MYOGUIDE SYSTEM MODEL 8008 by INTRONIX TECHNOLOGIES CORP.

The Intronix Model 8008 Myoguide System (Myoguide) is a medical device intended as a stimulator for nerve localization as well as an aid for guidance of injections into the muscles.

Device Description

Myoguide is a battery powered, handheld, EMG amplifier with audio feedback, LCD EMG signal and device status display, and current stimulation ranging from 0 mA - 20 mA. This device is internally powered and rated for continuous use. The patient input connection is a type BF applied part. Myoguide will automatically power off after 30 minutes of inactivity to conserve battery life.

Myoguide is designed to amplify electrophysiological signals from muscle and provide audio feedback to assist clinicians in locating areas of muscle activity. The Stimulator can be used as an adjunct. Myoguide provides muscle and nerve localization information, to accurately guide and monitor needle electrode insertion, and/or injection of neuromodulator drugs, into a muscle in the human body. Any drug used will be that of the physician.

The large LCD display provides the complete system status at a glance. EMG audio, EMG signal display, EMG RMS Value, Integrated EMG signal strength and stimulation capability, increases efficacy for injection point localization. The simple control panel is intuitive and easy to operate.

Myoguide operates in two modes: "[EMG]" and "[Stimulation]". The default mode, "[EMG]", records electromyographic (EMG) signals from electrodes placed on the subject. The second mode, "[Stimulation]", enables Myoguide's onboard stimulator to stimulate through the needle electrode that was used to record the EMG. This enables the clinician to record and stimulate through the same needle electrode. The switch is used to change the state of operation.

AI/ML Overview

The provided text is a 510(k) Summary for the Myoguide System, seeking substantial equivalence to predicate devices. It does not contain a study demonstrating the device meets specific acceptance criteria in terms of performance metrics. Instead, it relies on demonstrating equivalence in intended use and technological characteristics to previously cleared devices through non-clinical testing.

Here's an analysis based on the information provided and typical FDA 510(k) submission practices:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not define specific quantitative acceptance criteria or report device performance in the manner of a typical performance study with metrics like sensitivity, specificity, accuracy, etc. Instead, it focuses on demonstrating compliance with safety and electrical standards and equivalence in technological characteristics to predicate devices.

The "Comparison Table" provided in the document acts as a de-facto performance comparison, showing that the Myoguide System has similar specifications and features to its predicate devices. The implicit acceptance criteria here are that the Myoguide System's characteristics are within a range comparable to the predicate devices and comply with relevant international standards.

Characteristic	Myoguide System (Reported Performance)	Acceptance Criteria (Implicit, based on Predicate Devices)
Intended Use	Stimulator for nerve localization & aid for muscle injection guidance	Same as predicate devices (e.g., Medtronic Clavis EMG Device)
Overall Design	ABS plastic enclosure, battery powered, handheld, EMG amplifier with audio feedback, LCD EMG signal and device status display; two modes (EMG, Stimulation)	Comparable to predicate devices (e.g., STIMPOD NMS450, Clavis EMG Device) - similar physical form, power source, functionality. LCD display is a noted difference but deemed non-significant.
LCD Display	Yes; 160x64 resolution, with or without backlight	Presence of display (STIMPOD) or functional equivalent (Clavis audio/indicator lights) determined not a significant difference.
Mode of Operation	Continuous operation	Continuous operation (STIMPOD, Clavis)
Stimulation Wave	Square	Square (STIMPOD, Clavis)
Stimulation Pulse Rate	1 Hz, 3 Hz, 5 Hz, 7 Hz, or 10 Hz	Comparable range to predicate devices (STIMPOD: 1, 2, 5, 50, 100 Hz; Clavis: 1, 2 Hz)
Stimulation Pulse Width	50, 100, 200 or 500 μs	Comparable range to predicate devices (STIMPOD: 0.05, 0.1, 0.3, 0.5, 1.0 ms; Clavis: 0.1, 0.2 ms)
Stimulation Level	0 mA to 20 mA, steps by 1.0 mA	Comparable range to predicate devices (STIMPOD: 0-80 mA; Clavis: 0-15 mA)
Electrode Impedance	200Ω to 10kΩ	Comparable range to predicate devices (STIMPOD: 2000Ω to 0kΩ; Clavis: 200Ω to 7kΩ)
Compliance with IEC 60601-1 (Safety)	Yes	Yes (STIMPOD, Clavis)
Compliance with IEC 60601-1-2 (EMC)	Yes	Yes (STIMPOD, Clavis)
Compliance with IEC 60601-2-40	Yes	Yes (STIMPOD, Clavis)
Power Supply	Internally powered, 4AA alkaline or rechargeable batteries	Internally powered, 4AA or 9V alkaline/rechargeable batteries (STIMPOD, Clavis)
Weight	225g (8 oz)	Comparable to predicate devices (STIMPOD: 130g; Clavis: 185g)
Dimensions	150 x 100 x 54 mm (5.9" x 4.0" x 2.1")	Comparable to predicate devices (STIMPOD: 145 x 90 x 30 mm; Clavis: 140 x 80 x 20 mm)
Operating Conditions	+10°C to +40°C (+50°F to +104°F), 30 – 75% rH	Same as predicate devices (STIMPOD, Clavis)
Input Cable	Three input (anode, anode, needle) with proprietary instrument connection port; Single input adapter for standard touch-proof connection	Comparable to predicate devices (STIMPOD, Clavis)

2. Sample Size Used for the Test Set and Data Provenance

Test Set: Not applicable for this type of submission. There was no "test set" of patient data in the context of a clinical performance study. The testing was non-clinical (hardware, software, electrical safety, EMC).
Data Provenance: Not applicable. The testing was laboratory-based, focusing on the device itself rather than clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. As no clinical data was used or generated, there was no need for experts to establish ground truth from patient cases. The "ground truth" for non-clinical testing is typically defined by engineering specifications and international standards.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not performed.
The document explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing."
Therefore, there's no data on the effect size of AI assistance on human readers. The Myoguide System is a standalone medical device, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in a sense, the entire submission functions as a "standalone" assessment of the device's characteristics and safety. The performance is assessed based on its inherent design, and its compliance with electrical and safety standards.
However, it's not an "algorithm-only" performance study in the context of diagnostic AI, as the device is hardware-based with embedded software, intended for direct use by a clinician.

7. Type of Ground Truth Used

For the non-clinical testing (hardware, software, electrical safety, EMC), the "ground truth" was established based on:
- Software Design Specifications: The device's software was tested against its established specifications.
- Device Hazard Analysis: Identifying and mitigating risks.
- International Standards: Compliance with IEC 60601-1 (Safety), IEC 60601-1-2 (EMC), and IEC 60601-2-40 (specific to electrical nerve stimulators).
- Predicate Device Characteristics: The functional and technological characteristics of the predicate devices (STIMPOD NMS450 and Clavis EMG Device) served as a benchmark for substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that requires a "training set" of data for learning. Its functionality is based on fixed algorithms and hardware design.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set.

Summary

{0}------------------------------------------------

DEC 3 0 2011

Section 5 - 510(k) Summary

For

Myoguide System

1. Submission Sponsor

Intronix Technologies Corporation 26 McEwan Drive Suite 15 Bolton, Ontario L7E 1E6 CANADA Phone: (905) 951.3361 Fax: (905) 951.3192 Contact: Joe Wojewoda, Production and Quality Manager

2. Submission Correspondent

Emergo Group 611 West 5th Street, Third Floor Austin, TX 78701 Cell Phone: (508) 838.9139 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Richard Vincins, Vice President, QA Email: richard@emergogroup.com

3. Date Prepared

June 20th 2011

4. Device Name

Trade/Proprietary Name: Myoguide System Common/Usual Name: Myoguide System Model 8008 Classification Name: Electrical Peripheral Nerve Stimulator Classification Regulation: 868.2775 Classification Panel: Anesthesiology Product Code: BXN, secondary GWL Device Class: II

5. Predicate Devices

Medtronic A/S – Clavis EMG Device K062478 Xavant Technology - STIMPOD NMS450 K102084

{1}------------------------------------------------

6. Device Description

7. Intended Use

The Intronix Model 8008 Myoguide System (Myoguide) is a medical device intended as a stimulator for nerve localization as well as an aid for guidance of injections into the muscles.

8. Technological Characteristics and Substantial Equivalence

The following table compares the Myoguide System to the STIMPOD NMS450 and Clavis EMG predicate devices with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

{2}------------------------------------------------

Comparison Table

Comparison Table
Manufacturer	Intronix TechnologiesCorporation	Xavant Technology	Medtronic A/S	Myoguide SystemComparison to Predicate
Trade Name	Myoguide System	STIMPOD NM$450	Clavis EMG Device	NA
510(k) Number	K111985	K102084	K062478
Product Code	BXN, GWL	BXN	BXN, GWL	Same
RegulationNumber	868.2775	868.2775	890.1375	The product code lists868.2775 as the regulationnumber. The IntronixMyoguide System has thesame intended use as thepredicate device, theMedtronic Clavis EMGdevice.
RegulationName	Electrical peripheral nervestimulator	Electrical peripheral nervestimulator	Diagnostic electromyograph	See note above for theregulation number
Indications foruse:	The Intronix Model 8008Myoguide System (Myoguide)is a medical device intendedas a stimulator for nervelocalization as well as an aidfor guidance of injections intothe muscles.	This product is a nervestimulation device designedto be used by an anesthetistduring1. General Anaesthesia, forthe purpose of establishingthe efficacy of aNeuromuscularBlocking Agent using non-invasive surface electrodes(not supplied)2. Regional Anaesthesia forthe purpose ofa. nerve mapping using thenon-invasive Nerve Mapping	CLAVIS is a medical deviceintended as a stimulator fornerve localization aswell as an aid for guidance ofinjections into the muscle.	Same
Manufacturer	Intronix TechnologiesCorporation	Xavant Technology	Medtronic A/S	Myoguide SystemComparison to Predicate
Trade Name	Myoguide System	STIMPOD NMS450	Clavis EMG Device
Overall Design	Myoguide is a ABS plasticenclosure, battery powered,handheld, EMG amplifier withaudio feedback, LCD EMGsignal and device statusdisplay; Myoguide operates intwo modes: EMG andStimulation	b. nerve locating usinginvasive electrodes/needles(not supplied).The STIMPOD NMS450 is aABS plastic enclosure, batterypowered, handheld, EMGamplifier with audio feedback,LCD EMG signal and devicestatus display; STIMPODNMS450 operates in fourstimulation modes	Clavis EMG is a ABS plasticenclosure, battery powered,handheld, EMG amplifier withaudio feedback, and LCD EMGsignal; Clavis EMG operates intwo modes: EMG andStimulation	The three instruments areidentical in technologyaspects except theMyoguide and STIMPODhave an LCD display wherethe Clavis does not; this isnot a significant differenceas the Myoguide andSTIMPOD displays thesystem status, stimulationsettings, and EMG signaland utilizes audio indicatorswhere the Clavis device onlyutilizes indicators lights andaudio indicators
LCD Display	Yes; 160x64 resolution with orwithout backlight	Yes; with or without backlight	None	The Myoguide has an LCDdisplay for complete devicestatus and displays the EMGsignal same as theSTIMPOD; this is not asignificant difference as theMyoguide displays the EMGsignal and utilizes audioindicators where the Clavisdevice only utilizesindicators lights and audioindicators
Manufacturer	Intronix TechnologiesCorporation	Xavant Technology	Medtronic A/S	Myoguide SystemComparison to Predicate
Trade Name	Myoguide System	STIMPOD NMS450	Clavis EMG Device	Same
Mode of Operation	Continuous operation	Continuous operation	Continuous operation	Same
Stimulation Wave	Square	Square	Square	Same
StimulationPulse Rate	1 Hz, 3 Hz, 5 Hz, 7 Hz, or 10 Hz	1 Hz, 2 Hz, 5 Hz, 50 Hz, or 100 Hz	1 Hz or 2 Hz	Same
StimulationPulse Width	50, 100, 200 or 500 μs	0.05, 0.1, 0.3, 0.5 or 1.0 ms	0.1 ms or 0.2 ms	Same
StimulationLevel	0 mA to 20 mA, steps by 1.0 mA	0 mA to 80 mA, steps by 0.2 mA	0 mA to 15 mA, steps by 1.0 mA	Same
ElectrodeImpedance	200Ω to 10kΩ	2000Ω to 0kΩ	200Ω to 7kΩ	Same
Complies withIEC 60601-1	Yes	Yes	Yes	Same
Complies withIEC 60601-1-2	Yes	Yes	Yes	Same
Complies withIEC 60601-2-40	Yes	Yes	Yes	Same
Power Supply	Internally powered, 4AAalkaline or rechargeablebatteries	Internally powered, 4AAalkaline or rechargeablebatteries	Internally powered, 9Valkaline or rechargeablebattery	Same
Weight	225g (8 oz)	130g (4.6 oz)	185 g (6.5 oz)	Same
Dimensions(LxWxH)	150 x 100 x 54 mm (5.9" x4.0" x 2.1")	145 x 90 x 30 mm (5.7" x 3.5"x 1.2")	140 x 80 x 20 mm	Same
OperatingConditions	+10°C to +40°C (+50°F to+104°F)30 – 75% rH	+10°C to +40°C (+50°F to+104°F)30 – 75% rH	+10°C to +40°C (+50°F to+104°F)30 – 75% rH	Same
Input Cable	Three input (anode, anode,needle) with proprietaryinstrument connection port	Three input (anode, anode,needle) with proprietaryinstrument connection port	Three input (anode, anode,needle) with proprietaryinstrument connection port	Same
Manufacturer	ntronix TechnologiesCorporation	Xavant Technology	Medtronic A/S	Myoguide System
Trade Name	Myoguide System	STIMPOD NMS4	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Clavis EMG Device	Comparison to Predicat
nput Cable------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Single input adapter for------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Not available	Not available	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------N/A
Adapter	standard touch-prooi
	connectio

{3}------------------------------------------------

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

{5}------------------------------------------------

{6}------------------------------------------------

9. Non-Clinical Testing

The device's hardware and software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended. The Device Hazard analysis was completed and risk control implemented to reduce any identified hazards. The testing results supports that all the hardware specifications and software specifications have met the acceptance criteria for the device. The Myoguide System passed all testing and supports the claims of substantial equivalence and safe operation.

The Myoguide System complies with the applicable voluntary standards for Electromagnetic Compatibility and Safety. The device passed all the electrical and safety testing according to national and international standards.

10. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing. The verification and validation testing of the device software and electrical safety and EMC testing of the device was found to acceptable and supports the claims of substantial equivalence.

11. Conclusion

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate devices, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate devices.

It has been shown in this 510(k) submission that the difference between the Myoguide System and the predicate devices does not raise any questions regarding its safety and effectiveness. The Myoguide System, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.

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

Intronix Technologies Corporation C/O Mr. Richard Vincins, Vice President, Quality Affairs Emergo Group 611 West 5th Street Austin, Texas 78701

Re: K111985

Trade/Device Name: Myoguide System Model 8008 Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: II Product Code: BXN Dated: December 9, 2011 Received: December 13, 2011

Dear Mr. Vincins:

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.

DEC 3 0 2011

{8}------------------------------------------------

Page 2 - Mr. Vincins

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.fda.gov/AboutFDA/CentersOffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

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

{9}------------------------------------------------

Section 4 - Indications for Use Statement

510(k) Number (if known): Not Assigned

Device Name: Myoguide System

Indications for Use:

The Intronix Model 8008 Myoguide System (Myoguide) is a medical device intended as a stimulator for nerve localization as well as an aid for guidance of injections into the muscles.

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)

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

510(k) Number: K111985

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).