(90 days)
No
The description focuses on mechanical components and manual adjustment, with no mention of AI/ML terms, data processing, or performance metrics typically associated with AI/ML devices.
Yes
The device is indicated for treating obstructive sleep apnea (OSA) and reducing snoring, which are medical conditions, and it achieves its therapeutic effect by altering the anatomy (mandibular advancement).
No
The device is described as a treatment for obstructive sleep apnea and snoring, not for diagnosis.
No
The device description clearly outlines physical components (upper splint, lower splint, activation key, guide, screw) and describes its function as a physical intraoral device. It is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Classic device is an intraoral device that physically repositions the mandible to treat sleep apnea and snoring. It does not analyze any biological samples.
- Intended Use: The intended use is to treat a condition (OSA and snoring) by altering the physical structure of the airway, not by analyzing biological markers.
- Device Description: The description focuses on the mechanical components and how they work within the mouth.
- Performance Studies: The performance studies described are bench tests evaluating the physical properties and biocompatibility of the device, not studies evaluating the accuracy of a diagnostic test.
Therefore, the Classic device falls under the category of a medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Classic is a Mandibular Advancement Device (MAD) indicated for mild to moderate obstructive sleep apnea (OSA) and to alleviate or reduce snoring in adults.
Product codes
LRK
Device Description
Classic device is an intraoral device specially indicated for the treatment of snoring and obstructive sleep apnea syndrome. Its design makes it simple to use and comfortable to wear. It is intended for single-patient use by adults who are 18 years or older.
Classic device consists of two splints united to each other by a screw that allows controlled advancement of the mandible by the increase of the muscular tone at the airway level. Consequently, the flow of air through the upper airway is increased, and reducing snoring and apnea events. The maximum protrusion of Classic arch form is 10 mm, measuring from plate. This device needs an external controlling component such as screwdriver included in the kit. The device is according arches, maximizes tongue space and allow open, close and laterality movements during wear. These movements can be personalized by the doctor.
Each Classic device has the following components:
- Upper splint
- Lower splint
- Activation key
- Guide (Bar)
- OrthoApnea screw
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intraoral
Indicated Patient Age Range
adults who are 18 years or older.
Intended User / Care Setting
Not Found
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 Tests:
The proposed devices have been subject to bench testing to determine fulfillment of design and performance requirements. Bench testing followed the recommendations provided in FDA Guidance Document - Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea.
Performance testing on the Classic device included:
- Determination of flexural properties (ISO 178:2010)
- Determinations of the Tensile properties (ASTM D638-02)
- Biocompatibility evaluation in accordance (ISO 10993-1:2009)
Clinical Testing:
No clinical testing was performed. Non-clinical testing was used to support the determination of substantial equivalence.
Key Results:
Based on the similarities observed and results of non-clinical testing performed, we conclude that the proposed devices are substantially equivalent to the predicate devices.
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.”
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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.
February 25, 2021
Orthoapnea S.L. Jose Llecha Managing Director C / Flauta Magica 22 Malaga, Malaga 29006 SPAIN
Re: K203477
Trade/Device Name: Classic 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: November 15, 2020 Received: November 27, 2020
Dear Jose Llecha:
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.
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
1
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 (OS) 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 Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K203477
Device Name
Classic
Indications for Use (Describe)
Classic is a Mandibular Advancement Device (MAD) indicated for mild to moderate obstructive sleep apnea (OSA) and to alleviate or reduce snoring 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) | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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FORM FDA 3881 (6/20)
3
) ( OrthoApnea
Classic 510(k) Premarket Notification Submission
SECTION 5 - 510(k) SUMMARY
K203477
| DATE OF SUBMISSION: | 2020-11-15 |
|---|---|
| SUBMITTER NAME: | Orthoapnea S.L |
| SUBMITTER ADDRESS: | Calle Flauta Mágica 22 29006 Málaga SPAIN |
| CONTACT: | Jose Repollés Llecha |
|---|---|
| TELEPHONE: | +34 952 122 174 ext. 154 |
| e-mail: | jrepolles@orthoapnea.com |
DEVICE TRADE NAME: Classic
COMMON NAME: MANDIBULAR ADVANCEMENT DEVICE CLASSIFICATION NAME: INTRAORAL DEVICES FOR SNORING PRODUCT CODE: LRK REGULATION DESCRIPTION: Intraoral devices for snoring and intraoral
device for snoring and obstructive sleep apnea (21 CFR 872.5570)
PREDICATE DEVICE(S): K060388 (Airway Management Inc.) - Primary predicate K062951 (Airway Management Inc.) Reference device
A. Description of the Device
Classic device is an intraoral device specially indicated for the treatment of snoring and obstructive sleep apnea syndrome. Its design makes it simple to use and comfortable to wear. It is intended for single-patient use by adults who are 18 years or older.
Classic device consists of two splints united to each other by a screw that allows controlled advancement of the mandible by the increase of the muscular tone at the airway level. Consequently, the flow of air through the upper airway is increased, and reducing snoring and apnea events.
patient's
The maximum protrusion of Classic arch form is 10 mm, measuring from plate. This device needs an external controlling component such as screwdriver included in the kit. The device is according arches, maximizes tongue space and allow open, close and laterality movements during wear. These movements can be personalized by the doctor.
4
) ( OrthoApnea
Classic 510(k) Premarket Notification Submission
Each Classic device has the following components:
Image /page/4/Picture/3 description: The image shows a blue oral appliance with a metal adjustment mechanism. The appliance consists of an upper tray (1) and a lower tray (2), both made of a transparent blue material. A metal adjustment mechanism (3, 4, 5) connects the two trays, allowing for controlled movement of the lower jaw. The appliance is designed to treat sleep apnea and snoring by advancing the lower jaw and opening the airway.
| Component # | Component Name |
|---|---|
| 1 | Upper splint |
| 2 | Lower splint |
| 3 | Activation key |
| 4 | Guide (Bar) |
| 5 | OrthoApnea screw |
B. Intended Use
Classic is a device that consist in maxillary and mandibular devices connected with a personalized mechanism to reduce snoring and mild to moderate sleep apnea by holding the mandible forward during sleep.
C. Summary of Testing and Comparison to the Predicate Device
The devices are designed and manufactured in accordance with the following standards:
- ISO 20795-2 Second edition 2013-03-01 Dentistry Base polymers Part 2: Orthodontic base polymers
- ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- -ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity
- -ISO 10993-10:2009 Biological evaluation of medical devices – Part 10: Test for irritation and delayed-type hypersensitivity
- -ISO 5832-3 2016 Implants for surgery - Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
- -ISO 5832-1 2016 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
5
) | ( OrthoApnea
Classic
510(k) Premarket Notification Submission
And according the following guidance:
- -Intraoral Devices for Snoring and/or Obstructive Sleep Apnea-Guidance for Industry and FDA 2002
Comparison of Technological Characteristics
Table 1: Device Comparison
| Characteristic | Subject Device | Primary predicate | Reference predicate | SE / Comments |
|---|---|---|---|---|
| Model Name | Classic | TAP II | TAP III | - |
| 510K | K203477 | K060388 | K062951 | |
| Intended use | To reduce or alleviate nighttime snoring and mild to moderate obstructive sleep apnea (OSA). | The TAP II is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea, OSA. | The TAP III is intended to reduce or alleviate nighttime snoring and mild to moderate obstructive sleep apnea, OSA. | Yes |
| Material | Polymer PET G and TPU | |||
| Polymethylmethacrylate | ||||
| Stainless steel and Titanium alloy | Polycarbonate | |||
| Stainless steel | Polycarbonate | |||
| Stainless steel | Yes | |||
| Fixed /removable | Removable | Removable | Removable | Yes |
| Sterile | Non- sterile | Non-sterile | Non-sterile | Yes |
| Mandibular adjustment | Customized by physician or dentist. | Customized by physician or dentist. | Customized by physician or dentist. | Yes |
| Mandibular adjustment range | Up to 10.0 mm | Up to 7.0 mm | Up to 7.0 mm | Yes |
Classic device is substantially equivalent intended use as the identified predicates. Classic device is similar in fundamental scientific technology to the predicate devices in that they all have been designed, manufactured and tested in compliance with FDA'S Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea.
Classic device is substantially equivalent in materials, indications and intended use, packaging, labeling and performance to the predicate devices currently marketed in the U.S.
The only differences the subject device and the predicate are slight differences in adjustment and mandibular advancement range.
6
) | ( OrthoApnea
Classic
510(k) Premarket Notification Submission
Non-Clinical performance tests
The proposed devices have been subject to bench testing to determine fulfillment of design and performance requirements. Bench testing followed the recommendations provided in FDA Guidance Document - Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea.
Performance testing on the Classic device included:
- . Determination of flexural properties (ISO 178:2010)
- . Determinations of the Tensile properties (ASTM D638-02)
- Biocompatibility evaluation in accordance (ISO 10993-1:2009) .
but as we use widely used standard components in the market there are considered not necessary to perform additional tests.
Test data from the device was leveraged for the previous performance tests based on the use of identical device and packaging materials as well as identical manufacturing, packaging and cleaning processes.
D. Clinical Testing
No clinical testing was performed. Non-clinical testing was used to support the determination of substantial equivalence.
E. Conclusion of Substantial Equivalence
Based on the similarities observed and results of non-clinical testing performed, we conclude that the proposed devices are substantially equivalent to the predicate devices.