(268 days)
The Panthera Anti-Snoring X3 Device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
The Panthera Anti-Snoring X3 Device is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two customized splints that fit separately over the upper and lower teeth.
The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharvngeal space, improving their ability to exchange air during sleep.
The device is a prescription customized for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The maximum protrusion of the device is 5 mm in 1 mm increments.
This document is a 510(k) premarket notification for the Panthera Anti-Snoring X3 Device, seeking substantial equivalence to previously marketed devices. The document explicitly states that no human clinical study was deemed necessary to support substantial equivalence (page 12), and therefore, a study proving the device meets acceptance criteria based on human clinical data is not provided in this submission.
The acceptance criteria and device performance are instead established through non-clinical testing, primarily by demonstrating equivalence to a primary predicate device (The Panthera Anti-Snoring Device, K143244) and several reference predicate devices.
Here's a breakdown based on the provided text, addressing your points where possible, and indicating where information is not available due to the nature of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical study was performed, the "reported device performance" against clinical acceptance criteria is not applicable. Instead, the non-clinical testing focused on establishing substantial equivalence based on material properties, design, and mechanical strength.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Physical Properties | |
| Orthosis polishing | Met criteria (demonstrated by equivalence to predicate K143244) |
| Static compression resistance | Met criteria (demonstrated by equivalence to predicate K143244) |
| Dynamic compression resistance | Met criteria (demonstrated by equivalence to predicate K143244) |
| Build locations for 3-D printing | Met criteria (a test was conducted in accordance with FDA Guidance Document and standards ASTM D638 and NISTIR 8059) |
| Biocompatibility | |
| Biocompatible (ISO 14971, ISO 10993-1, ISO 10993-5, ISO 10993-10) | Biocompatible (based on using same materials, supplier, and proprietary manufacturing process as predicate K143244) |
| Fatigue Testing | |
| Sufficient mechanical strength for intended clinical application (for stop-clip system assembly) | Demonstrated sufficient mechanical strength |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable for a clinical test set as no clinical study was performed. For non-clinical testing, specific sample sizes for material and fatigue tests are not provided in this summary but would have been part of the underlying test reports.
- Data provenance: Not applicable in terms of country of origin or retrospective/prospective for a clinical study. The non-clinical testing was conducted by Panthera Dental Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no human clinical study was performed, there was no ground truth established by experts for a test set in this 510(k) submission.
4. Adjudication method for the test set
Not applicable. No human clinical study was performed with a test set requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical intraoral device, not an AI or imaging diagnostic tool, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" was established by industry standards (e.g., ASTM D638, NISTIR 8059) and regulatory biocompatibility standards (e.g., ISO 14971, ISO 10993). Equivalence to predicate devices with established safety and effectiveness also serves as a form of "ground truth" for substantial equivalence.
8. The sample size for the training set
Not applicable. No machine learning algorithm or training set was involved.
9. How the ground truth for the training set was established
Not applicable. No machine learning algorithm or training set was involved.
Summary of the Study (Non-Clinical Evidence for Substantial Equivalence):
The Panthera Anti-Snoring X3 Device's substantial equivalence was established through non-clinical testing and comparison to legally marketed predicate devices rather than a human clinical study.
-
Non-Clinical Testing:
- Material Equivalence: The device uses the same raw material (polyamide type 12), supplied by EOS, and the same proprietary manufacturing process (Selective Laser Sintering) as its primary predicate, The Panthera Anti-Snoring Device (K143244). This allowed for leveraging performance testing (orthosis polishing, static and dynamic compression resistance) from the predicate's submission.
- Mechanical Testing: A specific test was conducted to determine build locations for 3-D printing in accordance with FDA guidance and standards (ASTM D638, NISTIR 8059).
- Fatigue Testing: Because the mechanism for mandibular protrusion differed from the primary predicate (stop-clip system assembly vs. interlocking rods), dedicated fatigue testing was performed on the stop-clip system assembly. The results demonstrated sufficient mechanical strength for its intended clinical application.
- Biocompatibility: Assessed and confirmed to be biocompatible based on the use of identical materials, supplier, and manufacturing process as the primary predicate device, following ISO standards (14971, 10993-1, 10993-5, 10993-10).
-
Rationale for No Clinical Study: The FDA submission states that a human clinical study was "not deemed necessary" because the Panthera AS X3:
- Does not use a design dissimilar from the reference predicate devices.
- Does not use new technologies different from the primary and reference predicate devices.
- Does not deviate from the indications for use identified in the primary and reference predicate devices.
In essence, the "study" proving the device meets its "acceptance criteria" here is a comprehensive non-clinical assessment demonstrating that the device is materially, technologically, and functionally equivalent or superior in specific mechanical aspects to its established predicate devices, which already have demonstrated safety and effectiveness through their own market history or prior submissions.
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Panthera Dental Inc. Martine Fortin Regulatory Affairs and Quality Assurance Director 2035. rue du Haut-Bord Quebec City, G1N 4N7 Canada
February 22, 2018
Re: K171576
Trade/Device Name: The Panthera Anti-Snoring X3 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: January 26, 2018 Received: January 29, 2018
Dear Martine Fortin:
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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
for 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)
Device Name The Panthera Anti-Snoring X3 Device
Indications for Use (Describe)
The Panthera Anti-Snoring X3 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Panthera Dental. The logo features a black silhouette of a panther in a crouching position, ready to pounce. Below the panther, the word "PANTHERA" is written in a stylized, sans-serif font, with the word "DENTAL" underneath in a smaller font. The text is in a purple color.
5. 510 (k) Summary
[As required by 21 CFR 807.92]
| Date Prepared: | February 21, 2018 |
|---|---|
| Submitter: | Panthera Dental Inc.2035 rue du Haut-BordQuébec (QC) G1N 4R7CanadaTel: (418) 527-0388Fax: (418) 431-9942 |
| Official Contact: | Martine FortinQuality Assurance and Regulatory Affairs Directorregulatory@pantheradental.comTel: (418) 527-0388 |
| Device Trade Name: | Panthera Anti-Snoring X3 Device |
| Device Common Name: | Mandibular repositioning device |
| Classification: | 21 CFR 872.5570 (Class II) |
| Classification Name: | Intraoral devices for snoring and intraoral devices forsnoring and obstructive sleep apnea |
| Product code: | LRK |
| Primary Predicate: | The Panthera Anti-Snoring Device (K143244) |
SomnoDent Flex™ (K073004) Reference Devices: DynaFlex Anti-Snoring & Sleep Apnea Devices (K103076) MicrO2 Obstructive Sleep Apnea Device (K133683)
Description: The Panthera Anti-Snoring X3 Device is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two customized splints that fit separately over the upper and lower teeth.
The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharvngeal space, improving their ability to exchange air during sleep.
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Image /page/4/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black silhouette of a panther in a crouching position, with its tail curled upwards. Below the panther, the word "PANTHERA" is written in a bold, sans-serif font, with a purple line underneath it. Below "PANTHERA", the word "DENTAL" is written in a smaller, sans-serif font.
The device is a prescription customized for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The maximum protrusion of the device is 5 mm in 1 mm increments.
Indications for Use: The Panthera Anti-Snoring X3 Device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Technological: The following table displays the differences and similarities between the Panthera Anti-Snoring X3 Device and four (4) other previously marketed devices. Equivalence is based on similarities in indications for use, materials of construction, design, operating principles, etc.
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Image /page/5/Picture/0 description: The image shows a black panther above the words "PANTHERA DENTAL" in purple. The panther is in a crouching position, with its tail curled up. The word "PANTHERA" is in a larger font than the word "DENTAL", and there is a horizontal line above the word "DENTAL".
Table 5.1: Comparison chart between the submitted device and the predicates.
| The Panthera Anti-Snoring X3 Device | Primary PredicateThe Panthera Anti-Snoring Device(K143244) | SomnoDent Flex™(K073004) | Reference Devices | ||||
|---|---|---|---|---|---|---|---|
| Feature | DynaFlex Anti-Snoring & SleepApnea Devices(K103076) | MicrO2 ObstructiveSleep Apnea Device(K133683) | |||||
| Picture of thedevice | Image: The Panthera Anti-Snoring X3 Device | Image: The Panthera Anti-Snoring Device | Image: SomnoDent Flex | Image: DynaFlex Anti-Snoring & Sleep Apnea Devices | Image: MicrO2 Obstructive Sleep Apnea Device | N/A | |
| Regulationdescription | Intraoral device forsnoring andobstructive sleepapnea | Intraoral device forsnoring andobstructive sleepapnea | Intraoral device forsnoring andobstructive sleepapnea | Intraoral devices forsnoring andobstructive sleepapnea | Intraoral device forsnoring andobstructive sleepapnea | Same for all | |
| Class | Class II | Class II | Class II | Class II | Class II | Same for all | |
| Indicationsfor Use | To reduce or alleviatesnoring and mild tomoderate obstructivesleep apnea (OSA) inadults | To reduce or alleviatesnoring and mild tomoderate obstructivesleep apnea (OSA) inadults | To reduce or alleviatenight time snoring andmild to moderateobstructive sleepapnea | To reduce night timesnoring and mild tomoderate obstructivesleep apnea (OSA) inadults.The devices are wornwhile sleeping tosupport the lower jaw | To reduce night timesnoring and mild tomoderate obstructivesleep apnea (OSA) inadults. | Same asprimarypredicate andsimilar to thereferencepredicates | |
| Primary Predicate | Reference Devices | ||||||
| Feature | The Panthera Anti-Snoring X3 Device | The Panthera Anti-Snoring Device(K143244) | SomnoDent Flex™(K073004) | DynaFlex Anti-Snoring & SleepApnea Devices(K103076) | MicrO2 ObstructiveSleep Apnea Device(K133683) | ||
| in a forward positionprescribed by thedentist, and isremovable by thepatient | |||||||
| Materials ofconstruction | Made from polymers(polyamide type 12),supplied by EOS.The device is metal-free.Highly resilient anddurable biocompatiblepolymer material | Made from polymers(polyamide type 12),supplied by EOS.The device is metal-free.Highly resilient anddurable biocompatiblepolymer material | Made from SMHBFlex which is aproprietary softpolymer that ismolecularly bonded tothe device's hardsurface acrylic.Includes two metalscrews in themaxillary appliance | Made from hardacrylic outer shell andsoft vinyl liner inside.Includes two metalscrews in themaxillary appliance | Hard PMMA material | Same asprimarypredicate | |
| Design | Uses computer-aideddesign (CAD) andcomputer-aidedmanufacturing(CAM).Uses CAD thatenables a high degreeof customizationaccording to the | Uses computer-aideddesign (CAD) andcomputer-aidedmanufacturing(CAM).Uses CAD thatenables a high degreeof customizationaccording to the | Information not found | Information not found | Uses computer-aideddesign (CAD) andcomputer-aidedmanufacturing(CAM). | CAD/CAMsame asprimarypredicate andMicro2 | |
| Primary Predicate | Reference Devices | ||||||
| Feature | The Panthera Anti-Snoring X3 Device | The Panthera Anti-Snoring Device(K143244) | SomnoDent Flex™(K073004) | DynaFlex Anti-Snoring & SleepApnea Devices(K103076) | MicrO2 ObstructiveSleep Apnea Device(K133683) | ||
| physician or dentistprescription.The CAM andselective lasersintering guaranteeprecision, accuracyand consistency foreach patient. | physician or dentistprescription.The CAM andselective lasersintering guaranteeprecision, accuracyand consistency foreach patient. | ||||||
| Two customizedsplints that fitseparately over theupper and lower teethinside the mouth. | Two customizedsplints that fitseparately over theupper and lower teethinside the mouth. | Two customizedsplints that fitseparately over theupper and lower teethinside the mouth. | Two customizedsplints that fitseparately over theupper and lower teethinside the mouth. | Two customizedsplints that fitseparately over theupper and lower teethinside the mouth. | Same for all(customizedsplints) | ||
| The mandible splintcontains wingprotrusions thatinterface with theincline blocks builtinto the buccal of themaxillary splint | The mandible splintcontains triangularprotrusions allowingthe splints to engageby means ofinterlocking rods onthe side. | The mandible splintcontains triangularprotrusions thatinterface with theincline blocks builtinto the buccal of themaxillary splint | The mandible splintcontains triangularprotrusions thatinterface with theincline blocks builtinto the buccal of themaxillary splint | The mandible splintcontains protrusionsthat interface with theblock built into thebuccal of themaxillary splint | Similar toSomnoDentand DynaFlexwhich usescrew insteadof clip;Similar toprimarypredicatewhich uses | ||
| Primary Predicate | Reference Devices | ||||||
| Feature | The Panthera Anti-Snoring X3 Device | The Panthera Anti-Snoring Device(K143244) | SomnoDent Flex™(K073004) | DynaFlex Anti-Snoring & SleepApnea Devices(K103076) | MicrO2 ObstructiveSleep Apnea Device(K133683) | ||
| • Uppersplint | Bears on the posteriorteeth | Bears on the posteriorteeth | Stops after the firstmolar, sometimesafter the secondpremolar | Information not found | Information not found | rods instead ofclipSame asprimarvpredicate | |
| • Theorientation ofthe wings onthe lowersplint | Two wings at either70°, 90° or 110°(depending on themodel device chosen) | Two wings at 110° | Two wings at 70° | Two wings at 70° forthe Dorsal and 110°for the Dorsal AirPlus | Two wings at 90° | Same aspredicates | |
| • Occlusiontrays | It stops after premolarteeth | It stops after premolarteeth | It covers the entireocclusal surface ofupper and lowerretainers | It covers the entireocclusal surface ofupper and lowerretainers | Information not found | Same asprimarvpredicate | |
| Principle ofoperation/means ofmandibularadvancement | Adjustment of therelative position of thesplints guides themandible forward andmaintainsadvancement thusenlarging the airway. | Adjustment of therelative position of thesplints guides themandible forward andmaintainsadvancement thusenlarging the airway. | Adjustment of therelative position of thesplints guides themandible forward andmaintainsadvancement thusenlarging the airway. | Adjustment of therelative position of thesplints guides themandible forward andmaintainsadvancement thusenlarging the airway. | Adjustment of therelative position of thesplints guides themandible forward andmaintainsadvancement thusenlarging the airway. | Same for all | |
| Primary Predicate | Reference Devices | ||||||
| Feature | The Panthera Anti-Snoring X3 Device | The Panthera Anti-Snoring Device(K143244) | SomnoDent Flex™(K073004) | DynaFlex Anti-Snoring & SleepApnea Devices(K103076) | MicrO2 ObstructiveSleep Apnea Device(K133683) | ||
| The vertical openingof the jaw is not fixedin a single position | The vertical openingof the jaw is not fixedin a single position. | The vertical openingof the jaw is not fixedin a single position | The vertical openingof the jaw is not fixedin a single position | The vertical openingof the jaw is not fixedin a single position | |||
| Push-basedmandibularrepositioning device,allows for nasal and/ororal breathing | Traction-basedmandibularrepositioning device,allows for nasal and/ororal breathing | Push-basedmandibularrepositioning device,allows for nasal and/ororal breathing | Push-basedmandibularrepositioning device,allows for nasal and/ororal breathing | Push-basedmandibularrepositioning device,allows for nasal and/ororal breathing | Same asreferencepredicates | ||
| Fixed/removable | Removable | Removable | Removable | Removable | Removable | Same for all | |
| Adjustment | Adjusted via theadjustable clipassembly placed oneach side of themaxillary splint. Thelonger the stop-clip is,the further themandible is advanced.The dentist can selecta longer stop-clip untiloptimal advancementis achieved. | Adjusted via the useof interlocking rodsplaced on each side ofthe mandible splint.The shorter the rod,the further themandible is advanced.The dentist can selecta shorter connectingrod until optimaladvancement isachieved. | Adjusted via the useof the suppliedadjustment key wheninserting it in theadjustable screw. Theadjustable screws areplaced on each side ofthe maxillary splint.The more it isunscrewed, the furtherthe mandible isadvanced. The dentistcan select the proper | Adjusted via the useof the suppliedadjustment key wheninserting it in theadjustable screw. Theadjustable screws areplaced on each side ofthe maxillary splint.The more it isunscrewed, the furtherthe mandible isadvanced. The dentistcan select the proper | Advancements can beachieved by simplyremoving the currentupper or lower deviceand inserting the nextupper or lower devicein the mandibularadvancing series. | Similar toSomnoDentand DynaFlexpredicates | |
| The Panthera Anti-Snoring X3 Device | Primary Predicate | Reference Devices | |||||
| Feature | The Panthera Anti-Snoring Device(K143244) | SomnoDent Flex™(K073004) | DynaFlex Anti-Snoring & SleepApnea Devices(K103076) | MicrO2 ObstructiveSleep Apnea Device(K133683) | |||
| Image: The Panthera Anti-Snoring X3 Device | until optimaladvancement isachieved.Image: SomnoDent Flex | until optimaladvancement isachieved.Image: DynaFlex Anti-Snoring & Sleep Apnea Devices | Image: MicrO2 Obstructive Sleep Apnea Device | ||||
| Mandibularadjustment | Performed by dentistor physician | Performed by dentistor physician | Performed by dentistor physician | Performed by dentistor physician | Information not found | Same for all | |
| Mandibularadvancementrange | Up to 5 mm at 1 mmincrements | Up to 15 mm at 1 mmincrements | Up to 6.0 mm at 0.1mm increments | Information not found | Up to 6.0 mm | Similar topredicatesexceptDynaFlex | |
| Suppliedsterile/nonsterile | Non sterile | Non sterile | Non sterile | Non sterile | Non sterile | Same for all | |
| Targetpopulation | Adult patients | Adult patients | Adult patients | Adult patients | Adult patients | Same for all | |
| Single Use/reusable | Reusable | Reusable | Reusable | Reusable | Reusable | Same for all | |
| Verticalopening | Up to 6 mm | Up to 4 mm | Up to 4 mm | Information not found | Information not found | Similar to theprimary | |
| Feature | The Panthera Anti-Snoring X3 Device | Primary Predicate | The Panthera Anti-Snoring Device(K143244) | SomnoDent Flex™(K073004) | DynaFlex Anti-Snoring & SleepApnea Devices(K103076) | MicrO2 ObstructiveSleep Apnea Device(K133683) | |
| Prescription/OTC | Prescription only | Prescription only | Prescription only | Prescription only | Prescription only | Same for all | |
| Cleaning andMaintenance | Clean daily inlukewarm water witha soft toothbrush.Rinse, dry and store incase provided. Twicea week useantibacterialorthodontic cleansingsolution that arechlorine-free | Clean daily inlukewarm water witha soft toothbrush.Rinse, dry and store incase provided. Twicea week useantibacterialorthodontic cleansingsolution that arechlorine-free | Clean daily in cold orlukewarm water withthe brush provided ora soft toothbrush andmild detergent. Rinse,dry, and store in caseprovided. | Information not found | Clean daily | Same asprimarypredicate |
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Image /page/6/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black silhouette of a panther in a crouching position, with its tail curled upwards. Below the panther is the word "PANTHERA" in a bold, sans-serif font, with the word "DENTAL" underneath in a smaller font.
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Image /page/7/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position above the words "PANTHERA DENTAL" in purple. The word "PANTHERA" is in a larger font than the word "DENTAL", and the two words are stacked on top of each other.
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Image /page/9/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black silhouette of a panther in a stalking pose, with its tail curled upwards. Below the panther is the text "PANTHERA" in a bold, sans-serif font, with the word "DENTAL" underneath in a smaller font.
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Image /page/10/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position, with its tail curved upwards. Below the panther, the word "PANTHERA" is written in a purple, sans-serif font, with the word "DENTAL" written in a smaller font size below it.
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Image /page/11/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a stalking pose above the words "PANTHERA DENTAL" in a stylized font. The word "PANTHERA" is in a larger font and a purple color, while "DENTAL" is in a smaller font and a darker color.
Confidential
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Image /page/12/Picture/0 description: The image shows a logo for a dental company called Panthera Dental. The logo features a black panther in a crouching position, with its tail curled up. Below the panther is the word "PANTHERA" in a stylized purple font, with the word "DENTAL" in a smaller font underneath.
Non-Clinical Testing: The non-clinical testing includes assessment of the physical properties of the Panthera Anti-Snoring X3 Device and its ability to achieve its intended use. The Panthera Anti-Snoring X3 Device meets criteria to support substantial equivalence to the primary and reference predicate devices. The Panthera Anti-Snoring X3 Device and the Panthera Anti-Snoring Device are substantially equivalent based on the fact that both devices use the same raw material, have the same indications for use, type and duration of patient contact as well as the same Selective Laser Sintering fabrication process including the proprietary manufacturing. Therefore, the performance testing provided in the primary predicate submission K143244 (Panthera Anti-Snoring Device) serves in lieu of performing the two (2) performance tests for the proposed device: orthosis polishing and static and dynamic compression resistance. A test was conducted to determine the build locations for 3-D printing in accordance with the FDA Guidance Document, Technical Considerations for Additive Manufactured Medical Devices and following the standards ASTM D638 and NISTIR 8059.
Biocompatibility: A biocompatibility assessment of the device was performed. The purpose of this assessment was to ensure that biocompatibility had been established for the proposed device following the standards of ISO 14971, ISO 10993-1, ISO 10993-5 and ISO 10993-10. The Panthera Anti-Snoring X3 Device is biocompatible, based on the use of the same materials of construction, the same supplier and the same proprietary manufacturing process as the primary predicate device, the Panthera Anti-Snoring Device, marketed by Panthera Dental Inc.
Fatigue Testing: Considering that the mechanism of action for the protrusion of the lower iaw is different between the Panthera AS X3 and the mechanism of the Panthera AS, performance testing were conducted on the stop-clip system assembly. The results have demonstrated that the Panthera AS X3 has sufficient mechanical strength for its intended clinical application.
Clinical Testing: Human clinical study was not deemed necessary to support substantial equivalence. The Panthera AS X3 does not use design dissimilar from the reference predicate devices, does not use new technologies different from the primary and reference predicate devices, and does not deviate from the indications for use identified in the primary and reference predicate devices.
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Image /page/13/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position above the words "PANTHERA DENTAL" in purple. The word "PANTHERA" is in a larger font than the word "DENTAL". The panther is facing left and has a long, curved tail.
Substantial Equivalence Conclusion: The Panthera Anti-Snoring X3 Device is considered to be substantially equivalent to the primary predicate and any differences have been identified in other previously cleared reference devices and do not impact safety and effectiveness.
§ 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.”