Classic is a Mandibular Advancement Device (MAD) indicated for mild to moderate obstructive sleep apnea (OSA) and to alleviate or reduce snoring in adults.

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 patient's 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

AI/ML Overview

This document is an FDA 510(k) Premarket Notification for the "Classic" Mandibular Advancement Device (MAD). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving a specific performance metric against a set of acceptance criteria derived from a novel clinical study.

Therefore, many of the requested elements regarding acceptance criteria, study design, expert involvement, and ground truth for demonstrating device performance are not applicable in the context of this 510(k) submission document. The submission relies heavily on non-clinical testing and comparison to predicates to assert safety and effectiveness.

Here's a breakdown of the requested information based solely on the provided document:

1. A table of acceptance criteria and the reported device performance

This document does not present acceptance criteria in the typical sense of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy) derived from a specific clinical study aimed at proving the device meets those criteria. Instead, the "acceptance criteria" for a 510(k) submission are fundamentally about demonstrating substantial equivalence to a predicate device.

The closest one gets to "performance" here is demonstrating adherence to established standards and similar characteristics to the predicate.

Characteristic	Acceptance Criteria (Implied by Substantial Equivalence Goal)	Reported Device Performance (from "Table 1: Device Comparison")
Intended Use	Must be same as or similar to predicate	To reduce or alleviate nighttime snoring and mild to moderate obstructive sleep apnea (OSA). (Same as predicates)
Material	Must be same as or similar to predicate (biocompatible and safe)	Polymer PET G and TPU, Polymethylmethacrylate, Stainless steel and Titanium alloy (Similar; considered "Yes" for SE)
Fixed/Removable	Must be same as predicate	Removable (Same as predicates)
Sterile	Must be same as predicate	Non-sterile (Same as predicates)
Mandibular adjustment	Must be same as or similar to predicate's mechanism	Customized by physician or dentist. (Same as predicates)
Mandibular adjustment range	Must be comparable to predicate (with justification for differences)	Up to 10.0 mm (Slightly larger than predicate's 7.0 mm, but deemed substantially equivalent)
Compliance with Standards	Must comply with relevant ISO and ASTM standards for medical devices and materials.	Complies with ISO 20795-2, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 5832-3, ISO 5832-1. (Reported compliance)
Bench Testing Performance	Device properties (flexural, tensile) should meet expected performance for the material. Biocompatibility must be demonstrated.	Flexural properties (ISO 178:2010), Tensile properties (ASTM D638-02) were determined. Biocompatibility evaluation in accordance with ISO 10993-1:2009. (Testing performed, results implicitly satisfactory for SE)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This submission is for a physical medical device (intraoral device) and relies on non-clinical (bench) testing and comparison to predicates, not a clinical test set of patient data with a defined sample size as would be used for an AI/software device.
Data Provenance: The bench testing likely occurred at the manufacturer's facility or a certified lab. The document does not specify the country of origin for the data or whether it was retrospective or prospective, as it's not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No clinical test set with human data requiring expert ground truth establishment was used in this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No clinical test set with human data requiring adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a physical device, not an AI or software-as-a-medical-device (SaMD) product. No MRMC study was performed or required for this type of submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. For the non-clinical testing performed, the "ground truth" would be the established physical and chemical properties of the materials and the performance specifications of the device components as defined by the international standards (e.g., ISO, ASTM). Biocompatibility is assessed against the absence of toxic reactions as per ISO standards. There is no patient-level "ground truth" for disease state or outcomes.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of this device. It's not an AI/machine learning device.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set, this question is not relevant.

Summary

{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.

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

{2}------------------------------------------------

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM 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

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 TPUPolymethylmethacrylateStainless steel and Titanium alloy	PolycarbonateStainless steel	PolycarbonateStainless 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.

Regulation Number and Section

§ 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.”