(241 days)
The CES Ultra is indicated for the treatment of insomnia. depression or anxiety.
The CES Ultra is a device designed to deliver therapeutic electrical and stimulation for cranial electrotherapy stimulation (CES) applications. The stimulator is powered by a standard 9-volt alkaline battery and delivers a single channel of low-level, constant current electrical stimulation to electrodes connected to the patient's skin via conductive lead wires. Stimulation current is applied to the patient via either standard self-adhering conductive electrodes placed on the head or conductive clip-type electrodes attached to the patient's ear lobes. The stimulator's user controls include: a rotary stimulation amplitude control which allows user adjustment of stimulation current and includes an integral power on/off switch; and a pushbutton timer selector switch which allows user selection of either continuous stimulation or timed stimulation sessions with automatic stimulation shut-off.
The provided text is a 510(k) summary for the CES Ultra™ Stimulator, which is a Cranial Electrotherapy Stimulator (CES). Based on the information provided, no specific acceptance criteria or a study proving the device meets those criteria were required or conducted for this 510(k) submission.
Here's a breakdown of why and what information is available based on your requested points:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable | Not Applicable |
Reasoning: The document explicitly states: "Neither nonclinical nor clinical testing was required to demonstrate the substantial equivalence of the CES Ultra to the designated predicate devices." This means no specific performance criteria linked to clinical outcomes were set for this submission. The basis for clearance was substantial equivalence to already marketed devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable, as no clinical or nonclinical testing was required or conducted to demonstrate substantial equivalence against specific performance criteria.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable, as no clinical or nonclinical testing was required or conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical or nonclinical testing was required or conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done. The device is a direct therapeutic device (Cranial Electrotherapy Stimulator), not an AI-assisted diagnostic or interpretation tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in spirit, the substantial equivalence determination is a form of standalone evaluation. The FDA reviewed the device's technological characteristics (frequency, pulse width, amplitude) and compared them to those of legally marketed predicate devices to determine that the CES Ultra was "substantially equivalent." This means the device itself, based on its design and parameters, was deemed equivalent without needing a human-in-the-loop study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth Type: The ground truth for this submission was the established safety and effectiveness of the predicate devices (NF-1 Mindpeace CES, K895175, and HP-1 Healthpax CES, K883812). The "ground truth" for the CES Ultra's substantial equivalence was that its stimulation parameters (frequency, pulse width, and amplitude) were "well within the established range of such parameters that are generally accepted as safe and effective for CES" as demonstrated by the predicate devices.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" here refers to existing knowledge about CES devices from prior marketing clearances.
9. How the ground truth for the training set was established
- Not applicable in the context of an AI/ML training set. The "ground truth" for establishing substantial equivalence was based on the prior regulatory clearances and established safety and effectiveness of the predicate CES devices. These predicates had previously gone through their own approval processes, which may have involved clinical studies or other data to establish their safety and effectiveness. The CES Ultra leveraged this existing "ground truth" by demonstrating its similarity to these already-approved devices.
{0}------------------------------------------------
APR 5 - 2007
510(k) Summary of Safety and Effectiveness (as required by 21 CFR § 807.92)
- Date Prepared March 22, 2007 Submitter Neuro-Fitness, LLC 33631 S.E. Redmond / Fall City Rd. #2, Fall City, WA 98024 Phone: 425-222-0830, Fax: 425-222-7413 Contact: Michael Stevens Device Names Trade Name: CES Ultra™ Common Name: Cranial Electrotherapy Stimulator (CES) Classification Name: Stimulator, Cranial, Electrotherapy, a preamendment Class III device per 21 CFR § 882.5800 (JXK) Predicate Devices NF-1 Mindpeace CES, K895175, Neuro-Fitness, LLC HP-1 Healthpax CES, K883812, Healthdirections, Inc. Device Description The CES Ultra is a device designed to deliver therapeutic electrical and Summary of stimulation for cranial electrotherapy stimulation (CES) Technological applications. The stimulator is powered by a standard 9-volt Characteristics
- alkaline battery and delivers a single channel of low-level, constant current electrical stimulation to electrodes connected to the patient's skin via conductive lead wires. Stimulation current is applied to the patient via either standard self-adhering conductive electrodes placed on the head or conductive clip-type electrodes attached to the patient's ear lobes. The stimulator's user controls include: a rotary stimulation amplitude control which allows user adjustment of stimulation current and includes an integral power on/off switch; and a pushbutton timer selector switch which allows user selection of either continuous stimulation or timed stimulation sessions with automatic stimulation shut-off.
- Indications for Use The CES Ultra is indicated for the treatment of insomnia. depression or anxiety.
- Substantial The CES Ultra was originally determined by FDA to be Equivalence substantially equivalent to legally marketed CES devices under K895175. The CES Ultra utilizes stimulation parameters (i.e., frequency, pulse width and amplitude) that are well within the established range of such parameters that are generally accepted as safe and effective for CES.
- Device Testing Neither nonclinical nor clinical testing was required to demonstrate the substantial equivalence of the CES Ultra to the designated predicate devices. However, standard engineering bench testing has been performed where appropriate to verify conformance to specifications.
{1}------------------------------------------------
CES Ultra™ 510(k) Notification Neuro-Fitness, LLC March 22, 2007
Special Controls No Special Controls, including performance standards under section 514 of the Act, have been established for CES. However, the conductive lead wires to be used with the CES Ultra are subject to, and comply with, the requirements of 21 CFR Part 898, Performance Standard for Electrode Lead Wires and Patient Cables.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing left and has a sleek, modern design.
Public Health Service
APR 5 - 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Neuro-Fitness, LLC -% Mr. Michael Stevens Vice President P.O. Box 1031 Snoqualmie, Washington 98065
Re: K062284
Trade/Device Name: CES Ultra" Stimulator Regulation Number: 21 CFR 882.5800 Regulation Name: Cranial electrotherapy stimulator Regulatory Class: Class III Product Code: JXK Dated: March 5, 2007 Received: March 12, 2007
Dear Mr. Stevens:
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.
{3}------------------------------------------------
Page 2 - Mr. Michael Stevens
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 (240) 276-0120. 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 Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. M elkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use Statement
510(k) Number: K062284
Device Name: CES Ultra™ Stimulator
Indications for Use: The CES Ultra™ is indicated for the treatment of insomnia, depression, or anxiety.
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)
Doh
Page 1 of 1
(Division Sign-Off) (Division Sign-On) Restorative, Division of Generative, Division of or ovices
510(k) Number
§ 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.