(107 days)
Not Found
No
The description focuses on standard digital radiography technology, image stitching, and basic image enhancement features, with no mention of AI or ML algorithms for image analysis, diagnosis, or workflow optimization.
No.
The device is described as an imaging system for diagnostic purposes, not for treating conditions.
No
Explanation: The device is an image capture system (digital X-ray system) that produces images for diagnosis, but it does not perform the diagnosis itself. Its function is to replace conventional film for radiographic examinations.
No
The device description explicitly states it includes a flat panel digital detector (FPD), a synchronization module, and potentially a wireless access point, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The DelWorks DR System is a digital radiography system that captures X-ray images of the human body directly, without using any specimens taken from the body.
- Intended Use: The intended use clearly states it's for "digital image capture use in general radiographic examinations," which involves imaging the internal structures of the body using X-rays.
Therefore, the DelWorks DR System falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The DelWorks DR System is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. DelWorks DR System allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The DelWorks DR System represents the straightforward integration of a number of digital x-ray receptor panels using digital acquisition software. The DelWorks DR System is compatible with all modern HF generators. DelWorks DR System is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) The DelWorks DR System is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. Many of the compatible panels provide Auto-exposure detection. A synchronization module is available where exposure sync is required. This module connects between the digital panel and the x-ray high voltage generator. It provides "ready" synchronization and optical isolation between the two devices. Some of the detectors feature wireless Wi-Fi connection via a wireless access point. The software features Image Stitching (4 views can be combined into one single view) and other image enhancement features. The system software interacts with and controls technique factors of compatible generators via serial interfaces. DICOM output allows for transmission of images to the hospital radiology information system. The system employs Digital Radiography Operator Console (DROC) software, outputs a DICOM image. A USB "dongle" is provided to assure the authenticity of the software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
skull, chest, shoulders, spine, abdomen, pelvis, and extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of clinical image inspection, bench, and test laboratory results indicates that the new device is as safe and effective as the predicate devices. Clinical images collected demonstrate equal or better image quality as compared to our predicates.
Summary of Bench Testing Conducted: IEC Standards were employed for: Electrical Safety and Electromagnetic Compatibility. MTF and DQE measurements were supplied by the panel manufacturer in accordance with the FDA guidance document. Risk Analysis was conducted in accordance with FDA guidance documents. Software validation was performed using all panels. All of the digital panels have had previous successful 510(k) reviews.
Summary of Clinical Testing: Clinical images were acquired and evaluated by a board certified radiologist who concluded the images were of good diagnostic quality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
'Page 1 of 2
JUL 1 7 2014
510(k) Summary K140825 Submitted by Del Medical, Inc. 241 Covington Drive Bloomingale, IL 60108 (Tel) 800.800.6006 (Fax) 847.288.7011 Prepared by: Marc Lorenzo, Vice President Date Prepared: June 4, 2014
-
- Identification of the Device: Proprietary-Trade Name: DelWorks DR System Classification Name: Stationary X-Ray System, Product Code MQB, Regulation 892.1680 Common/Usual Name: Digital X-Ray Receptor Panel
-
- Equivalent legally marketed device: Sedecal Digital Radiographic Upgrade, Model: SDRU-T, K130883
-
- Indications for Use (intended use) DelWorks DR System is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. DelWorks DR System allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
-
- Description of the Device: The DelWorks DR System represents the straightforward integration of a number of digital x-ray receptor panels using digital acquisition software. The DelWorks DR System is compatible with all modern HF generators. DelWorks DR System is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) The DelWorks DR System is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. Many of the compatible panels provide Auto-exposure detection. A synchronization module is available where exposure sync is required. This module connects between the digital panel and the x-ray high voltage generator. It provides "ready" synchronization and optical isolation between the two devices. Some of the detectors feature wireless Wi-Fi connection via a wireless access point. The software features Image Stitching (4 views can be combined into one single view) and other image enhancement features. The system software interacts with and controls technique factors of compatible generators via serial interfaces. DICOM output allows for transmission of images to the hospital radiology information system. The system employs Digital Radiography Operator Console (DROC) software, outputs a DICOM image. A USB "dongle" is provided to assure the authenticity of the software.
-
- Safety and Effectiveness, comparison to predicate device. The results of clinical image inspection, bench, and test laboratory results indicates that the new device is as safe and effective as the predicate devices. Clinical images collected demonstrate equal or better image quality as compared to our predicates.
1
Substantial Equivalence Chart 6.
| Characteristic | Sedecal Digital Radiographic Upgrade, Model: SDRU-T, K130883 | DelWorks DR System K140825 |
|---|---|---|
| Intended Use: | Sedecal Digital Radiographic Upgrade Model SDRU-T is intended for digital image capture use in general radiographic examinations, wherever conventional screen film systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities. | DelWorks DR System is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. DelWorks DR System allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities. |
| Configuration | This submission is for the Digital Panel and Software only, no generator or stand provided. | This submission is for the Digital Panel and Software only, no generator or stand provided. |
| Digital Panels | Toshiba FDX4343R Detector | |
| Toshiba FDX3543RP Detector | Toshiba FDX4343R | |
| Toshiba FDX3543RP | ||
| Thales Pixium Portable 2430EZ* | ||
| Thales Pixium Portable 3543EZ* | ||
| Konica Aero DR 14x17 Detector* | ||
| Konica Aero DR 17x17 Detector* | ||
| Fuji FDR D-EVO G35s Detector | ||
| Fuji FDR D-EVO G35i Detector* | ||
| Fuji FDR D-EVO G43i Detector* | ||
| Fuji FDR D-EVO C24i Detector* | ||
| Fuji FDR D-EVO C35i Detector* | ||
| Fuji FDR D-EVO C43i Detector* | ||
| Varian PaxScan 4336R | ||
| Varian PaxScan 4343R | ||
| Thales Pixium RAD 4143 | ||
| Thales Pixium RAD 4343 | ||
| *Wireless Wi-Fi | ||
| Software | Digital Radiography Operator Console (DROC) software, outputs a DICOM image | SAME as K130883, |
| outputs a DICOM image. | ||
| DICOM | Yes | Yes |
| Interface | Ethernet | Ethernet or Wi-Fi |
| Power source | AC Line | AC Line |
| Electrical safety and EMC | Electrical Safety per IEC 60601-1 and EMC per IEC 60601-1-2. | Electrical Safety per IEC 60601-1 and EMC per IEC 60601-1-2. |
- Summary of Bench Testing Conducted: IEC Standards were employed for: Electrical Safety 7. and Electromagnetic Compatibility. MTF and DQE measurements were supplied by the panel . manufacturer in accordance with the FDA guidance document. Risk Analysis was conducted in accordance with FDA guidance documents. Software validation was performed using all panels. All of the digital panels have had previous successful 510(k) reviews.
- Summary of Clinical Testing: Clinical images were acquired and evaluated by a board certified 8. radiologist who concluded the images were of good diagnostic quality.
- ರು. Conclusion: After analyzing bench, clinical image, and external laboratory testing to applicable standards, it is the conclusion of Del Medical Inc that the DelWorks DR System is as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 17, 2014
Del Medical, Inc. % Mr. Daniel Kamm Principle Engineer 8870 Ravello Court NAPLES FL 34114
Re: K140825
Trade/Device Name: DelWorks DR System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: June 12, 2014 Received: June 16, 2014
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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.
ff your device is classified (see above) into cither class 11 (Special Controls) or class 111 (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 (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2-Mr. Kamm
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sm.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K140825
Device Name Del Works DR System
Indications for Use (Describe)
The DelWorks DR System is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. DelWorks DR System allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis. and extremities.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
5
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."