The Faxitron VisionCT is a Cabinet x-ray system that is used to provide two and three dimensional digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.

Device Description

The Faxitron VisionCT is specially designed for high detail radiographic imaging of surgically excised medical specimens. It is a fully shielded Cabinet X- ray System that has been designed to comply with 21 CFR 1020.40. It allows up to 4.0 times geometric magnification of excised specimens with minimal geometric distortion through the use of a focal spot size that is less than 15 microns. With optimized cabinet geometry and the superior contrast available from the low kV capability. the VisionCT provides enhanced image performance. It is configured to acquire high resolution digital images up to 15 x 15 cm in size, through the use an integrated detector and Faxitron Vision Specimen Radiography software. The Faxitron Software supports the DICOM Store, Print and Modality Worklist services.

AI/ML Overview

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a quantitative table format for the device's diagnostic performance (e.g., sensitivity, specificity for detecting specific tissue types). Instead, it focuses on technical specifications and comparability to predicate devices. The "reported device performance" is primarily descriptive of its capabilities rather than a set of performance metrics against specific targets.

However, based on the non-clinical testing data mentioned, we can infer some "performance" aspects:

Acceptance Criteria (Inferred/Implicit)	Reported Device Performance (from text)
Ability to provide 2D digital X-ray images of harvested specimens for rapid verification of excised tissue.	Demonstrated through sample clinical images of various anatomical regions (breast tissue, femoral head, other tissues such as fallopian tube, prostate, nasal polyp, and heart valve).
Ability to provide 3D digital X-ray images (CT Reconstruction).	Stated as a major difference and progression in technology from predicate devices. Sample clinical and phantom images provided.
Compliance with technical specifications.	All technical specifications (Focal spot size, kV, mA, power, beryllium window thickness, X-ray beam divergence, target material) are listed and implicitly met by the device.
Image quality for characterizing CT X-ray system contrast and detail imaging performance.	Data obtained from artifact analysis on sample clinical and phantom images with embedded test objects provided.
Compliance with electrical safety standards.	Successfully tested per IEC 61010-1, IEC 61010-2-091, and IEC 61010-2-101.
Compliance with electromagnetic compatibility standards.	Demonstrated through compliance with IEC 61326-1 and IEC 61326-2-6.
Compliance with cabinet X-ray system regulations.	Complies with 21 CFR 1020.40.
DICOM compliance.	Complies with NEMA PS 3.1 - 3.20 (DICOM).
Software functionality (GUI, 3D imaging support).	Faxitron Vision Software upgraded and thoroughly tested, including added capability for 3D X-ray images.

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

The document states: "The non-clinical performance testing data provided in this submission includes detector Xineos 1515 imaging performance data and sample clinical images to demonstrate the capability of the VisionCT to image various anatomical regions (breast tissue, femoral head, other tissues such as fallopian tube, prostate, nasal polyp, and heart valve)."

It also mentions: "The phantom images include those provided to compare the 2D images from the predicate device and 3D images from the subject device. In addition, a uniform phantom and phantom with embedded test objects with ranges of sizes and contrasts designed to characterize CT x-ray system contrast and detail imaging performance, are also provided."

Test Set Sample Size:
- Clinical Images: The exact number of "sample clinical images" is not specified. It's described generally as "sample clinical images... to image various anatomical regions." This implies a limited set of images from different tissue types.
- Phantom Images: Not specified, but includes a "uniform phantom and phantom with embedded test objects."
Data Provenance: Not specified in the provided text. It does not mention the country of origin or whether the data was retrospective or prospective for the clinical images. Given the context of a 510(k) summary, these are likely internal validation studies.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth on the "sample clinical images." The ground truth for these images would likely involve pathology or surgical confirmation of tissue excision, but this is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for a diagnostic interpretation of the test set. The focus is on the device's ability to provide images and its technical performance, not on a human interpretation study.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was performed or described.
The device is a specimen X-ray system providing 2D and 3D images for rapid verification of excised tissue during biopsy. It is not an AI-assisted diagnostic device, and therefore, no comparison of human readers with or without AI assistance is mentioned or relevant to this submission.

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

A standalone performance evaluation of the imaging system was done. The "non-clinical performance testing data provided" focuses on the device's technical specifications, imaging capabilities (2D and 3D), image quality using phantoms, and artifact analysis. This testing demonstrates the algorithm's (and hardware's) ability to produce images and reconstruct 3D data independently.
However, it's crucial to distinguish this from an "algorithm only" performance for a diagnostic task. The device itself provides images; the human still performs the "verification that the correct tissue has been excised." The standalone performance here refers to the system's ability to generate high-quality images, not its ability to make a diagnostic call itself.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the "sample clinical images," the implicit ground truth for verifying "correct tissue has been excised" would likely be pathology results or surgical confirmation that the specimen indeed represents the intended tissue. However, this is not explicitly stated.
For the phantom images, the ground truth is the known characteristics of the phantom (e.g., sizes and contrasts of embedded test objects).
For electrical safety and EMC, the ground truth is compliance with established international standards (IEC 61010 series, IEC 61326 series).

8. The Sample Size for the Training Set

The document does not mention a training set in the context of machine learning or AI. The Faxitron VisionCT is an imaging device, not an AI-based diagnostic algorithm that requires a separate training set. The "Faxitron Vision Software" mentioned is an operating software for the device, upgraded from a predicate, and was "thoroughly tested," but not in the sense of a machine learning training process.

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

As no training set (for machine learning) is discussed, this question is not applicable.

Summary

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling a symbol. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the text "U.S. FOOD & DRUG ADMINISTRATION" is displayed in blue.

Faxitron Bioptics, LLC % Mr. Douglas Wiegman VP Engineering 3440 E. Britannia Drive, Suite 150 TUCSON AZ 85706

May 9, @018

Re: K173309

Trade/Device Name: Faxitron VisionCT Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MWP Dated: March 30, 2018 Received: April 2, 2018

Dear Mr. Wiegman:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801) medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (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.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and

Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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INIDCATIONS FOR USE STATEMENT

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Indications for Use

510(k) Number (if known) K173309

Device Name Faxitron VisionCT

Indications for Use (Describe)

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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Premarket Notification 510(k) Summary

(As required by 21 CFR 807.92)

Device name - as required by 807.92(a)(2): Trade Name: Faxitron VisionCT Common/ Classification Name: Specimen X-ray System/ Cabinet X-Ray System Classification Regulation: 21 CFR 892.1680 Device Class: Class II MWP Product Code: Radiologic Devices Panel Panel: Company Name: Faxitron Bioptics, LLC [as required by 807.92(a)(1)] Company Address: 3440 East Britannia Drive, Suite150 Tucson, Arizona 85706 Contact: Ciaran Purdy, VP of Development Preparation Date: March 30, 2018

LEGALLY MARKETED PREDICATE DEVICES - as required by 21 CFR 807.92(a)(3)

The Faxitron VisionCT is substantially equivalent to following predicate devices:

A. Faxitron VersaVision Specimen Radiography System (K170786)
Faxitron BioVision Plus Specimen Radiography System (K153583) B.
C. XPERT 40 Specimen Radiography System (K071233)

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DEVICE DESCRIPTION - as required by 21 CFR 807.92(a)(4)

DEVICE TECHNICAL SPECIFICATIONS - as required by 807.92(a)(4)

Focal spot size	< 15 um
kV	15-50kV
mA	1.0mA max
Power	iso-watt limited to 11.5W max
Beryllium window thickness	0.010 " (254um)
X-ray beam divergence	40 deg. min.
Target Material	Tungsten (W)

X-Ray Tube

Radiographic Magnification: 1.2X to 4X Exposure Control: Automatic or Manual X-ray Duty Cycle: 75% Power Requirements: 100 - 240 VAC, 50/60 Hz, 200VA Max

Radiation Safety Radiation shielded cabinet Compartment door equipped with dual safety interlocks Radiation: Less than 0.1 mR/hr at 5 cm (2 in.) from exterior surface at maximum kV

INTENDED USE - as required by 807.92(a)(5)

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TECHNOLOGICAL CHARACTERISTICS SUMMARY- as required by 807.92(a)(6)

The technological characteristics of the VisionCT are also comparable to the predicate devices as shown below.

	Subject Device	Predicate Device	Predicate Device	Predicate Device
Device/ Model	Faxitron VisionCTSpecimenRadiographySystem	VersaVisionSpecimenRadiographySystem	XPERT 40SpecimenRadiographySystem	BioVision Plus
Manufacturer	Faxitron BiopticsLLC	Faxitron BiopticsLLC	Kub TechnologiesInc	Faxitron BiopticsLLC
510(k) #	N/A	K170786	K071233	K153583
Detectors	Xineos-1515 (byTeledyne DALSA)	Faxitron DC105,DC0615, DC1215and DC1524	Not Specified	Faxitron DC1215
Film Capable	No	Yes	Yes	No
Digital Capable	Yes	Yes	Yes	Yes
CTReconstructionOption	Yes	No	No	No
Detector sizes	15x15 cm	10 x 15 cm,6 x15 cm,12 x 15 cm,15 x 24 cm	12 cm x 15 cm20 cm x 20 cm	12 cm x 15 cm
DetectorResolution(contact)	5 lp/mm	10 & 20 lp/mm	10, 15, & 20 lp/mm	20 lp/mm
MagnificationRange	1.2X to 4X	1X to 8X	5X	1X to 3X
X-ray Tube· Focal spot· WindowThickness	< 15 µm0.010" Beryllium	< 15 µm0.010" Beryllium	50 um0.005" Beryllium	< 15 µm0.010" Beryllium
X-ray TubeTarget Material	Tungsten	Tungsten	Not specified	Molybdenum
Tube VoltageRange	15-50 kV	15-50 KV	10-50 KV	20-50 kV
Tube Current	Up to 1.0 mA	Up to 1.0 mA	Up to 1.0 mA	Up to 1.0 mA
Time Range	0 to 900 seconds	0 to 300 seconds	Not specified	0 to 20 seconds
X-ray coverage	15 x 15 cm	Up to 15 x 24 cm	12 cm x 15 cm20 cm x 20 cm	12 x 15 cm
DICOMcompliant	Yes	Yes	Yes	Yes
Power Ratings	100 - 240 VAC,50/60 Hz, 200VA	100 - 240 VAC,50/60 Hz, 150VA	90-250 VAC, 50/60Hz, 500VA	100 - 240 VAC,50/60 Hz, 150VA
Dimensions (cm)	21 W x 17 D x 25 H	53 W x 61 D x 77 H	58 W x 58 D x 127 H	56 W x 57 D x 170 H
Weight (kg)	60	77	136	90

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Fundamentally, the Faxitron VisionCT is the same as the referenced predicate devices in that it is a cabinet X-Ray system with the X-tube and digital CMOS Detector. Like the predicate devices, the Faxitron VisionCT is a cabinet x-ray system that is used to provide digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Like the VersaVision, the VisionCT only provides digital x-ray images (no film images).

The major difference between the identified predicate devices and the proposed Faxitron VisionCT is that in addition to the digital 2D x-ray images, the VisionCT also provides digital 3D x-ray images. The referenced predicate devices image top down (vertically); whereas, the VisionCT images horizontally. See Figure 4 and Figure 5 below comparing the operating principle. The horizontal imaging allows for the specimen to be rotated so images can be captured in 360 degrees. These images are then reconstructed to a 3D CT image. The capability of providing digital 3D x-ray images is a progression in technology and not a new intended use.

The Faxitron VisionCT uses Detector XINEOS-1515 (by Teledyne DALSA), which is different compared to those used in predicate devices. However, a detector with the same technological characteristics has been used in the previously cleared DENTRIa Series device (K160140).

The commercial name of the software used in VisionCT is called Faxitron Bioptics Vision Software. This Vision Software is upgraded from the software used in the predicate device VersaVision Specimen Radiography System (K170786). The upgrades mainly relate to the changes made to GUI and to support the features of the VisionCT. Faxitron has thoroughly tested the Vision Software including the added capability for providing 3D X-ray images.

NONCLINICAL PERFORMANCE DATA TESTING AND REVIEW- as required by 807.92(b)(1)

The VisionCT complies with 21 CFR 1020.40 (Cabinet x-ray systems) and NEMA PS 3.1 - 3.20 (DICOM). The non-clinical performance testing data provided in this submission includes detector Xineos 1515 imaging performance data and sample clinical images to demonstrate the capability of the VisionCT to image various anatomical regions (breast tissue, femoral head, other tissues such as fallopian tube, prostate, nasal polyp, and heat valve).

The phantom images include those provided to compare the 2D images from the predicate device and 3D images from the subject device. In addition, a uniform phantom and phantom with embedded test objects with ranges of sizes and contrasts designed to characterize CT x-ray system contrast and

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detail imaging performance, are also provided. Also, Faxitron provided data obtained from the artifact analysis on these sample clinical and phantom images.

The Electrical Safety of the Faxitron VisionCT is demonstrated through successful testing conducted per IEC 61010-1, IEC 61010-2-091, and IEC 61010-2-101. The Electromagnetic Compatibility was demonstrated through compliance with standards IEC 61326-1 and IEC 61326-2-6.

CONCLUSIONS- as required 807.92(b)(3)

Faxitron Bioptics concludes that the documentation and testing included in this submission indicates that the Faxitron VisionCT is safe and effective and substantially equivalent to the cited predicate devices.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.