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The SomnoGuard Series of mandibular advancement devices (SomnoGuard,2.0,AP and AP Pro) is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in adults.

The whole family of SomnoGuard mandibular advancement devices is used for treating snoring and obstructive sleep apnea. The main effect of all appliances is the advancement of the lower jaw, thereby opening the upper airway and reducing snoring and the breathing arrests due to obstructive sleep apnea.

SomnoGuard and its minor modification SomnoGuard 2.0 are one-part appliances manufactured from thermoflexible copolymeric material. SomnoGuard can be fitted without the need of taking a patient's dental impressions as a prerequisite to construct the ready-to-use device. To prepare fitting of the appliance it is necessary to heat the appliance in hot water that has been boiled for around 30 seconds. Thereafter, when the device was removed from the hot water and has cooled down for about 10 seconds, a physician or his or her trained staff inserts the device into the mouth of the patient. thereby first the lower jaw into the lower arch, then the upper jaw into the upper channel of the device. The patient then puts forward his or her lower jaw commonly at normal bite conditions to approximately half the maximum extension possible, with the plastic still warm and moldable, and then firmly bites the plastic. When doing this, patient sucks in while closing the mouth and pressing the tongue against the inner surface of the front teeth. In parallel, doctor presses his or her fingers on the outer walls of the mouthpiece to make sure that the appliance is properly molded. After fixing the bite impression by cold water the fitting is finished. To raise the molar bite when necessary (e.g. in case of a "deep-bite") the SomnoGuard pack contains a filler strip made of the same copolymeric material as the appliance itself. To raise the bite the strip is heated in hot water and then sticked in parts into the channel of the appliance.

SomnoGuard 2.0 differs from SomnoGuard by a slightly thicker molar biting zone (i.e. 1.5 mm on each site of the biting plate) and an increase of the molar side walls of 1.0 mm. As opposed to the SomnoGuard time consuming use of the filler strip can thus be avoided with the SomnoGuard 2.0 in patients with a "deep bite".

Both SomnoGuard and - 2.0 contain a hole in the front area, large enough for emergency breathing. Both one-part appliances are primarily considered by sleep specialists and dentists for short-term use up to about one year or as a first-line screening devices to find out whether patients suffering from snoring and / or obstructive sleep apnea (OSAS) respond to oral appliance therapy at all what can't be predicted for any appliance available in the marketplace prior to its usage. Thus in case of no therapeutic effect larger investments for the much more expensive custom dental lab made appliances can be avoided.

The SomnoGuard product family comprises another "boil-&-bite" member i.e., SomnoGuard AP (AP = Adjustable Positioner), a two-part infinitely adjustable (titratable) appliance enabling a protrusion of up to 12 mm, allowing lateral lower jaw movement and breathing through the mouth whenever needed. The device consists of two independent trays with each a thermoplastic body, and both parts linked to each other by a coupling protrusion mechanism. The outer tray shells consist of solid clear and transparent medical grade polycarbonate. The inner lining which accommodates the teeth impressions is made of a thermoplastic copolymer as it is similarly used with the SomnoGuard® one-part appliances. After the oral appliance is heated in a hot water bath its thermoplastic body moulds easily to the teeth and jaws allowing any medical doctor to fit very easily the device chair side.

An adjusting screw made of stainless steel allows the anterior adjustment of the lower tray against the upper tray between 0 and about 12 mm or even more depending on the length of the screw used. The adjustment is only possible extra-orally and when the upper and lower trays are disassembling both trays is also necessary for cleaning.

By using the scale on both sides of the thread you can exactly control the adjustment with an accuracy of about 0.5 mm. Upper and lower trays can be moved laterally.

The highly cost-effective device is considered for medium term use up to two years

All "boil-&-bite" appliances are simple to fit by dentists and other medical specialists, taking about 10 minutes and not requiring any special tools. Since with not any existing oral appliance available in the marketplace treatment outcome can be predicted for sure as already mentioned earlier, it always makes sense from a cost and economical point of view to start treatment at first with cheaper boil & bite devices before doing a larger investment for the fabrication of custom made dental appliances such as the SomnoGuard AP Pro which will be described thereafter.

The currently last family member is the SomnoGuard AP Pro, an always dental lab made two-part titratable mandibular adjustable positioner with its development closely related and derived from the preceeding development of the AP appliance. The SomnoGuard® AP Pro can easilty be constructed from comment acrylic/elastomeric thermoform dental materials in any dental lab after taking impressions of the lower and upper jaws and producing plaster models. The components used to connect the upper and lower travs of the dental appliance and enable the infinite advancement of the lower jaw are made from stainless steel. The component's technology is based on the preceding development of the SomnoGuard® AP. The components are very durable, more or less indestructible, inexpensive and can most often be reused when the oral appliance has to be remade for some reason. The cost-effectiveness of the SomnoGuard AP Pro and the fact that the device can easily be constructed by any dental lab using standard lab equipment are considered as key benefits compared to the more expensive competitive dental appliances.

All stainless steel components of the two-part appliances correspond to the material no.1.4301 (AISI-no. 304) resp. to DIN EN 10088-1. The chemical composition is commonly as follows:

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The provided document is a 510(k) summary for the SomnoGuard Series of mandibular advancement devices. It contains general information about the device, its intended use, and technological characteristics. However, it does not include any study data, acceptance criteria, or performance metrics. The document primarily focuses on establishing substantial equivalence to legally marketed predicate devices for regulatory clearance.

Therefore, I cannot provide the requested information from the given text. A 510(k) summary typically does not contain detailed study results or acceptance criteria in the format you've requested for device performance.

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The MDSA is an intraoral device (mandibular repositioning) for the treatment of snoring and sleep apnea. The device is worn during sleep with the intention to reduce the incidence of snoring and obstructive sleep apnea.

Prescription Device
Custom-Made
Mandibular Repositioning Device
Reduce Snoring
Treat Mild to Moderate Obstructive Sleep Apnea
Single Patient / Multi-Use
Not for Use in Persons Younger than 18 Years of Age
Home or Sleep Laboratory Environment

The MDSA is an intraoral dental device for the treatment of snoring and sleep apnea. The MDSA is worn during sleep with the intention to reduce the incidence of snoring and obstructive sleep apnea.

The MDSA is a prescription Custom Made titratable mandibular repositioning device for the dental treatment of patients suffering snoring and obstructive sleep apnea.

Patient's dental impressions must be used to construct the device. The MDSA is a 2-part device. With an upper containing the hook component in the front that when in the patient's mouth engages a shelf in the lower.

The MDSA is supplied with an Adjuster Key, which is used to move the hook in the upper to advance the lower jaw forward and accordingly advance the mandible and tongue thereby improving patency of the airway, decrease air turbulence and aid improvement of obstructive sleep apnea.

The MDSA can be molded with commonly available materials used by Dental Laboratories either Hard Acrylic and ball clasps or Double Laminate (Hard /Soft) Functional mouthguard materials for the construction of the device.

A Bite Registration taken at the same time as the impressions facilitates the Laboratory technician correctly locating the components during construction.

Because of its unique design when incitu the patient has full lateral movement and the device can be titrated to the individual patients needs.

The advantage of the MDSA is that its construction can be easily performed by a normally qualified Laboratory Technician using standard Laboratory Equipment. This affords a saving in costs to the end user.

The MDSA components are made from Medical Grade 316 Stainless Steel. The Hook/Screw component is welded into its outer housing to ensure security during use.

The provided text is a 510(k) summary for the MDSA (Anti-Snoring / Sleep Apnea Device). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with specific acceptance criteria and performance metrics typically found in a clinical trial report or a more extensive PMA submission.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the way a clinical study report would.

Specifically, the document lacks:

1. A table of acceptance criteria and reported device performance: There are no quantitative performance metrics (e.g., reduction in AHI, snore reduction percentages, or specific comfort scores) and no pre-defined acceptance criteria for these metrics.
2. Sample size used for the test set and data provenance: No test set is mentioned, nor any details about its size, country of origin, or retrospective/prospective nature.
3. Number of experts and their qualifications for ground truth: No experts are mentioned in the context of establishing ground truth for a test set.
4. Adjudication method: Not applicable as no ground truth is being established by experts.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned. The device is a physical intraoral device, not an AI-assisted diagnostic tool for human readers.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device.
7. Type of ground truth used: Not discussed, as no specific performance outcomes are being evaluated against a ground truth in this document.
8. Sample size for the training set: Not applicable as this is a physical medical device, not a machine learning model.
9. How ground truth for the training set was established: Not applicable.

What the document does provide is:

• Device Description: An intraoral dental device for the treatment of snoring and sleep apnea, worn during sleep, custom-made, titratable mandibular repositioning device.
• Intended Use: To reduce the incidence of snoring and obstructive sleep apnea.
• Technological Characteristics Summary: Compares the MDSA to a predicate device (TAP, K962516), highlighting similarities (indications for use, single patient, multi-use, prescription, non-sterile, custom fabricated, adjustable, environment, components, materials, removable) and minor differences (adjuster key vs. winder, hook/shelf mechanism vs. lingual bar).
• Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices, which means it is as safe and effective as a legally marketed device. This determination is based on the comparison of technological characteristics as outlined.

In conclusion, this 510(k) summary is a regulatory document to establish "substantial equivalence" of a new device to an existing one, not a clinical study report detailing performance against specific acceptance criteria.

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