Virtual C DRF-NEO Digital Imaging System
Device Facts
| Record ID | K212557 |
|---|---|
| Device Name | Virtual C DRF-NEO Digital Imaging System |
| Applicant | Portavision Medical, LLC |
| Product Code | OWB · Radiology |
| Decision Date | Sep 24, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1650 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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 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 pediatric patients (birth to 21 years) 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
Device Story
Mobile digital imaging system for radiographic and fluoroscopic procedures; provides guidance/visualization during surgery and interventions. Features 'Virtual C-arm' technology using Machine-Vision Collimator (MVC) with four independent shutters to automatically align radiation beam with detector active area; eliminates mechanical linkage (c-arm/u-arm) between x-ray source and detector. System displays real-time video of patient with superimposed shaded area representing radiation beam location. Operated by qualified medical professionals in healthcare facilities. Input: x-ray exposure; Output: static/dynamic digital images. Benefits: enables dynamic imaging without mechanical linkage; smaller detector panel optimized for pediatric patients. Healthcare providers use real-time visual feedback for precise beam positioning and procedural guidance.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1 series) and EMC testing (EN 60601-1-2, EN 301 489 series). Digital panel performance previously cleared under K171137.
Technological Characteristics
Mobile x-ray system; high-frequency inverter generator; stationary anode tube. Detector: Amorphous Silicon Direct deposition CsI:TI (DRTECH EVS 2430W). Connectivity: Ethernet/Wi-Fi. MVC collimator with machine-vision alignment. Software: Image acquisition, processing (noise reduction, zoom, pan, rotation), and DICOM communication. Electrical safety: IEC 60601-1, IEC 60601-2-54.
Indications for Use
Indicated for pediatric patients (birth to 21 years) requiring radiographic, multiradiographic, and fluoroscopic imaging for guidance and visualization during diagnostic, surgical, and interventional procedures of the skull, spinal column, and extremities. Not intended for mammography.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Virtual C DRF Digital Imaging System (K211191)
Reference Devices
- DRTECH FLAT PANEL DETECTOR EVS 2430W (K171137)
Submission Summary (Full Text)
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September 24, 2021
Image /page/0/Picture/1 description: The image contains 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, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Portavision Medical LLC % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K212557
Trade/Device Name: Virtual C DRF-NEO 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: August 11, 2021 Received: August 13, 2021
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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
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# Indications for Use
510(k) Number (if known) K212557
Device Name
Virtual C DRF-NEO 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 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 pediatric patients (birth to 21 years) 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
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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## 510(K) Summary, K212557
Image /page/3/Picture/1 description: The image shows the logo for PortaVision Medical. The logo consists of three blue circles that are overlapping. The letters P, V, and M are written in white inside the circles. 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: August 26, 2021
- 1. Identification of the Device: Trade/Device Names: Virtual C DRF-NEO 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
- 2. Equivalent legally marketed device: K211191 Trade/Device Name: Virtual C DRF 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 Device: DRTECH FLAT PANEL DETECTOR EVS 2430W 3. 510(K) Number K171137 Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system Regulatory Class: Il Product Code: MQB
- 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, extremities, and at the discretion of the medical professional the device may be used for other imaging applications on all pediatric patients (birth to 21 years) 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).
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- 5. Description of the Device: The Virtual C DRF-NEO system is a mobile imaging system that acquire, process and display both static radiographic images and dynamic radiographic images such as photo-spot 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-NEO 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.
- 6. Safety and Effectiveness, comparison to predicate device. This 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 flat panel detector and mobile cart. Otherwise, the two systems have the same functionality and uses.
| Characteristics | Predicate Device<br>Virtual C DRF Digital Imaging System<br>K211191 | Proposed Device<br>Virtual C DRF-NEO Digital Imaging<br>System |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for use by a qualified/trained<br>medical professionals, who have full<br>understanding of the safety information and<br>emergency procedures as well of<br>capabilities and function of the device. The<br>device provides radiographic,<br>multiradiographic and fluoroscopic imaging<br>and is used for guidance and visualization<br>during diagnostic radiographic, surgery, and<br>interventional procedures. The device is to<br>be used in healthcare facilities both inside<br>and outside of hospital, in a variety of<br>procedures of the skull, spinal column,<br>chest, abdomen, extremities, and at the<br>discretion of the medical professional the<br>device may be used for other imaging<br>applications on all patients except<br>neonates (birth to one month) within the<br>limits of the device. Applications can be<br>performed with the patient sitting,<br>standing, or lying in the prone or supine<br>position. The system is not intended for<br>mammography applications (Rx Only) | Intended for use by a qualified/trained<br>medical professionals, who have full<br>understanding of the safety information<br>and emergency procedures as well of<br>capabilities and function of the device. The<br>device provides radiographic, multi-<br>radiographic and fluoroscopic imaging and<br>is used for guidance and visualization<br>during diagnostic radiographic, surgery,<br>and interventional procedures. The device<br>is to be used in healthcare facilities both<br>inside and outside of hospital, in a variety<br>of procedures of the skull, spinal column,<br>chest, abdomen, extremities, and at the<br>discretion of the medical professional the<br>device may be used for other imaging<br>applications on all pediatric patients (birth<br>to 21 years) within the limits of the device.<br>Applications can be performed with the<br>patient sitting, standing, or lying in the<br>prone or supine position. The system is<br>not intended for mammography<br>applications. (Rx Only)<br>Comment: The new smaller panel is<br>better suited to smaller patients. |
| Energy Source | 110V-120V, Single 50-60 Hz | 110V-120V, Single 50-60Hz |
| Characteristics | Predicate Device<br>Virtual C DRF Digital Imaging System<br>K211191 | Proposed Device<br>Virtual C DRF-NEO Digital Imaging<br>System |
| System Weight and<br>Size | 121 lbs. 36" x 26" x 77" | 121 lbs. 36" x 26" x 77" |
| Generator Type | High frequency Inverter type | High frequency Inverter type |
| Maximum Output<br>Power | 80 KV x 2 mA = 160 watts | 80 KV x 2 mA = 160 watts |
| Fluoroscopy<br>Continuous | .1 – 2 mA | .1 – 2 mA |
| Radiography<br>KV range | 30 - 80 KV | 30 - 80 KV |
| mA range | 0.1 - 2 mA | 0.1 - 2 mA |
| Pulse width | 10 ms | 10 ms |
| Pulse rate | 1 - 15 fps | 1 - 15 fps |
| X-ray Tube | Stationary anode | Stationary anode |
| Indicators | Display on workstation monitor | Same as predicate |
| Collimator | Machine Vision motorized made by<br>PortaVision, model MVC Accession #<br>2010848-000<br>Image: Collimator | Machine Vision motorized made by<br>PortaVision, model MVC Accession #<br>2010848-000 SAME<br>Image: Collimator |
| Digital Panel<br>Specification | DRTECH EVS 4343WP & 4336WP<br>previously cleared K193031 | DRTECH EVS 2430W 10 x 12<br>DRTECH cleared K171137 |
| Pixel Pitch | EVS 4343WP: 140 μ<br>EVS 3643WP: 140 μ | EVS 2430W 76 μ |
| Resolution | EVS 4343WP: 3,072 x 3,072<br>EVS 3643WP: 2,560 x 3,072 | EVS 2430W<br>2,298 x 2882 |
| AD Conversion | 16 bits | 16 bits (SAME) |
| DQE | EVS 4343WP: 50.0 % at 1.0 lp/mm<br>EVS 3643WP: 52.3 % at 1.0 lp/mm | EVS 2430W<br>45% at 1.0 lp/mm |
| MTF | EVS 4343WP: 52.3 % at 2.0 lp/mm<br>EVS 3643WP: 46.8 % at 2.0 lp/mm | EVS 2430W<br>35% at 2.0 lp/mm |
| Frame Rate (Panel) | 15fps (1x1, Full resolution. | 20fps (1×1, Full resolution)<br>40fps (2×2, Full resolution) |
| Image acquisition | Amorphous Silicon Direct deposition<br>CsI:TI | Amorphous Silicon Direct deposition<br>CsI:TI |
| Characteristics | Predicate Device<br>Virtual C DRF Digital Imaging System<br>K211191 | Proposed Device<br>Virtual C DRF-NEO Digital Imaging<br>System |
| Connection | Ethernet or Wi-Fi | Same as predicate |
| DICOM | Yes | Same as predicate |
| Energy used and/or<br>delivered | Power Requirements described above.<br>No energy is delivered to the patient. | Same as predicate |
| Performance<br>Standard | 21CFR 1020.30 | Same as predicate |
| Electrical Safety | IEC60601-1:2005 + A1 (2012)<br>IEC60601-1-2:2007<br>IEC60601-1-3:2008<br>IEC60601-2-28:2010<br>IEC60601-2-43:2010<br>IEC60601-2-54:2009<br>NEMA PS 3.1-3.20 | Same as predicate |
| Photo | Image: Virtual C DRF Digital Imaging System | Image: Virtual C DRF-NEO Digital Imaging System |
- 7. Substantial Equivalence Chart:
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The following table compares The Virtual C DRF-NEO software to the predicate software.
| Feature | Predicate Device Virtual C DRF<br>K211191 | Proposed Device<br>Virtual C DRF-NEO |
|-------------------------------|--------------------------------------------|--------------------------------------|
| 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 |
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- 8. 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 + 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).
- 9. 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 panel received previous 510(k) clearance
- 10. 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-NEO Digital Imaging System is as safe and effective as the…
