(297 days)
Not Found
No
The 510(k) summary describes a mechanical device (a balloon catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on mechanical properties and animal studies, not algorithmic performance.
No
The device is described as a 'guiding catheter' intended to temporarily occlude the coronary sinus ostium and serve as a conduit for access and delivery of other devices, not to treat a disease or condition itself.
No
This device is a guiding catheter used for temporary occlusion and access to the coronary venous system, not for diagnosing a condition. It serves as a conduit for other devices or to perform a venogram, which is an imaging procedure, but the catheter itself does not diagnose.
No
The device description clearly outlines a physical, sterile, single-use catheter with lumens, a balloon, and connectors, indicating it is a hardware medical device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for temporary occlusion and as a conduit for accessing the coronary venous system. IVDs are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a catheter designed to be inserted into the body, with features like a balloon for occlusion and lumens for delivery of other devices and venograms. This is consistent with an in vivo medical device, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device is a medical device used for interventional procedures within the cardiovascular system.
N/A
Intended Use / Indications for Use
The Cardima Vueport™ Coronary Sinus Balloon Occlusion Guiding Catheter is intended for temporary occlusion of the coronary sinus ostium during a venogram and to serve as a conduit for access to the coronary venous system for the delivery of diagnostic and therapeutic agents and services.
The VUEPORT™ is intended for use to access the coronary sinus and to perform occlusive venograms. The catheter may serve as a conduit for the delivery and support of other devices.
Product codes
74 DQY
Device Description
The Cardima Vueport™ is a sterile, single use only, dual lumen, balloon tipped guiding catheter with various tip configurations. The Cardima Vueport™ has a "Y" adapter with one-way stopcock and each branch of the "Y" houses a lumen. The smaller lumen extends from a male luer to the balloon and is used for air delivery and inflation of the balloon. The larger lumen is a guide to the coronary sinus vasculature for the introduction of guidewires, catheters or other interventional devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety and effectiveness were evaluated through biocompatibility testing and performance testing was conducted on sterilized Vueport™ Coronary Sinus Balloon Occlusion Guiding Catheter. Reliability and mechanical testing was conducted on sterilized Vueport™ Coronary Sinus Balloon Occlusion Guiding Catheter with guidance in part from "Electrode Recording Catheter Preliminary Guidance, March 1995". The tests were used to assess the mechanical properties of the catheter and found to be acceptable for use in the stated intended use.
Animal studies were conducted to evaluate the ability of the Vueport™ balloon guiding catheter to occlude the coronary sinus ostium during a venogram. The balloon inflated and deflated and performed acceptable venographs. The Vueport™ performance was satisfactory when placed into the Coronary sinus ostium, the balloon inflated and deflated and performed acceptable venographs. Cardima Vueport™ Coronary Sinus Balloon Occlusion Guiding Catheter when compared to the control catheter (i.e., Elecath) the performance was equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
JUN 26 1998
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.
1
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.
2
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.
3
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 (301) 594-4648. AdditIonally, for quoberning office of Compliance at
advertising of your device, please contact ation ontitled advertising of your device, predoc the regulation entitled, (301) 594-4639. "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
4
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)
્ત્વ
Over-The-Counter Use_
.