Electrical stimulation delivered by the device is intended for the symptomatic relief of chronic intractable pain and or management of post-traumatic or post-surgical pain.

Device Description

VT-300 device is portable and battery operated. VT-300 Device is comprised of a PCBA and a lithium-ion battery enclosed in a polycarbonate housing. The device's dimensions are 2.1 inches wide, 3.3 inches long, and 0.75 inch in height.

Vecttor VT-300 provides Interferential Current Therapy. Eight electrodes attached to a pair of lead wires are intended to be positioned on the patient's body to deliver four channels of current from VT-300 dual output jacks. Temperature sensors continually monitor finger surface temperatures with the intention of identifying and then applying an Interferential Current Therapy level that results in specified temperature increases.

The user controls the VT-300 device using Vecttor Mobile App which is a mobile application downloadable on Bluetooth enabled mobile devices using Android or iOS operating systems from the Google Play or Apple App store. Vecttor Mobile App provides the necessary user interface to establish connection to the VT-300 device via Bluetooth, and operate VT-300 device to provide interferential current therapy.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Vecttor VT-300 device, which is a transcutaneous electrical nerve stimulator for pain relief. The document mainly focuses on demonstrating substantial equivalence to a predicate device (Vecttor VT-200) based on technological characteristics and non-clinical performance testing.

Crucially, this document states: "No clinical tests are being submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence."

This means that the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically related to clinical performance (e.g., human reader performance, ground truth establishment, sample sizes for medical imaging AI/ML models), is not present in this document.

The "acceptance criteria" presented are related to the device's technical specifications and compliance with recognized standards, not its clinical efficacy or AI/ML performance.

Therefore, I cannot provide the detailed information requested in the prompt based on the provided text, as it pertains to a different type of device clearance (hardware-based equivalence) and explicitly states the absence of clinical test data.

If the prompt were for an AI/ML medical device, the information requested would be highly relevant. However, for this specific device (a TENS unit), the clearance pathway does not require such studies to demonstrate substantial equivalence if predicate devices exist and technical specifications can be shown to be equivalent or safer.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 8, 2024

Artaflex Inc. Gerry Iuliano Owner 181 Whitehall Drive Markham, Ontario L3T 9T1 Canada

Re: K231575

Trade/Device Name: Vecttor VT-300 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: LIH Dated: February 8, 2024 Received: February 8, 2024

Dear Gerry Iuliano:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Robert Kang -S

for Pamela Scott, MS 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

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Indications for Use

510(k) Number (if known) K231575

Device Name Vecttor VT-300

Indications for Use (Describe)

Electrical stimulation delivered by the device is intended for the symptomatic relief of chronic intractable pain and or management of post-traumatic or post-surgical pain.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

VECTTOR VT-300

Submitter's name, address, telephone number, a contact person:

Gerry Iuliano, Owner

Artaflex Inc. - 181 Whitehall Dr., Markham Ontario L3T 9T1 Canada.

TEL: 905.470.0109 | FAX: 905.470.0621

Date the summary was prepared;

February 6, 2024

Name of the device

Trade Name: VECTTOR VT-300 Common Name: Interferential Current Therapy Device Classification Name: Interferential Current Therapy Product Code: LIH

Identification of the legally marketed device to which the submitter claims equivalence.

K121662 VECTTOR VT-200

Description of the device

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A statement of the intended use of the device

Electrical stimulation delivered by the device is intended for the symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain.

Comparison of the technological characteristics with predicate device

Vecttor VT-300 represents a modified version of predicate device Vecttor VT-200 (K121662) implementing design changes requested by applicant of K121662 for VT-200 predicate device, Dr. Donald Rhodes:

Modernized redesign including reduced size, wiring, and relocation of connection ports .
. Change power supply to on-board battery
Change thermistor temperature sensor to digital temperature sensor .
Change SD card with cloud-based application for managing patient treatments and data .
Change device display screen and tactile buttons interface to mobile device screen and . software application

VT-300 has the same intended use and similar technological characteristics and principles of operation as K121662 for VT-200 predicate device. Any differences in technological characteristics potentially raising questions of safety or effectiveness have been addressed through Bench Performance Testing and compliance with FDA recognized consensus standards.

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OUTPUT SPECIFICATIONS
#	Characteristics	Subject Device	Predicate Device(K121662)
0	510(k) Number	K231575	K121662
1	Waveform (e.g., pulsedmonophasic, biphasic)	Biphasic	Biphasic
2	Shape (e.g., rectangular,spike, rectified sinusoidal)	Pure Sinusoid	Pure Sinusoid
3	Maximum Output Voltage(volts p/p)	4.36 @ 500 Ω6.72 @ 2 kΩ8.08 @10 kΩ	4.36 @ 500 Ω6.72 @ 2 kΩ8.08 @10 kΩ
4	Maximum Output Current (mARMS)	3.08 @ 500 Ω1.19 @ 2 kΩ0.29 @10 kΩ	3.08 @ 500 Ω1.19 @ 2 kΩ0.29 @10 kΩ
5	Pulse Width (µsec)	Continuous Sine Wave	Continuous Sine Wave
6	Frequency (Hz) [or Rate (pps)]	1500Hz – 1580Hz2500Hz – 2580Hz	1500Hz – 1580Hz2500Hz – 2580Hz
7	For interferential modes only: -Beat Frequency (Hz)	1000Hz	1000Hz
8	For multiphasic waveformsonly: - Symmetrical phases?	Yes	Yes
9	- Phase Duration (includeunits) (state range, ifapplicable) (both phases, ifasymmetrical)	N/A	N/A
10	Net Charge (mC per pulse)	0 @ 500 ΩOutputs have no DCoutput by means of DCblocking capacitor andisolation transformers atoutputs	0 @ 500 ΩOutputs have no DCoutput by means of DCblocking capacitor andisolation transformers atoutputs
11	Maximum Phase Charge, (µC)@500 Ω	0.93 uC	0.93 uC
12	Maximum Current Density,(mA/cm², r.m.s.) @500 Ω	0.39	0.39
13	Maximum Power Density,(W/cm²) using smallestelectrode conductive surfacearea @500 Ω	0.6	0.6
14	Burst Mode	N/A	N/A
15	ON Time (seconds)	5	5
16	OFF Time (seconds)	1	1
17	Average DC current throughelectrodes when device is onbut no pulses are applied	Zero	Zero
	Mode or Program Name	1	1
	Duration of primary(depolarizing) phase (msec)	N/A	N/A
	Maximum Average Current (average absolute value), mA@500 Ω	0(No DC contentspresent)	0(No DC contentspresent)

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A brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence

VT-300 system and software verification & validation has been conducted to ensure design output meets the design input requirements. In addition, VT-300 complies with the following FDA recognized consensus standards:

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment Part 1: ● General requirements for basic safety and essential performance
. IEC 60601-1-2 Edition 4.0 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment Part 1-11: General . requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment Part 2-10: Particular . requirements for the basic safety and essential performance of nerve and muscle stimulators
. IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence

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A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence.

No clinical tests are being submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence

Conclusions

VT-300 has the same intended use as its predicate device. Any differences in technological characteristics potentially raising questions of safety or effectiveness have been addressed through Bench Performance Testing and compliance with FDA recognized consensus standards. In conclusion, VT-300 is substantially equivalent to VT-200.

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).