The BioVision Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has been excised during excisional or percutaneous biopsy.

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 Description

The BioVision Digital Specimen Radiography (DSR) System is a stand-alone cabinet digital X-ray imaging system to provide rapid verification that the correct tissue has been excised during percutaneous biopsy.

The BioVision Digital Specimen Radiography (DSR) System employs the use of Bioptics Vision image acquisition software. The Bioptics Vision software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal. Bioptics Vision software is the central part of this system. Bioptics Vision software is Digital Imaging and Communications in Medicine (DICOM) 3.0 compliant and comes with DICOM Print, Store and Modality Work List (MWL).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the BioVision Digital Specimen Radiography (DSR) System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details the design specifications and testing performed to demonstrate substantial equivalence to a predicate device, rather than explicit acceptance criteria and performance against those criteria in a tabular format typical for AI/CADe devices. However, we can infer the acceptance criteria and reported performance from the provided specifications and claims. The primary acceptance criterion is substantial equivalence to the predicate device, the piXarray 100 Digital Specimen Radiography (DSR) System, focusing on technological characteristics and safety.

Acceptance Criterion (Implied)	Reported Device Performance (BioVision DSR System)
Safety:
Conformance to 21 CFR 1020.40 (Cabinet X-ray systems)	Conforms to 21 CFR 1020.40.
Radiation emission not exceeding 0.5 milliroentgen in one hour at 5cm outside external surface	Radiation emitted does not exceed 0.5 milliroentgen in one hour at 5cm outside the external surface.
Robust quality system for design and manufacturing	Developed in a device design and manufacturing environment with a robust quality system, including detailed design inputs/outputs, V&V, risk assessment/management for software.
Functionality/Performance (against predicate):
Same Indications for Use	Same Indications for Use as the piXarray 100 DSR system.
Similar Technological Characteristics	Similar technological characteristics as the piXarray 100 DSR system (e.g., X-ray technology, power source, digital imaging, computer interface, hardware, OS). Differences identified (X-ray coverage, imaging area, energy range, resolution, footprint) are deemed not significant or evolutionary.
Software functionality, safety features, user interface, operation, and documentation accurately portray intended use	Developed, designed, tested, and validated to perform in this manner. Software controls subjected to significant verification and validation testing, including alpha validation of all functionality and hazard addressing.
Performs as well as the predicate device	Performance testing and validation studies substantiate that the BioVision DSR System performs as well as the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a test set in the context of clinical data, as the device is not an AI/CADe device that performs automated analysis on patient images. The testing conducted was primarily related to hardware and software validation, and safety compliance.

Sample Size for Test Set: Not applicable in the context of clinical image analysis. The "test set" for hardware and software validation is not quantified in terms of number of cases or images.
Data Provenance: Not applicable for clinical data. The validation activities mentioned are internal and related to device design and function. The document mentions "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," which suggests some limited, prospective, real-world deployment for further internal evaluation, but not as a formal clinical test set for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided as the submission does not detail a study involving expert-established ground truth on a clinical test set. The device is a digital X-ray imaging system, not an AI/CADe algorithm making diagnostic assessments.

4. Adjudication Method for the Test Set

This information is not provided as there is no mention of a formal clinical test set requiring adjudication in the context of image interpretation or diagnostic accuracy.

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

There was no MRMC comparative effectiveness study performed. Since this device is a digital specimen radiography system and not an AI/CADe or diagnostic aid intended to assist human readers, such a study is not relevant to its regulatory submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

A "standalone" performance study in the context of an algorithm's diagnostic accuracy was not performed. This device is a digital X-ray imaging system that produces images for human interpretation, not an algorithm that outputs a diagnostic result independently. The software in question (Bioptics Vision) handles image acquisition, display, analysis, and manipulation, not independent diagnostic assessment.

7. The Type of Ground Truth Used

The concept of "ground truth" as it applies to clinical diagnostic accuracy (e.g., pathology, outcomes data) is not relevant for this submission. The ground truth for the device's performance relates to its ability to accurately acquire and display X-ray images, adhere to safety standards (e.g., radiation leakage), and perform its stated functions in line with design specifications. The acceptance of the device's functionality is based on its ability to produce images that allow medical professionals to "rapidly verify that the correct tissue has been excised."

8. The Sample Size for the Training Set

This information is not applicable. The BioVision Digital Specimen Radiography (DSR) System is a hardware device with controlling software, not an AI/ML algorithm that is "trained" on a dataset. The software performs image acquisition and processing based on deterministic algorithms, not learned patterns from a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons stated in point 8.

Summary

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Ko91558

JUL 1 7 2009

PREMARKET NOTIFICATION 510(k) SUMMARY As required by §807.92

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

Trade Name:	BioVision Digital Specimen Radiography (DSR) 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
Premarket Notification submitter:Company Name:	Bioptics, Inc.
Company Address:	3440 E. Britannia Dr. Suite 150Tucson Az, 85706
Contact:	Carlos Reyes, Quality Engineer
Preparation Date:	May 2009

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

The BioVision Digital Specimen Radiography (DSR) System is substantially equivalent to the piXarray 100 Digital Specimen Radiography System, manufactured by Bioptics, Inc. as a cabinet X-ray system, K052433.

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

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

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

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

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

The Core Vision Digital Specimen Radiography (DSR) System is of compact and portable design, plugs into any A/C outlet, and requires no external X-ray shielding. The BioVision DSR System offers one-button operation utilizing automatic exposure control for optimal X-ray exposure.

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

Below is a specifications chart of the Predicate Device with the Core Vision DSR System.

Automatic kV Option Automatic Exposure Time Option Manual Exposure Time Selection Geometric Maqnification 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

Specifications

Included Included Included Included Included 5-45 KV 1.0 mA 11.2 cm Not required 26 X 75 mm 14 lp/mm 50 um nominal Included Included 0.2 mm Beryllium

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

Bioptics defines intended use as the objective intent of the manufacturer or person(s) legally responsible for the labeling of devices and includes labeling claims, advertising matter, and approved oral or written statements by such firms or their representatives. As such, Bioptics intends its advertising matter, specifications, user manual and other written or authorized oral statements to identify the objective intent of the Bioptics.

Bioptics intends that the submitted device's intended uses include, but are not limited to, the following:

Uses typical of those for "cabinet x-ray" or "specimen x-ray" devices. .
A device intended to generate and control x-rays for examination of various . anatomical regions.
A device intended to provide rapid verification, through x-ray examination, that the . correct tissue has been excised during percutaneous biopsy.
A device intended to create an x-ray image of biopsy material, including in the biopsy . procedure room or wherever medical professionals deem appropriate, to enable the rapid x-ray examination of the biopsy specimen and the rapid verification that the correct specimen was excised.

INDICATIONS FOR USE r.

The BioVision Digital Specimen Radiography (DSR) System is a cabinet digital Xray imaging system intended to generate and control X-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has been excised during percutaneous biopsy.

LEVEL OF CONCERN - as requested by recent FDA guidance G.

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

TECHNOLOGICAL CHARACTERISTICS SUMMARY - as required by 807.92(a)(6) H.

The BioVision Digital Specimen Radiography (DSR) System has the same indications for use as the piXarray 100 Digital Specimen Radiography (DSR) System, K052433. The Core Vision Digital Specimen Radiography (DSR) System has the same technological characteristics as the piXarray 100 Digital Specimen Radiography (DSR) System. Section III Substantial Equivalence of this submission provides a detailed COMPARISON MATRIX of the predicate piXarray 100 Digital Specimen Radiography (DSR) System to the Core Vision Digital Specimen Radiography (DSR) System.

The submitter claims that the BioVision Digital Specimen Radiography (DSR) System is substantially equivalent to the predicate device, the piXarray 100 Digital Specimen Radiography (DSR) System.

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The technological characteristics of the piXarray 100 Digital Specimen Radiography (DSR) System are very similar to those of the Core Vision Digital Specimen Radiography (DSR) System. The differences include:

TABLE OF DIFFERENCES BETWEEN THE piXarray 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM AND THE CORE VISION CABINET X-RAY SYSTEM

Characteristic	piXarray 100 DSR	BioVision
X-ray coverage	11.2 cm	19.0 cm
Imaging area (mm)	26 X 75	75 x 50, 100 x 150,120 x 180,180 x 240
Film or Digital Imaging	Digital Only	Yes
Energy Range	5-25 kV	5-45 kV
Resolution (contact mode)	14 lp/mm (35 microns)	10 lp/mm (50 microns)
Footprint(Overall Dimensions)	36cm w x 34cm d x 39cm h	53cm w x 38cm d x 170cm h
Used for excised andpercutaneous biopsy samples	Yes	Yes

The submitter concludes that the piXarray 100 Digital Specimen Radiography (DSR) System employs the same type of technological characteristics including X-ray technology, power source, digital imaging, computer interface for user functionality, computer hardware, operating system, and similar functionality to the BioVision Specimen Radiography System. The majority of differences are either not significant or relate to evolutionary changes in technology that has occurred since the release of the piXarray 100 Digital Specimen Radiography (DSR) System.

NON-CLINICAL PERFORMANCE DATA TESTING AND REVIEW - as required by I. 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 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 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. See Radiographic Control Certificate, Document # 1240 is included in this exhibit.

Additionally, the submitted device has been designed in a device design and manufacturing environment with a robust quality system.

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

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The submitter believes and claims that the submitted device was developed, designed, tested and validated to perform in a manner that accurately portrays 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. Refer to "Software Revision History", Document # 1239, included in Exhibit 9.

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. piXarray 100 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.

SUBSTANTIAL EQUIVALENCE SUMMARY J.

The piXarray 100 Digital Specimen Radiography (DSR) System has the same indications for use as the BioVision Digital Specimen Radiography (DSR) System. The BioVision Digital Specimen Radiography (DSR) System has the same technological characteristics as the piXarray 100 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 performance testing to further document equivalence. The results of this testing substantiates that the BioVision Digital Specimen Radiography (DSR) System performs as well as the predicate, the pixarray 100 Digital Specimen Radiography (DSR) System.

CONCLUSIONS K.

The performance testing and validation studies document that the BioVision Digital Specimen Radiography (DSR) System is substantially equivalent to the piXarray 100 Digital Specimen Radiography (DSR) System.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three branches of government. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

11 7 2009

Mr. Dung Nguyen Vice President Engineering Bioptics, Inc. 3440 East Britannia Drive. Suite 150 TUCSON AZ 85706

Re: K091558

Trade/Device Name: BioVision Digital Specimen Radiography (DSR) System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MWP Dated: May 13, 2009 Received: May 28, 2009

Dear Mr. Nguyen:

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.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/indr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Iadine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K091558

Device Name: BioVision Digital Specimen Radiography (DSR) System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Afel lemm

Page 1 of

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Regulation Number and Section

§ 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.