(80 days)
Not Found
No
The summary describes a tomosynthesis system for imaging specimens and does not mention any AI or ML components.
No
This device is designed for imaging surgically excised medical specimens to aid in diagnosis, not for treating diseases or conditions within a living body.
Yes
The device is described as providing "high detail radiographic imaging" and the images are verified by a radiologist to produce "diagnostic quality images," indicating its use in diagnosing characteristics of excised specimens.
No
The device description explicitly states it is a "Cabinet X-ray System" equipped with an x-ray source and a digital detector, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Function: The MOZART SUPRA Specimen Tomosynthesis System is an X-ray imaging system designed to create radiographic images of surgically excised medical specimens. While these specimens are taken from the body, the device's function is to image the physical structure of the specimen using X-rays, not to perform a diagnostic test on the specimen's biological components or properties.
- Intended Use: The intended use is to provide high detail radiographic imaging for evaluation, not to perform a diagnostic test on the specimen itself.
Therefore, the device falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The MOZART SUPRA Specimen Tomosynthesis System is a Cabinet x-ray system that is specifically designed to provide high detail radiographic imaging of surgically excised medical specimens from various anatomical regions, i.e. breast, both in 2-dimensional and 3-dimensional tomosynthesis views.
Product codes
MWP
Device Description
The MOZART SUPRA(XPERT84) Specimen Radiography System is a Cabinet X-ray System specifically designed to provide 3-D high detail radiographic imaging of surgically excised medical specimens utilizing tomosynthesis.
The MOZART SUPRA(XPERT84) is a fully self-contained and shielded cabinet system equipped with a 90kVp micro-focus x-ray source and a 10'' x 12" 49.5 micron high resolution CMOS Digital Detector.
- . 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.
The exceptionally high magnification capability (up to 5X) from the 0.005 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 is configured to acquire high resolution, DICOM compliant, digital x-ray images through the use of an integrated camera and Kubtec DIGICOM Specimen Radiography software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
surgically excised medical specimens from various anatomical regions, i.e. breast
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
Bench and Clinical Studies
Images attained by the system have been read and verified by a Board Certified Radiologist to product diagnostic quality images.
Key Metrics
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
June 12, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
KUB Technologies, Inc. % Chester Lowe, Ph.D. Chief Technology Officer 111 Research Drive STRATFORD CT 06615
Re: K200756
Trade/Device Name: Kubtec MOZART SUPRA (XPERT 84) Radiography System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MWP Dated: May 8, 2020 Received: May 11, 2020
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/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.
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- 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 mediation-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.
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) K200756
Device Name Kubtec MOZART SUPRA (XPERT 84) Radiography System
Indications for Use (Describe)
The MOZART SUPRA Specimen Tomosynthesis System is a Cabinet x-ray system that is specifically designed to provide high detail radiographic imaging of surgically excised medical specimens from various anatomical regions, i.e. breast, both in 2-dimensional and 3-dimensional tomosynthesis views.
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
MOZART SUPRA(XPERT84) Stationary X-ray System
Image /page/3/Picture/1 description: The image shows a Kubtec Mozart Supra medical imaging device. The device is white with blue accents and has a monitor on top displaying an image. The device has multiple drawers or compartments and is mounted on wheels for mobility. The Kubtec logo is visible on the side of the device.
510(k) Summary KUB Technologies, Inc. JUNE 2020
4
Image /page/4/Picture/0 description: The image shows the logo for KUBTEC MEDICAL IMAGING. The word "KUBTEC" is in large, blue, sans-serif font. Below it, in a smaller font, are the words "MEDICAL IMAGING", also in blue. The logo is simple and modern.
Document No.
E0905-A
A
Sheet 2 of 9
Title:
Revision No.
General Information
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 |
| Vbutani@kubtec.com | |
| Name: | Chester Lowe, Ph.D. |
| Title: | Chief Technology Officer |
| Telephone: | +1.203.364.8544 |
| Facsimile: | +1.203.255.7494 |
| Clowe@kubtec.com |
Establishment Number: KUB Technologies, Inc. # 3006051164
Identification of Devices:
| Proprietary/Trade Name: | Kubtec MOZART SUPRA(XPERT84) Radiography System |
|---|---|
| Classification name: | Stationary X-ray System |
| Classification: | Class II |
| CFR Section: | 21 CFR 892.1680 |
| Product Codes: | MWP |
| Common Name: | Stationary X-ray System |
Applicable Standards
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.
5
Image /page/5/Picture/0 description: The image shows the logo for KUBTEC MEDICAL IMAGING. The word "KUBTEC" is in large, bold, blue letters. Below it, in smaller blue letters, are the words "MEDICAL IMAGING". The logo is simple and modern, and the blue color gives it a professional look.
Conformance to voluntary standards
The subject device conforms to the following standards:
Title:
- 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 Meas-● urement, 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
6
| Title: | Mozart SUPRA 510(k) Summary |
|---|---|
| Document No. | E0905-A |
| Sheet 4 of 9 | Revision No. A |
Indications for Use
The MOZART SUPRA(XPERT84) Specimen Tomosynthesis System is a Cabinet x-ray system that is specifically designed to provide high detail radiographic imaging of surgically excised medical specimens from various anatomical regions, i.e. breast, both in 2-dimensional and 3-dimensional tomosynthesis views.
7
Image /page/7/Picture/0 description: The image shows the logo for KUBTEC Medical Imaging. The word "KUBTEC" is written in large, blue, sans-serif font. Below it, the words "MEDICAL IMAGING" are written in a smaller, sans-serif font, also in blue. The logo appears to be for a medical imaging company.
Title:
Device Description
The MOZART SUPRA(XPERT84) Specimen Radiography System is a Cabinet X-ray System specifically designed to provide 3-D high detail radiographic imaging of surgically excised medical specimens utilizing tomosynthesis.
The MOZART SUPRA(XPERT84) is a fully self-contained and shielded cabinet system equipped with a 90kVp micro-focus x-ray source and a 10'' x 12" 49.5 micron high resolution CMOS Digital Detector.
- . 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.
The exceptionally high magnification capability (up to 5X) from the 0.005 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 is configured to acquire high resolution, DICOM compliant, digital x-ray images through the use of an integrated camera and Kubtec DIGICOM Specimen Radiography software.
8
Image /page/8/Picture/0 description: The image shows the logo for KUBTEC Medical Imaging. The text "KUBTEC" is in large, bold, blue letters. Below that, the text "MEDICAL IMAGING" is in smaller, blue letters.
Sheet 6 of 9
Title:
Revision No.
Specifications:
| Cabinet | 71 L x 76.2 W x 162.5 cm H |
|---|---|
| Dimensions - Interior | 40.6 L x 33 W x 11.4 cm H) |
| Weight | 800 lbs (363 kg) |
| Temperature Range (User Operation) | 0-35 degrees C (32-95 F) |
| Humidity | 10 - 80% R.H |
| Power Requirements | 90-250v AC, 50/60Hz, 500VA |
| X-ray Source Specifications | |
| Maximum Potential | 90 kVp |
| Maximum Current | 0.25 mA |
| Total Wattage | 0.5 kW |
| Focal Spot | 5 $ \mu $ m nominal |
| Window Material | .005 in. Beryllium |
| Detector Specifications | |
| Type | CMOS |
| Imaging Area | 23 cm x 29 cm |
| Pixel Size | 49.5 $ \mu $ m - 10 lp/mm |
| Resolution | 4608 X 5890 |
| DQE | 76% @ 1 lp/mm |
| Data Output/Dynamic Range | 16-bits |
| Optical Camera Specifications | |
| Resolution | 13 megapixel |
Diagrams / Pictures / Drawings
Reprocessing, Cleaning, Disinfection, and Sterilization
The device is not sterile nor does it require sterilization.
Proposed Labels, Labeling, Advertisements, and Directions
Same as predicate
9
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 the word "KUBTEC" are the words "MEDICAL IMAGING" in smaller letters. The logo is simple and modern.
Summary of Safety and Effectiveness
Technological
KUB Technologies, Inc. believes that the subject device is substantially equivalent to other devices that have previously received US FDA 510(k) clearance including the predicate device.
This summary of 510(k) safety and effectiveness information is supplied in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 to show Substantial Equivalence of the proposed device and the predicate device.
Title:
There is no change for the indication for use from the predicate 510(k) approved device.
Electrical Safety and Electromagnetic Compatibility
Electrical safety and EMC testing were conducted on the MOZART SUPRA(XPERT84), consisting of the Cabinet System with it's operating computer. The system complies with the UL 61010-1 2012, UL 61010-1-12:2012, ul 61010-2-091, IEC 61326-1 2012/07/10 Ed: 2, IEC 61326-1 2012/07/10 Ed: 2 Japan and IEC 60601-2-37 standards for safety and the FCC 47CFR Part 15 Subpart B: 04/2019 standard for EMC.
The device complies with electrical safety standards that are applicable for this type of device including:
- 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 docu-● mentation - 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 ●
10
| Title: | Document No. | |
|---|---|---|
| KUBTEC | ||
| MEDICAL IMAGING | Mozart SUPRA | |
| 510(k) Summary | E0905-A | |
| Sheet 8 of 9 | Revision No. A |
Software Verification and Validation Testing
The system utilizes proprietary KUBTEC DIGICOM software. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Bench and Clinical Studies
Images attained by the system have been read and verified by a Board Certified Radiologist to product diagnostic quality images.
Substantial Equivalence Discussion
The Kubtec MOZART SUPRA is substantially equivalent to the following currently cleared devices:
510(k) Number: K183624 Trade Name: Kubtec MOZART 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.
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 and the predicates.
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 SUPRA, utilizes the predicate device, MOZART, having the following:
- addition of a low-voltage screw-drive linear actuator installed in the enclosed head of the cabinet, which ensures operator safety,
- with a 90 kVp monoblock X-ray tube versus the 50 kVp predicate to allow motion of the Xray source to capture the multiple projection images and,
- a CMOS detector of a slightly larger size (10"x12") mounted stationary in the bottom of the ● same shielded cabinet x-ray unit versus the predicate 5'' x 6"
11
Image /page/11/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 the word "KUBTEC" are the words "MEDICAL IMAGING" in smaller letters. The logo is simple and modern.
Mozart SUPRA 510(k) Summary
Document No.
E0905-A
A
Sheet 9 of 9
Title:
- 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.
| Xpert 40 | MOZART XPERT 42 | MOZART SUPRA XPERT 84 | |
|---|---|---|---|
| TUBE POTENTIAL | 10-50kV | 10-50kV | 40-90kV |
| FOCAL SPOT |