(53 days)
No
The document describes a standard mobile X-ray system with digital imaging capabilities and automatic exposure detection, but there is no mention of AI or ML algorithms for image analysis, diagnosis, or other functions.
No
The device is described as a "motorized mobile diagnostic x-ray system" used for taking "diagnostic radiographic exposures," indicating its purpose is to diagnose conditions rather than treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for taking diagnostic radiographic exposures." Additionally, the "Device Description" refers to it as a "motorized mobile diagnostic x-ray system."
No
The device description explicitly states it is a "motorized mobile diagnostic x-ray system" and details hardware components like a tube unit, wheel locks, and a digital x-ray panel. While it includes software, it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The description clearly states this is a "motorized mobile diagnostic x-ray system." Its purpose is to generate X-rays that pass through the patient's body to create images of internal structures. This is an in vivo diagnostic method (performed within the living body).
- Intended Use: The intended use is for "taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts." This involves imaging the patient directly, not analyzing samples taken from the patient.
The device is a diagnostic imaging system, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
Product codes (comma separated list FDA assigned to the subject device)
IZL, MQB
Device Description
This is a motorized mobile diagnostic x-ray system. The MDR16 Mobile Direct Radiographic System facilitates X-ray examinations, in situations where it is not possible to transport the patient to a ward with fixed equipment. The unit is stable and precise, yet easy to maneuver due to smooth battery-powered motorization. Electric tube unit and wheel locks, 180º column rotation, and a simple user interface provide for add operator convenience and rapid patient positioning. The MDR17 System allows the acquisition of X-ray images on digital panel, CR, or film, by setting techniques based on anatomic area. Technique presets can be customized. Immediate image display after acquisition, and the possibility of immediate transmission to PACS, help minimize workflow time. Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Furthermore, the intended operators of the MDR17 Mobile Direct Radiographic System are health care professionals familiar with and responsible for the x-ray examinations being performed. To minimize electrical, mechanical, and radiation hazards, Del Medical, Inc. adheres to recognized and established industry practice, and all equipment is subject to final performance testing. The digital x-ray panel includes automatic exposure detection. Two different size panels are available: 35 x 43 cm or 24 x 30 cm. The software is compatible with either panel via menu setting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
skull, spinal column, extremities, and other body parts.
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor or technician
health care professionals
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)
Bench testing was performed for EMC, mechanical safety, and electrical safety according to various FDA-recognized consensus standards. The identified risks were mitigated. Clinical testing was not required since the digital x-ray receptor panel had already received FDA clearance.
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.
K131106, K133534, K142718, K140825
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
§ 892.1720 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
November 20, 2017
Image /page/0/Picture/1 description: The image shows the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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. The logos are simple and professional in appearance.
Del Medical, Inc. % Daniel Kamm, P.E. Kamm and Associates 8870 Ravello Ct. NAPLES FL 34114
Re: K173018
Trade/Device Name: MDR17 Mobile Direct Radiographic System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: September 22, 2017 Received: September 28, 2017
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.
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
U .S. Food & Drug Administration 10903 New Hampshire Avenue Silv er Spring, MD 20993 w ww.fda.gov
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or (301) 796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173018
Device Name
MDR17 Mobile Direct Radiographic System
Indications for Use (Describe)
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
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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3
510(k) Summary: Del Medical, Inc. MDR17 Mobile Direct Radiographic System K173018
| Company: | Del Medical, Inc.
241 Covington Dr.
Bloomingdale, IL 60108 |
|----------------|------------------------------------------------------------------|
| Date Prepared: | September 22, 2017 |
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
1. General Information:
Establishment/Manufacturer/Location of Manufacturing Site: Del Medical, Inc. 241 Covington Dr. Bloomingdale, IL 60108 Establishment Registration Number: 1418964
2. Contact Person:
Tony Bavuso c/o Del Medical, Inc. 241 Covington Dr. Bloomingdale, IL 60108 Phone: 847-288-7021
3. Device Name and Classification
| Trade Name: | MDR17 Mobile Direct Radiographic System |
|---|---|
| Classification Name: | Mobile X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1720 |
| Device Class: | Class II |
| Product Code: | IZL |
| Subsequent Product Code: | MQB |
4. Legally Marketed Predicate Device
| Trade Name: | RadPRO® Mobile 40kW |
|---|---|
| Manufacturer: | Sedecal |
| 510(k) #: | K161345 |
| Classification Name: | Mobile X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1720 |
| Device Class: | Class II |
| Product Code: | IZL |
| Subsequent Product Code | MQB |
4
5. Indications for Use
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
-
Device Description: This is a motorized mobile diagnostic x-ray system. The MDR16 Mobile Direct Radiographic System facilitates X-ray examinations, in situations where it is not possible to transport the patient to a ward with fixed equipment. The unit is stable and precise, yet easy to maneuver due to smooth battery-powered motorization. Electric tube unit and wheel locks, 180º column rotation, and a simple user interface provide for add operator convenience and rapid patient positioning. The MDR17 System allows the acquisition of X-ray images on digital panel, CR, or film, by setting techniques based on anatomic area. Technique presets can be customized. Immediate image display after acquisition, and the possibility of immediate transmission to PACS, help minimize workflow time. Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Furthermore, the intended operators of the MDR17 Mobile Direct Radiographic System are health care professionals familiar with and responsible for the x-ray examinations being performed. To minimize electrical, mechanical, and radiation hazards, Del Medical, Inc. adheres to recognized and established industry practice, and all equipment is subject to final performance testing. The digital x-ray panel includes automatic exposure detection. Two different size panels are available: 35 x 43 cm or 24 x 30 cm. The software is compatible with either panel via menu setting.
-
Substantial Equivalence The MDR17 Mobile Direct radiographic x-ray system is substantially equivalent to the commercially available RadPRO® Mobile 40kW radiographic x-ray system with identical indications for use. (See Table below).
| Characteristic | RadPRO® Mobile 40kW;
Sedecal. K161345 | MDR17 Mobile Direct Radiographic
System |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Intended for use by a qualified/trained doctor
or technician on both adult and pediatric
subjects for taking diagnostic radiographic
exposures of the skull, spinal column, chest,
abdomen, extremities, and other body parts.
Applications can be performed with the
patient sitting, standing, or lying in the prone
or supine position. Not for mammography. | Intended for use by a qualified/trained doctor
or technician on both adult and pediatric
subjects for taking diagnostic radiographic
exposures of the skull, spinal column, chest,
abdomen, extremities, and other body parts.
Applications can be performed with the
patient sitting, standing, or lying in the prone
or supine position. Not for mammography.
(SAME) |
| Performance
Standard | 21 CFR 1020.30 | SAME |
| Configuration | Motorized, battery operated | SAME |
| Generator | High frequency | High frequency (SAME) |
| Generator
power level | 40 kW (One power level) | 40 kW (SAME) |
| kVp Range | 40 to 150 kVp | 40 to 130 kV in steps of 1 kV |
5
| Characteristic | RadPRO® Mobile 40kW;
Sedecal. K161345 | MDR17 Mobile Direct Radiographic
System |
|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| mA Range | 10 - 500 mA Selectable | 70 to 400 mA automatically associated to kV |
| Exposure Time
Range | 0.001 - 10 sec | $0,001 ÷ 3$ sec according to set mAs |
| mAs Range | 0.1 - 500 mAs | 0,1 to 320 mAs |
| Collimator | Ralco R221 DHHS Manual Collimator | Ralco R108 F Manual Collimator |
| Image
acquisition
Panels
(Both systems
use already
cleared digital
panels) | Canon CXDI 801C Wireless (CSI) K131106
Pixel size: 125 μm 2192 x 2800 pixels | Pixium 3543EZ Portable Wireless
(K133534, K142718 and other clearances)
Pixel size 148 μm, 2400 x 2880 pixels or the
Pixium 2430EZ Portable Wireless ,
Pixel size 148 μm, 1920 x 1560 pixels
Compatible with film and CR systems as well. |
| Software | Canon control software CXDI-NE | DelWorks DR Software K140825 |
| Connection | Wired or Wireless | SAME |
| DICOM | YES | YES |
| Power Source | Single Phase Line Regulation
from 100 - 240 Vac (+/-10%) | 115 or 230 VAC |
| Electrical
safety and EMC | IEC 60601-1 and
IEC 60601-1-2 | SAME |
| Standards
(Other than
Electrical and
EMC) | Wi-Fi 802.11b/g and:
FCC Rules and Regulations | SAME |
| Wi-Fi
communication
with detectors | Wi-Fi antenna system | SAME |
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Image /page/6/Picture/0 description: This image shows two different mobile X-ray machines. The first machine is a RadPRO Mobile 40kW Sedecal K161345, which is white and blue. The second machine is an MDR17 Mobile Direct Radiographic System, which is also white and gray. Both machines are designed to be easily moved around a hospital or clinic.
- Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device. The MDR17 Mobile Direct System uses similar radiographic x-ray system technology to the predicate device. The differences in the subject device, such as the x-ray generator, tube crane, collimator, and x-ray tube, do not affect the safety or effectiveness of the MDR17 Mobile Direct System can use a wireless flat panel detector similar to the predicate device, and the differences do not adversely affect the safety or effectiveness of the radiographic x-ray system.
The properties of the subject device presented in the comparison table above and described throughout this submission do not differ significantly from the legally marketed predicate device with regards to fundamental scientific technology, nor do they reflect a significant change in the indications for use. The differences between the subject device and the legally marketed predicate device have been assessed using Risk Management and through third-party evaluation using FDA-recognized consensus standards. The results of these efforts demonstrate that the device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness than the predicate.
- Performance Testing (Bench). Del Medical claims conformance to a signed statement of performance standards. This submission contains performance data and test results to demonstrate conformance with special controls for medical devices containing software for a moderate level of concern per the FDA document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005. Testing for verification of the device was found acceptable to support the claims of substantial equivalence.
EMC, mechanical safety, and electrical safety were evaluated according to various FDA-recognized consensus standards (see Table below). In conclusion, the identified risk of EMC, mechanical, and electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. Clinical testing is not required for a determination of substantial equivalence.
7
| Recognition
Number | Product
Area | Standard
Reference
Number | Standard Title and Edition |
|-----------------------|-----------------|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-5 | General | AAMI
ES60601-1 | AAMI / ANSI ES60601-1:2005/(R)2012 And C1:2009/(R)2012
And, A2:2010/(R)2012 (Consolidated Text) Medical Electrical
Equipment -- Part 1: General Requirements For Basic Safety
And Essential Performance (IEC 60601-1:2005, Mod) |
| 19-1 | General | IEC
60601-1-2 | IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical
Equipment - Part 1-2: General Requirements For Basic Safety
And Essential Performance - Collateral Standard:
Electromagnetic Compatibility - Requirements And Tests |
| 12-210 | Radiology | IEC
60601-1-3 | IEC 60601-1-3 Edition 2.0 2008-01, Medical Electrical
Equipment - Part 1-3: General Requirements For Basic Safety
And Essential Performance - Collateral Standard: Radiation
Protection In Diagnostic X-Ray Equipment |
| 5-89 | General | IEC
60601-1-6 | IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical
Equipment - Part 1-6: General Requirements For Basic Safety
And Essential Performance - Collateral Standard: Usability |
| 12-274 | Radiology | IEC
60601-2-54 | IEC 60601-2-54 Edition 1.0 2009-06, Medical Electrical
Equipment - Part 2-54: Particular Requirements For The Basic
Safety And Essential Performance Of X-Ray Equipment For
Radiography And Radioscopy [Including: Technical
Corrigendum 1 (2010), Technical Corrigendum 2 (2011)] |
| 5-87 | General | IEC 62366 | IEC 62366 Medical devices - Application of usability
engineering to medical devices |
- Performance Testing (Clinical). Because the digital x-ray receptor panel has already received FDA clearance, clinical testing was not required.
10. General Safety and Effectiveness Concerns
Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features, including an emergency stop button, are incorporated into the system design. In addition, operation of the MDR17 Mobile Direct System is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed. Furthermore, the intended operators of the MDR17 Mobile Direct System are health care professionals familiar with and responsible for the x-ray examinations being performed. To minimize electrical, mechanical, and radiation hazards, Del Medical, Inc. adheres to recognized and established industry practice, and all equipment is subject to final performance testing.
11. Conclusion as to Substantial Equivalence
The MDR17 Mobile Direct System is intended for the same use as the RadPRO® Mobile 40kW; (K161345.) It uses components similar to those cleared for the RadPRO® Mobile 40kW. It is Del Medical, Inc.'s opinion that the MDR17 Mobile Digital System is substantially equivalent to the cleared predicate device, the RadPRO® Mobile 40kW.