(30 days)
The CR25.0 is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR25.0 is intended to be used mainly in chest, skeletal, and gastro-intestinal x-ray imaging applications.
The ADC Compact Plus, the predicate device, is a computed radiology imaging system. Instead of screens and photographic film for producing the diagnostic image, the ADC Compact Plus system utilizes an "imaging plate." a plate coated with photo-stimulatable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. This imaging plate is inserted into a device that scans it with a laser and releases the latent image in the form of light which is converted into a digital bit stream. The bit stream of image data is stored locally and can also be stored in a PACS network in DICOM format.
The CR25.0 is very similar to the ADC Compact Plus and the ADC Solo. The electronics are being reorganized and made smaller, which will result in lower power requirements. However, the basic principles of operation are unchanged. Instead of upgrading the currently marketed economy system called the ADC Solo, components of the high-end ADC Compact Plus were reintegrated into a compact lower-cost system, resulting is no loss of resolution or other measures of image quality.
This 510(k) summary for the Agfa CR25.0 doesn't contain detailed acceptance criteria or performance data from a specific study. Instead, it relies on demonstrating substantial equivalence to a predicate device (ADC Compact Plus) through a "Special 510(k) for Device Modification." This type of submission typically focuses on showing that modifications to an already cleared device do not introduce new questions of safety or effectiveness.
Here's a breakdown of the requested information based on the provided text, and where gaps exist:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The submission focuses on substantial equivalence, implying the CR25.0 meets the performance of the predicate device. | "no loss of resolution or other measures of image quality" compared to the predicate device (ADC Compact Plus). "proper performance to specifications through various in-house reliability and imaging performance demonstration." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states that "performance data was collected," but details of the test set (number of images, cases, etc.) are not provided.
- Data Provenance: Not specified. It's implied that "in-house" testing was conducted, but the country of origin or whether it was retrospective/prospective is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not specified. There is no mention of expert review or ground truth establishment in relation to a test set for performance evaluation.
4. Adjudication Method for the Test Set
- Not specified. Since no expert review is mentioned, no adjudication method is detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a MRMC comparative effectiveness study is not mentioned. The submission focuses on device modification and substantial equivalence, not a comparative study with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- The CR25.0 is a computed radiography imaging system, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm does not directly apply in this context. The device's performance is inherently tied to producing diagnostic-quality images for human interpretation. The "imaging performance demonstration" refers to the system's ability to produce images, not an automated diagnostic output.
7. The Type of Ground Truth Used
- Not explicitly stated. Given the nature of a computed radiography system, "diagnostic quality images" for physician diagnosis is the primary output. The performance evaluation would likely focus on objective image quality metrics (e.g., resolution, signal-to-noise ratio, contrast) that ensure the produced images are suitable for clinical interpretation, rather than a specific disease outcome or pathology. The "ground truth" would be the technical specifications and expected image characteristics of a diagnostic imaging system.
8. The Sample Size for the Training Set
- Not applicable as the CR25.0 is a computed radiography imaging system, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the same reason as above (not an AI/machine learning algorithm).
Summary of Study (Based on Provided Text):
The "study" described is not a traditional clinical trial or comparative effectiveness study. It's a demonstration of substantial equivalence for a modified device (CR25.0) to its predicate (ADC Compact Plus).
- Objective: To demonstrate that the CR25.0, a modified version of the ADC Compact Plus, has "no loss of resolution or other measures of image quality" and meets essential performance specifications, thereby maintaining substantial equivalence to the legally marketed predicate device.
- Methodology: The submission states that "performance data was collected" through "various in-house reliability and imaging performance demonstration" tests. It also claims adherence to international standards (EN 60601-1-1 and EN 60601-1-2) for safety and essential performance. The specific details of these tests (e.g., types of phantoms used, metrics measured, experimental protocols) are not included in this summary, as per the format of a Special 510(k). The basis for acceptance is stated as "the declarations in Section IV provide certification that the data demonstrate equivalence."
- Conclusion: The manufacturer concluded that the CR25.0 is substantially equivalent to the predicate device, implying that its performance meets the requirements for a diagnostic imaging system as established by the predicate. FDA's clearance confirms this finding.
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JUL 2 2 2004
041701
510(k) Summary
CR25.0
Common/Classification Name: Computed Radiography, 21 CFR 892.1650
Agfa Corporation 10 South Academy Street Greenville, SC 29602-9048
Contact: Jeffery A. Jedlicka, Prepared: June 17, 2004
LEGALLY MARKETED PREDICATE DEVICES A.
This is a Special 510(k) for Device Modification. The predicate device is the device that was modified to produce the CR25.0, namely the ADC Compact Plus, which was cleared by FDA on. 28 September 2001 as K013138.
B. DEVICE DESCRIPTION
The ADC Compact Plus, the predicate device, is a computed radiology imaging system. Instead of screens and photographic film for producing the diagnostic image, the ADC Compact Plus system utilizes an "imaging plate." a plate coated with photo-stimulatable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. This imaging plate is inserted into a device that scans it with a laser and releases the latent image in the form of light which is converted into a digital bit stream. The bit stream of image data is stored locally and can also be stored in a PACS network in DICOM format.
The CR25.0 is very similar to the ADC Compact Plus and the ADC Solo. The electronics are being reorganized and made smaller, which will result in lower power requirements. However, the basic principles of operation are unchanged. Instead of upgrading the currently marketed economy system called the ADC Solo, components of the high-end ADC Compact Plus were reintegrated into a compact lower-cost system, resulting is no loss of resolution or other measures of image quality.
C. INTENDED USE
The CR25.0 is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR25.0 is intended to be used mainly in
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chest, skeletal, and gastro-intestinal x-ray imaging applications.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The CR25.0 has the same indications for use as the legally marketed predicate device, so the first decision point in the 510(k) Decision Algorithm is straight-forward. The CR25.0 has the same technological characteristics as the predicate device. This premarket notification has described most of the characteristics of the CR25.0 in sufficient detail 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 in Section IV provide certification that the data demonstrate equivalence.
TECHNOLOGICAL CHARACTERISTICS E.
The technological characteristics are the same in the proposed and predicate devices.
TESTING F.
The CR25.0 has been tested for proper performance to specifications through various in-house reliability and imaging performance demonstration the significal device also meets the requirements of EN 60601-1-1 and EN 60601-1-2.
CONCLUSIONS G.
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 shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three tail feathers and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is depicted in a simple, abstract style, with bold lines forming its wings and body.
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
Mr. Jeffery A. Jedlicka Manager of Regulatory Affairs AGFA Corporation Healthcare 10 South Academy Street GREENVILLE SC 29601
Re: K041701 Trade/Device Name: CR25.0 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: June 22, 2004 Received: June 22, 2004
AUG 23 2013
Dear Mr. Jedlicka:
This letter corrects our substantially equivalent letter of July 22, 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 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 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):
Device Name:___ CR25.0
Indications For Use:
The CR25.0 is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR25.0 is intended to be used mainly in chest, skeletal, and gastrointestinal x-ray imaging applications.
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 Device Evaluation (ODE)
Daniel B. Simmons
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number KOH701
Page 1 of 1
000046
§ 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.