(195 days)
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No
The summary describes a mechanical debridement instrument and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is used for debridement in the treatment of peri-implantitis affecting dental implants, which is a therapeutic intervention.
No
The device, TN-Brush, is described as a "debridement instrument" used for the "open debridement of titanium implant surfaces." This indicates a therapeutic or interventional function rather than a diagnostic one. It treats a condition (peri-implantitis) rather than identifying or characterizing it.
No
The intended use describes a "debridement instrument" and indicates it is used for "open debridement," which strongly suggests a physical tool or device, not software. The lack of a device description or mention of software further supports this.
Based on the provided information, the TN-Brush is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the TN-Brush is a "debridement instrument for titanium dental implants subjected to peri-implantitis." This describes a physical instrument used directly on a patient's implant.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Using reagents or other chemical processes
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The TN-Brush's function is a physical intervention on a dental implant, not an analysis of a biological sample.
N/A
Intended Use / Indications for Use
TN-Brush is a debridement instrument for titanium dental implants subjected to peri-implantitis. It is indicated for the open debridement of titanium implant surfaces in bone defects caused by peri-implantitis.
Product codes
ELB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.4840 Rotary scaler.
(a)
Identification. A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy.(b)
Classification. Class II.
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2017
GENOSS Co. Ltd. Hyeyoung Moon Staff 1F. Gyeonggi R&DB Center, 105 Gwanggyo-ro. Yeongtong-gu. Suwon-si Gyeonggi-do. 16229 Korea
Re: K170596
Trade/Device Name: TN-Brush Regulation Number: 21 CFR 872.4840 Regulation Name: Rotary Scaler Regulatory Class: Class II Product Code: ELB Dated: August 4, 2017 Received: August 8, 2017
Dear Hyeyoung Moon:
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.
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
1
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 (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE) 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,
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for CDR Lori A. Wiggins, MPT, CLT Acting 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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Image /page/2/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The letters "GENO" are in a dark green color, while the letters "SS" are in a lighter green color. The font is bold and slightly italicized, giving the word a dynamic appearance. The overall design is clean and modern.
Indication for use
| 510(k) Number: | K170596 |
|---|---|
| Device Name: | TN-Brush |
| Indication for use: | TN-Brush is a debridement instrument for titanium dental implants subjected to peri-implantitis. It is indicated for the open debridement of titanium implant surfaces in bone defects caused by peri-implantitis. |
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Indication for use