(41 days)
to position patients for a dia procedure employing some imaging technique or to position a patient for various treatments in or hospitals.
the Electrophysiology 40 Tilt Table (Model 9660) and the Delux Model 9660 are designed for clinical applications such as: to position patients for a dia procedure employing some imaging technique or to position a patient for various treatments in 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. As such this 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.
The provided text is a Summary of Safety & Effectiveness for a medical device, the Electrophysiology 40 Tilt Table (Model 9660). It is a premarket notification (510(k)) submission from 1997, which focuses on demonstrating substantial equivalence to a predicate device.
Unfortunately, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The summary states:
- "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 }."
- "This device is safe and effective for the application for which it is intended and has been tested to confirm its safety and effectiveness."
However, it does not provide any specific data, metrics, or details about these tests, nor does it define any acceptance criteria. It also doesn't involve any AI or algorithm performance.
Therefore, I cannot populate the table or answer the specific questions because the necessary information is not present in the provided text.
{0}------------------------------------------------
JAN 30 1997
EXHIBIT 15
K965105/A1
Summary of Safety & Effectiveness
This device, the Electrophysiology 40 Tilt Table (Model 9660) and the Delux Model 9660 are designed for clinical applications such as: to position patients for a dia procedure employing some imaging technique or to position a patient for various treatments in 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. As such this 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:
- This device offers mechanical support and adjustment to suspend and position a patient into various 1. arrangements where various parts of the patient would be accessible to an imaging system.
- This device uses conventional design, construction and those materials commonly found in 2. 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}.
- This device has benefited from design, development, testing and production procedures that conform to Good 3. Manufacturing Procedures.
- This device has performance characteristics substantially equivalent to its predicate device {which includes 4. differences to facilitate the various clinical applications for which it is intended }.
- This device is safe and effective for the application for which it is intended and has been tested to confirm its રું ર 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.
November 19, 1996
Date
Ronald Dahlke
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
24\DLVR\24111A.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.