CKIS-004A INJECTOR SYNCHRONIZATION OPTION

K061976 · Toshiba America Medical Systems, In.C · DXT · Sep 27, 2006 · Cardiovascular

Device Facts

• Record ID: K061976
• Device Name: CKIS-004A INJECTOR SYNCHRONIZATION OPTION
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: DXT · Cardiovascular
• Decision Date: Sep 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

This device is designed to facilitate contrast enhanced CT examinations. This device employs no intended uses that are not in cleared devices already found in the marketplace. The CKIS-004A, Injector Synchronization Option is intended to facilitate contrast enhanced CT examinations by interfacing the CT system to a contrast injection system. When employed, the CKIS-004A will allow both the CT scan and the contrast bolus to occur by activation of either the CT or the injector. The communications between the devices is based upon the CiA-425 standard.

Device Story

CKIS-004A Injector Synchronization Option facilitates contrast-enhanced CT examinations by providing a hardware/software interface between a CT scanner (Toshiba Aquilion) and a contrast injection device. Operation relies on the CiA-425 communications standard. The system allows synchronized activation of both the CT scan and the contrast bolus delivery via a single trigger from either the CT console or the injector. Used in clinical radiology settings by trained technicians or physicians. Synchronization ensures precise timing between contrast arrival and image acquisition, potentially improving diagnostic image quality and reducing contrast media waste.

Clinical Evidence

No clinical data provided; bench testing only. The device conforms to IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-44 safety standards.

Technological Characteristics

Hardware and software interface for CT scanner-injector synchronization. Utilizes CiA-425 communications standard. Compliant with IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-44. Designed under 21 CFR 820 Quality System Regulations.

Indications for Use

Indicated for patients undergoing X-ray imaging of the whole body via Computerized Tomography, including Axial, Volumetric (Helical), and CT Fluoroscopy, requiring contrast-enhanced examinations.

Regulatory Classification

Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Siemens Care Contrast CT (k043807)
• Medrad Stellant CT Injector (k033881)

Submission Summary (Full Text)

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

# 510(k) Summary

K 06 1976

| Date: | June 19, 2006 |
|---------------------------------------|--------------------------------------------------------------------------------------|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,<br>Tustin, CA 92781-2068 |
| Submitter's Contact: | Paul Biggins, Regulatory Affairs Specialist,<br>[phone] |
| Establishment Registration<br>Number: | 2020563 |
| Device Proprietary Name: | CKIS-004A Injector Synchronization Option |
| Common Name: | Scanner, Computed Tomography, X-Ray<br>[Fed. Reg. No. 892.1750, Pro. Code:<br>90JAK] |
| Regulatory Class: | II (per 21 CFR 892.1750) |
| Performance Standard: | 21 CFR Subchapter J,<br>Federal Diagnostic X-ray Equipment<br>Standard |
| Predicate Device(s): | Siemens Care Contrast CT; k043807<br>Medrad Stellant CT Injector; k033881 |
| Reason For Submission | Modification of cleared device |

### Description of this Device:

The CKIS-004A will be added to the previously cleared TSX-101A Aquilion CT This addition requires hardware and software modifications to the system. existing device. Application of this option will facilitate contrast enhanced CT examinations by providing an interface between the CT system and the contrast injection device. This interface is based upon the protocol contained in the CIA-425 standard.

## Summary of Intended Uses:

This device is designed to facilitate contrast enhanced CT examinations. This device employs no intended uses that are not in cleared devices already found in the marketplace.

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

# Ko61976

## Technological Characteristics:

This package is similar in uses and applications as those of the predicate devices. The main difference is in the method used to obtain the final results.

### Safety and Effectiveness Concerns:

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, that apply to this upgrade, will be met and reported via a supplement to the initial report for the predicate device. Additionally this system is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60601-2-32, IEC 60601-2-44. - Medical Device Safety standards and CiA -425 communications standard..

#### Substantial Equivalence:

Siemens Care Contrast CT; k043807 Medrad Stellant CT Injector; k033881

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Toshiba American Medical Systems, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, N.W. BUFFALO MN 55313

SEP 2 7 2006

K061976 Re:

> Trade/Device Name: CKIS-004A Injector Synchronization Option Regulation Number: 21 CFR \$892.1750 Regulation Name: Computed tomography x-ray system Product Code: JAK Regulation Number: 21 CFR §892.1650 Regulation Name: Angiographic injector and syringe Product Code: DXT Regulatory Class: II Dated: September 9, 2006 Received: September 12, 2006

Dear Mr. Job:

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.

Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. The letters "PA" are in the center of the logo in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.

Protecting and Promoting Public Health

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

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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will attow you to begin maiketing your device anyana Seations 10(l.) 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) 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 [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Nancy C Hodgon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

K061976

510(k) Number (if known):

Device Name: CKIS-004A Injector Synchronization Option

Indications For Use:

X-ray imaging of whole body - Computerized Tomography

Including:

Axial Volumetric (Helical) CT Fluoroscopy

The CKIS-004A, Injector Synchronization Option is intended to facilitate contrast enhanced CT examinations by interfacing the CT system to a contrast injection system. When employed, the CKIS-004A will allow both the CT scan and the contrast bolus to occur by activation of either the CT or the injector. The communications between the devices is based upon the CiA-425 standard.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division Sign-Off) Division of Reproduct and Radiological Devic 510(k) Number

Page 1 of