ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS

K040298 · Acist Medical Systems, Inc. · DXT · Mar 15, 2004 · Cardiovascular

Device Facts

• Record ID: K040298
• Device Name: ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS
• Applicant: Acist Medical Systems, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Mar 15, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The ACIST Medical Systems Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

Device Story

The ACIST Angiographic Injection System provides controlled infusion of radiopaque contrast media during angiographic procedures. The system consists of an automated manifold, an AngioTouch hand controller, and a reusable syringe kit. It serves as the interface between the injection system and the patient's angiographic catheter. The operator uses the hand controller to instantaneously and continuously vary the flow rate of contrast media delivery. This allows for precise, user-determined infusion during clinical procedures. The device is intended for use by healthcare professionals in clinical settings to facilitate diagnostic or interventional angiography.

Clinical Evidence

No clinical performance testing was performed or indicated for the determination of substantial equivalence.

Technological Characteristics

The system comprises an automated manifold, AngioTouch hand controller, and reusable syringe kit. It functions as an electromechanical interface for contrast media delivery. No specific materials, software algorithms, or connectivity features are detailed beyond the mechanical assembly for fluid infusion.

Indications for Use

Indicated for controlled infusion of radiopaque contrast media during angiographic procedures. Prescription use only.

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

• B2000, Automated Manifold Kit (w/o Transducer)
• BT2000, Automated Manifold Kit (w/Transducer)
• H1000, AngioTouch Hand Controller
• EH2000, AngioTouch Hand Controller
• H1000P, AngioTouch Hand Controller
• EH2000P, AngioTouch Hand Controller
• H1000IJ, AngioTouch Hand Controller
• H1000J, AngioTouch Hand Controller

Submission Summary (Full Text)

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K040298

MAR 1 5 2004

## SECTION 10 - 510(k) SUMMARY

January 30, 2004 Date of Application:

### Applicant's and Manufacturer Name and Street Address:

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

Name of Contact Person:

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

| Telephone and Fax Number of Contact Person: | |
|---------------------------------------------|----------------------------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |
| Proprietary Name: | ACIST Angiographic Injection System Contrast<br>Management Disposable Kits |
| Common Name: | Angiographic Contrast Management System |
| Classification<br>Number & Name: | 21 CFR 880.5440, Intravascular Administration Se |
| Class: | Class II |
| Classification Panel: | CV |
| Product Code: | FPA |

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#### Predicate Device(s):

. B2000, Automated Manifold Kit (w/o Transducer) BT2000, Automated Manifold Kit (w/Transducer) H1000. AngioTouch Hand Controller EH2000, AngioTouch Hand Controller H1000P, AngioTouch Hand Controller EH2000P. AngioTouch Hand Controller H1000IJ, AngioTouch Hand Controller H1000J. AngioTouch Hand Controller

#### Device Intended Use:

The ACIST Medical Systems Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

#### Device Description:

The ACIST Medical Systems Angiographic Injection System Contrast Management Disposable Kits provide the interface between the ACIST Injection System and the Angiographic patient catheter for the delivery of contrast media at a userdetermined variable flow rate that can be instantaneously and continuously varied.

The Contrast Management Disposable Kits are comprised of the following elements:

- Automated Manifold .
- AngioTouch Hand Controller .
- Reusable Syringe Kit * .

* Not affected by this change, but provided with the Contrast Management Disposable Kits is the Reusable Syring Kit.

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

- There are no differences in technological characteristics with respect to the . predicate device.
#### Summary of Non-Clinical Performance Data for Determination of Substantial Equivalence with Predicate Device:

- Non-clinical performance testing was not indicated for determination of B substantial equivalence.

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### Summary of Clinical Performance Data for Determination of Substantial Equivalence with Predicate Device:

- Clinical performance testing was not indicated for determination of substantial . equivalence.
## Summary of Conclusions Drawn from Non-Clinical & Clinical Tests:

- Non-clinical and clinical testing was not performed. 대

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its wing, representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2004

ACIST Medical Systems, Inc. c/o Mr. Carl M. Beaurline c/o Mr. Carl M. Beaufine
Vice President, Quality Assurance/Regulatory Affairs 7450 Flying Cloud Drive, Suite 150 Eden Prairie, MN 55344

K040298 Re:

K040298
Trade/Device Name: ACIST Angiographic Injection System
Trade/Device Name: ACIST Angiographic Injection System
11:10 PM Internation and 1660 Fradel Don Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: DXT Dated: March 4, 2004 Received: March 9, 2004

Dear Mr. Beaurline:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQ(e) prematic in substantially equivalent (for the indications
referenced above and have determined the devices markets in interstate referenced above and have determined the us vices is sabicate devices marketed in interstate
for use stated in the enclosure) to legally marketed previce. Device Amendments, for use stated in the enclosure) to legally manced to the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment its with the provision of the Federal commerce prior to May 28, 1976, the enactions with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance when are and one of the Act. The and Cosmetic Act (Act) that co not require approval or a previsions of the Act. The Act. The Act. The Act. The Act. The You may, therefore, market the deVice, subject or the general vannual registration, listing of
general controls provisions of the Act Include requirements misbranding and general controls provisions of the Act Increacy requirements of the research misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may be subject to such additional controlis. Listing may organt of 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In be found in the Code of Federal Regarations, your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualic of a substition with other requirements of the Act
that FDA has made a determination that your device areas agencies. You must that FDA nas made a delertimation inal younger in the Federal agencies. You must in or any Federal statules and regulations administered to: registration and listing (21 l
east of the Act's requirements, including, but not limited to: registration as set comply with all the Act STequirements, mortaing, out not and can and and set as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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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 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,

Dura R. Lulmel

Br
Di
Di

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

Enclosure

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# Indications for Use

510(k) Number:

K040298

Device Name: ACIST Angiographic Injection System

Indications for Use:

The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

X Prescription Use (21 CFR 801 Subparl D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Dana R. Lachner

Page 1 of

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ 8040298