FS IV MINI C-ARM SYSTEM

K974058 · Hologic, Inc. · JAA · Jan 12, 1998 · Radiology

Device Facts

• Record ID: K974058
• Device Name: FS IV MINI C-ARM SYSTEM
• Applicant: Hologic, Inc.
• Product Code: JAA · Radiology
• Decision Date: Jan 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended 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.

Device Story

FS IV Mini C-arm is a compact, mobile X-ray imaging system. Device captures fluoroscopic images of patient anatomy; used by physicians in surgical, orthopedic, podiatric, and emergency care settings. System provides real-time visualization to assist clinicians during procedures. Output is displayed for physician review to guide clinical decision-making and surgical intervention. Benefits include portable, localized imaging capability for various clinical environments.

Clinical Evidence

Bench testing only. Results indicate conformance to all applicable FDA performance standards for fluoroscopic imaging systems.

Technological Characteristics

Compact, mobile C-arm fluoroscopic imaging system. Complies with 21 CFR 1020.30-1020.32 performance standards for fluoroscopic X-ray systems.

Indications for Use

Indicated for patients requiring general fluoroscopic visualization for surgical orthopedic, podiatric, critical care, emergency care, and light anatomy imaging procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Fluoroscan III Mini C-arm System
• OEC Series 6600 Digital Mobile C-arm
• XiScan Dual Digital Mini C-arm
• Lunar ORCA Orthopedic C-arm

Submission Summary (Full Text)

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Hologic, Inc.

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K974058

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## 510(K) SUMMARY FS IV Mini C-arm System

| Submitter Name: | Hologic, Inc. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 590 Lincoln Street<br>Waltham, MA 02154 |
| | JAN 12 1998 |
| Contact Person: | Nandini Murthy, Regulatory Scientist |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| 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 System<br>OEC Series 6600 Digital Mobile C-arm<br>XiScan Dual Digital Mini C-arm<br>Lunar ORCA Orthopedic C-arm |
| Device Description: | The FS IV Mini C-arm system is a compact, mobile C-<br>arm specifically designed for X-ray imaging. |
| Intended Use: | The FS IV Mini C-arm system is designed to provide<br>physicians with general fluoroscopic visualization<br>of a patient including, but not limited to, surgical orthopedic and<br>podiatric, critical and emergency care procedures and light<br>anatomy imaging situations. |
| Performance Data: | Results of bench testing for the FS IV mini C-arm imaging<br>system indicates conformance to all applicable performance<br>standards promulgated by the FDA for fluoroscopic imaging<br>systems. |
| Conclusion: | Based on a comparison to other devices determined to be<br>substantially equivalent through the 510(k) premarket<br>notification process and the claim that the FS IV device meets<br>the federal performance standard for fluoroscopic x-ray systems<br>per 21 CFR 1020.30-1020.32, Hologic, Inc. concludes that the<br>FS IV mini C-arm system is as safe, as effective and performs as<br>well as other legally marketed mini C-arm devices. |

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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 [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)