The candidate Pro-Sport Avazzia device is a micro-current transcutaneous electro-stimulation device. It is an easy-to-use, handheld, AA battery-operated portable device for use in the home or clinic.
The device is a portable, battery operated microcurrent electrical stimulation device that applies charge and power to the tissue through electrodes where maximum power delivered to the load is controlled and limited, and an automatic shut off is implemented.
The user can passively place the electrodes where indicated and apply stimulation for a period of time.
The user controls the output by selecting the preset mode and power setting. The device's controls and visual indicators are located on the upper side of the case and on the upper cover.
The Pro-Sport™ device incorporates a more sophisticated digital liquid crystal display user interface to help the user select the mode and see parameters like the power level, time, and other information and has one mode that allows practitioners to set up their own therapy signals.

AI/ML Overview

The provided document is a 510(k) summary for the Avazzia Pro-Sport™ device, which is a microcurrent transcutaneous electro-stimulation device. The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness.

This submission focuses on comparing the new device, Avazzia Pro-Sport™, to its predicate devices (Body-Stim™, Biomodulator™, Best-RSI™, Best-Pro 1™, Model BEST -- AV1™, K062641). The acceptance criteria for such a device are primarily based on demonstrating substantial equivalence to the predicate, rather than meeting specific performance metrics from a clinical study for a novel device.

Here's an analysis based on the provided text, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for K123099 are essentially the characteristics of the predicate device, as the goal is to show substantial equivalence. The document doesn't provide specific quantitative performance metrics like sensitivity/specificity for a diagnostic device, but rather technical specifications and shared indications for use.

Parameter	Acceptance Criteria (Predicate)	Reported Device Performance (Avazzia Pro-Sport™)	Conclusion (Meets/Does Not Meet)
Labeling Claims/Indication	TENS: symptomatic relief & management of chronic, intractable pain; adjunctive treatment in post-surgical & post-traumatic pain	TENS: symptomatic relief & management of chronic, intractable pain; adjunctive treatment in post-surgical & post-traumatic pain	Meets
Device Name/Model	Best-Pro 1, Best-RSI, Biomodulator, Body-Stim	Avazzia Pro Sport™	Not applicable (new model name)
Manufacturer	Avazzia, Inc.	Avazzia, Inc.	Meets
Power Source	2 - 1.5 V AA batteries	2 - 1.5 V AA batteries	Meets
Number of Output Modes	4 preset modes	24 (including 14 preset and AVA user programmable)	Exceeds (Enhanced feature)
Low Battery Indication	Yes	Yes	Meets
Timer Range	60 minutes	60 minutes	Meets
Compliance with Voluntary Standards	Yes	Yes (IEC 60601-1, IEC 60601-1-2)	Meets
Compliance with 21 CFR 898	Yes	Yes	Meets
Weight	7oz	7oz	Meets
Dimensions	2.6" X 1.35" X 4.7"	2.6" X 1.35" X 4.7"	Meets
Housing Materials	Handheld ABS plastic housing with Polypac plastic nameplate and onboard electrodes	Handheld ABS plastic housing with Polypac plastic nameplate and onboard electrodes	Meets
User Interface Display	LEDs	LCD (digital display)	Differs (Enhanced feature)
Design Material	PCBs inside plastic case housing	PCBs inside plastic case housing	Meets
Energy Type	Electro-stimulation	Electro-stimulation	Meets
Pulse Duration	0.1 - 1.15 mS	0.1 - 1.15 mS	Meets
Pulse Frequency	0.5 to 2500 Hz	0.5 to 2500 Hz	Meets
Output Voltage	20 - 650 V	20 - 650 V	Meets
Current Amplitude TENS	0 - 90mA	0 - 90mA	Meets
Timeout	60 minutes	60 minutes	Meets
Waveform	Pulsed, damped, asymmetric biphasic sinusoidal	Pulsed, damped, asymmetric biphasic sinusoidal	Meets

The "study" that proves the device meets the acceptance criteria is primarily the comparison to the predicate device and verification and validation tests (e.g., safety and EMC compliance), as stated in the "Conclusions" section: "Verification and validation tests as well as certificates and test reports contained in this submission demonstrate that the submitted models are substantially equivalent to the safety and effectiveness as that of the cleared devices." The document explicitly states that the new device has the same technological characteristics as the predicate for all listed electrical parameters. The differences are in the user interface (LCD vs. LED, more modes, user-programmable mode), which the submission argues "do not pose new questions regarding safety and effectiveness."

2. Sample size used for the test set and the data provenance

This document does not describe a clinical study with a "test set" of patients or data in the way one might for a diagnostic or therapeutic AI device. The "test set" here refers to the device itself and its components undergoing engineering and electrical safety testing. The submission confirms "Verification and validation tests" were performed, but does not provide details on the sample size for these tests (e.g., how many devices were tested, how many cycles of operation).

The data provenance is internal testing performed by Avazzia, Inc. There is no mention of external data or country of origin for such data. This appears to be a prospective set of engineering tests conducted on the new device model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert clinical ground truth. The "ground truth" for electrical and mechanical specifications is established by engineering standards and functional requirements.

4. Adjudication method for the test set

Not applicable. No expert adjudication process is described as this is an engineering compliance summary, not a clinical study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI or imaging device, and no MRMC study involving human readers is mentioned or relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm or AI system. It is a physical electro-stimulation device. Its performance is evaluated based on its electrical output characteristics and user interface functionality, not algorithmic performance.

7. The type of ground truth used

The ground truth used for this submission is:

Predicate Device Specifications: The established, cleared specifications and performance of the previous (predicate) TENS devices.
Voluntary Standards: International Electro-technical Commission (IEC) standards for medical electrical equipment (IEC 60601-1 for safety and IEC 60601-1-2 for EMC).
Regulatory Requirements: 21 CFR 898 for device compliance.
Engineering Specifications: Internal design requirements for the device's electrical output (pulse duration, frequency, voltage, current, waveform) and physical characteristics (weight, dimensions, materials).

8. The sample size for the training set

Not applicable. There is no machine learning or AI component to this device, therefore no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

Summary

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Avazzia, Inc

123096

510(k) Summary

Submitter's Identifications: Manufacturer and Sponsor:

Avazzia, Inc. 13140 Coit Road., Suite 515 Dallas, TX 75240 USA Establishment Registration # 3004839404 Official Contact Person: Tammy Lahutsky Date of Summary Preparation: April 2014

Classifications: TENS, Class II 21 CFR 882.5890 GZJ

Information of the 510(k) Cleared Devices (Predicate Device):

Body-Stim™, Biomodulator™, Best-RSI™, Best-Pro 1™, Model BEST -- AV1™, (K062641) 4/30/2007, TENS, Class II 21 CFR 882.5890 GZJ

Intended Use:

Pro-Sport™ is indicated for:

. symptomatic relief and management of chronic, intractable pain
adjunctive treatment in the management of post-surgical and post-traumatic pain .

Trade Names of Candidate Devices: Best AV2 Pro Sport™ Device

Description of Candidate Devices:

Description of Candidate Devices as might be found in the labeling or promotional material: The candidate Pro-Sport Avazzia device is a micro-current transcutaneous electro-stimulation device. It is an easy-to-use, handheld, AA battery-operated portable device for use in the home or clinic.

Description of the Candidate Devices - How the devices work:

The device is a portable, battery operated microcurrent electrical stimulation device that applies charge and power to the tissue through electrodes where maximum power delivered to the load is controlled and limited, and an automatic shut off is implemented.

The user can passively place the electrodes where indicated and apply stimulation for a period of time.

The user controls the output by selecting the preset mode and power setting. The device's controls and visual indicators are located on the upper side of the case and on the upper cover.

The Best-Pro 1™, Best-RSI™, Biomodulator™, Body-Stim™ devices have 4 pre-set modes.

Image /page/0/Picture/20 description: The image shows the word "AVAZIA" in a bold, sans-serif font. The letters are black, and there is a thick black line underlining the entire word. The letters are evenly spaced, and the word is centered in the image.

Patent(s) Pending

MAY 2 3 2014

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The Pro-Sport™ device incorporates a more sophisticated digital liquid crystal display user interface to help the user select the mode and see parameters like the power level, time, and other information and has one mode that allows practitioners to set up their own therapy signals.

Scientific Concepts that form the basis of the devices:

Various modes in the candidate device are suited for TENS applications.

Design Description: Significant physical and performance characteristics of the device including stimulation output specifications & Summary of the Technological Characteristics Compared to the Predicates are shown below:

Discussion of any different technological characteristics between the devices and the predicate devices:

The candidate device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device as summarized in the table of the technological characteristics.

The differences between the candidate device and the predicate device are:

the Pro-Sport user-interface implements a menu system that allows the user to select from a ● list of preset modes beyond the 4 modes in the predicate devices
. the Pro-Sport AVA mode allows the stimulation parameters to be programmed by the user
. the Pro-Sport displays values in a digital display format instead of an LED that represents a range of values which allows values to be displayed in smaller incremental values

Summary of Technical Characteristics
(i.e., design, material, chemical composition, energy source)
Parameter	Avazzia Candidate Device	Predicate Devices
Labeling Claims Indicationfor UseSee Note 1	TENS	TENS
Device Name and Model	Avazzia Pro Sport™	Best-Pro 1, Best-RSI,Biomodulator, and Body Stim
510(k) Number	K123099	K062641
Manufacturer	Avazzia, Inc.	Avazzia, Inc.
Power Source(s): Number,Size and Type of Batteries	2 - 1.5 VAA batteries	2 - 1.5 VAA batteries
Number of Output Modes	24	4 models = 4
Low Battery indication?	Yes	Yes
Timer Range (minutes)	60 minutes	60 minutes
Compliance with VoluntaryStandards?	Yes	Yes

AVAZIA

Patent(s) Pending

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Summary of Technical Characteristics(i.e., design, material, chemical composition, energy source)
Parameter	Avazzia Candidate Device	Predicate Devices
Compliance with 21 CFR898?	Yes	Yes
Weight (lbs., oz.)	7oz	7oz
Dimensions (in.)[W x H x D]	2.6" X 1.35" X 4.7"	2.6" X 1.35" X 4.7"
Housing Materials andConstruction	Handheld ABS plastic housingwith a Polypac plastic nameplateand onboard electrodes	Handheld ABS plastic housingwith a Polypac plasticnameplate and onboardelectrodes
User Interface Display	LCD	LEDs
Design material	PCBs inside plastic case housing	PCBs inside plastic casehousing
Energy type	Electro-stimulation	Electro-stimulation

Stimulation Output Specifications
	Avazzia Candidate Device	Predicate Devices
Pulse Duration	0.1 - 1.15 mS	0.1 - 1.15 mS
Pulse Frequency	0.5 to 2500 Hz	0.5 to 2500 Hz
Output Voltage	20 – 650 V	20 - 650 V
Current Amplitude TENS	0 - 90mA	0 - 90mA
Timeout	60 minutes	60 minutes
Waveform	Pulsed, damped, asymmetricbiphasic sinusoidal	Pulsed, damped, asymmetricbiphasic sinusoidal
Number of modes ofstimulation	14 preset modes including AVAuser programmable mode	4 preset modes

Summary of how the technological characteristics of your device compare to the predicate device:

Do the candidate Devices have the same indications for use? Yes
Do the candidate Devices have the same Technological Characteristics? Yes
. Do the candidate devices pose any new questions regarding safety of effectiveness? No
. Do the candidate devices have accepted scientific methods for evaluating safety and effectiveness? Yes
. Do the candidate devices demonstrate no diminishment of performance? Yes

The Avazzia device technological specifications are the same; therefore, differences in user interface do not pose new questions regarding safety and effectiveness.

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Conclusions:

The devices have intended uses and technological characteristics that are substantially equivalent to the predicate devices Body-Stim™, Biomodulator™, Best-RSI™, Best-Pro 1™, Model BEST -A V ]™ (K062641), since their purpose, application, mechanism of action, utilized materials, basic technical characteristics, functionality and manufacturing processes are similar. Verification and validation tests as well as certificates and test reports contained in this submission demonstrate that the submitted models are substantially equivalent to the safety and effectiveness as that of the cleared devices.

Accessories

Self-adhesive conductive electrode pads Finger electrode Cutaneous electrodes Soft tissue electrodes - Y electrodes Comb electrode Small Circular Electrode: Common name: Pencil electrode Lead wires

The software verification is conducted according to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff -May 11, 2005.

The four candidates devices and accessories meet safety requirements IEC 60601-1 and requirements EMC:IEC 60601-1-2.

Conclusions:

The device has intended uses and technological characteristics that are substantially equivalent to the predicate devices Body-Stim™, Biomodulator™, Best-RSI™, Best-Pro 17M, Model BEST -AVI™ (K062641).

Image /page/3/Picture/10 description: The image shows the logo and contact information for Avazzia. The logo is in bold, and the website address is listed below it. The copyright information indicates that the image is copyrighted in 2014 by Avazzia, Inc., and all rights are reserved. The address is 13140 Coit Rd., Ste 515, Dallas, TX 75240 USA, and the phone number is 214-575-2820, with a fax number of 214-575-2824.

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

May 23, 2014

Avazzia, Inc. c/o Tammy Lahutsky Regulatory Affairs 13140 Coit Road, Suite 515 Dallas. TX 75240

Re: K123099

Trade Name: Best AV2 Pro-Sport™ Regulation Number: 21 CFR 882.5950 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: May 14, 2014 Received: May 16, 2014

Dear Ms. Lahutsky:

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. Iisting 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.

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

. , ,

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Page 2 of 2 - Ms. Tammy Lahutsky

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 (800) 638-2041 or (301) 796-7100 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aquel -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K123099

Device Name Best AV2 Pro Sport™ Device

Indications for Use (Describe)

· symptomatic relief and management of chronic, intractable pain

· adjunctive treatment in the management of post-surgical and post-traumatic pain

. .

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

S Date: 2014.05.23 09:42:33 -04'00'

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Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).