ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B

K984231 · Invasatec · DXT · May 31, 2000 · Cardiovascular

Device Facts

• Record ID: K984231
• Device Name: ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
• Applicant: Invasatec
• Product Code: DXT · Cardiovascular
• Decision Date: May 31, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The Acist™ CMS-2000 Angiographic Injection System with Contrast Management is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures. The Angiographic Contrast Management System allows the user to safely use contrast media for multiple procedures.

Device Story

Accessory to ACIST Injection System; enables multi-procedure use of contrast media. Two-part kit: Part A (non-patient contact, holds contrast) and Part B (patient contact, disposable). Part A and B connected for procedure; Part B disconnected/discarded post-procedure; syringe cap applied to Part A to maintain sterility. System utilizes one-way check valves to prevent retrograde flow and contamination of fluid in dual-port syringe/container. Used in clinical angiographic settings; operated by medical staff. Benefits include safe, efficient contrast media management across multiple patients/procedures.

Clinical Evidence

Bench testing only. Biological challenge tests demonstrated the device's ability to maintain sterility of contrast media and syringe components for continued use. Pressure testing verified the interconnect between Parts A and B. Packaging validation testing verified the modified packaging configuration.

Technological Characteristics

Dual-port syringe and contrast media container system. Features one-way check valves to prevent retrograde flow. Two-part kit configuration (Part A non-patient contact, Part B patient contact). Sterile, single-use components. Mechanical design focused on fluid path isolation and sterility maintenance.

Indications for Use

Indicated for controlled infusion of radiopaque contrast media during angiographic procedures. Intended for use by clinicians in a professional healthcare setting.

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 Injection System (K963882)
• Merit Contrast Management System (K961794)
• NAMIC Contrast Saving Delivery System (K903493)

Submission Summary (Full Text)

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K984231

## 510(k) SUMMARY General Information

| Date Prepared | November 23, 1998 |
|-------------------|---------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II |
| Trade Name | Angiographic Contrast Management System |
| Common Name | Intravascular Fluid Delivery Set |
| Submitter | ACIST Medical System<br>10250 Valley View Road<br>Eden Prairie, MN 55344<br>612-941-3507 |
| Contact | Kate Anderson<br>Manager, QA/Regulatory |
| Predicate Devices | Acist Injection System (K963882)<br>ACIST Medical Systems |
| | Merit Contrast Management System (K961794)<br>Merit Medical Systems, Inc. |
| | NAMIC Contrast Saving Delivery System (K903493)<br>North American Instrument Corporation, Angiographic System<br>Division |

## Device Description

The ACIST Medical Systems Angiographic Contrast Management System is an accessory to the ACIST Injection System. It is designed to allow the user to safely use contrast media for multiple procedures . It consists of a two-park kit—Parts A, a non-patient contact kit, and B, a patient contact kit. Part A is initially set up and filled with contrast media. Part B is then attached to Part A via a connector and the system is ready to initiate a procedure. " The Drish attached it Part R VILLE Collection of the procedure, Part B is disconnected and discarded. The syringe cap is placed on Part A to maintain sterility between procedures.

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The Angiographic Contrast Management System is provided sterile and is intended for single use only.

## Indication

The Acist™ Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures. The Angiographic Contrast Management System allows the user to safely use contrast media for multiple procedures.

## Technological Characteristics

The Angiographic Contrast Management System is designed to prevent patient contacting fluids from contaminating the fluid contained within the dual port syringe and contrast media container. Like the predicate Merit and Namic products, the Angiographic Contrast Management System is designed with one-way check valves to prevent retrograde flow.

As with the Namic product, Biological Challenge tests were conducted demonstrating the ability of the device to maintain the sterility of the contrast media and syringe, allowing continued used of those components. Pressure testing verified the interconnect between Parts A and B. Packaging validation testing verified the modified packaging configuration.

#### Summary

In summary, the above listed predicate devices and the ACIST Angiographic Contrast Management System are substantially equivalent based on design, performance characteristics, and indications for use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 3 1 2000

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

K984231) and K991103 Re: (

R9042017 and RS-2000 Angiographic Injection System with Contrast Management Regulatory Class: Class II DXT Product Code: November 25, 1998 and March 26, 1999 Dated: November 25, 1998 and April 1, 1999 Received:

Dear Mr. Beaurline:

We have reviewed your Section 510(k) notifications of intent to market we nave reviewed your beceiver on the determined the device is the device fereienced above and his marketed predicate devices substantlainy equivatine co-regary many 28, 1976, the enactment Marketed in Incerdate Seathernments or to devices that have been date of the Medical Device famakers' of the Federal Food,
reclassified in accordance with the provisions of the dovice reclassified in accordance with eno pro therefore, market the device, Drug, and Cosmeric Acc (nec). Iou may and the Act. However, you Subject to the general some that the medical devices you use as are responsible to decembine ther been determined as substantially components in the neve casion ification process (Section 510 (k) of equivalence under the premained with market prior to May 28, 1976, the Please note: If you enactment date of the Medical Device Amendments. enactment auce or the components in bulk (i.e., unfinished) and further parchase your acterilize) you must submit a new 510(k) before process (e.g., Secrific) your kit/tray. The general controls Incruding these components in jequirements for annual registration, provisions of the nec incruas beganism
listing of devices, good manufacturing practice, and labeling, and frocing or as as as a so adulteration.

If your device is classified (see above) into either class II (Special II your device 15 crassized (bot class to the subject to such Controls) of Class III (Frenailer of the major regulations affecting your device additional concerner of Federal Regulations, Title 21, Parts 800 ound in the oly equivalent determination assumes compliance to 895. co 653. A Jubstanced in that is that is a requirements, as set with the Ourlows of System Regulation (QS) for Medical Devices:

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#### Page 2 - Mr. Carl M. Beaurline

General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation 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 Regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notifications. 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 the 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" (21 CFR 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,

Sincerely yours,

Bunn E. Atuvenym

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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# PART A - INDICATIONS FOR USE FORM

Page of

K984231 510(k) Number:

Device Name:

Acist™ CMS-2000 Angiographic Injection System with Contrast Management

Indications for Use:

The Acist™ CMS-2000 Angiographic Injection System with Contrast Management 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 Device Evaluation (ODE)

Christopher M. Kure for Dillard.

Prescription Use X (Per 21 CFR 801.109)

OR

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