(162 days)
KPR
No
The summary mentions "Smart" Features designed to simplify exam setup and improve workflow, but the description focuses on automating existing manual tasks and does not mention AI, ML, or image processing capabilities typically associated with AI/ML in medical imaging.
No
The device is described as a "diagnostic x-ray system" used for "acquiring radiographic images," indicating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The DRX-Evolution Plus is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging."
No
The device description explicitly lists multiple hardware components including x-ray generators, control panels, patient support tables, image receptors/detectors, tube support devices, x-ray tube, and collimator. While it mentions "Smart" Features which are software-based, the core device is a physical x-ray system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "diagnostic x-ray system for general radiographic x-ray imaging." This describes a system that produces images of the human body using X-rays, which is an in vivo (within the living body) diagnostic method.
- Device Description: The description details components like X-ray generators, patient support tables, image receptors, and X-ray tubes. These are all characteristic of an X-ray imaging system, not a device used to examine specimens in vitro (outside the living body).
- Input Imaging Modality: The input modality is X-ray, which is used for imaging the body directly.
- Anatomical Site: The device images "various portions of the human body" and the "chest." This further confirms its use for imaging the body directly.
IVD devices are used to examine specimens such as blood, urine, or tissue samples outside the body to provide diagnostic information. This device does not perform such functions.
N/A
Intended Use / Indications for Use
The DRX-Evolution Plus is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging. This device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging. This device also supports Dual Energy chest imaging. The Dual Energy feature is not to be used for imaging pediatric patients.
Product codes
KPR
Device Description
The DRX-Evolution Plus is a general purpose x-ray system used for acquiring radiographic images of various portions of the human body. The system consists of a combination of components including various models of high voltage x-ray generators, control panels or workstation computers, various models of patient support tables, wall-mounted image receptors/detectors for upright imaging, various models of tube support devices, x-ray tube, and collimator (beam-limiting device). In addition to general radiography applications, the system also includes the optional Dual Energy functionality.
The DRX-Evolution Plus can be used with digital radiography (DR) and computed radiography (CR) receptors.
"Smart" Features are added to the DRX-Evolution Plus system to provide remote exam set-up capabilities for existing functions of the DRX-Evolution Plus system. These remote capabilities simplify exam set up and improve workflow for the operator while preparing for the patient exposure. The "smart" features, described below, are designed to reduce the technologist's manual tasks and to speed up workflow for existing features of the system. Implementation of these features does not change the intended use of the system and does not affect the Dual Energy functionality.
. Real-time Video Assistance:
The subject DRX-Evolution Plus uses the real-time video output of the visual auxiliary components (cameras) to display the patient on the user interface to assist the operator in guiding the patient to adjust the position and posture, and assisting adjustment X-ray field, X-ray gantry position, etc.
Long Length Imaging (LLI): .
The subject DRX-Evolution Plus provides the capability for the operator to select LLI parameters on the user interface without needing to physically be in the exam room.
. Collimation:
The subject DRX-Evolution Plus allows the operator to collimate the intended location of the x-ray beam remotely from the user interface.
Patient Picture: ●
The subject DRX-Evolution Plus can now use cameras to take a picture of the patient to be delivered with the x-ray image.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Chest (for Dual Energy), various portions of the human body (for general radiography).
Indicated Patient Age Range
The Dual Energy feature is not to be used for imaging pediatric patients.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
All detectors listed in Table 1 underwent non-clinical integration testing with the DRX-Evolution Plus system. These tests included functional testing, installation testing, media verification tests, performance tests, regression tests, risk mitigation testing, and serviceability testing. The Lux 35 Detector testing included comprehensive image quality tests, vacuum testing to validate its liquid ingress (IP57) requirement, and Dual Energy functionality and performance testing to verify that the Lux 35 Detector performed as expected.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical safety and performance test results for the "Smart" Feature user options, developed to enhance workflow and exam set-up, indicated that the subject device as described in this submission meets the predetermined safety and effectiveness criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
March 12, 2024
Image /page/0/Picture/1 description: The image contains the logos of the U.S. Food and Drug Administration (FDA) and the Department of Health & Human Services. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The Department of Health & Human Services logo is a symbol of three faces in profile, arranged in a circular pattern.
Carestream Health, Inc. % Robert Faust Senior Regulatory Affairs Manager 150 Verona Street ROCHESTER, NY 14608
Re: K233381
Trade/Device Name: DRX-Evolution Plus System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR Dated: February 2, 2024 Received: February 5, 2024
Dear Mr. Faust:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Smita Kakar
for
Lu Jiang Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K233381
Device Name DRX-Evolution Plus
Indications for Use (Describe)
The DRX-Evolution Plus is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging. This device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging. This device also supports Dual Energy chest imaging. The Dual Energy feature is not to be used for imaging pediatric patients.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Carestream
K233381
510(k) Summary
| 510(k) Owner Name: | Carestream Health, Inc. |
|---|---|
| 510(k) Owner Address: | 150 Verona Street |
| Rochester, NY, 14608 | |
| 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 | COA COLANDI |
510(k) Owner Phone: 603-686-2054 510(k) Owner Fax: 585-627-8802
Contact Person & Info:
Robert Faust Senior Regulatory Affairs Manager robert.faust(a)carestream.com 603-686-2054
Date Summary Prepared: March 5, 2024
Predicate
510(k) Submitter: Carestream Health, Inc. 510(k) Number: K190330 Trade Name: DRX-Evolution Plus Device: System, X-Ray, Stationary Regulation Description: Stationary x-ray system Review Panel: Radiology Product Code: KPR Regulation Number: 21 CFR 892.1680 Device Class: II
Subject Device 510(k) Submitter: Carestream Health, Inc. Trade Name: DRX-Evolution Plus Device: System, X-Ray, Stationary Regulation Description: Stationary x-ray system Review Panel: Radiology Product Code: KPR Regulation Number: 21 CFR 892.1680 Device Class: II
Indications for Use / Intended Use:
The DRX-Evolution Plus is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging. This device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging. This device also supports Dual Energy chest imaging. The Dual Energy feature is not to be used for imaging pediatric patients.
Device Description:
The DRX-Evolution Plus is a general purpose x-ray system used for acquiring radiographic images of various portions of the human body. The system consists of a combination of components including various
4
models of high voltage x-ray generators, control panels or workstation computers, various models of patient support tables, wall-mounted image receptors/detectors for upright imaging, various models of tube support devices, x-ray tube, and collimator (beam-limiting device). In addition to general radiography applications, the system also includes the optional Dual Energy functionality.
The DRX-Evolution Plus can be used with digital radiography (DR) and computed radiography (CR) receptors.
"Smart" Features are added to the DRX-Evolution Plus system to provide remote exam set-up capabilities for existing functions of the DRX-Evolution Plus system. These remote capabilities simplify exam set up and improve workflow for the operator while preparing for the patient exposure. The "smart" features, described below, are designed to reduce the technologist's manual tasks and to speed up workflow for existing features of the system. Implementation of these features does not change the intended use of the system and does not affect the Dual Energy functionality.
. Real-time Video Assistance:
The subject DRX-Evolution Plus uses the real-time video output of the visual auxiliary components (cameras) to display the patient on the user interface to assist the operator in guiding the patient to adjust the position and posture, and assisting adjustment X-ray field, X-ray gantry position, etc.
Long Length Imaging (LLI): .
The subject DRX-Evolution Plus provides the capability for the operator to select LLI parameters on the user interface without needing to physically be in the exam room.
. Collimation:
The subject DRX-Evolution Plus allows the operator to collimate the intended location of the x-ray beam remotely from the user interface.
Patient Picture: ●
The subject DRX-Evolution Plus can now use cameras to take a picture of the patient to be delivered with the x-ray image.
In addition to the enhanced workflow features described above, additional digital detectors have been (bench) tested and integrated for use with the DRX-Evolution Plus system:
| Detector Name | 510(k)
Number | Pixel Size | Pixel Matrix | Scintillator
Material | Can be used for
Dual Energy |
|----------------|------------------|------------|--------------|--------------------------|--------------------------------|
| DRX Plus 2530C | K183245 | 98μm | 3016 x 2504 | Cesium Iodide | No |
| Focus 35 HD | K213646 | 100μm | 3500 x 4300 | Cesium Iodide | No |
| Focus 43 HD | K213529 | 100μm | 4267 x 4267 | Cesium Iodide | No |
| DRX-LC | K220536 | 139μm | 3064 x 8696 | Cesium Iodide | No |
| Lux 35 | K203159 | 139μm | 2560 x 3072 | Cesium Iodide | Yes |
Table 1
Substantial Equivalence:
Based upon information provided within this submission, we believe that the subject DRX-Evolution Plus, is substantially equivalent to the legally marketed DRX-Evolution Plus (predicate device).
In accordance with FDA Final Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued July 28, 2014, the critical decision points outlined in the proposed 510(k) Decision-Making Flowchart in Appendix A have been considered. The proposed predicate device, DRX-Evolution Plus, has been found substantially equivalent by FDA through the 510(k) process and is
5
legally marketed. The Indications for Use for the subject device are identical to the predicate indications for use.
According to ISO 14971 Risk Management methodology, any new risks that may raise additional questions of safety and performance have been identified and mitigated as far as possible. There have been no changes to risk control measures in the current product risk analysis. Testing to recognized FDA consensus standards and internal non-clinical (bench) testing support substantial equivalence.
Comparison of Technological Characteristics
A comparison chart (Table 2) provides the similarities and differences between the subject and predicate devices.
| Property | Predicate Device
DRX-Evolution Plus
K190330 | Subject Device
DRX-Evolution Plus
K233381 |
|---------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Digital Radiography Imaging
Devices (Detector) | DRX Plus 3543 and 3543C
Detectors
DRX Plus 4343 and 4343C
Detectors | Supports the same detectors as
the predicate devices and the
additional detectors listed
below:
DRX Plus 2530C (K183245)
Focus HD 35 (K213646)
Focus HD 43 (K213529)
LUX 35 (K203159)
DRX-LC (K230059) |
| Application System Software | Image View Software | Same |
| Electrical Safety | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-2-54 | Same |
| Visualization of the Patient | Physically Visualize the Patient | Real-time Video Assistance
from User Interface |
| LLI Upper and Lower Limit
Selection | LLI Selection on Tube Head | LLI Selection from User
Interface |
| Collimation | Manual / IR Remote Control
Collimation | Collimation from User
Interface |
| Patient Picture | Not Available | Patient Picture from User
Interface |
Table 2: Comparison Chart
Summary of Non-Clinical Performance and Safety Testing and Data:
Non-clinical testing such as standards testing are the same as that of the predicate. The verification and validation testing of the subject device demonstrates that the subject device performs as well as the predicate and is substantially equivalent. Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.
6
DRX-Evolution Plus complies with and/or was tested in accordance with the following FDA and International Standards:
- . AAMI ES60601-1:2005 +C1:A2: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012) (FDA Consensus Standards number 19-4)
- IEC 60601-1-6: 2010 + A1: 2013, Edition 3.1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (FDA Consensus Standards number 5-89)
- IEC 60601-1-3:2008 (Second Edition) + A1:2013 Medical electrical equipment Part 1-3: . General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (FDA Consensus Standards number 12-269)
- IEC 60601-2-54:2009, AMD1:2015 Medical electrical equipment Part 2-54: Particular ● requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (FDA Consensus Standards number 12-317)
- . IEC 62366: 2007 + A1: 2014, Edition 1.0 - Medical devices - Application of usability engineering to medical devices (FDA Consensus Standards number 5-114)
- ISO 14971:2019 Medical devices Applications of risk management to medical devices ● (FDA Consensus Standards number 5-125)
Conclusion from clinical and nonclinical tests:
All detectors listed in Table 1 underwent non-clinical integration testing with the DRX-Evolution Plus system. These tests included functional testing, installation testing, media verification tests, performance tests, regression tests, risk mitigation testing, and serviceability testing. The Lux 35 Detector testing included comprehensive image quality tests, vacuum testing to validate its liquid ingress (IP57) requirement, and Dual Energy functionality and performance testing to verify that the Lux 35 Detector performed as expected.
Non-clinical safety and performance test results for the "Smart" Feature user options, developed to enhance workflow and exam set-up, indicated that the subject device as described in this submission meets the predetermined safety and effectiveness criteria.