(13 days)
No
The summary focuses on hardware modifications for image acquisition and ergonomics, with no mention of AI/ML for image processing or analysis.
No.
The device is used for diagnostic imaging (producing x-ray images) and does not provide therapy or treatment.
No
Explanation: The device produces x-ray images, which are then used by a dental professional for diagnosis. The device itself is an imaging system and does not interpret the images or provide a diagnosis.
No
The device description explicitly states it is a digital imaging receptor used in place of dental x-ray film and mentions modifications to hardware and firmware to support these hardware changes. This indicates it is a hardware device with associated software/firmware, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "patients undergoing an intra-oral dental x-ray examination" to produce "instant, digital, intra-oral x-ray images." This describes an imaging device used on a patient to visualize internal structures.
- Device Description: The description clearly states it's a "digital imaging receptor" used "in place of dental x-ray film." This further reinforces its role as an imaging device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease. This device does not process or analyze biological specimens.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral x-ray images of a patient's mouth while reducing the necessary x-ray dosage.
Product codes
EAP, MOB
Device Description
The new control mechanism differs from the predicate in that image acquisition may additionally be triggered through a hardwire to an x-ray tube. This modification allows for a quicker x-ray response time and may improve ergonomics as it eliminates the need for a standalone remote module. The existing firmware has been altered to support the modified and additional hardware. The new remote module may be housed within a specified x-ray source. The modification in no way effects the fundamental technology governing image acquisition.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
intra-oral dental, patient's mouth
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)
A risk analysis established the areas of concern. The principal risk is unintended x-ray exposure. These areas have been evaluated following bench, and thirdparty safety testing. All validation activities have demonstrated that the predetermined acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1810 Intraoral source x-ray system.
(a)
Identification. An intraoral source x-ray system is an electrically 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 inside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
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JUN - 7 2004
Exhibit IV: 510(k) Summary Schick Computed Oral Radiology System
Common/Classification Name: Solid State X-ray Imager 21 CFR892.1650
Schick Technologies, Inc. 30-00 47th Avenue Long Island City, NY 11101 718-937-5765, 718-937-5962 (FAX) Contact: Daniel Michaeli, Prepared: May 24, 2004
A. Legally Marketed Predicate Devices
The original Computed Oral Radiology System notification was cleared on January 318, 1994 (K933455). The device and its predicate are small digital imaging receptors that may be used in place of dental x-ray film.
B. Modification Description
The new control mechanism differs from the predicate in that image acquisition may additionally be triggered through a hardwire to an x-ray tube. This modification allows for a quicker x-ray response time and may improve ergonomics as it eliminates the need for a standalone remote module.
The existing firmware has been altered to support the modified and additional hardware. The new remote module may be housed within a specified x-ray source. The modification in no way effects the fundamental technology governing image acquisition.
C. Indications for Use
The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral x-ray images of a patient's mouth while reducing the necessary x-ray dosage. This device modification in no way alters the indications for use of this machine beyond what was originally cleared in K933455.
D. Substantial Equivalence Summary
A risk analysis established the areas of concern. The principal risk is unintended x-ray exposure. These areas have been evaluated following bench, and thirdparty safety testing. All validation activities have demonstrated that the
1
predetermined acceptance criteria were met. Where appropriate, warnings have been incorporated within the user manual.
E. Conclusions
Schick Technologies has demonstrated through a risk analysis and validation studies that the device modification is substantially equivalent to the already cleared and marketed device.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font. The text is left-aligned and appears to be part of a document or presentation. The words are capitalized and spaced evenly.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Daniel Michaeli Director of Science Development Schick Technologies, Inc. 30-30 47th Avenue LONG ISLAND CITY NY 11101
AUG 23 2013
Re: K041385
Trade/Device Name: Computed Oral Radiology System Regulation Number: 21 CFR 892.1810 Regulation Name: Intraoral source x-ray system Regulatory Class: II Product Code: EAP and MOB Dated: May 24, 2004 Received: May 25, 2004
Dear Mr. Michaeli:
This letter corrects our substantially equivalent letter of June 7, 2004.
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.
If vour device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K041385
Computed Oral Radiology System Device Name:
Indications For Use:
The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral x-ray images of a patient's mouth while reducing the necessary x-ray dosage.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Nancy C Langdon
and Radiological Devic 510(k) Numl
Prescription Use