(297 days)
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.
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.
The Cardima Vueport™ is a sterile, single use only, dual lumen, balloon tipped guiding catheter with various tip configurations. The Cardima Vueport™ is a "Y" connector and each branch of the "Y" houses a lumen. The smaller lumen extends from a one-way stopcock (vented and included with the Vueport), to inflate the balloon and is used for air delivery and withdrawal. The connector on a female luer is attached to the occluded lumen to perform a coronary venogram. The larger lumen is a guide to the coronary sinus vasculature for the delivery of other devices and has an open atraumatic catheter tip.
The provided text describes a medical device, the Cardima Vueport™ Coronary Sinus Balloon Occlusion Guiding Catheter, and its approval through the 510(k) pathway, which establishes substantial equivalence to a predicate device. This type of submission generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria for performance metrics typically seen in AI/ML device evaluations.
Therefore, the information required to populate a table of acceptance criteria and performance, as well as details about test sets, ground truth establishment, and MRMC studies, is not present in the provided document. The submission focuses on substantial equivalence based on intended use, design, and physical characteristics.
However, I can extract the information that is available:
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) submission for this device relies on demonstrating substantial equivalence to a predicate device (Electro-Catheter Corp., Elecath Occlusion Catheter (K945963) and Zeppelin Balloon Guiding Catheter (K945963)), rather than establishing specific performance acceptance criteria for a novel functionality or algorithm.
The document states:
- "Safety and effectiveness were evaluated through biocompatibility testing, reliability and mechanical testing and animal studies."
- "Mechanical properties of the catheter and found to be acceptable."
- "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."
These statements indicate that the device met its intended function and was comparable to the predicate, but specific performance metrics (e.g., sensitivity, specificity, accuracy, or precise quantitative measures) with defined acceptance thresholds are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The "test set" and "data provenance" concepts are typically associated with AI/ML or clinical trials. The document mentions "animal studies" without specifying the sample size or further details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as there is no mention of "experts" establishing a "ground truth" for a test set in the context of an AI/ML or similar evaluation. The evaluation was primarily based on mechanical functionality, biocompatibility, and animal studies, which likely involved veterinary professionals or skilled device operators.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are relevant for human expert review processes, which are not described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done or mentioned. This type of study is specific to evaluating AI-assisted workflows, and the Vueport™ device is a physical catheter, not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to performance studies aiming for objective accuracy (like for AI/ML) is not explicitly stated in the provided text. The "ground truth" for the device's acceptable performance was assessed through:
- Biocompatibility testing: Likely adherence to standards for biological safety.
- Reliability and mechanical testing: Adherence to engineering specifications.
- Animal studies: Successful occlusion of the coronary sinus ostium and performance of "acceptable venographs" (presumably evaluated by veterinarians or imaging specialists looking for clear visualization of the venous system). The "equivalence" to the control catheter in animal studies serves as the benchmark.
8. The sample size for the training set
This information is not provided. The concept of a "training set" applies to machine learning, which is not relevant for this device.
9. How the ground truth for the training set was established
This information is not provided as there is no "training set."
In summary, the provided document is a 510(k) summary for a physical medical device (catheter) demonstrating substantial equivalence. It does not contain the type of detailed performance data, acceptance criteria tables, or study designs (e.g., test set, ground truth experts, MRMC studies) typically associated with AI/ML device evaluations or detailed clinical trial reports.
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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.
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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 (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
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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)
્ત્વ
Over-The-Counter Use_
.
§ 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).