(29 days)
To provide diagnostic quality images to aid in physician diagnosis. Intended to provide diagnostic quality images to aid in physician diagnosis for general radiography and gastro-intestinal imaging applications.
The predicate and newly modified devices are computed radiograpy imaging systems. Instead of traditional screens and photographic film for producing the diagnostic image, these systems utilize an "imaging plate," a plate coated with photo-stimulable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. After exposure, this imaging plate is inserted into a digitizer that scans it with a laser and releases the latent image in the form of light that is converted into a digital image file. The image can then be previewed on a computer workstation, adjusted if necessary then stored locally, sent to an archive, printed or sent to a softcopy capable display such as a PACS system.
The CR85-X and the ADC Compact Plus are similar. The CR85-X utilizes an improved light collector to obtain maximum light efficiency. However, the basic principles of operation are unchanged.
The provided text describes a Special 510(k) for a device modification (Agfa's CR85-X Digitizer) and primarily focuses on demonstrating substantial equivalence to a predicate device (Agfa's ADC Compact Plus). As such, it does not detail a study with specific acceptance criteria and performance metrics in the way one might expect for a de novo device submission.
Instead, the submission asserts that the modified device (CR 85-X) has the same indications for use and technological characteristics as the predicate device. For the "few characteristics that may not be precise enough to ensure equivalence," the submission states that "performance data was collected, and this data demonstrates substantial equivalence." However, in keeping with the format of a Special 510(k), these specific performance data were not included in the submission. The declarations provide certification that the data demonstrate equivalence.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert involvement, and study types are not explicitly present in the provided document.
Here's an attempt to answer the questions based on the available information, noting when information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Goal: Substantial Equivalence to predicate device (ADC Compact Plus/CR 75.0) | "Performance data was collected, and this data demonstrates substantial equivalence." (Specific metrics not provided in this document). |
| Proper performance to specifications | Tested through various in-house reliability and imaging performance demonstration tests (details not provided). |
| Compliance with EN 60601-1-1 (medical electrical equipment - General requirements for safety) | Meets requirements. |
| Compliance with EN 60601-1-2 (medical electrical equipment - Electromagnetic compatibility) | Meets requirements. |
| Diagnostic quality images to aid in physician diagnosis | Stated in Indications for Use. Demonstrated to be equivalent to predicate. |
| Diagnostic quality images for general radiography, orthopedic, and gastro-intestinal imaging applications | Stated in Indications for Use. Demonstrated to be equivalent to predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified in the provided document. The submission states, "performance data was collected," but does not detail the size or nature of the test set.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The document does not describe the methodology for establishing ground truth for any performance testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. The device is a digitizer for computed radiography (CR) systems, providing digital images. It is not an AI-assisted diagnostic tool for which an MRMC study comparing human readers with and without AI assistance would typically be conducted. The focus is on the imaging system's equivalence in producing diagnostic quality images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device itself is a standalone hardware digitizer. Its "performance" refers to its ability to scan exposed X-ray cassettes and convert latent images into digital files of diagnostic quality, functionally equivalent to its predicate. The document implies performance testing of the device's imaging capabilities was done (e.g., "imaging performance demonstration tests"), but no specific details on such a standalone study are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. Since the focus is on maintaining diagnostic image quality compared to a predicate, the "ground truth" for performance would likely revolve around objective image quality metrics and potentially expert assessment of usability and diagnostic utility, but this is an inference, not stated fact.
8. The sample size for the training set
- Not applicable/Not specified. This device is a hardware digitizer, not an AI/ML algorithm that requires a training set in the conventional sense. Its "training" would be its design and engineering to meet specifications.
9. How the ground truth for the training set was established
- Not applicable/Not specified, as it's not an AI/ML algorithm requiring a training set with established ground truth.
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Kob2742.
Agfa Corporation Premarket Notification: CR85-X Digitizer September 7, 2006
510(k) Summary CR85-X
OCT ] 3 2006
Common/Classification Name: Computed Radiography, 21 CFR 892.1650
Agfa Corporation 10 South Academy Street Greenville, SC 29602-9048
Contact: Judith Harbour, Prepared: September 7, 2006
LEGALLY MARKETED PREDICATE DEVICES A.
This is a Special 510(k) for a device modification. The modified device is Agfa's CR85-X Digitizer.
The predicate device is Agfa's previous version of the same device, namely the ADC Compact Plus, which was cleared by FDA on 19 September 2001. The indications of the CR 85-X are the same as the predicate device, ADC Compact Plus, currently named the CR 75.0.
DEVICE DESCRIPTION B.
The predicate and newly modified devices are computed radiograpy imaging systems. Instead of traditional screens and photographic film for producing the diagnostic image, these systems utilize an "imaging plate," a plate coated with photo-stimulable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. After exposure, this imaging plate is inserted into a digitizer that scans it with a laser and releases the latent image in the form of light that is converted into a digital image file. The image can then be previewed on a computer workstation, adjusted if necessary then stored locally, sent to an archive, printed or sent to a softcopy capable display such as a PACS system.
The CR85-X and the ADC Compact Plus are similar. The CR85-X utilizes an improved light collector to obtain maximum light efficiency. However, the basic principles of operation are unchanged.
். INTENDED USE
The CR85-X is used to scan exposed X-ray cassettes, containing an erasable image plate (IP). This device is part of a system, consisting of X-ray cassettes with erasable phosphor image plates, an identification station for the cassettes and a workstation where the resulting digital image information is further processed and routed. It is intended that this device is only operated in a radiological environment by qualified personnel.
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D. SUBSTANTIAL EQUIVALENCE SUMMARY
Agfa's CR85-X has the same indications for use and the same technological characteristics as the predicate device. This premarket notification has described the characteristics of the devices in sufficient defail to assure substantial equivalence. For the few characteristics that may not be precise enough to ensure equivalence, performance data was collected, and this data demonstrates substantial equivalence. In keeping with the format of a Special 510(k) for Device Modification, performance data were not included in the submission, but the declarations provide certification that the data demonstrate equivalence.
The technological characteristics are the same in the proposed and predicate devices.
ii TESTING
The CR85-X has been tested for proper performance to specifications through various in-house reliability and imaging performance demonstration tests. The device also meets the requirements of EN 60601-1-1 and EN 60601-1-2.
G. CONCLUSIONS
This Special 510(k) for Device Modification submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health
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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure with three lines extending upwards from its back.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Judith Harbour Manager, Regulatory Affairs AGFA Corporation Healthcare 10 South Academy Street GREENVILLE SC 29602-9048
Re: K062742
AUG 2 3 2013
Trade/Device Name: CR 85-X Digitizer Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: September 7, 2006 Received: September 14, 2006
Dear Ms. Harbour:
This letter corrects our substantially equivalent letter of October 13, 2006.
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 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 nredicate 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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Indications for Use
510(k) Number (if known):
Kobi2742
Device Name: CR 85-X Digitizer
Indications For Use:
To provide diagnostic quality images to aid in physician diagnosis. Intended to TO provide diagnostic quality intagoe to and gastro-intestinal imaging applications.
Prescription Use
(Part 21 CFR 801 Subpart D)
Image /page/4/Picture/8 description: The image shows a word that has been crossed out. The word appears to be "AUDITOR", but it is difficult to read because it has been crossed out with a thick black line. The image is in black and white and the word is in all capital letters.
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David H. Bergman
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.