NO (d) | The current<br>range is<br>covered |
| Energy Type<br>(1) | 4 X AAA alkaline batteries, 6V | 4 X AAA alkaline batteries, 6V | NO (e) | Both units<br>are battery<br>powered |
| Activation<br>Labeling: | ON/OFF Power button<br>According to ISO 15223 | ON/OFF Power button<br>According to ISO 15223 | NO (e)<br>NO (d) | |
| Anatomical<br>site of use<br>Testing | Location of peripheral<br>nerves<br>SAFETY TESTING | Location of peripheral<br>nerves<br>SAFETY TESTING | NO (a) , (b),<br>(c) | |
| | Passed<br>(IEC 60601-1) 3rd edition | Passed<br>(IEC 60601-1) 3rd edition | NO (b) , (h) | |
| | RADIATED RADIO<br>FREQUENCY<br>ELECTROMAGNETIC<br>FIELD 80 MHz TO 2500<br>MHz<br>IEC61000-4-3<br>Passed | RADIATED RADIO<br>FREQUENCY<br>ELECTROMAGNETIC<br>FIELD 80 MHz TO 2500<br>MHz<br>IEC61000-4-3<br>Passed | NO (b) , (h) | |
| | ELECTROMAGNETIC<br>COMPATIBILITY<br>Passed<br>(IEC 60601-1-2) | ELECTROMAGNETIC<br>COMPATIBILITY<br>Passed<br>(IEC 60601-1-2) | NO (b) , (h) | |
| | Medical electrical<br>equipment. Particular<br>requirements for the | Medical electrical<br>equipment. Particular<br>requirements for the | NO(b) , (h) | |
| Device Name: | STIMPOD ST2-3010 | STIMPOD NMS450 | Affects<br>Indications<br>for Use /<br>Technology | Comments |
| | safety of nerve and<br>muscle stimulators | safety of nerve and<br>muscle stimulators | | |
| | PASSED<br>(IEC 60601-2-10) | PASSED<br>(IEC 60601-2-10) | | |
| Weight (5) | 130g | 130g | NO (e) | Same weight |
| Size (unit) (5) | 145mm x 90mm x 30mm | 145mm x 90mm x 30mm | NO (e) | Identical<br>enclosures |
| Enclosure (4) | Manufactured from ABS | Manufactured from ABS | NO (i) | Identical<br>enclosures |
| Dial (4) | Tactile membrane with<br>capacitive sensing wheel.<br>Manufactured from<br>polycarbonate | Tactile membrane with<br>capacitive sensing wheel.<br>Manufactured from<br>polycarbonate | NO (e) | Same<br>keypads,<br>different<br>coloring and<br>function |
| LCD (4) | Not covered | Not covered | NO (e) | |
| Cable (4) | KE-PVC moulding<br>Connector – Gold plated | KE-PVC moulding<br>Connector – Gold plated | NO (e), (l) | Similar cable<br>construction, |
| Packaging (7) | Non-sterile<br>Multiple Use<br>Packaging in a<br>polypropylene carry case | Non-Sterile<br>Multiple Use<br>Packaging in a<br>polypropylene carry case | NO (e), (f) | Packaged in<br>the same<br>way |
| Software (6) | Language: C<br>Architecture | Language: C<br>Architecture | | |
| | - User Inputs<br>• Keypad<br>• Dial | - User Inputs<br>• Keypad<br>• Dial | | |
| | - External Inputs<br>• Open circuit<br>detection Low<br>voltage<br>• No Open circuit<br>detection High<br>voltage<br>• Battery Voltage<br>• Cable ID x 1<br>• No accelerometer | - External Inputs<br>• Open circuit<br>detection Low<br>voltage<br>• Open circuit<br>detection High<br>voltage<br>• Battery Voltage<br>• Cable ID x 3<br>• Accelerometer | NO (d), (g) | |
| | - Outputs<br>• Display Menu<br>• Display Main<br>Screen | - Outputs<br>• Display Menu<br>• Display Main<br>Screen | | |
| Device Name: | STIMPOD ST2-3010 | STIMPOD NMS450 | Affects<br>Indications<br>for Use /<br>Technology | Comments |
| | (Closed Circuit)<br>○ Red LED (Open<br>Circuit)<br>○ Buzzer Alarm<br>○ Square Wave<br>Stimulation Low<br>Voltage<br>○ No Square Wave<br>Stimulation High<br>voltage | (Closed Circuit)<br>○ Red LED (Open<br>Circuit)<br>○ Buzzer Alarm<br>○ Square Wave<br>Stimulation Low<br>voltage<br>○ Square Wave<br>Stimulation High<br>voltage | | |
| Waveform<br>Pulse Width<br>(3) | Monophasic Square Wave<br>0.1, 0.2, 0.3ms | Monophasic Square Wave<br>0.05, 0.1, 0.3, 0.5, 1ms | NO (h) | Similar and<br>within the<br>range of the<br>predicate |
| Shelf Life (7) | 5 Years | 5 Years | NO (e) | |
| Control<br>Mechanism<br>(3) | Digitally controlled by a<br>microprocessor | Digitally controlled by a<br>microprocessor | NO (g) | |
| Electronics | PCB:2 layer board<br>POWER SOURCE:: 4 x<br>AAA<br>POWER SUPPLY: Switch<br>Mode<br>MAX POWER<br>CONSUMPTION: ± 40mA<br>MAX VOLTAGE: 100V | PCB:2 layer board<br>POWER SOURCE:: 4 x<br>AAA<br>POWER SUPPLY: Switch<br>Mode<br>MAX POWER<br>CONSUMPTION: 79mA<br>MAX VOLTAGE: 400V | NO (h) | |
| Device<br>Cleaning | <b>Cleaning:</b> Soap and water,<br>applied with a damp cloth is<br>suitable to clean and<br>disinfect the STIMPOD. It is<br>imperative that no moisture<br>penetrates the STIMPOD.<br><b>Disinfecting:</b> Any<br>commercially available<br>methanol - free disinfectant<br>in an ethyl alcohol base<br>can be used for disinfection | <b>Cleaning:</b> Soap and water,<br>applied with a damp cloth is<br>suitable to clean and<br>disinfect the STIMPOD. It is<br>imperative that no moisture<br>penetrates the STIMPOD.<br><b>Disinfecting:</b> Any<br>commercially available<br>methanol - free disinfectant<br>in an ethyl alcohol base can<br>be used for disinfection. | NO (e) | |
| 510(k) | This submission. | K102084 | | |

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## A detailed comparison has provided the following conclusions:

The bolded letters reference the relevant section on the table above. This is indicated in the column "affects indications for use / Technology"

## Clinical Use

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The target populations on which product usage would occur are the same as those of the cited predicate device.

The Stimpod ST2-3010 employs a subset of the indications for use of the Stimpod NMS450, the same contraindications for use, and the same warnings and precautions within labelling

Each of the above devices:

- used for the same clinical condition or purpose; (a) ●
- . have similar relevant critical performance according to expected clinical effect for specific intended use. (b)

#### Technical Characteristics

The STIMPOD ST2-3010 is equivalent to the identified predicate in design and utilized materials of construction of the currently marketed aforementioned predicate devices.

Also, the principles of operation of the subject device are directly equivalent to those of the cited predicate

Each of the above devices:

- are used under similar conditions of use; (c) ●
- have similar specifications and properties; (d)
- are of similar design; (e) ●
- use similar deployment methods; (f) ●
- have similar principles of operation; (g) and ●
- have similar electrical performance. (h) .

As indicated in the table above, the ST2-3010 and the NMS450 are exact matches on technical characteristics, with the following exceptions:

- 1. Current Range 0-10 compared to Current Range 0-5 (Nerve Locating)
- a. The ST2-3010 can adjust the current up to 10mA. The NMS450 however can only adjust the current to 5mA. However, the NMS450 can adjust pulse width up to 1ms, whereas the ST2-3010 can only adjust pulse width up to 0.3ms. That concludes that the maximum charge output of the ST2-3010 is 3uC, which is only 60% of the maximum charge output (5uC) of the NMS450. Thus patient safety is not affected by this change.
- 2. Pulse width options 0.1, 0.2, 0.3ms compared to 0.05, 0.1, 0.3, 0.5, 1.0ms
- a. The pulse width options of the ST2-3010 are a subset of the pulse width options of the NMS450, and therefor do not affect patient safety.
- 3. No High Voltage stimulation vs. High Voltage Stimulation
- a. As the ST2-3010 is only a nerve location device, it only employs the low voltage section of the electrical circuit, exactly the same as the Nerve Locating mode on the NMS450

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#### Biological Characteristics

Each of the above devices has:

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

#### Contents ST2-3010 Peripheral Nerve Stimulator Kit.

The Kit will include the following parts:

- Peripheral Nerve Stimulator a.
- b. Stimulation Adaptor Cable
- Carrying Case C.
- Instructions for Use d.

Note: Needles, ECG electrodes and batteries are not supplied