(154 days)
No
The description mentions image processing for reconstruction but does not mention AI or ML algorithms.
No
The device is described as an imaging system used to verify excised tissue during biopsy procedures, not to treat a medical condition.
Yes
Explanation: The device is used to provide rapid verification that the correct tissue has been excised during the biopsy procedure. This involves evaluating the specimen for diagnostic purposes, in this case, confirming the presence of the correct tissue.
No
The device is a cabinet x-ray system, which is a hardware device that includes an x-ray tube, detector, and linear actuator, in addition to software for image processing.
Based on the provided information, the MOZART (XPERT42) device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, treatment, or prevention of disease. The key is that the analysis is performed outside the living body (in vitro).
- MOZART's Function: The MOZART system is an X-ray imaging system. It uses X-rays to create images of harvested specimens. While it examines tissue specimens, the method of examination is through physical imaging (radiography), not through biochemical, immunological, or molecular analysis of the specimen's components.
- Intended Use: The intended use is to "provide rapid verification that the correct tissue has been excised during the biopsy procedure." This is a form of anatomical verification through imaging, not a diagnostic test performed on the specimen itself to determine the presence of disease markers or other biological characteristics.
In summary, the MOZART is a medical imaging device used to visualize physical structures within a specimen, not a device that performs diagnostic tests on the biological or chemical properties of the specimen.
N/A
Intended Use / 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.
It is not used for mammography
Product codes
MWP
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 specimens both in two-dimensional and three-dimensional 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.
- . The subject x-ray cabinet system Kubtec Mozart Xpert 42 is not intended for mammography.
Tomosynthesis is an advanced radiographic application that produces individual coronal "slice" images through an anatomical region of inters (ROI). To produce these slices 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
- Producing a number of slice images throughout the entire volume of the anatomy 2.
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 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, MOZART (XPERT42), has a low-voltage screw drive linear actuator installed in the enclosed head of the cabinet with the same 50 kVp monoblock Xray tube as the predicate to allow motion of the X-ray source to capture the multiple projection images and an Amorphous Selenium detector mounted stationary in the bottom of the cabinet x-ray unit.
Mentions image processing
Yes, "Once acquired, these projection images are subject to image processing that registers and reconstructs them into individual tomographic slices." and "performing any post reconstruction processing on the 3D tomographic image and rendering said 3D tomographic image on a display."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray / Tomosynthesis
Anatomical Site
Harvested specimens from various anatomical regions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Kubtec successfully completed internal and external safety testing requirements. (61010-1 3th edition, 21 CFR 1020.40). The software validation and verification testing was also performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
August 31, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
KUB Technologies, Inc. % Chester Lowe, Ph.D. Chief Technology Officer 111 Research Drive STRATFORD CT 06615
Re: K210956
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: August 1, 2021 Received: August 11, 2021
Dear Dr. 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/cfpmp/bmn.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.
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
1
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 (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Thalia T. 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
2
Indications for Use
510(k) Number (if known) K210956
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.
It is not used for mammography
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) |
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3
Kubtec MOZART (XPERT42) Stationary X-Ray System K210956
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 vertical unit with the words "kubtec" and "MOZART" printed on it, a monitor displaying a medical image, and a keyboard and mouse. The device is on wheels, suggesting it is portable. The background is plain white.
4
| Title: | Mozart (XPERT42) 510K Summary | Document No. | E0805-D |
|---|---|---|---|
| Sheet 2 of 8 | Revision No. | D |
510(K) Summary
Date Prepared: August 27, 2021
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: | Vbutani@kubtec.com |
| Name: | Chester Lowe, Ph.D. |
| Title: | Chief Technology Officer |
| Telephone: | +1.203.364.8544 |
| Facsimile: | +1.203.255.7494 |
| Email: | Clowe@kubtec.com |
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 MOZART(XPERT 42) |
|---|---|
| 510(k) Number: | K183624 |
| Classification | Class: II |
| Regulation Number: | 21 CFR 892.1680 |
5
Title:
Document No.
E0805-D
D
510K Summary
Mozart (XPERT42)
Revision No.
Product Code: MWP Regulation Name: Stationary X-ray System
I. INDICATIONS FOR USE
The MOZART(XPERT42) is a Cabinet x-rav 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 specimens both in two-dimensional and three-dimensional 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.
- . The subject x-ray cabinet system Kubtec Mozart Xpert 42 is not intended for mammography.
Tomosynthesis is an advanced radiographic application that produces individual coronal "slice" images through an anatomical region of inters (ROI). To produce these slices 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
- Producing a number of slice images throughout the entire volume of the anatomy 2.
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 configured to acquire high resolution, DICOM compliant, digital x-ray images through the use of an integrated camera and Kubtec DIGICOM Specimen Radiography software.
6
| Title: | Document No. | |
|---|---|---|
| KUBTEC | ||
| MEDICAL IMAGING | Mozart (XPERT42) | |
| 510K Summary | E0805-D | |
| Sheet 4 of 8 | Revision No. | |
| D |
To support the Tomosynthesis application, the predicate device, MOZART (XPERT42), has a low-voltage screw drive linear actuator installed in the enclosed head of the cabinet with the same 50 kVp monoblock Xray tube as the predicate to allow motion of the X-ray source to capture the multiple projection images and an Amorphous Selenium 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 3th 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:
-
- 510(k) Number: K183624 Trade Name: Kubtec MOZART (XPERT42) -Primary predicate
- 510(k) Number K111508 Trade Name: Hologic TRIDENT SPECIMEN RADIOGRAPHY SYS -Secondary predicate
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Title:
Image /page/7/Picture/1 description: The image shows the words "Document No." in bold black font. The words are stacked on top of each other, with "Document" on the top line and "No." on the bottom line. The text is centered and there is a white background.
Revision No.
Image /page/7/Picture/2 description: The image contains the logo for KUBTEC Medical Imaging. The word "KUBTEC" is written in large, bold, blue letters. Below the word "KUBTEC" is the phrase "MEDICAL IMAGING" in smaller, blue letters. The logo is simple and modern.
Mozart (XPERT42) 510K Summary
Sheet 5 of 8
E0805-D
D
| Predicate Device: | |
|---|---|
| Device Name: | Kubtec MOZART (XPERT 42) (Primary) |
| 510(k) Number: | K183624 |
| Classification | Class: II |
| Regulation Number: | 21 CFR 892.1680 |
| Product Code: | MWP |
| Regulation Name: | Stationary X-ray System |
| Device Name: | Hologic TRIDENT SPECIMEN RADIOGRAPHY SYSTEM Model:RC |
| (Secondary) | |
| 510(k) Number: | K111508 |
| Classification | Class: II |
| Regulation Number: | 21 CFR 892.1680 |
| Product Code: | MWP |
| Regulation Name: | Stationary X-ray System |
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 42), the technological differences amount to the changing from a CMOS Detector to an Amorphous Silicon Detector. 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 42, 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 Amorphous Silicon detector mounted stationary in the bottom , the same as the predicate CMOS detector, of the same shielded cabinet x-ray unit with proprietary software installed into an off the shelf personal computer, Microsoft Windows 10 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.
Both the predicate and proposed systems utilize the same DIGICOM software.
8
| Title: | Mozart (XPERT42) 510K Summary |
|---|---|
| Sheet 6 of 8 |
Revision No.
D
The "Level of Concern" of Kubtec MOZART (XPERT42) Specimen Radiography System software (DIGICOM) is "moderate"
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.
Technical Specifications - Mozart (XPERT42) vs Predicate Mozart (XPERT 42)
Cabinet
Same as Predicate
| MOZART (PREDICATE) K183624 | MOZART (PROPOSED) | |
|---|---|---|
| TUBE POTENTIAL | 10-50kV | 10-50kV |
| FOCAL SPOT | 45% | >50% |
| MTF | ||
| 1 Lp/mm | >80% | >90% |
| Bit Depth | 16 bits | 16 bits |
10
Image /page/10/Picture/0 description: The image shows the logo for KUBTEC Medical Imaging. The word "KUBTEC" is written in large, bold, blue letters. Below it, the words "MEDICAL IMAGING" are written in smaller, thinner, blue letters.
V. CONCLUSION
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 proposed modified MOZART(XPERT42) is as safe and effective as the predicate device MOZART (XPERT42), the technological differences amount to the changing from a CMOS detector to an Amorphous Selenium. It has no new indications for use, thus rendering it substantially equivalent to the predicate device and conforms to applicable medical device safety standards.