1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS

K983003 · Cordis Neurovascular, Inc. · KRA · Sep 17, 1998 · Cardiovascular

Device Facts

• Record ID: K983003
• Device Name: 1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS
• Applicant: Cordis Neurovascular, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Sep 17, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MASS TRANSIT Infusion Catheters are indicated for the selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature.

Device Story

Single-lumen infusion catheter designed for navigation of small, tortuous vasculature; used for delivery of diagnostic, therapeutic, and embolic agents. Features hydrophilic coating for lubrication and PTFE-lined inner lumen to facilitate guidewire movement. Shaft tapers from 3.0F proximally to 2.8F distally. Operated by clinicians in clinical settings to access target vasculature; output is the delivery of agents to the site. Benefits include improved access to complex vascular anatomy for targeted therapy.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Single-lumen catheter; 3.0F to 2.8F tapered shaft; hydrophilic coating; PTFE-lined inner lumen. Biocompatible materials.

Indications for Use

Indicated for selective infusion of diagnostic, therapeutic, and embolic agents into peripheral, coronary, and neurovasculature.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• MASS TRANSIT Infusion Catheter (Cordis Endovascular Systems, Inc.)

Submission Summary (Full Text)

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K983003

## Attachment 4

## Summary of Safety and Effectiveness

| General Provisions | Trade Name: MASS TRANSIT Infusion Catheter |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Common/Classification Name: Continuous Flush Catheter |
| Name of Predicate Devices | Cordis Endovascular Systems, Inc. MASS TRANSIT Infusion Catheter |
| Classification | Class II |
| Performance Standards | The FDA under section 514 of the Food, Drug and Cosmetic Act has not established performance standards. |
| Intended Use and Device Description | The MASS TRANSIT Infusion Catheters are indicated for the selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature. |
| | The device description for the MASS TRANSIT Infusion Catheters is as follows. <ul><li>Single lumen catheter designed to access small, tortuous vasculature for the delivery of diagnostic, embolic, and therapeutic agents.</li><li>The shaft tapers from 3.0F proximally to 2.8F distally.</li><li>The catheter has a hydrophilic coating to provide lubrication for navigation of vessels.</li><li>The inner lumen is lined with PTFE to facilitate movement of guidewires and other devices.</li></ul> |
| Biocompatibility | All materials used in the MASS TRANSIT Infusion Catheters are biocompatible. |
| Summary of Substantial Equivalence | The MASS TRANSIT Infusion Catheters are substantially equivalent to the previously cleared MASS TRANSIT Infusion Catheters. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 1998

Mr. Martine D. Schneider Sr. Regulatory Affairs Associate Cordis Endovascular System, Inc. 14000 N.W. 57th Ct. Miami Lakes, FL 33014

Re : K983003 Trade Name: Mass Transit Infusion Catheter Requlatory Class: II Product Code: KRA Dated: August 27, 1998 Received: August 28, 1998

Dear Mr. Schneider:

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 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). 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, qood 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 Requlations, 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 regulation may result in regulatory action. In addition, --FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket

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Page 2 - Mr. Martine D. Schneider

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 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 requlation 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,

Ohi+tlyllstora-for

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment 2

## Indications for Use Statement

| 510(k) Number<br>(if known) | The 510(k) number has not yet been assigned. |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | MASS TRANSIT Infusion Catheter Catheters |
| Indications for<br>Use | The MASS TRANSIT Infusion Catheters are indicated for the selective infusion of<br>various diagnostic, therapeutic, and embolic agents into the peripheral, coronary,<br>and neurovasculature. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chistopher M. Ahrenholz TTC

(Division Sign-Off) Division of Cardiovascular and Iveurological Devic 98300 3 510(k) Number

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use