(218 days)
- Protection of teeth and restorations from injury due to bruxism or clenching.
- Temporary relief of Temporo Mandibular joint Disorder (TMD) and bruxism by reducing muscle tension.
- Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.
The Brux-TMD QuickSplint is a patented anterior bite plate that covers the upper or lower front teeth from bicuspid though bicuspid. It is a two-component device with a hard plastic shell and a softer compliant lining that conforms to the supporting teeth. The operator may optionally place it on the anterior maxillary or mandibular arch. The Brux-TMD QuickSplint is easily and quickly assembled in a provider's office for same day use by the patient. While it is worn, the Brux-TMD QuickSplint temporarily inhibits the full force of parafunctional teeth clenching, and gives the pericranial musculature an opportunity to relax. This reduces the muscular tension that underlies the pain associated with many bruxism headaches and the pain associated with TMD dysfunction. It reduces the muscle tension in trigeminal innervated cranial-facial muscles, thereby reducing the pain occurrence. In addition, it physically protects the teeth from nighttime bruxing activities by covering the dental occlusal surfaces with a durable plastic covering.
The provided text describes a medical device, the Brux-TMD QuickSplint, and its FDA 510(k) premarket notification. However, it does not contain information about acceptance criteria, a study that proves the device meets specific acceptance criteria, or any details related to AI performance metrics.
The document focuses on:
- Device Description: The physical characteristics and mechanism of action of the Brux-TMD QuickSplint.
- Intended Use: The conditions the device is designed to address (bruxism, clenching, TMD, associated pain and headaches).
- Comparison to Predicate Devices: A table comparing the Brux-TMD QuickSplint to existing, legally marketed devices, highlighting similarities in indications, design, use, reusability, disinfection methods, and risk.
- FDA 510(k) Clearance: The formal letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.
The document primarily addresses the substantial equivalence of the new device to existing ones, a regulatory pathway that often relies on demonstrating similar characteristics and intended use rather than conducting new, extensive performance studies against specific acceptance criteria, especially for unclassified devices like this one.
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MigraTherapy LLC
Premarket Notification for Brux-TMD QuickSplint
NOV 222 2011
510(k) Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness for the DEVICE is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) Summary.
| Applicant: | MigraTherapy LLC. |
|---|---|
| Address: | 4403 Manchester AvenueSuite 103Encinitas, Ca 92024 |
| Contact Person: | Louis Kirby, MD |
| Telephone: | 602 908-1680 or 760 840-6034 |
| Fax: | 602 957-4053 |
| Preparation Date: | 29 March 2011 |
| Device Trade Name: | Brux-TMD QuickSplint |
| Common Name: | None |
| Classification Name: | Unclassified |
| Product Code: | MQC |
| Legally MarketedPredicates: | 1. MCI Clenching Inhibitor2. Custom fabricated full occlusal coverage3. Dr. Hays Bite Guard |
テ
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MigraTherapy LLC
510(k) Summary of Safety and Effectiveness for the Brux-TMD QuickSplint device, continued:
| Device Description: | The Brux-TMD QuickSplint is a patented anterior bite plate thatcovers the upper or lower front teeth from bicuspid though bicuspid.It is a two-component device with a hard plastic shell and a softercompliant lining that conforms to the supporting teeth. The operatormay optionally place it on the anterior maxillary or mandibular arch. | ||
|---|---|---|---|
| The Brux-TMD QuickSplint is easily and quickly assembled in aprovider's office for same day use by the patient. | |||
| While it is worn, the Brux-TMD QuickSplint temporarily inhibits thefull force of parafunctional teeth clenching, and gives the pericranialmusculature an opportunity to relax. This reduces the musculartension that underlies the pain associated with many bruxismheadaches and the pain associated with TMD dysfunction. It reducesthe muscle tension in trigeminal innervated cranial-facial muscles,thereby reducing the pain occurrence. In addition, it physicallyprotects the teeth from nighttime bruxing activities by covering thedental occlusal surfaces with a durable plastic covering. | |||
| Intended Use: | 1. Protection of teeth and restorations from injury due tobruxism or clenching.2. Temporary relief of Temporo Mandibular joint Disorder(TMD) and bruxism by reducing muscle tension.3. Temporary treatment of Temporal Mandibular Disorder(TMD) along with the relief of associated headaches andpains. | ||
| The Brux-TMD QuickSplint is to be worn at night and removed inthe morning except in the presence of severe pain in which case itmay be worn during the day for limited periods as instructed by theprescriber. | |||
| The intended user includes patients diagnosed with bruxism, patientswith headaches and pain related to bruxism, Patients with TMD,patients with headaches and pain related to TMD and patients whomay damage teeth or dental restorations from the clenching andgrinding related to bruxism activity. | |||
| In the professional office, Brux-TMD QuickSplint can be placed thesame day as the office visit and following dental procedures(endodontic, oral surgery, placement of cosmetic dental prostheticsand periodontal surgery) where bruxing activity might damage the |
results or cause increased pain. The Brux-TMD QuickSplint is described as temporary and should be considered transitional if the
CONFIDENTIAL
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MigraTherapy LLC
307 3
patient experiences benefits.
These indications and patient populations are substantially the same as the predicate devices.
| Comparison of predicate devicesBrux-TMDQuickSplintK11066 | MCI-MyohealthClenchinginhibitorK040315 | Full coverage,custom fabricatedbite plate (pre-1972 device) | Dr. Hays BiteGuardK014079 | |
|---|---|---|---|---|
| Indications | Protection of teethand restorationsfrom injury due tobruxism or clenching | Same | Same | Same |
| Treatment ofTemporalMandibular Disorder(TMD) along withthe relief ofassociated headachesand pains. | Same | Same | Same | |
| Relief of bruxismrelated headachesand pains. | Same | Same | Same | |
| Regulatory | Pre-MarketNotification 510(k) | Pre-MarketNotification510(k) | Preamendment | Pre-MarketNotification 510(k) |
| Design | Custom fittedmouth guard | Same | Same | Same |
| Use | Nighttime | Same | Same | Same |
| Reusable | Yes | Same | Same | Same |
| Method ofdisinfection | Soap and water; airdry | Same | Same | Same |
| Materials | Polycarbonate tray;vinyl polysiloxaneliner | Polycarbonate,thermoplasticliner | methacrylate acrylic | Lexan and Elvax |
| Risk ofexposure | None | None | None | None |
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's name arranged in a circular fashion on the left side, with a dotted line separating the text from a stylized symbol on the right. The symbol consists of three curved lines that resemble a stylized human figure or abstract representation of health and well-being.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 22 2011
Dr. Louis Kirby CEO Migra Therapy LLC 4403 Manchester Avenue, Suite 103 Encinitas, California 92024
Re: K111066
Trade/Device Name: Brux-TMD QuickSplint Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MQC Dated: November 10, 2011 Received: November 14, 2011
Dear Dr. Kirby:
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. 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.
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Page 2 - Dr. Kirby
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices /Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthon D. Aratzer
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
Intended Use:
Indications
-
- Protection of teeth and restorations from injury due to bruxism or clenching.
-
- Relief of bruxism related headaches and pains.
- Treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated 3. headaches and pains.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
DRH. Office of Device Evaluation (ODE)
WILLA VOLLMER, HS for Susan Rummer 11/17/11
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K11 1066
CONFIDENTIAL
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