(90 days)
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Not Found
No
The summary mentions image processing but does not explicitly mention AI, ML, or related terms like deep learning (DNN), nor does it provide details about training or test sets typically associated with ML models.
No
This device is described as software used to process images for diagnosis, not to provide therapy or treatment.
Yes
The Intended Use/Indications for Use states that the software enables a "dentist to diagnose the dental state of the teeth of a patient," which directly indicates a diagnostic purpose.
Yes
The device description explicitly states "Software for extraoral X-ray units" and the intended use describes the software processing digital images. There is no mention of accompanying hardware being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of Vipersoft is to process digital images from extraoral X-ray units to help a dentist diagnose the dental state of a patient's teeth. This involves analyzing images of the patient's anatomy directly, not analyzing biological samples taken from the patient.
- The description focuses on image processing for diagnosis based on anatomical structure. The software processes images from X-rays, which are used to visualize the physical structure of the teeth and surrounding areas. This is characteristic of medical imaging devices, not IVDs.
Therefore, Vipersoft falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The software, Vipersoft, for extraoral X-ray units is used to process digital images from extraoral X-ray units in order to enable a dentist to diagnose the dental state of the teeth of a patient.
Product codes
90 EHD, 90 LMB, 90 LMD
Device Description
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Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
Extraoral X-ray units
Anatomical Site
Teeth (dental state)
Indicated Patient Age Range
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Intended User / Care Setting
Dentist
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
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§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 1999
Integra Medical W. Edward Johansen C/o W. Edward Johansen, Atty. 11661 San Vicente Blvd. Los Angeles, CA 90049
Re:
K984030 Vipersoft™ (Software for Extraoral X-ray Units Dated: November 10, 1998 Received: November 12, 1998 Regulatory class: II 21 CFR 892.1800/Procode: 90 EHD Regulatory class: I 21 CFR 892.2010/Procode: 90 LMB 21 CFR 892.2020/Procode: 90 LMD
Dear Mr. Johansen:
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 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). 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, isting 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 obligation you might have under sections 531 through 542 of 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 yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
1
PREMARKET NOTIFICATION
INDICATIONS FOR USE
510(k) Number:
Device Name:__Software for extraoral X-ray units
Indications for Use:
The software, Vipersoft, for extraoral X-ray units is used to process digital images from extraoral X-ray units in order to enable a dentist to diagnose the dental state of the teeth of a patient.
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal, ENI, and Radiological De 510(k) Number
Prescription Use: √ OR
Over-The-Counter-Use :_
(Per 21 CFR 801.109