(154 days)
Not Found
No
The summary describes a standard X-ray system for specimen imaging with no mention of AI or ML capabilities in the device description, intended use, or performance studies.
No
Explanation: The device is used for imaging harvested specimens to verify tissue excision, not for treating or preventing disease in a living patient.
Yes
The device provides X-ray images of harvested specimens to verify that the correct tissue has been excised during a biopsy, which is a diagnostic purpose.
No
The device description explicitly states it is a "Cabinet X-ray System" and mentions hardware components like an integrated camera and an a-Se detector, indicating it is a hardware device with integrated software.
Based on the provided information, the Kubtec XPERT 80 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide x-ray images of harvested specimens to verify that the correct tissue has been excised. This is a diagnostic imaging procedure performed on tissue outside of the living body, but it's for the purpose of guiding a surgical procedure (biopsy verification), not for diagnosing a disease based on the analysis of biological samples.
- Device Description: The description clearly states it's a "Cabinet X-ray System" for "radiographic imaging of surgically excised medical specimens." This aligns with imaging equipment, not IVD devices which typically involve reagents, calibrators, controls, and instruments used to examine specimens like blood, urine, or tissue for the presence of specific substances or characteristics indicative of a disease or condition.
- Lack of IVD Characteristics: The description does not mention any components or functions typical of IVD devices, such as analyzing biological samples, detecting biomarkers, or performing chemical or biological tests.
While the device is used on specimens in vitro (outside the body), its function is imaging, not diagnostic testing of biological properties. Therefore, it falls under the category of medical imaging equipment, not IVD.
N/A
Intended Use / Indications for Use
The Kubtec XPERT 80 is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various 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 XPERT 80 Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens. 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. It has been designed to comply with 21 CFR 1020.40.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
harvested specimens from various 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 to the following standards The software and verification testing was also performed.
The Proposed XPERT 80 Specimen Radiography System with a-Se detector was successfully tested by INTERTEK to IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements as well to EMC Directive 2004/108/EC
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
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KUB Technologies, Inc. % Chester Lowe, Ph.D. Chief Technology Officer 111 Research Drive STRATFORD CT 06615
Re: K210957
Trade/Device Name: Kubtec Xpert 80 Specimen Radiography System 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/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.
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
August 31, 2021
1
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,
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) K210957
Device Name KUBTEC XPERT 80 Specimen RADIOGRAPHY SYSTEM
Indications for Use (Describe)
The Kubtec XPERT 80 is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various 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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Image /page/3/Picture/0 description: The image contains two logos for KUBTEC. The first logo is for "KUBTEC MEDICAL IMAGING", with "KUBTEC" in a larger, bold, blue font and "MEDICAL IMAGING" in a smaller, lighter blue font underneath. The second logo is for "KUBTEC SCIENTIFIC IMAGING", with "KUBTEC" in a larger, bold, yellow font and "SCIENTIFIC IMAGING" in a smaller, lighter yellow font underneath.
XPERT 80 Premarket Notification 510(k) Summary K210957
Date: August 20, 2021
Identification of Devices:
| Proprietary/Trade Name: | Kubtec XPERT 80 Specimen Radiography System |
|---|---|
| Classification name: | Cabinet X-ray System |
| Classification: | Class II |
| CFR Section: | 21 CFR 892.1680 |
| Product Codes: | MWP |
| Common Name: | Stationary X-ray System |
Applicant:
KUB Technologies, Inc. 111 Research Drive Stratford, CT 06615 USA
Contact Person:
| 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
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Image /page/4/Picture/0 description: The image contains two logos for KUBTEC. The first logo is for KUBTEC Medical Imaging, with "KUBTEC" in large blue letters and "MEDICAL IMAGING" in smaller blue letters underneath. The second logo is for KUBTEC Scientific Imaging, with "KUBTEC" in large gold letters and "SCIENTIFIC IMAGING" in smaller gold letters underneath. The logos are stacked vertically, with the medical imaging logo on top and the scientific imaging logo on the bottom.
SUBSTANTIAL EQUIVALENCE
The proposed Kubtec XPERT 80 Specimen Radiography System is substantially equivalent to the following currently cleared devices:
-
- 510(k) Number: K071233 Trade Name: Kubtec XPERT 40/80/80L Specimen Radiography System (primary predicate)
-
- 510(k) Number: K 111508 Trade Name: Hologic TRIDENT SPECIMEN RADIOGRAPHY
-
- 510(k) Number: K 193166 Trade Name: Siemens MAMMOMAT Revelation
The only difference between the predicate to the Kubtec XPERT 40/80/80L Specimen Radiography System K071233 is the addition of the Amorphous Selenium detector and imaging qualities are exhibited by predicates 2 and 3.
DEVICE DESCRIPTION
The XPERT 80 Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens. 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. It has been designed to comply with 21 CFR 1020.40.
| Xpert 80 (Predicate) | Xpert 80 (Proposed) | |
|---|---|---|
| TUBE POTENTIAL | 90kV | 90kV |
| FOCAL SPOT | 55% | >70% |
| MTF | ||
| 1 Lp/mm | >85% | >95% |
| Bit Depth | 16 bits | 16 bits |
Radiographic Magnification: 1.0x to 10x Exposure Control: Automatic or Manual X-ray Duty Cycle: 100%
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Image /page/6/Picture/0 description: The image contains two logos for KUBTEC. The first logo is in blue and reads "KUBTEC MEDICAL IMAGING". The second logo is in yellow and reads "KUBTEC SCIENTIFIC IMAGING". The word "KUBTEC" is in a larger font than the words "MEDICAL IMAGING" and "SCIENTIFIC IMAGING".
Radiation Safety - 21CFR1020.40 Radiation shielded cabinet Compartment door equipped with dual safety interlocks
Radiation leakage: Less than 0.1 mR/hr at 5 cm from any exterior surface at maximum kV.
INDICATIONS FOR USE
The Kubtec XPERT 80 is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.
It is not used for mammography
COMPARISON TO PREDICATE DEVICE
The Kubtec XPERT80 Specimen Radiography System equipped with the Amorphous Selenium detector is substantially equivalent to the following currently cleared devices:
510(k) Number: K071233 Trade Name: Kubtec XPERT 40/80/80L Specimen Radiography System (primary predicate) 510(k) Number: K 111508 Trade Name: Hologic TRIDENT SPECIMEN RADIOGRAPHY 510(k) Number: K 193166 Trade Name: Siemens MAMMOMAT Revelation
Predicate Device:
| Device Name: | Kubtec XPERT 40/80/80L SPECIMEN RADIOGRAPHY
SYSTEM |
|--------------------|---------------------------------------------------------|
| 510(k) Number: | K071233 |
| 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 |
| 510(k) Number: | K111508 |
| Classification | Class: II |
| Regulation Number: | 21 CFR 892.1680 |
| Product Code: | MWP |
| Regulation Name: | Stationary X-ray System |
| Device Name: | Siemens MAMMOMAT Revelation |
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Image /page/7/Picture/0 description: The image shows two logos for KUBTEC. The top logo is for KUBTEC Medical Imaging, with the word "KUBTEC" in blue and "MEDICAL IMAGING" in a smaller font below it. The bottom logo is for KUBTEC Scientific Imaging, with the word "KUBTEC" in yellow and "SCIENTIFIC IMAGING" in a smaller font below it. The logos are simple and modern, with a focus on the company name.
510(k) Number: Classification Regulation Number: Product Code: Regulation Name:
K193166 Class: II 21 CFR 892.1715 MUE Full-field digital mammography system
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.
Both systems produce digital images which can be sent to hardcopy printers, softcopy diagnostic workstations and/or stored in archive.
The proposed XPERT 80 Specimen Radiography System, utilizes the predicate devices.XPERT 80 Specimen Radiography System, with the same 90 kVp monobloc Xray tube installed in the enclosed head of the cabinet as the predicate and both the Hologic TRIDENT(Predicate 2) and the proposed XPERT 80 Specimen Radiography System utilize the Amorphous Silicon 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 10 Operating System, and a 2 megapixel or greater portrait type monitor.
The performance of the proposed AXS-2430V2 detector has been verified and cleared via 510k K193166 as incorporated into the Siemens MAMMOMAT Revelation.
Both systems utilize the same DIGICOM software.
The "Level of Concern" of XPERT 80 Specimen Radiography System software (DIGICOM) is "moderate"
SUMMARY OF STUDIES AND SAFETY
Kubtec successfully completed internal and external safety testing requirements to the following standards The software and verification testing was also performed.
The Proposed XPERT 80 Specimen Radiography System with a-Se detector was successfully tested by INTERTEK to IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements as well to EMC Directive 2004/108/EC
8
Image /page/8/Picture/0 description: The image contains two logos for KUBTEC. The first logo is in blue and says "KUBTEC MEDICAL IMAGING". The second logo is in yellow and says "KUBTEC SCIENTIFIC IMAGING".
Design controls and design transfer with appropriate risk management and analysis have been maintained per ISO 13485:2016, KUBTEC's Standard Operating Procedures via Quality and Regulatory Assurance (QARA) and Engineering, 21 CFR Part 820, and to 21 CFR 1020.40.
| Agency | Standard | Recognition
Number | Description |
|--------|----------------|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC | 60601-1-2 | 19-36 | Medical electrical equipment - Part 1-2:
General requirements for basic safety and
essential performance - Collateral Standard:
Electromagnetic disturbances -
Requirements and tests |
| IEC | 60601-1-10 | 19-37 | Medical electrical equipment - Part 1-10:
General requirements for basic safety and
essential performance - Collateral Standard:
Requirements for the development of
physiologic closed-loop controllers |
| IEC | 60601-1-11 | 19-38 | Medical electrical equipment - Part 1-11:
General requirements for basic safety and
essential performance - Collateral Standard:
Requirements for medical electrical
equipment and medical electrical systems
used in the home healthcare environment |
| IEC | 60601-1-12 | 19-39 | Medical electrical equipment - Part 1-12:
General requirements for basic safety and
essential performance - Collateral Standard:
Requirements for medical electrical
equipment and medical electrical systems
intended for use in the emergency medical
services environment |
| IEC | 61010-1 | 19-34 | Safety requirements for electrical equipment
for measurement, control, and laboratory
use - Part 1: General requirements |
| IEC | 62304 1st Ed | 13-79 | Medical device software - Software life
cycle processes |
| ISO | 14971 2nd Ed | 5-40 | Medical devices - Application of risk
management to medical devices |
| ISO | 15223-1 | 5-117 | Medical devices - Symbols to be used with
medical device labels, labelling, and
information to be supplied - Part 1: General
requirements |
| | | | |
| | | | Medical electrical equipment - Radiation
dose documentation - Part 1: Radiation dose
structured reports for radiography and
radioscopy |
| IEC | 61910-1 1st Ed | 12-290 | |
| NEMA | PS 3.1 - 3.20 | 12-300 | Digital Imaging and Communications in
Medicine (DICOM) Set |
| CFR | 21 CFR 1020.40 | N/A | Cabinet X-Ray Systems |
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Image /page/9/Picture/0 description: The image contains two logos for KUBTEC. The first logo is for "KUBTEC MEDICAL IMAGING", with "KUBTEC" in blue and "MEDICAL IMAGING" in a smaller font size below it. The second logo is for "KUBTEC SCIENTIFIC IMAGING", with "KUBTEC" in gold and "SCIENTIFIC IMAGING" in a smaller font size below it. The logos are stacked vertically, with the medical imaging logo on top and the scientific imaging logo on the bottom.
CONCLUSION:
The Kubtec proposed KUBTEC XPERT 80 Specimen Radiography System equipped with an Amorphous Selenium Detector is as safe and effective as the predicate device, the technological differences amount to the change of the type of detector to produce the 2-D x-ray 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.