(38 days)
to support a patient and facilitate a diagnostic procedure employing some imaging technique or to position a patient for various treatments in clinics or hospitals.
This device, the Fluoroview "" Series Fluoroscopic Tables (Model 9680) and the Time Table C-Arm Stretcher. Model 9670 is designed for clinical applications such as: to support a patient and facilitate a diagnostic procedure employing some imaging technique or to position a patient for various treatments in clinics or hospitals. This device is used by a physician or a health care professional: this device is not operated by a patient. This is a Class II device has a Classification name as: Mobile Fluoroscopic Tilting Table, as described in 21 CFR Part 892.11980. U.S. Imaging Tables, Incorporated has determined this device is substantially equivalent to a predicate medical device which is currently in commerce and is identified as: Deluxe "C" Arm Stretcher, Model 056-004. and is manufactured by Biodex Medical Systems. Inc. of Shirley New York.
This document is a 510(k) summary for a Class II medical device, specifically fluoroscopic tables and a C-arm stretcher designed for patient positioning during diagnostic imaging or treatment. It aims to demonstrate substantial equivalence to a predicate device.
Based on the provided text, it's explicitly stated that the device's substantial equivalence is based on its mechanical support, conventional design and materials, adherence to Good Manufacturing Procedures, performance characteristics, and safety and effectiveness for its intended application.
However, the provided text does not contain any information regarding specific acceptance criteria, study methodologies, sample sizes, expert qualifications, ground truth establishment, or any of the detailed metrics typically associated with proving a device meets acceptance criteria through a formal study.
The document primarily focuses on establishing substantial equivalence to a predicate device by asserting:
- The device offers mechanical support and adjustment.
- It uses conventional design, construction, and materials.
- It conforms to Good Manufacturing Procedures.
- It has performance characteristics substantially equivalent to its predicate.
- It is safe and effective for its intended use.
Therefore, I cannot populate the requested table or sections because the necessary detailed information is not present in the provided text. The document describes the basis for regulatory clearance (substantial equivalence), but not a rigorous study proving specific performance metrics against pre-defined acceptance criteria.
Missing Information:
- Specific quantitative acceptance criteria are not mentioned. The document states "performance characteristics substantially equivalent to its predicate device," but doesn't define what those characteristics are or what thresholds must be met.
- No study details are provided. There's no mention of a particular study, its design, endpoints, or results. The statement "This device has been tested to confirm its safety and effectiveness" is a general claim, not a description of a specific study.
- Sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, or training set information are entirely absent.
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JAN 2 7 1997
EXHIBIT 15 Summary of Safety & Effectiveness
This device, the Fluoroview "" Series Fluoroscopic Tables (Model 9680) and the Time Table C-Arm Stretcher. Model 9670 is designed for clinical applications such as: to support a patient and facilitate a diagnostic procedure employing some imaging technique or to position a patient for various treatments in clinics or hospitals. This device is used by a physician or a health care professional: this device is not operated by a patient. This is a Class II device has a Classification name as: Mobile Fluoroscopic Tilting Table, as described in 21 CFR Part 892.11980. U.S. Imaging Tables, Incorporated has determined this device is substantially equivalent to a predicate medical device which is currently in commerce and is identified as: Deluxe "C" Arm Stretcher, Model 056-004. and is manufactured by Biodex Medical Systems. Inc. of Shirley New York.
A determination of substantial equivalence is based upon the following:
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This device offers mechanical support and adjustment to suspend and position a patient into various arrangements where various parts of the patient would be accessible to an imaging system.
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This device uses conventional design, construction and those materials commonly found in
most similar Tables. This device uses conventional design, construction and those materials similar to the predicate, substantially equivalent device {except where this device is suited to a more general purpose design}.
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This device has benefited from design, development, testing and production procedures that conform to Good Manufacturing Procedures.
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This device has performance characteristics substantially equivalent to its predicate device { which includes differences to facilitate the various clinical applications for which it is intended}.
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This device is safe and effective for the application for which it is intended and has been tested to confirm its safety and effectiveness.
U.S. Imaging Tables, Incorporated continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this device.
CERTIFICATION:
I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.
Date
Safety and Effectiveness applies for th
Signed by Mr. Ronald Denezzo Acting Operations Manager U.S. Imaging Tables, Incorporated 28 Central Avenue Happauge, NY 11788 V-516 231 7300 F-516 231 7542
C:\24\DL VR\24106A.DOC
§ 892.1980 Radiologic table.
(a)
Identification. A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.