(86 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of an oral appliance, with no mention of AI/ML, image processing, or data-driven performance metrics.
Yes
The device is indicated for the reduction of snoring during sleep, which addresses a medical condition (snoring) and is designed to have a therapeutic effect by widening the pharyngeal airway to prevent occlusion.
No
Explanation: The device description states its purpose is to aid in the reduction of snoring by maintaining an anterior positioning of the mandible which widens the pharyngeal airway to prevent occlusion. This is a functional intervention to alleviate a condition, not to diagnose it.
No
The device description explicitly states it is an "oral appliance comprised of an upper and lower tray constructed in one piece," which is a physical hardware component.
Based on the provided information, the SNOR LOCK device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce snoring during sleep by positioning the mandible. This is a physical intervention within the body, not a test performed on samples taken from the body.
- Device Description: The device is an oral appliance that interacts with the teeth and jaw. It does not involve the analysis of biological samples like blood, urine, or tissue.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, or analysis of biological markers.
- Performance Studies: The performance studies focus on physical and biological safety testing (cytotoxicity, genotoxicity, sensitization, toxicity), which are relevant for medical devices that interact with the body, but not specifically for IVDs.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SNOR LOCK does not fit this definition.
N/A
Intended Use / Indications for Use
SNOR LOCK is indicated for use for adults 18 years and above as an aid in the reduction of snoring during hours of sleep.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The SNOR LOCK is an oral appliance comprised of an upper and lower tray constructed in one piece. The trays engage with the maxillary and mandibular dentition and the device maintains an anterior positioning of the mandible which widens the pharyngeal airway to prevent occlusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults 18 years and above
Intended User / Care Setting
Not Found
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)
The following test articles were tested based on the referenced standard. All the test results met the preset test criteria.
Testing institution's method - Appearance, Dimension, Weight / Appearance, pH, Heavy metals, Potassium premanganate reducing substance, Residue on evaporation, Ultraviolet absorption spectrum of extracts
ISO 10993-5 – Cytotoxicity
ISO 10993-3 - Genotoxicity (Bacterial Reverse Mutation)
ISO 10993-10 - Guinea Pig Maximization Test for Skin sensitization
ISO 10993-11 – Subchronic toxicity
The bench and biocompatibility testing performed demonstrates that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.”
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November 10, 2022
Solbaro Co., Ltd Jinwook Seo Regulatory Affair 4th fl. 137, Janggam-ro Gamgok-myeon, Eumseong-gun, Chungcheongbuk-do 27603 SOUTH KOREA
Re: K222475
Trade/Device Name: Snor Lock 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: August 8. 2022 Received: August 16, 2022
Dear Jinwook Seo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of 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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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K222475
Device Name SNOR LOCK
Indications for Use (Describe)
SNOR LOCK is indicated for use for adults 18 years and above as an aid in the reduction of snoring during hours of sleep.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY K222475
Date: August 8, 2022
1. SUBMITTER
Solbaro Co., Ltd. 4th fl. 137, Janggam-ro, Gamgok-myeon, Eumseong-gun, Chungcheongbuk-do, Republic of Korea TEL : +82-70-8844-2714 FAX : +82-43-881-2875 Contact Name: Jinwook Seo Email: penbedht(@hanmail.net
2. DEVICE
·Trade Name: SNOR LOCK ·Common Name: Antisnoring device ·Classification Name: Device, Anti-Snoring ·Regulation Number 872.5570 ·Class: 2 ·Classification Product Code: LRK
3. PREDICATE DEVICE
PureSleep®(OTC use), Sleep Science Partners, Inc. K190058
4. DEVICE DESCRIPTION
The SNOR LOCK is an oral appliance comprised of an upper and lower tray constructed in one piece. The trays engage with the maxillary and mandibular dentition and the device maintains an anterior positioning of the mandible which widens the pharyngeal airway to prevent occlusion.
5. INDICATIONS FOR USE
SNOR LOCK is indicated for use for adults 18 years and above as an aid in the reduction
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of snoring during hours of sleep.
6. NON-CLINICAL TESTING
The following test articles were tested based on the referenced standard. All the test results met the preset test criteria.
Testing institution's method -Appearance, Dimension, Weight / Appearance, pH, Heavy metals, Potassium premanganate reducing substance, Residue on evaporation, Ultraviolet absorption spectrum of extracts
ISO 10993-5 – Cytotoxicity
ISO 10993-3 - Genotoxicity (Bacterial Reverse Mutation)
ISO 10993-10 - Guinea Pig Maximization Test for Skin sensitization
ISO 10993-11 – Subchronic toxicity
| | Proposed Device | Predicate Device | Discuss/Justify the
Differences | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| 510(k) Number | New | K190058 | - | |
| Trade Name | SNOR STOP
(SNOR LOCK) | PureSleep®(OTC use) | - | |
| Manufacturer | Solbaro Co., Ltd. | Sleep Science Partners, Inc. | - | |
| Common Name | Antisnoring device | Antisnoring device | Equivalent | |
| Classification
Name | Intraoral devices for snoring
and obstructive sleep apnea | Intraoral devices for snoring and
obstructive sleep apnea | Equivalent | |
| Device Class | 2 | 2 | Equivalent | |
| Product Code | LRK | LRK | Equivalent | |
| Device Description | The SNOR LOCK is an oral
appliance comprised of an
upper and lower parts
constructed in mouthpiece. The
mouthpiece engage with the
maxillary and mandibular
dentition and the device | The PureSleep® device for Over-
the-Counter (OTC) use is an
intraoral mandibular
repositioning device that
increases the pharyngeal space to
improve the user's ability to
exchange air and to decrease air
turbulence, a causative factor in
snoring. The device consists of
two dental trays designed to
conform to the shape of the upper | Equivalent | |
| | | | | |
| | | maintains an anterior
positioning of the mandible
which widens the pharyngeal
airway to prevent occlusion. | and lower jaws. | |
| Indication for use | | SNOR LOCK is indicated for
use for adults 18 years and
above as an aid in the reduction
of snoring during hours of
sleep. | PureSleep® (OTC) is indicated
for use for adults 18 years and
above as an aid in the reduction
of snoring during hours of sleep. | Equivalent |
| Indicatio
n for use | Prescriptio
n Status | OTC | OTC | Equivalent |
| | Patient
Population | Adult persons 18 years of age
or older | Adult persons 18 years of age or
older | Equivalent |
| Mode of action | | Mandibular repositioning
device (MRD) that advances
the lower jaw to increase
pharyngeal space and alleviate
snoring. | Mandibular repositioning device
(MRD) that advances the lower
jaw to increase pharyngeal space
and alleviate snoring. | Equivalent |
| Environment | | During sleep, at home | During sleep, at home | Equivalent |
| | Placement of device | In the mouth, on the lower and
upper Jaws | In the mouth, on the lower and
upper Jaws | Equivalent |
| | Preparation / Set-up | Connect upper and lower parts
per bite type. | Connect upper and lower parts
per bite type. | Equivalent |
| Molding / Fitment | | Custom impression to each
individual's mouth using a
"boil and bite" approach and
thermal setting (heat sensitive)
resins. Molded to the entire
upper and lower arch of teeth. | Custom impression to each
individual's mouth using a "boil
and bite" approach and thermal
setting (heat sensitive) resins.
Molded to the entire upper and
lower arch of teeth. | Equivalent |
| Design | | Image: Snore Lock | Image: PureSleep | Differences
Mandibular
advancement of
proposed device is
fixed in 6mm and |
| | | | | |
| | SNOR LOCK is an all-in-one mouthpiece (intraoral device) that is designed to have lower tray anterior to the upper tray. This allows 6mm advancement of mandible and pharyngeal space. | Consists of an upper and lower tray. Outer shell provides with structural support and inner shell is lined with softer material that is heat sensitive and thus allows for custom fitting. | frame is loacated inside mouthpiece. | |
| Adjustments | 6 mm of mandibular advancement | Adjustable jaw advancement position. Adjustably positions the mandible forward in three positions, 4mm apart anteriorly, while maintaining a 9mm inferior placement for user comfort | Differences
Mandibular advancement of proposed device is fixed in 6mm | |
| Single use / Reusable | Single patient, multi-use(reusable) | Single patient, multi-use | Equivalent | |
| Cleaning instructions | Clean/rinse daily with toothbrush & toothpaste.
Deep clean once per week with commercial denture cleanser(ex. Polident). | Clean/rinse daily with toothbrush and toothpaste or with effervescent oral device cleaning tablets.
Deep clean once per week. | Equivalent | |
| Sterile | No | No | Equivalent | |
| Materials | Body : ethylene-vinyl acetate copolymer resin
Frame : ethylene propylene copolymer, colorant | Polypropylene homopolymer and ethylene vinyl acetate copolymer | Differences
SNOR LOCK has additional chemical substances; colorant, ethylene propylene copolymer | |
| Biocompatibility | Meets ISO 10993-1 for a surface device contacting mucosal membrane for a | Meets ISO 10993-1 for a surface device contacting mucosal membrane for a prolonged | Equivalent | |
| | prolonged contact duration
(>24h to 30 days): cytotoxicity,
sensitization,
genotoxicity and subchronic
toxicity | contact duration (>24h to 30
days): cytotoxicity, sensitization
and irritation | | |
7. SUBSTANITAL EQUIVALENCE
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8. SUBSTANTIAL EQUIVALENCE DISCUSSION
SNOR LOCK has the same Indications for Use and the principle of operations as the predicate device. Even though there is a slight difference in design(mandibular advancement is fixed in 6mm), it does not affect the equivalence and functioning of intended use-reduction of snoring. It has similar physical properties, and demonstrates biocompatibility and performance specifications comparable to the predicate devices.
The chemical compositions might slightly differ from the predicate devices. Additional components are used as frame material and frame colorant. Both devices have used ethylene-vinyl acetate copolymer as base material, which has a major contact with a patient tissue. Additional polymer material used in SNOR LOCK, ethylene propylene copolymer, is a elastomer with established biocompatibility and widely medical use, including surface of infusion bag. Light Brown model(008031) of SNOR LOCK is created by addition of every colorant with the same ratio. By conducting biocompatibility test using this model as a worst case, risk of each product lines with different color are fully assessed. Both SNOR LOCK and predicate deivce are met the requirement of anti-snoring device.
The bench and biocompatibility testing performed demonstrates that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. Therefore, it is concluded that SNOR LOCK is substantially equivalent to the predicate devices.