-Symptomatic relief of post-surgical and/or post traumatic acute pain
-Symptomatic relief of chronic intractable pain
-Relaxation of muscle spasms
-Maintaining and increasing range of motion
-Increases local blood circulation

Device Description

The Avid IF2, Model AV-IF19A is an Interferential Stimulator that produces a low electrical current that is transmitted via lead wires to electrodes placed on the skin in the area predetermined by a clinician. Operating parameters can be adjusted throughout their range by a trained clinician but the end-user is limited to protocol selection and amplitude. The user interface consists of an LCD display and a keypad.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Avid IF2 Interferential Stimulator, Model AV-IF19A. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria for a new clinical claim or an AI algorithm.

Therefore, the requested information regarding acceptance criteria, study design for proving device performance (including sample size, expert involvement, adjudication methods, MRMC studies, standalone performance), and ground truth establishment cannot be extracted from this document.

This document describes a device based on well-established technology (transcutaneous electrical nerve stimulation for pain relief) and demonstrates its similarity to previously cleared devices. It relies on device specification comparison and waveform analysis to prove substantial equivalence, not clinical performance data derived from patient studies or AI algorithm validation.

However, I can extract the information that is present, which primarily revolves around the comparative specifications used to demonstrate "equivalency" rather than "acceptance criteria" for a novel performance claim.

Here's an attempt to frame the available information in the context of your request, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicates)

The "acceptance criteria" in this context are not typically quantitative metrics for clinical performance for a novel claim but rather a demonstration that the new device's technical specifications and operational characteristics are substantially equivalent to predicates. The study proving this involves comparing the new device's outputs and functionalities to those of the predicate devices.

Table 1: "Acceptance Criteria" (Substantial Equivalence Parameters) and Reported Device Performance

"Acceptance Criteria" (Comparison Parameter to Predicates)	Predicate K030507 (T.E.A.R. Tech3)	Predicate K090532 (T.E.A.R. Tech3)	Avid IF2 (Model AV-IF19A)
Device Characteristics & Output Specifications
Primary Mode of Operation	IF, HVPC, NMES	IF, HVPC, NMES, PDC	IF Only
Power Source	Li-ion or 2x3 'AA' alkaline, external power supply	Li-ion or 2x3 'AA' alkaline, external power supply	2 internal, non-removable, rechargeable Lithium-ion batteries or external power supply
Patient Leakage Current (Normal Condition)	<500 µA	<500 µA	<500 µA
Patient Leakage Current (Single Fault Condition)	<500 µA	<500 µA	<500 µA
No. of Output Channels (IF Mode)	2	2	2
Synchronous/Alternating (IF Mode)	Synchronous	Synchronous	Synchronous
Channel Isolation Method (IF Mode)	Transformer coupled	Transformer coupled	Transformer coupled
Reciprocal (IF Mode)	No	No	No
Regulated Current or Voltage (IF Mode)	Regulated voltage	Regulated voltage	Regulated voltage
Microprocessor Control	Yes	Yes	Yes
Embedded Firmware	Yes	Yes	Yes
Automatic Overload Trip	Yes	Yes	Yes
Automatic No-Load Trip	Yes (w/override option)	Yes (w/override option)	Yes (w/override option)
Automatic Shut Off	Yes	Yes	Yes
Patient Override Control	Yes	Yes	Yes
Voltage/Current Level (IF Mode)	5.75V	5.75V	6.0V
Constant Voltage (IF Mode)	Yes	Yes	Yes
Timer Range	1 min to 24 hours or continuous	1 min to 24 hours or continuous	1 min to 24 hours or continuous
Compliance with EN60601-1 (Safety)	Not Tested	Yes	Yes
Compliance with IEC60601-1-2 (EMC)	Not Tested	Yes	Yes
Compliance with 21 CFR 898 (Mandatory 05/09/02)	Yes	Yes	Yes
Weight (with batteries)	10.6 oz.	10.6 oz.	6.8 oz. (New device is lighter)
Dimensions	5.7 x 3.0 x 1.5 inches	5.7 x 3.0 x 1.5 inches	4.9 x 2.85 x 1.0 inches (New device is smaller)
Housing Materials	Molded ABS/PC plastic	Molded ABS/PC plastic	Molded ABS/PC plastic
Waveform	IF- Sym. Biphasic	IF- Sym. Biphasic	IF- Sym. Biphasic
Max. Output Current (500 Ohm Load, IF Mode)	50mA ±10%	50mA ± 10%	50mA ± 10%
Max. Output Voltage (500 Ohm Load, IF Mode)	25V ± 10%	25V ± 10%	25V ± 10%
Shape (IF Mode)	Square or rectangular	Square or rectangular	Square or rectangular
Symmetry (IF Mode)	Symmetrical	Symmetrical	Symmetrical
Net Phase Charge (IF Mode)	0µC	0µC	0µC
Peak Phase Current (500 Ohm, IF Mode)	50mA	50mA	50mA
Peak Phase Voltage (500 Ohm, IF Mode)	25V	25V	25V
Phase Rise Time (500 Ohm, IF Mode)	< 2µS	< 2µS	< 2µS
Phase Decay Time (500 Ohm, IF Mode)	< 2µS	< 2µS	< 2µS
Phase Duration Range (at 50% max. width, IF Mode)	7µS – 125µS	7µS – 125µS	7µS – 125µS
Interphase Interval (IF Mode)	0µS	0µS	0µS
Frequency Range (IF Mode)	4000 Hz - 4240 Hz	4000 Hz - 4240 Hz	4000 Hz - 4240 Hz
Beat Frequencies (IF Mode)	1-240 Hz	1-240 Hz	1-240 Hz
Current Density - Peak (per sq. cm, 500 Ohm, IF Mode)	2.47mA	2.47mA	2.47mA
Current Density - Ave. (per sq. cm, 500 Ohm, IF Mode)	1.235mA	1.235mA	1.235mA
Power Density - Peak (per sq. cm, 500 Ohm, IF Mode)	61.7mW	61.7mW	61.7mW
Power Density - Ave. (per sq. cm, 500 Ohm, IF Mode)	30.85mW	30.85mW	30.85mW
Max. Phase Charge (500 Ohms, IF Mode)	6.25µC	6.25µC	6.25µC
Max. Phase Charge (2K Ohms, IF Mode)	1.56 µC	1.56 µC	1.56 µC
Max. Phase Charge (10K Ohms, IF Mode)	0.33 µC	0.33 µC	0.33 µC
Waveform Quality	(Visual inspection of scope traces show "cleaner waveforms and less voltage variation over load" for Avid IF2 compared to predicates)	(Visual inspection of scope traces show "cleaner waveforms and less voltage variation over load" for Avid IF2 compared to predicates)

Since this document is a 510(k) Premarket Notification for a Transcutaneous Electrical Nerve Stimulator, it does not describe an AI/ML device or a clinical performance study with human subjects, therefore, the following requested information is not applicable and not present in the provided text:

Sample sized used for the test set and the data provenance: Not a clinical study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for device specification comparison.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, no AI component.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no AI component.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is the established and accepted specifications of legally marketed predicate devices, and the new device's ability to meet those or be within acceptable variance. It's a technical comparison, not a clinical "ground truth" derived from patient outcomes or expert reads.
The sample size for the training set: Not applicable, no AI component.
How the ground truth for the training set was established: Not applicable, no AI component.

Summary of the Study Proving Device Meets "Acceptance Criteria" (Substantial Equivalence):

The "study" conducted to demonstrate that the Avid IF2 Interferential Stimulator meets its "acceptance criteria" (i.e., is substantially equivalent to predicate devices) primarily involved:

Technical Specification Comparison: Detailed tables comparing key electrical output parameters (e.g., max current/voltage, waveform shape, frequency range, phase charge, current/power density) between the Avid IF2 and two previously cleared T.E.A.R. Tech3 predicate devices (K030507 and K090532).
Functionality Comparison: Qualitative descriptions of shared functional aspects, such as user interface, power source, software control, and safety features.
Waveform Analysis: Presentation of oscilloscope traces (waveform drawings) under various resistive loads (500 Ohm, 2000 Ohm, and 10,000 Ohm) for the Avid IF2, along with claims that these show "cleaner waveforms and less voltage variation over load" compared to the predicates, further supporting equivalence or improvement.
Compliance with Standards: Demonstration of compliance with relevant electrical safety (EN60601-1), EMC (IEC60601-1-2), and FDA regulations (21 CFR 898).

The "data provenance" is essentially the manufacturer's internal testing and characterization of their device and comparison to published specifications or their own predicate devices. It is a retrospective analysis based on the design and testing of the new device against existing predicate information.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.

June 12, 2019

Vision Quest Industries, Inc. Mohamed Ouerghi Director of QA/RA 1390 Decision Street, Suite A Vista, California 92081

Re: K183692

Trade/Device Name: Avid IF2 Interferential Stimulator, Model AV-IF19A Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: LIH Dated: March 12, 2019 Received: March 14, 2019

Dear Mohamed Ouerghi:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Carlos Pena, PhD, MS Director OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183692

Device Name

Avid IF2 Interferential Stimulator, Model AV-IF19A

Indications for Use (Describe)

The Avid IF2 Interferential Stimulator, Model AV-IF19A is indicated for use in the following applications:

-Symptomatic relief of post-surgical and/or post traumatic acute pain
-Symptomatic relief of chronic intractable pain

-Relaxation of muscle spasms

-Maintaining and increasing range of motion

-Increases local blood circulation

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

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

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510(k) SUMMARY

510(k) Owner:	Vision Quest Industries, Inc.18011 Mitchell South,Irvine, CA, 92614
Contact:	Mohamed OuerghiDirector of QA/RAVision Quest Industries, Inc.Phone 760-477-8201Mobile 760-691-0168Fax 760-727-5950mouerghi@vqorthocare.com
Date Summary Prepared:	12/24/ 2018
Proprietary Name:	Avid IF2 Interferential Stimulator,Model AV-IF19A
Device Name and Classification:	Interferential Current Therapy Stimulator, Class II,21 CFR 882.5890, Product Code LIH
Predicate Devices:	T.E.A.R. Tech3 by Vision Quest Industries, Inc.K030507 and K090532
Device Description:	The Avid IF2, Model AV-IF19A is an InterferentialStimulator that produces a low electrical current thatis transmitted via lead wires to electrodes placed onthe skin in the area predetermined by a clinician.Operating parameters can be adjusted throughouttheir range by a trained clinician but the end-user islimited to protocol selection and amplitude. The userinterface consists of an LCD display and a keypad.
Statement of Intended Use:	The Avid IF2 Interferential Stimulator, Model AV-IF19A, is indicated for use in the followingapplications:☐ Symptomatic relief of post-surgical and/orpost traumatic acute pain☐ Symptomatic relief of chronic intractablepain☐ Relaxation of muscle spasms☐ Maintaining and increasing range of motion☐ Increases local blood circulation

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Substantial Equivalence

The Avid IF2 is a generation design improvement to the company's previous device, the T.E.A.R. Tech3 IF/Muscle Stimulator. The company's previous models combined many stimulation modes in one device. The Avid IF2 only has the IF mode. Therefore, as far as modes of stimulation is concerned the equivalency will be established by focusing on the IF mode.

Indications for Use

The Avid IF2 has the same indications for use as the predicate devices when these are used in IF mode.

Device Functionality Equivalency

Like the predicate devices, the new device uses a microcontroller and LCD ● display to create a user friendly interface.
The Avid IF2 Stimulator is self-contained and includes two non-removable, rechargeable lithium ion batteries and an external power supply like the predicates.
The Avid IF2 Stimulator also contains a single output jack for both output channels, and a user interface consisting of a touchscreen LCD for improved user experience. The device software contains self-tests for proper function and readiness. The electrodes used for stimulation are the same used with the predicates. The lead wires are of proprietary design.
The user is able to select presets on the device for the desired treatment and waveform output based upon prescriptions from the treating clinician. This is accomplished by displayed menu items and selection through the device interface. If desired. the user will be able to upload data stored on the device to Vision Quest Industries, Inc. (via wired interface or wirelessly). The device has the ability to move from preset to preset without patient interaction. This allows for easy use of physician prescribed protocols.

Device Characteristics and Output Specifications Equivalency

The Avid IF2 only has the IF mode. The first predicate device from Vision Quest Industries, Inc. has three modes of stimulation: High Volt Pulsed Current (HVPC), Interferential (IF), and a Neuromuscular Electrical Stimulation (NMES) mode. The second predicate device from Vision Quest Industries, Inc. has four modes of stimulation: High Volt Pulsed Current (HVPC), Interferential (IF), Neuromuscular Electrical Stimulation (NMES) mode, and Pulsed Direct Current (PDC).

The next two tables compare the Avid IF 2 to its predicates.

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510(k) Number	K030507	K090532	Unassigned
Device Name	T.E.A.R. Tech3	T.E.A.R. Tech3	Avid IF2
Manufacturer	Vision Quest Industries, Inc.	Vision Quest Industries, Inc.	Vision Quest Industries, Inc.
Power Source	1 battery pack consisting of aLithium-ion battery or2 battery packs consisting of 3'AA' alkaline cells each orexternal power supply	1 battery pack consisting of aLithium-ion battery or 2battery packs consisting of 3'AA' alkaline cells each orexternal power supply	2 internal, non-removable,rechargeable Lithium-ionbatteries or external powersupply
-Method of Line CurrentIsolation	Use of UL2601-1 approvedexternal power supply	Use of UL2601-1 approvedexternal power supply	Use of UL2601-1 approvedexternal power supply
-Patient Leakage Current
-Normal Condition(μΑ)	<500	<500	<500
-Single fault condition(μΑ)	<500	<500	<500
No. of Output Modes	3 (IF, HVPC, NMES)	4 (IF,HVPC,NMES, PDC)	1 (IF)
No. of Output Channels	IF Mode - 2IF Mode - 1NMES Mode- 2HVPC Mode- 1	IF Mode - 2IF Mode - 1NMES Mode - 2HVPC Mode - 1PDC - 2	IF Mode - 2IF Mode - 1
Synchronous orAlternating	IF - SynchronousNMES - Synchr. Or Alt.HVPC - Synchr. Or Alt.	IF - SynchronousNMES - Synchr. Or Alt.HVPC - Synchr. Or Alt.PDC - Synchronous	IF - Synchronous
Method of ChannelIsolation	IF - Transformer coupledNMES - Transformer coupledHVPC – N/A	IF - Transformer coupledNMES - Transformer coupledHVPC – N/APDC - Transformer coupled	IF - Transformer coupled
Reciprocal	IF - NoNMES - YesHVPC - Yes	IF – NoNMES - YesHVPC - YesPDC – No	IF - No
Regulated Current orRegulated Voltage	IF - Regulated voltageNMES – Regulated currentHVPC - Regulated voltage	IF - Regulated voltageNMES- Regulated currentHVPC – Regulated voltagePDC – Regulated current	IF - Regulated voltage
Software/Firmware/Microprocessor Control	Microprocessor Control	Microprocessor Control	Microprocessor Control
Software Provided	Yes-Embedded Firmware	Yes- Embedded Firmware	Yes- Embedded Firmware
Automatic Overload Trip	Yes	Yes	Yes
Automatic No-Load Trip	Yes (w/override option)	Yes (w/override option)	Yes (w/override option)
Automatic Shut Off	Yes	Yes	Yes
Patient Override Control	Yes	Yes	Yes
Indicator Display:
Unit Functioning	Yes	Yes	Yes
On/Off Status	Yes	Yes	Yes
Low Battery	Yes	Yes	Yes
Device Characteristics Comparison
510(k) Number	K030507	K090532	Unassigned
Device Name	T.E.A.R. Tech3	T.E.A.R. Tech3	Avid IF2
Manufacturer	Vision Quest Industries, Inc.	Vision Quest Industries, Inc.	Vision Quest Industries, Inc.
Voltage/Current Level	5.75V	5.75V	6.0V
Other	LCD panel displays allparameter settings.	LCD panel displays allparameter settings.	LCD panel displays allparameter settings.
Constant Current	IF- NoNMES- YesHVPC- No	IF - NoNMES - YesHVPC - NoPDC - Yes	IF – No
Constant Voltage	IF- YesNMES- NoHVPC- Yes	IF – YesNMES - NoHVPC - YesPDC – No	IF - Yes
Timer Range (minutes)
Timer Settings	1 min to 24 hours orcontinuous	1 min to 24 hours orcontinuous	1 min to 24 hours orcontinuous
Compliance withvoluntary Standards	Standards-AAMI/ANSI NS41986	NA	NA
Compliance withEN60601-1 (Safety)	Not Tested	Yes	Yes
Compliance withIEC60601-1-2 (EMC)	Not Tested	Yes	Yes
Compliance with 21 CFR898 (Mandatory05/09/02)	Yes	Yes	Yes
Weight (with batteries)	10.6 oz.	10.6 oz.	6.8 oz.
Dimensions (inches)	5.7 x 3.0 x 1.5	5.7 x 3.0 x 1.5	4.9 x 2.85 x 1.0
Housing Materials and	Molded ABS/PC plastic	Molded ABS/PC plastic	Molded ABS/PC plastic
Construction	housing	housing	housing

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Technical Explanations:

The following device performance description/comparison to predicate devices are provided in accordance with the FDA document "Guidance Document for Powered Muscle Stimulator 510(k)s" Attachment II section 3, issued on June 9, 1999.

The above document also requires some explanations of calculations and modulations - these are provided below.

Interference Pattern

The interference pattern is created using two different frequencies. When the four electrode stimulation is selected two separate frequencies are provided on the two electrode pairs.

Interference occurs at the patient. When two electrodes stimulation is selected the two frequencies are combined inside the device and the interference pattern is delivered via the one electrode pair.

Current Density

Current density is calculated using 2 different electrode sizes. A 2" round electrode equal to 20.27 sq. cm and a 2" x 1.25" rectangular electrode is equal to 16.13 sq. cm. This second electrode is used in the Limited mode output where amplitude is limited to 60% of full power.

In the IF mode current density is the pulsed current over the electrode area. Each phase is 50% of the pulse thus the average is given as half.

Power Density

Power density is calculated in a similar manner to current density except that the peak phase power density is the max voltage times the max current.

Maximum Phase Charge

In the IF mode, charge (Q) can be calculated as follows:

(Peak voltage/load) X duration of pulse

Waveform Drawings Explanations

(Drawings are provided on following pages)

The waveform drawings are provided in accordance with the "Guidance Document for Powered Muscle Stimulator 510(k) s".

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Waveform Drawings Explanations

The waveform drawings are provided in accordance with the "Guidance Document for Powered Muscle Stimulator 510(k) s".

Waveform Drawing 1

Figure 1 This drawing shows the output waveform in the IF stimulation mode. Waveforms are given with purely resistive loads of 500 Ohms, 2000 Ohms, and 10,000 Ohms as required.

Image /page/8/Figure/4 description: Figure 1 shows a graph of amplitude in volts versus time in microseconds. There are three different loads plotted on the graph: 500 Ohms, 2000 Ohms, and 10000 Ohms. The amplitude oscillates between approximately 25 volts and -25 volts. The time ranges from 0 to 450 microseconds.

Waveform Drawing 2

Figure 1 Modality = IF Mode = 6/6 This drawing represents the frequency of a series of pulses when the device is in the IF mode with frequency modulation. The modulation parameters are six second ramping between the preset frequencies.

When the device is turned on pulses begin at 60% of the user selected frequency (4000Hz plus beat frequency) over a six second period, ramp up to 160% of the selected frequency. Over the next six second period the frequency ramps down to 60% of the setting again and the cycle starts over.

Figure 2 Modality = IF Mode = 6|6 This drawing represent the frequency of a series of pulses when the device is in the IF mode with frequency modulation. The modulation parameters are six seconds, abruptly changing between the preset frequencies.

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When the device is turned on pulses begin at 60% of the user selected frequency (4000Hz plus beat frequency) over a six second period, instantly change to 160% of the selected frequency for six seconds. The frequency then instantly decreases down to 60% of the setting again and the cycle starts over.

Image /page/9/Figure/1 description: This image shows two waveform drawings, labeled as Figure 1 and Figure 2. Figure 1 shows a triangular waveform, while Figure 2 shows a square waveform. Both figures have a y-axis labeled "Freq." with values of "160% of User Setting", "User Setting", and "60% of User Setting". The x-axis is labeled "time (each hash mark = 1 second)".

Waveform Description

The waveforms from the Avid IF2 are the same as the predicate devices. A description of the waveforms is provided below in table format allowing comparison of measured values. For a visual comparison, scope traces of all three devices are also provided below.

Note that the scope traces of all three devices show a slight improvement with each generation; cleaner wave forms and less voltage variation over load.

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Output Specifications Comparison
510(k) Number	K030507	K090532	Unassigned
Device Name	T.E.A.R. Tech3	T.E.A.R. Tech3	Avid IF2
Manufacturer	Vision Quest Industries, Inc.	Vision Quest Industries, Inc.	Vision Quest Industries, Inc.
Waveform	IF- Sym. Biphasic NMES-Sym/Asym. Biphasic HVPC-Twin peak pulsedmonophasic	IF - Sym. BiphasicNMES - Sym/Asym. BiphasicHVPC - Twin peak pulsedmonophasicPDC - Symmetrical biphasicand unbalanced triphasic	IF - Sym. Biphasic
Max. OutputCurrent (500Ohm Load)	IF Mode- 50mA ±10%NMES Mode- 100mA ±10%HVPC-.66A ±10%	IF Mode- 50mA+/- 10%NMES Mode - 100mA+/- 10%HVPC-.66A+/- 10%PDC-100mA	IF Mode - 50mA+/- 10%
Max. OutputVoltage (500Ohm Load)	IF- 25V ± 10%NMES- 50V ±10%HVPC 330V ±10%	IF- 25V +/- 10%NMES- 50V +/- 10%HVPC- 330V +/- 10%PDC - 50V	IF- 25V +/- 10%
Shape	IF- Square or rectangularNMES- Rectangular waveHVPC- Dual exponential spike	IF - Square or rectangularNMES - Rectangular waveHVPC - Dual exponentialspikePDC - Rectangular wave	IF - Square or rectangular
Symmetry	IF- SymmetricalNMES- Symmetrical orAsymmetricalHVPC - No	IF - SymmetricalNMES - Symmetrical orAsymmetricalHVPC - NoPDC - Symmetrical andAsymmetrical	IF - Symmetrical
Net Phase Charge	IF - 0µCNMES – 0µCHVPC- 8.25µC	IF – 0µCNMES – 0µCHVPC – 8.25μCPDC - Symm. – 0µCAsymm. – 6µС	IF – 0µC
Peak PhaseCurrent (500Ohm)	IF-50mANMES - 100mAHVPC-0.66A	IF - 50mANMES - 100mAHVPC – 0.66APDC-100mA	IF - 50mA
Peak PhaseVoltage (500Ohm)	IF-25VNMES - 50VHVPC-330V	IF - 25VNMES - 50VHVPC - 330VPDC - 50V	IF - 25V
Phase Rise Time(500 Ohm,max.width)	IF - < 2µSNMES- <2µSHVPC- <1µS	IF - < 2µSNMES- <2µSHVPC- <1µSPDC - <2µS	IF - < 2µS
Phase DecayTime (500 Ohm,max. width)	IF- < 2µSNMES- <2µSHVPC- 27µS	IF- < 2µSNMES- <2µSHVPC- 27µSPDC - <2µS	IF- < 2µS
Phase DurationRange (at 50%max. width)	IF - 7µS – 125μSNMES - 30µS – 300μςHVPC-5µS	IF - 7µS – 125μςNMES - 30µS – 300μHVPC-5µSPDC - 60uS	IF - 7µS – 125μς
Output Specifications Comparison
510(k) Number	K030507	K090532	Unassigned
Device Name	T.E.A.R. Tech3	T.E.A.R. Tech3	Avid IF2
Manufacturer	Vision Quest Industries, Inc.	Vision Quest Industries, Inc.	Vision Quest Industries, Inc.
Interphase	IF – 0µS	IF – 0µS	IF – 0µS
Interval	NMES - 0 - 250µS	NMES - 0 - 250µS
	HVPC - 100 - 300µS	HVPC - 100 - 300µS
		PDC – 900µS, 1800µS
Frequency Range	IF- 4000 Hz - 4240 Hz	IF- 4000 Hz - 4240 Hz	IF- 4000 Hz - 4240 Hz
	NMES - 1-200 Hz	NMES- 1-200 Hz
	HVPC - 1-200 Hz	HVPC - 1-200 Hz
		PDC - Symm: 278Hz
		Asymm: 222Hz
Interference	IF - Yes	IF - Yes	IF - Yes
Pattern	NMES - No	NMES - No
	HVPC - No	HVPC - No
		PDC – No
Beat	IF- 1-240 Hz	IF- 1-240 Hz	IF- 1-240 Hz
Frequencies	NMES - NA	NMES - NA
	HVPC - NA	HVPC – NA
		PDC - NA
Burst Mode	No	No	No
Current Density
Peak (per sq.	IF - 2.47mA	IF – 2.47mA	IF - 2.47mA
cm)	NMES - 4.93mA	NMES - 4.93mA
(500 Ohm	HVPC - 65.1mA	HVPC - 65.1mA
Load)		PDC - 0.98mA
Ave. (per sq.	IF - 1.235mA	IF - 1.235mA	IF - 1.235mA
cm)	NMES - 0.295mA	NMES - 0.295mA
(500 Ohm	HVPC - 0.13mA	HVPC - 0.13mA
Load)		PDC - 0.059mA
Power Density
Peak (per sq.	IF - 61.7mW	IF - 61.7mW	IF - 61.7mW
cm)	NMES - 247 mW	NMES - 247 mW
(500 Ohm	HVPC – 10.7 W	HVPC - 10.7 W
Load)		PDC - 49.4mW
Ave. (per sq.	IF - 30.85mW	IF - 30.85mW	IF - 30.85mW
cm)	NMES - 14.8 mW	NMES - 14.8 mW
(500 Ohm	HVPC - 21.4 mW	HVPC - 21.4 mW
Load)		PDC - 2.96mW
Max. Phase
Charge
500 Ohms	IF- 6.25µC	IF- 6.25µC	IF- 6.25µC
	NMES - 30 µC	NMES - 30 µC
	HVPC- 9.9 µC	HVPC- 9.9 µC
		PDC - 6µC
2K Ohms	IF- 1.56 µC	IF- 1.56 µC	IF- 1.56 µC
	NMES - 7.5 µC	NMES - 7.5 µC
	HVPC- 1.65 µC	HVPC- 1.65 µC
		PDC – 1.5µC
10K Ohms	IF- 0.33 µC	IF- 0.33 µC	IF- 0.33 µC
	NMES - 1.5 µC	NMES - 1.5 µC
	HVPC- 0.33 µC	HVPC- 0.33 µC
		PDC - 0.3µC

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Image /page/12/Figure/0 description: The image shows a graph of four electrode stimulation with a 500 Ohm resistive load. The graph shows voltage in DC on the y-axis ranging from -50 to 50, and time in microseconds on the x-axis ranging from -250 to 250. The graph shows a square wave pattern, with the voltage alternating between approximately 20 and -20. There are two yellow markers on the graph, one at approximately (-150, 20) and the other at approximately (0, 20).

Image /page/12/Figure/2 description: The image shows the text "Four Electrode Stimulation, 500 Ohm Resistive Load - Predicate (K090532)". The text describes a type of electrical stimulation using four electrodes and a 500 Ohm resistive load. The term "Predicate" is also included, along with a code or identifier, K090532.

Image /page/12/Figure/3 description: The image shows a graph with voltage on the y-axis and time in microseconds on the x-axis. The voltage ranges from -50 to 50 V, while the time ranges from -250 to 250 microseconds. The graph shows a square wave oscillating between approximately 20 V and -20 V. There are some oscillations at the rising and falling edges of the square wave.

Image /page/12/Figure/5 description: The image shows a graph of four electrode stimulation with a 500 Ohm resistive load. The x-axis represents time in microseconds, ranging from -250 to 250. The y-axis represents voltage in DC, ranging from -50 to 50. The graph shows a square wave pattern, alternating between approximately 20 and -20 volts.

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Image /page/13/Figure/0 description: The image shows a graph of four electrode stimulation with a 200 Ohm resistive load. The x-axis represents time in microseconds, ranging from -250 to 250. The y-axis represents voltage in DC, ranging from -50 to 50. The graph displays a square wave pattern, alternating between approximately 20 and -20 voltage levels.

Image /page/13/Figure/2 description: The image shows the title of a document or presentation. The title reads "Four Electrode Stimulation, 200 Ohm Resistive Load - Predicate (K090532)". The title describes an experiment or setup involving four electrodes and a 200 Ohm resistive load. The term "Predicate" and the code "K090532" may refer to a specific project or experiment identifier.

Image /page/13/Figure/3 description: The image shows a graph with voltage on the y-axis and time on the x-axis. The voltage ranges from -50 to 50 V, and the time ranges from -250 to 250 microseconds. The graph shows a square wave with a high voltage of approximately 20 V and a low voltage of approximately -20 V. The wave oscillates between these two voltages.

Image /page/13/Figure/5 description: The figure shows a graph of four electrode stimulation with a 200 Ohm resistive load. The x-axis represents time in microseconds, ranging from -250 to 250. The y-axis represents voltage in DC, ranging from -50 to 50. The graph shows a square wave pattern, with the voltage alternating between approximately 20 and -20.

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Image /page/14/Figure/0 description: The image shows a graph of four electrode stimulation with a 2000 Ohm resistive load. The x-axis represents time in microseconds, ranging from -250 to 250. The y-axis represents voltage in DC, ranging from -50 to 50. The graph shows a square wave pattern, with the voltage alternating between approximately 25 and -25.

Image /page/14/Figure/2 description: The image shows the text "Four Electrode Stimulation, 2000 Ohm Resistive Load – Predicate (K090532)". The text describes a four-electrode stimulation setup with a 2000 Ohm resistive load. The term "Predicate (K090532)" likely refers to a specific condition or setting within the experiment or system.

Image /page/14/Figure/3 description: The image shows a graph with voltage (V) on the y-axis and time (µs) on the x-axis. The graph displays a square wave oscillating between approximately -25V and +25V. The x-axis ranges from -250 µs to 250 µs, while the y-axis ranges from -50V to 50V. The graph also shows some ringing or overshoot at the transitions of the square wave.

Image /page/14/Figure/5 description: The image shows a graph titled "Four Electrode Stimulation, 2000 Ohm Resistive Load – Predicate (K030507)". The graph shows voltage in DC on the y-axis ranging from -50.0 to 50.0, and time in microseconds on the x-axis ranging from -250.0 to 250.0. The graph shows a square wave pattern, with the voltage alternating between approximately 25 and -25.

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Image /page/15/Figure/0 description: The image shows a graph of two electrode stimulation with a 500 Ohm resistive load. The x-axis represents time in microseconds, ranging from -250 to 250. The y-axis represents voltage in DC, ranging from -50 to 50. The graph shows a series of positive and negative pulses, with the voltage alternating between approximately 20 and -20.

Two Electrode Stimulation, 500 Ohm Resistive Load - Predicate (K090532)

Image /page/15/Figure/3 description: The image shows a graph of voltage in DC as a function of time in microseconds. The voltage ranges from -50 to 50, and the time ranges from -250 to 250. The graph shows a periodic square wave with voltage alternating between approximately 23 and -23.

Image /page/15/Figure/4 description: The image shows a graph of two electrode stimulation with a 500 Ohm resistive load. The x-axis represents time in microseconds, ranging from -250 to 250. The y-axis represents voltage in DC, ranging from -50 to 50. The graph shows a periodic waveform with positive and negative voltage peaks.

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Substantial Equivalence Summary

Based on the data contained in the previous two tables we conclude that the Avid IF2 is equivalent to its predicates. In addition, it provides cleaner wave forms and less voltage variation over load as shown in the scope traces of all three devices

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).