(118 days)
GENERAL RADIOGRAPHIC MEDICAL X-RAY PROCEDURES
STERNE ACU-RAY HF
The provided text is a 510(k) clearance letter from the FDA for the "STERNE ACU-RAY HF Series Portable X-Ray Unit". It states that the device is substantially equivalent to legally marketed predicate devices for general radiographic medical X-ray procedures.
However, this document does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications that would be required to answer the requested questions.
The letter is simply an FDA clearance notice, confirming that the device can be legally marketed. It does not include the technical details or study results that would typically be found in a submission to demonstrate substantial equivalence.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and the study proving device performance based on the input text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 8 1997
Brent Nelson Sterne Equipment Co., LTD. 7 Research Rd. Brampton, Ontario L6W 1P4 Canada
Re:
K972204 ACU-Ray HF Series Portable X-Ray Unit Dated: June 23, 1997 Received: September 17, 1997 Regulatory class: II 21 CFR 892.1720/Procode: 90 IZL
Dear Mr. Nelson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 II (Special Controls) or 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 Quality System Regulation (QS) 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 notification submission does 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.
W.T.Liau Yu
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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Page__________________________________________________________________________________________________________________________________________________________________________ 이
510 (k) Number (if known): N/A
Device Name: STERNE ACU-RAY HF
Indications for Use: GENERAL RADIOGRAPHIC MEDICAL X-RAY PROCEDURES
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
Over The Counter Use_________
(Optional Format 1-2-96)
David A. Heyman
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.