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 Description

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Virtual C DRF-NEO Digital Imaging System." This document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technical specifications and summaries of non-clinical testing. It explicitly states that "No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification."

Therefore, based on the provided text, there is no study that proves the device meets specific acceptance criteria related to its performance in a clinical or standalone setting. The submission relies on establishing substantial equivalence to a predicate device, and thus, does not include information on acceptance criteria based on clinical performance metrics or studies involving human readers or ground truth.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not define specific clinical acceptance criteria for the "Virtual C DRF-NEO Digital Imaging System" or present a study comparing its performance against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications.

Acceptance Criteria	Reported Device Performance
Not defined in the document for clinical or standalone performance.	Not applicable as no such study was presented.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical test set was used, as "No clinical data is necessary to evaluate safety or effectiveness." The assessment was based on non-clinical bench testing and comparison to technical specifications of a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. No clinical test set was used, and therefore, no experts were involved in establishing ground truth for clinical performance.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

Not applicable. No MRMC comparative effectiveness study was conducted. The device is a digital imaging system, not an AI-assisted diagnostic tool that would typically involve a multi-reader study to evaluate improvement with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. No standalone performance study was conducted. The assessment was based on demonstrating substantial equivalence to a predicate device.

7. The Type of Ground Truth Used

Not applicable. For the purpose of this 510(k) submission, the ground truth was effectively the technical specifications and validated performance of the predicate device and the digital panel component (DRTECH EVS 2430W with K171137 clearance), against which the proposed device's characteristics were compared for substantial equivalence. No clinical ground truth (e.g., pathology, outcomes data) was used for evaluating the new device's performance in a clinical context.

8. The Sample Size for the Training Set

Not applicable. No training set was involved, as this submission is not for an AI/ML algorithm requiring a training phase.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

Summary

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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)

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
1. 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
1. 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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1. 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.
1. 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 DeviceVirtual C DRF Digital Imaging SystemK211191	Proposed DeviceVirtual C DRF-NEO Digital ImagingSystem
Intended Use	Intended for use by a qualified/trainedmedical professionals, who have fullunderstanding of the safety information andemergency procedures as well ofcapabilities and function of the device. Thedevice provides radiographic,multiradiographic and fluoroscopic imagingand is used for guidance and visualizationduring diagnostic radiographic, surgery, andinterventional procedures. The device is tobe used in healthcare facilities both insideand outside of hospital, in a variety ofprocedures of the skull, spinal column,chest, abdomen, extremities, and at thediscretion of the medical professional thedevice may be used for other imagingapplications on all patients exceptneonates (birth to one month) within thelimits of the device. Applications can beperformed with the patient sitting,standing, or lying in the prone or supineposition. The system is not intended formammography applications (Rx Only)	Intended for use by a qualified/trainedmedical professionals, who have fullunderstanding of the safety informationand emergency procedures as well ofcapabilities and function of the device. Thedevice provides radiographic, multi-radiographic and fluoroscopic imaging andis used for guidance and visualizationduring diagnostic radiographic, surgery,and interventional procedures. The deviceis to be used in healthcare facilities bothinside and outside of hospital, in a varietyof procedures of the skull, spinal column,chest, abdomen, extremities, and at thediscretion of the medical professional thedevice may be used for other imagingapplications on all pediatric patients (birthto 21 years) within the limits of the device.Applications can be performed with thepatient sitting, standing, or lying in theprone or supine position. The system isnot intended for mammographyapplications. (Rx Only)Comment: The new smaller panel isbetter suited to smaller patients.
Energy Source	110V-120V, Single 50-60 Hz	110V-120V, Single 50-60Hz
Characteristics	Predicate DeviceVirtual C DRF Digital Imaging SystemK211191	Proposed DeviceVirtual C DRF-NEO Digital ImagingSystem
System Weight andSize	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 OutputPower	80 KV x 2 mA = 160 watts	80 KV x 2 mA = 160 watts
FluoroscopyContinuous	.1 – 2 mA	.1 – 2 mA
RadiographyKV 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 byPortaVision, model MVC Accession #2010848-000Image: Collimator	Machine Vision motorized made byPortaVision, model MVC Accession #2010848-000 SAMEImage: Collimator
Digital PanelSpecification	DRTECH EVS 4343WP & 4336WPpreviously cleared K193031	DRTECH EVS 2430W 10 x 12DRTECH cleared K171137
Pixel Pitch	EVS 4343WP: 140 μEVS 3643WP: 140 μ	EVS 2430W 76 μ
Resolution	EVS 4343WP: 3,072 x 3,072EVS 3643WP: 2,560 x 3,072	EVS 2430W2,298 x 2882
AD Conversion	16 bits	16 bits (SAME)
DQE	EVS 4343WP: 50.0 % at 1.0 lp/mmEVS 3643WP: 52.3 % at 1.0 lp/mm	EVS 2430W45% at 1.0 lp/mm
MTF	EVS 4343WP: 52.3 % at 2.0 lp/mmEVS 3643WP: 46.8 % at 2.0 lp/mm	EVS 2430W35% at 2.0 lp/mm
Frame Rate (Panel)	15fps (1x1, Full resolution.	20fps (1×1, Full resolution)40fps (2×2, Full resolution)
Image acquisition	Amorphous Silicon Direct depositionCsI:TI	Amorphous Silicon Direct depositionCsI:TI
Characteristics	Predicate DeviceVirtual C DRF Digital Imaging SystemK211191	Proposed DeviceVirtual C DRF-NEO Digital ImagingSystem
Connection	Ethernet or Wi-Fi	Same as predicate
DICOM	Yes	Same as predicate
Energy used and/ordelivered	Power Requirements described above.No energy is delivered to the patient.	Same as predicate
PerformanceStandard	21CFR 1020.30	Same as predicate
Electrical Safety	IEC60601-1:2005 + A1 (2012)IEC60601-1-2:2007IEC60601-1-3:2008IEC60601-2-28:2010IEC60601-2-43:2010IEC60601-2-54:2009NEMA PS 3.1-3.20	Same as predicate
Photo	Image: Virtual C DRF Digital Imaging System	Image: Virtual C DRF-NEO Digital Imaging System

1. 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 DRFK211191	Proposed DeviceVirtual 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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1. 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).
1. 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
1. 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 predicate device, has insignificant technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.