(104 days)
The DR 600 system is a General Radiography X-ray imaging system used in hospitals, clinics and medical practices by radiographers, radiologists and physicists to make, process and view static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.
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.
Applications can be performed with the patient in the sitting, standing or lying position.
This system is not intended for mammography applications.
The DR 600 with Tomosynthesis is a tomographic and solid state x-ray system (product codes IZF and MQB) intended to capture tomographic slices and static images of the human body. The DR 600 with Tomosynthesis is a ceiling mounted tomographic and general radiographic system that consists of a tube and operator console with a motorized patient table and/or wall stand. The DR 600 with Tomosynthesis uses Agfa's NX workstation with MUSICA2 ™ image processing and flat-panel detectors of the scintillator-photodetector type (Cesium Iodide - CsI or Gadolinium Oxysulfide - GOS). 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.
The provided text describes the Agfa DR 600 with Tomosynthesis device and its K193262 510(k) submission. However, it does not contain specific acceptance criteria or a detailed clinical study demonstrating the device's meeting of these criteria. The document focuses on showing substantial equivalence to predicate devices primarily through technological characteristics and bench testing, not through comparative clinical effectiveness studies with explicit acceptance criteria for diagnostic performance.
Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not present in the provided text. The document explicitly states: "No clinical trials were performed in the device. No animal or clinical studies were performed in the development of the new device."
Based on the available information, here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance (as inferred from the document's approach to substantial equivalence):
Since no specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC) are presented, the "acceptance criteria" for this 510(k) appear to be primarily focused on demonstrating substantial equivalence to predicate devices through technical specifications, image quality evaluations (bench testing), and compliance with various electrical safety, EMC, and software standards.
| Acceptance Criteria (Inferred from Document) | Reported Device Performance |
|---|---|
| 1. Technological Characteristics are Identical/Equivalent to Predicates: - Communications (DICOM) - Flat Panel Detectors (type, material, sizes, pixel size, dynamic range) - Operator Workstation (Agfa NX) - Image Processing (MUSICA DTS, MUSICA2, MUSICA3/3+) - Operating System (Windows 7, 8, 8.1, 10) - Display System (Separately cleared medical display) - Power Supply - Generators2. Indication for Use statement is consistent/identical to predicates.3. Performance/Functionality as Intended: - Confirmed functions and performs as intended. - Supports a tomographic workflow and Smart Dr visualization (including adult and pediatric patients).4. Image Quality Equivalent to Predicate: - For both adult and pediatric patients.5. Software Validation: - Verification and validation plans confirmed. - Risk assessment shows no unacceptable risks.6. Electrical Safety and EMC Compliance: - Adherence to specified IEC standards (60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-28, 60601-2-54). - Compliance with FDA Subchapter J mandated performance standard 21 CFR 1020.30 and 1020.31.7. Quality Management System Compliance: - Adherence to ISO 13485:2015, ISO 14971:2012, ACR/NEMA PS3.1-3.20 (DICOM). | 1. Technological Characteristics: - Communications: Same as both predicates (DICOM). - Flat Panel Detectors: Same as both predicates (Flat Panel Detectors, GOS/CsI Scintillator, various sizes 17x17, 14x17, 10x10 in., 148 µm pixel size in primary predicate, 139 µm in other, 16 bit dynamic range in primary predicate, 14 bit in other). The new device shares characteristics with both, indicating equivalence. - Operator Workstation: Same as both predicates (Agfa NX). - Image Processing: MUSICA DTS, MUSICA2, MUSICA3/3+. The addition of tomographic image processing is identical to the DR 800 (K183275) primary predicate device. - Operating System: Same as predicate K183275 (Windows 7, 8, 8.1, 10). - Display System: Same as both predicates (Separately cleared medical display K051901). - Power Supply: Same as predicate K152639 (50-60 Hz, 380/400/415/440/480V + 10%). - Generators: Same as predicate K183275 (Choice of three models: 50, 65KW, 80 KW). - Overall: "Principles of operation and technological characteristics of the new and predicate devices are the same."2. Indication for Use: "The DR 600 system is a General Radiography X-ray imaging system... In addition, the system provides the Agfa tomosynthesis option... Digital tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep." This is stated to be "virtually identical" to K152639 with the tomosynthesis addition from K183275.3. Performance/Functionality: - "Technical and acceptance testing was completed on the DR 600 in order to confirm the medical device functions and performs as intended. All deviations or variances are documented... All design input requirements have been tested and passed." - "Functionality evaluations were conducted with three qualified radiographers. Usability and TBD. The results of these tests fell within the acceptance criteria for the DR 600; therefore, the DR 600 supports a tomographic workflow and Smart Dr visualization including adult and pediatric patients."4. Image Quality: "Image quality bench tests were conducted in support of this 510(k) submission in which anthropomorphic adult and pediatric images taken with the DR 600 and the primary predicate device, DR 800 (K183275) were compared to ensure substantial equivalency. The test results indicated the image processing of the DR 600 passed the acceptance criteria and was equal to the image processing for the primary predicate, DR 800 (K183275) device for both adult and pediatric patients."5. Software Validation: "Verification and validation testing confirmed the device meets performance, safety, usability and security requirements... For the NX22 (NX Nomad) software there are a total of 342 risks in the broadly acceptable region and 27 risks in the ALARP region with only one of these risks identified. Zero risks were identified in the Not Acceptable Region."6. Electrical Safety and EMC Compliance: Document states compliance with all listed IEC standards and FDA performance standards.7. Quality Management System Compliance: Document states adherence to all listed ISO and other standards. |
Study Details (Based on the provided text):
-
Sample sizes used for the test set and the data provenance:
- Test Set: No specific numerical sample size is mentioned for image quality evaluations beyond "anthropomorphic adult and pediatric images." The document mentions "functionality evaluations were conducted with three qualified radiographers," but this refers to human user testing of workflow and usability, not diagnostic image performance.
- Data Provenance: Not explicitly stated, but likely retrospective as it refers to comparisons of images taken with the new device and a predicate device. The comparison of anthropomorphic phantom images suggests a controlled laboratory setting.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states "Laboratory data and image quality evaluations conducted with internal and independent specialists confirm that performance is equivalent to the predicates." It also mentions "clinical image quality evaluations for adults and pediatric patients" and "functionality evaluations were conducted with three qualified radiographers."
- Number of Experts: At least "three qualified radiographers" for functionality, and "internal and independent specialists" for image quality, but exact numbers or specific qualifications (e.g., years of experience, board certification) are not detailed.
- Qualifications: "Qualified radiographers" and "internal and independent specialists."
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method is described for the image quality evaluations or other performance tests. The comparison to predicates implies direct visual or quantitative comparison by specialists.
-
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 MRMC comparative effectiveness study was done. The document explicitly states: "No clinical trials were performed in the device. No animal or clinical studies were performed in the development of the new device."
- Therefore, no effect size of human readers improving with AI assistance is provided as this type of study was not conducted. The device in question is an imaging system, not an AI-based diagnostic assistance tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "performance data including clinical image quality evaluations for adults and pediatric patients" involved the system's output. The "image processing of the DR 600 passed the acceptance criteria and was equal to the image processing for the primary predicate, DR 800 (K183275) device for both adult and pediatric patients." This implies an evaluation of the algorithm's output (image quality) without necessarily focusing on a human-in-the-loop diagnostic task. So, in essence, standalone image quality performance was evaluated against a predicate.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for image quality evaluation appears to be comparison to a cleared predicate device's image quality, as judged by "internal and independent specialists," using anthropomorphic phantoms. There is no mention of pathological confirmation or patient outcomes for establishing ground truth, as it was not a clinical trial.
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The sample size for the training set:
- This device is an X-ray system with image processing, not a machine learning/AI algorithm that requires a "training set" in the traditional sense of AI development. The software capabilities (MUSICA DTS, MUSICA2, MUSICA3/3+) are described as being identical to previously cleared versions in predicate devices. Therefore, a "training set" for a new AI model is not applicable here.
-
How the ground truth for the training set was established:
- Not applicable, as no new AI model training set is described. The image processing algorithms are identical to those previously cleared.
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March 9, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Agfa N.V. % Ms. ShaeAnn Cavanagh Regulatory Affairs Manager, North America Agfa US Corp. 10 South Academy Street GREENVILLE SC 29601
Re: K193262
Trade/Device Name: DR 600 with Tomosynthesis Regulation Number: 21 CFR 892.1740 Regulation Name: Tomographic x-ray system Regulatory Class: Class II Product Code: IZF, MQB Dated: February 7, 2020 Received: February 10, 2020
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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
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Indications for Use
510(k) Number (if known)
Device Name DR 600 with Tomosynthesis
Indications for Use (Describe)
The DR 600 system is a General Radiography X-ray imaging system used in hospitals, clinics and medical practices by radiographers, radiologists and physicists to make, process and view static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.
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.
Applications can be performed with the patient in the sitting, standing or lying position.
This system is not intended for mammography applications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
Agfa N.V. DR 600 with Tomosynthesis
SUBMITTER I.
Agfa N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Wim Govaerts, Prepared: November 26, 2019 Telephone: + 32 3444 6246
DEVICE II.
Name of Device: DR 600 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
III. PREDICATE DEVICES
This is a 510(k) for Agfa's DR 600 with Tomosynthesis which is a tomographic and solid state xray system. It is substantially equivalent to both of Agfa's predicate devices, DR 800 with Tomosynthesis (primary - K183275) and DR 600 (K152639).
Primary Predicate 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
Predicate Device: DR 600 Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) Classification Name: Stationary X-Ray System Regulatory Classification: Class II, 21 CFR 892.1680 Product Code: MQB
Neither the DR 800 with Tomosynthesis (K183275) primary predicate device nor the DR 600 (K152639) predicate device has not been subject to a design-related recall.
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IV. DEVICE DESCRIPTION
The DR 600 with Tomosynthesis is a tomographic and solid state x-ray system (product codes IZF and MQB) intended to capture tomographic slices and static images of the human body. The DR 600 with Tomosynthesis is a ceiling mounted tomographic and general radiographic system that consists of a tube and operator console with a motorized patient table and/or wall stand. The DR 600 with Tomosynthesis uses Agfa's NX workstation with MUSICA2 ™ image processing and flat-panel detectors of the scintillator-photodetector type (Cesium Iodide - CsI or Gadolinium Oxysulfide - GOS). 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 600 with Tomosynthesis to Agfa's radiography portfolio.
The optional image processing allows users to conveniently select image processing settings for different patient sizes and examinations. The image processing algorithms in the new device are identical to those previously cleared in the DR 800 (K183275- primary) and DR 600 (K152639) predicate devices and other devices in Agfa's radiography portfolio today. The addition of the tomographic image processing is identical to the DR 800 (K183275) primary predicate device.
Principles of operation and technological characteristics of the new and predicate devices are the same. The new device is virtually identical to Agfa's predicate DR 600 (K152639) with the exception that it has additional MUSICA Digital TomoSynthesis (DTS) software for processing tomographic slices. MUSICA DTS software is identical to the software in Agfa's predicate DR 800 with Tomosynthesis (K183275). It uses the same flat panel detectors to capture and digitize the image. Laboratory data and image quality evaluations conducted with internal and independent specialists confirm that performance is equivalent to the predicates. Differences in devices do not alter the intended diagnostic effect nor do they impact the safety and effectiveness of the device.
Configuration information for the flat-panel detectors can be found in the DR 14s (K161368), DR 14e/17e (K172784), DX-D 40/45/60 (K142184) and DR 600 User Manuals. The DR 14s, DR 14e/17e, RF FL4343 and DX-D 40/45/60 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-K183275) will integrate with the detectors. The NX Service Manual, Chapter 4 and associated appendices addresses the installation and configuration with other system components.
V. INDICATIONS FOR USE
The DR 600 system is a General Radiography X-ray imaging system used in hospitals, clinics and medical practices by radiographers, radiologists and physicists to make, process and view static Xray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.
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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.
Applications can be performed with the patient in the sitting, standing or lying position.
This system is 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 600 with Tomosynthesis is intended for general populations, including adult and pediatric patients of all ages. There are no specific pediatric and neonatal design features; however, the DR 600 with Tomosynthesis provides the following specific design features and instructions that enable safer use of the device with pediatric and neonatal patients:
| Pediatric Imaging Design Features | Standard or Optional |
|---|---|
| Protocols or exposure indices | Standard - make own exam treeoptional - 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 processingfor tomo |
| Reconstruction algorithm | no specific pediatric reconstruction algorithm |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES
Agfa's DR 600 with Tomosynthesis and the DR 800 with Tomosynthesis primary predicate device (K183275) are tomographic x-ray systems, Product Code IZF. The new device and DR 600 predicate device (K152639) are solid state x-ray systems, Product Code MQB). Agfa's DR 600 with Tomosynthesis is substantially equivalent to both predicate devices (K183275 & K152639) in that it uses precisely the same technology to capture and transmit images. The complete DR 600 system consists of a stationary table, ceiling mounted suspension equipped with a collimator and tube housing assembly, integrated x-ray generator, NX MUSICA software and one or more DR flat-panel detectors.
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Principles of operation and technological characteristics of the new and predicate devices are the same. The new device is virtually identical to Agfa's predicate DR 600 (K152639) with the exception that it has additional MUSICA Digital TomoSynthesis (DTS) software for processing tomographic slices. MUSICA DTS software is identical to the software in Agfa's predicate DR 800 with Tomosynthesis (K183275). It uses the same flat panel detectors to capture and digitize the image. Laboratory data and image quality evaluations conducted with internal and independent specialists confirm that performance is equivalent to the predicates. Differences in devices do not alter the intended diagnostic effect nor do they impact the safety and effectiveness of the device.
The optional image processing allows users to conveniently select image processing settings for different patient sizes and examinations. The image processing algorithms in the new device are identical to those previously cleared in the DR 800 (K183275- primary) and DR 600 (K152639) predicate devices and other devices in Agfa's radiography portfolio today. The addition of the tomographic image processing is identical to the DR 800 (K183275) primary predicate device.
Agfa's DR 600 with Tomosynthesis has an Indications For Use statement virtually identical to predicate device (K152639) except it includes the addition of tomosynthesis. However, the tomosynthesis addition is identical to the statement in primary predicate device (K183275). Intended uses are the same. The devices have the same technological characteristics.
The DR 600 with Tomosynthesis indications for use is equivalent to predicate (K152639) because both include the delineation of anatomical areas and primary predicate (K183275) includes imaging applications and the application of tomosynthesis. The DR 600 with Tomosythnesis and both predicate devices (K183275 and K152639) include the statement that the devices are not indicated for mammography.
The new device and the DR 800 with Tomosynthesis primary predicate device (K183275) are tomographic x-ray systems, Product Code IZF. The new device and DR 600 predicate device (K152639) are solid state x-ray systems, Product Code MQB). Agfa's DR 600 with Tomosynthesis is substantially equivalent to both predicate devices (K183275 & K152639) in that it uses precisely the same technology to capture and transmit images.
Descriptive characteristics and performance data including image quality evaluations by internal and external specialists are adequate to ensure equivalence.
Table 2 on the next page summarizes the similarities and differences between the new device and predicates.
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| DR 600 with Tomosynthesis(NEW DEVICE) | DR 800 with Tomosynthesis(PRIMARY PREDICATE)K183275 | DR 600(PREDICATE)K152639 | |
|---|---|---|---|
| Communications | Same as both predicate | DICOM | DICOM |
| Flat PanelDetectors | Same as both predicates | Flat Panel Detectors | Flat Panel Detectors |
| Detector Material | Same as both predicates | Gadolinium Oxysulfide (GOS) orCesium Iodide (CsI) Scintillator | Gadolinium Oxysulfide(GOS) or Cesium Iodide(CsI) Scintillator |
| Detector Sizes | Same as both predicates | 17x17 in.14 x 17 in10 x 10 in | 14 x 17 in |
| Pixel Size | Same as both predicates | 148 µm | 139 µm |
| Dynamic Range | Same as both predicates | 16 bit | 14 bit |
| OperatorWorkstation | Same as both predicates | Agfa NX | Agfa NX |
| Image processing | MUSICA DTSMUSICA2MUSICA3/3+ | MUSICA DynamicMUSICA DTSMUSICA2MUSICA3/3+ | MUSICA2 |
| Operating System | Same as predicate K183275 | Windows 7, 8, 8.1, 10 | Windows XP Pro |
| Display System | Same as both predicates | Separately cleared medical display(K051901) | Separately clearedmedical display(K051901) |
| Power Supply | Same as predicate K152639 | 50-60 Hz100-240V auto ranging | 50-60 Hz380/400/415/440/480V+ 10% |
| Generators | Same as predicate K183275 | Choice of three models:50, 65KW, 80 KW | Choice of four models:32-80 KW |
| Indications for UseStatements | The DR 600 system is a GeneralRadiography X-ray imaging systemused in hospitals, clinics and medicalpractices by radiographers, radiologistsand physicists to make, process andview static X-ray radiographic imagesof the skeleton (including skull, spinalcolumn and extremities), chest,abdomen and other body parts onadult, pediatric or neonatal patients. Inaddition, the system provides the Agfatomosynthesis option, which isintended to acquire tomographic slicesof human anatomy and to be used withAgfa DR X-ray systems. Digitaltomosynthesis is used to synthesizetomographic slices from a singletomographic sweep. Applications canbe performed with the patient in thesitting, standing or lying position. Thisdevice is not intended formammography applications. | The DR 800 system is indicatedfor performing dynamic imagingexaminations (fluoroscopy and/orrapid sequence) of the followinganatomies/procedures: Positioningfluoroscopy procedures, Gastro-intestinal examinations, Urogenitaltract examinations, andAngiography. It is intended toreplace fluoroscopic imagesobtained through intensifiertechnology. In addition, thesystem is intended for projectradiography of all body parts. Inaddition, the system provides theAgfa Tomosynthesis option, whichis intended to acquire tomographicslices of human anatomy and to beused with Agfa DR X-ray systems.Tomosyntheis is used to synthesizetomographic slices from a singletomographic sweep. The DR 800is not intended for mammographyapplications. | DR 600 system is aGenRad X-Ray imagingsystem used in hospitals,clinics and medicalpractices by physicians,radiographers andradiologists to make,process, and view staticX-Ray radiographicimages of the skeleton(including skull, spinalcolumn and extremities),chest, abdomen andother body parts on adultand pediatric patients.Applications can beperfomed with thepatient in the sitting,standing or lyingposition. DR 600 is notindicated for use inmammography. |
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Table 1: Device Comparison Table
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 for adults and pediatric patients, performance/functionality and usability data has been provided.
- Technical and acceptance testing was completed on the DR 600 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.
- functionality evaluations were conducted with three qualified . Usability and radiographers. The results of these tests fell within the acceptance criteria for the DR 600; therefore, the DR 600 supports a tomographic workflow and Smart Dr visualization including adult and pediatric patients.
- Clinical image validation was conducted during testing in support for the 510(k) clearance ● for the flat-panel detectors (K161368, K172784 and K142184) in a previous premarket submission. Refer to these 510(k) clearances for full image quality validation testing for the detectors. Image quality bench tests were conducted in support of this 510(k) submission in which anthropomorphic adult and pediatric images taken with the DR 600 and the primary predicate device, DR 800 (K183275) were compared to ensure substantial equivalency. The test results indicated the image processing of the DR 600 passed the acceptance criteria and was equal to the image processing for the primary predicate, DR 800 (K183275) device for both adult and pediatric patients
Performance data including clinical image quality evaluations for adults and pediatric patients, performance/functionality and usability data are adequate to ensure equivalence.
Software Verification and Validation Testing
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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.
Software verification testing for Digital TomoSynthesis (DTS) was completed in scope of the DR 600 system. Four software iterations were tested. including the tube head and XRDi. 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.
For the NX22 (NX Nomad) software there are a total of 342 risks in the broadly acceptable region and 27 risks in the ALARP region with only one 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 assessment is assessed on solution level for the DR 600 and also includes separate risk assessments for the NX 22 software and XRDi.
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 600 with Tomosynthesis and NX 22 has been determined to be moderate.
Electrical Safety and Electromagnetic Compatibility (EMC) Testing:
- IEC 60601-1: 2012 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: 2008 Medical Electrical Equipment Part 1-3: General Requirements for ● Safety and Essential Performance - Collateral Standard: Radiation Protection in Diagnostic X-Ray Equipment
- IEC 60601-1-6: 2010 Medical Electrical Equipment Part 1-6: General Requirements for . Safety and Essential Performance - Collateral Standard Usability
- IEC 60601-2-28: 2010 Medical Electrical Equipment Part 2-28 Particular Requirements ● for Safety and Essential Performance of X-Ray Tube Assemblies for Medical Diagnosis
- IEC 60601-2-54: 2009 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 600 with Tomosynthesis is compliant to the FDA Subchapter J mandated performance standard 21 CFR 1020.30 and 1020.31.
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 ●
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- ACR/NEMA PS3.1-3.20: 2011 Digital Imaging and Communications in Medicine (DICOM) .
Guidance Documents
Agfa utilized the following guidance documents in the development of the DR 600 with Tomosynthesis:
- 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 (January 2005)
- Off-the-Shelf Software Use in Medical Devices (September 2019) ●
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices ● (October 2018)
- . Guidance for Pediatric Information for X-ray Imaging Device Premarket Notifications (November 2017)
Summarv
Based on the performance data as documented in the above testing, the DR 600 with Tomosynthesis is found to have a safety and effectiveness profile that is similar to the predicate device.
VIII. CONCLUSIONS
Agfa's DR 600 with Tomosynthesis has indications for use that is consistent with that of the legally marketed predicate devices (K183275 & K152639). Intended uses are the same. Laboratory tests conclude that the device is substantially equivalent to the predicates. 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 DR 800 with Tomosynthesis primary predicate device (K183275) are tomographic x-ray systems, Product Code IZF. The new device and DR 600 predicate device (K152639) are solid state x-ray systems, Product Code MQB). Agfa's DR 600 with Tomosynthesis is substantially equivalent to both predicate devices (K183275 & K152639) in that it uses precisely the same 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.
§ 892.1740 Tomographic x-ray system.
(a)
Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.