(24 days)
No
The summary describes a mobile x-ray unit and its components, focusing on hardware, safety standards, and integration of previously cleared software and digital panels. There is no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No.
The device is described as a mobile x-ray unit used for diagnostic radiographic exposures, which means it helps in identifying conditions rather than treating them.
Yes
The device is used for "taking diagnostic radiographic exposures," indicating its role in the diagnostic process by producing images used for diagnosis.
No
The device description clearly states it is a "mobile x-ray unit" and describes hardware components like a telescoping tubestand, battery/line operation, and integration with digital x-ray acquisition panels. While it mentions using previously cleared software, the device itself is a physical x-ray machine.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that this device is a mobile x-ray unit used for taking radiographic exposures of various body parts. This is an in vivo diagnostic imaging technique, meaning it is performed on a living subject.
- Lack of mention of biological samples: There is no mention of the device analyzing or interacting with any biological samples.
Therefore, the Paragon 2 mobile x-ray unit falls under the category of medical imaging devices, not In Vitro Diagnostics.
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
The Paragon 2 is a mobile x-ray unit that covers all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These battery or line operated units combine stand-alone feature for exposures with battery assisted motor drive. Any of the following digital x-ray acquisition panels are available: Toshiba's FDX4343RPW, FDX 3543RPW, or FDX2520RPW. Integration of the panels and the software with the mobile system was straightforward since the panels and software have already been cleared. (K130883) The device complies with the US Federal Safety Performance Standard and is UL listed. The Paragon 2 has a telescoping tubestand which enhances visibility while transporting the unit. The Paragon 2 employs the digital x-ray panels and software employed in our premarket notification K143232.
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 for use at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater.
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, test laboratory results, rick analysis and software validation and integration testing results indicate that the new device is as safe and effective as the predicate devices. All digital panels have previous FDA clearance and are provided unmodified.
Laboratory testing included performance testing to the DHHS Radiation Safety Performance Standard, Electrical Safety per IEC-60601. EMC per IEC-60601-1-2; IEC 60601-1-3 Radiation protection in diagnostic X-ray equipment, IEC 60601-2-54 Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment for Radiography and Radioscopy. Software integration testing and risk analysis was performed to confirm proper implementation of the (already cleared) software. Every unit manufactured undergoes thorough performance testing which includes visual and configuration testing, leakage testing, hi-pot testing, power supply testing, (batteries, etc.), generator controls (voltage, current, timing), and image acquisition.
Not required because all of the proposed digital panels have prior 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.
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2016
Meridian Medical Systems, LLC % Daniel Kamm, P.E. Submission Correspondent Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K162687
Trade/Device Name: Paragon 2 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL, MQB Dated: September 24, 2016 Received: September 27, 2016
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 (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.
1
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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Oals
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) K162687
Device Name Paragon 2
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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary 510(k) Number K162687 MERIDIAN MEDICAL SYSTEMS LLC 352 Harris Drive Aurora , OH 44202 Date Prepared: October 17, 2016 Contact: Larry Cornell,
1. Identification of the Device:
Trade/Device Name: Paragon 2 Regulation Number: 21CFR892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: II Product Code: IZL and MQB Common/Usual Name: Digital Mobile Diagnostic X-Ray System
2. Equivalent legally marketed device: K161345
Trade/Device Name: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR. Manufacturer: Sedecal SA (Spain) Regulation Number: 21CFR892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: II Product Code: IZL and MQB Common/Usual Name: Digital Mobile Diagnostic X-Ray System
-
- Reference device: K143232 (The mobile device incorporates this device) Trade/Device Name: Universal Digital Interface 2W, UDI 2W. Manufacturer: MERIDIAN MEDICAL SYSTEMS LLC Regulation Number: 21CFR892.1680 Regulation Name: Stationary X-ray System Regulatory Class: II Product Code: MQB Common/Usual Name: Digital X-ray panel and software
-
- Indications for Use (intended use): Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic 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.
-
- Description of the Device: The Paragon 2 is a mobile x-ray unit that covers all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These battery or line operated units combine stand-alone feature for exposures with battery assisted motor drive. Any of the following digital x-ray acquisition panels are available: Toshiba's FDX4343RPW, FDX 3543RPW, or FDX2520RPW. Integration of the panels and the software with the mobile system was straightforward since the panels and software have already been cleared. (K130883) The device complies with the US Federal Safety Performance Standard and is UL listed. The Paragon 2 has a telescoping tubestand which enhances visibility while transporting the unit. The Paragon 2 employs the digital x-ray panels and software employed in our premarket notification K143232.
4
-
- Safety and Effectiveness, comparison to predicate device. Bench, test laboratory results, rick analysis and software validation and integration testing results indicate that the new device is as safe and effective as the predicate devices. All digital panels have previous FDA clearance and are provided unmodified.
| Characteristic | K161345 Trade/Device Name: RadPRO®
Mobile 40kW; RadPRO® Mobile 40kW
FLEXPLUS, | Meridian Medical Paragon 2 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | SAME |
| Configuration | Battery or line operated mobile | SAME |
| Performance
Standard | 21 CFR 1020.30 | SAME |
| Generator | High frequency made by Sedecal | SAME |
| Generator
power level | One available power level: 40 kW | Four available power levels:
20 KW, 32 KW, 40 KW, 50 KW. These
four power levels were cleared in
Sedecal's K101517 which was the
predicate for K161345. Those same
generators are used in the Paragon 2. |
| Collimator | Ralco R221 DHHS Manual Collimator | SAME |
| Characteristic | K161345 Trade/Device Name: RadPRO®
Mobile 40kW; RadPRO® Mobile 40kW
FLEXPLUS, | Meridian Medical Paragon 2 |
| Image
acquisition | Canon CXDI 401C Wireless (CSI) K133693
Pixel size: 125 μm 3320 × 3408 pixels
Canon CXDI 701C Wireless (CSI) K131106
Pixel size: 125 μm 2800 × 3408 pixels
Canon CXDI 701G Wireless (GOS) K131106
Pixel size: 125 μm 2800 × 3408 pixels
Canon CXDI 801C Wireless (CSI) K131106
Pixel size: 125 μm 2800 × 2192 pixels
Canon CXDI 801G Wireless (GOS) K131106
Pixel size: 125 μm 2800 × 2192 pixels | Toshiba panels are employed:
FDX4343R/RPW,
Active Area 43 (H)×43 (V) cm
Pixel Matrix 3036 (H)×3040 (V)
Pixel Pitch 140μ m
FDX3543RP/RPW
Active Area 345(H)×423(V)mm
Pixel Matrix 2466(H)×3040(V)
Pixel Pitch 140μ m
FDX2530RPW.
Active Area 245 (H)×295 (V) mm
Pixel Matrix 1750 (H)×2108 (V)
Pixel Pitch 140μ m
The Paragon 2 employs the digital x-ray
panels and software employed in our
premarket notification K143232. |
| Software | Canon control software CXDI-NE | ECOM DROC, cleared with Toshiba
panels (Sedecal) in K130883 AND
K143232. |
| Connection | Ethernet or Wireless Wi-Fi | SAME |
| DICOM | YES | YES |
| Power Source | AC Line or Rechargeable Battery | SAME |
| Electrical
safety and EMC | Electrical Safety per IEC-60601. UL listed;
EMC per IEC-60601-1-2;
IEC 60601-1-3 Radiation protection in
diagnostic X-ray equipment
IEC 60601-2-54 Particular Requirements
For The Basic Safety And Essential
Performance Of X-Ray Equipment for
Radiography and Radioscopy | SAME |
7. Substantial Equivalence Chart
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Image /page/6/Picture/0 description: This image shows the characteristics of the RadPRO® Mobile 40kW and RadPRO® Mobile 40kW FLEXPLUS, as well as the Meridian Medical Paragon 2. There are photos of the RadPRO® Mobile, RadPRO® Mobile Flex Plus, Standard Column, and Telescopic Column. The trade/device name is K161345.
-
- Summary of Laboratory Testing and Bench Testing: Laboratory testing included performance testing to the DHHS Radiation Safety Performance Standard, Electrical Safety per IEC-60601. EMC per IEC-60601-1-2; IEC 60601-1-3 Radiation protection in diagnostic X-ray equipment, IEC 60601-2-54 Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment for Radiography and Radioscopy. Software integration testing and risk analysis was performed to confirm proper implementation of the (already cleared) software. Every unit manufactured undergoes thorough performance testing which includes visual and configuration testing, leakage testing, hi-pot testing, power supply testing, (batteries, etc.), generator controls (voltage, current, timing), and image acquisition.
-
- Summary of Clinical Testing: Not required because all of the proposed digital panels have prior FDA clearance.
-
- Conclusion After analyzing bench and laboratory testing to applicable standards, it is the conclusion of Meridian Medical that the Paragon 2 Mobile X-Ray Systems are as safe and effective as the predicate devices, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices.