(53 days)
No
The document mentions "MUSICA image processing" but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The focus is on standard image processing techniques for radiography and fluoroscopy.
No.
The device is an imaging system (X-ray) used for diagnosis and image acquisition, not for therapeutic intervention or treatment.
Yes
The device captures tomographic, static, and dynamic images of the human body for examinations such as gastro-intestinal and urogenital tract procedures, angiography, and digital subtraction angiography, all of which are used by medical professionals to make a diagnosis.
No
The device description explicitly states it is a "fluoroscopic x-ray system" that is "floor-mounted" and "consists of a tube and operator console with a motorized tilting patient table." This clearly indicates the presence of significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for imaging examinations of the human body using X-rays. This involves capturing images of internal structures.
- Device Description: The device is described as a fluoroscopic x-ray system that captures images.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body. IVD devices are specifically designed for testing these types of samples in a laboratory setting.
The device is a medical imaging system used for diagnostic purposes, but it falls under the category of in vivo diagnostic devices, as it is used to examine the patient directly.
N/A
Intended Use / Indications for Use
The DR 800 with DSA system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures:
- · Positioning fluoroscopy procedures
- · Gastro-intestinal examinations
- · Urogenital tract examinations
- · Angiography
- · Digital Subtraction Angiography
It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for projection radiography of all body parts.
In addition, the system provides the Agfa Tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-ray systems. Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.
Not intended for cardiovascular and cerebrovascular contrast studies. Not intended for mammography applications.
Product codes
JAA, IZF
Device Description
Agfa's DR 800 with DSA medical device is a fluoroscopic x-ray system that includes digital angiography (product code JAA) intended to capture tomographic, static and dynamic images of the human body. The DR 800 is a floor-mounted radiographic, fluoroscopic and tomographic system that consists of a tube and operator console with a motorized tilting patient table. FLFS overlay and bucky with optional wall stand and ceiling suspension. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital, wide dynamic range and angiographic image capture. It is capable of replacing other direct radiography, tomography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes.
This submission is to add the newest version of the DR 800 with Digital Subtraction Angiography (DSA) to Agfa's radiography portfolio.
Mentions image processing
The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital, wide dynamic range and angiographic image capture.
The image processing algorithms in the new device are similar to those previously cleared in the DR 800 with Tomosynthesis (K183275) and other devices in Agfa's radiography portfolio today which includes DR 600 with Tomosynthesis (K193262) and DR 400 (K141192). The addition of the angiographic image processing is similar to the primary predicate device (K190373).
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, Fluoroscopy, Digital Subtraction Angiography, Digital Tomosynthesis
Anatomical Site
human anatomy, body parts, Gastro-intestinal, Urogenital tract, chest, extremities
Indicated Patient Age Range
general populations, including adult and pediatric patients.
Intended User / Care Setting
qualified personnel, such as radiography technicians or those with equivalent qualifications.
hospital.
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
DSA software verification testing for NX 23 was completed in scope of the DR 800 with DSA X-Software testing of MUSICA image processing included digital subtraction Ray System. angiography (DSA). HERDE defects were identified; however, they were solved between test execution and the completion of the final report and will be part of the next maintenance software release.
Additional validation testing for NX 23 was completed and data provided in the premarket 510(k) notification for the DX-D Imaging Package - XD Detectors which is currently pending 510(k) clearance (K211790). Refer to this submission for all verification and validation documentation for NX 23 GenRad software applications and the XD Detector workflow.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Laboratory testing, software testing, bench testing, clinical image validation
Sample Size: Not specified
AUC: Not specified
MRMC: Not specified
Standalone Performance: Technical and acceptance testing was completed on the DR 800 with DSA in order to confirm the medical device functions and performs as intended. All planned verification activities have been successfully completed. Performance functionality and usability evaluations were conducted with qualified experts. The results of these tests fell within the acceptance criteria for the DR 800 with DSA; therefore, the DR 800 supports GenRad, Full Leg/ Full Spine (FLFS), roadmapping and Digital Subtraction Angiography (DSA) workflow.
Key Results: Clinical image validation was conducted using anthropomorphic phantoms and evaluated by qualified experts. The radiographers evaluated the DSA image quality on the DR 800 by comparing overall image quality with the primary predicate A device (K190373). Diagnostic confidence for DSA image quality and roadmapping on the DR 800 was between good and excellent. Clinical image quality evaluation is not essential in establishing substantial equivalence for the DR 800 with DSA. Adequate Bench Testing results should be sufficient to determine device safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K161368, K103597, K103050, K112670, K141192, K152639, K180589, K191884, K193262, K081963, K051901, K211790
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
August 31, 2021
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. To the right of the box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Agfa N.V. % Ms. ShaeAnn Cavanagh Regulatory Affairs Manager, North America Agfa US Corp. 10 South Academy Street GREENVILLE SC 29601
Re: K212145
Trade/Device Name: DR 800 with DSA Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA Dated: July 8, 2021 Received: July 9, 2021
Dear Ms. Cavanagh:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
, for
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212145
Device Name DR 800 with DSA
Indications for Use (Describe)
The DR 800 with DSA system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures:
- · Positioning fluoroscopy procedures
- · Gastro-intestinal examinations
- · Urogenital tract examinations
- · Angiography
- · Digital Subtraction Angiography
It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for projection radiography of all body parts.
In addition, the system provides the Agfa Tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-ray systems. Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.
Not intended for cardiovascular and cerebrovascular contrast studies. Not intended for mammography applications.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------ | ----------------------------------------------------------- |
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3
510(K) SUMMARY
Agfa N.V. DR 800 with DSA
SUBMITTER I.
Agfa N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Wim Govaerts, Prepared: July 8, 2021 Telephone: + 32 3444 6246
DEVICE II.
Name of Device: DR 800 with DSA Common Name: System, X-Ray, Fluoroscopic Image-Intensified Classification Name: Fluoroscopic Image-Intensified X-Ray System Regulatory Classification: Class II, 21 CFR 892.1650 Product Code: JAA
PREDICATE DEVICE(S) III.
This is a 510(k) for Agfa's DR 800 with DSA which is a fluoroscopic x-ray system, including digital angiography. It is substantially equivalent to Shimadzu Corporation's primary predicate device A. SONIAL VISION G4 (K190373) and Agfa's predicate device B, DR 800 with Tomosynthesis (K183275).
- Primary Predicate Device (A): SONIALVISION G4 Common Name: System, X-Ray, Fluoroscopic Image-Intensified Classification Name: Fluoroscopic Image-Intensified X-Ray System Regulatory Classification: Class II, 21 CFR 892.1650 Product Code: JAA
-
- Predicate Device (B): DR 800 with Tomosynthesis Name of Device: DR 800 with Tomosynthesis Common Name: System, X-Ray, Tomographic Classification Name: Tomographic X-ray System Regulatory Classification: Class II, 21 CFR 892.1740 Product Code: IZF
Common Name: System, X-Ray, Fluoroscopic Image-Intensified Classification Name: Fluoroscopic X-ray System Regulatory Classification: Class II, 21 CFR 892.1650 Product Code: JAA
- Predicate Device (B): DR 800 with Tomosynthesis Name of Device: DR 800 with Tomosynthesis Common Name: System, X-Ray, Tomographic Classification Name: Tomographic X-ray System Regulatory Classification: Class II, 21 CFR 892.1740 Product Code: IZF
4
The SONIALVISION G4 (K190373) primary predicate device has not been subject to a designrelated recall. The DR 800 with Tomosynthesis (K183275) predicate device was part of a Class II recall initiated on February 10, 2020. The recall was related specifically to the tomosynthesis software functionality where an image acquisition sequence did not stop automatically after expected number of exposures. No injuries were reported. Agfa has taken these reported defects into consideration and is mindful of these events while developing the subject device, DR 800 with DSA.
IV. DEVICE DESCRIPTION
Agfa's DR 800 with DSA medical device is a fluoroscopic x-ray system that includes digital angiography (product code JAA) intended to capture tomographic, static and dynamic images of the human body. The DR 800 is a floor-mounted radiographic, fluoroscopic and tomographic system that consists of a tube and operator console with a motorized tilting patient table. FLFS overlay and bucky with optional wall stand and ceiling suspension. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital, wide dynamic range and angiographic image capture. It is capable of replacing other direct radiography, tomography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes.
This submission is to add the newest version of the DR 800 with Digital Subtraction Angiography (DSA) to Agfa's radiography portfolio.
The image processing algorithms in the new device are similar to those previously cleared in the DR 800 with Tomosynthesis (K183275) and other devices in Agfa's radiography portfolio today which includes DR 600 with Tomosynthesis (K193262) and DR 400 (K141192). The addition of the angiographic image processing is similar to the primary predicate device (K190373).
Principles of operation and technological characteristics of the new and predicate devices are the same. The new device is virtually identical to Agfa's DR 800 with Tomosynthesis (K183275) with the exception that it has additional DSA software for processing digital angiographic studies. The SONIALVISION G4 (primary predicate A. K190373) contains similar software algorithms for processing angiographic studies of the human body. The DR 800 with Tomosynthesis (predicate B. K183275) uses the same flat panel detectors to capture and digitize the image. Differences in devices do not alter the intended diagnostic effect. Laboratory data and image quality evaluations conducted with independent radiologists confirm that performance is equivalent to the predicates.
Configuration information for the flat-panel detectors can be found in the DR 14s (K161368) user manuals. The DR 14s and RF FL 4343 flat-panel detectors can be integrated in an X-ray system that communicates to a workstation. The Service Manual details the possible configurations and integrations with the NX workstation and X-ray generator. All of Agfa's DR X-ray systems (i.e. DX-D 100-K103597, DX-D 300-K103050, DX-D 600-K112670, DR 400-K141192, DR 600-K152639, DR 800 with MUSICA Dynamic -K180589, DR 800 with Tomosynthesis - K 183275, DR 100s – K191884 & DR 600 with Tomosynthesis – K193262) will integrate with the detectors. The NX4.x.23 Service Manual, Chapter 4 and associated appendices addresses the installation and configuration with other system components.
5
V. INDICATIONS FOR USE
The DR 800 with DSA system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures:
- Positioning fluoroscopy procedures
- · Gastro-intestinal examinations
- Urogenital tract examinations
- Angiography
- Digital Subtraction Angiography
It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for projection radiography of all body parts.
In addition, the system provides the Agfa Tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-rav systems. Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.
Not intended for cardiovascular and cerebrovascular contrast studies. Not intended for mammography applications.
NOTE: The mammography applications embedded in the MUSICA software are for previously cleared CR imaging applications (K081963) and not intended for direct radiography (DR) imaging. Furthermore, the additional mammography software is only available through additional license keys that must be purchased. These license keys are only available outside of the USA.
PEDIATRIC USE SUMMARY
The DR 800 with DSA medical device is intended for general populations, including adult and pediatric patients. Specific design features of the DR 800 with DSA for pediatric use include but not limited to using the FLFS application without the grid, specific AEC values and NX protocol settings per pediatric age range. The following specific design features and instructions enable safer use of the device with pediatric patients:
| Pediatric Imaging Design Features | Standard or Optional |
|---|---|
| Protocols or exposure indices | Standard - make own exam tree |
| optional - make use of age groups | |
| Filter and removable grid | Standard |
| Collimator alignment | Standard |
| Variable focal spot size | Standard |
| Post-processing application | Standard/ no specific pediatric post processing |
| for tomosynthesis | |
| Reconstruction algorithm | no specific pediatric reconstruction algorithm |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES
6
Agfa's DR 800 with DSA, Shimadzu Corporation's SONIALVISION G4 primary predicate device (K190373) and Agfa's DR 800 with Tomosynthesis predicate device (K183275) are all fluoroscopic x-ray imaging devices, Product Code JAA. Agfa's DR 800 with DSA is substantially equivalent to the primary predicate device (K190373) in that it uses similar technology to capture and transmit angiographic images. The DR 800 is a floor-mounted radiographic, fluoroscopic and tomographic system that consists of a tube and operator console with a motorized tilting patient table, FLFS overlay and bucky with optional wall stand and ceiling suspension. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital, wide dynamic range and angiographic image capture. It is capable of replacing other direct radiography, tomography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes.
Principles of operation and technological characteristics of the new and predicate devices are the same. The new device is virtually identical to Agfa's DR 800 with Tomosynthesis (K183275) with the exception that it has additional DSA software for processing digital angiographic studies. The SONIALVISION G4 (primary predicate A, K190373) contains similar software algorithms for processing angiographic studies of the human body. The DR 800 with Tomosynthesis (predicate B, K183275) uses the same flat panel detectors to capture and digitize the image. Differences in devices do not alter the intended diagnostic effect.
The image processing algorithms in the new device are similar to those previously cleared in the DR 800 with Tomosynthesis (K183275) and other devices in Agfa's radiography portfolio today which includes DR 600 with Tomosynthesis (K193262) and DR 400 (K141192). The addition of the digital angiographic image processing is similar to the primary predicate device (K190373).
Agfa's DR 800 with DSA has an Indications For Use statement virtually identical to the predicate B device (K183275) except it includes the addition of Digital Subtraction Angiography and the contraindication for cardiovascular and cerebrovascular contrast studies. The DR 800 with DSA new device has a similar Indications For Use statement as the primary predicate A device (K190373). Intended uses are the same. The devices have technological characteristics.
The DR 800 indications for use is equivalent to both the predicate devices (K190373 & K183275) because both include fluoroscopic, radiographic and tomographic image processing and all are indicated for use in general and pediatric patient populations. The DR 800 with DSA and both predicate devices (K190373 & K183275) include the statement that the device is not indicated for mammography. The DR 800 with DSA and both predicates (K190373 & K183275) use DICOM for sending and receiving images and none of the devices are indicated for interventional procedures.
There is a difference between the new device and primary predicate device (K190373) Indication for Use statement regarding a general reference to the human body; however, standard practice dictates that diagnostic procedures for general human anatomy include chest and extremities. Another difference between the new device and primary predicate device (K190373) is that the new device Indications For Use statement lists out examples of imaging procedures; it is logical to conclude these same imaging procedures are also indicated with the predicate device based on standard medical practice. The differences between the subject device, DR 800 with DSA, and predicate devices (K190373 & K183275) do not seem to impact safety or effectiveness.
7
Performance data, image quality clinical evaluations, and usability/functionality data are adequate to ensure equivalence. Descriptive characteristics and performance data including image quality evaluations by qualified experts are adequate to ensure equivalence. Differences in devices do not alter the intended therapeutic/diagnostic effect.
8
| PRODUCT COMPARISON TABLE | ||||
|---|---|---|---|---|
| DR 800 with DSA | ||||
| (New Device) | SONIALVISION G4 | |||
| (PREDICATE A- K190373) | DR 800 w/ Tomo | |||
| (PREDICATE B - K183275) | Explanation of | |||
| Differences | ||||
| Communication | Same as both Predicates | DICOM | DICOM | N/A |
| Flat Panel | ||||
| Detectors | Same as both Predicates | Flat Panel Detector | Flat Panel Detector | N/A |
| Detector | ||||
| Material | Gadolinium Oxysulfide (GOS) or | |||
| Cesium Iodide (CsI) scintillator | Cesium Iodide (CsI) scintillator | Gadolinium Oxysulfide (GOS) | ||
| or Cesium Iodide (CsI) | ||||
| scintillator | Includes GOS | |||
| Detector Sizes | 17x17 in. | |||
| 14 x 17 in | ||||
| 10 x 10 in | 17x17 in. | 17x17 in. | ||
| 14 x 17 in | ||||
| 10 x 10 in | Includes 14x17 in & | |||
| 10x10 in as well | ||||
| Pixel size | Same as Predicate K183275 | 139 µm | 148 $μ$ m | Comparable |
| Dynamic | ||||
| Range | Same as both Predicates | 16 bit | 16 bit | N/A |
| Power Supply | Same as Predicate K183275 | -- | 50-60 Hz | |
| 100-240V auto ranging | Unable to find info for | |||
| predicate K190373 | ||||
| Operator | ||||
| Workstation | Same as Predicate K183275 | Diagnostic Workstation | Agfa NX using Microsoft 7/10 | |
| Image | ||||
| processing | Same as Predicate K183275 | SUREengine-Advance | MUSICA 3 | |
| MUSICA 4 | Agfa's image | |||
| processing software | ||||
| Radiography | Fluoroscopic, Tomographic, GenRad | |||
| radiography & DSA | SPOT, division & serial radiography, | |||
| DSA | Fluoroscopic, Tomographic, | |||
| GenRad radiography | Includes DSA like | |||
| predicate K190373 | ||||
| Display System | Same as both Predicates | Separately cleared medical display | Separately cleared medical | |
| display (K051901) | N/A | |||
| Tabletop | ||||
| Features | Tilt +/- 90°, 240 x 80 cm | |||
| 265 kg maximum weight | Tilt +/- 90°, 240 x 89 cm | |||
| 318 kg maximum weight | Tilt +/- 90°, 240 x 80 cm | |||
| 265 kg maximum weight | Slight difference in | |||
| height & weight | ||||
| doesn't affect S&E | ||||
| Generators | Choice of three models: | |||
| 50, 65KW, 80 KW | 80 KW | Choice of three models: | ||
| 50, 65KW, 80 KW | Same choice of 80KW | |||
| as predicate K190373 | ||||
| Indications for | ||||
| Use | The DR 800 with DSA system is | |||
| indicated for performing dynamic | ||||
| imaging examinations (fluoroscopy | ||||
| and/or rapid sequence) of the following | ||||
| anatomies/procedures: | ||||
| • Positioning fluoroscopy | ||||
| procedures | ||||
| • Gastro-intestinal examinations | ||||
| • Urogenital tract examinations | ||||
| • Angiography | ||||
| • Digital Subtraction Angiography | ||||
| It is intended to replace fluoroscopic | ||||
| images obtained through image | ||||
| intensifier technology. | ||||
| In addition, the system is intended for | ||||
| projection radiography of all body | ||||
| parts. In addition, the system provides | ||||
| the Agfa Tomosynthesis option, which | ||||
| is intended to acquire tomographic | ||||
| slices of human anatomy and to be | ||||
| used with Agfa DR X-ray systems. | ||||
| Digital Tomosynthesis is used to | ||||
| synthesize tomographic slices from a | ||||
| single tomographic sweep. | ||||
| Not intended for cardiovascular and | ||||
| cerebrovascular contrast studies. | ||||
| Not intended for mammography | ||||
| applications. | The equipment is intended to be used | |||
| for the fluoroscopy/radiography | ||||
| diagnosis in hospital. The equipment | ||||
| must only be operated by qualified | ||||
| personnel, such as radiography | ||||
| technicians or those with equivalent | ||||
| qualifications. The equipment is used | ||||
| for total patient population. | ||||
| The equipment is NOT intended to be | ||||
| used for Mammography screening. | ||||
| The equipment is NOT intended to be | ||||
| used for interventional procedure. | ||||
| The equipment is used for radiographic, | ||||
| fluoroscopic, angiographic and | ||||
| pediatric examinations. Stored images | ||||
| in the equipment can be used for re- | ||||
| monitoring, image processing, storing | ||||
| to optical media (CD/DVD), and | ||||
| sending to DICOM server. The | ||||
| Tomosynthesis option for the | ||||
| SONIALVISION G4 is intended to | ||||
| generate tomographic images of human | ||||
| anatomy including chest or extremities. | ||||
| Tomosynthesis technique is used to | ||||
| produce a specific cross-sectional plane | ||||
| of the body by reconstruction of | ||||
| tomographic acquisition. The device is | ||||
| not intended for mammographic | ||||
| applications | The DR 800 system is | |||
| indicated for performing | ||||
| dynamic imaging | ||||
| examinations (fluoroscopy | ||||
| and/or rapid sequence) of the | ||||
| following anatomies/ | ||||
| procedures: • Positioning | ||||
| fluoroscopy procedures | ||||
| • Gastro-intestinal | ||||
| examinations | ||||
| • Urogenital tract examinations | ||||
| • Angiography | ||||
| It is intended to replace | ||||
| fluoroscopic images obtained | ||||
| through image intensifier | ||||
| technology. In addition, the | ||||
| system is intended for project | ||||
| radiography of all body parts. | ||||
| In addition, the system | ||||
| provides the Agfa | ||||
| Tomosynthesis option, which | ||||
| is intended to acquire | ||||
| tomographic slices of | ||||
| human anatomy and to be used | ||||
| with Agfa DR X-Ray systems. | ||||
| Tomosynthesis is used to | ||||
| synthesize tomographic slices | ||||
| from a single tomographic | ||||
| sweep. The DR 800 is not | ||||
| intended for mammography | ||||
| applications. | 1. General reference to | |||
| the human body versus | ||||
| delineation of body | ||||
| parts - standard | ||||
| practice includes chest | ||||
| and extremities in | ||||
| general |
- List of imaging
procedures instead of a
general statement -
same imaging
procedures can be
completed on the
primary predicate
device |
9
VII. PERFORMANCE DATA
Laboratory testing and software testing (for a moderate level of concern device) using equivalent test protocols were evaluated by qualified individuals to demonstrate that adequate design controls (according to 21 CFR 820.30) were in place.
Verification and validation testing confirmed the device meets performance, safety, usability and security requirements. Pediatric indications were also taken into account. Results were verified and validated.
No clinical trials were performed in the device. No animal or clinical studies were performed in the development of the new device. No patient treatment was provided or withheld.
Bench Testing
Image quality evaluations, performance/functionality and usability data has been provided.
- . Technical and acceptance testing was completed on the DR 800 with DSA in order to confirm the medical device functions and performs as intended. All deviations or variances are documented in a defect database and addressed in the CRD documentation and verified. All mitigations have been tested and passed. All design input requirements have been tested and passed. All planned verification activities have been successfully completed.
- . Performance functionality and usability evaluations were conducted with qualified experts. The results of these tests fell within the acceptance criteria for the DR 800 with DSA; therefore, the DR 800 supports GenRad, Full Leg/ Full Spine (FLFS), roadmapping and Digital Subtraction Angiography (DSA) workflow.
- . Clinical image validation was conducted using anthropomorphic phantoms and evaluated by qualified experts. The radiographers evaluated the DSA image quality on the DR 800 by comparing overall image quality with the primary predicate A device (K190373). Diagnostic confidence for DSA image quality and roadmapping on the DR 800 was between good and excellent.
Clinical image quality evaluation is not essential in establishing substantial equivalence for the DR 800 with DSA. Adequate Bench Testing results should be sufficient to determine device safety and effectiveness.
Software Verification and Validation Testing
Verification and validation plans comprise of test protocols. The complete device has been certified and validated. During the final risk analysis meeting, the risk management team concluded that the medical risk is no greater than with conventional x-ray film previously released to the field.
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DSA software verification testing for NX 23 was completed in scope of the DR 800 with DSA X-Software testing of MUSICA image processing included digital subtraction Ray System. angiography (DSA). HERDE defects were identified; however, they were solved between test execution and the completion of the final report and will be part of the next maintenance software release.
Additional validation testing for NX 23 was completed and data provided in the premarket 510(k) notification for the DX-D Imaging Package - XD Detectors which is currently pending 510(k) clearance (K211790). Refer to this submission for all verification and validation documentation for NX 23 GenRad software applications and the XD Detector workflow.
For the NX 23 (NX Orion) software there are a total of 535 risks in the broadly acceptable region and 37 risks in the ALARP region with only four of these risks identified. Zero risks were identified in the Not Acceptable Region. Therefore, the device is assumed to be safe, the benefits of the device are assumed to outweigh the residual risk. The software risk assessed on solution level for the DR 800 with DSA.
The term "Level of Concern" means the level of risk that the software device is determined to be if the software were to fail. The Level of Concern for the DR 800 with DSA and NX 23 has been determined to be moderate.
Electrical Safety and Electromagnetic Compatibility (EMC) Testing:
- IEC 60601-1: 2005 Medical Electrical Equipment: General Requirements for Safety and . Essential Performance.
- IEC 60601-1-2: 2014 Medical Electrical Equipment Part 1-2: General Requirements for ● Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests.
- IEC 60601-1-3: 2013 Medical Electrical Equipment Part 1-3: General Requirements for ● the Basic Safety and Essential Performance - Collateral Standard Radiation Protection in Diagnostic X-Ray Equipment
- IEC 60601-2-54:2019 Medical Electrical Equipment Part 2-54: Particular Requirements ● for the Basic Safety and Essential Performance of X-Ray Equipment for Radiography and Radioscopy.
The DR 800 is compliant to FDA Subchapter J mandated performance standards 21 CFR 1020.30 - 1020.32
Agfa's in-house standard operating procedures were also used for the development of the device and software; these procedures conform to the following standards:
- ISO 13485:2015 Medical Devices Quality Management Systems ●
- ISO 14971:2012 Application of Risk Management to Medical Devices ●
- ACR/NEMA PS3.1-3.20: 2011 Digital Imaging and Communications in Medicine (DICOM) ●
- IEC 62366-1:2015 Medical Devices – Part 1: Application of Usability Engineering to Medical Devices
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- IEC 62304:2006 Medical Device Software Software Lifecycle Processes [Including . Amendment 1 (2016)]
Guidance Documents
Agfa utilized the following guidance documents in the development of the DR 800 with DSA:
- Guidance for the Content of Premarket Submissions for Software Contained in Medical ● Devices (May 2005)
- Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software (Jan 2005)
- Off-the-Shelf Software Use in Medical Devices (September 2019)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices . (Oct 2018)
- Guidance for Pediatric Information for X-ray Imaging Device Premarket Notifications (Nov 2017)
Summarv
Based on the performance data as documented in the above testing, the DR 800 with DSA is found to have a safety and effectiveness profile that is similar to both of the predicate devices.
VIII. CONCLUSIONS
Agfa's DR 800 with DSA has indications for use that is consistent with that of the legally marketed predicate devices (K190373 & K183275). Intended uses are the same. Laboratory tests conclude that the device is substantially equivalent to the predicate. Differences in devices do not alter the intended diagnostic effect nor do they impact the safety and effectiveness of the device.
The new device and the SONIAL VISION G4 primary predicate device A (K190373) and predicate device B, DR 800 with Tomosynthesis (K183275) are fluoroscopic x-ray systems, Product Code JAA. Agfa's DR 800 with DSA device is substantially equivalent to both the primary predicate device A (K190373) and predicate device B (K183275) in that it uses the same basic technology to capture and transmit images.
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.