(65 days)
Not Found
No
The description focuses on data collection and transmission for user viewing, with no mention of AI/ML algorithms for analysis or interpretation.
No
The device is described as a toothbrush intended to remove plaque and debris and aid in tooth decay prevention, which are general hygiene and preventive functions. The description explicitly states that the data collection and transmission are "not intended for the diagnosis and treatment of disease or to affect the structure or function of the body," which are key characteristics of therapeutic devices.
No
The device description explicitly states: "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." Its purpose is to collect brushing usage data for user convenience and education, not for diagnostic purposes.
No
The device description clearly outlines hardware components (toothbrush with capacitive sensor, Bluetooth radio, battery) that are integral to the device's function of collecting and transmitting data. While there is a software component (Beam App), the device itself is not solely software.
Based on the provided information, the Beam Brush is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as "to remove plaque and debris from its user's teeth and aide in the prevention of tooth decay." This is a physical action on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the mechanical function of a toothbrush and the collection/transmission of brushing usage data. It does not describe any components or processes for analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
- Lack of Diagnostic Claims: The document explicitly states that 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." This directly contradicts the purpose of an IVD.
- Anatomical Site: The anatomical site is "teeth," which is the target of the physical cleaning action, not a source of a sample for in vitro analysis.
- Predicate Device: The predicate device is a manual toothbrush, which is not an IVD.
In summary, the Beam Brush is a manual toothbrush with added functionality for tracking usage data. Its purpose is physical cleaning and data collection for user information, not in vitro diagnosis.
N/A
Intended Use / 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").
Product codes (comma separated list FDA assigned to the subject device)
EFW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
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.
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
§ 872.6855 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.
0
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
1
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.
2
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.
3
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
4
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
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Section 4.0