(43 days)
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.
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. The system design features an x-ray source that produces a high resolution, 5 -45 micron focal spot. The control system, coupled with a touch panel screen for operator interface. The XPERT system features a DICOM 3.0 compliant DIGICOM computer and software application. The DIGICOM enables the display and analysis of x-ray images, either live (real time) or previously captured, and the storage and transmission of these imagines to the PACS.
The provided text does not contain detailed information regarding acceptance criteria, specific device performance metrics, or a robust study design with sample sizes, expert qualifications, adjudication methods, or comparative effectiveness. The submission primarily focuses on establishing substantial equivalence to a predicate device based on physical and performance characteristics, and compliance with general safety and software validation.
Here's an analysis based on the limited information available:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, no specific quantitative acceptance criteria or numerical performance metrics are outlined for the device itself. The "Performance Data" section states: "The subject device complies electrical and radiation safety requirements and utilizes software that has been validated." This suggests the "acceptance criteria" are related to established electrical and radiation safety standards and successful software validation, rather than clinical performance for tissue verification.
2. Sample Size Used for the Test Set and Data Provenance
No information is provided regarding a specific "test set" in the context of clinical performance data used to demonstrate statistical equivalence or superiority. The submission focuses on substantial equivalence to the predicate device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. There is no mention of experts being used to establish ground truth for a test set, as no such test set for clinical performance is described.
4. Adjudication Method
Not applicable. No adjudication method is mentioned as there is no described study involving expert review of device outputs against a ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The submission does not discuss human readers or AI assistance.
6. Standalone (Algorithm Only) Performance
Not applicable. The device is an X-ray system, not an AI algorithm. Its performance is tied to its ability to generate images, not to interpret them autonomously.
7. Type of Ground Truth Used
Based on the available information, the "ground truth" implicitly refers to the expected functioning of an X-ray system for imaging tissue specimens. This would be assessed through technical validation against engineering and safety standards, and potentially comparison of image quality against the predicate device. There is no mention of clinical outcomes data, pathology, or expert consensus being used as ground truth for a performance study.
8. Sample Size for the Training Set
Not applicable. The device is a hardware X-ray system that produces images; it does not explicitly describe an AI component that would require a "training set" in the machine learning sense. The software is validated, which implies testing, but not a "training set" for an AI model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI component.
Summary of what is present:
The submission for the KUB Technologies, Inc. XPERT Specimen Radiography System (K083510) is a 510(k) premarket notification. The primary argument for clearance is substantial equivalence to a predicate device (XPERT 40, K071233).
- Acceptance Criteria (Implied):
- Compliance with electrical and radiation safety requirements.
- Validated software.
- Similar physical and performance characteristics to the predicate device.
- Ability to provide digital X-ray images of harvested tissue specimens for rapid verification.
- Study That Proves Device Meets Criteria:
- The document states that the "subject device complies electrical and radiation safety requirements and utilizes software that has been validated."
- It also states, "The subject device represents a minor modification to the predicate device."
- The "performance data" section in {1} is very brief and does not detail a specific clinical or technical study beyond stating compliance with safety requirements and software validation. The conclusion explicitly states: "We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device."
In essence, the "study" demonstrating the device meets its (implied) acceptance criteria is the documentation of its technical specifications, compliance with relevant standards, successful software validation, and the argument that as a minor modification to a previously cleared predicate, its safety and effectiveness are maintained. No detailed clinical performance study with defined criteria, test sets, experts, or ground truth is described in the provided text.
{0}------------------------------------------------
510 (k) Summary
Date Prepared [21 CFR 807.92(a)(1)]
11/21/08
Submitter's Information [21 CFR 807.92(a)(1)]
This 510(k) is being submitted by Joseph Azary on behalf of KUB Technologies, Inc.
Submitter / Regulatory Consultant:
Joseph Azary 80 Shelton Technology Center Shelton, CT 06484 Tel: (203) 922-0105 Fax: (203) 922-0130
Manufacturer:
KUB Technologies, Inc. 270 Rowe Avenue, Suite E Milford, CT 06460 Contact: Vikram Butani Tel: (203) 364-8544 Fax: (203) 255-7494 FDA Establishment Registration# Pending
{1}------------------------------------------------
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
The device trade names are:
- ア XPERT Specimen Radiography System
- A XPERT 20
Specimen X-Ray System / Cabinet Class II, Product Code MWP, 21 CFR 892,1680
Predicate Device [21 CFR 807.92(a)(3)]
0 XPERT 40 (K071233)
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.
The system design features an x-ray source that produces a high resolution, 5 -45 micron focal spot. The control system, coupled with a touch panel screen for operator interface.
The XPERT system features a DICOM 3.0 compliant DIGICOM computer and software application. The DIGICOM enables the display and analysis of x-ray images, either live (real time) or previously captured, and the storage and transmission of these imagines to the PACS.
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 complies electrical and radiation safety requirements and utilizes software that has been validated. The subject device represents a minor modification to the predicate device.
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 consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
KUB Technologies, Inc. % Mr. Joseph Azary Regulatory Consultant Orchid Design Orthopedic Solutions 80 Shelton Technology Center SHELTON CT 06484
Re: K083510
Trade/Device Name: Kubtec XPERT 20 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: November 21, 2008 Received: November 26, 2008
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 ndictions for use stated in the enclosure) to legally marketed predicate devices marketed in intentive 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, Or to 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 the 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 (PMA), 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 ? Prister.
{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 100-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permitts your levice 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 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 538-204 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.support/index.html.
Sincerely yours,
Janine M. Morris
(anine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: Kubtec XPERT 20
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 (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)
Helus Hossen
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
产
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§ 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.