(88 days)
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No
The summary does not mention AI, ML, deep learning, or any related concepts, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is indicated for use to provide a video image during dental procedures, which suggests an imaging or visualization function rather than a therapeutic one.
No
Explanation: The device is described as being used when a video image is desired, indicating it is an imaging tool rather than one that diagnoses conditions.
No
The summary describes a device that provides a "video image" during dental procedures. While it doesn't explicitly mention hardware, the function of capturing and providing a video image strongly implies the presence of a camera or other imaging hardware, which would make it a hardware device with potentially integrated software. The lack of a "Device Description" section prevents a definitive confirmation, but the stated function points away from a software-only device.
Based on the provided information, the Flexiscope Optomodul is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use during dental procedures when a video image is desired. This indicates it's a device used on the patient or in the patient's body to provide visual information during a procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The Flexiscope Optomodul does not fit this description.
- Imaging Modality: The input imaging modality is "video image," which is consistent with a device used for visualization during a procedure, not for analyzing biological samples.
- Anatomical Site: The anatomical site is "dental," further supporting its use in a clinical setting for direct visualization.
Therefore, the Flexiscope Optomodul is a medical device used for visualization during dental procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Flexiscope Optomodul is indicated for use during dental procedures when a video image is desired. The Flexiscope Optomodul is indicated for use during dental procedures when a video image is desired.
Product codes
EIA
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
dental
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
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Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is left-aligned. The text is black and the background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 1999
Schoelly Fiberoptic, GmbH C/O Mr. Joseph Ress Medical Device Regulatory Consultants 45 Pontiac Road Newton, Massachusetts 02468
K984641 Re : Flexiscope Optomodul Trade Name: Regulatory Class: I EIA Product Code: December 29, 1998 Dated: Received: December 31, 1998
Dear Mr. Ress
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 The general controls provisions of the Act 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 requlatory 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 obligation you might have under sections 531 through 542 of
Image /page/0/Picture/9 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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Page 2 - Mr. Ress
the Act for devices under the Electronic Product Radiation Control 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 device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2M41 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timot Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix K - Indications for Use
STATEMENT FOR INDICATIONS FOR USE
510 (K) Number:
Device Name: Flexiscope Optomodul
Indications for Use:
The Flexiscope Optomodul is indicated for use during dental
in the country bear when a video image is desired. The Flexiscope Optomodul Is Indreason 2007 - 100 mm a video image is desired.
(PLEASE DO MOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Susan Runne
(Division Sign-Off)
OR
(Controllon of Dental, Infection Control, and General Hosp 510(k) Number