(121 days)
Not Found
No
The summary describes a standard X-ray system for specimen imaging and does not mention any AI or ML capabilities in its description, intended use, or performance studies.
No
The device is used to image excised specimens for verification, not to treat a condition or disease in a living patient.
Yes
The device is used to provide rapid verification of excised tissue during biopsy procedures, which is a diagnostic function.
No
The device description explicitly states it is a "fully shielded Cabinet X-ray System" and includes hardware components like an integrated digital X-Ray detector. While it uses software ("Faxitron Vision software"), it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- PathVisionXL Function: The PathVisionXL is a cabinet x-ray system used to create images of harvested specimens (tissue that has already been removed from the body). Its purpose is to provide rapid verification that the correct tissue has been excised during a biopsy procedure. It is essentially an imaging tool for ex vivo (outside the living body) specimens.
- No Diagnostic Testing on Samples: The device does not perform any chemical, biological, or immunological tests on the specimen itself to diagnose a condition. It simply provides an image of the physical specimen.
While the information provided by the PathVisionXL is used in the context of a diagnostic procedure (biopsy), the device itself is an imaging system for specimens, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The PathVisionXL is a Cabinet x-ray system that is used to provide film and/or 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 PathVisionXL 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. The larger (XL) cabinet allows up to 10.0 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 PathVisionXL provides enhanced image performance. It is designed to acquire a large high resolution digital images up to 43 x 43 cm in size, through the use an integrated digital X-Ray detector and Faxitron Vision 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The PathVisionXL complies with 21 CFR 1020.40 (Cabinet x-ray systems) and following safety, EMC and performance standards:
- IEC 61010-1:2010 (Third edition), Safety requirements for electrical . equipment for measurement, control, and laboratory use - Part 1: General requirements
- IEC 61010-2-091:2012, Safety requirements for electrical equipment for . measurement, control, and laboratory use. Part 2-091: Particular requirements for cabinet X-ray systems
- IEC 61010-2-101:2015, Safety requirements for electrical equipment for . measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
- IEC 61326-1:2012, Electrical equipment for measurement, control and . laboratory use - EMC requirements Part 1: General requirements
- IEC 61326-2-6:2012, Electrical equipment for measurement, control and . laboratory use - EMC requirements Part 1: General requirements
- NEMA PS 3.1 3.20 (2016), Digital Imaging And Communications In . Medicine Set
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
March 14, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Faxitron Bioptics, LLC % Ciaran Purdy VP of Development 3440 E. Britannia Dr., Suite 150 TUCSON AZ 85706
Re: K183142
Trade/Device Name: PathVisionXL Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MWP Dated: February 15, 2019 Received: February 19, 2019
Dear Ciaran Purdy:
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 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
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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
Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name PathVisionXL
Indications for Use (Describe)
The PathVisionXL is a Cabinet x-ray system that is used to provide film and/or 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the word "faxitron" in a stylized font. The letters are a teal color, except for the "x", which is orange and has a dotted pattern that fades out towards the right. The font is bold and sans-serif.
Premarket Notification 510(k) Summary K183142
(As required by 21 CFR 807.92)
| Device name - as required by 807.92(a)(2): | |
|---|---|
| Trade Name: | PathVisionXL |
| Common/ Classification Name: | Specimen X-ray System/ Cabinet X-Ray |
| System Classification Regulation: | 21 CFR 892.1680 |
| Device Class: | Class II |
| Product Code: | MWP |
| Panel: | Radiologic Devices Panel |
| Company Name: | |
| [as required by 807.92(a)(1)] | Faxitron Bioptics, LLC |
| Company Address: | 3440 East Britannia Drive, |
| Suite 150 | |
| Tucson, Arizona 85706 | |
| Contact: | Ciaran Purdy, |
| VP of Development | |
| Preparation Date: | October 3, 2018 |
LEGALLY MARKETED PREDICATE DEVICES - as required by 21 CFR 807.92(a)(3)
The Faxitron PathVisionXL is substantially equivalent to following predicate device:
- Faxitron PathVision Specimen Radiography System (K122428) A.
4
DEVICE DESCRIPTION - as required by 21 CFR 807.92(a)(4)
The PathVisionXL 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. The larger (XL) cabinet allows up to 10.0 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 PathVisionXL provides enhanced image performance. It is designed to acquire a large high resolution digital images up to 43 x 43 cm in size, through the use an integrated digital X-Ray detector and Faxitron Vision 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 |