(64 days)
Not Found
No
The summary describes a neuromuscular stimulation device controlled by a smartphone app. There is no mention of AI, ML, or any algorithms that would suggest learning or adaptive capabilities based on data. The device's function appears to be a fixed stimulation protocol.
Yes
The device is used to reduce mild obstructive sleep apnea and snoring, which are medical conditions, and it delivers neuromuscular stimulation for this therapeutic purpose.
No
The device is a tongue muscle stimulation device intended to reduce mild obstructive sleep apnea and snoring, not to diagnose a condition.
No
The device description explicitly states it is a "removable tongue muscle stimulation device" that delivers "small electric currents delivered through the mouthpiece." This indicates a physical hardware component (the mouthpiece) is integral to the device's function, in addition to the software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The eXciteOSA® device is a physical device that delivers electrical stimulation directly to the tongue muscle. It does not analyze any biological samples taken from the patient.
- Intended Use: The intended use is to treat a condition (mild obstructive sleep apnea and snoring) by directly stimulating a muscle, not by providing diagnostic information based on in vitro analysis.
The device is a therapeutic device that provides neuromuscular stimulation, not a diagnostic device that analyzes samples.
N/A
Intended Use / Indications for Use
eXciteOSA® is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce mild obstructive sleep apnea (AHI
§ 872.5575 Neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea.
(a)
Identification. A neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea consists of a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue to strengthen tongue musculature to reduce snoring and obstructive sleep apnea.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance testing must demonstrate the wireless compatibility, electrical safety, battery safety, and electromagnetic compatibility of the device in its intended use environment.
(2) Software verification, validation, and hazard analysis must be performed.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Patient labeling must include:
(i) Information on device components, setup, and use of the device including placement of sensors and mouthpieces, and images or illustrations;
(ii) A summary of technical specifications;
(iii) Instructions on how to clean and maintain the device;
(iv) A statement that the patient should maintain regular follow up visits with dentist and sleep specialist; and
(v) A statement that patients should have a comprehensive dental examination prior to using this device.
(5) A human factors assessment must evaluate simulated use of the device to demonstrate that the user can correctly use device based on the labeling and instructions for use.
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January 18, 2023
Signifier Medical Technologies Ltd % Darren Scheer Principal RegChoice LLC 13014 N. Dale Mabry Hwy STE 803 Tampa, Florida 33618
Re: K223446
Trade/Device Name: eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) Regulation Number: 21 CFR 872.5575 Regulation Name: Neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea Regulatory Class: Class II Product Code: QNO Dated: November 14, 2022 Received: December 19, 2022
Dear Darren Scheer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
eXciteOSA without remote control (3000);
eXciteOSA with remote control (6000)
Indications for Use (Describe)
eXciteOSA® is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce mild obstructive sleep apnea (AHI Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Prepared on: 2022-11-14
| 21 CFR 807.92(a)(1) | |||
|---|---|---|---|
| Applicant Name | Signifier Medical Technologies Ltd | ||
| Applicant Address | 5-17 Hammersmith Grove London W6 0LG United Kingdom | ||
| Applicant Contact Telephone | 442070960586 | ||
| Applicant Contact | Mr. Yasser Zayni | ||
| Applicant Contact Email | yasser.z@signifiermedical.com | ||
| Correspondent Name | RegChoice LLC | ||
| Correspondent Address | 13014 N. Dale Mabry Hwy STE 803 Tampa FL 33618 United States | ||
| Correspondent Contact Telephone | 8133633004 | ||
| Correspondent Contact | Dr. Darren Scheer | ||
| Correspondent Contact Email | dscheer@regchoice.com |
Device Name
| 21 CFR 807.92(a)(2) | |||
|---|---|---|---|
| Device Trade Name | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | ||
| Common Name | Neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea | ||
| Classification Name | Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea | ||
| Regulation Number | 872.5575 | ||
| Product Code | QNO |
Legally Marketed Predicate Devices
| 21 CFR 807.92(a)(3) | |||
|---|---|---|---|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| DEN200018 | eXciteOSA without remote control, eXciteOSA with remote contre | QNO |
Device Description Summary
| 21 CFR 807.92(a)(4) | |||
|---|---|---|---|
| -- | -- | -- | --------------------- |
eXciteOSA® is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the to reduce mild obstructive sleep apnea (AHI