(197 days)
No
The description focuses on CAD software for design and additive manufacturing, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment planning.
Yes
Explanation: The device is indicated to reduce snoring and mild to moderate obstructive sleep apnea, which are medical conditions, and it achieves this by supporting the lower jaw in a specific position, thus providing a therapeutic effect.
No
The EndSnorZ™ Sleep Appliance is described as a treatment device, specifically a mandibular advancement device used to reduce snoring and mild to moderate obstructive sleep apnea. Its function is to hold the lower jaw in a forward position for therapeutic purposes, not to diagnose a condition.
No
The device description clearly states it consists of physical components (upper and lower splints, connector) made of biocompatible materials and manufactured using additive manufacturing and injection molding. While CAD software is used in the design phase, the device itself is a physical appliance.
Based on the provided information, the EndSnorZ™ Sleep Appliance is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- EndSnorZ™ Function: The EndSnorZ™ Sleep Appliance is a physical device worn in the mouth to mechanically reposition the lower jaw. It does not analyze any biological specimens.
- Intended Use: Its intended use is to reduce snoring and mild to moderate obstructive sleep apnea by physically supporting the lower jaw. This is a mechanical intervention, not a diagnostic test.
Therefore, the EndSnorZ™ Sleep Appliance falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
EndSnorZ™ Sleep Appliance is indicated to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. EndSnorZ™ Sleep Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The EndSnorZ Sleep Appliance is a mandibular advancement device. It holds the mandible in a protrusive position determined by the trained dentist.
The device consists of upper and lower splints (trays), which are additive manufactured using a biocompatible light curable resin, and a connector, made of a biocompatible medical-grade synthetic polymer with injection molding technology. The connectors attach the upper and lower splints to maintain the forward position of the lower jaw. The device is adjustable in 0.5 mm increments.
The device is customized to conform to the patient's upper and lower dentition, provided to Prismatik in patient scans. After loading the patient's scan, the splints are designed according to the scan and the clinician's prescription. Prismatik's computer aided design (CAD) software is used for the design phase. The connectors are applied after the splints are manufactured.
This is a non-sterile device, to be used only by the single patient for whom it is custom-designed and is to be worn during sleep.
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
18 years of age or older.
Intended User / Care Setting
Prescribed by the dentist. Worn while sleeping at home or in sleep laboratory.
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)
Laboratory Testing
Testing was performed by Prismatik to:
. validate the design and process for manufacturing the EndSnorZ Sleep Appliance:
. validate the position of the devices on the build platform of the SprintRay 3D printing machine for printing the devices with the Keysplint Soft Resin;
. validate that Prismatik's Wave CAD software accurately designs the sleep appliances and is 21 CFR Part 11 compliant: and
. compare the following mechanical properties of EndSnorZ Sleep Appliance to the Predicate: tensile strength of the connectors and the dimensional retention of connectors when exposed to artificial saliva.
Results of all laboratory testing confirmed substantial equivalence.
Biocompatibility
The following ISO 10993 testing was performed by the manufacturers of the Reference devices' printer resin and the connector polymer to assess the safety and biocompatibility of the resin and synthetic polymer materials.
Part 5 (Cytotoxicity Elution - MEM), Part 10 (Intracutaneous/Intradermal) Reactivity), Part 10 (Maximization for Delayed-Type Hypersensitivity)
Prismatik also contracted for GLP Cytotoxicity testing (per ISO 10993, Part 5) of the injection molded connectors. The test results showed that the materials and the manufactured connectors are safe and biocompatible for the stated intended use.
Animal | Human Testing
No animal or human testing are required for this product type.
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.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Prismatik Dentalcraft, Inc. % Patsy Trisler Regulatory Consultant Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250
Re: K211069
Trade/Device Name: EndSnorZ™ Sleep Appliance 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: September 28, 2021 Received: October 1, 2021
Dear Patsy Trisler:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211069
Device Name
EndSnorZTM Sleep Appliance
Indications for Use (Describe)
EndSnorZ™ Sleep Appliance is indicated to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. EndSnorZ™ Sleep Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.
| 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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510(k) Summary – K211069
| Submitter Name: | Prismatik Dentalcraft, Inc. |
|---|---|
| Submitter Address: | 2144 Michelson Drive |
| Irvine, CA 96212 | |
| Contact Person: | Herbert Crane |
| Vice President, RA/QA | |
| Telephone: | 949.222.3531 |
| Date Prepared: | October 21, 2021 |
| Device Trade Name: | EndSnorZ™ Sleep Appliance |
| Common Name | Anti-Snoring Device |
| Classification Name | |
| and Number | Intraoral devices for snoring and for obstructive sleep apnea |
| 21 CFR 872.5570 | |
| Product Code | LRK |
| Regulatory Class | II |
| Primary Predicate | |
| Device: | K183270, Silent Nite sl, Prismatik Dentalcraft, Inc. |
| Reference Devices: | #1: K183598, KeyPrint KeySplint Soft, Keystone Industries |
| (Product Codes: MQC, KMY) | |
| #2: K203712, The Slide, Biotex, Inc. (Product codes LQZ, LRK) | |
| Indications for Use | |
| Statement: | EndSnorZ™ Sleep Appliance is indicated to reduce snoring and |
| mild to moderate obstructive sleep apnea in patients 18 years of | |
| age or older. EndSnorZ™ Sleep Appliance is worn while | |
| sleeping to support the lower jaw in a forward position prescribed | |
| by the dentist. The appliance is removable by the patient. | |
| Device Description | |
| and Summary of | |
| Technological | |
| Characteristics | The EndSnorZ Sleep Appliance is a mandibular advancement |
| device. It holds the mandible in a protrusive position determined | |
| by the trained dentist. | |
| The device consists of upper and lower splints (trays), which are | |
| additive manufactured using a biocompatible light curable resin, | |
| and a connector, made of a biocompatible medical-grade | |
| synthetic polymer with injection molding technology. The | |
| connectors attach the upper and lower splints to maintain the | |
| forward position of the lower jaw. The device is adjustable in 0.5 | |
| mm increments. | |
| The device is customized to conform to the patient's upper and | |
| lower dentition, provided to Prismatik in patient scans. After | |
| loading the patient's scan, the splints are designed according to | |
| the scan and the clinician's prescription. Prismatik's computer | |
| aided design (CAD) software is used for the design phase. The | |
| connectors are applied after the splints are manufactured. |
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This is a non-sterile device, to be used only by the single patient for whom it is custom-designed and is to be worn during sleep. Mechanism of Action The EndSnorZ™ Sleep Appliance is designed so the lower jaw is in an advanced (forward protruding) state during sleep. This forward position improves the flow of air through the patient's pharyngeal space during sleep, repositioning the mandible and thus reducing snoring and mild to moderate OSA. Device Testing Laboratory Testing Testing was performed by Prismatik to: . validate the design and process for manufacturing the EndSnorZ Sleep Appliance: validate the position of the devices on the build platform of . the SprintRay 3D printing machine for printing the devices with the Keysplint Soft Resin; validate that Prismatik's Wave CAD software accurately . designs the sleep appliances and is 21 CFR Part 11 compliant: and compare the following mechanical properties of EndSnorZ . Sleep Appliance to the Predicate: tensile strength of the connectors and the dimensional retention of connectors when exposed to artificial saliva. Results of all laboratory testing confirmed substantial equivalence. Biocompatibility The following ISO 10993 testing was performed by the manufacturers of the Reference devices' printer resin and the connector polymer to assess the safety and biocompatibility of the resin and synthetic polymer materials. Part 5 (Cytotoxicity Elution - MEM), Part 10 (Intracutaneous/Intradermal) Reactivity), Part 10 (Maximization for Delayed-Type Hypersensitivity) Prismatik also contracted for GLP Cytotoxicity testing (per ISO 10993, Part 5) of the injection molded connectors. The test results showed that the materials and the manufactured connectors are safe and biocompatible for the stated intended use. Animal | Human Testing No animal or human testing are required for this product type. The EndSnorZ™ Sleep Appliance as compared to the predicate Comparison to Predicate and Silent Nite sl device: Reference Devices: ■ The intended use is the same. · The mechanisms of action are the same. . The materials used to make the device components are similar to the predicate. Further, the materials and methods for fabricating the splints are the same as the materials and additive manufacturing methods used for Reference #1: The resin is the same KeyPrint KeySplint
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Soft resin used for 3D printing the EndSnorZ sleep appliance splints. And, Reference #2 sleep appliance devices are also fabricated with additive manufacturing workflow and methods using a similar light-cured resin.
The following Substantial Equivalence Comparison table includes key similarities and differences of the EndSnorZ Sleep Appliance compared to the Predicate and both Reference devices.
- Based on documentation presented in the 510(k), including Substantial comparative testing between the subject and Predicate devices, Equivalence Conclusion and the presentation of similarities in technological characteristics to the Reference devices, it can be concluded that the differences in the base materials and methods of manufacture do not raise new questions of safety and effectiveness. Thus the EndSnorZ Sleep Appliance is substantially equivalent to the Predicate device.
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EndSnorZ™ Sleep Appliance Premarket Notification: Traditional 510(k)
Substantial Equivalence Comparison Table
| Element | New Device | Primary Predicate | Reference Device
#1 | Reference Device
#2 | Differences |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name: | EndSnorZ Sleep Appliance | Silent Nite® sl | KeyPrint® KeySplint
Soft ™ | The Slide | N/A |
| 510(k) #: | K211069 | K183270 | K183598 | K203712 | N/A |
| Classification | 21 CFR 872.5570 | 21 CFR 872.5570 | 21 CFR 872.5570 | 21 CFR 872.5570 | New device, Predicate |
| Product Code: | LRK | LRK | MQC, KMY | LQZ, LRK | and Reference #2: no |
| Class: | II | II | II | II | differences |
| Submitter: | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | KeyStone Industries | Biotex, Inc. | N/A |
| Indications for
Use: | indicated to reduce
snoring and mild to
moderate obstructive
sleep apnea (OSA) in
patients 18 years of age
or older. EndSnorZ
Sleep Appliance is worn
while sleeping to support
the lower jaw in a forward
position prescribed by the
dentist. The appliance is
removable by the patient. | indicated to reduce
snoring and mild to
moderate obstructive
sleep apnea (OSA) in
patients 18 years of age
or older. Silent Nite® sl is
worn while sleeping to
support the lower jaw in a
forward position
prescribed by the dentist.
The appliance is
removable by the patient. | indicated for the
fabrication of
orthodontic and
dental appliances
such as
mouthguards,
nightguards, splints
and repositioners. | is for use to reduce
night-time snoring
and mild to moderate
obstructive sleep
apnea (OSA) in
adults. | New device, Predicate,
and Reference #2: no
differences.
Reference #1: may be
used during sleep, but
not for use to reduce
snoring or OSA. |
| Method of Use: | Single patient user,
removable and
reusable appliance | Single patient user,
removable and
reusable appliance | Single patient user,
removable and
reusable appliance | Single patient user,
removable and
reusable appliance | None |
| Rx or OTC | Rx | Rx | Rx | Rx | None |
| Environment | During sleep at home or
in sleep laboratory | During sleep at home or
in sleep laboratory | During sleep at home | During sleep at home | As noted |
| DESIGN: | | | | | |
| Rigid Trays | Upper and lower | Upper and lower | Upper and lower | Upper and lower | None |
| Adjustable | Yes | Yes | Yes | Yes | None |
| MATERIALS: | | | | | |
| Splints/Trays | Methacrylate-based light-
cured polymer resin used
to additively manufacture
splints. | Polyurethane or PETG
heat-sensitive materials
used to manufacture splints | Methacrylate-based
light-cured polymer
resin used to
additively
manufacture splints. | Methacrylate-based
light-cured polymer
resin used to
additively
manufacture splints | Materials & fabrication
method is different
compared to predicate
but identical to Ref #1
and similar to Ref #2. |
| Advancement
mechanism | Synthetic polymer nylon | Synthetic polymer nylon | N/A | Synthetic
polycarbonate | Compared to Predicate
same material type but
from difference sources,
both are manufactured
by injection molding
methods. |
| PHYSICAL
PROPERTIES: | | | | | |
| Connector
adjustment range: | 20.5mm to 26mm | 21mm to 26mm | N/A | N/A | Similar as noted |
| Maximum
adjustment: | 5.5mm; increments of
0.5 mm | 5.0 mm; increments of
1.0mm | N/A | N/A | Similar as noted |
| Total achievable
mandibular
advancement: | Approximately 10mm | Approximately 10mm | N/A | N/A | Similar as noted |
| STERILITY | Non-sterile | Non-sterile | Non-sterile | Non-sterile | None |
| BIOCOMPATIBLE | All materials meet
requirements of ISO
10993 | All materials meet
requirements of ISO 10993 | All materials meet
requirements of ISO
10993 | All materials meet
requirements of ISO
10993 | None |
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