Not Found
No
The description focuses on the mechanical function of the device as a mandibular repositioning appliance and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is intended to treat medical conditions (snoring and obstructive sleep apnea) by repositioning the jaw, which directly impacts a physiological function.
No
The Meridian PM is described as a treatment device (mandibular advancement device) for snoring and obstructive sleep apnea, not a device used to diagnose these conditions. While it is "used in a patient treatment model for specific diagnosis," this implies it's part of a treatment pathway after a diagnosis, not a diagnostic tool itself.
No
The device description explicitly states it consists of two physical parts, an upper and lower appliance, which are custom-fitted trays made of material that undergoes physical and biocompatibility testing. This indicates it is a hardware device, not software-only.
Based on the provided information, the Meridian PM device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults by repositioning the lower jaw. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The description clearly states it's a physical device (mandibular repositioning device) that is custom-fitted and worn by the patient. It acts to increase pharyngeal space and improve air exchange. This is a mechanical/physical treatment, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
In summary, the Meridian PM is a therapeutic medical device used to treat a condition, not a diagnostic device used to identify or characterize a condition through in vitro testing.
N/A
Intended Use / Indications for Use
The Meridian PM is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Product codes (comma separated list FDA assigned to the subject device)
LRK, LQZ
Device Description
The Center for Craniofacial & Dental Sleep Medicine wishes to submit their Anti-Snoring & Sleep Apnea Device(s) trade name, Meridian PM, that falls under FDA Regulation Number §872.5570 and Product Codes LRK and LQZ defined as follows:
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.
The summary report is submitted in accordance with FDA's "Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Sleep Apnea; Guidance for Industry and FDA."
For discussion purposes only, the Meridian PM is a single device consisting of two parts and upper appliance and lower appliance it is collectively known as the Meridian PM : The Meridian PM treats snoring and Obstructive Sleep Apnea (OSA).
The Meridian PM device is used in a patient treatment model for specific diagnosis of simple snoring, and/or Obstructive Sleep Apnea (OSA).
The upper and lower appliances help to reposition the lower jaw such that it is moved to a forward position during sleep.
The Meridian PM system is used for treating snoring and obstructive sleep apnea and consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable vertical wings, or by the industry standard "Herbst mechanism" which is a rod and tube type assembly that orientates the jaws in a predetermined relationship. These device(s) function as a mandibular repositioning or mandibular advancment device (MAD) as Meridian PM acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep, decreasing symptoms of OSA. The devices will be custom made for each patient and allow the dentist or physician to control the degree of mandibular advancement at the time of device(s) will be sold by prescription only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults.
Intended User / Care Setting
Dentist or Physician
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 Performance Data
The Center for Craniofacial and Dental Sleep Medicine completed a number of non-clinical performance tests, including:
- Determination Of Flexural Properties Test Method : ISO 178:2010/Amd.1:2013(E) Method A
- Plane-Strain Fracture Toughness and Strain Energy Release Rate of Plastic Materials Test Method : ASTM D5045 -14 (modified notch geometry)
- Tensile Properties Test Method : ASTM D638-14 - Modified specimen length, test speed and grip separation
The Meridian passed all the testing in accordance with internal requirements, applied national standards, and applied international standards shown below to support substantial equivalence of the subject device:
Biocompatibility - The biological compatibility of the Meridian PM was evaluated in accordance with ISO 10993-1:2009 and guidance document entitled Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing within a Risk Management Process" dated 16 June 2016. Under these, for the stated indications for use, each component of the device's biological compatibility was evaluated for in vitro cytotoxicity, skin sensitization, and chemical characterization.
- Biocompatibility testing per ISO 10993-1: Passed
- Biocompatibility testing per ISO 10993-5 Cytotoxicity: Passed
- Biocompatibility testing per ISO 10993-10 Tests for irritation and skin sensitization: Passed
- Biocompatibility testing per ISO 10993-18 Chemical Characterization: Passed
Risk Analysis - Formal Risk Assessment of the Meridian PM was performed in accordance with ISO 14971. With respect to perceivable conditions in which the device would be subjected to a worst-case environmental or human error scenario, Center for Craniofacial and Dental Sleep Medicine believes the outcomes of these risks are considered acceptable within the context of ISO 14971, and that all potential risks have been mitigated to the lowest form.
Performance Testing Summary
The Meridian PM meets all the requirements for overall design, biocompatibility, and performance testing confirm that the output meets the design inputs and specifications. The Meridian PM passed all testing stated above as shown by the acceptable results obtained. The Meridian PM complies with the applicable voluntary standards for biocompatibility. The device passed all the testing in accordance with national and international standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym in a blue square, followed by the full name "U.S. Food & Drug Administration" in blue text. The text is stacked, with "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below.
The Center for Craniofacial & Dental Sleep Medicine % Cheryl Fisher Prinicipal Consultant FisherMed Consulting LLC 260 Howard Drive, Santa Clara California 95051
November 28, 2017
Re: K170053
Trade/Device Name: Meridian PM 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: October 2, 2017 Received: October 20, 2017
Dear Cheryl Fisher:
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170053
Device Name Meridian PM
Indications for Use (Describe)
The Meridian PM is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Meridian PM
K170053
1. Submission Sponsor
Center for Craniofacial and Dental Sleep Medicine
4545 Sweetwater Blvd.
Sugarland
TX, 77479
United States
Contact: Sam Cress D.D.S.
Title: Director
2. Submission Correspondent
FisherMed Consulting, LLC
820 Civic Center Drive
Santa Clara, CA 95050
Office Phone: (408) 410-5920
Contact: Cheryl Fisher
Title: Principal Consultant, RA/QA
3. Date Prepared
6/15/2017
4. Device Identification
| Trade/Proprietary Name: | Meridian PM |
|---|---|
| Common/Usual Name: | Intraoral Devices for Snoring and/or Obstructive Sleep Apnea |
| Classification Name: | Intraoral Devices for Snoring and/or Obstructive Sleep Apnea |
| Regulation Number: | 872.5570 |
4
Product Code: LRK, Device, Anti Snoring- Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
LQZ, Device, Jaw Repositioning- Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea
Device Class: Class II
Dental Classification Panel:
5. Legally Marketed Predicate Device(s)
Main Predicate K153291 OptiSleep Device by SICAT
Secondary Predicate K113516 CAST device by TheraSom
6. Indication for Use Statement
The Meridian PM is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
7. Device Description
The Center for Craniofacial & Dental Sleep Medicine wishes to submit their Anti-Snoring & Sleep Apnea Device(s) trade name, Meridian PM, that falls under FDA Regulation Number §872.5570 and Product Codes LRK and LQZ defined as follows:
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.
The summary report is submitted in accordance with FDA's "Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Sleep Apnea; Guidance for Industry and FDA."
For discussion purposes only, the Meridian PM is a single device consisting of two parts and upper appliance and lower appliance it is collectively known as the Meridian PM : The Meridian PM treats snoring and Obstructive Sleep Apnea (OSA).
The Meridian PM device is used in a patient treatment model for specific diagnosis of simple snoring, and/or Obstructive Sleep Apnea (OSA).
The upper and lower appliances help to reposition the lower jaw such that it is moved to a forward position during sleep.
5
The Meridian PM system is used for treating snoring and obstructive sleep apnea and consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable vertical wings, or by the industry standard "Herbst mechanism" which is a rod and tube type assembly that orientates the jaws in a predetermined relationship. These device(s) function as a mandibular repositioning or mandibular advancment device (MAD) as Meridian PM acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep, decreasing symptoms of OSA. The devices will be custom made for each patient and allow the dentist or physician to control the degree of mandibular advancement at the time of device(s) will be sold by prescription only.
6
8. Substantial Equivalence Discussion
The following table compares the Meridian PM to the predicate device(s) with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues based on the similarities to the predicate device.
| Feature | Meridian PM | SICAT
OPTISLEEP | TheraSom-CAST | Comparison |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510 (k) Number | K170053 | K153291 | K113516 | Same method |
| Manufacturer | Center for
Craniofacial and
Dental Sleep
Medicine | SICAT GmbH & Co | Family Dental
Service PC | NA |
| Primary Device Similarities to support Substantial Equivalence | | | | |
| Classification # | 872-5570 | 872-5570 | 872-5570 | Same |
| Product Code | Primary LRK
Secondary LQZ | Primary LRK
Secondary LQZ | Primary LRK
Secondary LQZ | Same |
| Indications for
use | The Meridian PM is
intended to reduce
nighttime snoring and
mild to moderate
obstructive sleep
apnea (OSA) in adults. | In adult
population
• To reduce or
alleviate snoring
• To reduce or
alleviate mild to
moderate
obstructive
sleep apnea
(OSA) | The TheraSom-
CAST is used to
reduce or
alleviate the
occurrence
of snoring and/or
for the treatment
of mild to
moderate
obstructive
sleep apnea
(OSA) in patients
18 years of age
or older | Similar to both
predicates the
Meridian PM
Indications for use
is aligned with
product code LRK |
| Mode of Action | | | | |
| | These devices
function as a
mandibular
repositioner, which
acts to increase the
patient's pharyngeal
space, improving their
ability to exchange air
during sleep. | This 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 the
ability to
exchange air
during sleep by
reducing
mechanical
obstructions of
the airway. | The device
functions as a
mandibular
repositioner,
which acts to
improve the
patient's ability
to breathe
without
obstruction of
the pharyngeal
airway | Similar mode of
action with slight
technical
deviations
discussed below,
not incurring
additional patient
risks |
| Material | Acrylic | Milled Acrylic | Cast Metal | The Meridian PM
and OptiSleep
devices are made
of an acrylic
material while the
TheraSom is made
of a dental metal
alloy there is no
significant
difference
between the
Meridian PM and
the OptiSleep
regarding the
acrylic base
material used |
| | The main parts of the
device(s) are made of
Acrylic Material,
Stainless Steel, and
Dental Alloy Material | The main parts
of the device are
made of
Polymethylmeth
acrylate. The
exchangeable
connectors are
made of
Polyamide | Dental Alloy
Material | |
| Mode of Care | | | | |
| Insertion | Adjustable by Dentist or Physician during the duration of use | Adjustable by Dentist or Physician during the duration of use | Adjustable by Dentist or Physician during the duration of use | Same |
| | the upper and lower appliance to be inserted at the same time | the upper and lower appliance to be inserted at the same time | the upper and lower appliance to be inserted at the same time | Same |
| Usage | Removable and Reusable by the same patient.
Night Time Usage Only for Meridian PM device | Removable and Reusable by the same patient.
Night Time Usage Only | Removable and Reusable by the same patient.
Night Time Usage Only | Same |
| Biocompatible | Yes | Yes | Yes | Same |
| OTC or Rx | Rx | Rx | Rx | Same |
| Device Technological Differences Difference | | | | |
| Fabrication | Hand made from acrylic and wire formation | Computer generated – milled from acrylic | Hand waxed and metal casted | Hand made component exists in the TheraSom device and a similar acrylic material is used in the OptiSleep device neither of these variations incur additional risk to the patients than are already present in the currently marketed devices. |
| Retention | Upper appliance has acrylic coverage on the occlusal and mid | Upper and lower appliance has acrylic | Upper appliance has metal casting that are formed | The Meridian PM and OptiSleep both have and acrylic coverage |
| posterior teeth with | buccal and | height of contour | on commensurate | |
| retention clasp –
Lower appliance has
cast metal retention
from the buccal of the
posterior teeth
wrapping to the
lingual with acrylic
anterior lingual
coverage | lingual aspect of
the teeth to the
gum line | of the cuspid and
bicuspid teeth –
Lower appliance
and metal casting
covering the
occlusal surface
of the premolars
and molar teeth | dentition on the
upper appliance
the Meridian PM
and the TheraSom
device both utilize
a metal casting in
the lower
appliance for
retention
incurring no
additional risk the
patient than are
already present in
currently
marketed devices. | |
Table 5A - Comparison of Characteristics
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9. Non-Clinical Performance Data
As part of demonstrating the substantial equivalence of Meridian PM to the predicate devices that are subject to this 510(k) submission, The Center for Craniofacial and Dental Sleep Medicine completed a number of non-clinical performance tests, including:
- . Determination Of Flexural Properties Test Method : ISO 178:2010/Amd.1:2013(E) Method A
- Plane-Strain Fracture Toughness and Strain Energy Release Rate of Plastic Materials Test Method : ASTM D5045 -14 (modified notch geometry)
- Tensile Properties Test Method : ASTM D638-14 - Modified specimen length, test speed and grip separation
The Meridian passed all the testing in accordance with internal requirements, applied national standards, and applied international standards shown below to support substantial equivalence of the subject device:
Biocompatibility - The biological compatibility of the Meridian PM was evaluated in accordance with ISO 10993-1:2009 and guidance document entitled Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing within a Risk Management Process" dated 16 June 2016. Under these, for the stated indications for use, each component of the device's biological compatibility was evaluated for in vitro cytotoxicity, skin sensitization, and chemical characterization.
- Biocompatibility testing per ISO 10993-1: Passed
- . Biocompatibility testing per ISO 10993-5 Cytotoxicity: Passed
- . Biocompatibility testing per ISO 10993-10 Tests for irritation and skin sensitization: Passed
- Biocompatibility testing per ISO 10993-18 Chemical Characterization: Passed
Risk Analysis - Formal Risk Assessment of the Meridian PM was performed in accordance with ISO 14971. With respect to perceivable conditions in which the device would be subjected to a worst-case environmental or human error scenario, Center for Craniofacial and Dental Sleep Medicine believes the outcomes of these risks are considered acceptable within the context of ISO 14971, and that all potential risks have been mitigated to the lowest form.
10. Performance Testing Summary
As part of demonstrating the substantial equivalence of Meridian PM to the predicate devices that are subject to this 510(k) submission, Center for Craniofacial and Dental Sleep Medicine completed a number of tests. The Meridian PM meets all the requirements for overall design, biocompatibility, and performance testing confirm that the output meets the design inputs and specifications. The Meridian PM passed all testing stated above as shown by the acceptable results obtained.
11
The Meridian PM complies with the applicable voluntary standards for biocompatibility. The device passed all the testing in accordance with national and international standards.
11. Statement of Substantial Equivalence
It has been shown in this 510(k) submission that the differences between the Meridian PM and the predicate device do not raise any different questions. The performance testing provided demonstrates that the subject device is substantially equivalent to the predicate devices. The Enter for Craniofacial and Dental Sleep Medicine Meridian PM, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.