ELEXOMA MEDIC

K070412 · Redplane AG · QJQ · May 21, 2008 · Neurology

Device Facts

• Record ID: K070412
• Device Name: ELEXOMA MEDIC
• Applicant: Redplane AG
• Product Code: QJQ · Neurology
• Decision Date: May 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The "Elexoma Medic" is a battery operated portable cranial electrotherapy stimulator (CES) device that applies electrical current to a patient's head through electrodes clipped onto the patient's earlobes to treat insomnia, depression, or anxiety and The "Elexoma Medic" is a battery operated portable transcutaneous electrical nerve stimulator (TENS) device used to apply microcurrent through self-adhesive electrodes to a patient's skin for the symptomatic relief of intractable pain, chronic intractable pain, post-traumatic and postsurgical pain relief. The "Elexoma Medic" is a prescription device according to Federal law.

Device Story

Elexoma Medic is a battery-operated, portable device functioning as both a Cranial Electrotherapy Stimulator (CES) and a Transcutaneous Electrical Nerve Stimulator (TENS). For CES, device delivers electrical current to patient's head via earlobe-clip electrodes to treat insomnia, depression, or anxiety. For TENS, device delivers microcurrent via self-adhesive skin electrodes for symptomatic relief of intractable, chronic, post-traumatic, or postsurgical pain. Device is prescription-only; operated by patient under clinical guidance. Output parameters are controlled by device circuitry to provide therapeutic stimulation. Benefits include non-pharmacological management of specified psychiatric symptoms and pain conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use compared to existing legally marketed devices.

Technological Characteristics

Battery-operated portable device. Dual-mode functionality: Cranial Electrotherapy Stimulator (CES) and Transcutaneous Electrical Nerve Stimulator (TENS). CES utilizes earlobe-clip electrodes; TENS utilizes self-adhesive skin electrodes. Delivers electrical current/microcurrent stimulation. No specific materials, software architecture, or connectivity standards disclosed in the provided documentation.

Indications for Use

Indicated for patients suffering from insomnia, depression, or anxiety (via CES) and patients requiring symptomatic relief of intractable pain, chronic intractable pain, post-traumatic pain, or postsurgical pain (via TENS). Prescription use only.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 2 1 2008

Redplane AG % Mr. Jaen Labuschagne Baarerstrasse 8 Zug, Switzerland 6300

Re:

K070412 Trade/Device Name: Elexoma Medic Regulation Number: 21 CFR 882.5800 Regulation Name: Cranial Electrotherapy Stimulator Regulatory Class: Class III Product Code: JXK, GZJ Dated: February 6, 2008 Received: February 21, 2008

Dear Mr. Labuschagne:

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 - Mr. Jaen Labuschagne

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATION FOR USE STATEMENT FOR CES AND TENS COMPONENTS

K070412

510(k) Number (if known):

Device Name:

Elexoma Medic

Indication for Use:

The "Elexoma Medic" is a battery operated portable cranial electrotherapy stimulator (CES) device that applies electrical current to a patient's head through electrodes clipped onto the patient's earlobes to treat insomnia, depression, or anxiety

and

The "Elexoma Medic" is a battery operated portable transcutaneous electrical nerve stimulator (TENS) device used to apply microcurrent through self-adhesive electrodes to a patient's skin for the symptomatic relief of intractable pain, chronic intractable pain, post-traumatic and postsurgical pain relief.

The "Elexoma Medic" is a prescription device according to Federal law.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Optional Format 1-2-96)

Neel R. Dyal for ktn

Division of General, Restorative, and Neurological Devices

510(k) N