(75 days)
Routine Radiolgraphic/Fluoroscopic examinations of the entire human anatomy, gastrointestinal tract, full vascular/interventional capabilities, and organ examinations.
The Clinix mp is a remote controlled R/F X-ray system intended for radiographic/ fluoroscopic examinations of the entire human anatomy. This device may include signal analysis and display equipment, patient equipment supports, components and accessorial
The provided text describes a medical device, the Clinix mp, an R/F X-ray system. However, it does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document is primarily a 510(k) summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to a predicate device and confirming regulatory compliance rather than presenting detailed performance study results.
Therefore, I cannot fulfill your request for the specific information you asked for based on the text provided. The text only states:
- "Effectiveness is established by MECALL's evaluation throughout all phases of the Clinix mp development. The product will perform in accordance with the development specifications."
This is a general statement about internal evaluation and adherence to specifications, not a detailed report of a study with specific acceptance criteria and performance metrics.
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Picker 510(k) Notice
Clinix mp
Summary of Safety and Effectiveness
This is a summary of the information submitted by Picker International, Inc. to the Office of Device Evaluation (DRAERD) of the FDA as required by the Federal Food, Drug, and Cosmetic Act as amended on November 18, 1990 in section 513(f)(3) for the Universix 190.
The Clinix mp is a remote controlled R/F X-ray system intended for radiographic/ fluoroscopic examinations of the entire human anatomy. This device may include signal analysis and display equipment, patient equipment supports, components and accessorial
Functional specifications and operator's instructions (preliminary) are included in the attachments. Final documentation will be provided with production units.
The Clinix mp is substantially equivalent to legally marketed devices. The Clinix mp is under control of health care professionals who are trained and responsible for fluoroscopic examinations. The Clinix mp will be certified to complis with Federal Diagnostic X-ray Performance Standards. Labeling (Product Bulletin and Operator's Manual) will be provided to the user of the equipment.
MECALL adheres to FDA GMPs, 21 CFR 1020.30-31, voluntary standards for safety/effectiveness (UL 187) all of which mandate that components are tested to minimize hazards (electrical, mechanical, and radiation).
Effectiveness is established by MECALL's evaluation throughout all phases of the Clinix mp development. The product will perform in accordance with the development specifications. The Clinix mp represents the current state-of- the-art technology, therefore, is equivalent to legally marketed remote C-arm systems.
MECALL has reviewed all known information and performed an investigation as to the causes of safety/effectiveness concerning the Clinix mp. In addition, all information contained in this 510(k) Notice is accurate and complete.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Robert L. Turocy Regulatory Compliance Manager Picker International, Inc. World Headquarters 595 Miner Road CLEVELAND OH 44134
FEB 1 9 2013
Re: K960920 Trade/Device Name: Clinix mp Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: March 5, 1996 Received: March 6, 1996
Dear Mr. Turocy:
This letter corrects our substantially equivalent letter of May 20, 1996.
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 (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing pactice medied as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as oor form arketing 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/ReportaProblem/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,
Janine M. Morris
Acting 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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510(k) Number (if known): K960920
Device Name: Clinix mp
Indications for Use:
Indications for Use: Routine Radiolgraphic/Fluoroscopic examinations of the entire human anatomy, gastrointestinal tract, full vascular/interventional capabilities, and organ examinations.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jliand L. Sypon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.