Who is the manufacturer of ZQuiet Advance?

Sleeping Well, LLC filed the 510(k) submission for ZQuiet Advance (K213088).

What is the FDA product code for ZQuiet Advance?

LRK. It is classified under 21 CFR 872.5570 as a Class 2 device in the Dental panel.

What is the regulatory pathway for ZQuiet Advance?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ZQuiet Advance?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ZQuiet Advance

K213088 · Sleeping Well, LLC · LRK · Jun 15, 2022 · Dental

Device Facts

Record ID	K213088
Device Name	ZQuiet Advance
Applicant	Sleeping Well, LLC
Product Code	LRK · Dental
Decision Date	Jun 15, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.5570
Device Class	Class 2
Attributes	Therapeutic

Intended Use

ZQuiet Advance is intended as an aid in the reduction of snoring for adults at least 18 years old.

Device Story

ZQuiet Advance is an intraoral mandibular advancement device (MAD) for home use during sleep to reduce snoring. The device consists of separate upper and lower dental trays constructed of a rigid plastic outer shell lined with thermal impression material. Users perform a 'boil-and-bite' procedure to customize the fit to their dentition. The trays are connected by semi-rigid side straps that allow for three positions of mandibular advancement (up to +6 mm). By protruding the lower jaw, the device widens the upper airway to decrease air turbulence. The device is reusable and intended for a single user. It is operated by the patient without physician intervention.

Clinical Evidence

No clinical testing was performed. Evidence is based on non-clinical bench testing (strap compression, physical properties) and a Human Factors Evaluation to mitigate risks associated with critical tasks.

Technological Characteristics

Materials: Polypropylene, Ethylene Vinyl Acetate Copolymer, Acetal Homopolymer. Principle: Mandibular advancement via semi-rigid straps. Form factor: Two-piece intraoral tray system. Customization: Boil-and-bite thermal resin. Biocompatibility: Meets ISO 10993-1 for mucosal membrane contact (>24h to 30 days). Sterility: Non-sterile.

Indications for Use

Indicated for adults at least 18 years old as an aid in the reduction of snoring.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

PureSleep OTC (K190058)

Reference Devices

ZQuiet OTC (K180124)

Related Devices

K090503 — ZQUIET MOUTHPIECE · Sleeping Well, LLC · Mar 10, 2009
K093407 — ZQUIET MOUTHPIECE · Sleeping Well, LLC · Jun 22, 2010
K231138 — Aniti-Snore Mouthguard+ · Oscimed SA · Jan 16, 2024
K220688 — SilentZPro 2.0 · Shinrin-Yoku Traders, LLC · Dec 2, 2022
K250122 — SleepRight Snore Aid · Splintek, Inc. · May 19, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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. June 15, 2022 Sleeping Well, LLC % William McLain President Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 Leola, Pennsylvania 17540 Re: K213088 Trade/Device Name: ZQuiet Advance Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea Regulatory Class: Class II Product Code: LRK Dated: May 13, 2022 Received: May 16, 2022 Dear William Mclain: 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, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213088 Device Name ZQuiet Advance Indications for Use (Describe) ZQuiet Advance is intended as an aid in the reduction of snoring for adults at least 18 years old. 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ #### 3 510(K) Summary - ZQuiet Advance - K213088 #### 3.1 Submission Owner Mr. Daniel Webster Vice President Sleeping Well, LLC PO Box 1240 Shelburne, VT 05482 Phone: (802) 985-3013 Email: dan@ZQuiet.com #### 3.2 Submission Correspondent Mr. William G. McLain President and Principal Consultant Keystone Regulatory Services, LLC 342 E. Main Street Suite 207 Leola, PA 17540 Phone: (717) 656-9656 Email: bill.mclain@keystoneregulatory.com #### 3.3 Date Summary Prepared September 23, 2021 #### Device Trade Name 3.4 ZQuiet Advance #### 3.5 Device Common Name Intraoral Device for Snoring #### 3.6 Device Classification Name Device, Anti-Snoring, 21 CFR 872.5570, LRK, Class II ### 3.7 Legally Marketed Device To Which The Device Is Substantially Equivalent - · Predicate Device PureSleep OTC cleared under K190058 - · Reference Device ZQuiet OTC cleared under K180124 {4}------------------------------------------------ #### 3.8 Description Of The Device The ZQuiet Advance is an intraoral appliance designed to reduce snoring by advancing the lower jaw. The principal effect of mandibular advancement devices is the protrusion of the lower jaw, thereby widening the upper airway to decrease air turbulence, a causative factor in snoring. This device combines several essential functions: Separate upper and lower dental trays with thermal impression material to engage the upper and lower dentition, a mechanism to provide the forward positioning of the lower jaw relative to the upper jaw in 3 positions determined by the user's bite providing up to +6 mm of possible advancement. The design allows the maintenance of the forward positioning of the lower jaw while allowing minor sagittal and vertical movement. The ZQuiet Advance is a "Boil-and-Bite" device that uses thermal impression resin for device retention. The upper and lower trays are both constructed out of a rigid plastic outer tray to provide the device structure and attachment points for the connecting semi-rigid straps that provide the adjustability. Both the upper and lower trays are lined with material that is moldable when heated in a water bath and provides the ability to conform the device to the individual's teeth. #### 3.9 Indication for Use ZQuiet Advance is intended as an aid in the reduction of snoring for adults at least 18 years old. #### 3.10 Technological Characteristics The proposed ZQuiet Advance has identical technical characteristics to the PureSleep OTC cleared under K190058. Table 1 below summarizes the overall technological characteristics between the proposed, predicate, and reference devices. {5}------------------------------------------------ | Feature | Proposed - ZQuiet (K213088) | Device Predicate - PureSleep OTC (K190058) | Reference - ZQuiet OTC (K180124) | Device Comments on Sim- ilarities and Differ- ences | |-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Proprietary Name | ZQuiet Advance | PureSleep OTC | ZQuiet OTC | Not applicable | | Manufacturer | Sleeping Well, LLC | Sleep Science Partners, Inc. | Sleeping Well, LLC | Not applicable | | 510(k) Number | K213088 | K190058 | K180124 | Not applicable | | Classification Regulation | 21 CFR 872.5570 | 21 CFR 872.5570 | 21 CFR 872.5570 | The classification regulation is identical among the proposed, predicate, and reference devices. | | Classification Name | Intraoral Device for Snoring and Obstructive Sleep Apena | Intraoral Device for Snoring and Obstructive Sleep Apena | Intraoral Device for Snoring and Obstructive Sleep Apena | The classification name is identical among the proposed, predicate, and reference devices. | | Labeling | | | | | | Indications for Use | Intended as an aid in the reduction of snoring for adults at least 18 years old. | Indicated for use for adults 18 years and above as an aid in the reduction of snoring during hours of sleep. | Intended as an aid in the reduction of snoring for adults at least 18 years old. | There are minor definitions in wording of the indication for use, however, they are all indicated for the reduction of snoring in adults 18 years and above. | | Feature | Proposed - ZQuiet (K213088) | Predicate - PureSleep (K190058) | Reference - ZQuiet (K180124) | Comments on Similarities and Differences | | Rx or OTC | OTC | OTC | OTC | The proposed, predicate, and reference devices are all indicated for OTC use. | | Patient Population | Adults | Adults | Adults | There are no differences among the proposed, predicate, and reference device related to the patient population. They are all indicated for adult use. | | Labeling | Language, visuals and structure are based on FDA guidance documents and closely resemble the predicate device labeling for which an HFE/UE study was conducted concluding that the device is clinically safe for OTC use. | Language, visuals and structure are based on FDA guidance documents and designed for OTC use. An HFE/UE study supported the conclusion that the device is clinically safe for OTC use. | Labeling designed for OTC use with the same contraindications and warnings. | The instructions for use are similar among the proposed, predicate, and reference devices in that they all are formatted for OTC use and contain instructions, contraindications, warning, precautions, and instructions for sizing and fitting the device. They differ in the particulars associated with assembly of the respective products. | | Feature | Proposed Device ZQuiet Advance (K213088) | Predicate Device PureSleep OTC (K190058) | Reference Device ZQuiet (K180124) | Comments on Sim- ilarities and Differ- ences | | Clinical Condi- tions Impacting Safe and Effec- tive Use | Presence of: loose restorations, missing an- terior or posterior teeth, malocclusion, undercuts, limited fine motor skills, central sleep apnea, any severe respiratory disor- der, history of jaw pain or temporomandibular disorder (TMD), loose, sore or damaged teeth, loose caps, dental im- plants withing the last 3 months, orthodontia or dentures, sore or bleeding gums, advanced periodontal disease. Use under 18 years of age. | Presence of: central sleep apnea, chronic asthma, emphysema, COPD or any other serious breath- ing or respiratory disor- der; loose, damaged or weakened teeth, loose or damaged fillings or caps; abscess, mouth sores, bleeding gums or severe gum disease; dental im- plant within the last 3 months, braces, full den- tures or sleep using an- other dental appliance; diagnosis of temporo- mandibular joint disor- der (TMD), symptoms of TMD such as clicking, popping, grating or lock- ing of your jaw or jaw pain when you open your mouth, yawn or chew; jaw or tooth pain from clenching your jaw or grinding your teeth. Use under 18 years of age. | Not included as the ref- erence device is not in- cluded for a labeling comparison. | Both the proposed and predicate devices con- tain references to loose restorations, missing an- terior or posterior teeth, malocclusion, undercuts, central sleep apnea, any severe respiratory disor- der, history of jaw pain or temporomandibular disorder (TMD), loose, sore or damaged teeth, loose caps, dental im- plants withing the last 3 months, orthodontia or dentures, sore or bleeding gums, advanced periodontal disease. Use under 18 years of age. The predicate device does not mention the presence of malocclu- sions, undercuts, or limited fine motor skills. | | Feature | Proposed ZQuiet Advance (K213088) | Predicate PureSleep OTC (K190058) | Reference ZQuiet OTC (K180124) | Comments on Similarities and Differences | | | | Technology | | | | Mode of Action | Mandibular advance- ment to increase pharyn- geal space to alleviate snoring. | Mandibular advance- ment to increase pharyn- geal space to alleviate snoring. | Mandibular advance- ment to increase pharyn- geal space to alleviate snoring. | There are no difference among the proposed, predicate, and refer- ence devices related to mode of action. They are all mandibular advancement devices. | | Environment | Home use, during sleep. | Home use, during sleep. | Home use, during sleep. | There are no difference among the proposed, predicate, and reference devices related to the environment of use. They are all for home use during sleep. | | Placement of Device | In the mouth, on the lower and upper jaw. | In the mouth, on the lower and upper jaw. | In the mouth, on the lower and upper jaw. | There are no difference among the proposed, predicate, and reference devices related to the placement of the device. They are all placed in the mouth, on the lower and upper jaw. | Table 1: Substantial Equivalence Table {6}------------------------------------------------ Table 1: Substantial Equivalence Table {7}------------------------------------------------ Table 1: Substantial Equivalence Table {8}------------------------------------------------ Table 1: Substantial Equivalence Table {9}------------------------------------------------ | Feature | Proposed - ZQuiet Advance (K213088) | Predicate - PureSleep OTC (K190058) | Reference - ZQuiet OTC (K180124) | Device OTC | Comments on Similarities and Differences | |-------------------------|-------------------------------------------------|-------------------------------------------------|--------------------------------------------------------------|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Preparation / Set-Up | Connect upper and lower parts per bite type. | Connect upper and lower parts per bite type. | None. Prefabricated mouthpiece selected per bite type. | | Both the proposed and predicate device consist of separate upper and lower trays that are connected based on the bite type. See comments on Design below for additional details. The reference device is dissimilar to proposed device in that the top and bottom trays arrive at the customer in once piece. Bite type directs the user to select a properly dimensioned mouth piece. There is no assembly for the reference device. | Table 1: Substantial Equivalence Table {10}------------------------------------------------ | Feature | Proposed - ZQuiet (K213088) | Predicate - PureSleep (K190058) | Reference - ZQuiet (K180124) | Device OTC | Device OTC | Comments on Similarities and Differences | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|------------|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Molding / Fit- ment | Custom impression to each individual's mouth using a "boil and bite" approach and thermal setting (heat sensitive) resins. | Custom impression to each individual's mouth using a "boil and bite" approach and thermal setting (heat sensitive) resins. | None. | | | The proposed and predicate device are identical in terms of the method to fit the device to the user. They both rely on a "boil-and-bite" method where resin is softened via heating and and an impression is made based on the user biting into the soft material. The reference device differs from the proposed de- vice in that the reference device does not require molding. The device size is selected based on the user's bite type. | Table 1: Substantial Equivalence Table {11}------------------------------------------------ | Feature | Proposed - ZQuiet (K213088) | Predicate - PureSleep Device OTC (K190058) | Reference - ZQuiet Device OTC (K180124) | Comments on Similarities and Differences | |---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Design | Consists of upper and lower trays, each with a rigid outer shell with the tray of the shell lined with thermal impression material that allows for customer fitting. The thermal impression material mates with the anterior teeth. Trays are connected by semi-rigid side straps that are used to determine the amount of mandibular advancement. | Consists of upper and lower trays, each with a rigid outer shell withe the tray of the shell lined with thermal impression material that allows for customer fitting. Trays are connected by inter-locking pins and holes the with the pin/hole selection determining the amount of mandibular advancement. | Consists of upper and lower non-custom open trays connected by a resilient hinge. | Both the proposed and predicate devices consist of upper and lower trays. They differ in that the proposed device only has impression material to mate with the posterior teeth. They also differ in the method of connection. The proposed device uses straps with lengths selected based on bite types. The predicate device uses notches selected based on bite types. The reference device requires no adjustment since the entire device is a singe piece and size is selected based on bite type. | Table 1: Substantial Equivalence Table {12}------------------------------------------------ | Feature | Proposed - ZQuiet (K213088) | Predicate - PureSleep (K190058) | Reference - ZQuiet (K180124) | Comments on Similarities and Differences | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Adjustments | Adjustable jaw advancement positions based on bite type. Adjustably positions the mandible forward in three positions up to +6 mm maximum advancement. | Adjustable jaw advancement positions based on bite type. Adjustably positions the mandible forward in three positions. | Mouthpiece with 2 varying levels of advancement selected per bite type. Similar jaw advancement levels up to +6 mm maximum advancement. | While the methods of adjustment differ based on the Design table entry above, the range of adjustment among the proposed, predicate, and reference devices is the same in that up to 6 mm of advancement is available. | | Single Use / Reusable | Single user, multi-use. | Single user, multi-use. | Single user, multi-use. | There are no differences among the proposed, predicate, and reference devices related to use/reuse. They are all reusable for a single user. | Table 1: Substantial Equivalence Table {13}------------------------------------------------ | Feature | Proposed - ZQuiet Device Advance (K213088) | Predicate - PureSleep Device OTC (K190058) | Reference - ZQuiet Device OTC (K180124) | Comments on Similarities and Differences | |-----------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Cleaning Instructions | Clean/rinse daily with toothbrush and tooth- paste or with oral appli- ance cleaning solution. | Clean/rinse daily with toothbrush and tooth- paste or with efferves- cent oral device cleaning tablets. | Clean/rinse daily with toothbrush and tooth- paste or with oral appli- ance cleaning solution. | The proposed, predicate, and reference devices are all similar in that instructions for daily cleaning are provided. Additionally, they all recommend the use of a toothbrush and tooth- paste. Regarding the use of cleaning solutions, the proposed and reference devices are identical in their recommendation. The proposed and pred- icate devices differ only in the recommended use of cleaning tablets for the predicate device. | | Sterility | Non-sterile | Non-sterile | Non-sterile | The proposed, predicate, and reference devices are identical regarding steril- ity status. They are all non-sterile. | Table 1: Substantial Equivalence Table {14}------------------------------------------------ | Feature | Proposed - ZQuiet (K213088) | Device Advance | Predicate - PureSleep (K190058) | Device OTC | Reference - ZQuiet (K180124) | Device OTC | Comments on Similarities and Differences | |------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Materials | Polypropylene, Ethylene Vinyl Acetate Copolymer, and Acetal Homopolymer | | Polypropylene homopolymer and ethylene vinyl acetate copolymer | | Thermoplastic elastomer | | The material among the proposed, predicate, and reference devices are different. They are similar in that they have all been selected based on providing a device that facilitates meeting its intended use. | | Biocompatibility | Meets ISO 10993-1 for a surface device contacting mucosal membrane for a prolonged contact duration (>24h to 30 days): cytotoxicity, sensitization and irritation. Material testing provided by the device manufacturer. | | Meets ISO 10993-1 for a surface device contacting mucosal membrane for a prolonged contact duration (>24h to 30 days): cytotoxicity, sensitization and irritation. The source of the biocompatibility data is unknown. | | Meets ISO 10993-1 for a surface device contacting mucosal membrane for a prolonged contact duration (>24h to 30 days): cytotoxicity, sensitization and irritation. Material testing provided by the device manufacturer. | | The proposed, predicate, and reference devices are similar in that testing was presented that demonstrated the materials are biocompatible for their intended use. The source of testing differs in that the proposed device testing was provided by the material manufacturer where the reference device was provided by the device manufacturer. | Table 1: Substantial Equivalence Table {15}------------------------------------------------ #### 3.11 Non-Clinical Testing Non-clinical testing consisted of strap compression testing, physical properties testing, and a Human Factors Evaluation. The results of compression testing of the straps used to support the advancement of the mandible were compared to straps utilized in devices with a similar design. Physical properties testing was conducted by the material manufacturer. The Human Factors Study concluded that the identified risks associated with critical tasks were adequately mitigated. #### 3.12 Biocompatibility Biocompatibility testing was conducted by the device manufacturer and was demonstrated to meet the requirements described in the guidance "Use of International Standard ISO 10993-1. 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", Dated September 4, 2020 for mucosal membrane contacting devices with permanent duration. #### 3.13 Clinical Testing No clinical testing was performed in association with this submission. #### 3.14 Conclusions The results of the comparison of design, labeling, materials, intended use and technological characteristics demonstrate that the proposed ZQuiet Advance is as safe and effective as the legally marketed predicate devices. Therefore, Sleeping Well, LLC concludes that the proposed ZQuiet Advance is as safe and effective as, and therefore substantially equivalent to, the identified predicate devices.