(307 days)
No
The description focuses on the mechanical design and CAD/CAM manufacturing of custom oral splints for mandibular repositioning. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended to alleviate snoring and mild to moderate obstructive sleep apnea, which are conditions affecting a patient's health.
No
Explanation: The device is intended to treat snoring and sleep apnea by repositioning the mandible, not to diagnose these conditions. Diagnosis is not mentioned in its intended use or description.
No
The device description clearly states it is a set of removable intraoral patient-specific devices (splints) made of physical materials, not software.
Based on the provided information, the Hushd Pro Avera device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults." This is a therapeutic purpose, directly treating a condition within the body.
- Device Description: The device is a "removable intraoral patient specific device used for treating snoring and mild to moderate obstructive sleep apnea." It 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." This describes a physical intervention within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Hushd Pro Avera device does not interact with or analyze such specimens.
The device is a medical device, specifically a therapeutic device used to treat a physiological condition. It falls under the category of devices used in vivo (within the body), not in vitro (in glass/outside the body).
N/A
Intended Use / 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.
Product codes
LRK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral (oral cavity/mouth, teeth, jaws)
Indicated Patient Age Range
adults
Intended User / Care Setting
dentist or physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical testing was performed including:
- Mechanical properties testing (Flexural Modulus, Flexural Strength, Impact Strength)
- Biocompatibility testing (Cytotoxicity, Irritation, Sensitization, System Toxicity, Pyrogen)
- Risk analysis 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"
Key results: The device meets all design specifications and is able to achieve its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
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 (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).
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
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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4
K232025 510(k) Summary
SUBMITTER
| Date Prepared: | May 7, 2023 |
|---|---|
| Submitter: | Good Sleep Co Pte Ltd. |
| 226 Ocean Drive | |
| Singapore, 098617 | |
| Singapore | |
| Official Contact: | Joel Simpson |
| Director | |
| Tel:+658752941 | |
| Email: joel@goodsleepco.health |
DEVICE
| Trade/Proprietary Name: | Hushd Pro Avera |
|---|---|
| Classification Name : | Device Anti-Snoring |
| Common Name : | Intraoral device for snoring and |
| mild to moderate obstructive | |
| 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. |
5
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
Device | Predicate
Device | Reference
Device | Reference
Device | Reference
Device |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacture | Good Sleep Co
Pte Ltd. | Panthera Dental,
Inc. | MicroDental
laboratories | Greystone IP Ltd | Panthera Dental Inc. |
| Trade Name | Hushd Pro Avera | The Panthera
Anti-Snoring
Device | MicrO2
Obstructive Sleep
Apnea Device | Soundly
Mandibular
Advancement
Device | Panthera Anti-
Snoring X3 Device |
| 510(k) Number | K232025 | K143244 | K133683 | K220330 | K171576 |
| Regulation
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
Use | The Hushd Pro
Avera device is | The Panthera
Anti-Snoring | The
MICRODENTAL | The Soundly
Mandibular | The Panthera Anti-
Snoring X3 Device |
| | intended to reduce
or alleviate
snoring and mild
to moderate
obstructive sleep
apnea (OSA) in
adults. | device is intended
to reduce or
alleviate snoring
and mild to
moderate
obstructive sleep
apnea (OSA) in
adults. | , Inc, micr02
device is intended
to reduce night
time snoring and
mild to moderate
obstructive sleep
apnea (OSA) in
adults. | Advancement
Device is intended
to reduce or
alleviate snoring
and mild to
moderate
Obstructive Sleep
Apnea(OSA)
whilst sleeping in
adults. | is intended to
reduce or alleviate
snoring and mild to
moderate
obstructive sleep
Apnea(OSA) in
adults. |
| Principle of
Operation | Mandibular
Repositioners,
Repositions the
lower jaw forward
to increase the
patency of the | Mandibular
Repositioners,
Repositions the
lower jaw forward
to increase the
patency of the | Mandibular
Repositioners,
Repositions the
lower jaw forward
to increase the
patency of the | Mandibular
Repositioners,
Repositions the
lower jaw forward
to increase the
patency of the | Mandibular
Repositioners,
Repositions the
lower jaw forward
to increase the
patency of the |
| Adjustment
mechanism | airway
Advancements
can be achieved
by simply
removing the
current upper or
lower device and
inserting the next
upper or lower
device in the
mandibular
advancing series. | airway
Adjusted via the
use of interlocking
rods placed on
each side of the
mandible splint.
The shorter the
rod, the further
mandible is
advanced. The
dentist can select a
shorter connecting
rod until optimal
advancement is
achieved | airway
Advancements
can be achieved
by simply
removing the
current upper or
lower device and
inserting the next
upper or lower
device in the
mandibular
advancing series. | airway
User choose
which of the 3
lower splints to
wear-self titration | airway
Adjusted via the
adjustable clip
assembly placed on
each side of the
maxillary splint.
The longer the stop-
clip is, the further
the mandible is
advanced. The
dentist can select a
longer stop-clip
until optimal
advancement is
achieved. |
| Mandibular
advancement
range | Up to 10mm
50-90% of the
patient's
maximum
comfortable
mandibular
advancement at
1mm increment | Up to 15mm at
1mm increment | Up to 6.0mm | 3 positions at
40%,60% & 70%
of the patient's
maximum
comfortable
mandibular
advancement
Maximum
advancement is
12mm | Up to 5mm at 1mm
increments |
| Material | Made from
polymers
(polyamide type
12), Supplied by
EOS | Made from
polymers
(polyamide type
12), Supplied by
EOS | Hard PMMA
material | Form labs Dental
LT Clear V2 | Made from
polymers(polyamide
type12), supplied by
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
Population | Adults | Adults | Adults | Adults | Adults |
| Design | Two customized
intra oral splints | Two customized
intra oral splints | Two customized
intra oral splints | Two customized
intra oral splints | Two customized
splints that fit |
| | that fit separately
over the upper and
lower teeth. | that fit separately
over the upper and
lower teeth. | that fit separately
over the upper and
lower teeth. | that fit separately
over the upper and
lower teeth. | separately over the
upper and lower
teeth inside the
mouth. |
| | These separate
maxillary and
mandible splints
are designed with
twin-mated posts,
when interface
together,
functioning as
mandible
repositioner
holding the
mandible forward
during sleep | The mandible
splint contains a
triangular
protrusion
allowing the
splints to engage
by means of
interlocking rods
on the sides. | These separate
maxillary and
mandible splints
are designed with
twin-mated posts,
when interface
together,
functioning as
mandible
repositioner
holding the
mandible forward
during sleep | The mandibular
advancement is
achieved by the
interlocking of
opposing wedge
faces on the upper
and lower jaw
position, There are
no locking side
arms, so the
splints can be
disengaged by a
small forward and
downward
movement of
lower jaw. The
upper splint is
supplied with 3
sizes of
mandibular
advancement, tied
to the patient's
maximum
mandibular
advancement. | The mandible splint
contains wing
protrusions that
interface with the
incline blocks built
into the buccal of
the maxillary splint. |
| Manufacture
Technology | Use the computer
-aided design
(CAD) and
Computer-aided
manufacturing(CA
M)
Use CAD that
enables a high
degree of
customization
according to the
physician or
dentists
prescription to
accommodate the
complex dental
anatomy of
individual
patients. The
CAM and
selective laser
sintering
guarantees
precision,
accuracy and | Use the computer
-aided design
(CAD) and
Computer-aided
manufacturing(CA
M)
Use CAD that
enables a high
degree of
customization
according to the
physician or
dentists
prescription to
accommodate the
complex dental
anatomy of
individual
patients. The
CAM and
selective laser
sintering
guarantees
precision,
accuracy and | Use the computer
-aided design
(CAD) and
Computer-aided
manufacturing(CA
M) | Use the computer
-aided design
(CAD) and
Computer-aided
manufacturing(CA
M) | Uses computer-
aided(CAD) and
computer-aided
manufacturing(CA
M).
Uses CAD that
enables a high
degree of
customization
according to the
physician or dentist
prescription. The
CAM and selective
laser sintering
guarantee precision,
accuracy and
consistency of each
patient. |
6
7
8
| 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.
9
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.