(232 days)
Not Found
No
The description focuses on mechanical adjustments and material composition, with no mention of AI or ML technologies.
Yes
The device is described as a "custom-fitted mandibular repositioning device intended to reduce or alleviate nighttime snoring and obstructive sleep apnea," indicating a therapeutic purpose.
No
The device description indicates it is a treatment device (mandibular repositioning device to alleviate snoring and sleep apnea), not a diagnostic one.
No
The device description clearly describes a physical, custom-fitted mandibular device made of materials like casted framework and thermo-plastic, with mechanical components for adjustment. It is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices 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 SUAD™ Device is a physical, custom-fitted oral appliance that is placed inside the mouth to mechanically reposition the jaw. It does not analyze any biological samples.
- Intended Use: Its intended use is to physically reduce or alleviate snoring and sleep apnea by altering the position of the mandible.
The device description and intended use clearly indicate it's a mechanical device for physical intervention, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
A custom-fitted mandibular repositioning device intended to reduce or alleviate nighttimc snoring and obstructive slocp apnca.
Contraindications:
The device is contraindicated for paticnts who:
- Have central siccp apnea
- Have severe respiratory disorders
- Have an edentulous arch
- Have loose tecth or advanced periodontal discase
- Are under 18 years of age.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The SUAD™ Device is a Mandibular advancement device/appliance (MAD). The SUAD™ Device has the following modifications: the combination of the materials used, the assembly and the fabrication technique. The casted framework is substantially equivalent to the casted framework used in dentures used prior to 1976. The "tube and rod" assembly of the pivot and ube is substantially equivalent to the Herbst appliance. The angle of the connecting tube to the pivot has been changed to allow for greater stability of the appliance. The framework is used to strengthen the device. The smooth "buttons," frames that cover all the occlusal and incisal surfaces, and the use of the vacuum-formed thermo-plastic to hold the appliance results in less exposed wires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intraoral
Indicated Patient Age Range
Not applicable to patients under 18 years of age.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.”
0
I.
| 510(k) Summary of Safety and Effectiveness | JUL 0 8 2003 | ||
|---|---|---|---|
| Submitter: | Patrick J. Strong | ||
| Strong Dental Inc. | |||
| 33 Princess Street, Suite 403 | |||
| Leamington, Ontario, Canada | |||
| N8H 5C5 | |||
| Telephone: | 1-800-339-4452 | ||
| Facsimile: | (519) 322-1320 | ||
| Contact Person: | Patrick J. Strong or Mary Lou Strong | ||
| Description of the Device: | |||
| Trade name: | The SUAD™ Device | ||
| Descriptive name: | Mandibular advancement device/appliance (MAD) | ||
| Common Name: | Sleep apnea/Anti-snoring device | ||
| Product code: | LRK Anti-snoring device | ||
| Device Class: | Class II | ||
| Establishment Registration | |||
| Number: | None | ||
| Intended Use: | To reduce or alleviate nighttime snoring and | ||
| obstructive sleep apnea (OSA). |
The Removable Herbs1 Appliance is the predicate device for the SUAD™ Device, having all the same functional characteristics. The Removable Herbst Appliance (510(k) K955822) is a custom-fitted mandibular device that allows patients to move their jaw laterally and vertically without disengaging the appliance. The device is adjusted to provide the anticipated relief of the condition by moving the mandible forward in 1mm increments by adding advancement shims onto the posts.
The SUAD" Device has the following modifications: the combination of the materials used, the assembly and the fabrication technique. Detailed drawings of The SUAD" device are available in the patent, Patent No. US 6,418,933 B1 [Reference 1 ].
1
1. 510(k) Summary of Safety and Effectiveness (continued)
The SUAD™ Device functions in a similar manner to other comparative predicate devices and the intended uses are the same (See Table 1). The general differences or modifications between the device and predicate devices are minor and do not raise new safety concerns. Table 2 lists the risks identified for this device and summarizes how Strong Dental Inc. has addressed the risk.
The casted framework is substantially equivalent to the casted framework used in dentures used prior to 1976. The "tube and rod" assembly of the pivot and ube is substantially equivalent to the Herbst appliance. The angle of the connecting tube to the pivot has been changed to allow for greater stability of the appliance. The framework is used to strengthen the device. The smooth "buttons," frames that cover all the occlusal and incisal surfaces, and the use of the vacuum-formed thermo-plastic to hold the appliance results in less exposed wires.
2
دت بے بے اس
I. 510(k) Summary of Safety and Effectiveness (continued)
- ·
Table 1. Substantial Equivalence Comparison
| Attribute | SUAD™ | Herbst | Klearway | Silencer | TAP |
|---|---|---|---|---|---|
| USE | |||||
| Intraoral device | Yes | Yes | Yes | Yes | Yes |
| Reduce snoring | Yes | Yes | Yes | Yes | Yes |
| Reduce obstructive | |||||
| sleep apnea | Yes | Yes | Yes | Yes | Yes |
| DESIGN | |||||
| Removable device | Yes | Yes | Yes | Yes | Yes |
| Custom fit | Yes | Yes | Yes | Yes | Yes |
| Adjustable | Yes | Yes | Yes | Yes | Yes |
| Allows lateral and | |||||
| vertical movement | Yes | Yes | Yes | Yes | Yes |
| Clasps required | No | Yes | Yes | Yes | Yes |
| Frames cover all | |||||
| occlusal and incisal | |||||
| surfaces | Yes | Yes | Yes | Yes | Yes |
| Buttons attached to | |||||
| frames to attach | |||||
| conventional elastics | Yes | No | No | No | No |
| Angle of upper | |||||
| connecting tube | |||||
| redirected for greater | |||||
| stability of the upper | |||||
| form | Yes | No | No | No | No |
| Casted framework | |||||
| inserted into upper | |||||
| and lower frames | Yes | No | No | No | No |
| MATERIALS | |||||
| Base material, vinyl | Yes | Yes | Yes | Yes | Yes |
| Ethylene acrylic | |||||
| overlay | Yes | Yes | Yes | Yes | Yes |
| Steel metal | |||||
| components | Yes | Yes | Yes | Yes | Yes |
| Casted metal | |||||
| framework | Yes | No | No | No | No |
| TESTING | |||||
| Not applicable | Yes | Yes | Yes | Yes | Yes |
3
I. 510(k) Summary of Safcty and Effectivencss (continued)
Table 2. Risk Profile
| Identified risk | Special controls |
|---|---|
| Intraoral gingival, palatal, or dental soreness | The internal framework and specific materials |
| used provides for a comfortable fit. | |
| Obstruction of oral breathing | The angle of the upper connecting tube has |
| been redirected, allowing for greater stability of | |
| the upper form. With the retruded force of the | |
| mandible, the new direction of the tube forces | |
| the upper frame to stay in a properly seated | |
| position. | |
| Loosening or flaring of lower anterior teeth or | |
| general tooth movement | The frames are designed to cover all the |
| occlusal and incisal surfaces. |
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Strong Dental Incorporated C/O Clyde A. Takeguchi, Ph. D. Phoenix Regulatory Associates, Limited 21525 Ridgetop Circle, Suite 240 Sterling, Virginia 20166
JUL 0 8 2003
Re: K023836 Trade/Device Name: SUAD™ Device Regulation Number: 21 CFR 872.5570 Regulation Name: Anti-Snoring Device Regulatory Class: II Product Code: LRK Dated: April 11, 2003 Received: April 11, 2003
Dear Dr. Takeguchi:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
5
Page 2 - Dr. Takeguchi
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Suer Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
II. Indications for Usc
510(k) Number: K023836
Devicc Name: SUAD™ Devicc
A custom-fitted mandibular repositioning device intended to reduce or alleviate nighttimc snoring and obstructive slocp apnca.
Contraindications:
The device is contraindicated for paticnts who:
- Have central siccp apnea ●
- Have severe respiratory disorders .
- Have an edentulous arch .
- Have loose tecth or advanced periodontal discasc .
. .
- Are under 18 years of age. .
Keen Mely for MSP
ivision Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Denta
510(k) Number: K 023836