CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER

K973298 · Cardima, Inc. · DQY · Jun 26, 1998 · Cardiovascular

Device Facts

• Record ID: K973298
• Device Name: CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER
• Applicant: Cardima, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jun 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The VUEPORT is intended for use to access the coronary sinus and perform occlusive venograms. The catheter may serve as a conduit for the delivery and support of other devices.

Device Story

Vueport is a sterile, single-use, dual-lumen, balloon-tipped guiding catheter. One lumen connects to a syringe for balloon inflation/deflation to temporarily occlude the coronary sinus ostium; the other lumen provides an open atraumatic tip for coronary venous system access and venogram performance. Used in clinical settings by physicians. Device facilitates coronary venography by providing stable occlusion and serving as a conduit for other interventional devices. Benefits include improved visualization of the coronary venous system during diagnostic procedures.

Clinical Evidence

No human clinical data. Evidence consists of bench testing (mechanical properties) and animal studies. Animal studies evaluated the ability to occlude the coronary sinus ostium and perform venograms, showing performance equivalent to the control catheter (Elecath).

Technological Characteristics

Dual-lumen, balloon-tipped guiding catheter. Includes a one-way stopcock and syringe for balloon inflation. Sterile, single-use. Gamma radiation sterilization (AAMI Method 3).

Indications for Use

Indicated for patients requiring coronary sinus access for occlusive venography and as a conduit for delivery/support of other 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

• Elecath Occlusion Catheter (K945963)
• Omniguide Guiding Catheter (K945963)

Submission Summary (Full Text)

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JUN 26 1998

K973298

# Summary of Safety and Effectiveness

### Trade Name:

Cardima Vueport™ Coronary Sinus Balloon Occlusion Guiding Catheter

#### Manufacturer:

Cardima, Inc. 47266 Benicia Street Fremont, CA 94538-7330 Contact: Shelley Trimm Contact: Shelley niner: 29-51-009

#### Classification Name:

Catheter Cardiovascular Balloon Type (21 CFR 870.1240)

#### Device Classification:

Class II (21 CFR 870.1240) Panel: Circulatory System Devices Panel, DCRND

## Intended Use and Product Description:

The Cardima Vueport™ Coronary Sinus Balloon Occlusion Guiding Catheter is intended for The Cardima Vueport™ Coronary sinus balloon Cocium during ourhold in the more as a conduit for
temporary occlusion of the coronary sinus ostium during a venogram and to serve temporary occlusion of the Goronary of the coronary venous system.

The Cardima Vueport™ is a sterile, single use only, dual lumen, balloon tipped guiding catheter The Cardima Vueport™ is a sterile, single use only, dual libro and groupen and services and groupel end
with various the Cardina vese a lumn. The smaller lumen extends from a with various tip configurations. The Cardima Villeport™ The Sare (sentiotion a one-way stopcock
and each branch of the "Y" houses a lumen. The smaller lument of the vented and each branch of the "Y" houses a lument "The smakes lanned 3 oc syringe to the balloon and is used for air delivery and wind and time of the resporarily (included with the Vueport), to intee the banon), the conner on a female uer to the occluded to perform a coronary venogram. The larger luments
open atraumatic catheter tip. The larger lumen is a guide to the coronary sinus vasculature for
es and and and open atraumatic catheter tup. The larger lamor is any any and

### Sterilization, Packaging and Pyrogenicity:

Vueport is individually packaged in a Paperboard-SBS polyethylene coated (in-side only) tray and Vueport is individually packaged in a Papelbularu-Sus polych is heat-sealed to provide a
inserted into a standard Tyvek/PET-polyethylene pouch. The pouch is heat-sealed to p inserted into a standard Tyveliryed in programment politics and in the Posts.
microbial barrier, and is then gamma sterilization" (1991) microbial barner, and is then gen Sterilization" (1991).

Cardima is using Method 3 of the AAM "Guideline for Gamma Radiation" (1991). The 1
0 million of the Alabal Andress any new or unique challenges to the current validated Cardima is using Method 3 of the AAMI Gallenges to the current validated
Vueport™ design does not introduce any new or unique challenges to the current validation process us Vueport™ design does not introduce any new on anique onalibrily of engineers used for Vueport was deemed unnecessary.

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### Substantial Equivalence:

Cardima Vueport™ Coronary Sinus Balloon Occlusion Guiding Catheter is substantially Cardima Vueport™ Coronary Sinus Balloon Occusion Catheter The Vueport™ also shares
equivalent to Electro-Catheter Corp., Elecath Occlusion Catheter (K94596), cleared 2/8/95 u equivalent to Electro-Catheter Corp., Elecath Occusion Catheter (K945963, cleared 2/895 under
similar characteristics with the Zeppiin Balloon Guiding Catheter (K945963, cle equivalence the name: The Omniguide Guiding Catheter with BanGori, Establinoni Services of September 1970 personalism
on similarities of intended use, design, and physical characteristi on similanties of intended ass, assign, bench, bench studies.

## Summary of Safety and Effectiveness:

Gammer of effectiveness were evaluated through biocompatibility testing and
Safety and effective and pershanises teating was conducted on sterlized Vueport™ Safety and effectiveness were evaluated through plants on servilized Vueport w
animal studies. Reliability and mechanical testing was conducted on serifized Vueport of animal studies. Reliability and mechanical testing was conduction on on from "Electrode
Coronary Sinus Balloon Occlusion Guiding Catheter with guidance in part from "Electro Coronary Sinus Balloon Occlusion Guiding Catheler ware used to assess the Recording Catheter Preliminary Guidance, March 1995 . The tests wire association in the stated intended use.
Machanical properties of the catheter and found to be acceptable

Animal studies were conducted to evaluate the ability of Vueport™ balloon guiding catheter to
manded to the consistence the advains a venegram . The Vueport™ performance was Animal studies were conducted to evaluate the ability of the Vueport™ performance was
occlude the coronary sinus ostium during a venogram. The balloon inflated and deflated occlude the coronary sinus ostium during a venogram. The balloon inflated and deflated and
satisfactory when placed into the Coronary sinus ostium, the balloon inflated and satisfactory when placed into the coronaly shus ostimaly sinus Balloon Occlusion
performed acceptable venographs. Cardima Vueport™ Coronary Sinus Balloon Occlusion performed acceptable venographs. Cardima Vuepon … Coronaly onlie Galleria
Guiding Catheter when compared to the control catheter (i.e., Elecath) the performance was equivalent.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

11 36. r ~

JUN 26 1998

Ms. Shelley Trimm Cardima, Inc. 47266 Benicia Street P.O. Box 14172 Fremont, CA 94538-7330

K973298 Re: K973298
VUEPORT Coronary Sinus Balloon Occlusion Guiding Catheter Regulatory Class: II (two) Product Code: 74 DQY Dated: June 5, 1998 Received: June 8, 1998

Dear Ms. Trimm:

We have reviewed your Section 510(k) notification of intent to market We nave reviewed your beceien one have determined the device is the device referenced above and no have tions for use stated in the substantially equivatent (10) or dicate devices marketed in enclosure) to regarly marketed productions the enactment date of the interstate commerce prior co naj cost that have been reclassified Medical Device Amendates, of to acrethe Federal Food, Drug, and in accordance with the provisions of therefore, market the device, subject to Cosmetic Acc (Act). Tourmay) choices . . . The general controls the general controls provisions quirements for annual registration, provisions of the Act Incrane acquiring practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special II your device Is Classifica (bes aboro), it may be subject to such Controls) of Class III (Fremailor of regulations affecting your device additional Controls. "Extreming major englations, Title 21, Parts 800
can be found in the Code of Federal Regulations, Title 21, Parts 800 Can be found in the code of Evalent determination assumes compliance as set co 095. In Subbeancearly ufacturing Practice requirements, as set with the Current Good handrageaulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS General regulation (21 Original administration (FDA) will verify such Inspections, the rood and brog with the GMP regulation may result in assumptions. Faller to comply hish one publish further announcements
regulatory action. In addition, FDA may publish further and an this reguratory action. In datable Register. Please note: this concerning your device in the ification submission does not affect any response to your premailed inder sections 531 through 542 of the Act obrigation you might ... Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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### Page 2 - Ms. Shelley Trimm

This letter will allow you to begin marketing your device as described
ing the many of the circus of an a man ED finding of substantial This letter will allow you to begin market normal of substantial
in your 510(k) premarket notification. The Finding of substantial in your 310(K) premarket notifications and thus, pormits vou equivalence of your device to a regard mand thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling If you desire specific advice for your additionally 809.10 for in vitro regulation (21 CFR Farl our and addressions of Compliance at diagnostic devices), prease contact the promotion and [phone]. AdditIonally, for quoberning office of Compliance at
advertising of your device, please contact ation ontitled advertising of your device, predoc the regulation entitled, [phone]. "AISO, premarket notification"(21 CER 807.97).
"Misbranding by reference to premarket notification under the Art may "Misbranding by relerence to premaries notefulers under the Act may Other general information of Small Manufacturers Assistance at its internet be obtained Irom che broision or 301) 443–6597, or at its internet
toll-free number (800) 638–2041 or (301) 443–6597, btml" coil=rree number (000) -0007 -050 - 1000 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 -

Sincerely yours,

Thomas J. Callehan

Thomas J. Vallahan, 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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510(k) Number (if known):_|(_97 329 8

Coronary Sinus Device Name: We porz T Cathe FER Ba Hoon Declusion Griding Indications For Use:

> The VUEPORT is intended for use to access the coronary sinus and The voll occlusive venograms. The catheter may serve as a conduit for the delivery and support of other devices.

Tara A. Ryan

(Division Sign Off)

Division of Calleras a and Neurological Devices 510(k) Number.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

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Over-The-Counter Use_

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