(268 days)
No
The device description and performance studies focus on mechanical function, material properties, and manufacturing processes. There is no mention of AI or ML in the text.
Yes
The device is intended to treat or alleviate a medical condition (snoring and obstructive sleep apnea) in adults, which aligns with the definition of a therapeutic device.
No
The device is described as a "mandibular repositioner" intended to treat snoring and mild to moderate obstructive sleep apnea by increasing pharyngeal space, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "removable intraoral device" consisting of "two customized splints" and an "adjustment mechanism," indicating it is a physical hardware device.
Based on the provided information, the Panthera Anti-Snoring X3 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, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Panthera Anti-Snoring X3 Device is a physical, intraoral device that mechanically repositions the lower jaw. It does not perform any tests on biological samples.
- Intended Use: Its intended use is to reduce snoring and alleviate sleep apnea through a mechanical action, not through diagnostic testing.
Therefore, the device falls under the category of a medical device, but not specifically an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults
Intended User / Care Setting
Dentist or physician / Not specified, but implied as a clinical setting for fitting and adjustment, and home use for patient.
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The Panthera Anti-Snoring Device (K143244), SomnoDent Flex™ (K073004)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
DynaFlex Anti-Snoring & Sleep Apnea Devices (K103076), MicrO2 Obstructive Sleep Apnea Device (K133683)
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.”
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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
2
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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5. 510 (k) Summary
[As required by 21 CFR 807.92]
| Date Prepared: | February 21, 2018 |
|---|---|
| Submitter: | Panthera Dental Inc. |
| 2035 rue du Haut-Bord | |
| Québec (QC) G1N 4R7 | |
| Canada | |
| Tel: (418) 527-0388 | |
| Fax: (418) 431-9942 | |
| Official Contact: | Martine Fortin |
| Quality Assurance and Regulatory Affairs Director | |
| regulatory@pantheradental.com | |
| Tel: (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 for |
| snoring 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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Table 5.1: Comparison chart between the submitted device and the predicates.
| | The Panthera Anti-
Snoring X3 Device | Primary Predicate
The Panthera Anti-
Snoring Device
(K143244) | SomnoDent Flex™
(K073004) | Reference Devices | | | |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--|
| Feature | | | | DynaFlex Anti-
Snoring & Sleep
Apnea Devices
(K103076) | MicrO2 Obstructive
Sleep Apnea Device
(K133683) | | |
| Picture of the
device | 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 | |
| Regulation
description | Intraoral device for
snoring and
obstructive sleep
apnea | Intraoral device for
snoring and
obstructive sleep
apnea | Intraoral device for
snoring and
obstructive sleep
apnea | Intraoral devices for
snoring and
obstructive sleep
apnea | Intraoral device for
snoring and
obstructive sleep
apnea | Same for all | |
| Class | Class II | Class II | Class II | Class II | Class II | Same for all | |
| Indications
for Use | To reduce or alleviate
snoring and mild to
moderate obstructive
sleep apnea (OSA) in
adults | To reduce or alleviate
snoring and mild to
moderate obstructive
sleep apnea (OSA) in
adults | To reduce or alleviate
night time snoring and
mild to moderate
obstructive sleep
apnea | To reduce night time
snoring and mild to
moderate obstructive
sleep apnea (OSA) in
adults.
The devices are worn
while sleeping to
support the lower jaw | To reduce night time
snoring and mild to
moderate obstructive
sleep apnea (OSA) in
adults. | Same as
primary
predicate and
similar to the
reference
predicates | |
| | | Primary Predicate | Reference Devices | | | | |
| Feature | The Panthera Anti-
Snoring X3 Device | The Panthera Anti-
Snoring Device
(K143244) | SomnoDent Flex™
(K073004) | DynaFlex Anti-
Snoring & Sleep
Apnea Devices
(K103076) | MicrO2 Obstructive
Sleep Apnea Device
(K133683) | | |
| | | | | in a forward position
prescribed by the
dentist, and is
removable by the
patient | | | |
| Materials of
construction | Made from polymers
(polyamide type 12),
supplied by EOS.
The device is metal-
free.
Highly resilient and
durable biocompatible
polymer material | Made from polymers
(polyamide type 12),
supplied by EOS.
The device is metal-
free.
Highly resilient and
durable biocompatible
polymer material | Made from SMH
BFlex which is a
proprietary soft
polymer that is
molecularly bonded to
the device's hard
surface acrylic.
Includes two metal
screws in the
maxillary appliance | Made from hard
acrylic outer shell and
soft vinyl liner inside.
Includes two metal
screws in the
maxillary appliance | Hard PMMA material | Same as
primary
predicate | |
| Design | Uses computer-aided
design (CAD) and
computer-aided
manufacturing
(CAM).
Uses CAD that
enables a high degree
of customization
according to the | Uses computer-aided
design (CAD) and
computer-aided
manufacturing
(CAM).
Uses CAD that
enables a high degree
of customization
according to the | Information not found | Information not found | Uses computer-aided
design (CAD) and
computer-aided
manufacturing
(CAM). | CAD/CAM
same as
primary
predicate and
Micro2 | |
| | | Primary Predicate | Reference Devices | | | | |
| Feature | The Panthera Anti-
Snoring X3 Device | The Panthera Anti-
Snoring Device
(K143244) | SomnoDent Flex™
(K073004) | DynaFlex Anti-
Snoring & Sleep
Apnea Devices
(K103076) | MicrO2 Obstructive
Sleep Apnea Device
(K133683) | | |
| | physician or dentist
prescription.
The CAM and
selective laser
sintering guarantee
precision, accuracy
and consistency for
each patient. | physician or dentist
prescription.
The CAM and
selective laser
sintering guarantee
precision, accuracy
and consistency for
each patient. | | | | | |
| | Two customized
splints that fit
separately over the
upper and lower teeth
inside the mouth. | Two customized
splints that fit
separately over the
upper and lower teeth
inside the mouth. | Two customized
splints that fit
separately over the
upper and lower teeth
inside the mouth. | Two customized
splints that fit
separately over the
upper and lower teeth
inside the mouth. | Two customized
splints that fit
separately over the
upper and lower teeth
inside the mouth. | Same for all
(customized
splints) | |
| | The mandible splint
contains wing
protrusions that
interface with the
incline blocks built
into the buccal of the
maxillary splint | The mandible splint
contains triangular
protrusions allowing
the splints to engage
by means of
interlocking rods on
the side. | The mandible splint
contains triangular
protrusions that
interface with the
incline blocks built
into the buccal of the
maxillary splint | The mandible splint
contains triangular
protrusions that
interface with the
incline blocks built
into the buccal of the
maxillary splint | The mandible splint
contains protrusions
that interface with the
block built into the
buccal of the
maxillary splint | Similar to
SomnoDent
and DynaFlex
which use
screw instead
of clip;
Similar to
primary
predicate
which uses | |
| | | Primary Predicate | Reference Devices | | | | |
| Feature | The Panthera Anti-
Snoring X3 Device | The Panthera Anti-
Snoring Device
(K143244) | SomnoDent Flex™
(K073004) | DynaFlex Anti-
Snoring & Sleep
Apnea Devices
(K103076) | MicrO2 Obstructive
Sleep Apnea Device
(K133683) | | |
| • Upper
splint | Bears on the posterior
teeth | Bears on the posterior
teeth | Stops after the first
molar, sometimes
after the second
premolar | Information not found | Information not found | rods instead of
clip
Same as
primarv
predicate | |
| • The
orientation of
the wings on
the lower
splint | Two wings at either
70°, 90° or 110°
(depending on the
model device chosen) | Two wings at 110° | Two wings at 70° | Two wings at 70° for
the Dorsal and 110°
for the Dorsal AirPlus | Two wings at 90° | Same as
predicates | |
| • Occlusion
trays | It stops after premolar
teeth | It stops after premolar
teeth | It covers the entire
occlusal surface of
upper and lower
retainers | It covers the entire
occlusal surface of
upper and lower
retainers | Information not found | Same as
primarv
predicate | |
| Principle of
operation/
means of
mandibular
advancement | Adjustment of the
relative position of the
splints guides the
mandible forward and
maintains
advancement thus
enlarging the airway. | Adjustment of the
relative position of the
splints guides the
mandible forward and
maintains
advancement thus
enlarging the airway. | Adjustment of the
relative position of the
splints guides the
mandible forward and
maintains
advancement thus
enlarging the airway. | Adjustment of the
relative position of the
splints guides the
mandible forward and
maintains
advancement thus
enlarging the airway. | Adjustment of the
relative position of the
splints guides the
mandible forward and
maintains
advancement thus
enlarging 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 & Sleep
Apnea Devices
(K103076) | MicrO2 Obstructive
Sleep Apnea Device
(K133683) | | |
| | The vertical opening
of the jaw is not fixed
in a single position | The vertical opening
of the jaw is not fixed
in a single position. | The vertical opening
of the jaw is not fixed
in a single position | The vertical opening
of the jaw is not fixed
in a single position | The vertical opening
of the jaw is not fixed
in a single position | | |
| | Push-based
mandibular
repositioning device,
allows for nasal and/or
oral breathing | Traction-based
mandibular
repositioning device,
allows for nasal and/or
oral breathing | Push-based
mandibular
repositioning device,
allows for nasal and/or
oral breathing | Push-based
mandibular
repositioning device,
allows for nasal and/or
oral breathing | Push-based
mandibular
repositioning device,
allows for nasal and/or
oral breathing | Same as
reference
predicates | |
| Fixed/
removable | Removable | Removable | Removable | Removable | Removable | Same for all | |
| Adjustment | Adjusted via the
adjustable clip
assembly placed on
each side of the
maxillary splint. The
longer the stop-clip is,
the further the
mandible is advanced.
The dentist can select
a longer stop-clip until
optimal advancement
is achieved. | Adjusted via the use
of interlocking rods
placed on each side of
the mandible splint.
The shorter the rod,
the further the
mandible is advanced.
The dentist can select
a shorter connecting
rod until optimal
advancement is
achieved. | Adjusted via the use
of the supplied
adjustment key when
inserting it in the
adjustable screw. The
adjustable screws are
placed on each side of
the maxillary splint.
The more it is
unscrewed, the further
the mandible is
advanced. The dentist
can select the proper | Adjusted via the use
of the supplied
adjustment key when
inserting it in the
adjustable screw. The
adjustable screws are
placed on each side of
the maxillary splint.
The more it is
unscrewed, the further
the mandible is
advanced. The dentist
can select the proper | Advancements can be
achieved by simply
removing the current
upper or lower device
and inserting the next
upper or lower device
in the mandibular
advancing series. | Similar to
SomnoDent
and DynaFlex
predicates | |
| | The Panthera Anti-
Snoring X3 Device | Primary Predicate | Reference Devices | | | | |
| Feature | The Panthera Anti-
Snoring Device
(K143244) | SomnoDent Flex™
(K073004) | DynaFlex Anti-
Snoring & Sleep
Apnea Devices
(K103076) | MicrO2 Obstructive
Sleep Apnea Device
(K133683) | | | |
| | Image: The Panthera Anti-Snoring X3 Device | | until optimal
advancement is
achieved.
Image: SomnoDent Flex | until optimal
advancement is
achieved.
Image: DynaFlex Anti-Snoring & Sleep Apnea Devices | Image: MicrO2 Obstructive Sleep Apnea Device | | |
| Mandibular
adjustment | Performed by dentist
or physician | Performed by dentist
or physician | Performed by dentist
or physician | Performed by dentist
or physician | Information not found | Same for all | |
| Mandibular
advancement
range | Up to 5 mm at 1 mm
increments | Up to 15 mm at 1 mm
increments | Up to 6.0 mm at 0.1
mm increments | Information not found | Up to 6.0 mm | Similar to
predicates
except
DynaFlex | |
| Supplied
sterile/non
sterile | Non sterile | Non sterile | Non sterile | Non sterile | Non sterile | Same for all | |
| Target
population | Adult patients | Adult patients | Adult patients | Adult patients | Adult patients | Same for all | |
| Single Use/
reusable | Reusable | Reusable | Reusable | Reusable | Reusable | Same for all | |
| Vertical
opening | Up to 6 mm | Up to 4 mm | Up to 4 mm | Information not found | Information not found | Similar to the
primary | |
| Feature | The Panthera Anti-
Snoring X3 Device | Primary Predicate | The Panthera Anti-
Snoring Device
(K143244) | SomnoDent Flex™
(K073004) | DynaFlex Anti-
Snoring & Sleep
Apnea Devices
(K103076) | MicrO2 Obstructive
Sleep Apnea Device
(K133683) | |
| Prescription/
OTC | Prescription only | Prescription only | Prescription only | Prescription only | Prescription only | Same for all | |
| Cleaning and
Maintenance | Clean daily in
lukewarm water with
a soft toothbrush.
Rinse, dry and store in
case provided. Twice
a week use
antibacterial
orthodontic cleansing
solution that are
chlorine-free | Clean daily in
lukewarm water with
a soft toothbrush.
Rinse, dry and store in
case provided. Twice
a week use
antibacterial
orthodontic cleansing
solution that are
chlorine-free | Clean daily in cold or
lukewarm water with
the brush provided or
a soft toothbrush and
mild detergent. Rinse,
dry, and store in case
provided. | Information not found | Clean daily | Same as
primary
predicate | |
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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.