TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1

K024377 · Kalaco Scientific, Inc. · QJQ · Jul 21, 2003 · Neurology

Device Facts

• Record ID: K024377
• Device Name: TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1
• Applicant: Kalaco Scientific, Inc.
• Product Code: QJQ · Neurology
• Decision Date: Jul 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Treatment with the TESA device is intended to reduce the symptoms of depression, anxiety and insomnia. The TESA device is intended for use by or on the order of a licensed health care practitioner. A trained technician will administer actual treatment.

Device Story

TESA is a transcranial electrotherapy stimulation device. It uses three electrodes (one forehead, two behind ears) to deliver low-amplitude AC current. A built-in microprocessor controls treatment parameters (0-99:59 minutes; 0-4 mA peak current). The device delivers a modulated high-frequency square wave designed to eliminate DC components; electrodes are AC-coupled for safety. It features real-time electrode impedance monitoring; if contact is poor, the device stops treatment and illuminates a fault LED. Operated by a trained technician under physician order, the device provides symptomatic relief for depression, anxiety, and insomnia. The healthcare provider uses the device to deliver non-invasive stimulation, with the patient or operator able to terminate treatment via a manual 'current off' button.

Clinical Evidence

No clinical data. Verification of hardware and software functionality was performed using pass/fail criteria to ensure compliance with safety standards including UL2601-1, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, and IEC 60601-2-10.

Technological Characteristics

Transcranial electrotherapy stimulator; delivers modulated high-frequency AC square wave; 0-4 mA output; 3-electrode configuration. Features microprocessor-based control, AC-coupled patient interface, and real-time electrode impedance monitoring. Complies with UL2601-1 and IEC 60601 series safety standards.

Indications for Use

Indicated for patients suffering from symptoms of depression, anxiety, and insomnia. Intended for use under the order of a licensed healthcare practitioner.

Regulatory Classification

Identification

A cranial electrotherapy stimulator is a prescription device that applies electrical current that is not intended to induce a seizure to a patient's head to treat psychiatric conditions.

Special Controls

In combination with the general controls of the FD&C Act, the virtual reality behavioral therapy device for pain relief is subject to the following special controls:

*Classification.* (1) Class II (special controls) when intended to treat insomnia and/or anxiety. The special controls for this device are:(i) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device to treat insomnia and/or anxiety. (ii) Components of the device that come into human contact must be demonstrated to be biocompatible. (iii) The device must be designed and tested for electrical safety and electromagnetic compatibility (EMC) in its intended use environment. (iv) Appropriate software verification, validation, and hazard analysis must be performed. (v) The technical parameters of the device, including waveform, output mode, pulse duration, frequency, train delivery, maximum charge, and energy, must be fully characterized and verified. (vi) The labeling for the device must include the following: (A) The intended use population and the intended use environment; (B) A warning that patients should be monitored by their physician for signs of worsening; (C) A warning that instructs patients on how to mitigate the risk of headaches, and what to do should a headache occur; (D) A warning that instructs patients on how to mitigate the risk of dizziness, and what to do should dizziness occur; (E) A detailed summary of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device; (F) Instructions for use that address where to place the electrodes, what stimulation parameters to use, and duration and frequency of treatment sessions. This information must be based on the results of clinical studies for the device; (G) A detailed summary of the device technical parameters, including waveform, output mode, pulse duration, frequency, train delivery, and maximum charge and energy; and (H) Information on validated methods for reprocessing any reusable components between uses. (vii) Cranial electrotherapy stimulator devices marketed prior to the effective date of this reclassification must have an amendment submitted to the previously cleared premarket notification (510(k)) demonstrating compliance with these special controls. (2) Class III (premarket approval) when intended to treat depression. (c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 19, 2020, for any cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 19, 2020, been found to be substantially equivalent to any cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Alpha-Stim CS (K903014)
• Liss Cranial Stimulator, SBL202-B (K903654)
• HealthPax HP-1 (K883812)

Submission Summary (Full Text)

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### JUL 2 1 2003

# 510(k) Summary

| Submitter's Name: | Kalaco Scientific, Inc. |
|----------------------------|-------------------------------------------------------|
| Submitter's Address: | 6514 N. 85th Place, Scottsdale, AZ 85250-5742 |
| Submitter's Telephone: | [phone] |
| Contact Name: | Raymond R. Wallage |
| Date Summary was Prepared: | December 25, 2002 |
| Trade or Proprietary Name: | Transcranial Electrotherapy Stimulator-A (TESA) |
| Common or Usual Name: | CES |
| Classification Name: | Stimulator, Cranial Electrotherapy (21 CFR 882. 5800) |

Predicate Devices:

| Device Name | 510(k) Number |
|-----------------------------------|---------------|
| Alpha-Stim CS | K903014 |
| Liss Cranial Stimulator, SBL202-B | K903654 |
| HealthPax HP-1 | K883812 |

### Description of the Device and Summary of the Technological Characteristics:

The TESA is a transcranial electrotherapy stimulation device. Three electrodes are applied, one to the forehead and one behind each ear. TESA delivers low amplitude AC current for a desired time of 0 to 99:59 minutes. Treatment can be stopped by pressing the "current off" button. Either the operator or patient may press this button at any time. During treatment, peak current amplitude can be adjusted over the available range of 0 - 4 mA. Treatment parameters are monitored and controlled by a built in microprocessor. The display on the front of TESA indicates remaining treatment time and shows the current setting.

During treatment, a modulated high frequency square wave is delivered to the patient electrodes. The amplitude and duration of the positive and negative going portions of this waveform have been carefully designed to deliver no DC component. Moreover, the electrodes are AC coupled to the patient to insure no DC component in the event of device failure.

Additional safety features of the TESA device include rapid measurement of electrode impedance to insure good electrode contact and to maintain controlled current output over changing load conditions (e.g. when electrode contact changes). Detection of poor electrode contact causes the device to stop treatment and illuminate an electrode fault LED. Further treatment is blocked until electrode/skin impedance is restored to nominal range.

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#### Indications for Use:

Treatment with the TESA device is intended to reduce the symptoms of depression, anxiety and insomnia.

The TESA device is intended for use by or on the order of a licensed health care practitioner. A trained technician will administer actual treatment.

#### Substantial Equivalence:

The TESA device uses a proprietary stimulation waveform, but the current amplitude and frequencies are similar to prodicate devices such as the Alpha-Stim CS.

#### Testing:

Various tests of the hardware and software have been performed to verify that the device works as described in this document. Verification procedures with pass/fail critcria were developed to ensure that the product met all the specified requirements. As part of this vorification, a certified body will be used to determine that the device conforms to the recognized safety standards listed below. The device will not be marketed until it has been tested and complies with the standards.

UL2601-1 IEC 60601-1 IEC 60601-1-1 IEC 60601-1-2 IEC 60601-1-4 IEC 60601-2-10

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2003

Kalaco Scientific, Inc. c/o Grace Bartoo, Ph.D., RAC Vice President Regulatory and Clinical Affairs Instrumentation for Science and Medicine, Inc. 131 Glenn Way, Suite 7 San Carlos, California 94070

Re: K024377

Trade/Device Name: Transcranial Electrotherapy Stimulator-A, Model TESA-1 Regulation Number: 21 CFR 882.5800 Regulation Name: Cranial Electrotherapy Stimulator Regulatory Class: Class III Product Code: JXK Dated: Undated Received: April 22, 2003

Dear Dr. Bartoo:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.

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Page 2 - Grace Bartoo, Ph.D., RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark M Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative

and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# D Indications for Use Statement

| Ver/ 3 - 4/24/96 | |
|---------------------------|--------------------------------------------------------------------------------------------------------|
| Applicant: | Kalaco Scientific, Inc. |
| 510(k) Number (if known): | K024377 |
| Device Name: | TESA |
| Indications For Use: | Treatment with the TESA device is intended to reduce the symptoms of depression, anxiety and insomnia. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*for*
Mark N Millman

(Division Sign-Off)

Division of General, Restorative and Neurological Devices

| 510(k) Number | K024377 |
|---------------|---------|
|---------------|---------|

| Prescription Use per 21 CFR 801.109 <img alt="checkmark" src=""/> | Over the Counter Use __________ |
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