(101 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on neuromuscular stimulation and control via a smartphone app, without mentioning any AI/ML functionalities.
Yes
The device is intended to reduce mild obstructive sleep apnea and snoring by delivering neuromuscular stimulation to the tongue, which is a therapeutic action.
No
The device description clearly states its purpose is to deliver neuromuscular stimulation to the tongue to reduce mild obstructive sleep apnea and snoring, which is a therapeutic function rather than a diagnostic one.
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) that delivers the therapy, in addition to the software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
- eXciteOSA® Function: The description clearly states that eXciteOSA® is a device that delivers neuromuscular stimulation to the tongue. It works by directly interacting with the patient's body (in vivo) to improve muscle function and reduce symptoms.
- No Specimen Examination: There is no mention of the device examining any biological specimens from the patient.
Therefore, eXciteOSA® falls under the category of a therapeutic or treatment device, not an in vitro diagnostic device.
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
May 16, 2024
Signifier Medical Technologies Ltd % Darren Scheer Principal RegChoice LLC 13014 N. Dale Mabry Hwy STE 803 Ste 803 Tampa, Florida 33618
Re: K240328
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: February 2, 2024 Received: February 5, 2024
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 (the 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 available 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510/k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
| 510(k) #: | K240328 | 510(k) Summary | Prepared on: | 2024-04-17 | |
|---|---|---|---|---|---|
| ----------- | --------- | ---------------- | -- | -------------- | ------------ |
| Contact Details | 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 | 813-363-3004 | ||||
| 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 | ||
| K223446 | 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 tongue in order to reduce | ||||
| mild obstructive sleep apnea (AHI |