(135 days)
Not Found
No
The device description and performance studies focus on physical properties and mechanical function, with no mention of AI or ML.
Yes
The device is intended to reduce snoring by repositioning the jaw to increase pharyngeal space, which is a therapeutic action aimed at improving a health-related condition (snoring).
No
The device is described as an intraoral device intended to reduce snoring by repositioning the jaw, which is a therapeutic function, not a diagnostic one. It does not mention any role in identifying or characterizing a medical condition.
No
The device description explicitly states it is an "intraoral device that is composed of an upper and lower intraoral trays with a handle," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The Difiney Anti Snoring Device is an intraoral device that physically repositions the jaw to address snoring. It does not perform any tests on bodily samples.
- Intended Use: The intended use is to reduce snoring by altering the physical structure of the airway, not by analyzing biological markers.
The information provided clearly describes a physical medical device used within the mouth, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The Difiney Anti Snoring Device is intended to help reduce snoring in adults 18 years of age or older.
Product codes
LRK
Device Description
The Difiney Anti Snoring device is an intraoral device that is composed of an upper and lower intraoral trays with a handle that is used during the process of customizing the trays. The Difiney Anti Shoring device repositions the jaw anteriorly relative to the maxilla in order to increase the patient's pharyngeal space to improve the ability to exchange air and decrease air turbulence, a causative factor in snoring.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pharyngeal space
Indicated Patient Age Range
18 years of age or older.
Intended User / Care Setting
Home use
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)
Not Applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
April 18, 2024
Fissiontech LLC % Libray Chang Manager Shanghai Spica Management Consulting Co., Ltd. 609 Room, No. 133 Shengang Avenue, Pudong New District Shanghai, 200120 China
Re: K233850
Trade/Device Name: Difiney Anti Snoring Device 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: April 8, 2024 Received: April 8, 2024
Dear Libray Chang:
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 (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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).
Sincerely,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director
2
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) K233850
Device Name Difiney Anti Snoring Device
Indications for Use (Describe)
The Difiney Anti Snoring Device is intended to help reduce snoring in adults 18 years of age or older.
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 K233850
| Type of submission | Traditional |
|---|---|
| Date prepared | April 8, 2024 |
| Submission sponsor | |
| Manufacturer Name | FISSIONTECH LLC |
| Address | 1 LIBERTY STREET, FLOOR 3, NEW YORK CITY |
| NEW YORK 10006 | |
| Tel | 314 475 4711 |
| mike@everymarket.com | |
| Contact Person | Mike Lee |
| Device identification | |
| Trade Name | Difiney Anti Snoring Device |
| Regulation Number | 21 CFR 872.5570 |
| Regulation Name | Intraoral devices for snoring and intraoral devices for |
| snoring and obstructive sleep apnea | |
| Device Classification | Class II |
| Product Code | LRK |
| Panel | Dental |
| Application correspondent | |
| Company Name | Shanghai Spica Management Consulting Co., Ltd. |
| Address | 609 Room, No.133 Shengang Avenue, Pudong New |
| District, Shanghai, China | |
| Tel | 86-13020102321 |
Page 1 of 6
5
Summary
Contact Person
Libray Chang
Predicate device information
| Sponsor | Apnea Sciences Corporation |
|---|---|
| Trade/Device Name | SnoreRx |
| 510(K) number | K170285 |
| Regulation Number | 21 CFR 872.5570 |
Indications for use
The Difiney Anti Snoring device is intended to help reduce snoring in adults 18 years of age or older.
Device description
The Difiney Anti Snoring device is an intraoral device that is composed of an upper and lower intraoral trays with a handle that is used during the process of customizing the trays. The Difiney Anti Shoring device repositions the jaw anteriorly relative to the maxilla in order to increase the patient's pharyngeal space to improve the ability to exchange air and decrease air turbulence, a causative factor in snoring.
Performance Testing - Clinical
Not Applicable.
Performance Testing - Animal
Not Applicable.
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Technological Characteristic Comparison
Provided below is a comparison of the subject device with the predicate device.
| Table 14A: General Comparison | ||
|---|---|---|
| Item | Subject Device | Predicate Device (K170285) | Comparison |
|---|---|---|---|
| Product Code | LRK | LRK | Same |
| Class | Class II | Class II | Same |
| Classification | |||
| Name | Anti-Snoring Device | Anti-Snoring Device | Same |
| Proprietary | |||
| Name | Difiney Anti Snoring Device | SnoreRx | / |
| Technological | |||
| Features | Mandibular repositioning to advance the mandible | ||
| relative to the maxilla to increase pharyngeal space. | Mandibular repositioning device that advances | ||
| the lower jaw to increase pharyngeal space. | Similar | ||
| Intended Use | The Difiney Anti Snoring device is intended to | ||
| help reduce snoring in adults 18 years of age or | |||
| older. | Minimize air turbulence that causes snoring. | ||
| Device is intended for OverThe-Counter use. | Similar |
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| Materials | - Polycarbonate resin
- Ethylene vinyl acetate copolymer | - Polycarbonate resin
- Ethylene vinyl acetate copolymer | Same |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------|
| Desirable
Characteristics | Home use, heat sensitive / moldable, adjustable
jaw advancement position | Home use, heat sensitive / moldable, adjustable
jaw advancement position | Same |
| Specifications: - Physical:
- Mechanical:
- Single use: | - Custom-fitted intraoral device
- Repositions mandible anteriorly up to 4 mm
- Reusable | - Custom-fitted intraoral device
- Repositions mandible anteriorly up to 6 mm
- Reusable | Similar |
| Sterility | Non-sterile | Non-sterile | Same |
| Biocompatibility | ISO 10993 | ISO 10993 | Same |
Summary
Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
Biocompatibility test
-
Bio-compatibility assessment was conducted in accordance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Physical properties -
ASTM D790-17 for flexural strength and flexural modulus.
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- ASTM D638-22 for Tensile Strength and Elongation at break.
- ASTM D570-22 for water absorption.
- ASTM D3418-21 for melting temperature.
- ASTM D792-20 for Density.
9
Conclusion
Based on the comparison of the indications for use, technical characteristics and performance, we find that the Difiney Anti Snoring Device is substantially equivalent to the predicate SnoreRx with 510(K) number K170285.