XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM

K984406 · Xitec, Inc. · OXO · Feb 2, 1999 · Radiology

Device Facts

• Record ID: K984406
• Device Name: XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM
• Applicant: Xitec, Inc.
• Product Code: OXO · Radiology
• Decision Date: Feb 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The XiScan Expert Imaging Systems are intended for fluoroscopic imaging of patient extremities.

Device Story

XiScan Expert Imaging Systems are compact, mobile mini c-arm systems for fluoroscopic imaging of patient extremities. Systems include XiScan Office Expert and XiScan Surgical Expert versions. Operation modes include manual or automatic exposure rate control (AERC), with selectable low-dose or standard-dose settings. Surgical Expert includes remote hand-held keypad for patient information management and image storage. Systems provide image manipulation options. Used in clinical/surgical settings by healthcare professionals to visualize extremities; output assists in diagnostic or procedural decision-making.

Clinical Evidence

Bench testing only. Comparison of patient X-ray exposure rates for imaging various anatomies against predicate devices confirmed similarity.

Technological Characteristics

Mini c-arm fluoroscopic X-ray system. Features manual and automatic exposure rate control (AERC) modes. Includes low-dose and standard-dose settings. Surgical version includes remote keypad. Connectivity for image storage. Class II device (21 CFR 892.1650, 892.1720).

Indications for Use

Indicated for fluoroscopic imaging of patient extremities.

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 Premier
• Fluoroscan OfficeMate
• OEC Mini 6600 Digital Mobile C-arm

Submission Summary (Full Text)

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# 2 1999 FEB

# 510(k) Summary for XiScan Expert Imaging Systems

KG84406

#### 1. SPONSOR

XiTec, Inc. 4 New Park Road East Windsor, CT 06088

Contact Person: Steven Hanright Telephone: [phone]

Date Prepared: December 8, 1998

## 2. DEVICE NAME

| Proprietary Name: | XiScan Expert Imaging Systems |
|----------------------|----------------------------------------------|
| Common/Usual Name: | Mini c-arm systems |
| Classification Name: | Image-intensified fluoroscopic X-ray systems |

#### 3. PREDICATE DEVICES

Fluoroscan Premier Fluoroscan OfficeMate OEC Mini 6600 Digital Mobile C-arm

## DEVICE DESCRIPTION 4.

The XiScan Expert Imaging Systems are compact, mobile, mini c-arm systems specifically designed for fluoroscopic imaging of patient extremities. Two versions are available: the XiScan Office Expert and the XiScan Surgical Expert. The systems can be operated in either manual or automatic exposure rate control (AERC) modes, with options of reduced radiation LOW DOSE and high resolution STANDARD DOSE when using AERC. Both systems offer a range of options for image manipulations. The Surgical Expert also features a remote, hand-held keypad to manage on-screen patient information and image storage.

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#### 5. INTENDED USE

The XiScan Expert Imaging Systems are intended for fluoroscopic imaging of patient extremities.

#### BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The XiScan Expert Imaging Systems have the same intended use, and similar technical specifications, as compared to the predicate devices. All devices are mini c-arm systems with similar technique factors, SIDs, field-of-view sizes, and image enhancement options. A bench test comparison of the devices confirmed that the patient X-ray exposure rates for imaging various anatomies are similar. Based on these comparisons, the XiScan Expert Imaging Systems are substantially equivalent to the Fluoroscan and OEC mini c-arm systems.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1999 FEB

Xitec Sheila M. Hemeon-Heyer, Esq., RAC Senior Staff Consultant c/o Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re:

K98406 XiScan Office Expert Imaging System XiScan Surgical Expert Imaging System Dated: December 8, 1998 Received: December 9, 1998 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA 21 CFR 892.1720/Procode: 90 IZL

Dear Ms. Hemeon-Heyer:

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 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. 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 III (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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation 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 the Electronic Product 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 [phone]. Additionally, for questions on the promotion 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/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting 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): KG8 440 6

XiScan Expert Imaging Systems Device Name: __

Indications For Use:

The XiScan Expert Imaging Systems are intended for fluoroscopic imaging of patient extremities.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Simid C. Sypm

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use -------------------

(Optional Format 1-2-96)