ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH

K993774 · Acist Medical Systems · DXT · Dec 7, 1999 · Cardiovascular

Device Facts

• Record ID: K993774
• Device Name: ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH
• Applicant: Acist Medical Systems
• Product Code: DXT · Cardiovascular
• Decision Date: Dec 7, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The Acist 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 is an automatic contrast medium injector used in clinical settings to deliver radiopaque contrast media during angiographic procedures. The system consists of an injector head, control panel, power supply, and cables, along with sterile disposable components including a hand controller, contrast syringe, and valving. The device allows the operator to deliver contrast media to a catheter at a user-determined, variable flow rate that can be adjusted instantaneously and continuously. By providing precise control over the infusion, the system assists clinicians in performing angiography, facilitating the visualization of blood vessels. The addition of a 'RESUME' feature (the subject of this 510(k)) allows for continued operation, improving workflow efficiency for the physician during the procedure.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and functional comparison to the predicate device.

Technological Characteristics

System components include an injector head, control panel, power supply, and sterile disposable kits (syringe, hand controller, valving). Operates as an automatic contrast medium injector for variable flow rate delivery. Connectivity involves standard power and interconnect cabling. No specific materials or software architecture details provided.

Indications for Use

Indicated for patients undergoing angiographic procedures requiring controlled infusion of radiopaque contrast media.

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

• Acist® Angiographic Injection System, Model CL100H without the 'RESUME' feature

Submission Summary (Full Text)

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K993774

DEC - 7 1999

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# 510(k) SUMMARY

# 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]

# Address of Manufacturing and Sterilization Site:

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

Sterilization: Not applicable to this product.

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Acist® Angiographic Injection System, Model CL100H Proprietary Name:

Common Name: Contrast Injector

Classification Name: Injector, Contrast Medium, Automatic

Classification Number: 870.1650

Class: II

Classification Panel: Cardiovascular

Product Code: IZO

#### Description:

The Acist® Angiographic Injection System delivers contrast media to a catheter at a userdetermined variable flow rate that can be instantaneously and continuously varied.

The system is comprised of the following elements:

- Injector Head
- Control Panel .
- Power Supply
- AC Power and Interconnect Cables ●

Not affected by this change, but provided with the system are the sterile disposable components. These are contained in two separate kits (D-1000 and H-1000) and include the Hand Controller, Contrast Syringe, and the valving to provide the interface between the system and the angiographic patient catheter

Predicate Device: Acist® Angiographic Injection System, Model CL100H without the "RESUME" feature.

#### Indications for Use:

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

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 7 1999

Mr. Carl M. Beaurline Vice President, Quality Assurance/Regulatory Affairs Acist Medical Systems, Inc. 7450 Flying Cloud Drive Eden Prairie, MN 55344

K993774 Re: Trade Name: Acist Angiographic Injection System Regulatory Class: II Product Code: DXT Dated: November 4, 1999 November 8, 1999 Received:

Dear Mr. Beaurline:

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 leqally 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). 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 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 regulation (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

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Page 2 - Mr. Carl M. Beaurline

your premarket notification submission does not affect any obliqation 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 requlations.

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" (21CFR 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,

Chistopher M. Heaton

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# SECTION 6 - STATEMENT OF INDICATIONS FOR USE / LABELING

# PART A - INDICATIONS FOR USE FORM

Page _________________________________________________________________________________________________________________________________________________________________________ of

510(k) Number:

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.

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

Concurrence of CDRH, Office of I

Christopher tu White

510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

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