(9 days)
Agfa's DX-Si system is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. The DX-Si can be used to column radiographic exposures of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. The DS-Xi is not indicated for use in mammography.
Use with separately cleared accessories allows the DX-Si to be conveniently used in generating urological, tomographic, pediatio and dental images.
The predicate and new devices are nearly identical computed radiography imaging systems. The DX-Si (new device) is a combination of previously cleared systems combined and marketed as a single system. The devices are the DX-S Digitizer with NX workstation and Siemens OEM version of its Multix Top x-ray system.
The new device includes an interface that allows users to select initial xray exposure settings and review exposure parameters from the digitizer workstation.
The basic principles of operation are unchanged.
The provided text describes the Agfa DX-Si integrated digital imaging system, which is a combination of existing cleared devices. The submission focuses on demonstrating substantial equivalence to its predicate devices rather than presenting novel performance studies for a new device. Therefore, much of the requested information about acceptance criteria and detailed study results is not present in the document.
Here's a breakdown of what can be extracted and what is not available due to the nature of the 510(k) submission for substantial equivalence:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the document. The submission states: "The DX-Si integrated digital imaging system has been tested for proper performance to specifications through various in-house and imaging performance tests." However, the specific acceptance criteria (e.g., image quality metrics, dose limits, diagnostic accuracy thresholds) and the quantified performance results against these criteria are not detailed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided. The document does not describe a clinical study with a test set of images.
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)
This information is not provided. As no clinical study with a test set is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. Similarly, without a described test set and ground truth establishment, no adjudication method is mentioned.
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
This information is not provided. The document makes no mention of an MRMC study or AI assistance. The DX-Si system is described as a conventional digital imaging system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The DX-Si is a medical imaging system, not an algorithm being tested in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided.
8. The sample size for the training set
This information is not applicable/not provided. The DX-Si is a hardware and software system for image acquisition and viewing. It's not an AI model that requires a "training set" in the machine learning sense. The testing referred to ("in-house and imaging performance tests") would likely involve engineering and image quality assessments rather than training data for an algorithm.
9. How the ground truth for the training set was established
This information is not applicable/not provided.
Summary of available information regarding the "study" and acceptance criteria:
The "study" in this context refers to the technological comparison and performance testing against specifications, not a clinical trial.
- Acceptance Criteria: While not explicitly listed in a table, the document implies that the device was deemed acceptable because it demonstrated "proper performance to specifications" and "met the requirements of EN 60601-1-1 and EN 60601-1-2" (electrical safety and electromagnetic compatibility standards). The primary acceptance criterion for 510(k) purposes was demonstrating substantial equivalence to the predicate devices.
- Reported Device Performance: The document states that the device "has been tested... and shown to meet the requirements." No specific quantitative performance metrics (e.g., spatial resolution, DQE, MTF) are provided. The "performance" is implicitly tied to being substantially equivalent to the cleared predicate devices, which are already accepted as providing "diagnostic quality images."
In essence, the 510(k) for K063421 for the DX-Si system relies on demonstrating that the new combined system has "the same technological characteristics" and "the same indications for use" as its previously cleared predicate devices. This type of premarket notification often focuses on engineering testing and comparison to established components rather than de novo clinical trials or detailed performance studies against specific diagnostic acceptance criteria.
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510(k) Summary DX-Si
Common/Classification Name: Computed Radiography, 21 CFR 892.1650
Agfa Corporation 10 South Academy Street Greenville, SC 29602-9048
Contact: Jeffery A. Jedlicka, Prepared: October 6, 2006
NOV 2 2 2006
A. LEGALLY MARKETED PREDICATE DEVICES
This is a 510(k) for Agfa's DX-Si integrated digital imaging system. The DX-Si is a combination of Agfa's DX-S digitizer with NX workstation and an x-ray system manufactured by Siemens Medical Solutions, AG.
The predicate devices are Agfa's Computed Radiography System DX-S with NX workstation which was cleaned by FDA on January 17, 2006 (K053634) and Siemens Multix Top x-ray system (K971452, K010571), last cleared by FDA on March 28,2001
B. DEVICE DESCRIPTION
The predicate and new devices are nearly identical computed radiography imaging systems. The DX-Si (new device) is a combination of previously cleared systems combined and marketed as a single system. The devices are the DX-S Digitizer with NX workstation and Siemens OEM version of its Multix Top x-ray system.
The new device includes an interface that allows users to select initial xray exposure settings and review exposure parameters from the digitizer workstation.
The basic principles of operation are unchanged.
C. INTENDED USE
Agfa's DX-Si integrated digital imaging system is intended for use in providing diagnostic quality images to aid the physician with diagnosis. The DX-Si can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.
Separately cleared accessories allow the DX-Si to be conveniently used in generating pediatric, dental, urological and tomographic images.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
Agfa's DX-Si integrated digital imaging system has the same indications for use as the legally marketed predicate devices, so the first decision
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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.
TECHNOLOGICAL CHARACTERISTICS uj
The technological characteristics are the same in the proposed and predicate devices.
F. TESTING
The DX-Si integrated digital imaging system has been tested for proper performance to specifications through various in-house and imaging performance tests. All components have been tested and shown to meet the requirements of EN 60601-1-1 and EN 60601-1-2.
G. CONCLUSIONS
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.
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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design of a human figure, with three overlapping profiles facing to the right. The figure is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.
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
AGFA Corporation % Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709
AUG 23 2013
Re: K063421
Trade/Device Name: DX-Si Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB and KPR Dated: November 6, 2006 Received: November 13, 2006
Dear Mr. Rongero:
This letter corrects our substantially equivalent letter of November 22, 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 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. Morri 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
063421 510(k) Number (if known):
Device Name: DX-Si
Indications for Use:
Agfa's DX-Si system is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. The DX-Si can be used to column radiographic exposures of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. The DS-Xi is not indicated for use in mammography.
Use with separately cleared accessories allows the DX-Si to be conveniently used in generating urological, tomographic, pediatio and dental images.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
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)
Jeneve Chogdon
(Division Sign-Off Division of Reproductive, A bdomin and Radiological Devices 5 !: x; 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.