eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)

K240328 · Signifier Medical Technologies, Ltd. · QNO · May 16, 2024 · Dental

Device Facts

• Record ID: K240328
• Device Name: eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
• Applicant: Signifier Medical Technologies, Ltd.
• Product Code: QNO · Dental
• Decision Date: May 16, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.5575
• Device Class: Class 2
• Attributes: Therapeutic

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 <15) and snoring for patients that are 18 years or older.

Device Story

Removable tongue muscle stimulation device; delivers neuromuscular stimulation via mouthpiece to tongue; improves tongue muscle function to keep upper airway open during sleep; reduces snoring/vibration. Used by patient at home; operated via smartphone app (iOS/Android) using Bluetooth Smart. Device consists of mouthpiece with electrodes and control unit. Smartphone app manages therapy sessions. Benefits patient by reducing mild OSA and snoring symptoms.

Clinical Evidence

No clinical data performed. Substantial equivalence supported by non-clinical performance testing, including electrical, software, firmware, and functional verification per IEC 60601-1-2, 60601-1-11, 60601-1-6, and 60601-2-10 standards.

Technological Characteristics

Neuromuscular tongue muscle stimulator; mouthpiece with electrodes; Bluetooth Smart connectivity; smartphone-controlled. Key components: microcontroller, battery fuel gauge, mouthpiece trigger comparator circuit, moisture detection sensor, external DAC. Powered by internal battery. Software-driven stimulation parameters. Sterilization/biocompatibility not specified.

Indications for Use

Indicated for patients 18 years or older with mild obstructive sleep apnea (AHI <15) and snoring.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the neuromuscular tongue stimulator for reduction of snoring and obstructive sleep apnea is subject to the following special controls:

*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.

Predicate Devices

• eXciteOSA without remote control, eXciteOSA with remote control (K223446)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

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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

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#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K240328

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) #: | 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 | [e-mail] | | | | |
| 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 | [e-mail] | | | | |

| Device Name | | | | 21 CFR 807.92(a)(2) | |
|---------------------|----------------------------------------------------------------------------------------------------|--|--|---------------------|--|
| Device Trade Name | eXciteOSA without remote control (3000);<br>eXciteOSA with remote control (6000) | | | | |
| Common Name | Neuromuscular tongue muscle stimulator for the reduction of snoring and<br>obstructive sleep apnea | | | | |
| Classification Name | Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring<br>And Obstructive Sleep Apnea | | | | |
| Regulation Number | 872.5575 | | | | |
| Product Code | QNO | | | | |

| Legally Marketed Predicate Devices<br>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<br>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<br>mild obstructive sleep apnea (AHI <15) and snoring for patients that are 18 years or older. The small electric currents delivered through<br>the mouthpiece stimulate the tongue and improve its muscle function. The improved function of the tongue muscle will help in keeping<br>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 11 Pro & iPhone 11 Pro Max and above, with iOS 15.0 and higher. The mobile app software can also be used with Bluetooth support and Android 10.0 and above. eXciteOSA® uses Bluetooth Smart; mobile devices used must be compatible with Bluetooth Smart.

### Intended Use/Indications for Use

eXciteOSA® is a removable tongue 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 the replacement of the microcontroller from a difference #1), and for the minor changes listed below (difference #2), this subject device has the same technological characteristics of the predicate device.

The first difference, replacement of the microcontroller, was required due to supply issues and is not critical to the intended therapeutic use of the device. This change did not impact the functionality or safety of the device, as evidenced in the testing results and risk analysis submitted with this notification.

The second difference includes the following minor changes:

- Layout of components within control unit to accommodate new MCU
- · Replacement of battery fuel gauge
- · Mouthpiece trigger comparator circuit to detect mouthpiece presence with lower applied voltage
- · Moisture detection to warn user of moisture presence in the USB-C connector, with feedback via an ADC signal to the MCU

· Changed from blue and amber LEDs to blue, and red, which are much more visible. The yellow LED position was also slightly moved so it is no longer under the blue 'S' logo, for better visibility.

- External DAC to match the output resolution of the previous MCU internal DAC
- Optional extender cable to be provided to end-user

These minor changes (difference #2) do not rise to the need of submitting a 510(k) in accordance with FDA Guidances, Deciding When to Submit a 510(k) for a Change to an Existing Device (2017) and The Special 510(k) Program(2019). These changes are justified via risk analysis.

#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Clinical tests were not performed. Various non-clinical tests were performance studies were conducted according to IEC standards 60601-1-2, 60601-1-11, 60601-1-6, and 60601-2-10. Additional device-specific electrical, software, firmware, and functional verification testing was performed. The device passed all relevant tests. These test results support the finding of substantial equivalence to the predicate device.

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)

## 21 CFR 807.92(a)(5)