RADx Intraoral Appliance for Snoring and Sleep Apnea

{0}------------------------------------------------ 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 12, 2023 Achaemenid LLC % Joseph Azary Regulatory Consultant Aztech Regulatory & Quality LLC 543 Long Hill Avenue Shelton, Connecticut 06484 Re: K230532 Trade/Device Name: RADx Intraoral Appliance for Snoring and Sleep Apnea 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: LQZ, LRK Dated: June 15, 2023 Received: June 22, 2023 Dear Joseph Azary: 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. {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about 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. # Michael E. Adjodha # -5 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230532 ### Device Name RADx Intraoral Appliance for Snoring and Sleep Apnea Indications for Use (Describe) Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults. Type of Use (Select one or both, as applicable) ري Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. Page 4-1 {3}------------------------------------------------ K230532 Image /page/3/Picture/1 description: The image shows a black and white emblem. The emblem features a bird with outstretched wings, a sun above its head, and two swords crossed below. The bird has a geometric pattern on its chest, and the swords have snakes wrapped around them. # 510(k) Summary ACHAEMENID RADx INTRAORAL APPLIANCE FOR SNORING & SLEEP APNEA # 1. SUBMITTER/510(K) HOLDER Achaemenid LLC 2318 Main Street Stratford, CT 06615 Contact Name: Joseph Azary (Aztech Regulatory & Quality LLC) Email: jazary@erols.com Telephone: (203) 242-6670 Date Prepared: February 23, 2023 #### 2. DEVICE NAME | Proprietary Name: | RADx Intraoral Appliance for Snoring and Sleep Apnea | |------------------------------|--------------------------------------------------------------| | Common/Usual Name: | Intraoral Devices for Snoring and Obstructive Sleep<br>Apnea | | Classification Name: | Intraoral Devices for Snoring and Obstructive Sleep<br>Apnea | | Classification Regulation: | 21 CFR 872.5570 | | Classification Product code: | LQZ | | Subsequent Product Code: | LRK | | Classification: | Class 2 | | Medical Specialty (Panel): | Dental | #### 3. PREDICATE DEVICES - Primary Predicate Device - Slow Wave DS8, 510(k) K191320 - Reference Predicate Device Panthera Anti-Snoring Device, 510(k) K143244 ● {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a black and white emblem featuring an eagle-like bird with outstretched wings. Above the bird's head is a radiant sun-like symbol. Below the bird, there are two caduceus symbols, each with a staff entwined by two snakes and topped with wings. The bird has a patterned chest, and the overall design appears to be a stylized or heraldic representation. #### 4. DEVICE DESCRIPTION The RADx White Night and RADx White Night-p Intraoral Appliance for Snoring and Mild to Moderate Sleep Apnea are removable intraoral devices used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two custom fabricated adjustable rods 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 pharyngeal space, improving their ability to exchange air during sleep. The device is a prescription device 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 device can be adjusted only by the user and / or the dentist in increments of 0.5 mm. The custom oral appliance is checked for proper and comfortable fit as well as the appropriate initial progressive arm attachment. The dentist will provide the patient with subsequent progressive arms from 1.0 mm up to 5.0mm in 0.5mm increments. There are 9 different arms each identified with a number for each side of the jaw. The arms are also identified as either "L" for left or "R" for right. # Variants / Configurations There are two variants of the device. The RADx White Night has removable progressive arms with the female housing active as the receptacle for the arms. The RADx White Night-p was designed with the upper housing and arm as one piece. In this version, the fixed upper tray-arm combination are the progressive parts of the entire apparatus. #### 5. INTENDED USE Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a black and white emblem with an eagle-like bird in the center. Above the bird's head is a radiant sun symbol. The bird is flanked by stylized wings, and below it are two crossed staffs entwined with snakes, resembling caducei. The overall design has a symmetrical and heraldic appearance. #### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6. The subject device has the same intended use, materials and operating principles as the predicate devices. Additionally, the differences in technological characteristics do not raise new questions of safety or effectiveness. Therefore, based on the substantial equivalence evaluation, the company concludes that the subject device is equivalent to the predicate devices. #### 7. PERFORMANCE TESTING The following standards were either used as a reference and/or for testing of the subject device: - . Cytotoxicity Testing per ISO 10993-5 Biological Evaluation of Medical Devices - Part 5: Tests for in vitro Cytotoxicity. - Intracutaneous Irritation Testing per ISO 10993-10 Biological Evaluation of . Medical Devices - Part 10: Tests for Irritation and Skin Sensitization. - Sensitization Testing per ISO 10993-10 Biological Evaluation of Medical ● Devices - Part 10: Tests for Irritation and Skin Sensitization. - Systemic Toxicity Testing per ISO 10993-11 Biological Evaluation of Medical . Devices - Part 11: Tests for Systemic Toxicity. - . Pyrogen Testing per United States Pharmacopeia 43, Formulary 38, General Chapter <151>, Pyrogen Test. - Genotoxicity Testing per ISO 10993-3 Biological Evaluation of Medical Devices . - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity. - Acute Systemic Toxicity per United States Pharmacopeia 35, Biological . Reactivity Tests, In Vivo - . Implantation per United States Pharmacopeia 35, Biological Reactivity Tests, In Vivo {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a black and white emblem. The emblem features a bird with outstretched wings, a sun above its head, and two staffs with snakes intertwined at the bottom. The bird has a triangular pattern on its chest. The sun has rays emanating from it. # Summary of Testing | Standard | Description of Test | Results | |----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | ISO 10993-5 (2009)<br>Cytotoxicity<br>BioMed Clear and<br>dental LT Clear V2<br>Resins | Biological Evaluation of Medical<br>Devices - Part 5: Tests for in vitro<br>cytotoxicity<br>ISO Elution Method | Non-Cytotoxic | | ISO 10993-5 (2009)<br>Cytotoxicity<br>BioMed Clear and<br>dental LT Clear V2<br>Resins | Biological Evaluation of Medical<br>Devices - Part 5: Tests for in vitro<br>cytotoxicity<br>MTT Cytotoxicity Test | No cytotoxic potential | | ISO 10993-10 (2010)<br>Sensitization<br>BioMed Clear and<br>dental LT Clear V2<br>Resins | Biological Evaluation of Medical<br>Devices - Part 10: Tests for irritation<br>and skin sensitization<br>ISO Guinea Pig Maximization<br>Sensitization Study | Non-sensitizer | | ISO 10993-10 (2010)<br>Irritation<br>BioMed Clear and<br>dental LT Clear V2<br>Resins | Biological Evaluation of Medical<br>Devices - Part 10: Tests for irritation<br>and skin sensitization<br>USP Intracutaneous Study in Rabbits | Non-Irritant | | ISO 10993-10 (2010)<br>Irritation<br>BioMed Clear and<br>dental LT Clear V2<br>Resins | Biological Evaluation of Medical<br>Devices - Part 10: Tests for irritation<br>and skin sensitization<br>ISO Oral Mucosal Irritation Study in<br>Hamsters 14 day | Non-Irritant | | USP 88<br>Acute Systemic Toxicity<br>BioMed Clear and<br>dental LT Clear V2<br>Resins | United States Pharmacopeia 35,<br>Biological Reactivity Tests, In Vivo<br>Acute Systemic Toxicity | No evidence of systemic toxicity | | USP 88<br>Implantation<br>BioMed Clear and<br>dental LT Clear V2<br>Resins | United States Pharmacopeia 35,<br>Biological Reactivity Tests, In Vivo<br>Modified USP Muscle Implantation<br>Study in Rabbits - 7 day | Macroscopic reaction was not significant as<br>compared to the negative control article. | | ISO 10993-11 (2017)<br>Systemic Toxicity<br>BioMed Clear and<br>dental LT Clear V2<br>Resins | Biological Evaluation of Medical<br>Devices - Part 11: Test for systemic<br>toxicity | Non-Toxic | | USP 43, National<br>Formulary 38, General<br>Chapter <151> (2020)<br>Pyrogen Test | Pyrogen Test | Absence of Pyrogens | | BioMed Clear and<br>dental LT Clear V2<br>Resins | | | | ISO 10993-3 (2003)<br>Genotoxicity<br>BioMed Clear and<br>dental LT Clear V2<br>Resins | Biological Evaluation of Medical<br>Devices - Part 3: Tests for<br>genotoxicity, carcinogenicity and<br>reproductive toxicity | Non-Mutagenic | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a black and white emblem or logo. At the center is a stylized eagle with outstretched wings. Above the eagle is a radiant sun or halo-like symbol. The eagle's body has a geometric pattern. Below the eagle are two crossed staffs, each entwined with snakes, resembling caduceus symbols. The overall design appears to be symbolic and possibly related to medicine or healing. # 8. SAFETY AND EFFICACY Biocompatibility: A biocompatibility assessment of the device was performed. The purpose of the biocompatibility assessment was to ensure that biocompatibility had been established for the device. The device is biocompatible, based on the identical use of materials of construction of the predicate devices. Clinical Testing: Human clinical studies were not deemed necessary to evaluate the safety or effectiveness of the subject device. The subject device uses similar designs as the predicate devices, uses identical materials, had same indications for use, and equivalent technological characteristics. Risks: As with the predicate devices, the subject device can have risks for dental or soft tissue soreness, TMJ dysfunction, obstruction to oral breathing, dental movement or changes in dental occlusion. The Instructions for Use include warnings, precautions and contraindications to address such risks. The device is manufactured using the same equipment and same materials as the predicate devices. ## 9. CONCLUSION Information presented supports substantial equivalence of the RADx Intraoral Appliance for Snoring and Sleep Apnea to the predicate devices based on similarities in intended use, design, principles of operation, material composition and performance specifications. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows a black and white emblem featuring an eagle-like bird with outstretched wings. Above the bird's head is a radiant sun-like symbol. Below the bird, there are two caduceus symbols, each with a staff entwined by two snakes and topped with wings. The bird has a patterned chest, and the overall design appears to be a stylized or heraldic representation. Achaemenid LLC believes that based on the indications for use, technological characteristics, and comparison to predicate devices the RADx Intraoral Appliance for Snoring and Sleep has been shown to be substantially equivalent to the predicate and is safe and effective for its intended use.