(156 days)
No
The summary describes a mechanical oral appliance for treating sleep apnea and snoring. There is no mention of AI, ML, image processing, or any software-based analysis or decision-making. The device's function is purely mechanical.
Yes
The device is intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA), which are medical conditions, by directly interacting with the user's anatomy (guiding the mandible forward) to achieve a therapeutic outcome.
No
Explanation: The device is described as an appliance intended to treat snoring and sleep apnea by guiding the mandible forward, not for diagnosing these conditions.
No
The device description clearly outlines a physical, customized oral appliance made of acrylic and laminate, with mechanical components (trays, interlocking system, adjustable hinge, Herbst Telescopic Hardware). It is a hardware device, not software.
Based on the provided information, the Emerald Herbst appliance is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) by physically repositioning the mandible. This is a therapeutic intervention, not a diagnostic one.
- Device Description: The device is a physical oral appliance designed to alter the anatomical position of the jaw. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
- Lack of Diagnostic Function: The description focuses on the mechanical function of the device in maintaining an open airway. There is no mention of it analyzing biological samples or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples from the human body to provide information about a person's health status. The Emerald Herbst appliance does not fit this description.
N/A
Intended Use / Indications for Use
The Emerald Herbst appliance is intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adults 18 years of age or older.
Product codes
LRK, LQZ
Device Description
The Emerald Herbst appliance is a customized oral device featuring both lower and upper trays and interlocking system. The product is non-sterile, biocompatible, and provided in a sealed box with instructions for use and an adjustment screw. The upper and lower trays are connected by an adjustable hinge allowing the patient to open and close the mouth while wearing the appliance. The Herbst Telescopic Hardware on the side of the device allows the patient to move forward and left and right but not backwards. This freedom of movement is important for comfort and overall success of the device.
The Emerald Herbst appliance is intended to treat snoring and mild to moderate sleep apnea (OSA) in adults 18 years of age or older by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway.
The Emerald Herbst is offered in two options:
- Hard devices which are all acrylic and retained with ball clasps that allow the device to be tightened if it becomes loose.
- Hard / Soft which has a laminate layer that provides a soft layer on the tooth surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandible, mouth, pharyngeal space.
Indicated Patient Age Range
adults 18 years of age or older
Intended User / Care Setting
Intended for use at home or sleep labs.
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)
Performance Testing: The Emerald Herbst is equivalent to the predicate device, Pink Series, as it uses all the same materials, same manufacturing procedure and same manufacturer. Therefore, no mechanical testing was conducted to establish equivalence. The Emerald Herbst was subjected to pre and post accelerated aging test measured by deflection strength. Aging did not decrease the strength of the device.
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 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".
May 10, 2023
Island Dental Lab, Inc dba Emerald Dental % Colette Cozean, Phd Regulatory Consultant The EyeDeas Company 21581 Midcrest Dr. Lake Forest, California 92630
Re: K223624
Trade/Device Name: Emerald Herbst 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, LQZ Dated: November 30, 2022 Received: December 5, 2022
Dear Colette Cozean, Phd:
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.
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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 -2
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
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Indications for Use
510(k) Number (if known) K223624
Device Name Emerald Herbst
Indications for Use (Describe)
The Emerald Herbst appliance is intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adults 18 years of age or older.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(k) Summary
| Applicant: | Island Dental Lab, Inc dba Emerald Dental Lab
76 S. Central Ave., # 1D
Valley Stream, NY, 11580
516-327-0810
347-522-9800 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Colette Cozean, PhD
21581 Midcrest Drive
Lake Forest, CA 92630
(949) 855-2885
colettecozean@gmail.com |
| Date Prepared | August 15, 2022 |
| Proprietary Name | Emerald Herbst Appliance (Hard and Hard/Soft) |
| Common Name | Device, Snoring and Mild to Moderate Obstructive Sleep Apnea |
| Classification Name | Intraoral devices for snoring; intraoral devices for snoring and obstructive sleep apnea
(Class II, 21 CFR872.5570, Product Code LRK and LQZ) |
| Primary Predicate Device | Respire Pink Series with DentiTrac(K170692) refers to Herbst ( (K131138),
Respire Pink Series – Herbst EF (K150572) |
| Reference Device | Dent-O-Cryl Orthodontic Acrylic (K942667) is used to justify the
use of a different color. Emerald Dental certifies that the Herbst
Emerald Device uses the following identical materials found in
the Respire Pink Series: |
Description: The Emerald Herbst appliance is a customized oral device featuring both lower and upper trays and interlocking system. The product is non-sterile, biocompatible, and provided in a sealed box with instructions for use and an adjustment screw. The upper and lower trays are connected by an adjustable hinge allowing the patient to open and close the mouth while wearing the appliance. The Herbst Telescopic Hardware on the side of the device allows the patient to move forward and left and right but not backwards. This freedom of movement is important for comfort and overall success of the device.
The Emerald Herbst appliance is intended to treat snoring and mild to moderate sleep apnea (OSA) in adults 18 years of age or older by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway.
The Emerald Herbst is offered in two options:
- Hard devices which are all acrylic and retained with ball clasps that allow the device to be tightened if 1. it becomes loose.
-
- Hard / Soft which has a laminate layer that provides a soft layer on the tooth surface.
These two options are also available in the predicate, Respire Pink Series.
Indications for Use: The Emerald Herbst appliance is intended to treat snoring and mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older. This indication for use is identical to that of the predicate device(s).
Technological Characteristics: The Emerald Herbst appliance consists of upper and lower interlocking, customized trays. The Emerald Herbst appliance is customized on models of the patient's teeth, using standard orthodontic acrylics and standard orthodontic ball clasps for retention. The Emerald Herbst appliance allows for inter1ocking of the upper and lower trays to adjust the mandibular position of the user. The technical characteristics are identical to the predicate devices.
4
Mechanism of Action: All predicate devices (Respire Pink Series) also function as mandibular advancement devices to increase the patient's pharyngeal space and improve the ability to exchange air during sleep. They each have customized upper and lower trays that interlock to advance the mandible. The mechanism of action of the subject device is substantially equivalent to the predicate devices.
Substantial Equivalence Table:
| | | Subject
Device | Primary
Predicate
Device | Included in
Primary
Predicate
Device | Included in
Primary
Predicate
Device | |
|--------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------------|--|
| | | Emerald
Dental | Respire Pink
Series | Respire Pink
Series -
Herbst | Respire Pink
Series -
Herbst EF | |
| | | | K170692 | K131138 | K150572 | |
| Intended Use | | | | | | |
| | Indication for
Use | Intended to
treat snoring
and mild to
moderate
obstructive
sleep apnea
(OSA) in adult
patients 18
years of age
or older | Intended to
treat snoring
and mild to
moderate
Obstructive
Sleep Apnea
(OSA) in adult
patients 18
years of age
or older | Intended to
treat mild to
moderate
OSA | Intended to
treat mild to
moderate
OSA | |
| | Class | II | II | II | II | |
| | Intended as
Intraoral
Device | Yes | Yes | Yes | Yes | |
| | Intended to
reduce snoring | Yes | Yes | Yes | Yes | |
| | Intended to
treat mild to
moderate OSA | Yes | Yes | Yes | Yes | |
| | Intended for
nighttime use | Yes | Yes | Yes | Yes | |
| | Intended for
single patient
multiuse | Yes | Yes | Yes | Yes | |
| | Intended for
use at home
or sleep labs | Yes | Yes | Yes | Yes | |
| | Intended for
adults, 18
years or older | Yes | Yes | Yes | Yes | |
| Design | | | | | | |
| | Customized fit
for each
patient | Yes | Yes | Yes | Yes | |
| | Mechanism of
action:
Mandibular | Yes | Yes | Yes | Yes | |
| | Can be
adjusted or
refit | Yes | Yes | Yes | Yes | |
| | Range of
forward
movement of
mandible | Yes | Yes | Yes | Yes | |
| | Upper & lower
trays
disengage for
easy removal | Yes | Yes | Yes | Yes | |
| | Permits
patient to
breathe
through the
mouth | Yes | Yes | Yes | Yes | |
| | Has tracking
device | No | Yes | No | No | |
| | Cleaned and
inspected daily
by patient | Yes | Yes | Yes | Yes | |
| Materials | | | | | | |
| | Hard surface
material | Yes | Yes | Yes | Yes | |
| | Soft lining
material | No Hard, Yes
Hard/Soft | No Herbst,
Yes Herbst EF | No | Yes | |
| | Advancement
mechanism | Yes | Yes | Yes | Yes | |
| | Advancement
mechanism -
Herbst
telescoping
hinge,
stainless steel | Yes | Yes | Yes | Yes | |
| | Cobalt Chrome
Mesh inside
Acrylic | Yes | Yes | Yes | Yes | |
| Mechanism | | | | | | |
| | Mechanism of
Action | Mandibular
Advancement | Mandibular
Advancement | Mandibular
Advancement | Mandibular
Advancement | |
| | Method of
Positioning the
Mandible | Herbst
Telescoping
Hinge | Herbst
Telescoping
Hinge | Herbst
Telescoping
Hinge | Herbst
Telescoping
Hinge | |
| | Maximum
Amount of
Mandible
Protrusion | 6 mm | 6 mm | 6 mm | 6 mm | |
| Labeling | | | | | | |
| | Prescription
Only | Yes | Yes | Yes | Yes | |
5
6
Clinical and Non-Clinical Data: A biocompatibility and physical properties assessment was completed based on the material composition of the primary predicate, which concluded that the subject device was substantially equivalent to the primary predicate device. A risk assessment has also been conducted with the subject device, which concluded there are no additional risks as compared to the predicate device(s).
Performance Testing: The Emerald Herbst is equivalent to the predicate device, Pink Series, as it uses all the same materials, same manufacturing procedure and same manufacturer. Therefore, no mechanical testing was conducted to establish equivalence. The Emerald Herbst was subjected to pre and post accelerated aging test measured by deflection strength. Aging did not decrease the strength of the device.
Differences: The Emerald Herbst is green unlike the Pink Series, which is pink. Both colors have received premarket approval in K942667 for the reference device, Dent-O-Cryl. This reference device justifies the use of all colors submitted by Dentauraum for Dent-O-Cryl, including the Emerald Herbst green and the Pink Series pink color additives. This 510(k) contains all the information considered by the FDA to determine substantial equivalence, including physical parameters and biocompatibility.
Summary: Based on the intended use, technical characteristics, biocompatibility assessment, labeling and other data provided in this submission, the Emerald Herbst appliance demonstrates substantial equivalence to the predicate devices in both safety and efficacy.