(90 days)
CS Imaging software is intended to be used with Carestream's dental digital imaging systems by healthcare professionals to display, adjust, measure, print and store 2D digital images of the dento-maxillofacial region of the human anatomy to support image diagnosis.
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This document is a 510(k) clearance letter for the CS Imaging software. It clears the device for marketing and states its intended use. However, it does not contain the acceptance criteria or a study proving the device meets those criteria, nor does it provide any performance metrics as typically found in clinical studies.
A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance against specific acceptance criteria with detailed study results as requested in the prompt. While a substantial equivalence determination often relies on comparing technical characteristics and showing that the new device performs as intended and is as safe and effective as a predicate device, the detailed study data you've requested regarding acceptance criteria and performance metrics are not typically presented in the FDA's 510(k) clearance letter itself. These details would usually be found in the manufacturer's 510(k) submission summary or detailed study reports.
Therefore, I cannot provide the requested information based solely on the provided text. The document confirms that the CS Imaging software is cleared for marketing with the indications for use described, but it does not detail:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for test sets.
- Results from multi-reader multi-case (MRMC) comparative effectiveness studies.
- Results from standalone performance studies.
- The type of ground truth used.
- Sample size for the training set or how its ground truth was established.
The provided text only includes:
- Device Name: CS Imaging
- Indications for Use: "CS Imaging software is intended to be used with Carestream's dental digital imaging systems by healthcare professionals to display, adjust, measure, print and store 2D digital images of the dento-maxillofacial region of the human anatomy to support image diagnosis."
- Regulatory Class: II
- Product Code: LLZ
- Regulation Number: 21 CFR 892.2050
- Regulation Name: Picture archiving and communications system
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Image /page/0/Picture/0 description: The image contains a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle symbol to the right of the department's name, which is arranged in a circular fashion around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle symbol is composed of three curved lines that suggest the shape of an eagle's head and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Marie-Pierre Labat-Camy Regulatory Affairs Manager TROPHY 4 rue F. Pelloutier - Croissy-Beaubourg 77435 MARNE LA VALLEE CEDEX 2 FRANCE
FEB 1 6 2012
Re: K113419 Trade/Device Name: CS Imaging Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 16, 2011 Received: November 18, 2011
Dear Ms. Labat-Camy:
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 your 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
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice modiour de roo realited be n the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as bet form in the qq your device as described in your Section 510(k) premarket with and in the FDA finding of substantial equivalence of your device to a legally marketed noaticate 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,
Mary Pastel
Mary S. Pastel, Sc.D. 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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Traditional 510(k) Submission: CS Imaging
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: CS Imaging
Indications for Use:
CS Imaging software is intended to be used with Carestream's dental digital imaging systems by healthcare professionals to display, adjust, measure, print and store 2D digital images of the dento-maxillofacial region of the human anatomy to support image diagnosis.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD).
Mary S Postel
Division Sig Office of In Vitro Diagnostic Device ion and Safety
510(k) K113419
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§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).