(67 days)
Agfa's DX-D Imaging Package is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. Agfa's DX-D Imaging Package is not indicated for use in mammography.
The new device is a direct radiography imaging system of similar design and construction to the predicates. Agfa's DX-D Imaging Package uses Agfa's familiar NX workstation with MUSICA2TM image processing and flat panel detectors of the scintillator-photodetector type. Flat panel detectors with scintillators of both Cesium Iodide (Csl) and Gadolinium Oxysulfide (GOS) are available. The device is used to capture and digitize x-ray images without a separate digitizer common to computed radiography systems.
Please note: The provided text is a 510(k) summary for a radiographic imaging system. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria, a dedicated study proving performance against those criteria, or the methodology typically associated with AI/CAD device evaluation (e.g., sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies).
Therefore, many of the requested sections will be marked as "Not provided in the document."
Here's the breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not provided in the document. The 510(k) summary focuses on substantial equivalence to predicate devices based on similar technology and intended use, rather than presenting specific quantitative acceptance criteria and device performance metrics against them. It mentions "laboratory testing and an image comparison study" but does not detail their results or acceptance thresholds.
2. Sample Size Used for the Test Set and Data Provenance
Not provided in the document. The document refers to "laboratory testing and an image comparison study," but no details are given regarding the sample size of images/cases used in these studies, nor their provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not provided in the document. The document does not describe the establishment of a ground truth for a test set, nor the involvement or qualifications of experts for such a purpose.
4. Adjudication Method for the Test Set
Not provided in the document. No information on adjudication methods for a test set is present.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not provided in the document. The text does not mention an MRMC comparative effectiveness study or any effect size related to human readers improving with AI assistance. The device described is a direct radiography imaging system, not an AI/CAD system.
6. If a Standalone (Algorithm Only) Performance Study Was Done
Not applicable. The device is an imaging system (hardware and associated software for image processing), not a standalone algorithm or AI. The document refers to "image processing" (MUSICA2™) but not as an AI-driven diagnostic algorithm that would require standalone performance evaluation.
7. The Type of Ground Truth Used
Not provided in the document. No information on the type of ground truth used is present. The document focuses on demonstrating that the new imaging package produces "diagnostic quality images," implying clinical interpretability, but does not detail how this was quantitatively assessed with a ground truth.
8. The Sample Size for the Training Set
Not applicable/Not provided. The device is a direct radiography imaging system. While its image processing (MUSICA2™) would have been developed and "trained" in a broader sense, the document does not describe it as an AI/machine learning model with a distinct "training set" in the context of device approval. The 510(k) relies on substantial equivalence to existing technology, not on novel AI performance evaluation.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. As above, the device's nature and the content of the 510(k) summary do not include details about ground truth establishment for a training set in the context of AI approval.
{0}------------------------------------------------
NOV - 6 2009
510(K) SUMMARY: AGFA DX-D IMAGING PACKAGE
Common/Classification Name: Computed Radiography System, 21 CFR 892.1650 Proprietary Name: DX-D Imaging Package Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Jeffery A. Jedlicka, Prepared: August 18 2009 Telephone: (864) 421-1815 Facsimile: (864) 421-1635
A. LEGALLY MARKETED PREDICATE DEVICES
This is a 510(k) for Agfa's DX-D Imaging Package. The predicate devices are two devices with similar technology: Agfa's Computed Radiography Systems with NX Workstations (K090672) and Varian Medical's PaxScan 4030 (K024147).
B. DEVICE DESCRIPTION
The new device is a direct radiography imaging system of similar design and construction to the predicates. Agfa's DX-D Imaging Package uses Agfa's familiar NX workstation with MUSICA2TM image processing and flat panel detectors of the scintillator-photodetector type. Flat panel detectors with scintillators of both Cesium Iodide (Csl) and Gadolinium Oxysulfide (GOS) are available. The device is used to capture and digitize x-ray images without a separate digitizer common to computed radiography systems.
Principles of operation and technological characteristics of the new and predicate devices are the same.
C. INTENDED USE
Agfa's DX-D Imaging Package has the same intended use as the predicate devices; namely to provide diagnostic images to assist the physician with diagnosis.
The device uses Agfa's flat panel detectors with amorphous silicon scintillators and NX workstations with MUSICA image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.
Agfa's DX-D Imaging Package is not indicated for use in mammography.
D. SUBSTANTIAL EQUIVALENCE SUMMARY '
Agfa's DX-D Imaging Package has a similar Indications For Use statement as the legally marketed predicate device (Agfa DX-S with NX workstation). The devices have the same technological characteristics. Descriptive characteristics and performance data are adequate to ensure equivalence.
Differences in devices do not alter the intended therapeutic/diagnostic effect.
{1}------------------------------------------------
E. TECHNOLOGICAL CHARACTERISTICS
Agfa's DX-D Imaging Package is substantially equivalent to a prior Agfa computed radiography systems (K090672) and to a similar Varian direct radiography system (K024147). The new device has an indications statement largely similar to that of the Agfa predicate. Intended uses of all the devices are the same, namely to provide diagnostic quality images.
F. TESTING
The new device combines proven technology from both predicates. It combines the NX user workstation of the Agfa predicate with flat panel detectors of the Varian predicate. Differences between the new device and the predicates are minor and have been evaluated via laboratory testing and in an image comparison study.
CONCLUSIONS G.
This 510(k) 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.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's emblem on the left, which features a stylized human figure. To the right of the emblem, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is displayed in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AGFA Healthcare Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services. LLC 1394 25th Street NW BUFFALO MN 55313
Re: K092669
Trade/Device Name: DX-D Imaging Package Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: October 5, 2009 Received: October 29, 2009
AUG 2 3 2013
Dear Mr. Job:
This letter corrects our substantially equivalent letter of November 6, 2009.
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
{3}------------------------------------------------
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
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K1922669
Device Name: DX-D Imaging Package
Indications for Use:
Agfa's DX-D Imaging Package is indicated for use in providing diagnostic quality images to aid the physician with diagnosis.
Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.
Agfa's DX-D Imaging Package is not indicated for use in mammography.
AND/OR
Prescription Use X (Part 21 CFR 801 Subpart D) 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)
Herbstmann
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devi 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.