(259 days)
The Temporary Occlusion Balloon Catheter is intended for the temporary occlusion of blood vessels in neuro and peripheral vasculature.
Not Found
The provided 510(k) summary (K984214) describes a Temporary Occlusion Balloon Catheter and outlines performance testing done to establish substantial equivalence to predicate devices.
This is not an AI/ML device. The performance testing described is for a physical medical device. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable.
Here's an analysis based on the information provided, focusing on what is relevant for a non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Benchmarks (Implied) | Reported Device Performance |
|---|---|
| In-vitro Testing: | |
| Tip linear stiffness similar to predicates | Performs similar to predicate devices |
| Catheter kink resistance similar to predicates | Performs similar to predicate devices |
| Catheter preparation time similar to predicates | Performs similar to predicate devices |
| Balloon inflation/deflation times similar to predicates | Performs similar to predicate devices |
| Deflatability similar to predicates | Performs similar to predicate devices |
| Animal Study Testing: | |
| Device works as intended (temporary occlusion of blood vessels) | Device works as intended |
| Biocompatibility: | |
| All appropriate biocompatibility tests passed | All appropriate biocompatibility tests were successfully performed on the materials used |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for in-vitro tests (e.g., number of catheters tested for stiffness, kink resistance). For animal studies, the number of animals used is not specified.
- Data Provenance: Not applicable in terms of country of origin or retrospective/prospective data as this pertains to physical device performance testing rather than clinical data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a physical device's performance is established through direct measurements and observations during in-vitro and animal testing, not typically through expert consensus on medical images or clinical outcomes.
4. Adjudication method for the test set
Not applicable. Adjudication methods are typically used when interpreting ambiguous clinical data or images, which is not the primary focus of this device's performance evaluation.
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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
- In-vitro testing: Physical measurements and functional performance observations.
- Animal study testing: Direct observation of device function (temporary vessel occlusion) and potential biological response in a living model. Biocompatibility results would be based on laboratory testing against established standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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510(k) Summary of Safety and Effectiveness
Trade Name
The trade name is :
- ace maine is .
Cordis Endovascular Systems, Inc. Temporary Occlusion Balloon Catheter .
The predicate devices are listed in the table below: Predicate Devices
| Device | Company | Product Code | Predicate for: | ||
|---|---|---|---|---|---|
| Prowler Infusion | Cordis Endovascular | 74DQQ | Intended Use, Sterilization, | ||
| Catheter | Systems, Inc. | Manufacturing Process, | |||
| Packaging, Materials | |||||
| NDSB Balloon | Interventional | 74HBZ | Intended Use, Design | ||
| Catheter | Therapeutics Corporation | ||||
| NDSB Occlusion | Interventional | 74DXC | Intended Use, Design | ||
| Balloon Catheter | Therapeutics Corporation | Intended Use, Design | |||
| NDSB Balloon | Interventional | 74DXC | |||
| Catheter | Therapeutics Corporation | ||||
| This is a Class II Device.ClassificationThe FDA under Section 514 of the Food, Drug and Cosmetic Act has not establishedPerformance | |||||
| Standard | performance standards for this device. | ||||
| Intended use | The Temporary Occlusion Balloon Catheter is intended for the temporary occlusionof blood vessels in neuro and peripheral vasculature. | ||||
| PerformanceTesting | In-vitro testing showed that the Temporary Occlusion Catheter performs similar tothe predicate devices as far as: | ||||
| Tip linear stiffness� | |||||
| Catheter kink resistance | |||||
| Catheter preparation time�In-vitro clinical simulation | |||||
| Balloon inflation/deflation times | |||||
| Doflatability | |||||
| Animal study testing indicated that the device works as intended. | |||||
| All appropriate biocompatibility tests were successfully performed on the materials used toBiocompatiblilitymanufacture the Temporary Occlusion Balloon Catheter. |
Continued on next page
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510(k) Summary of Safety and Effectiveness, Continued
Summary of Substantial Equivalence
The Temporary Occlusion Balloon Catheter is similar in its basic design, construction, indication for use, and performance characteristics to the predicate devices.
and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contra
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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 an eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 10 1999
Ms. Alina Caraballo Requlatory Affairs Manager Cordis Endovascular Systems, Inc. P.O. Box 025700 33102-5700 Miami Lakes, FL
Re:
Cordis Endovascular Temporary Occlusion Balloon Trade Name: Catheter Regulatory Class: II Product Code: DXC Dated: May 20, 1998 Received: May 21, 1998
Dear Ms. Caraballo:
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, labelinq, 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 Requlations, 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 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
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Page 2 - Ms. Alina Caraballo
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.
This letter will allow you to beqin 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
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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510(k) Number: K984214
Indications for Use Statement
The Temporary Occlusion Balloon Catheter is intended for the temporary occlusion of blood vessels in neuro and peripheral vasculature.
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
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).