(264 days)
No
The device description and performance studies focus on mechanical design and physical properties, with no mention of AI/ML algorithms or data processing.
Yes
The intended use of the ZQuiet Advance is to reduce snoring, which is a medical condition, making the device a therapeutic device.
No
Explanation: The device description clearly states its purpose is to reduce snoring by advancing the lower jaw, which is a treatment or therapy, not a diagnostic function. There is no mention of it identifying, detecting, or measuring a medical condition.
No
The device description clearly details a physical intraoral appliance made of rigid plastic and thermal impression material, designed to be placed in the mouth. It is not a software-only device.
Based on the provided information, the ZQuiet Advance is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to aid in the reduction of snoring by physically advancing the lower jaw. This is a mechanical action within the body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical appliance that is placed in the mouth to alter the position of the jaw. It does not involve any reagents, assays, or analysis of biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of substances in biological samples
- Diagnosis, monitoring, or screening of diseases or conditions based on laboratory tests
The ZQuiet Advance is a medical device, specifically an intraoral appliance, but its function and intended use fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
"ZQuiet Advance is intended as an aid in the reduction of snoring for adults at least 18 years old."
Product codes
LRK
Device Description
"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."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth, lower and upper jaw
Indicated Patient Age Range
"adults at least 18 years old"
Intended User / Care Setting
Home use, during sleep.
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 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. No clinical testing was performed in association with this submission."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.”
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)
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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.