(203 days)
No
The summary describes a standard X-ray imaging system and software for specimen radiography, with no mention of AI or ML capabilities for image analysis, processing, or interpretation.
No
This device is an imaging system designed to verify tissue excision during biopsy procedures, not to treat a disease or condition.
Yes.
The device is used to provide rapid verification that the correct tissue has been excised during a biopsy, which is a diagnostic purpose to ensure the procedure's success and potentially limit patient recalls.
No
The device is described as a "Cabinet x-ray system" and a "fully shielded Cabinet X- ray System," explicitly mentioning hardware components like an integrated detector and the system's physical design. While it includes software ("Faxitron Vision Specimen Radiography software"), it is not solely software.
Based on the provided information, the Faxitron VisionCT is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Faxitron VisionCT's Function: The Faxitron VisionCT is a cabinet x-ray system used to create images of harvested specimens (tissue removed from the body). Its purpose is to provide rapid verification that the correct tissue has been excised during a biopsy procedure.
- Focus on Imaging: The device's primary function is to generate images of the specimen. While this information is used to inform a clinical decision (whether the correct tissue was removed), the device itself is not performing a diagnostic test on the specimen's biological properties or composition. It's essentially an imaging tool for excised tissue.
The description clearly states it's a "Cabinet x-ray system" for imaging "harvested specimens." This aligns with the definition of a medical imaging device used in a surgical or pathology setting, rather than an IVD device that analyzes the specimen's biological characteristics.
N/A
Intended Use / Indications for Use
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.
Product codes
MWP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
various anatomical regions (breast tissue, femoral head, other tissues such as fallopian tube, prostate, nasal polyp, and heat valve)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical performance testing data 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 detail imaging performance, are also provided. Also, Faxitron provided data obtained from the artifact analysis on these sample clinical and phantom images.
Electrical Safety was demonstrated through successful testing per IEC 61010-1, IEC 61010-2-091, and IEC 61010-2-101. Electromagnetic Compatibility was demonstrated through compliance with standards IEC 61326-1 and IEC 61326-2-6.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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)
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.
| 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)
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.
DEVICE TECHNICAL SPECIFICATIONS - as required by 807.92(a)(4)
| Focal spot size |