(26 days)
No
The document mentions "MUSICA2 image processing" but does not contain any terms or descriptions indicative of AI or ML technology, such as "AI," "ML," "deep learning," "neural network," or descriptions of training/test sets for such algorithms.
No
The device is described as providing "diagnostic quality images to aid the physician with diagnosis," making it a diagnostic tool, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use in providing diagnostic quality images to aid the physician with diagnosis."
No
The device description explicitly states it is a "combination of a conventional mobile x-ray system with digital image capture equipment" and a "modification of the predicate mobile x-ray system," indicating it includes hardware components.
Based on the provided information, the Agfa DX-D 100 is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Agfa DX-D 100 is an X-ray system used to create radiographic images of the internal structures of the body. It works by passing X-rays through the patient and capturing the resulting image on a digital detector. This is an in vivo (within the living body) diagnostic imaging process, not an in vitro process.
- Intended Use: The intended use clearly states it provides "diagnostic quality images to aid the physician with diagnosis" of various body parts. This aligns with the function of a medical imaging device, not an IVD.
Therefore, the Agfa DX-D 100 is a medical imaging device, specifically a digital mobile X-ray system, and not an IVD.
N/A
Intended Use / Indications for Use
Agfa's DX-D 100 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 100 is not indicated for use in mammography.
Product codes
IZL
Device Description
The new device is a combination of a conventional mobile x-ray system with digital image capture equipment. The new device is essentially a modification of the predicate mobile x-ray system, Sedecal Easy Moving Plus (K090322). In this case, the digital detector available with the predicate has been replaced with Agfa's system, its previously cleared DX-D Imaging Package (K092669). The DX-D 100 uses Agfa's familiar NX workstation with MUSICA2TM image processing and flat panel detectors of the scintillator-photodetector type (Cesium Iodide or Gadolinium Oxysulfide).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
No clinical testing was performed in the development of the DX-D 100.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Agfa HealthCare NV Premarket Notification: DX-D 100
JAN - 3 2010
510(K) SUMMARY: AGFA DX-D 100
Common/Classification Name: Mobile X-Ray System, 21 CFR 892.1720 Proprietary Name: DX-D 100 Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Phil Cuscuna, Prepared: October 29, 2010 Telephone: (416) 240-7317 Facsimile: (416) 240-7359
LEGALLY MARKETED PREDICATE DEVICES A.
This is a 510(k) for Agfa's DX-D 100, which is a combination of a mobile x-ray system and a digital detector.
B. DEVICE DESCRIPTION
The new device is a combination of a conventional mobile x-ray system with digital image capture equipment. The new device is essentially a modification of the predicate mobile x-ray system, Sedecal Easy Moving Plus (K090322). In this case, the digital detector available with the predicate has been replaced with Agfa's system, its previously cleared DX-D Imaging Package (K092669). The DX-D 100 uses Agfa's familiar NX workstation with MUSICA2TM image processing and flat panel detectors of the scintillator-photodetector type (Cesium Iodide or Gadolinium Oxysulfide).
Principles of operation and technological characteristics of the new and predicate devices are the same.
C. INTENDED USE
Agfa's DX-D 100 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 100 is not indicated for use in mammography.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
Agfa's DX-D 100 has an Indications For Use statement nearly identical to the statements for the two predicate devices (Agfa DX-D Imaging Package and the Sedecal Easy Moving Plus). Intended uses are the same. 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.
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Agfa HealthCare NV .. Premarket Notification: DX-D 100
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| PRODUCT COMPARISON TABLE | |||
|---|---|---|---|
| AGFA DX-D-100 | |||
| (NEW DEVICE) | AGFA DX-D Imaging | ||
| Package (PREDICATE- | |||
| K092669) | Sedecal Easy Moving | ||
| Plus (PREDICATE- | |||
| K090322) | |||
| Communications | Same as predicate | DICOM | N/A |
| Detector Material | Same as predicate | Gadolinium Oxysulfide | |
| (GOS) or Cesium Iodide | |||
| (CSI) scintillator | N/A | ||
| Detector Sizes | Same as predicate | 14x17 in. & 17x17 in | N/A |
| Active Matrix | Same as predicate | 3056x3056 (17x17 in.) | |
| 3072x2560 (17x14 in.) | N/A | ||
| Pixel size | Same as predicate | 139 μm | N/A |
| Fill factor | Same as predicate | 100% | N/A |
| Dynamic Range | Same as predicate | 14 bit | N/A |
| Maximum Image | |||
| Acquisitions/hr. | Same as predicate | 150 | N/A |
| Image processing | Same as predicate | MUSICA2 | N/A |
| Operating system | Same as predicate | Windows XP | Windows XP |
| Image Acquisition | Agfa DX-D Imaging | ||
| Package | Agfa DX-D Imaging | ||
| Package | Canon 50G | ||
| Display System | 15" LCD touch screen | Standard PC display or | |
| separately cleared medical | |||
| display (e.g. K051901) | 15" LCD touch screen | ||
| Configuration | Same as predicate | N/A | Battery operated mobile x- |
| ray system | |||
| Electrical Safety | Same as predicate | IEC-60601 | IEC-60601 |
| Performance | |||
| Standard | Same as predicate | N/A | 21CFR1020.30 |
| Generators | Same as predicate | N/A | Choice of four models, 20- |
| 50 kW | |||
| Collimator | Same as predicate | N/A | Ralco 221 (manual) |
and the same of the comments of the comments of
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E. TECHNOLOGICAL CHARACTERISTICS
Agfa's DX-D 100 includes both a mobile x-ray system for patient exposure and digital image capture equipment.
b c d
The x-ray system components of each device will include one of four generators (20-50 kW) and one of four x-ray tubes (Toshiba 140 - 300 KHU) on a battery powered cart that allows the device to be easily positioned wherever the patient is located (e.g.: emergency or acute care locations).
Each device also includes a flat panel digital detector of either Cesium Iodide or Gadolinium Phosphate (CsI or GOS) and Agfa's NX computer workstation for previewing and processing the digital image.
F. TESTING
The new device combines proven technology from both predicates which have been combined to create the new device. The new device includes minor modifications that have been fully tested.
The device has been tested and shown to conform to electronic medical product safety, radiology, and medical imaging standards including:
PRODUCT STANDARDS
- IEC 60601-1-1: Medical electrical equipment Part 1: General requirements for basic safety and essential . performance, plus collateral standard: Electromagnetic compatibility - requirements and tests.
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General Requirements For Safety Collateral ● Standard: Electromagnetic Compatibility - Requirements And Tests
- ACR/NEMA PS3.1-3.18: Digital Imaging and Communications in Medicine (DICOM) .
- . IEC 60601-1-3: Medical electrical equipment - Part 1: General requirements for safety 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
- IEC 60601-2-7 (1998-02) Medical electrical equipment Part 2-7: Particular requirements for the safety of . high-voltage generators of diagnostic X-ray generators
- IEC 60601-2-28 Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies . for medical diagnosis
- IEC 60601-2-32 Particular Requirements For The Safety Of Associated Equipment Of X-Ray Equipment .
MANAGEMENT STANDARDS
- ISO 14971 Application of Risk Management to Medical Devices ●
- . ISO 13485 Medical Devices - Quality Management Systems - Requirements For Regulatory purposes
Performance of the complete system has been validated. Sample images have been provided.
No clinical testing was performed in the development of the DX-D 100.
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/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing segments.
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 Healthcare N. V. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K103597
Trade/Device Name: DX-D 100 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: December 7, 2010 Received: December 8, 2010
Dear Mr. Job:
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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting of medical
JAN - 3 2010
4
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,
signature
David G. Brown, Ph.D. 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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Agfa HealthCare NV Premarket Notification: DX-D 100
Indications for Use
JAN - 3 2010
KI03597 510(k) Number (if known):
Device Name: DX-D 100
Indications for Use:
Agfa's DX-D 100 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 100 is not indicated for use in mammography.
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 In Vitro Diagnostic Devices (OIVD)
Zuker D'Aken
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103597
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