(77 days)
The FS IV Mini C-arm system is designed to provide physicians with general fluoroscopic visualization of a patient including, but not limited to, surgical orthopedic and podiatric, critical and emergency care procedures and light anatomy imaging situations.
The FS IV Mini C-arm system is a compact, mobile C-arm specifically designed for X-ray imaging.
The provided text describes the 510(k) summary for the Hologic FS IV Mini C-arm System, which is a fluoroscopic imaging system. It does not contain information about a study with acceptance criteria and device performance in the context of an AI-powered diagnostic device. Instead, it discusses the regulatory submission for a hardware medical device (X-ray system).
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, or MRMC studies, as these details are not present in the provided text.
The "Performance Data" section explicitly states: "Results of bench testing for the FS IV mini C-arm imaging system indicates conformance to all applicable performance standards promulgated by the FDA for fluoroscopic imaging systems." This indicates that the device's performance was evaluated against general FDA performance standards for fluoroscopic imaging systems through bench testing, rather than a clinical study comparing its diagnostic accuracy to specific acceptance criteria.
The "Conclusion" further supports this by stating: "Based on a comparison to other devices determined to be substantially equivalent through the 510(k) premarket notification process and the claim that the FS IV device meets the federal performance standard for fluoroscopic x-ray systems per 21 CFR 1020.30-1020.32, Hologic, Inc. concludes that the FS IV mini C-arm system is as safe, as effective and performs as well as other legally marketed mini C-arm devices." This confirms the assessment was based on substantial equivalence to predicate devices and adherence to federal performance standards for X-ray systems, not specific clinical performance metrics related to diagnostic accuracy typically found in AI/algorithm studies.
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Hologic, Inc.
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서는 문제들을 하는 글 카쓰는 바로 바꾸고 ㅠ ㅠ ㅎㅎ ㅎㅎ
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510(K) SUMMARY FS IV Mini C-arm System
| Submitter Name: | Hologic, Inc. |
|---|---|
| Submitter Address: | 590 Lincoln StreetWaltham, MA 02154 |
| JAN 12 1998 | |
| Contact Person: | Nandini Murthy, Regulatory Scientist |
| Phone Number: | (781) 890-2300 |
| Fax Number: | (781) 890-8031 |
| Date Prepared: | Oct 24, 1997 |
| Device Trade Name: | FS IV Mini C-arm System |
| Device Common Name: | Fluoroscopic imaging system |
| Predicate Devices: | Fluoroscan III Mini C-arm SystemOEC Series 6600 Digital Mobile C-armXiScan Dual Digital Mini C-armLunar ORCA Orthopedic C-arm |
| Device Description: | The FS IV Mini C-arm system is a compact, mobile C-arm specifically designed for X-ray imaging. |
| Intended Use: | The FS IV Mini C-arm system is designed to providephysicians with general fluoroscopic visualizationof a patient including, but not limited to, surgical orthopedic andpodiatric, critical and emergency care procedures and lightanatomy imaging situations. |
| Performance Data: | Results of bench testing for the FS IV mini C-arm imagingsystem indicates conformance to all applicable performancestandards promulgated by the FDA for fluoroscopic imagingsystems. |
| Conclusion: | Based on a comparison to other devices determined to besubstantially equivalent through the 510(k) premarketnotification process and the claim that the FS IV device meetsthe federal performance standard for fluoroscopic x-ray systemsper 21 CFR 1020.30-1020.32, Hologic, Inc. concludes that theFS IV mini C-arm system is as safe, as effective and performs aswell as other legally marketed mini C-arm devices. |
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Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 1998
Nandini Murthy, RAC Regulatory Scientist Hologic, Inc. 590 Lincoln Street Waltham, MA 02154
Re:
K974058 FS IV Mini C-arm System Dated: Ocotober 24, 1997 Received: October 27, 1997 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA
Dear Ms. Murthy:
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 ise 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, 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 Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 marked 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. Thau 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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510(k) Number (if known): K 974058
Device Name: FS IV MINI C-ARM SYSTEM
Indications For Use:
The FS IV Mini C-arm system is designed to provide physicians with general fluoroscopic visualization of a patient including, but not limited to, surgical orthopedic and podiatric, critical and emergency care procedures and light anatomy imaging situations.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Seymour
Division Sign Off
ivision Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devi 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.