(25 days)
No
The document mentions "image processing algorithms" and "MUSICA imaging processing" but does not use terms like AI, ML, deep learning, or neural networks. The description of the technology and testing focuses on traditional image processing and substantial equivalence to predicate devices.
No.
Explanation: The device is an X-ray imaging system used to make, process, and view static X-ray radiographic images for diagnostic purposes, not for treatment or therapy.
Yes
The device is an X-ray imaging system used by radiographers and radiologists to view static X-ray radiographic images of various body parts for adult, pediatric, or neonatal patients, which implies a diagnostic purpose. The text also states that "Differences in devices do not alter the intended diagnostic effect."
No
The device description explicitly states that the DR 100s is an "integrated mobile digital radiography x-ray system" and includes hardware components such as a "mobile x-ray unit with integrated x-ray generator" and "DR detectors." While it includes software (NX software and MUSICA image processing), it is not solely software.
Based on the provided text, the DR 100s system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- DR 100s Function: The DR 100s system is an X-ray imaging system. It uses X-rays to create images of the internal structures of the body. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it is used to "make, process and view static X-ray radiographic images of the skeleton... chest, abdomen and other body parts". This is consistent with in vivo imaging, not in vitro diagnostics.
Therefore, the DR 100s system falls under the category of medical imaging devices, specifically radiography systems, and is not an IVD.
N/A
Intended Use / Indications for Use
The DR 100s system is a mobile X-ray imaging system used in hospitals, clinics and medical practices by radiographers and radiologists 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. Applications can be performed with the patient in the sitting, standing or lying position. This device is not intended for mammography applications.
Product codes
IZL
Device Description
Agfa's DR 100s is a mobile x-ray system, a direct radiography system (product code ILL) intended to capture images of the human body. The device is an integrated mobile digital radiography x-ray system. The complete DR 100s systems consists of the mobile x-ray unit with integrated x-ray generator and NX software and one or more DR detectors. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital image capture. It is compatible with Agfa's computed radiography systems as well.
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
adult, pediatric or neonatal patients.
Intended User / Care Setting
Used in hospitals, clinics and medical practices by radiographers and radiologists.
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
Bench Testing:
- Technical and acceptance testing was completed on the DR 100s 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.
- Usability and functionality evaluations were conducted with internal experts. The results of these tests fell within the acceptance criteria for the DR 100s X-ray system therefore, the DR 100s supports a General radiographic workflow including adult and pediatric patients.
- Clinical image validation was conducted during testing in support for the 510(k) clearances for the flat-panel detectors (K161368 and K172784) and MUSICA software (K183275) in a previous submission. Image quality bench tests were conducted in support of this 510(k) submission in which anthropomorphic adult and pediatric images taken with the DR 100s and the predicate device, DX-D 100 (K103597) were compared to ensure substantial equivalency. The test results indicated the image processing of the DR 100s passed the acceptance criteria.
- 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:
- Verification and validation plans comprise of test protocols. The complete device has been certified and validated.
- For the NX21 (NX Mentor) software validation was completed in preparation of the DR 800 with Tomosynthesis 510(k) which was cleared February 1, 2019 (K183275). NX21 risk analysis identified 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.
- The Level of Concern for the DR 100s and NX 21 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 60601-2-54: 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 100s is compliant to the FDA Subchapter J mandated performance standard 21 CFR 1020.30 and 1020.31.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K152639, K141192, K183275, K141602, K161368, K172784, K103050, K112670, K081963, K121095, K051901
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
August 9, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Agfa N.V. % ShaeAnn Cavanagh, RAC Regulatory Affairs Manager, North America Agfa US Corp. 10 South Academy Street GREENVILLE SC 29601
Re: K191884
Trade/Device Name: DR 100s Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: July 12, 2019 Received: July 15, 2019
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
1
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) K191884
Device Name DR 100s
Indications for Use (Describe)
The DR 100s system is a mobile X-ray imaging system used in hospitals, clinics and medical practices by radiographers and radiologists 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.
Applications can be performed with the patient in the sitting, standing or lying position.
This device 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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5. 510(K) Summary
510(K) SUMMARY
Agfa N.V. DR 100s
SUBMITTER I.
Agfa N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Wim Govaerts, Prepared: July 12, 2019 Telephone: + 32 3444 6246
DEVICE II.
Name of Device: DR 100s Common Name: System. X-Rav. Mobile Classification Name: Mobile X-ray System Regulatory Classification: Class II, 21 CFR 892.1720 Product Code: IZL
PREDICATE DEVICES III.
This is a 510(k) for Agfa's DR 100s, which mobile x-ray system. It is substantially equivalent to Agfa's DX-D 100 (K103597).
Name of Device: DX-D 100 Common Name: System, X-Ray, Mobile Classification Name: Mobile X-ray System Regulatory Classification: Class II, 21 CFR 892.1720 Product Code: IZL
The DX-D 100 (K103597) predicate device was part of three Class II recalls and one Class III recall between 2013-2015. Two of the Class II recalls involved unintended movements. These recalls were initiated on May 15, 2013 and May 29, 2015 and terminated by CDRH on December 31, 2014 and January 18, 2017 respectively. The other Class II recall involved liquid contacting the workstation touch screen. This recall was initiated on June 6, 2014 and terminated by CDRH on July 21, 2014. The Class III recall involved a labeling mix up involving the incorrect KW power. This recall was initiated on May 13, 2014 and terminated by CDRH on August 13, 2014. No injuries were reported for any of these recalls.
4
DEVICE DESCRIPTION IV.
Agfa's DR 100s is a mobile x-ray system, a direct radiography system (product code ILL) intended to capture images of the human body. The device is an integrated mobile digital radiography x-ray system. The complete DR 100s systems consists of the mobile x-ray unit with integrated x-ray generator and NX software and one or more DR detectors. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital image capture. It is compatible with Agfa's computed radiography systems as well.
This submission is to add another mobile unit to Agfa's direct 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 DX-D 100 (K103597) and other devices in Agfa's radiography portfolio today, which includes DR 600 (K152639), DR 400 (K141192) and DR 800 (K183275).
Significant dose reduction can be achieved using the DR 100s with patented Agfa's MUSICA imaging processing and CsI flat-panel detectors. Testing with board certified radiologists determined that Cesium Bromide (CR) and Cesium Iodine (DR) detectors when used with MUSICA imaging processing can provide dose reduction between 50-60% for adult patients and up to 60% for pediatric and neonatal patients when compared to traditional Barium Fluoro Bromide CR systems (K141602).
Principles of operation and technological characteristics of the new and predicate device are the same. The new device is virtually identical to Agfa's DX-D 100(K103597) with the exception that it has a telescopic column and ergonomic design. It uses the same flat panel detectors to capture and digitize the image. Differences in devices do not alter the intended diagnostic effect.
Configuration information for the flat-panel detectors can be found in the DR 14s (K161368), DR 14e/17e (K172784) and DR 100s User Manuals. The DR 14s, DR 14e/17e and RF FL4343 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 21 Service Manual. Chapter 4 and associated appendices addresses the installation and configuration with other system components.
INDICATIONS FOR USE V.
The DR 100s system is a mobile X-ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists 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.
Applications can be performed with the patient in the sitting, standing or lying position.
5
This device 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 100s is intended for general populations, including adult and pediatric patients of all ages. Specific design features of the DR 100s for pediatric use include but not limited to using the specific AEC values. NX protocol settings per pediatric age range and automatic brightness control with pediatric settings to lower the dose for pediatric applications.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. PREDICATE DEVICES
Agfa's DR 100s and DX-D 100 predicate device (K103597) are mobile x-ray imaging devices, Product Code IZL. Agfa's DR 100s is substantially equivalent to the predicate device (K103597) in that it uses precisely the same technology to capture and transmit images. The DR 100s is an integrated mobile digital radiography x-ray system. The complete DR 100s systems consists of the mobile x-ray unit with integrated x-ray generator and NX software and one or more DR detectors. The new device uses Agfa's NX workstation with MUSICA image processing and flat-panel detectors for digital image capture. It is compatible with Agfa's computed radiography systems as well.
Principles of operation and technological characteristics of the new and predicate device are the same. The new device is virtually identical to Agfa's DX-D 100(K103597) with the exception that it has a telescopic column and ergonomic design. It uses the same flat panel detectors to capture and digitize the image. The flat-panel detector general information and technical specifications are summarized in Table 1 on the next page. The DX-D 100 used the DX-D 10 and DX-D 20 flat-panel detectors. The DR 100s uses the DR 14s, DR 10s, DR 14e, DR 10e and DR 17e detectors. Differences in devices do not alter the intended diagnostic effect.
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 DX-D 100 (K103597) and other devices in Agfa's radiography portfolio today, which includes DR 600 (K152639), DR 400 (K141192) and DR 800 (K183275).
Agfa's DR 100s has an Indications For Use statement virtually identical to the predicate device (K103597) except it includes the addition of pediatric or neonatal patients and patient position. Intended uses are the same. The devices have technological characteristics.
The DR 100s indications for use is equivalent to the predicate (K103597) because both include the delineation of anatomical areas and imaging applications. The DR 100s and predicate device (K103597) include the statement that the devices are not indicated for mammography.
6
The new device and the DX-D 100 predicate device (K103597) are mobile x-ray systems Product Code IZL. Agfa's DR 100s is substantially equivalent to the predicate device (K103597) in that it uses precisely the same technology to capture and transmit images.
Descriptive characteristics and performance data including image quality evaluations are adequate to ensure equivalence. Differences in devices do not alter the intended therapeutic/diagnostic effect.
| Performance
Characteristics | DX-D 30 Flat-
Panel Detector
(K121095) | DX-D 35 Flat-
Panel Detector
(K121095) | DR10s Wireless
Detector
(K161368) | DR 14s Wireless
Detector (K161368) | DR 14e Wireless
Detector
(K172784) | DR 17e Wireless
Detector
(K172784) | DR 10e Wireless
Detector
(K172784) |
|--------------------------------|----------------------------------------------------|----------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Model | 5401/100 | 5401/200 | Pixium 2430 EZ-C | Pixium 3543 EZ-C &
Pixium 3543 EZ-G | 6011/101
6011/102 | 6011/103
6011/104 | 6011/111 |
| Manufacturer | Canon Medical
Systems | Canon Medical
Systems | Thales AVS | Thales AVS | Innolux
Corporation | Innolux
Corporation | Innolux
Corporation |
| Scintillator | CsI | CsI | CsI | CsI, GOS | CsI, GOS | CsI, GOS | CsI |
| Cassette size
Active Area | 35x43cm/
14x17in | 24x30cm | 24x30cm | 35x43cm/ 14x17in | 35x43cm/ 14x17in | 43x43cm/ 17x17in | 24x30cm |
| Pixel Size | 125 μm | 125 μm | 148 μm | 148 μm | 150 μm | 150 μm | 150 μm |
| A/D Conversion | 12 bits | 14 bits | 16 bits | 16 bits | 16 bit | 16 bit | 16 bit |
| Interface to
Generator | Ethernet | Ethernet | AED &
Synchronized | AED &
Synchronized | AED &
Synchronized | AED &
Synchronized | AED &
Synchronized |
| Communication | Wireless | Wireless | Wireless | Wireless | Wireless or wired | Wireless or wired | Wireless or wired |
| Power | Battery:
replaceable &
rechargeable | Battery:
replaceable &
rechargeable | Battery:
replaceable &
rechargeable | Battery: replaceable
& rechargeable | Battery:
replaceable &
rechargeable | Battery:
replaceable &
rechargeable | Battery:
replaceable &
rechargeable |
| Weight | 3.4 kg (7.5 lbs) | 2.3 kg (5.1 lbs) | 1.6 kg (3.53 lbs) | 2.8 kg (6.17 lbs) | 2.95 kg (6.50 lbs) | 3.65 kg (8.04 lbs) | 1.47 kg (3.24 lbs) |
| DQE | 1 lp/mm:
CsI = 0.451
2 lp/mm:
CsI = 0.349 | 1 lp/mm:
CsI = 0.451
2 lp/mm:
CsI = 0.349 | 1 lp/mm:
CsI = 0.524
2lp/mm:
CsI = 0.469
3lp/mm:
CsI = 0.303 | 1 lp/mm:
GOS = 0.293
CsI = 0.541
2lp/mm:
GOS = 0.196
CsI = 0.447
3lp/mm:
GOS = 0.079
CsI = 0.307 | 1 lp/mm:
GOS = 0.335
CsI = 0.594
2lp/mm:
GOS = 0.206
CsI = 0.465
3lp/mm:
GOS = 0.107
CsI = 0.288 | 1 lp/mm:
GOS = 0.335
CsI = 0.594
2lp/mm:
GOS = 0.206
CsI = 0.465
3lp/mm:
GOS = 0.107
CsI = 0.288 | 1 lp/mm:
GOS = 0.335
CsI = 0.594
2lp/mm:
GOS = 0.206
CsI = 0.465
3lp/mm:
GOS = 0.107
CsI = 0.288 |
| MTF | 1 lp/mm:
CsI = 0.630
2 lp/mm:
CsI = 0.360 | 1 lp/mm:
CsI = 0.630
2 lp/mm:
CsI = 0.360 | 1 lp/mm:
CsI = 0.640
2lp/mm:
CsI = 0.362
3lp/mm:
CsI = 0.197 | 1 lp/mm:
GOS = 0.527
CsI = 0.639
2lp/mm:
GOS = 0.209
CsI = 0.358
3lp/mm:
GOS = 0.081
CsI = 0.194 | 1 lp/mm:
GOS = 0.583
CsI = 0.594
2lp/mm:
GOS = 0.295
CsI = 0.320
3lp/mm:
GOS = 0.159
CsI = 0.186 | 1 lp/mm:
GOS = 0.583
CsI = 0.594
2lp/mm:
GOS = 0.295
CsI = 0.320
3lp/mm:
GOS = 0.159
CsI = 0.186 | 1 lp/mm:
GOS = 0.583
CsI = 0.594
2lp/mm:
GOS = 0.295
CsI = 0.320
3lp/mm:
GOS = 0.159
CsI = 0.186 |
| Table 1: Detector Performance Characteristics |
|---|
| ----------------------------------------------- |
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| | DR 100s
(NEW DEVICE)
Agfa | DX-D 100
(PREDICATE – K103597)
Agfa |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Communications | Same as predicate | DICOM |
| Flat Panel
Detectors | Same as predicate | Flat Panel Detectors |
| Detector Material | Same as predicate | Gadolinium Oxysulfide (GOS) or Cesium
Iodide (CsI) scintillator |
| Detector Sizes | 17x17 in.
14 x 17 in
10 x 10 in | 17x17 in.
14 x 17 in |
| Image processing | MUSICA2
MUSICA3/3+ | MUSICA2 |
| Operating System | Windows 10 | Windows XP |
| Display System | Same as predicate | Separately cleared medical display
(K051901) |
| Operator
Workstation | Same as predicate | Agfa NX |
| Power Supply | 50-60 Hz
115-230V auto ranging | 50-60 Hz
100-240V auto ranging |
| Battery | Lead Crystal 12v, 18 Ah | Lead Crystal 12v 14Ah |
| Generators | Choice of two models:
32kW - 40kW | Choice of four models:
20 - 50 kW |
| Indications for Use
Statements | DR 100s system is a mobile X-ray imaging system
used in hospitals, clinics and medical practices by
physicists, radiographers and radiologists 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.
Applications can be performed with the patient in
the sitting, standing or lying position.
This device is not intended for mammography
applications. | 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 extremitites, chest,
abdomen and other body parts.
DX-D 100 is not indicated for use in
mammography. |
Table 2 below summarizes the similarities and differences between the new device and predicate.
Table 2: 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.
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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 development of 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 100s 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.
- . Usability and functionality evaluations were conducted with internal experts. The results of these tests fell within the acceptance criteria for the DR 100s X-ray system therefore, the DR 100s supports a General radiographic workflow including adult and pediatric patients.
- Clinical image validation was conducted during testing in support for the 510(k) . clearances for the flat-panel detectors (K161368 and K172784) and MUSICA software (K183275) in a previous submission. Refer to these 510(k) clearances for full image quality validation testing. Image quality bench tests were conducted in support of this 510(k) submission in which anthropomorphic adult and pediatric images taken with the DR 100s and the predicate device, DX-D 100 (K103597) were compared to ensure substantial equivalency. The test results indicated the image processing of the DR 100s passed the acceptance criteria.
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
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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For the NX21 (NX Mentor) software validation was completed in preparation of the DR 800 with Tomosynthesis 510(k) which was cleared February 1, 2019 (K183275). NX21 risk analysis identified 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 100s and also includes separate risk assessments for the NX 21 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 100s and NX 21 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 60601-2-54: 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 100s 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 ●
- 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 100s:
- 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 1999) ●
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- 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)
Summary
Based on the performance data as documented in the above testing, the DR 100s is found to have a safety and effectiveness profile that is similar to the predicate device.
VIII. CONCLUSIONS
Agfa's DR 100s has indications for use that is consistent with that of the legally marketed predicate device (K103597). Intended uses are the same. Where technological characteristics differ, lab tests concluded that the device is substantially equivalent to the predicate in that it does not alter the intended therapeutic/diagnostic effect.
The new device and the DX-D 100 predicate device (K103597) are mobile x-ray systems Product Code IZL. Agfa's DR 100s is substantially equivalent to the predicate device (K103597) 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.