Transcutaneous Electrical Nerve Stimulation (TENS) for the temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

Device Description

Avazzia OTC TENS electronic pulse massage devices are electrically powered device intended for overthe-counter use and used to apply a microcurrent electrical pulses to electrodes on a user's skin to relieve pain. They are easy-to-use, handheld, AA battery-operated portable devices for use in the home or clinic. The candidate devices have pre-set modes. The devices are 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 apply the built-in onboard electrodes or place self-adhesive conductive electrodes where indicated and apply stimulation for a period of time. The user controls the output by selecting the mode and power setting.

AI/ML Overview

This document is a 510(k) premarket notification for the Avazzia OTC TENS Model Best-AV1™ family of devices. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial with acceptance criteria for device performance. Therefore, directly answering all your questions about acceptance criteria and a study proving the device meets them, in the typical sense of a diagnostic or therapeutic study, is not applicable to this document.

However, I can extract the information related to safety and performance from the perspective of substantial equivalence.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission for a TENS device, the "acceptance criteria" are primarily established by demonstrating that the new device (candidate) has similar technological characteristics and performance specifications to a predicate device that has already been cleared by the FDA, and that it does not raise new questions of safety or effectiveness. The reported device performance is presented as a comparison to the predicate.

Characteristic	Acceptance Criteria (Predicate Device K122744)	Reported Device Performance (Avazzia OTC TENS)
Power Source	Four 1.5 V AAA batteries	Two 1.5 V AA batteries
Patient Leakage Current (Normal Condition)	1.8 µA	13.7 µA
Patient Leakage Current (Single Fault Condition)	3.3 µA	27 µA
Avg DC current through electrodes (no pulses)	0 µA	0 µA
Number of output modes	3	2, 4
Number of output channels	Synchronous	1 (Synchronous/Alternating = n/a)
Regulated Current or Voltage	Voltage control	Voltage control
Software control	Yes	Yes
Automatic Overload Trip?	No	No
Automatic No-Load Trip?	No	Yes
Automatic Shut Off?	Yes	Yes
User Override Control?	Yes	Yes
Indicator Display: On/Off Status?	Yes	Yes
Indicator Display: Low Battery?	No	Yes
Indicator Display: Voltage/Current intensity?	No	Yes
Timer Range	5, 10, or 15 minutes	60 minutes
Compliance with Voluntary Standards?	Yes	Yes
Compliance with 21 CFR 898	Yes	Yes
Weight	8 OZ	7 OZ
Dimensions	2.2 x 7.8 x 0.9 In	4.6 x 2.5 x 1.3 In
Housing materials and construction	Enclosure: ABS	Enclosure: ABS
Waveform	Monophasic	Biphasic (positive square wave followed by a damped sinusoidal waveform)
Shape	Regular	Positive square wave followed by a damped sinusoidal waveform of variable duration depending on damping and body loading
Max output voltage at 500 Ω	12.8 V	-42 V
Max output voltage at 2,000 Ω	51 V	-122 V
Max output voltage at 10,000 Ω	368 V	-348 V
Max output current at 500 Ω	15,000 µA	3080 µA
Max output current at 2,000 Ω	3,200 µA	451 µA
Max output current at 10,000 Ω	600 µA	535 µA
Duration of primary (depolarizing phase)	0.040 µSec	506 µSec
Pulse Duration	120 to 6800 µSec	1100 µSec
Frequency	1 to 100 Hz	20 to 185 Hz
Net Charge per pulse at 500 Ω	18,000 µC	4.0 µC
Max Charge per pulse at 500 Ω	23 µC	10.12 µC
Max current density at 500 Ω	1.4 mA/cm²	1.6 mA/cm²
Max average power density at 500 Ω	230 mW/cm²	2.445 mW/cm²
Burst mode: pulses per burst	1	Up to 8
Burst mode: burst per second	0-25	Up to 77
Burst mode: burst duration	1 sec	Up to 6 mSec
Burst mode: Duty Cycle	5	46%
On Time	Potentiometer switch	0.46 Sec
Off time	Potentiometer switch	0.54 Sec

Study Proving Acceptance Criteria:

The document states: "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."

Specifically, it mentions:

"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 candidates devices and accessories meet general safety requirements IEC 60601-1 and requirements EMC: IEC 60601-1-2."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe a clinical trial or performance study with a "test set" of human subjects or patient data in the typical sense of evaluating a diagnostic or therapeutic performance. The "test set" here refers to the device itself undergoing engineering and safety testing. The provenance of this engineering test data is not explicitly stated beyond being part of the submission by Avazzia, Inc. in Dallas, Texas, USA. These tests are typically conducted in a laboratory setting.

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 that involved human experts establishing ground truth for a diagnostic or clinical outcome. The "ground truth" for the engineering performance and safety tests would be the established international standards (IEC 60601-1, IEC 60601-1-2) and the technical specifications of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving expert adjudication of clinical findings.

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 device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic or imaging device used by human "readers."

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

Not applicable. This is a medical device, not a standalone algorithm in the AI sense. The device's performance is inherently "standalone" in that its electrical output is measured without human intervention in the primary performance tests, but it is used by a human.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this 510(k) submission is based on:

Engineering Standards: Compliance with international safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2).
Predicate Device Specifications: The technical and performance characteristics of the previously cleared predicate device (Prospera OTC TENS Electronic Pulse Massager, Models PL009, PL009A, and PL029, K122744). The new device is deemed substantially equivalent if its performance is similar or better, and it doesn't introduce new safety concerns.
Software Verification: Adherence to FDA guidance for software in medical devices.

8. The sample size for the training set

Not applicable. This device does not employ a machine learning algorithm that requires a "training set" of data.

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

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth established for it.

Summary

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

May 12, 2017

Avazzia, Inc. Tammy Lahutsky Regulatory Affairs 13140 Coit Road Suite 515 Dallas, Texas 75240 (214) 575-2820 [voice] (214) 575-2824 [fax] tlahutsky@avazzia.com

Re: K162392

Trade/Device Name: Avazzia OTC TENS Model Best-AV1™: Med-Best™, Med-Sport™, Avazzia BlueTM, Avazzia Star™ Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: April 12, 2017 Received: April 14, 2017

Dear Tammy 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, 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.

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

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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 devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

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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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Indications for Use

510(k) Number (if known) K162392

Device Name

Avazzia OTC TENS Model Best-AV1™: Med-Best™, Med-Sport™, Avazzia Blue™, Avazzia Star™

Indications for Use (Describe)

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

Regulation Use (Part 21 CFR 601 Subpart E)	☑ Same Tissue Convention (21 CFR 601 Subpart C)
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__ Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Submitter's Identifications:

Manufacturer and Sponsor:

Avazzia, Inc. 13140 Coit Road., Suite 515 Dallas, TX 75240 USA Tel. 214-575-2820 Establishment Registration # 3004839404 Official Contact Person: Tammy Lahutsky Date of Summary Preparation: August 18, 2016

Trade Names of Candidate Devices:

Avazzia OTC TENS Model Best-AV1™: Med-Best™, Med-Sport™, Avazzia Blue™, Avazzia Star™

Classifications: TENS, Class II 21 CFR 882.5890 NUH

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

Primary Predicate:

Prospera OTC TENS Electronic Pulse Massager, Models PL009, PL009A, and PL029, K122744 03/28/2013, TENS Class II 21 CFR 882.5890 NUH, NGX

Reference Devices:

Avazzia TENS Model BEST-AV1™, K062641, 4/30/2007, TENS, Class II 21 CFR 882.5890 GZJ Avazzia TENS Model Best-AV2™, K123099, 05/23/2014, TENS, Class II, 21 CFR 882.5890, GZJ Gemore Technology Co. LTd. Low back pain relief system, models model GM310PP, GM320PP, GM321PP, K060222, 04/28/2006, TENS Class II 21 CFR 882.5890 NUH

Intended Use:

Description of Candidate Devices:

Description of Candidate Devices as might be found in the labeling or promotional material:

Description of the Candidate Devices - How the devices work:

The devices are 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.

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The user can apply the built-in onboard electrodes or place self-adhesive conductive electrodes where indicated and apply stimulation for a period of time.

The user controls the output by selecting the mode and power setting.

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 devices have the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device as summarized in the technological characteristics.

Accessories

Self-adhesive conductive electrode pads Soft tissue electrodes with common name: Y electrodes Lead wires

Nonclinical tests

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

Safety and effectiveness

The Avazia device technological specifications are the same; therefore, they do not pose new questions regarding safety and effectiveness.

Indications for use for TENS OTC has been established, therefore, indications for use do not pose new questions regarding safety and effectiveness.

Basis for a determination of substantial equivalence:

Do the candidate Devices have the same indications for use? Yes
Do the candidate Devices have the same Technological Characteristics? Yes

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. 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

Conclusions:

The Avazzia OTC TENS Model BEST – AV1™ devices have intended uses and technological characteristics that are substantially equivalent to predicate devices.

Summary of Technical Characteristics
		Candidates	Predicate
Device Name and Model		BEST-AV1, Med-Best, Med-Sport, Avazzia Blue,Avazzia Star	Models PL009, PL009A,and PL029
Manufacturer		Avazzia, Inc.	Propera
Power Source		Two 1.5 V AA batteries	Four 1.5 V AAA batteries
Method of Line Current Isolation		Battery Supply N/A	Battery Supply N/A
Patient Leakage Current
Normal Condition-	ua	13.7	1.8
Single Fault Condition-	ua	27	3.3
Average DC current through
electrodes when device is on but no	ua	0	0
pulses are being applied
Number of output modes	Number	2, 4	3
Number of output channels:		1	Synchronous
Synchronous/Alternating?-		n/a	ON/Off Switch or By
Method of Channel Isolation-		n/a	Software
Regulated Current or RegulatedVoltage		Voltage control	Voltage control
Software control		Yes	Yes
Automatic Overload Trip?		No	No
Automatic No-Load Trip?		Yes	No
Automatic Shut Off?		Yes	Yes
User Override Control?		Yes	Yes
Indicator Display
On/Off Status?-		Yes	Yes
Low Battery?-		Yes	No
Voltage/Current intensity?-		Yes	No
Timer Range	Minutes	60	5, 10, or 15
Compliance with Voluntary Standards?		Yes	Yes
Compliance with 21 CFR 898		Yes	Yes
Weight	OZ	7	8
Dimensions	In	4.6 x 2.5 x 1.3(117mm X 64mm X 33mm)	2.2 x 7.8 x 0.9
Housing materials and construction		Enclosure: ABS	Enclosure: ABS
Wavform		Biphasic	monophasic
Shape		positive square wavefollowed by a dampedsinusodial waveform ofvariable durationdepending on damping andbody loading	regular

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Summary of Technical Characteristics
		Candidates	Predicate
Device Name and Model		BEST-AV1, Med-Best, Med-Sport, Avazzia Blue,Avazzia Star	Models PL009, PL009A,and PL029
Max output voltage (+/- 20%)
- at 500 Ω	V	-42	12.8
- at 2,000 Ω	V	-122	51
- at 10,000 Ω	V	-348	368
- Max output current (+/- 20%)
- at 500 Ω	uA	3080	15,000
- at 2,000 Ω	uA	451	3,200
- at 10,000 Ω	uA	535	600
Duration of primary(depolarizing phase)	µSec	506	0.040
Pulse Duration	uSec	1100	120 to 6800
Frequency	Hz	20 to 185	1 to 100
Net Charge per pulse at 500 Ω	uC	4.0	18,000
Max Charge per pulse at 500 Ω	uC	10.12	23
Max current density at 500 Ω	mA/cm2	1.6	1.4
Max average power density at 500 Ω	mW/cm2	2.445	230
Burst mode
(a) pulse per burst		Up to 8	1
(b) burst per second		Up to 77	0-25
(c) burst duration (sec)		Up to 6mSec	1
(d) Duty Cycle		46%	5
On Time	Sec	0.46	Potentiometer switch
Off time	Sec	0.54	Potentiometer switch
Additional Features		N/A	N/A

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).