ACIST PLUS 4 ANGIOGRAPHIC CATHETER

K021015 · Acist Medical Systems · DQO · Apr 26, 2002 · Cardiovascular

Device Facts

• Record ID: K021015
• Device Name: ACIST PLUS 4 ANGIOGRAPHIC CATHETER
• Applicant: Acist Medical Systems
• Product Code: DQO · Cardiovascular
• Decision Date: Apr 26, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Acist PLUS 4™ Angiographic Catheter is intended for use to deliver radiopaque contrast medium to selected sites in the vasculature.

Device Story

The Acist PLUS 4™ Angiographic Catheter is a single-lumen diagnostic device used to deliver radiopaque contrast media to specific vascular sites. Constructed from a radiopaque plastic tube reinforced with an encapsulated stainless steel wire braid, the catheter supports injection pressures up to 8275 kPa. It features a female Luer hub at the proximal end and a non-tapered soft distal tip with multiple side-holes to balance injection force and stabilize tip position. The device is used by clinicians in a clinical setting to facilitate diagnostic imaging. It is supplied sterile for single use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-lumen catheter; materials include radiopaque plastic and encapsulated stainless steel wire braid. Supports injection pressures up to 8275 kPa. Features female Luer hub, non-tapered soft distal tip with multiple side-holes. Sterilized via Ethylene Oxide.

Indications for Use

Indicated for the delivery of radiopaque contrast medium to selected sites in the vasculature.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Acist 4 French Angiographic Catheter (K012983)

Submission Summary (Full Text)

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KO2/0/5 2.9

APR 2 6 2002

Image /page/0/Picture/2 description: The image shows the logo for Acist Medical Systems. The logo features the word "acist" in bold, black letters, with a stylized design above the "i". Below "acist" are the words "MEDICAL SYSTEMS" in a smaller, sans-serif font. The overall design is simple and professional.

## 510(k) SUMMARY Acist PLUS 4TM Angiographic Catheter

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 Contract Manufacturing and Sterilization Sites:

Manufacturing:

MedAmicus Incorporated 15302 Highway 55 West Minneapolis, MN 55447

Sterilization:

STERIS Corporation 380 90th Avenue N.W. Minneapolis, MN 55433

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| APR | 26 2002 |
|-----|---------|
|-----|---------|

| Proprietary Name: | Acist PLUS 4 ^TM Angiographic Catheter |
|------------------------|--------------------------------------------------|
| Common Name: | Angiographic Catheter |
| Classification Name: | Diagnostic Intravascular Catheter |
| Classification Number: | 870.1200 |
| Class: | II |
| Classification Panel: | Cardiovascular |
| Product Code: | DQO |

### Brief Description:

The Acist PLUS 4TM Angiographic Catheter is intended for use in the delivery of radiopaque contrast media to selected sites in the vascular system. It is a single-lumen catheter manufactured primarily from a radiopaque plastic tube that has an encapsulated stainless steel wire braid to provide strength for injection pressures up to 8275 kPa. The proximal end of the device incorporates a strain relief with a female plastic Luer hub for injection to the injection source. The stem and tip sections are radiopaque and are permanently formed to a variety of shapes to facilitate use in various parts of the patient's vasculature. The non-tapered soft distal tip has end and multiple side-holes to balance the injection force and stabilize tip position.

The device is packaged in a Tyvek-to-poly pouch, sterilized by a validated Ethylene Oxide sterilization cycle, and sold for single use only within a 24-month shelf life.

Acist 4 French Angiographic Catheter, K012983 Predicate Device:

Indications for Use:

The Acist PLUS 4™ Angiographic Catheter is intended for use to deliver radiopaque contrast medium to selected sites in the vasculature.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

APR 2 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K021015

Acist PLUS 4TM Angiographic Catheter Regulation Number: 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II (two) Product Code: 74 DQO Dated: March 19, 2002 Received: March 29, 2002

Dear Mr. Beaurline:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for abound in 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 r ou may , aters , or visions 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 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.

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Page 2 - Mr. Carl M. Beaurline

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis leter with and h your finding of substantial equivalence of your device to a legally 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of Compliance at (301) of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Cfe

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE FORM

Page 1 of 1

510(k) Number:

K021015

Device Name:

Acist PLUS 4™ Angiographic Catheter

Indications for Use:

The Acist PLUS 4™ Angiographic Catheter is intended for use to deliver radiopaque contrast medium to selected sites in the vasculature.

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

> Devices ivision of Carti 6021015

510(k) Numbe

Prescription Use_ (Per 21 CFR 801.109)

OR

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