(142 days)
FM 10/C is indicated to be used for:
- CES for the treatment of insomnia, depression, or anxiety. .
- TNS for Symptomatic relief and management of chronic intractable pain and/or . as an adjunctive treatment in the management of post-traumatic and postsurgical acute pain.
FM 10/C is portable Cranial Electrical Nerve Stimulator. FM 10/C combines uniquely two proven therapies CES for the treatment of insomnia, depression, or anxiety and TENS for symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain. Thus FM 10/C offers a partnership between Transcutaneous Electrical Nerve Stimulation (TENS) and Cranial Electrotherapy Stimulation (CES). FM 10/C has three modes viz. (i) TENS Burst (ii) TENS Conventional and (iii) CES mode. It provides easy mode selection through slide switch and user can select any one of the available modes through it. TENS and CES modes will not operate simultaneously so, if CES Leads are inserted then TENS modes are automatically blocked for the user and vice versa. TENS mode is programmable and user will have the option to select pulse width and pulse rate using analog pots. In addition treatment time is also selectable using a slide switch options available are 30 minutes or continuous treatment time. FM 10/c is only battery operated, with low battery indication.
The provided document does not contain information about acceptance criteria or a study that proves the device meets those criteria. Instead, it is a 510(k) premarket notification summary for a medical device (Cranial Electrical Nerve Stimulator, Model FM 10/C).
This document mainly describes the device, its intended use, and compares its technical specifications to two legally marketed predicate devices (CES Ultra and ELECTRONIC PAIN RELIEVERS) to claim substantial equivalence. The FDA letter confirms the substantial equivalence determination.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on technical specifications of the new device and predicate devices.
- Sample size used for the test set and the data provenance: No clinical testing or data is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
- If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an electrotherapy device, not an AI algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable, as no AI model or training data is discussed.
- How the ground truth for the training set was established: Not applicable.
The document serves to demonstrate that the FM 10/C device is substantially equivalent to existing devices in terms of its technology and intended use, primarily through technical specification comparison and safety considerations (e.g., battery operation). It does not present results from performance studies or clinical trials to meet specific acceptance criteria.
§ 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.