(170 days)
The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older.
The American Sleep Dentistry (ASD) Oral Appliances include five device models: the ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo. All are removable, intraoral devices which reposition the mandible and each is patient specific to individual patient anatomy.
The devices are comprised of thermoformed polymer splints (copolyester or EVA), which are connected via a hook and base mechanism or elastic bands or straps.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.
The document is a 510(k) Premarket Notification from the FDA regarding the "American Sleep Dentistry (ASD) Oral Appliances". It primarily focuses on demonstrating substantial equivalence to existing predicate devices for the purpose of market clearance.
It describes:
- The device's trade name, regulation number, and product code.
- The device's intended use: "reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older."
- A comparison of the technological characteristics (anatomic location, intended use, basic design, principles of operation, materials, manufacture) of the ASD Oral Appliances to several predicate devices.
- A detailed table comparing features like intended use, prescription/OTC use, principle of operation, design, materials, range and precision of adjustment, target population, where used, energy used/delivered, human factors, and sterility across the ASD devices and the predicate devices.
There is no mention of:
- Specific acceptance criteria (numerical thresholds for performance).
- Any performance studies, clinical trials, or validation test results demonstrating the device meets quantitative performance metrics.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC studies or effect sizes.
- Standalone algorithm performance.
- Types of ground truth used or how it was established.
The conclusion simply states that the new device has the "same intended use" and "same technological characteristics" as the predicate devices, thus not raising "new questions of safety and effectiveness," and is therefore "substantially equivalent." This is a regulatory determination based on comparison to existing devices, not a performance validation study.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 8, 2017
American Sleep Dentistry Ryan Gregerson President 1957 West Royal Hunte Drive Ste 250 Cedar City, Utah 84720-1903
Re: K163580
Trade/Device Name: ASD Oral Appliances 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: May 5, 2017 Received: May 9, 2017
Dear Ryan Gregerson:
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. 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
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mary S. Runner -A
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163580
Device Name
American Sleep Dentistry (ASD) Oral Appliances
Indications for Use (Describe)
The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older.
| 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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K163580 510(k) Summary
| Date: | May 31, 2017 |
|---|---|
| Sponsor: | American Sleep Dentistry, LLC1957 West Royal Hunte Dr, Ste 250Cedar City, UT 84720-1903Phone: 800-555-1518 |
| Contact Person: | Ryan Gregerson, Manager |
| Trade Names: | American Sleep Dentistry (ASD) Oral Appliances |
| Device Classification: | Class II |
| Classification Name: | Device, Anti-Snoring and device, jaw repositioning |
| Regulation: | 21 CFR 872.5570, Intraoral devices for snoring andintraoral devices for snoring and obstructive sleep apnea |
| Device Product Code: | LRK |
Device Description: The American Sleep Dentistry (ASD) Oral Appliances include five device models: the ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo. All are removable, intraoral devices which reposition the mandible and each is patient specific to individual patient anatomy.
The devices are comprised of thermoformed polymer splints (copolyester or EVA), which are connected via a hook and base mechanism or elastic bands or straps.
Intended Use: The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate Obstructive Sleep Apnea (OSA) in individuals 18 years of age or older.
Primary Predicate Device:
American Sleep Association (ASA) Oral Appliances (K130504)
Reference Predicate Devices:
Removable Acrylic Herbst (K070327) TAP III (K062951) EMA (K971794)
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Technological Characteristics:
The ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo Oral Appliances possess the same technological characteristics as one or more of the predicate devices.
These include:
- . Anatomic location (intraoral),
- Intended Use, to treat mild to moderate sleep apnea.
- Basic design (mandibular repositioning using upper and lower polymer trays with a . hook and base mechanism),
- . Principles of Operation
- . Materials (polymer and/or stainless steel), and
- Manufacture (appliance is patient specific fabricated by prescription to the specific ● requirements of a single patient).
The ASD Anterior model and predicate device, Tap III are both patient specific made Oral Appliances that include a hook and base mechanism placed on the anterior of the front teeth. The actual design differs slightly, but no new or different questions of safety and efficacy are raised by the differences.
The ASD Mezzo model and predicate devices Removable Acrylic Herbst and Tap III are all patient specific made Oral Appliances that include a hook and base mechanism like the TAP III, but are placed bilaterally like that of the Herbst appliance. The actual design differs slightly, but no new or different questions of safety and efficacy are raised by the differences.
The ASD Lateral model and predicate device Tap III are both patient specific made Oral Appliances that include a hook and base mechanism and is located the same as the TAP III, but the ASD Lateral model adds the additional anchors to the canine teeth for advanced stability. The actual design differs slightly, but no new or different questions of safety and efficacy are raised by the differences.
The ASD Lateral Mezzo model and predicate devices Removable Acrylic Herbst and Tap III are all patient specific made Oral Appliances that include a hook and base mechanism. The ASD Lateral Mezzo hook and base mechanism is like the TAP III, but are placed bilaterally like that of the Herbst appliance. The actual design differ slightly, but no new or different questions of safety and efficacy are raised by the differences.
The ASD Elastic model and predicate device EMA are both patient specific made Oral Appliances that include varying lengths of elastic bands or straps and are both placed bilaterally. The ASD Elastic, however anchors the straps in by stainless steel, while the EMA uses plastic anchors. The actual material differs slightly, but no new or different questions of safety and efficacy are raised by the differences.
The fundamental scientific technology of the ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo Oral Appliances is the same as previously cleared devices.
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| SubstantialEquivalenceComparisonFeatures | ASDAnterior,ASD Mezzo,ASD Lateral,ASD Elasticand ASDLateralMezzo | ASA OralAppliances[PrimaryPredicate] | RemovableAcrylicHerbst[ReferencePredicate] | Tap III[ReferencePredicate] | EMA[ReferencePredicate] |
|---|---|---|---|---|---|
| 510k # | K163580 | K130504 | K070327 | K062951 | K971794 |
| Intendeduse/Indicationsfor use: | Intended forthe reductionof nighttimesnoring andmild tomoderateobstructivesleep apnea(OSA) inindividuals 18years of ageor older. | Intended forthe reductionof nighttimesnoring andmild tomoderateobstructivesleep apnea(OSA) inindividuals 18years of ageor older. | Intended forthe reductionof snoringand mild tomoderateobstructivesleep apnea(OSA) bymoving thelower jaw intoa prescribedrelationshipto the upperjaw. | Intended toreduce oralleviatenighttimesnoring andmild tomoderateobstructivesleep apnea,OSA. | Treatment ofnasalrespiratorydysfunction ofobstructivesleep apneaand snoringin thosepatientswhererepositioningof themandible canincrease thepatient's airspace |
| Prescription/OTC Use | Prescription | Prescription | Prescription | Prescription | Prescription |
| Principle ofOperation | Once fittedto the patient,the devicepositions thelower jawforward,preventingsoft tissue ofthe throatfromcollapsingandobstructingthe airway,thereforealleviating orreducing thesymptoms ofnighttimesnoring andmild tomoderate | Once fitted tothe patient,the devicepositions thelower jawforward,preventingsoft tissue ofthe throatfromcollapsingandobstructingthe airway,thereforealleviating orreducing thesymptoms ofnighttimesnoring andmild tomoderate | Once fitted tothe patient,the devicepositions thelower jawforward,preventingsoft tissue ofthe throatfromcollapsingandobstructingthe airway,thereforealleviating orreducing thesymptoms ofnighttimesnoring andmild tomoderate | Once fitted tothe patient,the devicepositions thelower jawforward,preventingsoft tissue ofthe throatfromcollapsingandobstructingthe airway,thereforealleviating orreducing thesymptoms ofnighttimesnoring andmild tomoderate | Once fitted tothe patient,the devicepositions thelower jawforward,preventingsoft tissue ofthe throatfromcollapsingandobstructingthe airway,thereforealleviating orreducing thesymptoms ofnighttimesnoring andmild tomoderate |
| American Sleep Dentistry, LLCASD Oral AppliancesTraditional Premarket Notification [510(k)]May 2017 | |||||
| SubstantialEquivalenceComparisonFeatures | ASDAnterior,ASD Mezzo,ASD Lateral,ASD Elasticand ASDLateralMezzo | ASA OralAppliances[PrimaryPredicate] | RemovableAcrylicHerbst[ReferencePredicate] | Tap III[ReferencePredicate] | EMA[ReferencePredicate] |
| 510k # | K163580 | K130504 | K070327 | K062951 | K971794 |
| ObstructiveSleep Apnea(OSA). | ObstructiveSleep Apnea(OSA). | ObstructiveSleep Apnea(OSA). | ObstructiveSleep Apnea(OSA). | ObstructiveSleep Apnea(OSA). | |
| Design:ASDAnterior | Mandibularrepositionerhaving upperand lowerpolymer trayswith hook andbasemechanismplaced on theanterior of thefront teeth. | Mandibularrepositionerhaving upperand lowerpolymer trayswith bilateralHerbstmechanismswith bilateral,reclosable,polymerfasteners orboth | Mandibularrepositionerhaving upperand lowerpolymer trayswith bilateralHerbstmechanisms | Mandibularrepositionerhaving upperand lowertrays with aHook andBasemechanismplaced on theanterior of thefront teeth. | |
| Design:ASD Mezzo | Mandibularrepositionerhaving upperand lowerpolymer trayswith a hookand basemechanismplacedbilaterally | Mandibularrepositionerhaving upperand lowerpolymer trayswith bilateralHerbstmechanismswith bilateral,reclosable,polymerfasteners orboth | Mandibularrepositionerhaving upperand lowerpolymer trayswith bilateralHerbstmechanisms | Mandibularrepositionerhaving upperand lowertrays with aHook andBasemechanismplaced on theanterior of thefront teeth. | |
| American Sleep Dentistry, LLC | Traditional Premarket Notification [510(k)] | ||||
| ASD Oral Appliances | May 2017 | ||||
| SubstantialEquivalenceComparisonFeatures | ASDAnterior,ASD Mezzo,ASD Lateral,ASD Elasticand ASDLateralMezzo | ASA OralAppliances[PrimaryPredicate] | RemovableAcrylicHerbst[ReferencePredicate] | Tap III[ReferencePredicate] | EMA[ReferencePredicate] |
| 510k # | K163580 | K130504 | K070327 | K062951 | K971794 |
| Design:ASD Lateral | Mandibularrepositionerhaving upperand lowerpolymer trayswith hook andbasemechanismplaced on theanterior of theteeth. Withanchorsplaced on thecanine teeth. | Mandibularrepositionerhaving upperand lowerpolymer trayswith bilateralHerbstmechanismswith bilateral,reclosable,polymerfasteners orboth | Mandibularrepositionerhaving upperand lowerpolymer trayswith bilateralHerbstmechanisms | Mandibularrepositionerhaving upperand lowertrays with aHook andBasemechanismplaced on theanterior of thefront teeth. | |
| Design:ASD LateralMezzo | Mandibularrepositionerhaving upperand lowerpolymer trayswith a hookand basemechanismplacedbilaterally | Mandibularrepositionerhaving upperand lowerpolymer trayswith bilateralHerbstmechanismswith bilateral,reclosable,polymerfasteners orboth | Mandibularrepositionerhaving upperand lowerpolymer trayswith bilateralHerbstmechanisms | Mandibularrepositionerhaving upperand lowertrays with aHook andBasemechanismplaced on theanterior of thefront teeth. | |
| ASD Oral AppliancesMay 2017 | |||||
| SubstantialEquivalenceComparisonFeatures | ASDAnterior,ASD Mezzo,ASD Lateral,ASD Elasticand ASDLateralMezzo | ASA OralAppliances[PrimaryPredicate] | RemovableAcrylicHerbst[ReferencePredicate] | Tap III[ReferencePredicate] | EMA[ReferencePredicate] |
| 510k # | K163580 | K130504 | K070327 | K062951 | K971794 |
| Design:ASD Elastic | Mandibularrepositionerhaving upperand lowerpolymer traysand elasticbands orstraps withstainlesssteelanchors. | Mandibularrepositionerhaving upperand lowertrays withbilateralelastic bandsor straps withplasticanchors. | |||
| Materials:ASDAnteriorASD MezzoASD LateralASD LateralMezzo | |||||
| PolymerSplint | PETG/TPU,EVA | Acrylic | Acrylic | ||
| ConnectingMechanism | 303/304StainlessSteel | 303/304StainlessSteel | 303/304StainlessSteel | ||
| Materials:ASD Elastic | |||||
| PolymerSplint | PETG/TPU,EVA | Acrylic | |||
| ConnectingMechanism | Latex freePolymer | Latex freePolymer | |||
| eep Dentistry, LLC | Traditional Premarket Notification [510(k)] | ||||
| Opliances | May 2017 | ||||
| ASDAnterior,ASD Mezzo,ASD Lateral,ASD Elasticand ASDLateralMezzo | ASA OralAppliances[PrimaryPredicate] | RemovableAcrylicHerbst[ReferencePredicate] | Tap III[ReferencePredicate] | EMA[ReferencePredicate] | |
| K163580 | K130504 | K070327 | K062951 | K971794 | |
| Front to back+/- 1 mm | Front to back+/- 1 mm | Front to back+/- 1 mm | Front to back+/- 1 mm | Front to back+/- 1 mm | |
| Patientsdiagnosedwith mild tomoderateObstructive | Patientsdiagnosedwith mild tomoderateObstructive | Patientsdiagnosedwith mild tomoderateObstructive | Patientsdiagnosedwith mild tomoderateObstructive | Patientsdiagnosedwith mild tomoderateObstructive |
B. Substantial Equivalence Comparison Table:
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Traditional Premarket Notification [510(k)]
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Traditional Premarket Notification [510(k)]
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American Sleep ASD Oral Applia
Substantial
Equivalence
Comparison
Features
510k #
| Range andprecision ofadjustment | Front to back+/- 1 mm | Front to back+/- 1 mm | Front to back+/- 1 mm | Front to back+/- 1 mm | Front to back+/- 1 mm |
|---|---|---|---|---|---|
| TargetPopulation | Patientsdiagnosedwith mild tomoderateObstructiveSleep Apnea | Patientsdiagnosedwith mild tomoderateObstructiveSleep Apnea | Patientsdiagnosedwith mild tomoderateObstructiveSleep Apnea | Patientsdiagnosedwith mild tomoderateObstructiveSleep Apnea | Patientsdiagnosedwith mild tomoderateObstructiveSleep Apnea |
| Where Used: | Fitted by aclinician,used athome. | Fitted by aclinician,used athome. | Fitted by aclinician,used athome. | Fitted by aclinician,used athome. | Fitted by aclinician,used athome. |
| EnergyUsed/Delivered: | None | None | None | None | None |
| HumanFactors: | The device isfitted by thedentist. Thepatient isinstructed inits use andcare.Subsequentuse by thepatient is asdirected bythe dentist inaccordancewith theprovidedinstructionsfor use. | The device isfitted by thedentist. Thepatient isinstructed inits use andcare.Subsequentuse by thepatient is asdirected bythe dentist inaccordancewith theprovidedinstructionsfor use. | The device isfitted by thedentist. Thepatient isinstructed inits use andcare.Subsequentuse by thepatient is asdirected bythe dentist inaccordancewith theprovidedinstructionsfor use. | The device isfitted by thedentist. Thepatient isinstructed inits use andcare.Subsequentuse by thepatient is asdirected bythe dentist inaccordancewith theprovidedinstructionsfor use. | The device isfitted by thedentist. Thepatient isinstructed inits use andcare.Subsequentuse by thepatient is asdirected bythe dentist inaccordancewith theprovidedinstructionsfor use. |
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Traditional Premarket Notification [510(k)]
| ASD Oral Appliances | May 2017 | ||||
|---|---|---|---|---|---|
| SubstantialEquivalenceComparisonFeatures | ASDAnterior,ASD Mezzo,ASD Lateral,ASD Elasticand ASDLateralMezzo | ASA OralAppliances[PrimaryPredicate] | RemovableAcrylicHerbst[ReferencePredicate] | Tap III[ReferencePredicate] | EMA[ReferencePredicate] |
| 510k # | K163580 | K130504 | K070327 | K062951 | K971794 |
| Sterility: | Non-sterile.Device iscleanedbetween usesby the patientfollowinginstructionsprovided byitsmanufacturer | Non-sterile.Device iscleanedbetween usesby the patientfollowinginstructionsprovided byitsmanufacturer | Non-sterile.Device iscleanedbetween usesby the patientfollowinginstructionsprovided byitsmanufacturer | Non-sterile.Device iscleanedbetween usesby the patientfollowinginstructionsprovided byitsmanufacturer | Non-sterile.Device iscleanedbetween usesby the patientfollowinginstructionsprovided byitsmanufacturer |
Conclusion:
In comparison to the predicate devices, the ASD Oral Appliances have:
- The same intended use, and
- The same technological characteristics and so do not raise new questions of safety . and effectiveness.
Therefore, the proposed ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic and ASD Lateral Mezzo Oral Appliances are deemed substantially equivalent to the predicate devices based on a review of the descriptive characteristics of each device model.
§ 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.”