(19 days)
Agfa's Computed Radiography Systems with NX1.0 workstations are intended for use in the identification, generation, acquisition, processing and filing of computed radiography images in order to make them ready for interpretation by the physician.
Agfa's Computed Radiography Systems with NX1.0 workstations are indicated to provide diagnostic quality images to aid the physician with diagnosis.
The predicate and newly modified devices are computed radiography imaging systems. Instead of traditional screens and photographic film for producing the diagnostic image, these systems system 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 NX1.0 and QS 3.0 (predicate) workstations are similar. The NX1.0 workstation includes a number of improvements including:
- . A more intuitive user interface.
- Enhanced image processing. .
- Easier installation and updates, .
- Enhanced image manipulation, display and export capabilities, .
The basic principles of operation are unchanged.
The provided document is a 510(k) summary for a Computed Radiography System with NX1.0 Workstation. It describes device modifications and asserts substantial equivalence to a predicate device. However, it explicitly states that performance data was not included in the submission because it is a Special 510(k) for Device Modification. It instead refers to "declarations in Exhibits I and H" which certify that data demonstrates equivalence, but these exhibits are not provided in the input.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, and the study design are not available in the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The document states that performance data was collected to demonstrate substantial equivalence but was not included in the submission. It only generally asserts "proper performance to specifications" through in-house tests.
2. Sample size used for the test set and the data provenance
Not available in the provided document. No specific sample sizes for test sets are mentioned. The provenance of any data is also not stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not available in the provided document. No information regarding ground truth establishment or expert involvement in any test sets is provided.
4. Adjudication method for the test set
Not available in the provided document. No information about any adjudication methods is provided.
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 "Computed Radiography System with NX1.0 Workstation," which is an imaging system, not an AI-powered diagnostic tool for human readers. Its purpose is to generate, process, and file CR images for interpretation by a physician. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" is not relevant to this device's function or the information provided.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an imaging system that produces diagnostic images for human interpretation, not a standalone diagnostic algorithm. Its performance is related to image quality and system functionality, not algorithmic diagnostic accuracy.
7. The type of ground truth used
Not available in the provided document. No details on ground truth for any testing are provided.
8. The sample size for the training set
Not applicable. This is an imaging acquisition and processing system, not an AI/ML algorithm that requires a training set in the conventional sense. The "training" of such a system would involve engineering and calibration, not machine learning model training with a labeled dataset.
9. How the ground truth for the training set was established
Not applicable. As the device is not an AI/ML algorithm with a training set, this question is not relevant.
Summary of available information:
The document describes software modifications to an existing Computed Radiography system. It asserts "substantial equivalence" to a predicate device based on similar intended use and technological characteristics. Testing was conducted "for proper performance to specifications through various in-house reliability and imaging performance demonstration tests," and the device meets EN 60601-1-1 and EN 60601-1-2. However, the specific details of these "specifications," the performance metrics, the test methodology, and the results are explicitly stated as not included in the submission as it's a Special 510(k). The document relies on declarations (Exhibits I and H) that certify data demonstrates equivalence, but these exhibits are not provided.
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D. I of 2
Agfa Corporation Premarket Notification: Computed Radiography System with NX Workstation
510(k) Summary: Computed Radiography System with NX1.0 Workstation
Common/Classification Name: Computed Radiography, 21 CFR 892.1650
Agfa Corporation 10 South Academy Street Greenville, SC 29602-9048
Contact: Jeffery A. Jedlicka, Prepared: December 20, 2005
A. LEGALLY MARKETED PREDICATE DEVICES
This is a Special 510(k) for a device modification. The modified device is Agfa's Computed Radiography system with NX1.0 workstation.
The predicate device is Agfa's Computed Radiography System with QS 3.0 workstation which was introduced under a letter to file in March 2004. It's predecessor was the ADC QS/ID workstation was cleared by FDA on March 28,2001 (K010571).
DEVICE DESCRIPTION B.
The predicate and newly modified devices are computed radiography imaging systems. Instead of traditional screens and photographic film for producing the diagnostic image, these systems system 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 NX1.0 and QS 3.0 (predicate) workstations are similar. The NX1.0 workstation includes a number of improvements including:
- . A more intuitive user interface.
- Enhanced image processing. .
- Easier installation and updates, .
- Enhanced image manipulation, display and export capabilities, .
The basic principles of operation are unchanged.
INTENDED USE c.
Agfa's Computed Radiography Systems with NX1.0 workstations are intended for use in the identification, generation, acquisition, processing and filing of computed radiography images in order to make them ready for interpretation by the physician.
G-2
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D. SUBSTANTIAL EQUIVALENCE SUMMARY
Agfa's Computed Radiography Systems with NX1.0 workstations have the same indications for use as the legally marketed predicate devices, so the first decision point in the 510(k) Decision Algorithm is straight-forward. They have the same technological characteristics as the predicate device. This premarket notification has described the characteristics of the devices 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 Exhibits I and H provide certification that the data demonstrate equivalence.
TECHNOLOGICAL CHARACTERISTICS ni
The technological characteristics are the same in the proposed and predicate devices.
F. TESTING
The computed radiography system with NX1.0 workstation 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 shows the 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. Inside the circle is a stylized image of a human figure embracing a bird, which is a common symbol associated with health and human services.
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 Senior Regulatory Affairs and Compliance Manager AGFA Corporation Healthcare 10 South Academy Street AUG 23 2013 GREENVILLE SC 29601
Re: K053634
Trade/Device Name: Computed Radiography System with NX1.0 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB and LLZ Dated: December 20, 2005 Received: December 29, 2005
Dear Mr. Jedlicka:
This letter corrects our substantially equivalent letter of January 17, 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 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
Janine M. Morr 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
K053634 510(k) Number (if known):
Device Name: Computed Radiography System with NX1.0 Workstation
Indications for Use:
Agfa's Computed Radiography Systems with NX1.0 workstations are indicated to provide diagnostic quality images to aid the physician with diagnosis.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
ANDIOR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Daniel A. Leyson
Division of Ronand and Radiological D 510(k) Numbe
K-2
§ 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.