(64 days)
No
The description mentions "Machine-Vision Collimator (MVC)" and "x-ray source to detector alignment software," but these features appear to be based on traditional machine vision techniques for alignment and positioning, not AI/ML for image analysis or interpretation. There is no mention of AI, ML, deep learning, or related terms in the summary.
No
The device is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures, which are diagnostic or procedural, not therapeutic.
Yes
The device is described as providing "radiographic, multiradiographic and fluoroscopic imaging" for "guidance and visualization during diagnostic radiographic, surgery, and interventional procedures," explicitly stating its use for diagnostic purposes.
No
The device description clearly states it is a "mobile imaging system" that includes hardware components like a digital receptor panel, generator, and a novel collimator with built-in software. While software is a key component, it is integrated into and controls physical hardware for image acquisition and processing.
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 examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an imaging system that uses radiographic, multiradiographic, and fluoroscopic imaging to visualize internal structures of the body. It acquires, processes, and displays images.
- Intended Use: The intended use is for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures, and for imaging applications on various anatomical sites. This involves imaging the patient directly, not analyzing samples taken from the patient.
The device's function and intended use align with the definition of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device provides radiographic, multiradiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside and outside of hospital, in a variety of procedures of the skull, spinal column, extremities, and at the discretion of the medical professional the device may be used for other imaging applications on all patients except neonates (birth to one month) within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications
Product codes
OWB, JAA, OXO
Device Description
The Virtual C DRF system is a mobile imaging system that acquire, process and display both static radiographic images and dynamic radiographic images such as multi-rad and fluoroscopy. Dynamic image acquisition is performed without the limitation of a mechanical linkage between the x-ray source and the x-ray detector. The mechanical linkage typical in existing dynamic imaging systems is either a c-arm or u-arm that ensures the alignment of the imaging components during image acquisition. The Virtual C DRF System features a novel collimator with built-in x-ray source to detector alignment software (Machine-Vision Collimator (MVC), combine they provide the technology for a "virtual c-arm" system. The novel MVC utilized four independent shutter to automatically position the radiation beam, so the area of exposure always remains within the confines of the active area of the detector. In addition, the angle and inclination of x-ray source is displayed to the operator. A visual display provides real time video images of the patient and a shaded area within the video images represent the location and size of the radiation beam with respect to the patient. As compared to our predicate device, there are three main changes: The digital receptor panel become a DRTECH brand panel, the generator changes from Sedecal to Source-ray, and and the collimator is changed from Colimar to a PortaVision "Machine Vision" collimator. An initial report was submitted for that collimator.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic, multiradiographic and fluoroscopic imaging
Anatomical Site
skull, spinal column, extremities
Indicated Patient Age Range
all patients except neonates (birth to one month)
Intended User / Care Setting
qualified/trained medical professionals, in healthcare facilities both inside and outside of hospital
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
Bench testing was performed to assess the device safety and effectiveness. Electrical safety and EMC testing was performed on the unit.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification. The digital panels both received previous 510(k) clearances.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Portavision Medical LLC % Daniel Kamm Principal Engineer Kamm and Associates 8870 Ravello Ct NAPLES FL 34114
Re: K211191
Trade/Device Name: Virtual C DRF Digital Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: April 17, 2021 Received: April 21, 2021
Dear Daniel 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. 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
June 24, 2021
1
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 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 (OS) 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) K211191
Device Name Virtual C DRF Digital Imaging System
Indications for Use (Describe)
Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device provides radiographic, multiradiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside and outside of hospital, in a variety of procedures of the skull, spinal column, extremities, and at the discretion of the medical professional the device may be used for other imaging applications on all patients except neonates (birth to one month) within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system 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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3
Image /page/3/Picture/0 description: The image contains the text "510(K) Summary, K211191" at the top. Below that is a logo for PortaVision Medical. The logo consists of three blue circles with the letters P, V, and M in white inside each circle, respectively. The words "PortaVision Medical" are written in a smaller font below the circles.
PortaVision Medical LLC 800 Central Avenue Jefferson, Louisiana 70121 Phone: 866-783-4133 email: info@pvmed.net www.portavisionmedical.com Contact: Terry Ancar, President Date Prepared: June 18, 2021
-
- Identification of the Device: Trade/Device Names: Virtual C DRF Digital Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system Regulatory Class: II Product Codes: OWB, JAA, OXO Common/Usual Name: Mobile Fluoroscopic System
-
- Equivalent legally marketed device: K191503 Trade/Device Name: MobileRay Pulse SE Digital Imaging System Manufacturer: PortaVision Medical Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA, OXO Common/Usual Name: Mobile Fluoroscopic System
-
- Reference Imaging Chain:
Trade/Device Name: Insight Agile DRF Digital Imaging System K200396, Vieworks Vivix-D 1212G, 1717G and DRTECH EVS4343WP, 4336WP Detectors customer picks one of the units ) Manufcaturer: Imaging Engineering, LLC Regulation Number: 21 CFR 892.1650 Regulation Name: Image Intensified Fluoroscopic X-ray System Regulatory Class: II; Product Code: JAA and LLZ
-
- Alternate Devices:
K193031, DRTECH Corporation Trade/Device Name: EVS 4343WP, EVS 3643WP Flat Panel Detector (customer picks one of the units) (with RADINFO Software used in our main predicate K191503.) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II; Product Code: MQB
- Alternate Devices:
4
-
- Indications for Use: Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device. The device provides radiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside and outside of hospital, in a variety of procedures of the skull, spinal column, chest, abdomen, and extremities. The device may be used for other imaging applications on all patients except all patients except neonates (birth to one month) within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications. (RX Only)
-
- Description of the Device: The Virtual C DRF system is a mobile imaging system that acquire, process and display both static radiographic images and dynamic radiographic images such as multi-rad and fluoroscopy. Dynamic image acquisition is performed without the limitation of a mechanical linkage between the x-ray source and the x-ray detector. The mechanical linkage typical in existing dynamic imaging systems is either a c-arm or u-arm that ensures the alignment of the imaging components during image acquisition. The Virtual C DRF System features a novel collimator with built-in x-ray source to detector alignment software (Machine-Vision Collimator (MVC), combine they provide the technology for a "virtual c-arm" system. The novel MVC utilized four independent shutter to automatically position the radiation beam, so the area of exposure always remains within the confines of the active area of the detector. In addition, the angle and inclination of x-ray source is displayed to the operator. A visual display provides real time video images of the patient and a shaded area within the video images represent the location and size of the radiation beam with respect to the patient. As compared to our predicate device, there are three main changes: The digital receptor panel become a DRTECH brand panel, the generator changes from Sedecal to Source-ray, and and the collimator is changed from Colimar to a PortaVision "Machine Vision" collimator. An initial report was submitted for that collimator.
-
- Safety and Effectiveness, comparison to predicate device has similar indications for use and similar technological characteristics as the predicate device, and employs already 510(k) cleared digital panels. The chief differences are: The predicate uses a different falt panel detector and mobile cart Otherwise the two systems have the same functionality and uses.
-
- Substantial Equivalence Chart: Please see the next page.
5
| Characteristics | Predicate Device
MobileRay Pulse SE K191503 | Proposed Device
Virtual C DRF Digital Imaging System |
|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for use by a qualified/trained
medical professionals on both adult and
pediatric patients for diagnostic radiographic,
surgery, and interventional procedures. The
device is to be used in healthcare facilities
both inside and outside of hospital, in sterile
as well as nonsterile environments, and in a
variety of procedures of the skull, spinal
column, chest, abdomen, extremities, and at
the discretion of the medical professional the
device may be used for other imaging
applications. Applications can be performed
with the patient sitting, standing, or lying in
the prone or supine position. The system is
not intended for mammography applications. | Intended for use by a qualified/trained medical
professionals on both adult and pediatric
patients for diagnostic radiographic, surgery,
and interventional procedures. The device is to
be used in healthcare facilities both inside and
outside of hospital, in sterile as well as
nonsterile environments, and in a variety of
procedures of the skull, spinal column, chest,
abdomen, extremities, and at the discretion of
the medical professional the device may be
used for other imaging applications.
Applications can be performed with the patient
sitting, standing, or lying in the prone or supine
position. The system is not intended for
mammography applications. SAME |
| Energy Source | 110V-120V, Single 50-60 Hz | 110V-120V, Single 50-60Hz |
| System Weight
and Size | 136 lbs. 35.75" x 28" x 72.5" | 121 lbs. 36" x 26" x 77" |
| Generator Type | High frequency Inverter type | High frequency Inverter type
80 kVp x 2 ma = 160 watts for Source Ray
Generator
4w for Sedecal Generator (alternate available
generator) |
| Fluoroscopy | | |
| Pulse | 0.5 – 10 mA | N/A |
| Continuous | N/A | .1 – 2 mA |
| Radiography | | |
| KV range | 40 – 125 KV | 35 – 80 KV Source Ray Generator
40 - 125 KV if Sedecal Generator is selected. |
| mA range | 20 – 100 mA | n/a for Source Ray
.1 – 2 mA if Sedecal Generator is selected. |
| mAs range | 0.8 – 200 mAs | n/a for Source Ray
0.8 - 200 mAs if Sedecal Generator is selected. |
| Pulse width | 10 ms | 10 ms |
| Pulse rate | 1 - 7.5 fps | 1 - 15 fps DRTECH Detectors
1 - 30 fps Vieworks Detectors |
| X-ray Tube | Stationary anode | Stationary anode |
| Indicators | Display on workstation monitor | Same as predicate |
| Characteristics | Predicate Device
MobileRay Pulse SE K191503 | Proposed Device
Virtual C DRF Digital Imaging System |
| Collimator | Multi-leaf adjustable motorized, Collimare Touch LED
Image: Collimare Touch LED | Machine Vision motorized made by
PortaVision, model MVC Accession # 2010848-000
Image: Machine Vision motorized |
| Digital Panel
Specification | PerkinElmer XRpad2 3025 4346
as cleared in K161942, K161966 | Vivix-D1212G or D1717G previously cleared in
K200396
OR:
DRTECH EVS 4343WP or 4336WP previously
cleared K193031 |
| Pixel Pitch | $100 \mu$ | Vivix-D1212G $145 \mu$ or
Vivix-D1717G $140 \mu$
OR:
EVS 4343WP: $140 \mu$ or
EVS 3643WP: $140 \mu$ |
| Pixel Matrix | 2508 X 3004 | Vivix-D1212G 2048x2048 or
Vivix-D1717G 3072 x 3072
OR:
EVS 4343WP: 3,072 x 3,072
EVS 3643WP: 2,560 x 3,072 |
| AD Conversion | 16 bits | 16 bits (SAME) |
| DQE | 60% (1 cy/mm), | Vivix-D1212G 56 % @ 1 lp/mm
Vivix-D1717G 56 % @ 1 lp/mm
OR:
EVS 4343WP: 50.0 % at 1 lp/mm
EVS 3643WP: 52.3 % at 1 lp/mm |
| MTF | 40% (2 cy/mm) | Vivix-D1212G 30 % @ 2 lp/mm
Vivix-D1717G 30 % @ 2 lp/mm
OR
EVS 4343WP: 52.3 % at 2.0 lp/mm
EVS 3643WP: 46.8 % at 2.0 lp/mm |
| Image acquisition | Amorphous Silicon Direct deposition CsI:Tl | Amorphous Silicon Direct deposition CsI:Tl |
| Connection | Ethernet or Wi-Fi | Same as predicate |
| DICOM | Yes | Same as predicate |
| Performance
Standard | 21CFR 1020.30 | Same as predicate |
| Characteristics | Predicate Device
MobileRay Pulse SE K191503 | Proposed Device
Virtual C DRF Digital Imaging System |
| Electrical Safety | IEC60601-1:2005 + A1 (2012)
IEC60601-1-2:2007
IEC60601-1-3:2008
IEC60601-2-28:2010
IEC60601-2-43:2010
IEC60601-2-54:2009
NEMA PS 3.1-3.20 | Same as predicate |
| Software
features, human
factors, user
tools, analysis
tools, capabilities,
etc. | As described in user manual | Same as predicate (or same as alternate
configuration described in K200396) |
| Photo | Image: MobileRay Pulse SE K191503 | Image: Virtual C DRF Digital Imaging System |
| Alternate
Proposed
Configuration | This model is called Virtulal C DRF MBS. It employs the imaging chain cleared in K200396
(unmodified) | |
6
7
The following table compares The MobileRay Pulse SE software to the predicate software.
8
| Feature | Predicate Device
MobilePulse SE
K191503 | Proposed Device
Virtual C DRF |
|-------------------------------|-----------------------------------------------|----------------------------------|
| Acquiring image from detector | Yes | Yes |
| Viewing image | Yes | Yes |
| Change window/level | Yes | Yes |
| Invert | Yes | Yes |
| Lookup Table | Yes | Yes |
| Zoom | Yes | Yes |
| Pan | Yes | Yes |
| Noise Reduction | Yes | Yes |
| Patient Information | Yes | Yes |
| Annotation | Yes | Yes |
| Image rotation | Yes | Yes |
| X-Ray generator control | Yes | Yes |
| DICOM worklist and Send | Yes | Yes |
-
- Summary of non-clinical testing: Bench testing was performed to assess the device safety and effectiveness. Electrical safety and EMC testing was performed on the unit. The standards employed were: EN 60601-1-2 (2015): Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests EN 301 489-1 V2.2.0 (2017): Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements & EN 301 489-17 V3.2.0 (2017): Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions for Broadband Data Transmission Systems AND: IEC 60601-1: 2005 + Corr.1: 2006 + A1: 2012 EN 60601-1: 2006 + A11: 2011 + A1: 2013 + AC:2014 + A12:2014 UNE-EN 60601-1: 2008 + Erratum 2008 + Corr.: 2010 + A11: 2012 + AC:2014 + A12:2015 POSE000_14 (General procedure of Safety Lab) EMC and Electrical Safety performance for the digital receptor panels had previously been submitted to FDA in K193031. Software has been written and validated according to the FDA Software Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005 Cybersecurity concerns have been addressed in accordance with: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff (October 2, 2014).
-
- Summary of clinical testing: No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification. The digital panels both received previous 510(k) clearances
Conclusion: After analyzing software integration validation, safety testing data, and bench test images, it is the conclusion of PortaVision Medical LLC that the Virtual C DRF Digital Imaging System is as safe and effective as the predicate device, has insignificant technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate device.