FG INFUSION CATHETER

K971306 · Cordis Neurovascular, Inc. · KRA · Jul 14, 1997 · Cardiovascular

Device Facts

• Record ID: K971306
• Device Name: FG INFUSION CATHETER
• Applicant: Cordis Neurovascular, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Jul 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CES Infusion Catheters are intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures.

Device Story

FG Infusion Catheter is a diagnostic/therapeutic catheter used for selective infusion of agents into peripheral, coronary, and neurovasculatures. Device functions as a delivery mechanism for diagnostic, embolic, or therapeutic substances. Operated by clinicians in clinical settings. Benefits include targeted delivery of agents to specific vascular sites. Substantially equivalent to existing infusion catheters regarding design, construction, and intended use.

Clinical Evidence

Bench testing only. Biocompatibility testing performed according to FDA modified matrix of ISO-10993 (Blue Book Memorandum G95-1).

Technological Characteristics

Infusion catheter for vascular access. Biocompatibility verified per ISO-10993. Design and construction consistent with predicate infusion catheters.

Indications for Use

Indicated for selective infusion of diagnostic, embolic, and therapeutic agents into peripheral, coronary, and neurovasculatures. Prescription use only.

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

• MAGIC Infusion Catheter (K923368)
• CES Infusion Catheters (K965181)
• EDDY Infusion Catheter (K971306)

Submission Summary (Full Text)

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K971306

0-000036

# SUMMARY OF SAFETY AND EFFECTIVENESS

## I. General Provisions

JUL 14 1997

Common or Usual Name: Diagnostic, Intravascular Catheter
Proprietary Name: FG Infusion Catheter

## II. Name of Predicate Devices

MAGIC Infusion Catheter - K923368
Balt, distributed by Target Therapeutics
Product Code: 74DQO
*Predicate for design, intended use and packaging*

CES Infusion Catheters - K965181
Cordis Endovascular Systems, Inc.
Product Code: 74KRA
*Predicate for design, intended use, sterilization and packaging*

EDDY Infusion Catheter
Medi-tech - Boston Scientific Corporation
Product Code: 74KRA
*Predicate for design and intended use and packaging*

## III. Classification

Class II

## IV. Performance Standards

Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.

## V. Intended Use and Device Description

CES Infusion Catheters are intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures.

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0-000037

## VI. Biocompatibility

Entire FG Infusion Catheters were subjected to biocompatibility testing based on the FDA modified matrix of ISO-10993 (Blue Book Memorandum G95-1). The catheters demonstrated compatibility with biological tissue by meeting the acceptance criteria stipulated in the test protocols.

## VII. Summary of Substantial Equivalence

The CES FG Infusion Catheter is substantially equivalent in its basic design, construction, indications for use, performance characteristics, packaging and sterilization to other commercially available infusion catheters.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Lisa Wells
Manager, Regulatory Affairs
and Clinical Research
Cordis Endovascular Systems, Inc. JUL 14 1997
P.O. Box 025700
Miami, Florida 33102-5700

Re: K971306
FG Infusion Catheter
Regulatory Class: II (two)
Product Code: KRA
Dated: June 26, 1997
Received: June 30, 1997

Dear Ms. Wells:

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 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 requirement, 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 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.

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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" (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/dsmamain.html".

Sincerely yours,

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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0-000045

510(k) Number: __________

## Indications For Use

The CES FG Infusion Catheter is intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use __________


(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K471306