VECTTOR VT-200

K121662 · Alan Neuromedical Technologies, LLC · LIH · Nov 21, 2012 · Neurology

Device Facts

• Record ID: K121662
• Device Name: VECTTOR VT-200
• Applicant: Alan Neuromedical Technologies, LLC
• Product Code: LIH · Neurology
• Decision Date: Nov 21, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The VT-200 (VECTTOR system) is an interferential current therapy device used for pain management. It delivers electrical stimulation via electrodes placed on acupressure points of a patient's feet/legs and hands/arms. The device inputs include body temperature data measured by two thermistors placed on the patient's fingers during a testing sequence. Software uses this temperature data to automatically determine appropriate stimulation intensity. The device provides four channels of current through dual output jacks. It is intended for clinical use to assist healthcare providers in managing chronic intractable, post-traumatic, or post-surgical pain. The device automates manual intensity adjustment processes found in predicate systems.

Clinical Evidence

No clinical data provided. Performance testing was limited to functional and design verification and validation, confirming compliance with IEC 60601-1 and IEC 60601-1-2 consensus standards.

Technological Characteristics

Interferential current therapy device; four-channel electrical stimulation output; thermistor-based temperature sensing for intensity determination; software-controlled stimulation parameters; complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients requiring symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain.

Regulatory Classification

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.

Predicate Devices

• Dynatron STS (k010565)

Submission Summary (Full Text)

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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 [phone] -- phone [e-mail] -- 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:

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.

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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 [phone] or [phone] 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)

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

FDA Submission - VT-200

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