(158 days)
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No
The summary describes a device for apex localization based on precision measurements and a graphic display, with no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
No
The device is used for precise apex localization during root channel treatment, which is a diagnostic or procedural guidance function rather than a therapeutic one. It provides information to aid the treatment but does not directly treat the condition.
Yes
The device is described as providing "precise apex localization during root channel treatment," which involves identifying a specific anatomical landmark to guide a medical procedure. This function of precisely locating a biological structure for treatment purposes falls under the definition of diagnosis, as it informs the execution of the treatment.
No
The device description explicitly mentions a "large graphic display" and describes physical characteristics like "increasing precision at 0.1mm," indicating it is a hardware device with a display and measurement capabilities, not solely software.
Based on the provided information, the BINGO-1020 device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is performed outside of the body.
- BINGO-1020 Function: The description clearly states that the BINGO-1020 is used for "precise apex localization during root channel treatment." This is a procedure performed inside the patient's body, specifically within the root canal of a tooth. It's a diagnostic aid used in vivo (within a living organism) during a dental procedure.
Therefore, the BINGO-1020 falls under the category of a medical device used for a diagnostic purpose in vivo, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
BINGO-1020 is a modern device for precise apex localization during root channel treatment.
BINGO-1020 is distinguished by increasing precision at 0.1mm on wet/dry, large graphic display where current position of endo file is reflected and other essential information is displayed.
Product codes
LQY
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
root channel
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 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 a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 30 1999
Mr. David Albelda President Dent Corp™ Research & Development 7-11 S. Broadway White Plains, NY 10601
K992233 Re : Apex Locator Bingo-1020 Trade Name: Regulatory Class: Unclassified Product Code: LQY Dated: October 4, 1999 Received: October 6, 1999
Dear Mr. Albelda:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Mr. Albelda
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Che nol provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marice and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to ene regaracion Shorologi Maximally information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Paqe of I
S10(k) NUMBER (IF KNOWN): K992233
DEVICE NAME:
INDICATIONS FOR USE:
BINGO-1020 is a modern device for precise apex localization during root channel treatment.
BINGO-1020 is distinguished by increasing precision at 0.1mm on wet/dry, large graphic display where current position of endo file is reflected and other essential information is displayed.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PA IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use y (Per 21 CFR 801.109)
Divisir
Div
OR
Over-The-Counter-U (Optional Format
Susen Runne
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | Rax0233 |
|---|---|
| --------------- | --------- |
Control,
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