(64 days)
eXciteOSA® is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce mild obstructive sleep apnea (AHI <15) and snoring for patients that are 18 years or older.
eXciteOSA® is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the to reduce mild obstructive sleep apnea (AHI <15) and snoring for patients that are 18 years or older. The small electric currents delivered through the mouthpiece stimulate the tongue and improved function. The improved function of the tongue muscle will help in keeping the upper airway open during sleep and reduce the vibration of the throat region. Two tabs of the mouthpiece sit comfortably above and below the tongue. The mouthpiece is designed such that when the mouth is gently closed, it will naturally sit around the tongue and won't move during the therapy session. The device can be used at any point during the day. The device can be controlled by a smartphone application. This app can be downloaded from the App store (Apple iOS) or Play Store (Google Android). The mobile app software can be used on iPhone 6/6 Plus, iPhone 6/6s Plus, iPhone 7/7 Plus, iPhone 8/8 Plus, iPhone X, with iOS 11.0 and higher. The mobile app software can also be used with Android devices with BLE support (Bluetooth 4.0) and Android 7.0 and above. eXciteOSA® uses Bluetooth Smart; mobile devices used must be compatible with Bluetooth Smart.
The provided text is a 510(k) summary for the eXciteOSA device. It states that non-clinical and/or clinical tests were not performed because the "subject device are the same and no physical changes were made" compared to the predicate device (DEN200018).
Therefore, based on the input text:
- A table of acceptance criteria and the reported device performance: This information is not available in the provided text. The submission explicitly states no tests were performed.
- Sample sized used for the test set and the data provenance: Not applicable, as no tests were performed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no tests were performed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no tests were performed.
- 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: Not applicable, as no tests were performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as no tests were performed.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no tests were performed.
- The sample size for the training set: Not applicable, as no new training was performed or reported.
- How the ground truth for the training set was established: Not applicable, as no new training was performed or reported.
The 510(k) submission states that the device is substantially equivalent to the predicate device (DEN200018) and that the differences (deletion of some contraindications and minor software/firmware updates) were not critical to the intended therapeutic use and did not require new testing.
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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 <15) and snoring for patients that are 18 years or older.
Type of Use (Select one or both, as applicable)
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 <15) and snoring for patients that are 18 years or older. The small electric currents delivered through the mouthpiece stimulate the tongue and improved function. The improved function of the tongue muscle will help in keeping the upper airway open during sleep and reduce the vibration of the throat region.
Two tabs of the mouthpiece sit comfortably above and below the tongue. The mouthpiece is designed such that when the mouth is gently closed, it will naturally sit around the tongue and won't move during the therapy session. The device can be used at any point during the day.
The device can be controlled by a smartphone application. This app can be downloaded from the App store (Apple iOS) or Play Store
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(Google Android). The mobile app software can be used on iPhone 6/6 Plus, iPhone 6/6s Plus, iPhone 7/7 Plus, iPhone 8/8 Plus, iPhone X, with iOS 11.0 and higher. The mobile app software can also be used with Android devices with BLE support (Bluetooth 4.0) and Android 7.0 and above. eXciteOSA® uses Bluetooth Smart; mobile devices used must be compatible with Bluetooth Smart.
Intended Use/Indications for Use
eXciteOSA® is a removable tonque muscle that delivers neuromuscular stimulation to the tongue in order to reduce mild obstructive sleep apnea (AHI <15) and snoring for patients that are 18 years or older.
Indications for Use Comparison
The indications for use are the same as the predicate device.
Technological Comparison
Other than for the deletion of some contraindications (difference #1) and for minor software/firmware updates (difference #2), this subject device has the same technological characteristics of the predicate device.
The first difference, in contraindications, is not critical to the intended therapeutic use of the three supporting sources of data and the associated risk analysis.
The second difference, in software/firmware minor updates, does not rise to the need of submitting a 510(k) in accordance with FDA Guidance Deciding When to Submit a 510(k) for a Software Change to an Existing Device. These changes are justified via risk analysis.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-clinical and/or clinical tests were not performed, as the subject device are the same and no physical changes were made.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
§ 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.