(79 days)
A cabinet x-ray system used to provide digital x-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.
Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.
The Trident Specimen Radiography System is a self-contained, direct digital imaging system for imaging small to medium sized surgical and biopsy specimens. The system includes an X-ray generator, X-ray tube (microfocus), a-Se digital detector, 12 x 14 cm active imaging area, exposure timer, specimen chamber, control panel and an acquisition workstation. The lower 1/3 of the workstation's display monitor is the graphical user interface for the system. The upper 2/3 of the monitor is the display for the specimen radiographs. The system includes automatic exposure control functionality, but manual exposure techniques can also be sclected. The magnification tray can be adjusted and will allow images to be produced at 1.5 and 2.0 X magnifications.
The system is self-contained. Shielding is incorporated within the cabinet chamber system design, eliminating the need for separate additional shielding. The unit is mounted on a cart to be easily transported.
The provided information describes the Trident Specimen Radiography System but does not specify acceptance criteria or the details of a study comparing device performance against those criteria.
Instead, the document focuses on:
- Device Description: What the Trident system is and how it works.
- Indications for Use: What the device is intended for.
- Comparison to Predicate Devices: Stating that it has similar intended use, configuration, operation, and parameters to existing devices.
- Summary of Testing: Mentioning successful testing to safety and EMC standards (ISO 61010-1 and EMC Directive 2004/108/EC) and internal design control verification and validation according to 21 CFR Part 820 and 21 CFR 1020.40.
- 510(k) Clearance: The FDA's determination of substantial equivalence to predicate devices.
Therefore, I cannot provide the requested information about acceptance criteria, reported performance, sample sizes, expert qualifications, or adjudication methods for a performance study, as these details are not present in the provided text.
The document implies that the device "meets" its requirements by successfully passing safety, EMC, and internal verification/validation tests, and by being deemed substantially equivalent to predicate devices by the FDA. However, these are general compliance statements rather than a detailed performance study with specific acceptance criteria that would typically be found in a clinical or performance assessment report.
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Hologic, Inc.
Trident Specimen Radiography Syst 510(k) Premarket Notification
510(k) Summary
AUG 1 9 2011
This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.87 (b)
Product Name: Trident Specimen Radiography System, Model: RC
Product Classification Name: Cabinet X-Ray System
Product Classification Code: MWP CFR Section: 892.1680
Classification Panel: Radiology Class II
Manufacturer: Hologic, Inc. 36-37 Apple Ridge Road Danbury, CT_06810 USA
- Contact Person: Deborah Thomas Telephone Number: 781-999-7558 Fax Number: 866- 652-8674
Date Prepared: May 27, 2011
Predicate Devices:
K083510 Kubtec XPERT 40 Specimen Radiography System
K061361 Faxitron DX-50 Specimen Radiography System
Device Description:
The Trident Specimen Radiography System is a self-contained, direct digital imaging system for imaging small to medium sized surgical and biopsy specimens. The system includes an X-ray generator, X-ray tube (microfocus), a-Se digital detector, 12 x 14 cm active imaging area, exposure timer, specimen chamber, control panel and an acquisition workstation. The lower 1/3 of the workstation's display monitor is the graphical user interface for the system. The upper 2/3 of the monitor is the display for the specimen radiographs. The system includes automatic exposure control functionality, but manual exposure techniques can also be sclected. The magnification tray can be adjusted and will allow images to be produced at 1.5 and 2.0 X magnifications.
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The system is self-contained. Shielding is incorporated within the cabinet chamber system design, eliminating the need for separate additional shielding. The unit is mounted on a cart to be easily transported.
Indications for Use:
A cabinet x-ray system used to provide digital x-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.
Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.
Comparison with Predicate Devices:
The Trident Specimen Radiography System and predicate devices, Kubtec XPERT 40 Specimen Radiography System K083510, and the Faxitron DX-50 Specimen Radiography System K.061361, have the same intended use, general configuration, principles of operation, and similar operating parameters.
Summary of Testing
The Trident Specimen Radiography System was successfully tested by UL to ISO 61010-1 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use and by TUV Rheinland to EMC Directive 2004/108/EC.
Hologic successfully performed design control verification and validation tests in accordance with 21 CFR Part 820 and 21 CFR 1020.40 Cabinet X-Ray Systems.
Conclusion
The Trident Specimen Radiography System design, operation, construction and materials are similar to existing marketed device with no additional risks or hazards.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Deborah Thomas Senior Regulatory Affairs Specialist Hologic. Inc. 35 Crosby Drive BEDFORD MA 01730
AUG 1 9 2011
Re: K111508
Trade/Device Name: Trident Specimen Radiography System, Model: RC Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MWP Dated: July 29, 2011 Received: August 1, 2011
Dear Ms. Thomas:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Patel
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Hologic, Inc.
Trident Specimen Radiography System 510(k) Premarket Notification
Indications for Use
Premarket Notification: Trident Specimen Radiography System
510(k) No.
Device Name: Trident Specimen Radiography System, Model: RC
Indications For Use
A cabinet x-ray system used to provide digital x-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.
Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Mary S. Poll
510K. K11.508
§ 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.