Avid CT2

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 11/16/2020 Vision Quest Industries Inc. Mohamed Ouerghi Director of QA/RA 1390 Decision Street. Suite A Vista, California 92081 Re: K202490 Trade/Device Name: Avid CT2 Neuromuscular and Interferential Stimulation System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, LIH Dated: October 2, 2020 Received: October 5, 2020 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 {1}------------------------------------------------ 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, Xiaorui Tang, Ph.D. Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use #### 510(k) Number (if known) K202490 #### Device Name Avid CT2, Neuromuscular and Interferential Stimulation System, Model AV-CT20A #### Indications for Use (Describe) Interferential Stimulation can be used 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 - Maintain or increase range of motion - Increase local blood circulation Neuromuscular Stimulation can be used in the following applications: - · Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis - · Prevention or retardation of disuse atrophy - · Muscle-re-education | 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) SUMMARY | 510(k) Owner: | Vision Quest Industries, Inc.<br>18011 Mitchell South,<br>Irvine, CA, 92614 | |---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Mohamed Ouerghi<br>Director of QA/RA<br>Vision Quest Industries, Inc.<br>Phone 760-477-8201<br>Mobile 760-691-0168<br>Fax 760-727-5950<br>mouerghi@vqorthocare.com | | Date Summary Prepared: | 8/26/2020 | | Proprietary Name: | Avid CT2 Neuromuscular and<br>Interferential Stimulation System,<br>Model AV-CT20A | | Device Name and Classification: | Neuromuscular and Interferential Stimulator, Class II,<br>21 CFR 882.5890, Product Code LIH and<br>21CFR 890.5850, Product Code IPF | | Predicate Devices: | Surgi Stim/T.E.A.R. Tech by Vision Quest Industries, Inc.<br>K982388 and<br>Avid IF2 by Vision Quest Industries, Inc.K183692 | | Device Description: | The Avid CT2, Model AV-CT20A is a combination therapy<br>device. Like its predicate Avid IF2, it is an Interferential<br>Stimulator that produces a low electrical current that is<br>transmitted via lead wires to electrodes placed on the skin in the<br>area predetermined by a clinician. Operating parameters can be<br>adjusted throughout their range by a trained clinician but the<br>end-user is limited to protocol selection and amplitude. The user<br>interface consists of an LCD display and a keypad. The primary<br>difference between the two devices is the addition of user-<br>adjustable parameters that allow the existing interferential<br>waveform to turn on and off within a small, preselected range to<br>provide necessary control for neuromuscular stimulation. This<br>same method of gating the interferential on and off was used in<br>VQ's previous Surgi Stim stimulator. | {4}------------------------------------------------ Statement of Intended Use: The Avid CT2 Neuromuscular and Interferential Stimulator, Model AV-CT20A. is indicated for use in the following applications: Interferential Stimulation can be used 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 - · Maintain or increase range of motion - Increase local blood circulation Neuromuscular Stimulation can be used in the following applications: - · Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis - · Prevention or retardation of disuse atrophy - Muscle-re-education #### Substantial Equivalence The Avid CT2 is a minor product enhancement to the Avid IF2. The primary difference between the two devices is the addition of user-adjustable parameters that allow the existing interferential waveform to turn on and off within a small, preselected range to provide necessary control for neuromuscular stimulation. This same method of gating the interferential on and off was used in VQ's previous Surgi Stim stimulator. The Avid CT2 is equivalent to the Avid IF2 in all areas except these new user-adjustable parameters. For those parameters we are substantially equivalent to VO's Surgi Stim stimulator.. #### Indications for Use The Avid CT2 has the same indications for use as the Avid IF2 when these are used in IF mode. The Avid CT2 has the additional indications for use as allowed by neuromuscular stimulators. ### 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 and CT2 Stimulator is self-contained and includes two non-removable, rechargeable lithium ion batteries and an external power supply like the predicates. - The Avid IF2 and CT2 Stimulator also contain a single output jack for both output channels, and a user interface consisting of a touchscreen LCD for improved user experience. 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 Ouest 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. {5}------------------------------------------------ # Device Characteristics and Output Specifications Equivalency The Avid IF2 only has the IF mode whereas the Avid CT2 has an additional neuromuscular mode. The second 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 tables below compare the Avid CT2 to the two predicate devices. {6}------------------------------------------------ # Device Characteristics Comparison | 510(k) Number | K982388 | K183692 | Unassigned | |-------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------| | Device Name | Surgi Stim /T.E.A.R. Tech | Avid IF2 | Avid CT2 | | Manufacturer | Vision Quest Industries, Inc. | Vision Quest Industries, Inc. | Vision Quest Industries, Inc. | | Power Source | 2 battery packs consisting of<br>4 'AA' alkaline cells each or<br>external power supply | 2 internal, non-removable,<br>rechargeable Lithium-ion<br>batteries or external power<br>supply | 2 internal, non-removable,<br>rechargeable Lithium-ion<br>batteries or external power<br>supply | | —Method of Line Current<br>Isolation | Use of UL2601-1 approved<br>external power supply | Use of UL2601-1 approved<br>external power supply | Use of UL2601-1 approved<br>external power supply | | —Patient Leakage Current | | | | | —Normal Condition<br>(μΑ) | <500 | <500 | <500 | | —Single fault<br>condition (μΑ) | <500 | <500 | <500 | | No. of Output Modes | 3 (IF, HVPC, NMES) | 4 (IF) | 1 (IF, NMES) | | No. of Output Channels | IF Mode – 2<br>IF Mode – 1<br>NMES Mode– 2<br>NMES Mode –1<br>HVPC Mode – 1 | IF Mode – 2<br>IF Mode – 1 | IF Mode – 2<br>IF Mode – 1<br>NMES Mode – 2<br>NMES Mode –1 | | Synchronous or<br>Alternating | IF — Synchronous<br>NMES — Synchronous<br>HVPC — Synchr. Or Alt. | IF — Synchronous | IF — Synchronous<br>NMES — Synchronous | | Method of Channel<br>Isolation | IF - Transformer coupled<br>NMES - Transformer<br>coupled<br>HVPC – N/A | IF - Transformer coupled | IF - Transformer coupled<br>NMES - Transformer coupled | | Reciprocal | IF - No<br>NMES - No<br>HVPC - Yes | IF - No | IF – No<br>NMES - No | | Regulated Current or<br>Regulated Voltage | IF - Regulated voltage<br>NMES - Regulated voltage<br>HVPC - Regulated voltage | IF - Regulated voltage | IF - Regulated voltage<br>NMES– Regulated voltage | | Software/Firmware/<br>Microprocessor Control | Microprocessor Control | Microprocessor Control | Microprocessor Control | | Software Provided | Yes-Embedded Firmware | Yes- Embedded Firmware | Yes- Embedded Firmware | | Automatic Overload Trip | No | Yes | Yes | | Automatic No-Load Trip | No | 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 | | Voltage/Current<br>Level | 4.4V | 5.75V | 6.0V | | Other | LCD panel displays all<br>parameter settings. | LCD panel displays all<br>parameter settings. | LCD panel displays all<br>parameter settings. | | 510(k) Number<br>Device Name | K982388<br>Surgi Stim /T.E.A.R. Tech | K183692<br>Avid IF2 | Unassigned<br>Avid CT2 | | Manufacturer | Vision Quest Industries,<br>Inc. | Vision Quest Industries,<br>Inc. | Vision Quest Industries, Inc. | | Constant Voltage | NMES- No<br>HVPC- No<br>IF- Yes<br>NMES- Yes<br>HVPC- Yes | NMES - No<br>IF - Yes | NMES - No<br>IF - Yes<br>NMES - Yes | | Timer Range (minutes) | | | | | Timer Settings | 10 min to 8 hours or<br>continuous | 1 min to 24 hours or<br>continuous | 1 min to 24 hours or continuous | | Compliance with<br>voluntary Standards | Standards-AAMI/ANSI NS4<br>1986 | NA | NA | | Compliance with<br>EN60601-1 (Safety) | Not Tested | Yes | Yes | | Compliance with<br>IEC60601-1-2 (EMC) | Not Tested | Yes | Yes | | Compliance with 21<br>CFR 898 (Mandatory<br>05/09/02) | NA | Yes | Yes | | Weight (with batteries) | 10.6 oz. | 6.8 oz. | 6.8 oz. | | Dimensions (inches) | 5.7 x 3.0 x 1.5 | 4.9 x 2.85 x 1.0 | 4.9 x 2.85 x 1.0 | | Housing Materials and<br>Construction | Molded ABS/PC plastic<br>housing | Molded ABS/PC plastic<br>housing | Molded ABS/PC plastic housing | {7}------------------------------------------------ # Device Characteristics Comparison {8}------------------------------------------------ # 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 - 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 {9}------------------------------------------------ #### Waveform Drawings Explanations The waveform drawings are provided in accordance with the "Guidance Document for Powered Muscle Stimulator 510(k) s". ## Waveform Drawing 1 This drawing shows the output waveform in the IF stimulation mode. Waveforms are Figure 1 given with purely resistive loads of 500 Ohms, 2000 Ohms, and 10,000 Ohms as required. Image /page/9/Figure/4 description: Figure 1 shows a graph of amplitude in volts versus time in microseconds. There are three different plots on the graph, representing loads of 500 Ohms, 2000 Ohms, and 10000 Ohms. The amplitude varies between approximately -27 volts and 27 volts for the 500 and 2000 Ohm loads, and between -25 volts and 25 volts for the 10000 Ohm load. The time varies between 0 and 450 microseconds. ### Waveform Drawing 2 Modality = IF Mode = 6/6 Figure 1 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. {10}------------------------------------------------ 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/10/Figure/1 description: The image shows two waveform drawings, labeled as Figure 1 and Figure 2. Figure 1 displays a triangular waveform that oscillates between 60% and 160% of the user setting. Figure 2 shows a square waveform that also oscillates between 60% and 160% of the user setting. The x-axis of both figures represents time, with each hash mark indicating 1 second. #### Waveform Description The waveforms from the Avid CT2 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. {11}------------------------------------------------ | 510(k) Number | K982388 | K183692 | Unassigned | |------------------------------------------------|------------------------------------------------------------------------------------------|----------------------------|------------------------------------------------------------| | Device Name | Surgi Stim /T.E.A.R. Tech | Avid IF2 | Avid CT2 | | Waveform | IF- Sym. Biphasic<br>NMES-Sym. Biphasic<br>HVPC- Twin peak pulsed<br>monophasic | IF - Sym. Biphasic | IF - Sym. Biphasic<br>NMES-Sym. Biphasic | | Max. Output<br>Current (500<br>Ohm Load) | IF Mode - 50mA ±10%<br>NMES Mode- 50mA ±10%<br>HVPC- .66A ±10% | IF Mode - 50mA+/- 10% | IF Mode - 50mA+/- 10%<br>NMES Mode- 50mA ±10% | | Max. Output<br>Voltage (500<br>Ohm Load) | IF- 25V ± 10%<br>NMES- 25V ±10%<br>HVPC 330V ±10% | IF-25V +/- 10% | IF-25V +/- 10%<br>NMES-25V +/- 10% | | Shape | IF- Square or rectangular<br>NMES- Square or rectangular<br>HVPC- Dual exponential spike | IF - Square or rectangular | IF - Square or rectangular<br>NMES - Square or rectangular | | Symmetry | IF- Symmetrical<br>NMES- Symmetrical<br>HVPC - No | IF - Symmetrical | IF - Symmetrical<br>NMES - Symmetrical | | Net Phase Charge | IF - 0μC<br>NMES – 0μC<br>HVPC- 8.25μC | IF - 0μC | IF - 0μC<br>NMES – 0μC | | Peak Phase<br>Current (500<br>Ohm) | IF - 50mA<br>NMES - 50mA<br>HVPC - 0.66A | IF - 50mA | IF - 50mA<br>NMES-50mA | | Peak Phase<br>Voltage (500<br>Ohm) | IF-25V<br>NMES - 25V<br>HVPC-330V | IF-25V | IF-25V<br>NMES-25V | | Phase Rise Time<br>(500 Ohm,<br>max.width) | IF - < 2μS<br>NMES- <2μS<br>HVPC- <1μS | IF - < 2μS | IF - < 2μS<br>NMES - < 2μS | | Phase Decay<br>Time (500 Ohm,<br>max. width) | IF- < 2μS<br>NMES- <2μS<br>HVPC- 27μS | IF- < 2μS | IF- < 2μS<br>NMES- < 2μS | | Phase Duration<br>Range (at 50%<br>max. width) | IF - 7μS – 125μS<br>NMES - 7μS – 125μS<br>HVPC- 5μS | IF - 7μS – 125μS | IF - 7μS – 125μS<br>NMES - 7μS – 125μS | | Interphase<br>Interval | IF – 0μS<br>NMES – 0μS<br>HVPC- 100 - 300μS | IF - 0μS | IF - 0μS<br>NMES – 0μS | | Frequency Range | IF- 4000 Hz – 4240 Hz<br>NMES-4000Hz - 4240 Hz<br>HVPC - 1-200 Hz | IF- 4000 Hz – 4240 Hz | IF- 4000 Hz – 4240 Hz<br>NMES- 4000 Hz - 4240 Hz | | Interference<br>Pattern | IF – Yes<br>NMES - Yes<br>HVPC - No | IF - Yes | IF – Yes<br>NMES - Yes | | Beat<br>Frequencies | IF- 1-240 Hz<br>NMES-1-240Hz<br>HVPC-NA | IF- 1-240 Hz | IF- 1-240 Hz<br>NMES- 1-240 Hz | | Burst Mode | No | No | No | | Current Density | | | | | Peak (per sq.<br>cm) (500 Ohm<br>Load) | IF-2.47mA<br>NMES-2.47mA<br>HVPC-65.1mA | IF-2.47mA | IF-2.47mA<br>NMES-2.47mA | | Ave. (per sq.<br>cm)<br>(500 Ohm<br>Load) | IF-1.235mA<br>NMES-1.235mA<br>HVPC-0.13mA | IF-1.235mA | IF-1.235mA<br>NMES-1.235mA | | Output Specifications Comparison | | | | | 510(k) Number | K982388 | K183692 | Unassigned | | Device Name | Surgi Stim /T.E.A.R. Tech | Avid IF2 | Avid CT2 | | Power Density | | | | | Peak (per sq.<br>cm)<br>(500 Ohm<br>Load) | IF – 61.7mW<br>NMES – 61.7mW<br>HVPC – 10.7 W | IF – 61.7mW | IF – 61.7mW<br>NMES – 61.7mW | | Ave. (per sq.<br>cm)<br>(500 Ohm<br>Load) | IF – 30.85mW<br>NMES – 30.85mW<br>HVPC – 21.4 mW | IF – 30.85mW | IF – 30.85mW<br>NMES – 30.85mW | | Max. Phase<br>Charge | | | | | 500 Ohms | IF- 6.25µC<br>NMES – 6.25 µC<br>HVPC- 9.9 µC | IF- 6.25µC | IF- 6.25µC<br>NMES- 6.25µC | | 2K Ohms | IF- 1.56 µC<br>NMES – 1.56 µC<br>HVPC- 1.65 µC | IF- 1.56 µC | IF- 1.56 µC<br>NMES- 1.56 µC | | 10K Ohms | IF- 0.33 µC<br>NMES – 0.33 µC<br>HVPC- 0.33 µC | IF- 0.33 µC | IF- 0.33 µC<br>NMES- 0.33 µC | {12}------------------------------------------------ {13}------------------------------------------------ Image /page/13/Figure/0 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, with the voltage alternating between approximately 20 and -20. Image /page/13/Figure/2 description: The image shows the text "Four Electrode Stimulation, 500 Ohm Resistive Load – Predicate (K183692)". The text describes a four-electrode stimulation setup with a 500 Ohm resistive load. The term "Predicate" is also included, followed by an identifier in parentheses, "K183692". Image /page/13/Figure/3 description: The image shows a graph with voltage (V) on the y-axis and time (us) on the x-axis. The graph displays a square wave pattern, alternating between approximately 20V and -20V. The time scale ranges from -250 us to 250 us, indicating the duration of the pulses. The graph also includes the text "Pico Technology www.picotech.com" at the bottom. Image /page/13/Figure/4 description: The image shows the title of a document or presentation. The title is "Four Electrode Stimulation, 500 Ohm Resistive Load - Predicate (K982388)". The title provides information about the content of the document or presentation, which is likely related to four electrode stimulation with a 500 Ohm resistive load. Image /page/13/Figure/5 description: The image shows a graph with the x-axis labeled in microseconds from -250 to 250, and the y-axis labeled in volts from -50 to 50. The graph shows a square wave oscillating between approximately 25 volts and -25 volts. The wave has a period of approximately 200 microseconds. {14}------------------------------------------------ Image /page/14/Figure/0 description: The image shows a graph with voltage on the y-axis and time on the x-axis. The y-axis ranges from -50.0 to 50.0 DC, while the x-axis ranges from -250.0 to 250.0 microseconds. The graph displays a square wave pattern, alternating between approximately 20V and -20V. The text at the bottom indicates that the graph was created using Pico Technology. Four Electrode Stimulation, 200 Ohm Resistive Load – Avid CT2 Image /page/14/Figure/2 description: The image shows the text "Four Electrode Stimulation, 200 Ohm Resistive Load - Predicate (K183692)". The text describes a four-electrode stimulation setup with a 200 Ohm resistive load. The term "Predicate" is followed by a code, likely an identifier or reference number. The text is presented in a clear, readable font. Image /page/14/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 -50.0 to 50.0, while the time ranges from -250.0 to 250.0 microseconds. The graph displays a square wave pattern, alternating between approximately 20.0 and -20.0 voltage levels. #### Four Electrode Stimulation, 200 Ohm Resistive Load - Predicate (K982388) Image /page/14/Figure/5 description: The image shows a graph with the x-axis labeled in microseconds from -250 to 250 and the y-axis labeled in volts DC from -50 to 50. The graph shows a square wave that oscillates between approximately 22 volts and -22 volts. The graph also contains the text "Pico Technology www.picotech.com". {15}------------------------------------------------ Image /page/15/Figure/0 description: The image shows a graph titled "Four Electrode Stimulation, 2000 Ohm Resistive Load – Avid CT2". The graph shows the voltage (V) on the y-axis and time (µs) on the x-axis. The graph shows a square wave oscillating between approximately 25V and -25V. The x-axis ranges from -250 µs to 250 µs, and the y-axis ranges from -50V to 50V. Image /page/15/Figure/2 description: The image shows the text "Four Electrode Stimulation, 2000 Ohm Resistive Load – Predicate (K183692)". The text describes a four-electrode stimulation setup with a 2000 Ohm resistive load. The term "Predicate" is also included, followed by the identifier "(K183692)". Image /page/15/Figure/3 description: The image shows a graph of voltage versus time. The y-axis represents voltage in DC volts, ranging from -50 to 50. The x-axis represents time in microseconds, ranging from -250 to 250. The graph shows a square wave oscillating between approximately 25 volts and -25 volts. #### Four Electrode Stimulation, 2000 Ohm Resistive Load – Predicate (K982388) Image /page/15/Figure/5 description: The image shows a graph of voltage versus time. The y-axis represents voltage in DC volts, ranging from -50 to 50. The x-axis represents time in microseconds, ranging from -250 to 250. The graph shows a square wave oscillating between approximately 25 and -25 volts. {16}------------------------------------------------ Image /page/16/Figure/0 description: The image shows a graph with voltage on the y-axis and time in microseconds on the x-axis. The graph displays a periodic waveform that alternates between approximately 20V and -20V. The time scale ranges from -250 microseconds to 250 microseconds. The graph also includes the text 'Pico Technology www.picotech.com' at the bottom. # Two Electrode Stimulation, 500 Ohm Resistive Load – Avid CT2 Two Electrode Stimulation, 500 Ohm Resistive Load – Predicate (K183692) Image /page/16/Figure/3 description: The image shows a graph of voltage versus time. The y-axis represents voltage in DC, ranging from -50.0 to 50.0. The x-axis represents time in microseconds, ranging from -250.0 to 250.0. The graph shows a periodic square wave with voltage levels alternating between approximately -23 and 23. Two Electrode Stimulation, 500 Ohm Resistive Load - Predicate (K982388) Image /page/16/Figure/5 description: The image shows a graph of voltage over time. The y-axis represents voltage in DC volts, ranging from -50 to 50. The x-axis represents time in microseconds, ranging from -250 to 250. The graph shows a square wave pattern, alternating between approximately 25 volts and -25 volts. {17}------------------------------------------------ # Substantial Equivalence Summary Based on the data contained in the previous two tables and comparison waveforms we conclude that the Avid CT2 is equivalent to its predicates.