NAVIPORT DEFLECTABLE TIP GUIDING CATHETER

K974683 · Cardima, Inc. · DQY · Jun 22, 1999 · Cardiovascular

Device Facts

• Record ID: K974683
• Device Name: NAVIPORT DEFLECTABLE TIP GUIDING CATHETER
• Applicant: Cardima, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jun 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Cardima NAVIPORT Deflectable Tip Guiding Catheter (here after referred to as NAVIPORT) is intended to serve as a conduit for access into the chambers and coronary vasculature of the heart.

Device Story

The NAVIPORT is a sterile, single-use, dual-lumen, deflectable-tip guiding catheter used by physicians to access heart chambers and coronary vasculature. It features a handle-mounted control knob connected to a distal anchor ring via a stainless steel pull wire; rotating the knob deflects or straightens the catheter tip to facilitate navigation. A large central lumen with a proximal female luer allows for the delivery of medical devices (e.g., EP catheters) into the cardiovascular system. The device is operated by a physician in a clinical setting. It benefits patients by providing a steerable conduit to reach specific cardiac locations, reducing the difficulty of device placement while minimizing trauma to blood vessels and the endocardium.

Clinical Evidence

Safety and effectiveness were evaluated through bench testing (mechanical and reliability), biocompatibility testing, and animal studies. Animal studies confirmed the device's ability to access heart chambers and deliver medical devices without inducing trauma to blood vessels or the endocardium. No human clinical trial data was required.

Technological Characteristics

Dual-lumen, deflectable-tip catheter; stainless steel pull wire; handle-mounted steering mechanism; female luer connector. Sterilized via gamma radiation (minimum 25 kGy) per ANSI/AAMI/ISO 11137. Packaged in paperboard-SBS tray with Tyvek/polyethylene pouch.

Indications for Use

Indicated for use as a conduit for access into the chambers and coronary vasculature of the heart for the delivery of medical devices.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Medtronic's Marinr™ Steerable Intracardiac Electrode Catheter (K931794)
• Sherpa Guiding Catheter (K955651)

Reference Devices

• Cardima VENAPORT (K951603)

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness

#### Trade Name:

Cardima NAVIPORT™ Deflectable Tip Guiding Catheter

# Manufacturer :

Cardima, Inc. 4 % 66 Benibia Street Fremont, CA 94538-7330 Contact: Shelley Trimm Establishment Registration Number: 29-51-009

Classification Name:

Catheter Percutaneous (21 CFR 870.1250)

## Device Classification:

Class II (21 CFR 870.1250) Panel: Circulatory System Devices Panel, DCRND

#### Intended Use and Product Description:

The Cardima NAVIPORT Deflectable Tip Guiding Catheter (here after referred to as NAVIPORT) is intended to serve as a conduit for access into the chambers and coronary vasculature of the heart.

The NAVIPORT is a sterile, single use only, dual lumen, deflectable tip, guiding catheter with various curve reach configurations. NAVIPORT device is torquable and has a steering mechanism (control knob) in the handle. The control knob allows the catheter tip to be curved or to be straightened while the NAVIPORT is being routed to the desired location. The control knob is connected to an anchor ring located at the distal tip of the guiding catheter by a stainless steel pull wire. The pull wire runs from the control knob through a small closed lumen which terminates at the anchor ring. The anchor ring function is to allow the tip of the catheter to be deflected from the handle. A large central continuous lumen with a female luer at the proximal end and the deflectable tip at the distal end serves as a conduit for medical devices to the cardiovascular system.

# Sterilization, Packaging and Pyrogenicity:

Cardima follows the guidelines of ANSI/AAMI/ISO 11137 for sterilization validation and routine control of the radiation sterilization process for all Cardima products. The minimum sterilization dose of 25 kGy is supported per ISO TR 13409 "Sterilization of health care products -Radiation sterilization -Substantiation of 25kGy as a sterilization dose for small or infrequent production batches" (12-15-96). All NAVIPORT product will be sterilized in the same facility using identical gamma

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radiation parameters (minimum 25kGy dose) as other similar Cardima products. The NAVIPORT design, manufacturing materials, and environment does not introduce any new or unique challenges to the current validated sterilization program.

The NAVIPORT is individually packaged in a Paperboard-SBS polyethylene coated (in-side only) tray and inserted into a standard Tyvek/EETpolyethylene pouch. The pouch is heat-sealed to provide a microbial barrier. The NAVIPORT catheter utilizes the same packaging materials and packaging process as Cardima VENAPORT (K951603, cleared) . . .

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## Substantial Equivalence:

turing a WIND II Deflectable Tip Buiding Catheter is substantially equivalent to Medtronic's Marinr™ Steerable Intracardiac Electrode Catheter (K931794, Decision Date 6/6/94) and Sherpa Guiding Catheter (K955651, Decision Date 1/22/96). Establishment of equivalence is based on similarities of intended use, design, and physical characteristics as evaluated by physical bench testing, biocompatibility and animal studies.

#### Summary of Safety and Effectiveness:

Safety and effectiveness were evaluated through biocompatibility testing, reliability testing, mechanical testing, and animal studies. Testing was conducted on sterilized NAVIPORT Catheters with quidance in part from "Electrode Recording Catheter Preliminary Guidance", March 1995; "Catheter Guidance" by Carroll O'Neill, May 1991; "GUIDANCE ON PREMARKET NOTIFICATION {510(K)} SUBMISSIONS FOR SHORT AND LONG-TERM INTRAVASCULAR CATHETERS" April, 1993. The tests were used to assess the mechanical properties of the NAVIPORT catheter and testing results were found to be acceptable for the stated intended use.

Animal studies were conducted to evaluate the ability of NAVIPORT guiding catheter to access the cardiovascular system and to deliver medical devices ( i.e. EP catheters) to the heart chambers without inducing trauma to the blood vessels or to the surface of the endocardium. The NAVIPORT performance was acceptable when placed into the heart chambers.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three bars instead of snakes.

Public Health Service

JUL 2 2 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jack P. Douglas, Ph.D. Director of Regulatory Affairs Cardima, Inc. 47266 Benicia Street P.O. Box 14172 Fremont, CA 94538-7330

K974683 Re : NAVIPORT™ Deflectable Guiding Catheter Regulatory Class: II (Two) Product Code: DOY Dated: April 21, 1999 Received: April 23, 1999

Dear Dr. Douglas:

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, 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 A substantially equivalent determination assumes compliance with 895. 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 requlatory 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 requlations.

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Page 2 - Jack P. Douglas, Ph.D.

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,

Thomas J. Callahan

Thomas J. Callehan, 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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።

5 1 0(k) Number (if known): K974683

NAVIPORT Deflectable Guiding Catheter Device Name:

Indications For Use:

The NAVIPORT deflectable guiding catheter is intended to serve as a conduit for access into the chambers and coronary vasculature of the heart.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Christopher Ahn for Callahan

Prescription Use
(Per 21 CFR 801. 109)
✓

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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