BioVision Plus

K153583 · Faxitron Bioptics, LLC · MWP · Apr 1, 2016 · Radiology

Device Facts

• Record ID: K153583
• Device Name: BioVision Plus
• Applicant: Faxitron Bioptics, LLC
• Product Code: MWP · Radiology
• Decision Date: Apr 1, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The BioVision (Plus/ +) Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of harvested specimens from various anatomical regions, and to provide rapid verification that the correct tissue has been excised. Performing the verification directly in the same biopsy procedure room 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. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite.

Device Story

The BioVision (Plus/+) is a standalone cabinet digital X-ray imaging system for rapid verification of excised tissue specimens. It uses a 50kV microfocus X-ray tube to generate images of harvested tissue. The system features automatic exposure control and one-button operation. Images are processed by Faxitron Bioptics Vision software, which handles acquisition, calibration, display, analysis, and archiving. The system is operated by medical professionals in surgical suites or adjacent rooms. Output is transmitted via DICOM to Radiology and Pathology departments. By enabling immediate verification of excised tissue in the procedure room, the device reduces patient time under examination and potentially limits patient recalls. The device is a higher-resolution version of the predicate, utilizing a smaller focal spot and improved detector technology to enhance image sharpness.

Clinical Evidence

Bench testing only. No clinical data provided. Performance validation included spatial resolution tests (line pair gauge, ACR phantom), contrast resolution tests (Small Field Low Contrast Phantom), and electrical/radiation safety testing (21 CFR 1020.40, UL 61010-1).

Technological Characteristics

Cabinet X-ray system; 50kV microfocus tube; 0.2mm Beryllium window filtration; 21 lp/mm resolution; 24cm x 30cm imaging area; 1.0 mA max, 12W isopower. Software: Faxitron Bioptics Vision (DICOM 3.0 compliant). Connectivity: DICOM Print, Store, and Modality Work List. Power: A/C outlet. Sterilization: N/A (cabinet system).

Indications for Use

Indicated for examination of harvested specimens from various anatomical regions to verify correct tissue excision. Intended for use by medical professionals in surgical suites or adjacent rooms.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• BioVision Digital Specimen Radiography System (K091558)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping and connected by flowing lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 1, 2016

Faxitron Bioptics LLC % Mr. Carlos Reyes Quality Consultant 3440 E. Britannia Drive, Suite 150 TUCSON AZ 85743

Re: K153583

Trade/Device Name: Biovision (Plus/+) Digital Specimen Radiography (DSR) System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MWP Dated: March 7, 2016 Received: March 8, 2016

Dear Mr. Reyes:

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 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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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'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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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K153583

### Device Name

BioVision (Plus/ +) Digital Specimen Radiography (DSR) System

### Indications for Use (Describe)

The BioVision (Plus/ +)Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of harvested specimens from various anatomical regions, and to provide rapid verification that the correct tissue has been excised.

Performing the verification directly in the same biopsy procedure room 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. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite.

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.*

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."

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Image /page/3/Picture/0 description: The image shows the logo for BioVision+. The word "BioVision" is written in a teal sans-serif font, with the "V" slightly larger than the other letters. Above and to the right of the word is an orange graphic that resembles a comet, with a trail of orange circles. A teal plus sign is located to the right of the word "BioVision".

# EXHIBIT 1

510(k) SUMMARY

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## PREMARKET NOTIFICATION 510(k) SUMMARY As required by CFR 807.92

# Device Name - as required by 807.92(a)(2):

| Trade Name: | BioVision(Plus/+) Digital<br>Specimen Radiography<br>(DSR) System |
|----------------------------------------------------|-----------------------------------------------------------------------|
| Common/Classification Name: | Stationary x-ray system |
| Classification Regulation: | 21 CFR 892.1680 |
| Device Class: | Class II |
| Product Code (Procode): | MWP |
| Panel: | Radiologic Devices Panel |
| Premarket Notification submitter:<br>Company Name: | Faxitron Bioptics LLC |
| Company Address: | 3440 E. Britannia Dr. Suite 150<br>Tucson Az, 85706<br>[phone] |
| Contact: | Paul Hess, Carlos Reyes |
| Preparation Date: | November 2015 |

#### A. LEGALLY MARKETED PREDICATE DEVICE - as required by 807.92(a)(3)

The BioVision(Plus) Digital Specimen Radiography (DSR) System is substantially equivalent to the BioVision Digital Specimen Radiography System, manufactured by Faxitron Bioptics LLC. as a cabinet X-ray system, K091558.

#### B. DEVICE DESCRIPTION - as required by 807.92(a)(4)

The BioVision(Plus) Digital Specimen Radiography (DSR) System is a standalone cabinet digital X-ray imaging system designed to provide rapid verification that the correct tissue has been excised.

Performing the verification directly in the same procedure room 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 BioVision(Plus) Digital Specimen Radiography (DSR) System employs the use of Faxitron Bioptics Vision image acquisition software. The Vision software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal.

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Faxitron Bioptics Vision software is the central part of this system. The Vision software is Digital Imaging and Communications in Medicine (DICOM) 3.0 compliant and comes with DICOM Print, Store and Modality Work List (MWL).

#### C. DEVICE CLAIMS - as required by 807.92(a)(4)

The BioVision(Plus) Digital Specimen Radiography (DSR) System is of compact and portable design that plugs into any A/C outlet and requires no external X-ray shielding. The system offers one-button operation utilizing automatic exposure control for optimal X-ray exposure. This device offers high resolution digital X-ray imaging with small area formats.

The Vision software transfers images to Radiology and Pathology within seconds though DICOM interface.

#### D. PRODUCT AND TECHNICAL SPECIFICATIONS - as required by 807.92(a)(4)

The Faxitron Bioptics Vision software is the central part of this system and handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving and transmittal. The software is Digital Imaging and Communications in Medicine (DICOM) 3.0 compliant and comes with DICOM Print. Store and Modality Work List (MWL). The Vision software transfers images to Radiology and Pathology within seconds though the DICOM interface.

# Specifications

Automatic kV Option Automatic Exposure Time Option Manual Exposure Time Selection Geometric Magnification One-Button Calibration Energy Range Tube Current X-ray Coverage External X-ray shielding Imaging Area (mm) Resolution (contact mode) Focal Spot DICOM Interface (store, print, work list) Manual kV Selection Window Filtration

Included Included Included Included Included 5-50 KV 1.0 mA max, 12W isopower 28.4 cm Not required Up to 24cm X 30cm 21 lp/mm 10 um nominal Included Included 0.2 mm Beryllium

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#### E. INDICATED USE - as required by 807.92(a)(5)

The BioVision (Plus/ +) Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of harvested specimens from various anatomical regions, and to provide rapid verification that the correct tissue has been excised.

Performing the verification directly in the same biopsy procedure room 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. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adiacent to a surgical suite.

#### F. LEVEL OF CONCERN - as requested by recent FDA guidance

Faxitron Bioptics LLC has determined that the submitted device has a "moderate" software Level of Concern and has provided that documented record as part of this submission.

#### G. TECHNOLOGICAL CHARACTERISTICS SUMMARY – as required by 807.92(a)(6)

The BioVision(Plus) Digital Specimen Radiography (DSR) System has the same indications for use as the BioVision Digital Specimen Radiography (DSR) System, K091558. The BioVision (Plus) Digital Specimen Radiography (DSR) System has the same technological characteristics as the BioVision Digital Specimen Radiography (DSR) System. Section III Substantial Equivalence of this submission provides a detailed COMPARISON MATRIX of the predicate BioVision Digital Specimen Radiography (DSR) System to the BioVision (Plus) Specimen Radiography (DSR) System.

The submitter claims that the BioVision(Plus) Digital Specimen Radiography (DSR) System is substantially equivalent to the predicate device, the BioVision Digital Specimen Radiography (DSR) System.

The technological characteristics of the BioVision (Plus) Digital Specimen Radiography (DSR) System are very similar to those of the BioVision Digital Specimen Radiography (DSR) System. The differences include:

| Characteristic | BioVision(Plus) | BioVision (Predicate device) |
|---------------------------------------------|---------------------------|----------------------------------------------|
| X-ray coverage | 28.4 cm | 19.0 cm |
| Typical Imaging area (mm) | Up to 240mm x 300mm | 75 x 50, 100 x 150,120 x 180,<br>180 x 240mm |
| Film or Digital Imaging | Yes | Yes |
| Energy Range | 5-50 kV | 5-45 kV |
| Resolution (contact mode) | 21 lp/mm (24.1 microns) | 10 lp/mm (48.2 microns) |
| Footprint<br>(Overall Dimensions) | 53cm w x 38cm d x 170cm h | 53cm w x 38cm d x 170cm h |
| Used for excised and<br>harvested specimens | Yes | Yes |

## TABLE OF DIFFERENCES BETWEEN THE BIOVISION (PLUS) AND THE BIOVISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEMS

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Externally the BioVision and BioVision+ are virtually identical. The only physical difference is the branding label has the "+" and the rear identification label has the product name change.

| Item | BioVision (Plus) | BioVision |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| X-Ray Source | 50kV Microfocus Tube | 45kV Tube |
| X- Ray Power<br>Supply | 50kV Microfocus high voltage<br>supply | 45kV high voltage supply |
| X-Ray Detector | 21 line pair Faxitron X-Ray<br>Camera (Sensor Modules 343)<br>With Fiberoptic Faceplate and<br>Columnar CsI:Tl Phosphor Plate | 10 line pair Faxitron X-Ray<br>Camera (Sensor Modules 242)<br>With Fiberoptic Faceplate and<br>Columnar CsI:Tl Phosphor Plate |
| Specimen<br>Magnification | Three chamber shelves for 1.5<br>2.0 and 3.0 times<br>magnification | Two chamber shelves for 1.5<br>and 2.0 times magnification |

Internally the physical component changes that affect the function are

In essence the BioVision(Plus) is a higher resolution version of its equivalent predicate device. It achieves this by using a smaller focal spot on the X-Rav tube (micro focus) to increase image sharpness and higher resolution X-Ray detector. From the users point of view it functions in the exact same way and physically looks identical. The only difference the user will hopefully notice is the improved image quality.

The submitter concludes that the BioVision(Plus) Digital Specimen Radiography (DSR) System employs the same type of technological characteristics including X-rav technology, power source, digital imaging, computer interface for user functionality, computer hardware, operating system, and similar functionality to the predicate BioVision Specimen Radiography System. The majority of differences are either not significant or relate to evolutionary changes in technology that have occurred since the release of the BioVision Digital Specimen Radiography (DSR) System.

#### H. NON-CLINICAL PERFORMANCE DATA TESTING AND REVIEW - as required by 807.92(b)(1)

As a cabinet or specimen X-ray device, the submitted device is required to comply with Part 1020, FDA's performance standards for ionizing radiation emitting products and specifically to 21 CFR 1020.40 Cabinet X-ray systems. The BioVision(Plus) Digital Specimen Radiography (DSR) System conforms to 21 CFR 1020.40. Evidence of the compliance is provided throughout this submission and is referenced in the appropriate exhibits.

The radiation emitted from the BioVision(Plus) Digital Specimen Radiography (DSR) System cabinet x-ray system does not exceed an exposure of 0.5 milliroentgen in one hour at any point five centimeters outside the external surface Additionally, the submitted device has been designed in a device design and manufacturing environment with an ISO 13485 and 9001 quality system.

Extremely controlled and detailed design inputs and outputs define all of Faxitron Bioptics LLC product development activities. Some of these activities include, but are not limited

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to, detailed design specifications, verification and validation activities, and revision history and revision documentation. An emphasis on controlled software activities include risk assessment and management, level of concern and configuration management. These activities are thoroughly documented and reviewed and approved by appropriate authorized authorities.

The submitter believes and claims that the submitted device was developed, designed. tested and validated to perform in a manner that accurately portravs the submitted systems intended use, functionality, safety features, user interface, operation, and documentation. The results of these activities were reviewed by appropriate management and that review resulted in the documented determination that the submitted device met its design plan, is safe and effective, and, subsequent to FDA review of this submission, is ready for commercial distribution as a medical device.

The submitted device's software controls were subjected to significant verification and validation testing. Verification testing was performed during software coding and results were recorded as "comments" in the software code. Alpha validation testing included testing of all functionality and confirmation that all identified hazards have been adequately addressed by software functionality, the user interface or documentation.

Alpha validation activities included specified system software and operating software performance and environmental testing within the specified environment. Additionally, a few devices, labeled "Research Use Only," are being placed to further document the submitter's performance claims and attempt to identify any unknown hazards. Any significant findings will be investigated and resolved appropriately. If a significant finding rises to an appropriate level, the submitter will take appropriate FDA notification action.

The predicate device, BioVision Digital Specimen Radiography (DSR) System did not provide or reference any clinical tests submitted in compliance with 807.92(b)(2), therefore the submitter believes such clinical testing is not appropriate or required by FDA and has not made or provided any summary of such testing.

#### I. SUBSTANTIAL EQUIVALENCE SUMMARY

The BioVision Digital Specimen Radiography (DSR) System has the same indications for use as the BioVision(Plus) Digital Specimen Radiography (DSR) System. The BioVision Digital Specimen Radiography (DSR) System has the same technological characteristics as the BioVision(Plus)Digital Specimen Radiography (DSR) System. However, while the submitter believes the characteristics are sufficiently precise to assure equivalence, the submitter has carried out validation and imaging performance test identical to that of predicate device to further document equivalence. This performance data includes

- Spatial resolution tests to ensure the image quality, with a line pair gauge and . America College Radiology phantom.
- Contrast resolution tests using a Small Field Low Contrast Phantom.
- Product safety tests meet and exceed the requirements of CDRH 21 CFR 1020.40 ● and UL 61010-1, 3rd Edition for Safety Requirements for Electrical Equipment for measurement, control and laboratory use, including particular requirements for cabinet X-Ray systems.

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The results of this testing substantiates that the BioVision(Plus) Digital Specimen Radiography (DSR) System performs as well as the predicate, the BioVision Digital Specimen Radiography (DSR) System.

#### CONCLUSIONS J.

The performance testing and validation studies document that the BioVision(Plus) Digital Specimen Radiography (DSR) System is substantially equivalent to the BioVision Digital Specimen Radiography (DSR) System.