(216 days)
No
The description focuses on traditional manufacturing processes (impressions, plaster models, 3D scanning, 3D design software, 3D printing) and does not mention any AI or ML algorithms being used in the design or function of the device.
Yes
The device is intended to reduce or alleviate snoring and mild to moderate Obstructive Sleep Apnea (OSA), which are medical conditions, and operates through a physical mechanism (mandibular advancement) to achieve a therapeutic effect.
No
The device is described as a mandibular advancement device intended to reduce or alleviate snoring and mild to moderate Obstructive Sleep Apnea (OSA) by physically repositioning the jaw, not to diagnose a condition.
No
The device description clearly outlines physical components (lower jaw splint, upper jaw splints) that are 3D printed from a biocompatible photopolymer, making it a hardware device. While software is used in the design process, the final product is a physical medical device.
Based on the provided information, the Soundly Mandibular Advancement Device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Soundly Device Function: The Soundly device is a physical appliance worn by the patient to mechanically alter the position of the jaw during sleep. It directly interacts with the patient's anatomy to alleviate symptoms.
- Lack of Specimen Analysis: The device does not involve the collection, preparation, or analysis of any biological specimens from the patient. The process involves taking physical impressions and scans, but these are used to create a custom-fit device, not to analyze biological markers.
The device falls under the category of a medical device, specifically a mandibular advancement device, used for the treatment of snoring and mild to moderate Obstructive Sleep Apnea. Its function is therapeutic and mechanical, not diagnostic through the analysis of biological samples.
N/A
Intended Use / Indications for Use
The Soundly Mandibular Advancement Device is intended to reduce or alleviate snoring and mild to moderate Obstructive Sleep Apnea (OSA) whilst sleeping in adults.
Product codes
LRK, LQZ
Device Description
The Soundly Device is a mandibular advancement device to be worn by the patient in their own home at night whilst asleep. The advancement of the lower mandibular is an accepted method of reducing the incidence of light to moderate Obstructive Sleep Apnea (OSA). The Soundly Device consists of the following components:
- . A single lower jaw splint that covers the lower teeth to the gum line. The lower splint has two wedge-shaped projections on its upper surface. These indentations are shaped to receive complementary wedges on the upper splint and so advance the lower jaw compared to the natural positioning.
- . A set of three different upper jaw splints that cover the upper teeth to the gum line. Each upper jaw splint has a pair of wedges on its lower surface that interlock with the wedge indentation on the lower jaw. The set of three upper splints offer different amounts of mandibular advancement: They individually offer 40%, 60% or 70% of the maximum mandibular advancement that the patient's jaw can accommodate. The 70% value has an absolute maximum of 12 mm of mandibular advancement.
The dental impressions of the lower and upper jaw and a bite registration of the patient at maximum comfortable mandibular advancement are made by the prescribing dentist. The impressions are sent to the Soundly labs for processing. The impressions are turned into plaster models in the usual method and then the plaster models are subject to 3D scanning to make electronic 3D models of the mandibular arches. The 3D models are processed in 3D design software into the set of splints, which are then 3D printed in a biocompatible photopolymer. The finished set of splints are returned to the prescribing dentist for final fitting on the patient.
The perceived advantage of this digital method of production is that the splints should conform closely to the patient's actual teeth and gums as the edges have been positioned and shaped before printing, rather than having to be cut and filed after manufacture as is usual with thermoformed splints. Thus, the splints should be more comfortable than those produced by traditional methods.
The set of 3 upper splints allows the patient to self-titrate. The amount of mandibular advancement produced by the splints has been pre-scaled to the patient's comfortable range of jaw movement, and so the patient can choose which to wear to find the right balance of comfort and effectiveness. This would be more difficult or take longer with traditional fixed length tie bars or screw turnbuckles that require the dentist's intervention. The device could be worn all night and every night by the patient in order to reduce the incidence of OSA.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's mouth, lower and upper jaw/teeth/gums.
Indicated Patient Age Range
Adults. People over 18 years of age.
Intended User / Care Setting
Prescribing dentist for impressions and final fitting; patient for home use at night.
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 Tests:
Additive Manufacture Consistency:
- The accuracy of the manufactured splints with the source 3D CAD file when printed with aged printing resin. This was conducted by a comparison of the splint dimensional accuracy when printed with new resin and resin that had been subjected to extreme heat and freezing and the aged to 2 years old. All splints printed were within the acceptable dimensional accuracy target of >80% of the splint dimensions being within 150 micron of the CAD file dimension.
- The consistency of the printed splints with varied location on the print bed and across three different print runs was tested. The splints produced were confirmed as being fit for use by being fitted to the source Plaster of Paris models and being inspected by an independent practicing Orthodontist. All of the splints were free from air bubbles and inclusions. There was no interference or free space in the fit of the splints on the source models.
Physical Properties Testing:
The physical properties of the printed material were tested by the manufacturer for:
- Ultimate tensile strength
- Elongation
- Flexural modulus
- Flexural strength
- Shore hardness
In addition, Soundly MAD devices were tested for expected mis-handling by being dropped onto a tiled floor from increasing heights. This was to simulate being dropped whilst being handled or cleaned in a bathroom. The splints survived being dropped from 4 feet, 5 feet and 6 feet in different orientations. These drop tests were cumulative as the same splints were used for all of the tests. It was only when the splints were dropped from 7 feet (from above head height) did one of the splints break in half. This test proved that:
- The splints are resistant to the expected accidental dropping or misuse.
- When a splint is damaged by dropping, it is not by minor and perhaps unnoticed chipping, but by complete breakage and so the splint would not be used in a damaged state.
Biocompatibility:
The evidence of the 3D printing material biocompatibility was provided under a separate cover to FDA by the material manufacturer. The material was tested for the following biocompatibility parameters, as required by ISO 10993 and ISO 7405 for the cumulative use of "permanent":
- Cytotoxicity
- Sensitization
- Irritation
- Acute systemic toxicity
- Material mediated pyrogenicity
- Subacute/Subchronic toxicity
- Genotoxicity
- Implantation
The material passed each and all of the test requirements.
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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
September 8, 2022
Greystone IP Ltd Judy Purvis Director Unit 322, Moat House, 54 Bloomfield Avenue Belfast, BT5 5AD IRELAND
Re: K220330
Trade/Device Name: Soundly Anti Snoring Device 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, LOZ Dated: July 28, 2022 Received: August 4, 2022
Dear Judy Purvis:
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
1
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 medical devices and radiation-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) K220330
Device Name Soundly Mandibular Advancement Device
Indications for Use (Describe)
The Soundly Mandibular Advancement Device is intended to reduce or alleviate snoring and mild to moderate Obstructive Sleep Apnea (OSA) whilst sleeping, 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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510K SUMMARY K220330
1. SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON AND DATE PREPARED
Greystone IP Ltd Unit 322, Moat House 54 Bloomfield Avenue Belfast, BT5 5AD Northern Ireland
Contact Person: Judy Purvis
Phone: +44 7515788487
Date Prepared: 28th July 2022
2. DEVICE
Name of Device
Soundly Mandibular Advancement Device
Common or Usual Name
Mandibular Advancement Device
Classification Name/Product Code/CFR Reference
Mandibular Advancement Device, Product Code: LRK, LQZ CFR Reference: 21 CFR 872.5570
3. PREDICATE DEVICE
Primary Predicate device: Slow Wave DS8, K191320. This predicate has not been the subject of a design-related recall.
Reference device: O2 Vent Optima, K190236
4
4. DEVICE DESCRIPTION
The Soundly Device is a mandibular advancement device to be worn by the patient in their own home at night whilst asleep. The advancement of the lower mandibular is an accepted method of reducing the incidence of light to moderate Obstructive Sleep Apnea (OSA). The Soundly Device consists of the following components:
- . A single lower jaw splint that covers the lower teeth to the gum line. The lower splint has two wedge-shaped projections on its upper surface. These indentations are shaped to receive complementary wedges on the upper splint and so advance the lower jaw compared to the natural positioning.
- . A set of three different upper jaw splints that cover the upper teeth to the gum line. Each upper jaw splint has a pair of wedges on its lower surface that interlock with the wedge indentation on the lower jaw. The set of three upper splints offer different amounts of mandibular advancement: They individually offer 40%, 60% or 70% of the maximum mandibular advancement that the patient's jaw can accommodate. The 70% value has an absolute maximum of 12 mm of mandibular advancement.
The dental impressions of the lower and upper jaw and a bite registration of the patient at maximum comfortable mandibular advancement are made by the prescribing dentist. The impressions are sent to the Soundly labs for processing. The impressions are turned into plaster models in the usual method and then the plaster models are subject to 3D scanning to make electronic 3D models of the mandibular arches. The 3D models are processed in 3D design software into the set of splints, which are then 3D printed in a biocompatible photopolymer. The finished set of splints are returned to the prescribing dentist for final fitting on the patient.
The perceived advantage of this digital method of production is that the splints should conform closely to the patient's actual teeth and gums as the edges have been positioned and shaped before printing, rather than having to be cut and filed after manufacture as is usual with thermoformed splints. Thus, the splints should be more comfortable than those produced by traditional methods.
The set of 3 upper splints allows the patient to self-titrate. The amount of mandibular advancement produced by the splints has been pre-scaled to the patient's comfortable range of jaw movement, and so the patient can choose which to wear to find the right balance of comfort and effectiveness. This would be more difficult or take longer with traditional fixed length tie bars or screw turnbuckles that require the dentist's intervention. The device could be worn all night and every night by the patient in order to reduce the incidence of OSA.
5
5. INTENDED USE / INDICATIONS FOR USE
The Soundly Mandibular Advancement Device is intended to reduce or alleviate snoring and mild to moderate Obstructive Sleep Apnea (OSA) whilst sleeping in adults.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Both the Soundly Device and the Slow Wave DS8 are Mandibular Advancement Devices manufactured by a 3D printing process (an Additive Manufacture process). They both use the same 3D printing material, Dental LT Clear, which has an FDA clearance under the Master File process.
The reference device, O2 Vent Optima, is also made by Additive manufacture, but from a Polyamide material.
All 3 devices provide an airspace for oral breathing whilst wearing the device and all 3 devices provide the mandibular advancement to increase the patency of the airway, but they differ in the detail of the method of advancement.
A table to compare the technical characteristics is below:
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| # | Feature | Subject Device | Primary Predicate | Reference Device | Comparison |
|---|---|---|---|---|---|
| 1 | 510(k) | ||||
| number | Greystone IP Soundly MAD | Slow Wave DS8 | O2 Vent Optima | N/A | |
| 2 | Product | ||||
| Classification | Class II, 21 CFR 872.5570, LQZ, | ||||
| LRK | Class II, 21 CFR 872.5570, LQZ, | ||||
| LRK | Class II, 21 CFR 872.5570, LRK | Same for all | |||
| 3 | Device Picture | Image: Greystone IP Soundly MAD Note: the contact between the upper and lower splints are a pair of engaging wedges, not a pair of side arms | Image: Slow Wave DS8 Note that the contact between the upper and lower splints is a ramp, not a pair of side arms | Image: O2 Vent Optima Note the pair of exchangeable arms linking the upper and lower splints and the breathing vent | All devices are trays/splints fitted to both upper and lower mandibles. |
| All have an oral breathing gap at the front of the device. | |||||
| They use different methods to achieve the mandibular advancement to increase the airway patency | |||||
| 4 | Common | ||||
| Name | Intraoral device for snoring and mild | ||||
| to moderate Obstructive Sleep | |||||
| Apnea | Intraoral device for snoring and mild | ||||
| to moderate Obstructive Sleep | |||||
| Apnea | Intraoral device for snoring and mild | ||||
| to moderate Obstructive Sleep | |||||
| Apnea | All same | ||||
| 5 | Indication for | ||||
| Use | The Soundly Mandibular | ||||
| Advancement Device is intended to | |||||
| reduce or alleviate snoring and mild | |||||
| to moderate Obstructive Sleep | |||||
| Apnea (OSA) whilst sleeping in | |||||
| adults | Intended to reduce or alleviate | ||||
| snoring, mild to moderate | |||||
| Obstructive Sleep Apnea while | |||||
| sleeping in adults. | The O2Vent Optima is a removable | ||||
| medical device that is fitted in the | |||||
| patient's mouth and is intended to | |||||
| reduce or alleviate snoring and mild | |||||
| to moderate obstructive sleep | |||||
| apnea (OSA). The device is | |||||
| indicated for use during sleep to aid | |||||
| in the treatment of these conditions | Effectively the | ||||
| same | |||||
| 6 | Target | ||||
| Population | Adults | Adults | People over 18 years of age who | ||
| snore and/or have sleep apnea | No significant | ||||
| difference | |||||
| 7 | Principle of | ||||
| operation | Repositions the lower jaw forward | ||||
| to increase the patency of the | |||||
| airway. | Repositions the lower jaw forward | ||||
| and down to increase the patency | |||||
| of the airway | Repositions the lower jaw forward | ||||
| to increase the patency of the | |||||
| airway | Substantially the | ||||
| same | |||||
| # | Subject Device | Primary Predicate | Reference Device | ||
| Feature | Greystone IP Soundly MAD | Slow Wave DS8 | O2 Vent Optima | Comparison | |
| 8 | Method of | ||||
| operation | The mandibular advancement is | ||||
| achieved by the interlocking of | |||||
| opposing wedge faces on the upper | |||||
| and lower splints, which determines | |||||
| the lower jaw position. There are | |||||
| no locking side arms, so the splints | |||||
| can be disengaged by a small | |||||
| forward and downward movement | |||||
| of the lower jaw. The upper splint | |||||
| is supplied with 3 sizes of | |||||
| mandibular advancement, tied to | |||||
| the patient's maximum mandibular | |||||
| advancement, see next row. | The mandibular advancement is | ||||
| achieved by the lower jaw splint | |||||
| resting on a ramp on the upper jaw | |||||
| splint. The user finds the most | |||||
| comfortable position for | |||||
| themselves. The ramp means that | |||||
| under small amounts of mandibular | |||||
| advancement, the lower jaw is | |||||
| forced apart from the upper jaw. | |||||
| Under larger amounts of | |||||
| mandibular advancement, the lower | |||||
| jaw can move upwards, closer to | |||||
| the upper jaw. Either way, the | |||||
| airway is opened by the | |||||
| combination of pushing the jaws | |||||
| apart and advancing the lower jaw. | The lower jaw is advanced by the | ||||
| side arms between the upper and | |||||
| lower splints. There is a specific | |||||
| oral breathing vent in the front of | |||||
| the upper splint. | Different ways of | ||||
| achieving the | |||||
| same end, see | |||||
| discussion at the | |||||
| end of the table. | |||||
| 9 | Mandibular | ||||
| Advancement | 3 positions at 40%, 60% & 70% of | ||||
| the patient's maximum comfortable | |||||
| mandibular advancement | |||||
| Maximum advancement is 12mm | Up to 15 mm | Up to 8mm | Each has a range | ||
| of adjustment to | |||||
| titrate the balance | |||||
| of effectiveness | |||||
| and comfort | |||||
| 10 | Adjustment | ||||
| method | User chooses which of the 3 lower | ||||
| splints to wear - self titration | No fixed adjustment, the upper and | ||||
| lower splints rest on each other on | |||||
| angled wedges. The wearer adopts | |||||
| the most comfortable position | |||||
| between small advancement and | |||||
| mouth open to jaws clenched but | |||||
| jaw advanced | Changing the connectors between | ||||
| upper and lower splints. This can | |||||
| be done by either the dentist or the | |||||
| user | The amount of | ||||
| mandibular | |||||
| advancement can | |||||
| be adjusted by the | |||||
| patient, it does not | |||||
| depend upon a | |||||
| fixed setting made | |||||
| by the dentist | |||||
| 11 | Supplemental | ||||
| Oral Breathing | Yes, the front of the mouth is | ||||
| opened to allow oral breathing, see | |||||
| picture above. There is no physical | |||||
| connection between upper and | |||||
| lower splints so the mouth can be | |||||
| opened as wide as desired, or one | Yes, the front of the mouth is | ||||
| opened to allow oral breathing. | |||||
| There is no physical connection | |||||
| between upper and lower splints so | |||||
| the mouth can be opened as wide | |||||
| as desired, or one part easily | Yes, through a breathing duct in the | ||||
| front of the splint. The upper and | |||||
| lower splints are physically | |||||
| connected so the splint would have | |||||
| to be removed to open the mouth | |||||
| wider | All provide a route | ||||
| for oral breathing. | |||||
| The Soundly MAD | |||||
| and Slow Wave | |||||
| DS8 give the user | |||||
| simpler removal in | |||||
| # | Feature | Subject Device | Primary Predicate | Reference Device | Comparison |
| Greystone IP Soundly MAD | Slow Wave DS8 | O2 Vent Optima | |||
| part easily removed during any | |||||
| coughing/sneezing or discomfort | removed during any | ||||
| coughing/sneezing or discomfort | the event that the | ||||
| user is sneezing | |||||
| or coughing | |||||
| 12 | Method of | ||||
| manufacture | Dental impressions made by the | ||||
| prescribing dentist are scanned at | |||||
| the Soundly Dental Lab to create | |||||
| the 3D file for additive manufacture | |||||
| by 3D printing on Formlabs | |||||
| equipment | 3D intraoral scan is made by the | ||||
| prescribing dentist. The Slow | |||||
| Wave Dental Lab produces the | |||||
| splints by additive manufacture by | |||||
| 3D printing on Formlabs equipment | Customized for each patient in a | ||||
| dental laboratory located at the | |||||
| manufacturing site based on the | |||||
| dentist prescription | |||||
| Use of computer aided design | |||||
| (CAD) and computer aided | |||||
| manufacturing (CAM) and is made | |||||
| through additive manufacturing | |||||
| using laser sintering | All 3 devices are | ||||
| made by additive | |||||
| manufacturing | |||||
| from 3D scans of | |||||
| the teeth/models | |||||
| of the teeth | |||||
| 13 | Material | Formlabs Dental LT | |||
| Clear V2 | Formlabs Dental LT | ||||
| Clear V2 | PA2200 Polyamide 12 | ||||
| nylon material | All 3 made from a | ||||
| setting material | |||||
| built up in layers | |||||
| from a 3D scan. | |||||
| The materials are | |||||
| FDA approved for | |||||
| additive | |||||
| manufacturing | |||||
| 14 | Single | ||||
| use/Reusable | Reusable | Reusable | Reusable | All same | |
| 15 | Sterile/Non | ||||
| Sterile | Non-sterile | Non-sterile | Non-sterile | All same | |
| 16 | Prescription/ | ||||
| OTC | Prescription only | Prescription only | Prescription only | All same | |
| 17 | Cleaning & | ||||
| Maintenance | Routine cleaning with water, | ||||
| instructions in patient IFU | Routine cleaning with water or mild | ||||
| bleach, instructions in patient IFU | Routine cleaning with water or mild | ||||
| bleach, instructions in patient IFU | All similar |
7
8
9
Detailed comparison of the mandibular advancement methods (Rows #8, 9 and 10):
- . The O2 Vent Optima (Reference Device) has the traditional method of mandibular advancement – a pair of links between the upper and lower splints that sets the amount of the lower jaw advancement. These links are available as a series of lengths that can be changed to titrate the advancement to the optimal balance between effectiveness in reducing snoring/OSA and comfort in wearing the device. The side links can be easily changed by the patient and do not depend upon a visit to the dentist to change the amount of advancement. The maximum opening of the mouth whilst wearing the device is limited by the side links and it takes a few steps to remove the device from the mouth.
- . The Slow Wave DS8 (Primary Predicate) has no fixed link between the upper and lower splints. The interface between the two splints is an angled ramp that moves the lower jaw downwards as it is retracted (see image at row#3). In that way, the wearer can find the most comfortable position of the lower jaw for them. Wherever the lower jaw position is, the airway is opened up over the natural lying position without the device by the combination of advancement and dropping of the lower jaw, even when clenched. The mouth can be opened wider than the natural position of the device if the wearer needs to rapidly open their mouth or remove part of the device.
- . The Soundly MAD (Subject Device) also has no fixed link between upper and lower splints. The interface between the two splints is a pair of interlocking wedges that hooks the lower jaw in a lowered and advanced position. The patient is supplied with 3 upper splints to give them a range of 3 different advancement positions that are linked to their personal maximum mandibular advancement ability. The mouth can be opened wider than the natural position of the device if the wearer needs to rapidly open their mouth or remove part of the device.
Thus, the 3 devices achieve their mandibular advancement and increased airway patency by methods that are different in detail but have the same overall effect: the lower jaw is advanced; the airway is opened and there is provision for oral breathing. Also, all 3 devices give the patient the opportunity to self-titrate the amount of mandibular advancement to arrive at the suitable balance, for them, of comfort and effectiveness.
7. SPEČIAL CONTROLS/GUIDANCE USE
The Soundly MAD application has followed the specific FDA Guidance:
10
For Mandibular Advancement Devices:
"Intraoral Devices for Snoring and/or Obstructive Sleep Apnea - Class II Special Controls Guidance Document for Industry and FDA", published November 12, 2002.
For 3D Printing Methods of Manufacture
Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued December 5, 2017
For Biocompatibility
Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process", Issued June 2016. Updated September 2020
There are no deviations from these guidance documents in the preparation of this Abbreviated 510k
8. BRIEF SUMMARY OF NON-CLINICAL TESTS
Additive Manufacture Consistency:
The consistency of the additive manufacture process was confirmed by:
- . The accuracy of the manufactured splints with the source 3D CAD file when printed with aged printing resin. This was conducted by a comparison of the splint dimensional accuracy when printed with new resin and resin that had been subjected to extreme heat and freezing and the aged to 2 years old. All splints printed were within the acceptable dimensional accuracy target of >80% of the splint dimensions being within 150 micron of the CAD file dimension.
- The consistency of the printed splints with varied location on the print bed . and across three different print runs was tested. The splints produced were confirmed as being fit for use by being fitted to the source Plaster of Paris models and being inspected by an independent practicing Orthodontist. All of the splints were free from air bubbles and inclusions. There was no interference or free space in the fit of the splints on the source models.
Physical Properties Testing:
The physical properties of the printed material were tested by the manufacturer for:
- Ultimate tensile strength ●
11
- Elongation ●
- Flexural modulus .
- Flexural strength ●
- Shore hardness ●
In addition, Soundly MAD devices were tested for expected mis-handling by being dropped onto a tiled floor from increasing heights. This was to simulate being dropped whilst being handled or cleaned in a bathroom. The splints survived being dropped from 4 feet, 5 feet and 6 feet in different orientations. These drop tests were cumulative as the same splints were used for all of the tests. It was only when the splints were dropped from 7 feet (from above head height) did one of the splints break in half. This test proved that:
- The splints are resistant to the expected accidental dropping or misuse. ●
- When a splint is damaged by dropping, it is not by minor and perhaps ● unnoticed chipping, but by complete breakage and so the splint would not be used in a damaged state.
Biocompatibility:
The evidence of the 3D printing material biocompatibility was provided under a separate cover to FDA by the material manufacturer. The material was tested for the following biocompatibility parameters, as required by ISO 10993 and ISO 7405 for the cumulative use of "permanent":
- Cytotoxicity ●
- Sensitization .
- Irritation ●
- Acute systemic toxicity ●
- Material mediated pyrogenicity ●
- Subacute/Subchronic toxicity .
- Genotoxicity
- Implantation ●
The material passed each and all of the test requirements.
9. CONCLUSIONS
The conclusions drawn from the use of the specific quidance documents and comparison with the predicate and reference devices demonstrate that the subject device, the Soundly MAD device, conforms to the requirements of a Mandibular Advancement Device and is Substantially Equivalent to legally marketed devices, the Slow Wave DS8 [K191320] and the O2 Vent Optima [K190236].