(259 days)
Not Found
Not Found
No
The summary describes a physical device (balloon catheter) for temporary vessel occlusion and mentions only mechanical and performance testing, with no indication of software, image processing, or AI/ML components.
Yes
The device is intended for "temporary occlusion of blood vessels," which directly implies a therapeutic function by physically altering the physiological state (blood flow) for patient benefit.
No
The device is described as an "occlusion balloon catheter" intended for "temporary occlusion of blood vessels," which indicates a therapeutic or interventional purpose, not diagnostic.
No
The device is described as a "Temporary Occlusion Balloon Catheter," which is a physical medical device used for temporary occlusion of blood vessels. The performance studies also describe in-vitro and animal testing of a physical catheter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "temporary occlusion of blood vessels in neuro and peripheral vasculature." This describes a device used within the body for a therapeutic or interventional purpose.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Detecting or measuring substances in biological samples
- Being used in a laboratory setting
IVDs are devices used outside the body to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates within the body.
N/A
Intended Use / Indications for Use
The Temporary Occlusion Balloon Catheter is intended for the temporary occlusion of blood vessels in neuro and peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels in neuro and peripheral vasculature.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In-vitro testing showed that the Temporary Occlusion Catheter performs similar to the predicate devices as far as: Tip linear stiffness, Catheter kink resistance, Catheter preparation time, In-vitro clinical simulation, Balloon inflation/deflation times, Deflatability. Animal study testing indicated that the device works as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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. | |||||
| Classification | |||||
| The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established | |||||
| Performance | |||||
| Standard | performance standards for this device. | ||||
| Intended use | The Temporary Occlusion Balloon Catheter is intended for the temporary occlusion | ||||
| of blood vessels in neuro and peripheral vasculature. | |||||
| Performance | |||||
| Testing | In-vitro testing showed that the Temporary Occlusion Catheter performs similar to | ||||
| the 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 to | |||||
| Biocompatiblility | |||||
| manufacture 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
2
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
3
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
4
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