(47 days)
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No
The document 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 for imaging harvested specimens to verify correct tissue excision, not for treating a disease or condition.
Yes
The device provides rapid verification of excised tissue during biopsy procedures, which contributes to making a diagnosis, and potentially limits patient recalls.
No
The device description explicitly states it is a "Cabinet X-ray System" and details hardware components like a focal spot, cabinet geometry, and an integrated camera. It also mentions compliance with hardware performance standards (21 CFR 1020.40). While it includes software ("Faxitron Specimen Radiography software"), it is clearly part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide x-ray images of harvested specimens to verify that the correct tissue has been excised. This is a process performed outside of the living body, but it's focused on the physical structure of the tissue for surgical verification, not on analyzing biological samples for diagnostic information about a disease or condition.
- Device Description: The device is described as a "Cabinet X-ray System" for "specimen radiography." This aligns with imaging the physical specimen.
- Lack of IVD Characteristics: There is no mention of analyzing biological fluids, tissues, or other samples for the presence of specific analytes, markers, or characteristics related to a disease or condition. The focus is purely on generating an image of the excised tissue.
IVD devices are typically used to perform tests on samples taken from the body (like blood, urine, tissue biopsies) to diagnose, monitor, or screen for diseases or conditions. This device's purpose is to visually confirm the presence of the intended tissue after it has been removed from the body, which is a different function than an IVD.
N/A
Intended Use / Indications for Use
The PathVision 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 Faxitron PathVision Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens. The exceptionally high magnification capability (up to 6X) from the 0.02 mm focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 35 x 35 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images up to 23 x 29 cm in size through the use an integrated camera and Faxitron Specimen Radiography software.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
various anatomical regions
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The PathVision Specimen Radiography System is a Cabinet X-ray System and has been designed and tested to comply with the performance standards set forth in 21. CFR 1020.40 Cabinet X-ray Systems. Testing and performance data pertaining to this standard has been included as part of the submission. This device has also been successfully tested to the European EMC Directive and will undergo Safety testing to IEC 61010 prior to being placed on the market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
SEP
2 5
2012
Image /page/0/Picture/2 description: The image shows the word "faxitron" in a bold, sans-serif font. The "x" in the word has a design element that looks like a burst of pixels or a stylized representation of data transmission. The overall appearance of the word is modern and technological.
Premarket Notification 510 (k) Summary As required by 21 CFR 807.92
Device name - as required by 807.92(a)(2):
| Trade Name:. | PathVision Specimen Radiography System |
|---|---|
| -------------- | ---------------------------------------- |
Common/Classification Name: Specimen x-ray System/Cabinet X-ray System
Classification Regulation: 21 CFR 892.1680
Device Class: Class II
Product Code (Procode): MWP
Panel: Radiologic Devices Panel
Company Name: Faxitron Bioptics. LLC
Company Address: 3440 East Britannia Drive, Suite 150 Tucson, Arizona 85706
Contact: Douglas C. Wiegman, VP Engineering
August 5, 2012 Preparation Date:
LEGALLY MARKETED PREDICATE DEVICES - as required by 21 CFR 807:92(a)(3)
The Faxitron PathVision Digital Specimen Radiography System is substantially equivalent to the following to the following predicate devices:
- A. Hologic Trident Specimen Radiography System (K111508)
- B. Faxitron Specimen Radiography System Model MX20 (K072557)
- C. Bioptics BioVision Digital Specimen Radiography System (K091558)
Faxitron Bioptics LLC' PathVision 510(k) Submission Page 7 of 31
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DEVICE DESCRIPTION - as reguired by 21 CFR 807.92(a)(4)
The Faxitron PathVision Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens. The exceptionally high magnification capability (up to 6X) from the 0.02 mm focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 35 x 35 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images up to 23 x 29 cm in size through the use an integrated camera and Faxitron Specimen Radiography software.
DEVICE CLAIMS - as required by 807 92(a)
The Faxitron PathVision Specimen Radiography System is a fully shielded Cabinet Xray System that has been designed to comply with 21 CFR 1020.40. The system allows up to 6 times geometric magnification of excised specimens with minimal geometric distortion through the use of a focal spot size that is less than 20 microns. The x-rav coverage of the device allows the use of radiographic film sizes up to 35 x 35 cm. The device can also be configured to provide high resolution, DICOM compliant, digital images through the use an integrated digital camera that is up to 23 x 29 cm in size, and Faxitron 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) Cabinet Specifications:
- · Energy Range: 10-100 kV Constant Potential
- Tube Current: 0.3 mA from 10 kV to 40 kV, iso-watt limited to 12 o watts from 40 to 100 KV
- o Focal Spot Size: