FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM

K051025 · Hologic, Inc. · JAA · May 13, 2005 · Radiology

Device Facts

• Record ID: K051025
• Device Name: FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
• Applicant: Hologic, Inc.
• Product Code: JAA · Radiology
• Decision Date: May 13, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The Fluoroscan InSight is a Mini C-Arm Fluoroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including, but not limited to surgical orthopedic and podiatry use, critical and emergency care procedures, and light anatomy imaging situations.

Device Story

Mini C-Arm fluoroscopic imaging system; provides real-time visualization of patient anatomy. Inputs: X-ray radiation passed through patient anatomy; captured by image intensifier. Transformation: X-ray signals converted to digital images via digital camera; processed by system computer (2.4 GHz processor, 512 MB RAM). Output: Digital fluoroscopic images displayed on medical-grade 2 Mega Pixel 19.8" monochrome flat LCD. Used in OR, clinic, or emergency settings; operated by physicians/technicians. Healthcare providers use images for intraoperative guidance and diagnostic visualization; facilitates surgical procedures and clinical decision-making. Benefits: Real-time imaging for orthopedic/podiatric interventions.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and technological comparison.

Technological Characteristics

Mini C-Arm fluoroscopic system. X-ray source: grounded anode tube, 0.127mm Beryllium. Beam filtration: Stainless Steel (Al equivalence > 2.5mm). Focal spot: 0.045mm @ 7.5W. kVp range: 40-75kVp. Digital imaging chain: digital camera, 2.4 GHz processor, 512 MB RAM, 80 GB HDD, DVD RAM. Display: 19.8" monochrome flat LCD. Input: keyboard, footswitch, touch screen. Power: 100/120/220/240V, 50/60 Hz.

Indications for Use

Indicated for general fluoroscopic visualization of patients, including surgical orthopedic, podiatry, 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

• FS IV Mini C-Arm System (K974058)

Submission Summary (Full Text)

{0}------------------------------------------------

### F. 510(k) Summary

## F.1 Manufacturing Establishment and Contact Information

F.1.1 Manufacturer Name and Address:

Hologic, Inc. 35 Crosby Drive Bedford, MA 01730

F.1.2 Establishment Registration Number:

1221300

F.1.3 Name, Title, and Telephone Number of Contact:

Daniel F. Phelan Senior Regulatory Affairs Specialist [phone]

#### F.2 Device Identification

- F.2.1 Device Trade Name:
Fluoroscan InSight Mini C-Arm Fluoroscopic Imaging System

- F.2.2 Common / Usual Name:
Fluoroscopic Imaging System

- F.2.3 Proposed Intended Use:
The Fluoroscan InSight is a Mini C-Arm Fluoroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including, but not limited to surgical orthopedic and podiatry use, critical and emergency care procedures, and light anatomy imaging situations.

### F.3 Device Classification

- F.3.1 Classification:
Class II

- F.3.2 Classification Name and Rule:
Image-Intensified Fluoroscopic X-Ray System, 21 CFR 892.1650

- F.3.3 Classification Panel:
Radiology

- F.3.4 Product Code:
90 JAA

- F.3.5 Predicate Device
510(k) No.: K974058

Trade Name: FS IV Mini C- Arm System

January 12, 1998. SE Date:

Manufacturer: Hologic, Inc.

{1}------------------------------------------------

-

## F.4 Substantial Equivalence

| | Fluoroscan Premier(FS-IV) | Fluoroscan InSight |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| | Image: Fluoroscan Premier(FS-IV) | Image: Fluoroscan InSight |
| 510(k) Number | K974058 | Same |
| Indications for Use | Mini C-Arm Fluoroscopic Imaging System<br>designed to provide physicians with general<br>fluoroscopic visualization of a patient,<br>including, but not limited to surgical<br>orthopedic and podiatry use, critical and<br>emergency care procedures, and light<br>anatomy imaging situations | Same |
| Dimensions (HxWxD) | 60" (152cm) x 36" (91cm) x 32" (81cm) | 65" (165.1cm) x 35" (88.9cm) x 35" (88.9cm) |
| Weight (maximum) | 500 lbs (227 kg) | 650 lbs (295.46 kg) |
| Voltage (nominal) | 100/120/220/240 Single Phase | Same |
| Frequency | 50/60 Hz | Same |
| Source-Image receptor<br>distance | 17.5" (44cm) | Same |
| X-Ray Source | Grounded anode x-ray tube 0.005" (0.127<br>mm) Beryllium | Same |
| Beam Filtration | Stainless Steel with Al equivalence ><br>2.5mm | Same |
| Focal Spot | 0.0018" (0.045mm) @ 7.5 watts | Same |
| Field of View | Operator selectable, 4" or 6" collimation<br>(10.16 cm or 15.24 cm) at plane of Image<br>Intensifier | Same |
| Rated peak tube<br>potential | 75kVp | Same |
| Tube kVp range | 40 to 75kVp | Same |
| Tolerances | kVp ± 5%<br>mA ± 8% ≤ 0.035mA<br>mA ± 5% ≥ 0.035mA | Same |
| Maximum duty cycle<br>at 75 kVp/0.100mA | 50% | Same |
| Video Camera | Analog | Digital |
| System computer | 850 MHz processor | 2.4 GHz processor |
| minimum requirements | 128 MB RAM | 512 MB RAM |
| | CD-ROM | Serial 80 GB HDD |
| | 20 GB HDD | DVD RAM drive |
| | 3.5" Floppy | 3.5" Floppy drive |
| Operating System | Windows NT Embedded | Windows XP |
| Display | Dual 15" Hi-Res CRT | Medical grade 2 Mega Pixel 19.8" Monochrome<br>Flat LCD |
| Input Devices | Keyboard, Footswitch, Touch Screen | Same |

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird in the center. The text around the perimeter appears to be the name of a department or organization. The bird is depicted with three curved lines representing its body and wings, giving it a sense of motion. The logo has a simple, clean design, likely intended to represent the organization's values or mission.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 13 2005

Mr. Daniel F. Phelan Senior Regulatory Affairs Specialist HOLOGIC, Inc. 35 Crosby Drive BEDFORD MA 01730

Re: K051025

Trade/Device Name: Fluoroscan InSight Mini C-Arm Fluoroscopic Imaging System Regulation Number: 21 CFR §892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA r K Dated: April 21, 2005 Received: April 25, 2005

Dear Mr. Phelan:

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 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 898. 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 r carrar states and regarding, but not limited to registration and listing (21 CFR Part 807); labeling / 21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to ogin hances of substantial equivalence of your device to a legally premarket notification. The I Dri mailig of oation 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), please If you desire specific advice for your de restled in the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation entersely formation on your responsibilities under the Act from the 007.97). Tou may obtain outer general missance at its toll-free number (800) DIVISION of Stilan Manufactures, Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon

Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## A.2 Indications for Use Statement

510(k) Number (if known):K0510 25 ____________________________________________________________________________________________________________________________________________

Device Name: _Fluoroscan InSight Mini C-Arm Fluoroscopic Imaging System

Indications for Use:

The Fluoroscan InSight is a Mini C-Arm Fluoroscopic Imaging System designed to provide physicians TTle Fluoroscan frisualization of a patient, including, but not limited to surgical orthopedic and with general hoorosopic visualization of a patient, wis and light anatomy imaging situations.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter-Use

(Per 21 CFR 801.109)

(Optional Format 1)

Nancy Beaudoin

(Division Sign Division of Reproductive, Ab and Radiological Device 510(k) Number