Hushd Pro Avera

K232025 · Good Sleep CO Pte , Ltd. · LRK · May 9, 2024 · Dental

Device Facts

• Record ID: K232025
• Device Name: Hushd Pro Avera
• Applicant: Good Sleep CO Pte , Ltd.
• Product Code: LRK · Dental
• Decision Date: May 9, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hushd Pro Avera device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Device Story

Removable, patient-specific intraoral device; treats snoring and mild to moderate OSA. Consists of custom-made maxillary and mandibular splints; fits over teeth. Functions as mandibular repositioner; holds mandible forward during sleep; prevents tongue and soft tissue collapse into airway. CAD/CAM designed and manufactured; sequential devices provide gentle mandibular advancement based on dentist/physician prescription. Maximum protrusion 10mm. No mechanical adjustment mechanisms (pistons, straps, elastics); advancement achieved by replacing current splints with next in series. Used in home setting; patient-operated. Healthcare provider uses output to manage airway patency; benefits patient by reducing OSA symptoms and snoring.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including mechanical property evaluation (flexural modulus, flexural strength, impact strength) and biocompatibility testing (cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity) per ISO 10993-1.

Technological Characteristics

Custom-made intraoral splints; material: polyamide type 12 polymer. CAD/CAM manufacturing; selective laser sintering. Non-sterile. Mandibular repositioning via twin-mated posts. Max advancement 10mm. No active energy source. Standalone device.

Indications for Use

Indicated for adults with snoring and mild to moderate obstructive sleep apnea (OSA).

Regulatory Classification

Identification

Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.

Special Controls

*Classification.* Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”

Predicate Devices

• The Panthera Anti-Snoring Device (K143244)

Reference Devices

• MicrO2 Obstructive Sleep Apnea Device (K133683)
• Soundly Mandibular Advancement Device (K220330)
• Panthera Anti-Snoring X3 Device (K171576)

Submission Summary (Full Text)

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May 9, 2024

Good Sleep Co Pte Ltd. % Na Zhang Project Manager evo820, LLC 1 Bay Street Rancho Mission Viejo, California 92694

Re: K232025

Trade/Device Name: Hushd Pro Avera Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: Class II Product Code: LRK Dated: June 27, 2023 Received: July 7, 2023

Dear Na Zhang:

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 (OS) 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 (QS) 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

510(k) Number (if known) K232025

Device Name Hushd Pro Avera

Indications for Use (Describe)

The Hushd Pro Avera device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# K232025 510(k) Summary

# SUBMITTER

| Date Prepared: | May 7, 2023 |
|-------------------|------------------------------------------------------------------------------|
| Submitter: | Good Sleep Co Pte Ltd.<br>226 Ocean Drive<br>Singapore, 098617<br>Singapore |
| Official Contact: | Joel Simpson<br>Director<br>Tel:[phone]<br>Email: [e-mail] |

# DEVICE

| Trade/Proprietary Name: | Hushd Pro Avera |
|-----------------------------|---------------------------------------------------------------------------------|
| Classification Name : | Device Anti-Snoring |
| Common Name : | Intraoral device for snoring and<br>mild to moderate obstructive<br>sleep apnea |
| Classification Regulations: | 21CFR 872.5570 |
| Product Code: | LRK |
| Device Classification: | Class II |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |

# PRIDICATE DEVICE

| Predicate Device: | K143244 | The Panthera Anti-Snoring Device | Panthera Dental, Inc. |
|-------------------|---------|---------------------------------------|--------------------------|
| Reference Device: | K133683 | MicrO2 Obstructive Sleep Apnea Device | MicroDental laboratories |
| | K220330 | Soundly Mandibular Advancement Device | Greystone IP Ltd |
| | K171576 | Panthera Anti-Snoring X3 Device | Panthera Dental, Inc. |

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# DEVICE DESCRIPTION

The Hushd Pro Avera device series are a set of removable intraoral patient specific device used for treating snoring and mild to moderate obstructive sleep apnea. The device consists of number of custom made maxillary and mandibular splints fit over the upper and lower teeth. when interfaced together, functions as a mandibular repositioner holding the mandible forward during sleep thus preventing the togue and soft tissues of the throat from collapsing into the airway.

The Hushd Pro Avera device series are patient-specific devices, consisting of one or more maxillary device(s) and one or more mandibular device(s) that mates together. The sequential devices are CAD/CAM designed and manufactured according to the requested mandibular advancements position prescribed by the dentist or physician to provide a selection of gentle advancements according to patient comfort and need. As such, prescribed advancements can be achieved by simply removing current maxillary or mandibular device and inserting the next maxillary or mandibular device in the advancements series. The maximum protrusion of the device is 10mm.The Hushd Pro Avera device does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, straps or repositioning elastics.

# INDICATIONS FOR USE

The Hushd Pro Avera device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

### COMPARISON OF TECHNOLOGICAL WITH THE PREDICATE DEVICE

The subject device is substantial equivalent in intended use and technological characteristics to the predicate devices shown above. Below is a summary table comparing the subject device with the primary predicate and reference devices.

| Features | Submission<br>Device | Predicate<br>Device | Reference<br>Device | Reference<br>Device | Reference<br>Device |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacture | Good Sleep Co<br>Pte Ltd. | Panthera Dental,<br>Inc. | MicroDental<br>laboratories | Greystone IP Ltd | Panthera Dental Inc. |
| Trade Name | Hushd Pro Avera | The Panthera<br>Anti-Snoring<br>Device | MicrO2<br>Obstructive Sleep<br>Apnea Device | Soundly<br>Mandibular<br>Advancement<br>Device | Panthera Anti-<br>Snoring X3 Device |
| 510(k) Number | K232025 | K143244 | K133683 | K220330 | K171576 |
| Regulation<br>Number | 21 CFR 872.5570 | 21 CFR 872.5570 | 21 CFR 872.5570 | 21 CFR 872.5570 | 21 CFR 872.5570 |
| Classifications | Class II | Class II | Class II | Class II | Class II |
| Product Code | LRK | LRK | LRK | LRK, LQZ | LRK |
| Indications for<br>Use | The Hushd Pro<br>Avera device is | The Panthera<br>Anti-Snoring | The<br>MICRODENTAL | The Soundly<br>Mandibular | The Panthera Anti-<br>Snoring X3 Device |
| | intended to reduce<br>or alleviate<br>snoring and mild<br>to moderate<br>obstructive sleep<br>apnea (OSA) in<br>adults. | device is intended<br>to reduce or<br>alleviate snoring<br>and mild to<br>moderate<br>obstructive sleep<br>apnea (OSA) in<br>adults. | , Inc, micr02<br>device is intended<br>to reduce night<br>time snoring and<br>mild to moderate<br>obstructive sleep<br>apnea (OSA) in<br>adults. | Advancement<br>Device is intended<br>to reduce or<br>alleviate snoring<br>and mild to<br>moderate<br>Obstructive Sleep<br>Apnea(OSA)<br>whilst sleeping in<br>adults. | is intended to<br>reduce or alleviate<br>snoring and mild to<br>moderate<br>obstructive sleep<br>Apnea(OSA) in<br>adults. |
| Principle of<br>Operation | Mandibular<br>Repositioners,<br>Repositions the<br>lower jaw forward<br>to increase the<br>patency of the | Mandibular<br>Repositioners,<br>Repositions the<br>lower jaw forward<br>to increase the<br>patency of the | Mandibular<br>Repositioners,<br>Repositions the<br>lower jaw forward<br>to increase the<br>patency of the | Mandibular<br>Repositioners,<br>Repositions the<br>lower jaw forward<br>to increase the<br>patency of the | Mandibular<br>Repositioners,<br>Repositions the<br>lower jaw forward<br>to increase the<br>patency of the |
| Adjustment<br>mechanism | airway<br>Advancements<br>can be achieved<br>by simply<br>removing the<br>current upper or<br>lower device and<br>inserting the next<br>upper or lower<br>device in the<br>mandibular<br>advancing series. | airway<br>Adjusted via the<br>use of interlocking<br>rods placed on<br>each side of the<br>mandible splint.<br>The shorter the<br>rod, the further<br>mandible is<br>advanced. The<br>dentist can select a<br>shorter connecting<br>rod until optimal<br>advancement is<br>achieved | airway<br>Advancements<br>can be achieved<br>by simply<br>removing the<br>current upper or<br>lower device and<br>inserting the next<br>upper or lower<br>device in the<br>mandibular<br>advancing series. | airway<br>User choose<br>which of the 3<br>lower splints to<br>wear-self titration | airway<br>Adjusted via the<br>adjustable clip<br>assembly placed on<br>each side of the<br>maxillary splint.<br>The longer the stop-<br>clip is, the further<br>the mandible is<br>advanced. The<br>dentist can select a<br>longer stop-clip<br>until optimal<br>advancement is<br>achieved. |
| Mandibular<br>advancement<br>range | Up to 10mm<br>50-90% of the<br>patient's<br>maximum<br>comfortable<br>mandibular<br>advancement at<br>1mm increment | Up to 15mm at<br>1mm increment | Up to 6.0mm | 3 positions at<br>40%,60% & 70%<br>of the patient's<br>maximum<br>comfortable<br>mandibular<br>advancement<br>Maximum<br>advancement is<br>12mm | Up to 5mm at 1mm<br>increments |
| Material | Made from<br>polymers<br>(polyamide type<br>12), Supplied by<br>EOS | Made from<br>polymers<br>(polyamide type<br>12), Supplied by<br>EOS | Hard PMMA<br>material | Form labs Dental<br>LT Clear V2 | Made from<br>polymers(polyamide<br>type12), supplied by<br>EOS. |
| Biocompatible | Yes | Yes | Yes | Yes | Yes |
| Rx or OTC | Rx | Rx | Rx | Rx | Rx |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Target<br>Population | Adults | Adults | Adults | Adults | Adults |
| Design | Two customized<br>intra oral splints | Two customized<br>intra oral splints | Two customized<br>intra oral splints | Two customized<br>intra oral splints | Two customized<br>splints that fit |
| | that fit separately<br>over the upper and<br>lower teeth. | that fit separately<br>over the upper and<br>lower teeth. | that fit separately<br>over the upper and<br>lower teeth. | that fit separately<br>over the upper and<br>lower teeth. | separately over the<br>upper and lower<br>teeth inside the<br>mouth. |
| | These separate<br>maxillary and<br>mandible splints<br>are designed with<br>twin-mated posts,<br>when interface<br>together,<br>functioning as<br>mandible<br>repositioner<br>holding the<br>mandible forward<br>during sleep | The mandible<br>splint contains a<br>triangular<br>protrusion<br>allowing the<br>splints to engage<br>by means of<br>interlocking rods<br>on the sides. | These separate<br>maxillary and<br>mandible splints<br>are designed with<br>twin-mated posts,<br>when interface<br>together,<br>functioning as<br>mandible<br>repositioner<br>holding the<br>mandible forward<br>during sleep | The mandibular<br>advancement is<br>achieved by the<br>interlocking of<br>opposing wedge<br>faces on the upper<br>and lower jaw<br>position, There are<br>no locking side<br>arms, so the<br>splints can be<br>disengaged by a<br>small forward and<br>downward<br>movement of<br>lower jaw. The<br>upper splint is<br>supplied with 3<br>sizes of<br>mandibular<br>advancement, tied<br>to the patient's<br>maximum<br>mandibular<br>advancement. | The mandible splint<br>contains wing<br>protrusions that<br>interface with the<br>incline blocks built<br>into the buccal of<br>the maxillary splint. |
| Manufacture<br>Technology | Use the computer<br>-aided design<br>(CAD) and<br>Computer-aided<br>manufacturing(CA<br>M)<br>Use CAD that<br>enables a high<br>degree of<br>customization<br>according to the<br>physician or<br>dentists<br>prescription to<br>accommodate the<br>complex dental<br>anatomy of<br>individual<br>patients. The<br>CAM and<br>selective laser<br>sintering<br>guarantees<br>precision,<br>accuracy and | Use the computer<br>-aided design<br>(CAD) and<br>Computer-aided<br>manufacturing(CA<br>M)<br>Use CAD that<br>enables a high<br>degree of<br>customization<br>according to the<br>physician or<br>dentists<br>prescription to<br>accommodate the<br>complex dental<br>anatomy of<br>individual<br>patients. The<br>CAM and<br>selective laser<br>sintering<br>guarantees<br>precision,<br>accuracy and | Use the computer<br>-aided design<br>(CAD) and<br>Computer-aided<br>manufacturing(CA<br>M) | Use the computer<br>-aided design<br>(CAD) and<br>Computer-aided<br>manufacturing(CA<br>M) | Uses computer-<br>aided(CAD) and<br>computer-aided<br>manufacturing(CA<br>M).<br>Uses CAD that<br>enables a high<br>degree of<br>customization<br>according to the<br>physician or dentist<br>prescription. The<br>CAM and selective<br>laser sintering<br>guarantee precision,<br>accuracy and<br>consistency of each<br>patient. |

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| | consistency for | consistency for | | |
|--|-----------------|-----------------|--|--|
| | each patient | each patient | | |

Compared to the predicate device , the Hushd Pro Avera has the same intended use/Indications for use , principle of operation , fabricated by using the same material and a similar manufacturing technology except its adjustment mechanism , however the same adjustment mechanism was adopted by the reference device. The slight difference in twin-mate posts design between the subject device and reference device does not affect the equivalence in function and intended use of the devices. Therefore, the subject device is considered to be substantially equivalent to the predicate device and/or the reference device based on a comparison of intended use and technological characteristics.

### Non-Clinical PERFORMANCE DATA

Non-clinical testing have been conducted to verify that the Hushd Pro Avera meets all design specification which supports the conclusion that it's substantially equivalent (SE) to the predicate device.

A risk analysis on Hushd Pro Avera in accordance with ISO 14971:2007 and FDA guidance document "Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea" was conducted. All identified risks have been addressed through device design, biocompatibility and bench testing or through labeling provided to the consumer.

A risk assessment included assessment of the mechanical properties of the material of construction to evaluate its ability to achieve its intended use. The mechanical properties testing of the material of construction were performed by the manufacturer for :

- 트 Flexural Modulus
- Flexural Strength
- 트 Impact Strength

Biocompatibility testing for the final finished device was conducted in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The final finished device was tested for the following biocompatibility parameters:

- 트 Cytotoxicity
- Irritation
- 트 Sensitization
- 트 System Toxicity
- 트 Pyrogen

The subject device is able to achieve its intended use based on the same materials of construction, similar manufactory process and the identical application to the predicate device. There are no new questions of safety or efficacy raised by the Hushd Pro Avera devices compared to the predicate device.

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## CLINICAL PERFORMANCE DATA

The clinical performance of the subject device is deemed not necessary . The Hushd Pro Avera device has equivalent indication and method of use to its predicated and reference devices, therefore there was no clinical testing to support this device.

No clinical study was performed in association with this submission.

## CONCLUSION

The subject device has very similar technological characteristics (i.e. design, function, principle of operation, materials, biocompatibility and sterilization) to the predicate device . The intended use and indications for use of the subject device are the same as the predicate device.

In conclusion, the device is substantially equivalent based on a comparison of intended use, and technological characteristics, the device is safe and effective for its intended use.