(124 days)
The VersaVision 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.
The Faxitron VersaVision 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 8X) from the <15 micron 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 15 x 24 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images up to 15 x 24 cm in size through the use an integrated detector and Faxitron Vision Specimen Radiography software.
The provided text is a 510(k) premarket notification for the Faxitron VersaVision device. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving that the device meets specific acceptance criteria in the context of clinical performance (e.g., diagnostic accuracy for an AI/CAD system).
Instead, the document details the technical specifications, intended use, and nonclinical performance data testing against regulatory standards for an X-ray system. It does not describe a study involving specific acceptance criteria for diagnostic performance, sample sizes for test sets, ground truth establishment, or human reader performance.
Therefore, many of the requested items cannot be extracted from this document as they are not applicable to the type of submission presented.
However, I can extract information related to the device's technical specifications and compliance with regulatory standards.
Here's the closest interpretation of your request based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't define "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, etc.) for a diagnostic study. Instead, it refers to compliance with performance standards for X-ray systems.
| Acceptance Criteria (Regulatory Standard Compliance) | Reported Device Performance |
|---|---|
| Compliance with 21 CFR 1020.40 (Cabinet X-ray Systems Performance Standards) | Designed and tested to comply. Testing and performance data included in submission. |
| Compliance with Laser performance standards 21 CFR 1040.10 and 21 CFR 1040.11 (if applicable) | Designed and tested to comply. Testing and performance data included in submission. |
| Compliance with European EMC Directive (Electromagnetic Compatibility) | Successfully tested to the European EMC Directive. |
| Compliance with Safety testing to IEC 61010 (Safety requirements for electrical equipment for measurement, control, and laboratory use) | Successfully tested to IEC 61010 third edition. |
| Focal Spot Size | < 15 microns (50 micron optional) |
| Magnification Capability | Up to 8X geometric magnification |
| X-ray Coverage | 30 x 30 cm, allows radiographic film sizes up to 15 x 24 cm |
| Digital Active Image Area | 15 x 24 cm (Options: 6x15 cm, 12x15 cm, 10x15 cm) |
| DICOM Compliance (for digital system) | DICOM 3.0 compliant software (Store, Print, Modality Worklist) |
2. Sample size used for the test set and the data provenance
This information is not provided because the document describes testing against regulatory performance standards for an X-ray system, not a clinical study involving a "test set" of patient data for diagnostic evaluation. The testing would involve engineering and physics measurements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of diagnostic accuracy, is not mentioned as this is a submission for an X-ray system's technical and safety performance, not a diagnostic algorithm.
4. Adjudication method for the test set
Not applicable for the same reasons as above.
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
Not applicable. The device is a specimen X-ray system, not an AI or CAD system designed to assist human readers, and no MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is an X-ray imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this type of device submission, the "ground truth" relates to physical measurements and technical specifications, not clinical diagnoses.
8. The sample size for the training set
Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established
Not applicable.
Summary of what the document does provide:
The document concerns the Faxitron VersaVision, a Cabinet X-ray system for imaging excised specimens. The "study" referenced is the nonclinical performance data testing and review to demonstrate compliance with established regulatory standards for X-ray systems. This includes:
- Compliance with 21 CFR 1020.40 (Cabinet X-ray Systems)
- Compliance with Laser performance standards 21 CFR 1040.10 and 21 CFR 1040.11 (if applicable, though not explicitly stated as applying beyond the X-ray system itself)
- Compliance with European EMC Directive
- Compliance with Safety testing to IEC 61010
The document concludes that based on this documentation and testing, the VersaVision is safe, effective, and substantially equivalent to its predicate devices.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2017
Faxitron Bioptics LLC % Mr. Douglas Wiegman VP Engineering 3440 East Britannia Drive, Suite 150 TUCSON AZ 85706
Re: K170786 Trade/Device Name: VersaVision Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MWP Dated: June 22, 2017 Received: June 23, 2017
Dear Mr. Wiegman:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K170786 |
|---|---|
| Device Name | VersaVision |
Indications for Use (Describe)
The VersaVision 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) | |||||
|---|---|---|---|---|---|
| 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. | |||||
| burden, to: | The burden time for this collection of information is estimated to average 79 hours per response,estimate or any other aspect of this information collection, including suggestions for reducing thisDepartment of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff(@fda.hhs.gov | including the time to review instructions, search existing data sources, gather and maintain the dataneeded and complete and review the collection of information. Send comments regarding this burden | |||
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number." | |||||
| FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services (301) 443 |
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Image /page/3/Picture/0 description: The image shows the word "faxitron" in a sans-serif font. The letters are a teal color, except for the "x", which is orange and has a pattern of small circles emanating from the top left corner. The word is written in all lowercase letters.
Premarket Notification 510 (k) Summary As required by 21 CFR 807.92
Device name - as required by 807 . 92 (a)(2):
Trade Name: VersaVision
| Common/Classification Name: | Specimen x-ray System/Cabinet X-ray System |
|---|---|
| ----------------------------- | -------------------------------------------- |
Classification Regulation: 21 CFR 892.1680
Device Class: Class II
Product Code (Precode): MWP
Radiologic Devices Panel
Company Name: Faxitron Bioptics, LLC
Company Address : 3440 East Britannia Drive ,Suite150 Tucson, Arizona 85706
Contact:
Panel:
VP Engineering
Preparation Date: July 13, 2017
LEGALLY MARKETED PREDICATE DEVICES -as required by 21 CFR 807.92(a)(3)
The Faxitron VersaVision Digital Specimen Radiography System is substantially equivalent to the following predicate devices:
-
A. Faxitron BioVision Plus Specimen Radiography System (K153583)
Douglas C. Wiegman , -
B. Bioptics BioVision Specimen Radiography System (K091558)
-
C. Faxitron PathVision Specimen Radiography System (K122428)
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DEVICE DESCRIPTION - as required by 21 CFR 807.92(a)(4)
The Faxitron VersaVision 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 8X) from the <15 micron 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 15 x 24 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images up to 15 x 24 cm in size through the use an integrated detector and Faxitron Vision Specimen Radiography software.
DEVICE CLAIMS - as required by 807.92(a)
The Faxitron VersaVision Specimen Radiography System is a fully shielded Cabinet X- ray System that has been designed to comply with 21 CFR 1020.40. The system allows up to 8 times geometric magnification of excised specimens with minimal geometric distortion through the use of a focal spot size that is less than 15 microns. The x-ray coverage of the device allows the use of radiographic film sizes up to 15 x 24 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 15 x 24 cm in size, 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) |
|---|
| Cabinet Specifications: |
| Energy Range: 15-50 kV Constant Potential |
| Tube Current: 1.0 mA max, iso-watt limited to 11.5 watts |
| Focal Spot Size: < 15 microns, 50 micron optional |
| X-ray beam divergence : 40 deg Min. |
| Optional divergence 23 deg. Min. |
| Target material: Tungsten |
| Beryllium Window Filtration: 0.010" |
| X-ray Coverage: 30 x 30 cm |
| Power: 100-240 VAC, ±10%, 50/60 Hz, 150 VA |
| Dimensions: |
| External: 21" W x 24" D x 30" H |
| Internal: 12" W x 12" D x 14" H |
| Weight: 170 lbs. |
| Digital System Specifications: |
| Active image Area: 15 x 24 cm |
| Options: 6 x 15 cm, 12 x 15 cm, 10 x 15 cm |
| Typical Spatial resolution: 10-20 lp/mm depending on detector |
| DICOM 3.0 compliant software includes Store, Print and Modality |
| Work list |
| Network ready workstation and monitor included |
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INTENDEDUSE = as required by 807.92(a)(5)
Indications for Use: The VersaVision is a Cabinet x-ray system that is used to provide film and/or digital x-rav 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.
LEVEL OF CONCERN - as required by recent FDA guidance
Faxitron has determined that the submitted device has a "moderate" software Level of Concern and has provided a documented record as part of this submission.
TECHNOLOGICAL CHARACTERISTICS SUMMARY- as required by 807.92(a)(6)
The VersaVision Specimen Radiography System has the same indications for use, general configuration, and principles of operation as the predicate devices listed above. The technological characteristics of the VersaVision Specimen Radiography System have been compared to the predicate devices sited and is covered in detail in the Substantial Equivalence section of this submission.
NONCLINICAL PERFORMANCE DATA TESTING AND REVIEW- as required by 807.92(b)(1)
The VersaVision Specimen Radiography System is a Cabinet X-rav System and has been designed and tested to comply with the performance standards set forth in 21 CFR 1020.40 Cabinet X-ray Systems and Laser performance standards 21 CFR1040.10 and 21 CFR 1040.11.Testing and performance data perfaining to these standards has been included as part of the submission. This device has also been successfully tested to the European EMC Directive and Safety testing to IEC 61010 third edition.
Substantial Equivalence Summary
The VersaVision Specimen Radiography System has the same indications for use as the predicate devices sited. The technical characteristics of the VersaVision are very similar to the predicate devices. The x-ray tube and detector technologies used in the Versal/ision are the same as that used in the predicate devices. One major difference that we believe allows the VersaVision Radiography System to perform better than the predicate devices sited is the size of the focal spot (<15 microns), greater size of the digital detector and the optimized cabinet geometry which allows greater x-ray coverage and higher geometric magnification of excised specimens with minimal geometric distortion.
CONCLUSIONS- as required 807.92(b)(3)
We conclude that the documentation and testing included in this submission indicates that the Versa Vision Specimen Radiography System is safe and effective and substantially equivalent to the predicate devices sited.
§ 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.