(65 days)
The Beam Brush is a toothbrush to remove plaque and debris from its user's teeth and aide in the prevention of tooth decay. The Beam Brush collects brushing usage data and wirelessly transmits the data to a software application (Beam App) that runs on the user's own mobile device ("smartphone").
The Beam Brush is a manual toothbrush comprised essentially of a shaft with synthetic bristles on one end that are used to remove plaque and food debris from its user's teeth. The bristle material is Nylon 612 or Polyamide 612. The Beam Brush collects brushing usage data based on the principle that the human body possesses the property of being a good capacitor, such that the human body has a detectable capacitance. This capacitance is transferrable through a thermoplastic material. The Beam Brush comprises a capacitive sensor, which is completely enclosed in the toothbrush body. The capacitive sensor detects that the Beam Brush is in use based on the capacitance introduced by the human body when the Beam Brush is utilized for its intended purpose. The Beam Brush wirelessly transmits the collected data using radio frequency transmission, more specifically Bluetooth® radio. The Bluetooth® standard defines the parameters for transmission of data via radio frequency including a transmitting frequency of 2.4 GHz. The Beam Brush is a Class 2 Bluetooth® device, which has a transmission range of about 30 feet and a maximum power of 2.5 mW. The data is received by a user's own mobile device that runs a software application (Beam App), which is of a minor level of concern. The Beam App is an accessory to the Beam Brush and allows the user to view his/her brushing usage data for the user's convenience and education. The Beam App, collection of data, and transmission of data are not intended for the diagnosis and treatment of disease or to affect the structure or function of the body. The Beam Brush's capacitive sensor and Bluetooth® radio are powered by a single AA alkaline battery that is replaceable. The Beam Brush also comprises a replaceable brush head that connects to the handle at the base of the neck.
The provided text describes the Beam Brush/Beam App, a manual toothbrush with a capacitive sensor that collects brushing usage data and transmits it wirelessly to a mobile application. However, the document does not contain a study that proves the device meets specific acceptance criteria in the way typically required for a medical device that makes diagnostic or therapeutic claims.
The device is classified as a Class I manual toothbrush (21 CFR 872.6855) with the product code EFW. Class I devices are subject to general controls and typically do not require extensive clinical studies to demonstrate safety and effectiveness in the same way Class II or Class III devices do. The primary focus of the testing mentioned in this particular submission is on establishing substantial equivalence to a predicate device (Oral-B® "sub-brand" manual toothbrush, K073224) and ensuring electrical safety, electromagnetic compatibility, and software verification/validation.
Here's an analysis based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of specific, quantifiable acceptance criteria for clinical performance (e.g., plaque reduction percentage) and corresponding device performance data in the context of a clinical study. Instead, the "testing" section focuses on demonstrating mechanical integrity, electrical safety, and software functionality to support substantial equivalence.
| Acceptance Criteria Category | Specific Criteria (as inferred/stated) | Reported Device Performance |
|---|---|---|
| Mechanical Integrity | Pull-off force of brush head | Tested to demonstrate substantial equivalence to legally marketed toothbrushes for the brush head remaining connected during normal brushing. (Specific force values or pass/fail criteria are not provided.) |
| Electrical Safety | Compliance with IEC 60601-1 | Will comply with applicable requirements of IEC 60601-1. This evaluation demonstrates substantial equivalence regarding electrical safety. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | Will comply with applicable requirements of IEC 60601-1-2. This evaluation demonstrates substantial equivalence regarding EMC. |
| Radio Frequency (RF) Compliance | Compliance with FCC Equipment Authorization | Will comply with applicable requirements of FCC Equipment Authorization. |
| Software Functionality | Software Verification and Validation | Completed software verification and validation testing, demonstrating substantial equivalence when using the software application. (Specific test results or metrics are not provided.) |
2. Sample Size for Test Set and Data Provenance:
No information is provided about a specific "test set" for performance evaluation in a clinical context. The testing described focuses on engineering and regulatory compliance rather than clinical efficacy.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. The device's primary function as a manual toothbrush for plaque removal is well-established, and the data collection/transmission feature is stated to be for "convenience and education," not for diagnosis or treatment. Therefore, the concept of establishing "ground truth" by experts for clinical efficacy (e.g., disease detection) is not within the scope of this submission.
4. Adjudication Method:
Not applicable. No clinical study with expert adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was done. The device does not involve human readers interpreting data for diagnostic purposes with or without AI assistance.
6. Standalone Algorithm Performance:
The device has a "standalone" function in the sense that the sensor collects data and the app displays it, but this is not an "algorithm only" performance study in a diagnostic context. The software application is an accessory for displaying data, not a diagnostic or treatment algorithm. The Beam App is a minor level of concern software.
7. Type of Ground Truth Used:
The concept of "ground truth" (e.g., pathology, outcomes data) is not applicable in the context of this 510(k) submission. The device is a manual toothbrush, and its data collection feature is for user information, not for clinical decision-making. The ground truth for its basic function (plaque removal) is implicitly understood from the long history of manual toothbrushes.
8. Sample Size for the Training Set:
No training set is mentioned as the device does not employ machine learning or AI models that require training data for diagnostic or prognostic purposes.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is mentioned.
Summary of the Study and Device Justification:
The "study" or justification for the Beam Brush/Beam App's acceptance is based on demonstrating substantial equivalence to a legally marketed predicate manual toothbrush (Oral-B® "sub-brand" manual toothbrush, K073224). This substantial equivalence is primarily established through:
- Mechanical Testing: Demonstrating the brush head remains connected during normal use.
- Electrical Safety and EMC Testing: Compliance with international standards (IEC 60601-1 and IEC 60601-1-2) and FCC authorization for the electronic components.
- Software Verification and Validation: Ensuring the software accessory functions as intended and is of "minor level of concern."
The key takeaway is that the Beam Brush/Beam App is essentially a manual toothbrush with an added feature for collecting and displaying brushing duration data. The FDA cleared it as a Class I device based on its similarity to existing manual toothbrushes, with the data collection feature presented as an accessory for user education and convenience, explicitly not for diagnosis or treatment. Therefore, the acceptance criteria and supporting "study" are focused on regulatory compliance and basic functional safety rather than clinical efficacy against specific performance metrics for a diagnostic or therapeutic claim.
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l2 12 ll65
JUN 2 1 2012
510(k) SUMMARY
Section 5.0
Beam Technologies, LLC P.O. Box 17541 Louisville, KY 40217
Alex Curry Head of Product Beam Technologies, LLC P.O. Box 17541 Louisville, KY 40217
Telephone: 859.462.7562 Email: curry@beamtoothbrush.com
Date Summary Prepared:
Applicant Correspondent:
Applicant:
April 13, 2012
Proprietary Name of Device:
Beam Brush/ Beam App
Toothbrush, Manual
Generic/Classification Name:
Product code (Classification):
EFW (Class I, 21 CFR 872.6855)
Legally Marketed Predicate Device:
Oral-B® "sub-brand" manual toothbrush (K073224) (i.e. CrossAction, Advantage, Pulsar, Pro-Health) Procter & Gamble
DEVICE DESCRIPTION AND TECHNOLOGICAL CHARACTERISTICS
The Beam Brush is a manual toothbrush comprised essentially of a shaft with synthetic bristles on one end that are used to remove plaque and food debris from its user's teeth. The bristle material is Nylon 612 or Polyamide 612. The Beam Brush collects brushing usage data based on the principle that the human body possesses the property of being a good capacitor, such that the human body has a detectable capacitance. This capacitance is transferrable through a thermoplastic material. The Beam Brush comprises a capacitive sensor, which is completely enclosed in the toothbrush body. The capacitive sensor detects that the Beam Brush is in use based on the capacitance introduced by the human body when the Beam Brush is utilized for its intended purpose.
The Beam Brush wirelessly transmits the collected data using radio frequency transmission, more specifically Bluetooth® radio. The Bluetooth® standard defines the parameters for transmission of data via radio frequency including a transmitting frequency of 2.4 GHz. The Beam Brush is a Class 2
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Bluetooth® device, which has a transmission range of about 30 feet and a maximum power of 2.5 mW. The data is received by a user's own mobile device that runs a software application (Beam App), which is of a minor level of concern. The Beam App is an accessory to the Beam Brush and allows the user to view his/her brushing usage data for the user's convenience and education. The Beam App, collection of data, and transmission of data are not intended for the diagnosis and treatment of disease or to affect the structure or function of the body.
The Beam Brush's capacitive sensor and Bluetooth® radio are powered by a single AA alkaline battery that is replaceable. The Beam Brush also comprises a replaceable brush head that connects to the handle at the base of the neck.
INDICATIONS FOR USE
The Beam Brush is a toothbrush to remove plaque and debris from its user's teeth and aide in the prevention of tooth decay. The Beam Brush collects brushing usage data and wirelessly transmits the data to a software application (Beam App) that runs on the user's own mobile device ("smartphone").
TESTING
The Beam Brush was tested to determine the pull-off force of the brush head when it is improperly removed from the handle. This test demonstrates the substantial equivalence to legally marketed toothbrushes of the replaceable head of the manual toothbrush to remain connected during the normal course of brushing.
The Beam Brush is an alkaline battery operated manual toothbrush. All electrical components including the capacitive sensor and the Bluetooth® radio are housed within thermoplastic enclosures.
The Beam Brush will be evaluated and will comply with the applicable requirements of international standard IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance (Second Edition, 1988). The Beam Brush also will be evaluated and comply with the applicable requirements of international standard IEC 60601-1-2 Medical Electrical Equipment – Part 1: General Requirements for Safety; Electromagnetic Compatibility – Requirements and Tests (Second Edition, 2001). Additionally, the Beam Brush will be evaluated and will comply with the applicable requirements of Equipment Authorization by the Federal Communications Commission. Collectively, these evaluations and compliances demonstrate the Beam Brush's substantial equivalence to legally marketed toothbrushes in regard to electrical safety and electromagnetic compatibility.
The Beam Brush/Beam App completed software verification and validation testing. Collectively, these tests demonstrate that the Beam Brush/Beam App is substantially equivalent to legally marketed toothbrushes when using a software application that runs on the user's own mobile device.
CONCLUSIONS
The information provided supports the substantial equivalence to the predicate device of the Beam Brush/Beam App without raising any new safety and effectiveness issues.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of the department's name, which is arranged in a circular fashion around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Alex Curry Head of Product Beam Technologies, LLC P.O. Box 17541 Louisville, Kentucky 40217
UN 2 1 2017
Re: K121165
Trade/Device Name: Beam Brush/Beam APP Regulation Number: 21 CFR 872.6855 Regulation Name: Manual Toothbrush Regulatory Class: I Product Code: EFW Dated: April 13, 2012 Received: April 17, 2012
Dear Mr. Curry:
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 Eederal Register.
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Page 2 - Mr. Curry
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 vours.
hh for
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
Enclosure
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Indications for Use
Section 4.0
510(k) Number (if known): K121165
Proprietary Device Name: Beam Brush/ Beam App
Indications for Use: The Beam Brush is a toothbrush to remove plaque and debris from its user's teeth and aide in the prevention of tooth decay. The Beam Brush collects brushing usage data and wirelessly transmits the data to a software application (Beam App) that runs on the user's own mobile device ("smartphone").
Prescription Use × (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 IF NEEDED)
Concurrence of CDRH, Office of-Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Beam Technologies CONFIDENTIAL
Page 1 of 1
Section 4.0
§ 872.6855 Manual toothbrush.
(a)
Identification. A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.