ACIST GENTOO CONTRAST INJECTION SYSTEM

K020892 · Acist Medical Systems · DXT · Jan 27, 2003 · Cardiovascular

Device Facts

• Record ID: K020892
• Device Name: ACIST GENTOO CONTRAST INJECTION SYSTEM
• Applicant: Acist Medical Systems
• Product Code: DXT · Cardiovascular
• Decision Date: Jan 27, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The ACIST GENTOO Contrast Injection System for Computed Tomography is intended for use in the delivery of radiopaque contrast media to selected sites in the vascular system during computed tomography applications.

Device Story

ACIST GENTOO is a dual-syringe injector for contrast and saline delivery during CT imaging. System comprises injector head, syringe/patient kit, remote display, and power supply. Technologist programs injection protocols (flow rate, volume, pressure limits, scan delay) via remote display in control room. CMS technology allows multi-patient use of syringe kit (up to 8 cases) by replacing patient-contact components. Device automates fluid delivery, test injections, and KVO (keep vein open) functions. Output assists clinicians in achieving optimal contrast enhancement for CT scans, potentially improving diagnostic image quality.

Clinical Evidence

Bench testing only. Performance testing verified fluid delivery volume accuracy, flow rate accuracy, pressure limit accuracy, and timing parameters (scan delay, pause, KVO) against predicate specifications.

Technological Characteristics

Dual-syringe injector system; contrast and saline syringes; remote display and power supply units. Features CMS (Contrast Management System) for multi-case disposable kit usage. Programmable injection parameters including flow rate, volume, pressure, and scan delay. Includes syringe heater for fluid temperature control.

Indications for Use

Indicated for delivery of radiopaque contrast media to vascular sites during computed tomography procedures.

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

• Medrad EnVision CT Injection System and Disposable Kit
• Acist CMS2000 Angiographic Injection System Disposable Kits

Submission Summary (Full Text)

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

K02089z

JAN 2 7 2003

# 11-1

#### SECTION 11 - 510(k) SUMMARY

Date of Application: March 14, 2002

Applicant's Name and Address:

Acist Medical Systems, Inc. 7450 Flying Cloud Drive Suite 150 Eden Prairie, MN 55344

Name of Contact Person:

Carl M. Beaurline Vice President, Quality Assurance / Regulatory Affairs

Telephone and Fax Numbers:

Telephone - [phone] Fax - [phone]

Acist GENTOO Contrast Injection System Proprietary Name:

Common Name: CT Injection System

Classification Name: Injector and Syringe, Angiographic

II

DXT

Classification Number: 870.1650

Class:

Classification Panel: Cardiovascular

Product Code:

Predicate Devices:

- Medrad EnVision CT Injection System and Disposable Kit . ●
- Acist CMS2000 Angiographic Injection System Disposable Kits .

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

#### Device Intended Use:

The ACIST GENTOO Contrast Injection System for Computed Tomography is intended for use in the delivery of radiopaque contrast media to selected sites in the vascular system during computed tomography applications.

#### Device Description:

The ACIST GENTOO is a dual-syringe injector with one contrast syringe and one saline syringe that allows the user to program procedure protocols that specify injection parameters for both contrast and saline, and to allow the technologist to use saline for test injections. The ACIST GENTOO uses a two part injection molded dual syringe kit that incorporates ACIST's Contrast Management System (CMS) technology. The CMS functionality allows the user to disconnect and discard the patient contact portion of the kit at the end of each case, and use the syringe kit for up to 8 cases.

The four basic components of the device are distributed in the user facility between the:

- CT lab [(1) Injector Head and (2) Syringe and Patient Kits] and the .
- Control Room [(3) Remote Display and (4) Power Supply] where the CT imaging . equipment is operated.

#### Summary of Comparative Technological Characteristics with Predicate Device:

- Intended Use .
- Location of Use .
- . Weight
- Operating/Non-Operating Environmental Specifications .
- Protection Against Electrical Shock .
- Current Leakage and Continuity ●
- Fluid Delivery Performance .
- Flow Rate Range .
- Pressure Limit Parameters .
- Autofill Parameters .
- Test Inject Parameters .
- . Pause and KVO Parameters
- Scan Delay Parameters ●
- Syringe Heater Parameters .
- Safety Features .

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

### Summary of Comparative Performance Testing with Predicate Device To Demonstrate Substantial Equivalency:

- Fluid Delivery Volume Range ●
- Fluid Delivery Volume Accuracy .
- Flow Rate Range Accuracy ●
- Flow Rate Range Duration ●
- Pressure Limit Range .
- . . . . . Pressure Limit Accuracy
- Autofill Volume Range
- Autofill Fill Rate Default
- Autofill Fill Rate Range
- . Test Injection Fluids
- Test Injection Default
- . Test Injection Flow Rate Range
- . Test Injection Volume Range
- . Test Injection Volume Accuracy
- . Pause Range
- . Pause Accuracy
- . KVO Flow Rate
- KVO Volume Accuracy .
- Scan Delay Time Range .
- Scan Delay Time Accuracy .
- Syringe Heater Average Fluid Temperature .

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

Image /page/3/Picture/1 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 three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be part of a single, flowing design. The image is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 2 7 2003

Mr. Carl M. Beaurline Vice President, QA/RA ACIST Medical Systems, Inc. 7450 Flying Cloud Drive, Suite 150 Eden Praire, MN 55344

Re: K020892

> Trade/Device Name: Acist GENTOO Contrast Injection System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: DXT Dated: November 6, 2002 Received: November 7, 2002

Dear Mr. Beaurline:

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 (PMA), 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 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

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

Page 2 - Mr. Carl M. Beaurline

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 allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

{5}------------------------------------------------

# INDICATIONS FOR USE FORM

Page of of

11020892 510(k) Number:

Acist GENTOO Contrast Injection System Device Name:

Indications for Use:

# The Acist GENTOO Contrast Injection System for Computed Tomography is intended for use to deliver radiopaque contrast medium to selected sites in the vasculature during computed tomography applications.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

J. O'Connor

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K020892