(48 days)
Not Found
No
The description focuses on standard x-ray imaging technology and digital image display/storage (DICOM compliant software). There is no mention of AI, ML, or advanced image processing beyond basic magnification and contrast adjustments.
No.
The device is used to image excised tissue specimens for verification purposes, not for treating patients.
Yes
Explanation: The device provides images to "verify that the correct tissue has been excised during the biopsy procedure," which is a diagnostic purpose to ensure the biopsy was successful.
No
The device description clearly states it is a "self contained, shielded cabinet x-ray system" and includes hardware components like an x-ray source, adjustable sample positioning, a PC, and an LCD monitor. While it includes software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The XPERT Specimen Radiography System is an imaging device used to visualize harvested tissue specimens after they have been removed from the body. Its purpose is to verify that the correct tissue has been excised during the biopsy procedure.
- Lack of Diagnostic Testing: The device itself does not perform any biochemical, immunological, or molecular tests on the tissue sample to diagnose a condition or disease. It provides an image for visual inspection.
- Imaging Modality: The device uses X-ray imaging, which is a physical imaging modality, not a diagnostic test performed on a sample in vitro.
While the device is used in conjunction with a biopsy procedure (which is a diagnostic process), the device itself is a medical imaging device used for quality control and verification of the excised sample, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Provide digital x-ray images of harvested tissue specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.
Product codes (comma separated list FDA assigned to the subject device)
MWP
Device Description
The XPERT Specimen Radiography System is a self contained, shielded cabinet x-ray system designed to meet imaging requirements for surgically excised and needle core biopsies. This device does not expose the patient to radiation, it is used for biopsy tissue samples only. This equipment provides high resolution, high contrast, X-ray images, using either radiographic file up to 10x12" or digitally with the DICOM compliant DIGIVIEW digital detectors up to 8x10" in size.
With its small focal spot x-ray source and adjustable sample positioning capability, the XPERT 40 provides variable magnification for increased visibility and sharpness of detail for lesions and abnormalities in biopsies.
The device is provided with a PC including the DICOM compliant software and an LCD monitor for high resolution imaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Various anatomical regions (for harvested tissue specimens)
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)
The subject device has been subjected to and passed electrical and radiation safety requirements, as well software validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
btec
Ko 71233
GUN 2 0 2007
510 (k) Summary
Date Prepared [21 CFR 807.92(a)(1)} 4/30/07
Submitter's Information [21 CFR 807.92(a)(1)]
This 510(k) is being submitted by Joseph Azary on behalf of KUB Technologies, Inc.
Contact: Joseph Azary 543 Long Hill Avenue Shelton, CT 06484 Tel: (203) 944-9320 Fax: (203) 944-9317.
Manufacturer: KUB Technologies, Inc. 1317 Mill Plain Road, Unit A Fairfield, CT 06824 FDA Establishment Registration# Pending
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
The device trade names are:
-
XPERT Specimen Radiography System
-
XPERT 40
Specimen X-Ray System / Cabinet Class II, Product Code MWP, 21 CFR 892.1680
1
Predicate Device [21 CFR 807.92(a)(3)]
- piXarray by Biotics K052433 ்
- Dx-50 by Faxitron K061361 0
- MX 20 by Faxitron K953404 (the product formerly owned by Micro Focus Imaging) 0
Description of the Device [21 CFR 807.92(a)(4)]
The XPERT Specimen Radiography System is a self contained, shielded cabinet x-ray system designed to meet imaging requirements for surgically excised and needle core biopsies. This device does not expose the patient to radiation, it is used for biopsy tissue samples only. This equipment provides high resolution, high contrast, X-ray images, using either radiographic file up to 10x12" or digitally with the DICOM compliant DIGIVIEW digital detectors up to 8x10" in size.
With its small focal spot x-ray source and adjustable sample positioning capability, the XPERT 40 provides variable magnification for increased visibility and sharpness of detail for lesions and abnormalities in biopsies.
The device is provided with a PC including the DICOM compliant software and an LCD monitor for high resolution imaging.
Intended Use [21 CFR 807.92(a)(5)]
Provide digital x-ray images of harvested tissue specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.
Technological Characteristics [21 CFR 807.92(a)(6)]
The device is substantially equivalent to the predicate device based on a comparison on physical and performance characteristics.
Performance Data [21 CFR 807.92(b)(1)]
The subject device has been subjected to and passed electrical and radiation safety requirements, as well software validation testing.
Conclusion [21 CFR 807.92(b)(3)]
We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape and features the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
KUB Technologies, Inc. % Mr. Joseph M. Azary Official Correspondent Azary Technologies, LLC 543 Long Hill Avenue SHELTON CT 06484
Re: K071233
Trade/Device Name: Kubtec XPERT 40 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MWP Dated: April 30, 2007 Received: May 3, 2007
JUN 2 0 200
Dear Mr. Azary:
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.
Image /page/2/Picture/10 description: The image shows a logo for the FDA Centennial, which took place from 1906-2006. The logo is circular and contains the letters "FDA" in the center. Below the letters, the word "Centennial" is written. Below that are three stars. Below the logo, the words "Protecting and Promoting Public Health" are written in a decorative font.
3
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
Nancy Chogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
(07/233 510(k) Number (if known):
Device Name: Kubtec XPERT 40
Indications For Use:
Provide digital x-ray images of harvested tissue specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hubert Humphrey
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number.
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