Kubtec Mozart (Xpert42)

K183624 · Kub Technologies, Inc. · MWP · Jun 20, 2019 · Radiology

Device Facts

• Record ID: K183624
• Device Name: Kubtec Mozart (Xpert42)
• Applicant: Kub Technologies, Inc.
• Product Code: MWP · Radiology
• Decision Date: Jun 20, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Indications for Use

The MOZART(XPERT42) is a Cabinet x-ray system that is used to provide two dimensional and three dimensional tomographic 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.

Device Story

The Kubtec Mozart (Xpert42) is a cabinet X-ray system for specimen radiography. It captures 2D and 3D tomographic images of surgically excised tissue specimens. The device utilizes a 50 kVp monoblock X-ray tube and a stationary CMOS detector. A low-voltage screw-drive linear actuator moves the X-ray source to acquire multiple projection images in rapid succession. These projections are processed by proprietary software on an off-the-shelf PC to reconstruct 3D tomographic slices (1mm thickness). Used in clinical settings, the system is operated by healthcare professionals to verify that the correct tissue has been excised during biopsy. The output is displayed on a high-resolution monitor, allowing physicians to evaluate specimens layer-by-layer, identify lesion locations/extent, and visualize surgical margins in three axes. This facilitates lower re-excision rates by providing more anatomical information than 2D imaging alone.

Clinical Evidence

No clinical trial data provided. Substantial equivalence is supported by bench testing, including software verification and validation, and conformance to safety standards (IEC 61010-1, 21 CFR 1020.40).

Technological Characteristics

Cabinet X-ray system; 50 kVp monoblock X-ray tube; CMOS detector (11.4 x 14.6 cm active area); linear actuator for source motion; 1mm slice reconstruction; DICOM compliant; Windows 7 PC workstation; GPU-accelerated processing. Standards: IEC 61010-1, IEC PAS 61910-1, NEMA PS 3.1-3.20 (DICOM), ISO 15223-1, IEC 62304.

Indications for Use

Indicated for use in patients undergoing biopsy procedures to provide 2D and 3D tomographic digital X-ray images of harvested specimens from various anatomical regions for rapid verification of excised tissue.

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

• Kubtec XPERT 40 (K071233)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

KUB Technologies, Inc. % Chester Lowe Chief Technology Officer 111 Research Drive STRATFORD CT 06615

Re: K183624

Trade/Device Name: Kubtec Mozart (Xpert42) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MWP Dated: May 14, 2019 Received: May 20, 2019

Dear Mr. Lowe:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

June 20, 2019

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

Thalia Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K183624

Device Name Kubtec MOZART (XPERT42)

#### Indications for Use (Describe)

The MOZART(XPERT42) is a Cabinet x-ray system that is used to provide two dimensional and three dimensional tomographic 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.

Type of Use (Select one or both, as applicable)

| <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------|
| <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# MOZART (XPERT42) Stationary X-ray System

# 510(k) Summary KUB Technologies, Inc.

Image /page/3/Picture/2 description: The image shows a Kubtec Mozart system, which is a medical imaging device. The system consists of a white cabinet with the Kubtec logo and the word "MOZART" printed on it. A monitor is attached to the cabinet via an adjustable arm, and a keyboard and trackball are placed in front of the monitor. The monitor displays a grayscale image of what appears to be a tissue sample.

# 510(k) K183624

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| Image: KUBTEC MEDICAL IMAGING logo | Title: | Document No. |
|------------------------------------|-----------------------------|-------------------|
| | Mozart<br>Executive Summary | E0805-B |
| | Sheet 2 of 9 | Revision No.<br>B |

## 510(K) Summary

Date Prepared: May 14, 2019

# Submitter's Information

## Applicant:

KUB Technologies, Inc. 111 Research Drive Stratford, CT 06615 USA

## Contact Person:

| Name: | Vikram Butani |
|------------|--------------------------|
| Title: | President |
| Telephone: | +1.203.364.8544 |
| Facsimile: | +1.203.255.7494 |
| Email | [e-mail] |
| Name: | Chester Lowe, Ph.D. |
| Title: | Chief Technology Officer |
| Telephone: | +1.203.364.8544 |
| Facsimile: | +1.203.255.7494 |
| Email | [e-mail] |

### Establishment Number: KUB Technologies, Inc. # 3006051164

## Identification of Device:

| Proprietary/Trade Name: | Kubtec MOZART (XPERT 42) |
|-------------------------|--------------------------|
| Classification name: | Cabinet X-ray System |
| Classification: | Class II |
| CFR Section: | 21 CFR 892.1680 |
| Product Codes: | MWP |
| Common Name: | Stationary X-ray System |

### Predicate Device:

| Device Name: | Kubtec XPERT 40 |
|--------------------|-----------------|
| 510(k) Number: | K071233 |
| Classification | Class: II |
| Regulation Number: | 21 CFR 892.1680 |

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| Image: KUBTEC MEDICAL IMAGING logo | Title: | Document No. |
|------------------------------------|-----------------------------|-------------------|
| | Mozart<br>Executive Summary | E0805-B |
| | Sheet 3 of 9 | Revision No.<br>B |

| Product Code: | MWP |
|---------------------|-------------------------|
| Regulation Name: | Stationary X-ray System |
| INDICATIONS FOR USE | |

#### I. INDICATIONS FOR USE

The MOZART(XPERT42) is a Cabinet x-ray system that is used to provide two dimensional and three dimensional tomographic 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.

#### II. DEVICE DESCRIPTION

The MOZART Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimensional and threedimensional tomosynthesis views.

- It is the only cabinet specimen imaging system to utilize 3-D Tomosynthesis technology. ●
- . Creates images in 1mm digital slices of the specimen, allowing physicians to evaluate the specimen layer by layer.

It has been clinically proven for the following:

- Provides more anatomical information than single planar 2-D imaging alone.
- More precisely identifies the locations and extent of lesions than single planar 2-D imaging alone.
- Excludes overlying skin and surrounding breast tissue.
- Identifies surgical margins in three axes. ●
- . Facilitates lower re-excisions by visualizing more information than 2-D Imaging

Tomosynthesis is an advanced radiographic application that produces individual coronal "slice" images through an anatomical region of inters (ROI). To produce these multiple projection radiographic images are acquired in rapid succession as the X-ray tube sweeps and rotates across the ROI. Once acquired, these projection images are subject to image processing that registers and reconstructs them into individual tomographic slices.

Tomosynthesis provides visualization of human anatomy by

- Removing overlying anatomical structures, which could otherwise obscure a structure of interest by 1. superimposition in a two dimensional presentation, and
- 2. Producing a number of slice images throughout the entire volume of the anatomy

The exceptionally high magnification capability (up to 5X) 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 30 x 35 cm and can be

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| | Title: | Document No. |
|---------------------------|-----------------------------|-------------------|
| KUBTEC<br>MEDICAL IMAGING | Mozart<br>Executive Summary | E0805-B |
| | Sheet 4 of 9 | Revision No.<br>B |

configured to acquire high resolution, DICOM compliant, digital x-ray images through the use of an integrated camera and Kubtec DIGICOM Specimen Radiography software.

To support the Tomosynthesis application, the predicate device, XPERT 40, has a low-voltage screw drive linear actuator installed in the enclosed head of the cabinet with the same 50 kVp monoblock X-ray tube as the predicate to allow motion of the X-ray source to capture the multiple projection images and the same CMOS detector mounted stationary in the bottom of the cabinet x-ray unit.

#### III. SUMMARY OF STUDIES AND SAFETY

Kubtec successfully completed internal and external safety testing requirements. (61010-1 3m edition, 21 CFR 1020.40). The software validation and verification testing was also performed.

### Compliance with Section 514 of the Food, Drug and Cosmetic Act

The device conforms to the requirements included in FDA Class II, Product Code MWP, 21 CFR 892.1680 Stationary X-ray Systems -Radiology Cabinet X-ray Systems/

#### Conformance to voluntary standards

The subject device conforms to the following standards:

- 21 CFR 1020.40 Performance Regulations for Ionizing Radiation Cabinet x-ray systems ●
- IEC 61010-1 Edition 3.0 2010-06 Safety Requirements For Electrical Equipment For Measurement, ● Control, And Laboratory Use - Part 1: General Requirements [Including: Corrigendum 1 (2011)]
- IEC PAS 61910-1 First Edition 2007-07 Medical electrical equipment - Radiation dose documentation - Part 1: Equipment for radiography and radioscopy
- . NEMA PS 3.1 - 3.20 (2011) DICOM (Digital Imaging and Communications in Medicine) 3.0
- ISO 15223-1 Second Edition 2012-07-01 Medical Devices Symbols To Be Used With Medical ● Device Labels, Labelling, And Information To Be Supplied - Part 1: General Requirements
- IEC 62304:2006 Medical Device Software - Software Life Cycle Processes

#### IV. SUBSTANTIAL EQUIVALENCE

The Kubtec MOZART is substantially equivalent to the following currently cleared devices:

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| | Title: | Document No. |
|---------------------------|-----------------------------|----------------|
| KUBTEC<br>MEDICAL IMAGING | Mozart<br>Executive Summary | E0805-B |
| | Sheet 5 of 9 | Revision No. B |

- 1. 510(k) Number: K071233 Trade Name: Kubtec XPERT 40
The proposed and predicate devices utilize similar technology and materials, comparable safety and effectiveness features, and is similar in design and construction and introduces no new safety issues. The Kubtec MOZART is as safe and effective as the predicate device (XPERT 40), the technological differences amount to the addition of a mechanism to move the x-ray source linearly and proprietary software to compile the multiple images captured and creates a composite image, Imm slices, and a 2-D image. The Indications for Use and labeling are virtually the same or similar and our labeling contain the required Cautions, Warnings and Contraindications consistent to those required for similar cleared devices. Both systems produce digital images which can be sent to hardcopy printers, softcopy diagnostic workstations and/or stored in archive.

To support the Tomosynthesis application, the proposed device, MOZART, utilizes the predicate device, XPERT 40, having the addition of a low-voltage screw-drive linear actuator installed in the enclosed head of the cabinet, which ensures operator safety, with the same 50 kVp monoblock X-ray tube as the predicate to allow motion of the X-ray source to capture the multiple projection images and the same CMOS detector mounted stationary in the bottom of the same shielded cabinet x-ray unit with proprietary software installed into an off the shelf personal computer, Microsoft Windows 7 Operating System, and a 2 megapixel or greater portrait type monitor.

The workstation on the MOZART utilizes a more powerful GPU to facilitate the handling of the collected projection data. It utilizes a method of dynamically reconstructing 3D tomographic images from a set of projections images. This includes loading the set of projection images into memory, selecting a region of interest, applying any necessary preprocessing, selecting a reconstruction method reconstructing an image according to said reconstruction method to produce a 3D tomographic image focusing on said region of interest, performing any post reconstruction processing on the 3D tomographic image and rendering said 3D tomographic image on a display. US Patent US 8,233,690 B2 displaying the complete algorithm and process is included.

Indications for Use:

The MOZART (XPERT42) is a Cabinet x-ray system that is used to provide two dimensional and three dimensional tomographic 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.

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| Title: | Mozart<br>Executive Summary |
|--------------|-----------------------------|
| Sheet 6 of 9 | |

| Document No. | E0805-B |
|--------------|---------|
| Revision No. | B |

KUBTEC

MEDICAL IMAGING

| | Xpert 40 | MOZART |
|-----------------------------------|-------------------------------------|------------------------------|
| TUBE POTENTIAL | 10-50kV | 10-50kV |
| FOCAL SPOT | <50μm | <50μm |
| TUBE CURRENT | Up to 1mA | Up to 1mA |
| INPUT POWER | 90-250v AC, 50/60Hz, 500VA | 90-250v AC, 50/60Hz, 500VA |
| DETECTOR SIZE | From 5x5 cm up to 20x20 cm | 12 × 15 cm |
| FIELD OF VIEW | 20 degree | 20 degree |
| FILM COVERAGE | 25 x 30 cm | 25 x 30 cm |
| DETECTOR RESOLUTION | <48 µm/<96 µm | <48 µm |
| DETECTOR PIXELS | 1024 x 1024 / 2048 x 2000 | 1536 × 1944 |
| INTERIOR CHAMBER SIZE | 32.2 W × 37.9 D × 36 H cm | 32.2 W × 37.9 D × 36 H cm |
| EXTERIOR CABINET DIM | N/A | N/A |
| EXTERIOR CABINET DIM WITH<br>CART | 58.4 W × 58.4 D × 127.0 H cm | 58.4 W × 58.4 D × 127.0 H cm |
| WEIGHT | N/A | N/A |
| WEIGHT WITH CART | 250 lbs | 250 lbs |
| MAXIMUM COVERAGE | 25 cm x 30 cm | 25 cm x 30 cm |
| MAXIMUM GEOMETRIC | | |
| MAGNIFICATION | UP TO 5 TIMES | UP TO 5 TIMES |
| CLINICAL SOFTWARE | DIGICOM NORMAL | DIGICOM NORMAL / TomoSpec |
| | DIGICOM NC with Pathology<br>module | |
| SOFTWARE | | N/A |
| OPERATING SYSTEM | WINDOWS 7 PRO | WINDOWS 7 PRO |

## Technical Specifications – Mozart (XPERT42) vs Predicate XPERT 40

X-ray Tube - (Same as Predicate) 50 kVp 1mA mono-block, 100% duty cycle,

25-50 kVp

20-1000μΑ

Tungsten Target Beryllium Window

Detector - (Same type as Predicate) CMOS, Active Area 11.4 x 14.6 cm, Number of Pixels 2304 x 2940, 49.5µm pixel pitch, 2 fps

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Image /page/9/Picture/0 description: The image shows the logo for KUBTEC Medical Imaging. The logo is in blue and features the word "KUBTEC" in large, bold letters. Below "KUBTEC" are the words "MEDICAL IMAGING" in smaller letters.

Title:

Executive Summary

Sheet 7 of 9

Document No.

E0805-B

Revision No.

| | MOZART<br>Shad-o-Box 6K HS | Predicate<br>XPERT40<br>Shad-o-Box 4K EV |
|----------------------------|----------------------------|------------------------------------------|
| Technology | Active-pixel CMOS | Active-pixel CMOS |
| Active Area | 114 x 146 mm | 99 x 96 mm |
| No. of Pixels | 2304 x 2940 | 2048 x 2000 |
| Pixel Size | 49.5 μm | 48 μm |
| A/D conversion | 14-bit | 14-bit |
| Dynamic range | 73 dB | 75 dB |
| Max. frame rate (full res) | 9 fps | 2.7 fps |
| PC Interface | GigE | LVDS |
| Overall dimensions | 200 x 150 x 35 mm | 264 x 208 x 19 mm |
| Full-well Capacity | 850 ke | 2000 ke |
| Fill Factor | 79% | 85% |
| Conversion Gain | 52 e/DN | 125 e/DN |
| Read Noise | 180 e | 250-350 e |
| Dark Current (23°C) | 650 e/sec | 3-5 ke/sec |
| Sensitivity (50kV, Min-R) | 0.8 DN/μR | 0.1 DN/μR |
| Rad. Hardness (160kVp) | >200 KR | <50 KR |

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Image /page/10/Picture/0 description: The image shows the logo for KUBTEC MEDICAL IMAGING. The word "KUBTEC" is in large, bold, blue letters. Below that, in smaller blue letters, are the words "MEDICAL IMAGING". The logo is simple and modern.

Shad-o-Box 6K HS vs. Shad-o-Box 4K EV MTF (Min-R 2190)

Image /page/10/Figure/3 description: The image shows a graph comparing two lines, 'Shad-o-Box 4K EV' and 'Shad-o-Box 6K HS'. The x-axis is labeled 'lp/mm' and ranges from 0 to 10. The y-axis ranges from 0.0 to 1.0. Both lines decrease as the x-axis increases, with the 'Shad-o-Box 6K HS' line consistently lower than the 'Shad-o-Box 4K EV' line.

SOD - 48.9 cm (Same as Predicate) SDD - 50 cm (Same as Predicate)

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Image /page/11/Picture/0 description: The image shows the logo for KUBTEC Medical Imaging. The text "KUBTEC" is in large, blue, sans-serif font. Below that, the words "MEDICAL IMAGING" are in a smaller, sans-serif font, also in blue. The logo is simple and modern.

#### CONCLUSION V.

This 510(k) premarket notification submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Heal. We conclude the subject device to be as safe and effective as the predicate devices based upon the clinical and non-clinical data summarized above. The Kubtec MOZART(XPERT42) is as safe and effective as the predicate device XPERT40, the technological differences amount to the addition of a mechanism to move the x-ray source linearly and proprietary software to compile the multiple images captured and create a composite image, 1mm slices, and a 2-D image. It has no new indications for use, thus rendering it substantially equivalent to the predicate device and conforms to applicable medical device safety standards.