(102 days)
The CS 7600 is a digital intraoral dental radiographic imaging system intended for use by dentists and dental sub-specialists. The system captures, displays and stores diagnostic intraoral radiographic images. It consists of a scanner, re-usable imaging plates, acquisition software, disposable hygienic barrier envelopes, and optional Scan & Go device.
The CS 7600 is indicated for use in dental digital radiography using imaging plates (phosphor storage screens) for dental intra-oral x-ray imaging.
The CS 7600 is a computed radiography system for dental intraoral applications. Imaging plates (i.e., storage phosphor plates) are exposed in the same way as traditional x-ray film. The x-ray images on these plates are then fed into a small computed radiography system and scanned using a laser. The scanned image data from the plates is digitized, and the images are displayed on a monitor and saved to computer.
The CS 7600 system is capable of scanning the X-ray exposed imaging plates at various speeds, sizes and resolutions. Once an imaging plate is scanned, the image data is automatically erased from the plate and the plate ejected for reuse.
Re-usable intraoral imaging plates of sizes 0, 1, 2, 3 and 4 are included with the device, as are disposable hygienic barrier sheaths. The system includes an optional Scan and Go system, which uses RFID technology to automatically recognize imaging plates as they are scanned.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CS 7600 Dental Computed Radiography System:
Summary of Device Acceptance and Study Information for the CS 7600 Dental Computed Radiography System
Based on the provided 510(k) summary (K111649), the CS 7600 system's acceptance was predicated on its substantial equivalence to predicate devices, rather than meeting specific, numerical performance acceptance criteria and a detailed study demonstrating those metrics.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: - Indications for use - Operating principle and technology - Energy used - Materials | Demonstrated substantial equivalence to Kodak CR 7400 (K060079) and Soredex Digora Optime (K041050) in terms of: - Indications for use: Dental intraoral radiographic imaging - Operating principle and technology: Computed radiography using phosphor plates for dental diagnostic imaging - Energy used: X-ray - Materials: Re-usable imaging plates (sizes 0, 1, 2, 3, 4), disposable hygienic barrier envelopes, scanner. |
| Safety and Effectiveness: - Meeting user requirements - Compliance with regulations (e.g., FCC for RFID) | "Results of testing demonstrate that the device is safe and effective in meeting user requirements in accordance with its intended use." RFID technology tested for FCC and international low power transmitter compliance. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide details on a specific "test set" in the context of clinical image evaluation or performance metrics. The testing mentioned is primarily non-clinical, verification and validation testing of software, hardware, and media. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the 510(k) summary. The submission heavily relies on non-clinical testing and substantial equivalence, not a clinical study involving expert interpretation of images relative to a ground truth.
4. Adjudication Method for the Test Set
This information is not provided as there is no described clinical test set requiring adjudication in this 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not described or presented in this 510(k) summary. The submission focuses on the device itself (the CR system) and its equivalence to other CR systems, not on a human reader's performance with or without AI assistance generated by the device.
6. Standalone (Algorithm Only) Performance Study
As the CS 7600 is a computed radiography system (a hardware and software system for acquiring, processing, and displaying images), it does not feature an "algorithm only" component in the sense of an AI diagnostic algorithm. Its performance is inherent to its image acquisition and processing capabilities. Thus, a standalone algorithm-only performance study as typically understood for AI/CAD devices was not performed or described. The performance is tied to the system as a whole.
7. Type of Ground Truth Used
The 510(k) summary focuses on the technical performance and substantial equivalence of the imaging system. Therefore, the concept of "ground truth" as it applies to clinical diagnoses (e.g., pathology, expert consensus, outcomes data) is not relevant or mentioned for this submission. The "ground truth" for non-clinical testing would relate to engineering specifications and regulatory compliance.
8. Sample Size for the Training Set
The 510(k) summary does not mention a "training set" in the context of machine learning or AI. The device is a traditional computed radiography system, not a device with a machine learning component requiring a training set for model development.
9. How Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the method for establishing its ground truth is not applicable/not provided.
In conclusion, this 510(k) summary for the CS 7600 Dental Computed Radiography System focuses on demonstrating substantial equivalence to predicate devices and verifying general safety and effectiveness through non-clinical testing. It does not present detailed performance metrics, clinical study results, or information typically associated with AI/CADe submissions regarding reader performance, ground truth establishment, or training/test set specifics.
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510(k) Summary CS 7600
SEP 2 3 2011
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: Common name: Classification name:
CS 7600 Dental Computed Radiography System Extraoral source x-ray system
4. Device Classification
Class: II, 21 CFR 872.1800 Product Code: MUH
5. Intended Use
The CS 7600 is a digital intraoral dental radiographic imaging system intended for use by dentists and dental sub-specialists. The system captures, displays and stores diagnostic intraoral radiographic images. It consists of a scanner, re-usable imaging plates, acquisition software, disposable hygienic barrier envelopes, and optional Scan & Go device.
6. Device Description
The CS 7600 is a computed radiography system for dental intraoral applications. Imaging plates (i.e., storage phosphor plates) are exposed in the same way as traditional x-ray film. The x-ray images on these plates are then fed into a small computed radiography system and scanned using a laser. The scanned image data from the plates is digitized, and the images are displayed on a monitor and saved to computer.
The CS 7600 system is capable of scanning the X-ray exposed imaging plates at various speeds, sizes and resolutions. Once an imaging plate is scanned, the image data is automatically erased from the plate and the plate ejected for reuse.
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Re-usable intraoral imaging plates of sizes 0, 1, 2, 3 and 4 are included with the device, as are disposable hygienic barrier sheaths. The system includes an optional Scan and Go system, which uses RFID technology to automatically recognize imaging plates as they are scanned.
7. Substantial Equivalence
The CS 7600 is substantially equivalent the Kodak CR 7400 (K060079) and the Soredex Digora Optime (K041050). Each listed device is a computed radiography device utilizing phosphor plates for dental diagnostic imaging. The devices are equivalent in terms of indications for use, operating principle and technology, energy used, and materials.
8. Non-Clinical testing
Verification and validation testing of the CS 7600 was performed on software, hardware systems, media, and on the complete assembled device. The RFID technology has been tested for compliance with FCC and international rules for low power transmitters.
Results of testing demonstrate that the device is safe and effective in meeting user requirements in accordance with its intended use.
9. Conclusion
The CS 7600 is substantially equivalent to the predicate devices listed above. Testing has demonstrated that it is safe and effective for its intended use.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Mr. Daniel Hoefer Manager. Regulatory Affairs Carestream Health, Inc. 1765 The Exchange, Inc. ATLANTA GA 30339
Regulatorv Class: H Product Code: MUH Dated: September 8, 2011 Received: September 9, 2011
Trade/Device Name: CS 7600
Regulation Number: 21 CFR 872.1800
Regulation Name: Extraoral source x-ray svstem
Re: K111649
SEP 2 3 2011
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. Ilisting 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 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 Viro 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.hunl.
Sincerely Yours.
Mary Patel
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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Indications for Use
The CS 7600 is indicated for use in dental digital radiography using imaging plates (phosphor storage screens) for dental intra-oral x-ray imaging.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter
Michael D'Her
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K///649
§ 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.