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.

AI/ML Overview

Based on the provided text, the device in question, Hushd Pro Avera, is an intraoral device for snoring and mild to moderate obstructive sleep apnea. The text does not describe acceptance criteria or a study that proves the device meets those criteria from a clinical performance perspective. Instead, it explicitly states that no clinical performance data was deemed necessary or performed for this submission.

The submission relies on a demonstration of substantial equivalence to predicate and reference devices, supported by non-clinical performance data (material properties and biocompatibility).

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor specific details about sample size, expert ground truth establishment, or MRMC studies, as these types of studies were not conducted or reported in this 510(k) summary.

However, I can extract the information provided regarding the non-clinical testing and the rationale for not performing clinical studies.

Summary regarding Acceptance Criteria and Performance (based on provided text):

The provided 510(k) summary for the Hushd Pro Avera device focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing clinical performance against pre-defined acceptance criteria through a clinical study. The FDA's clearance (K232025) is based on this equivalence, along with successful non-clinical performance data and biocompatibility testing.

Here's an analysis of the requested information based on the document:

A table of acceptance criteria and the reported device performance

Clinical Performance: No clinical performance acceptance criteria or reported clinical performance data is provided in the document. The submission explicitly states: "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."
Non-Clinical Performance: The acceptance criteria for non-clinical testing are implied by the successful completion of the tests and the conclusion that the device "meets all design specification." The reported performance is that the tests were conducted and the device passed.

Acceptance Criteria (Non-Clinical)	Reported Device Performance (Non-Clinical)
Compliance with ISO 14971:2007 (Risk Analysis)	All identified risks have been addressed through device design, biocompatibility, and bench testing or through labeling provided to the consumer.
Material Mechanical Properties	Tests conducted by the manufacturer for Flexural Modulus, Flexural Strength, and Impact Strength. (Details of specific values or thresholds are not provided, only that tests were done to "evaluate its ability to achieve its intended use.")
Biocompatibility (ISO 10993-1)	Final finished device tested for: Cytotoxicity, Irritation, Sensitization, System Toxicity, Pyrogen. (Specific results are not provided, but the overall statement implies successful completion: "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.")
Design Specifications	The device "meets all design specification". (Specific design specifications are not enumerated.)

Sample sizes used for the test set and the data provenance
- Clinical Test Set: Not applicable, as no clinical test set was used for performance evaluation (no clinical study was conducted).
- Non-Clinical Test Set: The sample sizes for the non-clinical materials testing and biocompatibility testing are not specified in the document. However, these are generally standard tests conducted on representative samples of the device and its materials. The provenance is internal testing by the manufacturer.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as no clinical test set with human-established ground truth was used for performance evaluation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical test set requiring adjudication was used.
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 this device is a physical intraoral device, not an AI/software product, and no clinical studies (MRMC or otherwise) were conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Clinical Ground Truth: Not applicable, as no clinical studies were performed.
- Non-Clinical Ground Truth: For mechanical properties and biocompatibility, the ground truth is established by validated laboratory testing methods and compliance with international standards (ISO 10993-1, ISO 14971:2007).
The sample size for the training set
- Not applicable, as this is a physical device, not a machine learning model requiring a training set.
How the ground truth for the training set was established
- Not applicable, as there was no training set.

In conclusion, the core of this 510(k) submission and FDA clearance is based on the principle of substantial equivalence to existing devices, supported by non-clinical testing, rather than new clinical performance data or studies defining and meeting specific clinical acceptance criteria.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.226 Ocean DriveSingapore, 098617Singapore
Official Contact:	Joel SimpsonDirectorTel:+658752941Email: joel@goodsleepco.health

DEVICE

Trade/Proprietary Name:	Hushd Pro Avera
Classification Name :	Device Anti-Snoring
Common Name :	Intraoral device for snoring andmild to moderate obstructivesleep 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

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	SubmissionDevice	PredicateDevice	ReferenceDevice	ReferenceDevice	ReferenceDevice
Manufacture	Good Sleep CoPte Ltd.	Panthera Dental,Inc.	MicroDentallaboratories	Greystone IP Ltd	Panthera Dental Inc.
Trade Name	Hushd Pro Avera	The PantheraAnti-SnoringDevice	MicrO2Obstructive SleepApnea Device	SoundlyMandibularAdvancementDevice	Panthera Anti-Snoring X3 Device
510(k) Number	K232025	K143244	K133683	K220330	K171576
RegulationNumber	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 forUse	The Hushd ProAvera device is	The PantheraAnti-Snoring	TheMICRODENTAL	The SoundlyMandibular	The Panthera Anti-Snoring X3 Device
	intended to reduceor alleviatesnoring and mildto moderateobstructive sleepapnea (OSA) inadults.	device is intendedto reduce oralleviate snoringand mild tomoderateobstructive sleepapnea (OSA) inadults.	, Inc, micr02device is intendedto reduce nighttime snoring andmild to moderateobstructive sleepapnea (OSA) inadults.	AdvancementDevice is intendedto reduce oralleviate snoringand mild tomoderateObstructive SleepApnea(OSA)whilst sleeping inadults.	is intended toreduce or alleviatesnoring and mild tomoderateobstructive sleepApnea(OSA) inadults.
Principle ofOperation	MandibularRepositioners,Repositions thelower jaw forwardto increase thepatency of the	MandibularRepositioners,Repositions thelower jaw forwardto increase thepatency of the	MandibularRepositioners,Repositions thelower jaw forwardto increase thepatency of the	MandibularRepositioners,Repositions thelower jaw forwardto increase thepatency of the	MandibularRepositioners,Repositions thelower jaw forwardto increase thepatency of the
Adjustmentmechanism	airwayAdvancementscan be achievedby simplyremoving thecurrent upper orlower device andinserting the nextupper or lowerdevice in themandibularadvancing series.	airwayAdjusted via theuse of interlockingrods placed oneach side of themandible splint.The shorter therod, the furthermandible isadvanced. Thedentist can select ashorter connectingrod until optimaladvancement isachieved	airwayAdvancementscan be achievedby simplyremoving thecurrent upper orlower device andinserting the nextupper or lowerdevice in themandibularadvancing series.	airwayUser choosewhich of the 3lower splints towear-self titration	airwayAdjusted via theadjustable clipassembly placed oneach side of themaxillary splint.The longer the stop-clip is, the furtherthe mandible isadvanced. Thedentist can select alonger stop-clipuntil optimaladvancement isachieved.
Mandibularadvancementrange	Up to 10mm50-90% of thepatient'smaximumcomfortablemandibularadvancement at1mm increment	Up to 15mm at1mm increment	Up to 6.0mm	3 positions at40%,60% & 70%of the patient'smaximumcomfortablemandibularadvancementMaximumadvancement is12mm	Up to 5mm at 1mmincrements
Material	Made frompolymers(polyamide type12), Supplied byEOS	Made frompolymers(polyamide type12), Supplied byEOS	Hard PMMAmaterial	Form labs DentalLT Clear V2	Made frompolymers(polyamidetype12), supplied byEOS.
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
TargetPopulation	Adults	Adults	Adults	Adults	Adults
Design	Two customizedintra oral splints	Two customizedintra oral splints	Two customizedintra oral splints	Two customizedintra oral splints	Two customizedsplints that fit
	that fit separatelyover the upper andlower teeth.	that fit separatelyover the upper andlower teeth.	that fit separatelyover the upper andlower teeth.	that fit separatelyover the upper andlower teeth.	separately over theupper and lowerteeth inside themouth.
	These separatemaxillary andmandible splintsare designed withtwin-mated posts,when interfacetogether,functioning asmandiblerepositionerholding themandible forwardduring sleep	The mandiblesplint contains atriangularprotrusionallowing thesplints to engageby means ofinterlocking rodson the sides.	These separatemaxillary andmandible splintsare designed withtwin-mated posts,when interfacetogether,functioning asmandiblerepositionerholding themandible forwardduring sleep	The mandibularadvancement isachieved by theinterlocking ofopposing wedgefaces on the upperand lower jawposition, There areno locking sidearms, so thesplints can bedisengaged by asmall forward anddownwardmovement oflower jaw. Theupper splint issupplied with 3sizes ofmandibularadvancement, tiedto the patient'smaximummandibularadvancement.	The mandible splintcontains wingprotrusions thatinterface with theincline blocks builtinto the buccal ofthe maxillary splint.
ManufactureTechnology	Use the computer-aided design(CAD) andComputer-aidedmanufacturing(CAM)Use CAD thatenables a highdegree ofcustomizationaccording to thephysician ordentistsprescription toaccommodate thecomplex dentalanatomy ofindividualpatients. TheCAM andselective lasersinteringguaranteesprecision,accuracy and	Use the computer-aided design(CAD) andComputer-aidedmanufacturing(CAM)Use CAD thatenables a highdegree ofcustomizationaccording to thephysician ordentistsprescription toaccommodate thecomplex dentalanatomy ofindividualpatients. TheCAM andselective lasersinteringguaranteesprecision,accuracy and	Use the computer-aided design(CAD) andComputer-aidedmanufacturing(CAM)	Use the computer-aided design(CAD) andComputer-aidedmanufacturing(CAM)	Uses computer-aided(CAD) andcomputer-aidedmanufacturing(CAM).Uses CAD thatenables a highdegree ofcustomizationaccording to thephysician or dentistprescription. TheCAM and selectivelaser sinteringguarantee precision,accuracy andconsistency of eachpatient.

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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.

Regulation Number and Section

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a)
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.(b)
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.”