(474 days)
No
The device description and performance studies focus on the mechanical function and material properties of the intraoral appliance, with no mention of AI or ML technologies.
Yes
The device is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea, which are medical conditions, and it functions to improve a patient's ability to exchange air during sleep.
No
The device is described as an intraoral appliance intended for reducing snoring and mild to moderate obstructive sleep apnea by repositioning the mandible. It does not mention any diagnostic capabilities, such as taking measurements, analyzing data to identify a condition, or providing a medical diagnosis.
No
The device description clearly states it is an "intraoral device" consisting of "fitted trays" and an "expansion screw adjustment mechanism," indicating it is a physical hardware device.
Based on the provided information, the Sapphire Dorsal Comfort Fit Appliance is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Sapphire Dorsal Comfort Fit Appliance is an intraoral device that physically repositions the mandible to improve airflow during sleep. It does not analyze biological samples.
- Intended Use: Its intended use is for the reduction of night time snoring and mild to moderate obstructive sleep apnea, which is a physical intervention, not a diagnostic test.
The device is a medical device, but it falls under a different category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Sapphire Dorsal Comfort Fit Appliance is intended for use in patients 18 years of age or older for the reduction of night time snoring and mild to moderate obstructive sleep apnea.
Product codes
LRK
Device Description
The Sapphire Dorsal Comfort Fit Appliance is an intraoral device used for reducing snoring and mild to moderate obstructive sleep apnea. It consists of fitted trays which fit over the upper and lower teeth. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is made for each patient and has an expansion screw adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intraoral / pharyngeal space
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Prescribing dentist or physician / Not explicitly stated, implied to be used at home during sleep.
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
Non-Clinical Testing: Biocompatibility testing, including cytotoxicity, sensitization testing, was performed for the Sapphire Dorsal Comfort Fit Appliance in accordance with ISO 10993-1 and its applicable parts. Resin samples were tested for tensile per ASTM D638-14, static three-point bend per ISO 20795, fatigue three-point bend per ISO 20795, and fracture toughness per ASTM D5045. The full device assembly was challenged in a drop test to assure the integrity of the fully assembled device.
Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the Sapphire Dorsal Comfort Fit Appliance to the predicative device.
Key Metrics
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 and Human Services logo. To the right of that is the FDA logo, which 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.
September 17, 2019
Crane Dental Laboratory, Inc Kevin Crane President 3515 Buffalo Road, Suite 30 Rochester, NY 14624
Re: K181416
Trade/Device Name: Sapphire Dorsal Comfort Fit 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 18, 2019 Received: June 19, 2019
Dear Kevin Crane:
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.
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
1
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 medical devices and radiation-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,
for Srinivas Nandkumar, PhD Acting Assistant Director DHT1B: Division of Dental 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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2
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Sapphire Dorsal Comfort Fit Appliance
Indications for Use:
The Sapphire Dorsal Comfort Fit Appliance is intended for use in patients 18 years of age or older for the reduction of night time snoring and mild to moderate obstructive sleep apnea.
Type of Use (Select one or both, as applicable)
Prescription Use __ V
AND/OR
Over-the-Counter Use (21 CER 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiologic Health (CDRH)
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510(k) Summary
| Submission Owner: | Crane Dental Laboratory
Kevin Crane, President
3515 Buffalo Road, Suite 30
Rochester NY 14624
Phone: 585-730-5100 FAX: 530-730-5095
Email: kevin@cranedentallab.com |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kevin Crane, President
3515 Buffalo Road, Suite 30
Rochester, NY 14624
Phone: 585-730-5100
Email: kevin@cranedentallab.com |
| Submission Date: | September 16, 2019 |
| Device Name: | Trade Name – Sapphire Dorsal Comfort Fit
Appliance |
| Regulation Description: | Intraoral device for snoring and mild to
moderate
obstructive sleep apnea (OSA) device, anti-
snoring |
| Classification: | Regulation - Number 21 CFR 872.5570,
Intraoral devices
for snoring and obstructive sleep apnea
Definition - Regulation Medical Specialty
Review Panel - Dental
Product Code - LRK
Device Class - II |
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Substantial equivalence is claimed to:
Primary Predicate: SomnoMed Inc - SomnoMed MAS Flex "S" (K073004) Reference Device: SnoreRx (K170825)
Device Description:
The Sapphire Dorsal Comfort Fit Appliance is an intraoral device used for reducing snoring and mild to moderate obstructive sleep apnea. It consists of fitted trays which fit over the upper and lower teeth. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is made for each patient and has an expansion screw adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.
Indications for Use of the Device:
The Sapphire Dorsal Comfort Fit Appliance is intended for use in patients 18 years of age or older for the reduction of nighttime snoring and mild to moderate obstructive sleep apnea.
Intraoral gingival. nalatal. or dental soreness:
As similar to the predicate device, the Sapphire Dorsal Comfort Fit Appliance is a patient-specific dental device fitted to the upper and lower arches, constructed of medical-grade acrylic to contact the teeth on the lingual, occlusal and buccal surfaces, and a small area of the supporting tissue and dentalalveolar structures during sleep. The device design distributes the force of the repositioning of the mandibular arch throughout the appliance and the entire arch and supporting structures. Because the device is designed to eliminate single point contact with individual teeth and these supporting structures, it reduces the opportunity for gingival, palatal or dental soreness. Taking dental undercuts into consideration, the device is manufactured to reduce any possible soreness to the teeth and supporting structures.
Temporomandibular Joint (TMJ) Dysfunction Syndrome:
The Sapphire Dorsal Comfort Fit Appliance increases the patient's pharyngeal space by projecting the mandible down and forward to prevent the tongue and soft tissues from impeding the airway. The appliance is adjustable using a titration key and expansion screw, which enables the jaw to be brought forward in small increments by the prescribing dentist. It is recognized by the dental community that this type of repositioning can also affect the temporomandibular joints. The prescribing dentist should evaluate the TMJ prior to prescribing the Sapphire Dorsal Comfort Fit Appliance to be sure the patient does not possess risk factors to the TMJ that may be aggravated by using the appliance. Patients do sometimes report sensation in the first few initial uses of the appliance but resolves with continued wear. Patients who continue to have TMJ pain or discomfort that does not resolve through continued use should decide with their dentist to discontinue treatment with this modality.
Obstruction of Oral Breathing:
The design of the Sapphire Dorsal Comfort Fit Appliance will not obstruct oral breathing.
Loosening or flaring of lower anterior teeth or general tooth movements
Full arch coverage of the Sapphire Dorsal Comfort Fit Appliance helps to minimize these issues. The full arch design helps to reduce localized forces and pressure on individual teeth, or sections of teeth such as the lower anterior segment. The dentist can easily modify the amount of mandibular repositioning. This also helps to reduce the forces on the teeth and supporting alveolar structures.
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Material Composition:
- Orthocryl Acrylic-Polymethylmethacrylate Acrylic Splints ●
- Durasoft: Thermoplastic polyurethane(TPU)/ Polyethylenterephthalate-Glycol ● Copolyester (PET-G) laminate soft lining material adhered to the hard surface acrylic
- . Stainless Steel Expansion Screw
Non-Clinical Testing:
Biocompatibility testing, including cytotoxicity, sensitization testing, was performed for the Sapphire Dorsal Comfort Fit Appliance in accordance with ISO 10993-1 and its applicable parts. Resin samples were tested for tensile per ASTM D638-14, static three-point bend per ISO 20795, fatigue three-point bend per ISO 20795, and fracture toughness per ASTM D5045. The full device assembly was challenged in a drop test to assure the integrity of the fully assembled device.
The design of the Sapphire Dorsal Comfort Fit Appliance addresses the risks outlined in the Guidance Document: Class II Special Controls Guidance Document: Intraoral Device for Snoring and/or Sleep Apnea; Guidance for Industry and FDA issued on November 12, 2002.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Sapphire Dorsal Comfort Fit Appliance to the predicative device.
| | Proposed Device
Sapphire Dorsal
Comfort Fit Appliance
(K181416) | Primary Predicate
Device SomnoMed MAS
Flex "S" (K073004) | Reference Predicate
Device SnoreRx
(K170825) | Similarities
and
Differences |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Indications
for Use | Intended for use in patients
18 years of age or older for
the reduction of nighttime
snoring and mild to
moderate obstructive sleep
apnea. | Intended to reduce or
alleviate nighttime snoring
and mild to moderate
Obstructive Sleep Apnea
(OSA). | Minimize air turbulence
that causes snoring. | Same, Snore
Rx not
indicated for
sleep apnea |
| Usage | Single Patient Multiple Use | Single Patient Multiple Use | Single Patient Multiple Use | Same |
| Patient
Population | Adults age 18 and older | Adults age 18 and older | Adults age 18 and older | Same |
| Prescription
usage | Prescription only | Prescription only | Over-the-counter | Sapphire and
SomnoMed
same, Snore
Rx different |
| Basic Design | Dorsal Fin in lower
advanced by orthodontic
screw in upper tray | Two patient specific fitted
trays which fit over the
upper and lower teeth and
engage by means of
adjustable lugs. | Two trays which fit over
the upper and lower teeth
and engage by means of
notched adjustable locking
mechanism | Same basic
design
principles |
| Device
Functionality | Increase patient's
pharyngeal space to
improve air exchange by
repositioning the mandible | Increase patient's
pharyngeal space to
improve air exchange by
repositioning the mandible | Increase patient's
pharyngeal space to
improve air exchange by
repositioning the mandible | Same |
| Mandibular
Advancement | 6mm adjustment range | 6mm adjustment range | 6mm adjustment range | Same |
| Materials | Tray - hard surface acrylic | Tray - hard surface acrylic | Polycarbonate resin, | See below for |
Predicate Device Comparison:
6
K181416 Page 4 of 5
| | (Dentaurum Orthocryl
Liquid and Orthocryl
Powder)
Lining – Durasoft by
Scheu Dental GmbH
Expansion Screws -
Stainless Steel by
Dentaurum | (Dentaurum Orthocryl
Liquid and Orthocryl
Powder)
Lining -SMH-Flex S
Expansion Screws -
Stainless Steel by
Dentaurum | Ethylene vinyl acetate
copolymer | discussion of
material
differences |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|-----------------------------------------------------------|
| Colorants | Blue | Pink | None | See below for
discussion of
material
differences |
| Adjustability | By prescribing dentist or
physician | By prescribing dentist or
physician | By user | Sapphire and
SomnoMed
same, Snore
Rx different |
| Design | Patient-specific | Patient-specific | Device heated and formed
to patient anatomy | Sapphire and
SomnoMed
same, Snore
Rx similar |
| Sterility | Provided Non-Sterile | Provided Non-Sterile | Provided Non-Sterile | Same |
| Testing | Tensile ASTM D638-14
Static 3 point bend ISO
20795
Fatigue 3 point bend ISO
20795
Fracture toughness ASTM
D5045
Drop testing
Cytotoxicity ISO 10993
Sensitization ISO 10993
Irritation ISO 10993 | Tensile
Static 3 point bend
Fatigue 3 point bend
Fracture toughness | Drop testing | See below for
discussion of
testing
differences |
Material Difference Discussion:
The soft inner lining for the Sapphire Dorsal Comfort Fit Appliance is fabricated from Durasoft material, whereas the material of the soft inner lining for the SomnoMed MAS Flex "S" predicate device is SMH-flex. Both devices contain this soft inner lining for patient comfort.
The colorant used in the Sapphire Dorsal Comfort Fit Appliance is blue as opposed to the pink used in the SomnoMed MAS Flex "S" predicate device. The colorant only serves as an aesthetic additive and does not add to or enhance the structural properties of the resin.
All of the materials used in manufacturing the Sapphire Dorsal Comfort Fit Appliance have been assessed for biocompatibility and are safe and effective for their intended use.
Testing Discussion
Performance data on the base resin material for the tray was performed to evaluate the properties against the predicate material. The predicate SomnoMed MAS Flex "S" (K073004) uses the same base resin formulation as the Sapphire Dorsal Comfort Fit Appliance of Dentaurum Orthocryl Liquid and Orthocryl Powder. Different colorants are added to the resin formulation between the
7
Sapphire Dorsal Comfort Fit Appliance and the predicate. Since the colorant only serves as an aesthetic additive and does not add to the structural properties of the resin, it was determined to compare the colored resin formula of the Sapphire Dorsal Comfort Fit Appliance against the base resin with no colorant added to serve as a worst-case challenge to the material comparison and does not affect substantial equivalence. Tensile, static three-point bend, fracture toughness, and fatigue testing were performed.
Due to the difficulty in acquiring patient specific devices of the SomnoMed MAS Flex "S" device, a similar off the shelf device was chosen for the drop test comparison. The SnoreRx device has a similar use, design, patient population, and functionality and therefore, the testing does not affect substantial equivalence to a cleared device.
Conclusion:
Based on the similarities in design, function, intended use and indications for use, the Sapphire Dorsal Comfort Fit Appliance is substantially equivalent to the identified predicate device.