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

The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on acupressure points of a patient's feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain. Once these electrodes are placed, the machine determines the appropriate stimulation intensity by automatically measuring body temperatures through the use of two specially designed Thermistors placed on the fingers during a testing sequence. The VT-200 delivers four channels of current from dual output jacks through Treatment Leads and Electrodes which are positioned on the patient's body according to treatment protocols.

AI/ML Overview

Here's an analysis of the provided 510(k) notification for the VT-200 Interferential Current Therapy Device, focusing on the acceptance criteria and the study that proves the device meets them:

Summary of Acceptance Criteria and Device Performance:

Based on the provided text, the VT-200 device's acceptance criteria primarily revolve around its substantial equivalence to a predicate device and its compliance with recognized safety standards. There are no performance metrics specified in terms of clinical efficacy (e.g., specific pain reduction percentages) that would commonly be found for drug trials or more complex medical devices.

Acceptance Criteria	Reported Device Performance
Intended Use Equivalence: Same intended use as the predicate device (Dynatron STS)	The VT-200 and Dynatron STS have the same intended use: symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain.
Functional Equivalence: Same functional characteristics as the predicate device.	The VT-200 has the same functional characteristics as the Dynatron STS, automating some manual portions using software.
Safety Compliance (Electrical): Compliance with IEC 60601-1 (General Requirements for Safety).	Performance testing indicates the device is in compliance with IEC 60601-1.
Safety Compliance (EMC): Compliance with IEC 60601-1-2 (Electromagnetic Compatibility - Requirements and Tests).	Performance testing indicates the device is in compliance with IEC 60601-1-2.

Study Information:

It's important to note that the provided 510(k) summary does not describe a clinical study with human subjects to evaluate the therapeutic efficacy of the VT-200. Instead, it relies on proving substantial equivalence to a legally marketed predicate device (Dynatron STS) and demonstrating compliance with recognized electrical and electromagnetic safety standards.

Therefore, for categories related to clinical study design, sample size, ground truth, experts, and MRMC studies, the answer will be that this information is not applicable or not provided in the given document, as these types of studies were not conducted or reported for this 510(k) submission.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The "performance testing" mentioned refers to functional and design verification/validation against engineering standards, not a clinical test set with patient data.
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 / Not provided. No clinical ground truth was established by experts for a test set in this submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No test set requiring expert adjudication was described.
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:
- No, an MRMC study was not done. This device is an electrical stimulation therapy device, not an AI-assisted diagnostic or interpretation tool that would involve human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This question typically applies to AI/software as a medical device for diagnostic or interpretive purposes. The VT-200 is a physical therapy device; its "automation" refers to internal software logic for adjusting stimulation intensity, not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided for clinical efficacy. For the engineering performance testing, the "ground truth" would be the specifications and requirements defined by the IEC standards.
The sample size for the training set:
- Not applicable / Not provided. There is no mention of a "training set" in the context of machine learning or AI development for this device. The device's internal software "automatically measuring body temperatures" for intensity adjustment is a programmatic function, not a learned model in the typical AI sense that would require a training set.
How the ground truth for the training set was established:
- Not applicable / Not provided. As no training set was described, the method for establishing its ground truth is also not applicable.

Summary

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510(k) Notification: VT-200 May 24, 2012

510(k): K121662

510(k) SUMMARY

Submitter Information:

Alan Neuromedical Technologies 6001 B South Staples Corpus Christi, TX 78413 361-992-9432

NOV 2 1 2012

Regulatory Affairs Contact: Amy Pieper Regulatory Affairs Consultant (512) 657-9340 -- phone piepers@austin.rr.com -- email

Date Summary Prepared: March 1, 2012

Device Identification:

Trade Name: Common Name: Classification Name:

VT-200 Interferential Current Therapy Device Interferential Current Therapy (LIH)

Predicate Device:

Dynatron STS (K010565)

Intended Use:

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.

Functional Description and Technological Characteristics:

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510(k) Notification: VT-200 May 24, 2012

Substantial Equivalence:

The VT-200 and the Dynatron STS have the same intended use and functional characteristics. The VT-200 takes some of the manual portions of the Dynatron STS and automates them using software. In summary, the VT-200 is functionally equivalent to the Dynatron STS and therefore, substantially equivalent.

Performance Testing:

Performance testing of the VT-200 has been conducted for functional and design verification and validation. The testing indicates the device is in compliance with the following recognized consensus standards:

IEC 60601-1 Medical Electrical Equipment, Part 1 : General . Requirements for Safety
IEC 60601-1-2 Medical Electrical Equipment, Part 1: General . Requirements for Safety, Electromagnetic Compatibility-Requirements and Tests

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized emblem that resembles an abstract representation of a bird or a human figure with outstretched arms.

November 21, 2012

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002

Alan Neuromedical Technologies % Dr. Donald A. Rhodes President 6001-B S. Staples Street Corpus Christi, TX 78413

Re: K121662

Trade/Device Name: VECTTOR VT-200 Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LIH Dated: August 28, 2012 Received: September 26, 2012

Dear Dr. Rhodes:

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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Donald A. Rhodes, D.P.M., F.A.C.F.A.S.

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Notification: VT-200 May 24, 2012

INDICATIONS FOR USE

K121662 510(k) Number (if known):

Device Name: VT-200 (Interferential Current Therapy Device)

Indications For Use:

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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rahal Ram
(Division Sign-Off)

Page 1 of _

Division of Neurological and Physical Medicine Devices 510(k) Number

FDA Submission - VT-200

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Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

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