(73 days)
The Ceiling Mounted Lateral Positioners Model 6896.002 will be used for cardiac imaging required for electrophysiology and heart catherizations imaging
Ceiling Mounted Lateral Positioner, Model No. 6896.002
The provided document is a 510(k) premarket notification letter from the FDA for a device called "Ceiling Mounted Lateral Positioner, Model No. 6896.002." This letter confirms that the device has been found substantially equivalent to a predicate device.
This document does not contain any information regarding acceptance criteria, device performance metrics, study details (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set information.
The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, ensuring the new device is as safe and effective as the predicate. It typically relies on comparisons of design, materials, indications for use, and performance data from engineering tests, rather than extensive clinical studies with specified acceptance criteria and expert-adjudicated ground truth as would be found in a clinical trial report for an AI/ML medical device.
Therefore, I cannot provide the requested information based on the provided text.
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Image /page/0/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three human profiles within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is printed to the right of the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP | | 1997
Re:
Oscar Khutoryansky Vice President Trex Medical Corporation 2000 South 25th Avenue Broadview, Illinois 60153 K972442 Ceiling Mounted Lateral Positioner, Model No. 6896.002 Dated: June 25, 1997 Received: June 30, 1997 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA
Dear Mr. Khutoryansky:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the vice is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce rior 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
h Lillian Yiu, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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S 10(k; Number (if known): K972442
Devic : Nami: Ceiling Monnted Lateral Positioner, Model No. 6896.002 Indications For Use:
The Ceiling Mounted Lateral Positioners Model 6896.002
will be used for cardiac imaging required
for electrophysiology and heart
catherizations imaging
Oscar Klunbonsky
- VP
(PLE \SE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Bergman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use Per :' I Cl R 801. 109)
OR
Over-The-Counter Use
(Optional Formal 1-2-961
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.