(149 days)
The BRX PRO™ Bruxism Guard is indicated to protect the teeth and reduce damage caused by bruxing or nighttime grinding and reducing the noise associated with bruxing and grinding.
The BRX PRO is a prescription dual arch bruxism guard which protects the teeth and reduces the damage caused by nighttime bruxism and reduces the noise of bruxing or nighttime grinding. The BRX PRO's two arch trays, when filled with impression material, cover approximately eight teeth on each of the upper and lower arches, thereby creating an air-gap between the posterior teeth that prevents tooth contact upon clenching. The two polycarbonate trays are connected in the front with a dual position stainless steel "T-bar" pin in the upper tray and a pair of stainless steel slots in the lower tray that can be set by the prescriber to maintain the BRX PRO trays in a neutral position by selecting one of four positions, while allowing for lateral mandibular movement.
The provided text describes a 510(k) premarket notification for the BRX PRO™ bruxism guard. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance studies with clinical outcomes. As such, the information typically found in acceptance criteria of a clinical performance study for an AI-powered device is not fully present.
However, based on the provided text, I can infer and extract information related to the device's technical specifications and non-clinical testing.
Here's a breakdown of the requested information based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details non-clinical acceptance criteria related to material properties and biological safety. There is no performance data related to clinical effectiveness (e.g., reduction in bruxing events or noise) in this document, as it focuses on substantial equivalence of the device as a physical product.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Physical Characteristics: | |
| Flexural Modulus (≥ 2000 MPa) | Pass |
| Flexural Stress (≥ 65 MPa) | Pass |
| Water Absorption (≤ 32 µg/m³) | Pass |
| Water Solubility (≤ 1.6 µg/m³) | Pass |
| Charpy Notched Impact Strength (≥ 0.9 KJ/m²) | Pass |
| Biological Evaluation (ISO 10993 Series): | |
| Part 1: Risk Management Process | Pass |
| Part 5: In vitro cytotoxicity | Pass |
| Part 10: Irritation and skin sensitization | Pass |
| Other Applicable Standards: | |
| BS EN ISO 15223-1:2012 (Symbols) | Pass |
| BS EN ISO 20795-1:2013 (Dentistry - Base polymers) | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical bench testing, not clinical trials with patient data. Therefore, there is no "test set" in the context of patient data, nor information on country of origin or whether data was retrospective or prospective. The "samples" would refer to material samples tested in the lab. The sample sizes for these material tests are not specified in the document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document describes non-clinical bench testing of material properties and biological safety, not a clinical study requiring expert ground truth in the medical sense.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices where human interpretation is involved. The BRX PRO™ is a physical medical device (a bruxism guard), and its clearance is based on substantial equivalence to existing similar devices through non-clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The BRX PRO™ is a physical device, not an algorithm or AI software, so the concept of "standalone performance" for an algorithm doesn't apply.
7. The Type of Ground Truth Used
For the non-clinical tests described, the "ground truth" would be established by international standards and specifications (e.g., ISO for material properties, ISO for biological evaluation). The device's materials were tested against these pre-defined, objective chemical and physical properties.
8. The Sample Size for the Training Set
This information is not applicable. The BRX PRO™ is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2015
12th Man Technologies, Inc. Mr. Alex Stenzler President 7245 Garden Grove Blvd., Suite C Garden Grove, California 92841
Re: K151933
Trade/Device Name: BRX PROTM Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: MQC Dated: October 28, 2015 Received: October 30, 2015
Dear Mr. Stenzler:
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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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):K151933 Device Name: BRX PRO™
Indications for Use:
The BRX PRO™ Bruxism Guard is indicated to protect the teeth and reduce damage caused by bruxing or nighttime grinding and reducing the noise associated with bruxing and grinding.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of of ___________________________________________________________________________________________________________________________________________________________________
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510(k) Summary
| Submitter's Name | 12th Man Technologies, Inc.7245 Garden Grove Blvd., Suite GGarden Grove, CA 928411.714.705.4576 |
|---|---|
| Registration Number | 3009108174 |
| Contact Name | Alex Stenzler12th Man Technologies, Inc.7245 Garden Grove Blvd., Suite GGarden Grove, CA 92841Telephone: 1.714.705.4576Fax: 1.714.373.0505Email: alex.stenzler@12thmantec.com |
| Date Prepared | December 10, 2015 |
| Device Trade Name | BRX PRO™ |
| Device Common Name | Bruxism guard |
| Classification Name | None |
| Product Code | MQC |
| Device Classification | Unclassified |
| Panel | Dental |
| 510(k) Submission | Traditional |
| Legally Marketed Equivalent | SmartGuard (K123161)Brux-TMD QuickSplint (K111066) |
Description
The BRX PRO is a prescription dual arch bruxism guard which protects the teeth and reduces the damage caused by nighttime bruxism and reduces the noise of bruxing or nighttime grinding. The BRX PRO's two arch trays, when filled with impression material, cover approximately eight teeth on each of the upper and lower arches, thereby creating an air-gap between the posterior teeth that prevents tooth contact upon clenching. The two polycarbonate trays are connected in the front with a dual position stainless steel "T-bar" pin in the upper tray and a pair of stainless steel slots in the lower tray that can be set by the prescriber to maintain the BRX PRO trays in a neutral position by selecting one of four positions, while allowing for lateral mandibular movement.
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The impression materials that can be used to interface with the teeth are any of the approved for sale materials such as Mousse PVS (Parkell), individually selected by the dentist or physician fitting the patient with the BRX PRO and are typically a polyvinyl siloxane (PVS) available from many dental supply sources.
Predicate Devices
The design of the BRX PRO is substantially equivalent to the SmartGuard (K123161) and the Brux-TMD QuickSplint (K111066). The predicate devices are mouth guards designed to protect the teeth and reduce damage caused by bruxing or nighttime grinding and reduce the noise associated with bruxing and grinding. The Brux-TMD QuickSplint uses thermoplastic arches filled with impression material to interface to the teeth. The impression material is the same PVS as recommended for use in the BRX PRO and can be fitted in a prescriber's office. The BRX PRO Instructions-for-Use recommends that the dentist or prescriber uses commercially available polyvinyl siloxane impression materials to create the tray liner to obtain the ideal fit. Because these mouth guards can be used on either the upper or lower teeth, some dentists prescribe that the patient use mouth guards on both arches. The SmartGuard, Brux-TMD QuickSplint and the BRX PRO all use partial arches to create a posterior arch air gap.
Description of Operation
The BRX PRO comes with two sets of trays. A pair of impression trays (upper and lower) are sequentially filled with a PVS impression material by the prescriber to fit to the patient. Once trimmed by the dentist, the impressions are transferred to the treatment trays. The upper tray has a "T-bar" pin that extends out from the bottom of the tray. The pin has an anterior or posterior orientation so that when combined with the two slots in the lower tray, provides for a selection of four positions to fit the patient who may have a natural bite ranging from a Class III as well as an edge-to-edge bite position. The "T-bar" pin is inserted into the slot and rotated 90 degrees to connect the two trays. The slots provide for lateral movement of the mandible.
Indications for Use:
To protect the teeth and reduce damage caused by bruxing or nighttime grinding and reducing the noise associated with bruxing and grinding.
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| Substantial Equivalency Summary Comparison Table | |||
|---|---|---|---|
| Element ofComparison | BRX PRO™ | SmartGuard | Brux-TMD QuickSplint |
| Indications forUse | To protect the teeth andreduce damage causedby bruxing or nighttimegrinding and reducingthe noise associatedwith bruxing andgrinding. | To reduce damage to theteeth and reduce noiseassociated with bruxingand/or grinding | Prevent teeth grinding,reduces jaw clenching anddamage to teeth |
| Regulatory | Pre-Market Notification510(k) | K123161 | K111066 |
| Environmentof Use | Home Setting | Home Setting | Home Setting |
| Design | Custom fitted mouthguard | Custom fitted mouthguard | Custom fitted mouthguard |
| Use | Night time | Night time | Night time |
| Daily Durationof Use | Up to 8 hours per nightfor up to 30 days | Up to 12 hours per 24hour period | While asleep and limiteddaytime use |
| TransitionalDevice | Yes | NA | Yes |
| Reusable | Yes, Single Patient | Yes, Single Patient | Yes, Single Patient |
| Sterile | No | No | No |
| Method ofdisinfection | Denture cleaner | Denture cleaner | Soap and water |
| Tray Materials | Polycarbonate andstainless steel | Elvax (ethylene vinylacetate copolymer) | Polycarbonate |
| Traymanufacturingmethod | Injection molded | Injection molded | Injection molded |
| ImpressionMaterial | Prescriber selected andsupplied PVS | Elvax (ethylene vinylacetate copolymer) | Prescriber selected andsupplied PVS |
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Non-Clinical Testing
Non-clinical test results are submitted to confirm product conformance with device requirements and substantial equivalence to predicate device. These bench tests included:
-
- Packaging and Assembly / Shipping
-
- Materials Specifications
-
- Labeling Verification
-
- Physical Characteristics
| Physical Parameter | Test Method | ISO 20795-1:2013Requirement | Pass/Fail |
|---|---|---|---|
| Flexural Modulus | ISO 178 | ≥ 2000 MPa | Pass |
| Flexural Stress | ISO 178 | ≥ 65 MPa | Pass |
| Water Absorption | ISO 62 | ≤ 32 µg/m³ | Pass |
| Water Solubility | ISO 62 | ≤ 1.6 µg/m³ | Pass |
| Charpy Notched ImpactStrength (Linear relationwith Fracture) | ISO 179 | ≥ 0.9 KJ/m² | Pass |
-
- Manufacturing
| Applicable Standards Met | |||||
|---|---|---|---|---|---|
| Standard orRegulation | StandardOrganization orRegulatoryBody | Name of Test Performed | TestResults | ||
| ISO 10993-1:2009 COR 12010 | InternationalStandards Office | Biological Evaluation of MedicalDevices - Part 1: Evaluation andTesting within a Risk ManagementProcess | Pass | ||
| ISO 10993-5:2009 | InternationalStandards Office | Biological Evaluation of MedicalDevices – Part 5 Tests for in vitrocytotoxicity | Pass | ||
| ISO 10993-10:2009 | InternationalStandards Office | Biological Evaluation of MedicalDevices - Part 10 Tests for irritationand skin sensitization | Pass | ||
| BS EN ISO15223-1:2012 | InternationalStandards Office | Medical Devices - Symbols to be usedwith Medical Devices Labels,Labelling and Information to besupplied- Part 1: GeneralRequirements | Pass | ||
| BS EN ISO20795-1:2013 | InternationalStandards Office | Dentistry - Base polymers, Part 1:Denture base polymers | Pass |
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Substantial Equivalence
Based on the design, intended use, principle of operation, technological characteristics, performance data, and attribute comparison above, the 12th Man Technologies, Inc. BRX PRO bruxism guard is substantially equivalent to the currently marketed predicate devices which have been previously reviewed for market clearance by the FDA.
[510(k)] Number
N/A