(284 days)
Not Found
No
The document describes an intraoral camera system with fluorescence imaging for caries detection. It mentions image acquisition software and performance studies but does not mention AI, ML, or any related concepts like training/test sets for algorithmic development. The technology described is based on optical principles (fluorescence and reflectance).
No
The device is described as an aid in detection and for viewing/capturing images, not for treating or rehabilitating a condition.
Yes
The "Intended Use / Indications for Use" states that "The CS 1600 is indicated for use by health professionals as an aid in the detection of dental caries." The "Device Description" also mentions an "optical caries detection system." These directly indicate its use for diagnostic purposes.
No
The device description explicitly states that the system consists of an intraoral camera assembly connected via USB to a PC, along with associated software and accessories. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, the CS 1600 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- CS 1600 Function: The CS 1600 is an intraoral camera system that uses imaging (color video and fluorescence) to aid in the detection of dental caries and for general intraoral viewing and documentation. It operates by directly imaging the oral cavity, not by analyzing samples taken from the body.
- Intended Use: The intended use clearly states it's an "aid in the detection of dental caries" and for "viewing and capturing intraoral color video images." This is a direct imaging and visualization function, not an in vitro test.
- Device Description: The description reinforces that it's an "intraoral camera system" and an "optical caries detection system based on fluorescence imaging."
While the device aids in diagnosis (detecting dental caries), it does so through direct imaging of the body, not through the analysis of in vitro samples. Therefore, it falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CS 1600 Intraoral Camera (CS 1600) is intended for chairside use by health professionals during oral health examinations. It provides magnified digital color images of intraoral or extraoral anatomy via a video monitor or Personal Computer (PC). Both still and video images can be captured and stored.
In Caries Detection mode, the CS 1600 is intended as an aid in the detection and diagnosis of dental caries. It provides both video mode and still image detection mode. In still image mode, it provides a color-coded indication of the degree of fluorescence loss for affected areas of the tooth.
The digital video and still images may be digitally recorded for use with computerized patient records.
The CS 1600 is indicated for use by health professionals as an aid in the detection of dental caries. It is also indicated for use in viewing and capturing intraoral color video images for the purpose of:
- Allowing practitioners to view and magnify all regions of the oral cavity
- Assisting in communication with the patient by providing a view of treatment areas before and after a procedure
- Providing images for documentation in patient records.
Product codes
NBL
Device Description
The CS 1600 Intraoral Camera (CS 1600) is an intraoral camera system that also includes an optical caries detection system based on fluorescence imaging with reflectance enhancement. The system is intended for use by healthcare professionals in dental and dental sub-specialty clinical settings.
The system consists of an intraoral camera assembly which is connected via USB connection to a PC, and associated image acquisition software and accessories. Accessories include hygienic barrier sheaths and a collar attachment for the camera assembly that is used for maintaining an optimal working distance in either caries detection mode.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Fluorescence imaging, video/still digital imaging
Anatomical Site
Intraoral or extraoral anatomy (specifically, dental caries / oral cavity)
Indicated Patient Age Range
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Intended User / Care Setting
Chairside use by health professionals in dental and dental sub-specialty clinical settings, dentists and other oral health specialists.
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)
Bench top performance testing of the CS 1600 was performed on Hardware sub-systems, Software sub-systems, and on the complete assembled device. The system also has undergone laboratory testing for mechanical, electrical, biocompatibility and EMC/EMI compliance with standards. Results of testing demonstrate that the device is safe and effective in meeting user requirements in accordance with its intended use.
Clinical testing of the system in each caries detection mode has been completed. The conclusion of the study verified the efficacy for the intended use of the device under clinical conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.1745 Laser fluorescence caries detection device.
(a)
Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.(b)
Classification. Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.
0
Carestream Health, Inc.
K///423
MAR - 2 2012 1 of 3
510(k) Summary CS 1600 Intraoral Camera
1. Company Identification
Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 Establishment Registration: 1315356
2. Contact Person
Daniel Hoefer Manager, Regulatory Affairs, Carestream Dental 1765 The Exchange Atlanta, GA 30339 Tel 770 226 3287 Fax 770 850 5011
3. Device Name
Commercial name: CS 1600 Intraoral Camera Common name: Intraoral Camera with Fluorescence Caries Detection Classification name: Laser Fluorescence Caries Detection Device
4. Device Classification
Class: II Product Code: NBL
5. Intended Use
The CS 1600 Intraoral Camera (CS 1600) is intended for chairside use by health professionals during oral health examinations. It provides magnified digital color images of intraoral or extraoral anatomy via a video monitor or Personal Computer (PC). Both still and video images can be captured and stored.
In Caries Detection mode, the CS 1600 is intended as an aid in the detection and diagnosis of dental caries. It provides both video mode and still image detection mode. In still image mode, it provides a color-coded indication of the degree of fluorescence loss for affected areas of the tooth.
The digital video and still images may be digitally recorded for use with computerized patient records.
6. Device Description
The CS 1600 Intraoral Camera (CS 1600) is an intraoral camera system that also includes an optical caries detection system based on fluorescence imaging with reflectance
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Carestream Health, Inc.
2 of 3
enhancement. The system is intended for use by healthcare professionals in dental and dental sub-specialty clinical settings.
The system consists of an intraoral camera assembly which is connected via USB connection to a PC, and associated image acquisition software and accessories. Accessories include hygienic barrier sheaths and a collar attachment for the camera assembly that is used for maintaining an optimal working distance in either caries detection mode.
7. Substantial Equivalence
The CS 1600 is substantially equivalent the Kodak 1500 Intraoral Camera (Carestream Health, Inc., K091186), to the Inspektor Pro (Inspektor Dental Care by, K040063) and to the SoproLife (K092583, Sopro).
- The Kodak 1500, SoproLife, and CS 1600 are each intended for use in . dental or dental sub-specialty intraoral video image acquisition, for the purposes of viewing the oral cavity and patient communication.
- . The CS 1600, Inspektor Pro, and SoproLife are each intended for use as an aid in the detection and/or diagnosis of dental caries. The principle of operation for each fluorescence caries detection device is substantially equivalent.
- The technological characteristics are equivalent. Each device consists of a ● digital video camera with 0.25 inch CCD sensor assembled within a camera hand piece. Each connects either to a docking station or directly to a computer via USB, and displays on a chairside monitor. Video formats are similar.
- The intended users of each device are the same or equivalent. Each is ● intended for use by dentists and other oral health specialists.
- All of the devices are substantially equivalent in terms of energy used or . delivered, labeling, materials, biocompatibility, workflow, and technology.
- All of the devices conform to equivalent international standards for safety of . medical devices.
8. Non-Clinical testing
Bench top performance testing of the CS 1600 was performed on Hardware sub-systems, Software sub-systems, and on the complete assembled device. The system also has undergone laboratory testing for mechanical, electrical, biocompatibility and EMC/EMI compliance with standards.
Results of testing demonstrate that the device is safe and effective in meeting user requirements in accordance with its intended use.
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9. Clinical Testing
Clinical testing of the system in each caries detection mode has been completed. The conclusion of the study verified the efficacy for the intended use of the device under clinical conditions.
10. Conclusion
The CS 1600 Intraoral Camera is substantially equivalent to the predicate devices listed above. Testing has demonstrated that it is safe and effective for its intended use.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three wing-like extensions, suggesting movement or flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Carestream Health, Inc. C/O Mr. Daniel Hoefer Manager, Regulatory Affairs, Carestream Dental Carestream Dental, LLC 1765 The Exchange Atlanta, Georgia 30339
MAR - 2 2012
Re: K111423
Trade/Device Name: CS 1600 Intraoral Camera Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NBL Dated: February 23, 2012 Received: February 24, 2012
Dear Mr. Hoefer:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Hoefer
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.goy/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for Anthony, DiNotson
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital; Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
f
KIII423
Indications for Use
The CS 1600 is indicated for use by health professionals as an aid in the detection of dental caries.
It is also indicated for use in viewing and capturing intraoral color video images for the purpose of:
- Allowing practitioners to view and magnify all regions of the oral cavity .
- Assisting in communication with the patient by providing a view of treatment areas before and after . a procedure
- Providing images for documentation in patient records.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter
Susan Ruanes
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: