(85 days)
Not Found
No
The device description focuses on the physical design, materials, and manual fitting process of mandibular advancement devices. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea, which are medical conditions, and its function involves physically opening the upper airway to alleviate symptoms.
No
The device is a mandibular advancement device intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea. It is a therapeutic device that physically alters the position of the jaw to open the airway, not a device that diagnoses a condition. While some versions can be used as "first-line screening devices to find out whether patients suffering from snoring and / or obstructive sleep apnea (OSAS) respond to oral appliance therapy," this is a therapeutic trial, not a diagnostic assessment.
No
The device description clearly details physical components made of thermoplastic copolymeric material, polycarbonate, and stainless steel, and describes a physical fitting process. There is no mention of software as a component or function of the device.
Based on the provided text, the SomnoGuard Series of mandibular advancement devices is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The text describes the SomnoGuard devices as being inserted into the mouth to physically advance the lower jaw and open the airway. They are a physical intervention, not a tool for analyzing biological samples.
- The intended use is for treatment. The text explicitly states the devices are "intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in adults." IVDs are used for diagnosis, monitoring, or screening, not direct treatment.
- The device description focuses on mechanical function. The description details how the devices are fitted, how they work by advancing the jaw, and the materials used. There is no mention of analyzing blood, urine, tissue, or any other biological specimen.
In summary, the SomnoGuard devices are therapeutic devices that physically alter the anatomy to address a medical condition, which is distinct from the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
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:
C
§ 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
TOMED
GT
SEP - 8 2006
TOMED Dr. Toussaint GmbH · Lindberghstr. 3a · D - 64625 Bensheim
Dr. Toussaint GmbH
TOMED Dr. Toussaint GmbH Medical Products Lindberghstr. 3a D - 64625 Bensheim Germany
Tel.: +49-6251-98 33 44 Fax: +49-6251-98 33 45 eMail: w.toussaint@tomed.com http://www.tomed.com
510(k) SUMMARY of SAFETY and EFFECTIVENESS
A. General Information
-
- Submitter's Name: TOMED Dr. Toussaint, GmbH
-
- Address:
Lindberghstr. 3A Bersheim, Germany D-64625
-
- Telephone: 49-6251-983344
- Dr. Winfried Toussaint 4. Contact Person:
- May 1, 2006 5. Date Prepared:
-
- Registration Number: Pending
- B. Device
| 1. Name: | SomnoGuard Series (SomnoGuard, 2.0, AP, and AP Pro) |
|---|---|
| 2. Trade Name: | Anti-Snoring / Sleep Apnea Device |
| 3. Common Name: | Anti-Snoring / Sleep Apnea Device |
| 4. Classification Name: | Device, Anti-Snoring |
| 5. Product Code: | LRK |
| 6. Class: | II |
| 7. Regulation Number: | 872.5570 |
1
TOMED Dr. Toussaint GmbH
TOMED Dr. Toussaint GmbH . Lindberghstr. 3a . D - 64625 Bensheim
TOMED Dr. Toussaint GmbH Medical Products Lindberghstr. 3a D - 64625 Bensheim Germany
Tel .: +49-6251-98 33 44 Fax: +49-6251-98 33 45 eMail: w.toussaint@tomed.com http://www.tomed.com
C. Identification of Legally Marketed Devices
| 1. Names: | QuietKnight, Silencer (Version I. and II.), TheraSnore, TAP, Silencer, MDSA) |
|---|---|
| 2. K Number: | K962516, K033822, 033823, 926382, 972061, 954530, 042161 |
| 3. Date Cleared: | January 24, 1997, February 6, 2004, February 6, 2004, July 8, 1993, August 21, 1997, October 30, 1995, October 27, 2004 |
D. Description of the Device
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
2
Dedicated to Customer Value
TOMED Dr. Toussaint GmbH
TOMED Dr. Toussaint GmbH . Lindberghstr. 3a . D - 64625 Bensheim
TOMED Dr. Toussaint GmbH Medical Products Lindberghstr. 3a D - 64625 Bensheim Germany
Tel .: +49-6251-98 33 44 Fax: +49-6251-98 33 45 eMail: w.toussaint@tomed.com http://www.tomed.com
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.
3
TOMED
Dr. Toussaint GmbH
TOMED Dr. Toussaint GmbH . Lindberghstr. 3a . D - 64625 Bensheim
TOMED Dr. Toussaint GmbH Medical Products Lindberghstr. 3a D - 64625 Bensheim Germany
Tel .: +49-6251-98 33 44 Fax: +49-6251-98 33 45 eMail: w.toussaint@tomed.com http://www.tomed.com
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
4
TOMED
TOMED Dr. Toussaint GmbH · Lindberghstr. 3a · D · 64625 Bensheim
TOMED Dr. Toussaint GmbH Medical Products Lindberghstr. 3a D - 64625 Bensheim Germany
Dr. Toussaint GmbH
Tel .: +49-6251-98 33 44 Fax: +49-6251-98 33 45 eMail: w.toussaint@tomed.com http://www.tomed.com
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:
C