K Number

Device Name

ACIST GENTOO CONTRAST INJECTION SYSTEM

Manufacturer

ACIST MEDICAL SYSTEMS

Date Cleared

2003-01-27

(314 days)

Product Code

DXT PRE

Regulation Number

870.1650

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical and programmable parameters for contrast and saline delivery, with no mention of AI or ML terms or functionalities.

Therapeutic

No.
The device is used to deliver radiopaque contrast media, which is a diagnostic aid, not a therapeutic agent.

Diagnostic

This device is a contrast injection system used to administer contrast media for imaging, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description clearly outlines multiple hardware components including an Injector Head, Syringe and Patient Kits, Remote Display, and Power Supply, indicating it is not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is the "delivery of radiopaque contrast media to selected sites in the vascular system during computed tomography applications." This describes a device used in vivo (within the living body) to facilitate imaging, not a device used in vitro (outside the living body) to examine specimens like blood, urine, or tissue for diagnostic purposes.
Device Description: The description details a system for injecting fluids into a patient's vascular system. This aligns with an in vivo application.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.

Therefore, the ACIST GENTOO Contrast Injection System is a medical device used for in vivo procedures, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

DXT

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Computed Tomography

Anatomical Site

Vascular system

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 .

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
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.

Summary

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 - (952) 995-9319 Fax - (952) 941-4648

Acist GENTOO Contrast Injection System Proprietary Name:

Common Name: CT Injection System

Classification Name: Injector and Syringe, Angiographic

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 .

Device Intended Use:

Device Description:

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 .

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 .

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

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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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

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)

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

J. O'Connor

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