PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM

K052433 · Bioptics, Inc. · MWP · Oct 18, 2005 · Radiology

Device Facts

• Record ID: K052433
• Device Name: PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
• Applicant: Bioptics, Inc.
• Product Code: MWP · Radiology
• Decision Date: Oct 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The piXarray 100 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 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 Story

Standalone cabinet digital X-ray imaging system; provides rapid verification of excised tissue during biopsy. Input: X-ray exposure of biopsy specimens. Operation: One-button operation with automatic exposure control; Biopix software manages image acquisition, calibration, display, analysis, archiving, and transmittal. Output: High-resolution digital X-ray images. Used in surgical suites or procedure rooms by medical professionals. Output viewed via DICOM interface by radiology/pathology staff to confirm correct tissue excision; enables faster procedure completion and reduces patient recall rates.

Clinical Evidence

No clinical data. Bench testing only. Compliance with 21 CFR 1020.40 for cabinet X-ray systems verified; radiation exposure confirmed not to exceed 0.5 mR/hr at 5 cm from surface. Software verification and validation testing performed.

Technological Characteristics

Cabinet X-ray system; 5-45 kV energy range; 0.5 mA tube current; 0.2 mm Beryllium window filtration. Compact, portable design for A/C outlet use. Digital imaging with 18cm x 24cm cassette slot for film archival. DICOM 3.0 compliant. Software-controlled with automatic exposure control.

Indications for Use

Indicated for use in patients undergoing excisional or percutaneous biopsy to provide rapid verification that the correct tissue has been excised. 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

• Mammopath cabinet X-ray system (K021113)

Submission Summary (Full Text)

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K052433

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

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

| Trade Name: | piXarray 100 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:<br>Company Name: | Bioptics, Inc. |
| Company Address: | 3496 S. Dodge Blvd, Ste 110<br>Tucson, AZ 85629-5477 |
| Contact: | Jeffrey Orach, V.P. Manufacturing and Regulatory<br>Affairs |
| Preparation Date: | September 2, 2005 |

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

The piXarray 100 Digital Specimen Radiography (DSR) System is substantially equivalent to the Mammopath™ |trade mark of Fischer Imaging Corporation, Denver, Colorado] cabinet X-ray system. K021113.

#### DEVICE DESCRIPTION - as required by 807.92(a)(4) 13.

The piXarray 100 Digital Specimen Radiography (DSR) System is a standalone cabinet digital X-rav imaging system 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

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examination. Specimen radiography can potentially limit the number of patient recalls.

The piXarray 100 Digital Specimen Radiography (DSR) System employs the use of Biopix image acquisition software. The Biopix software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal. Biopix software is the central part of this system. Biopix software is Digital Imaging and Communications in Medicine (DICOM) 3.0 compliant and comes with DICOM Print, Store and Modality Work List (MWL).

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

The piXarray 100 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 piXarray 100 DSR System offers one-button operation utilizing automatic exposure control for optimal X-ray exposure. High resolution digital imaging with large area formats is available. Standard 18cm x 24cm cassette slot is available for film archival.

The Biopix 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 piXarray 100 Digital Specimen Radiography (DSR) System is of compact and portable design plugs into any A/C outlet and requires no external X-ray shiclding. The piXarray 100 DSR System offers onc-button operation utilizing automatic exposure control for optimal X-ray exposure. High-resolution digital imaging in large area formats is available.

Available imaging formats are: 50 mm x 50 mm 50 mm x 100 mm 100 mm x 100 mm Larger area formats are under development and can be made available upon request.

Standard 18cm x 24cm cassette slot for film archival is available.

The Biopix software handles the digital X-rav image acquisition, calibration. image display, image analysis and manipulation, patient database, image archiving, and transmittal. Biopix software is the central part of this system. Biopix software is Digital Imaging and Communications in Medicine (DIC OM) 3.0 compliant and comes with DICOM Print. Store and Modality Work List

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- A device intended to provide rapid verification, through x-ray examination, . that the correct tissue has been excised during excisional or 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 F.

The piXarray 100 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.

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

Bioptics 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 H. 807.92(a)(6)

The piXarray 100 Digital Specimen Radiography (DSR) System has the same indications for use as the Mammopath cabinet X-ray system, K021113. The piXarray 100 Digital Specimen Radiography (DSR) System has the same technological characteristics as the Mammopath cabinet X-ray system. Section III Substantial Equivalence of this submission provides a detailed COMPARISON MATRIX of the piXarray 100 Digital Specimen Radiography (DSR) System to the predicate Mammopath cabinet X-ray system.

The submitter claims that the piXarray 100 Digital Specimen Radiography (DSR) System is substantially equivalent to the predicate device. the Mammopath cabinet X-ray system.

The technological characteristics of the piXarray 100 Digital Specimen Radiography (DSR) System are very similar to those of the Mammopath cabinet X-rav system. The differences include:

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

| Characteristic | Mammopath System | piXarray DSR System |
|--------------------------------------|--------------------------|--------------------------|
| Energy Range | 10-35 kV | 5-45 kV |
| Tube Current | 0.1 mA | 0.5 mA |
| X-ray Coverage | 14.6 cm | 19.0 cm |
| Window Filtration | 0.8 mm Beryllium | 0.2 mm Beryllium |
| Footprint<br>(Overall<br>Dimensions) | 36cm w x 34cm d x 39cm h | 38cm w x 41cm d x 66cm h |

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 Mammopath cabinet X-ray system. The majority of differences are either not significant or relate to evolutionary changes in technology that has occurred since the release of the Mammopath cabinet X-ray system.

## NON-CLINICAL PERFORMANCE DATA TESTING AND REVIEW - as I. 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 piXarray 100 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 piXarray 100 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

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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, I ne such 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 veftware 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.

To the submitter's knowledge. the predicate device, Mammopath cabinet X-ray 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 Mammopath cabinet X-ray system. The piXarray 100 Digital Specimen Radiography (DSR) System has the same technological characteristics as the Mammopath cabinet X-ray 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

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piXarray 100 Digital Specimen Radiography (DSR) System performs as well as the predicate, the Mammopath cabinet X-ray system.

### CONCLUSIONS K.

The performance testing and validation studies document that the piXarray 100 The performance testing and vandation station as substantially equivalent to the Mammopath cabinet X-ray system.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 8 2005

Mr. Jeffrey Orach Vice President Manufacturing & Regulatory Affairs Bioptics, Inc. 3496 S. Dodge Blvd., Suite 110 TUCSON AZ 85713

Re: K052433

Trade/Device Name: piXarray 100 Digital Specimen Radiography (DSR) System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MWP Dated: September 2, 2005 Received: September 6, 2005

Dear Mr. Orach:

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 (Premarket Approval), it may be subject to such 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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgin nameting your antial equivalence of your device to a legally premarket notheation: The PDA midning of vacion for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spective advice for your device of earling of the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Also, please note the regulation entitled, "Thiseration on your responsibilities under the Art from the 197 807.97). You may obtain other gelerar mornational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon 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): ____________________________________________________________________________________________________________________________________________________

Device Name: piXarray 100 Digital Specimen Radiography (DSR) System

Indications for Use:

The piXarray 100 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 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Preseription Use

(Per 21 CFR 801.109)

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Over-The-Counter Use

Darryl Beaudoin

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