(464 days)
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No
The document describes a standard electrical stimulation device (CES/TENS) and makes no mention of AI, ML, or any related technologies.
Yes
The device is intended to treat medical conditions such as insomnia, depression, anxiety, and various types of pain through electrical stimulation.
No
The device is described as a cranial electrotherapy stimulator (CES) and transcutaneous electrical nerve stimulator (TENS) used for treatment (insomnia, depression, anxiety, pain relief), not for diagnosis.
No
The device description explicitly states it is a "battery operated portable cranial electrotherapy stimulator (CES) device" and a "battery operated portable transcutaneous electrical nerve stimulator (TENS) device" that applies electrical current through electrodes. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Elexoma Medic Function: The Elexoma Medic is a device that applies electrical current directly to the patient's body (either the head via earlobe electrodes or the skin via self-adhesive electrodes). It is a therapeutic device, not a diagnostic one that analyzes samples.
The description clearly states its intended use is for treating conditions like insomnia, depression, anxiety, and pain by applying electrical stimulation. This is a form of therapy, not in vitro diagnosis.
N/A
Intended Use / 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.
Product codes
JXK, GZJ
Device Description
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. It is also a battery operated portable transcutaneous electrical nerve stimulator (TENS) device used to apply microcurrent through self-adhesive electrodes to a patient's skin.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Patient's head (earlobes), patient's skin
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 882.5800 Cranial electrotherapy stimulator.
(a)
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.(b)
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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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 (240) 276-0120. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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
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