CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER

K984214 · Cordis Neurovascular, Inc. · DXC · Aug 10, 1999 · Cardiovascular

Device Facts

• Record ID: K984214
• Device Name: CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER
• Applicant: Cordis Neurovascular, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Aug 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Temporary Occlusion Balloon Catheter is intended for the temporary occlusion of blood vessels in neuro and peripheral vasculature.

Device Story

Temporary Occlusion Balloon Catheter designed for temporary vessel occlusion in neuro and peripheral vasculature. Device consists of a catheter with an inflatable balloon; operated by clinicians in clinical settings. Principle of operation involves navigating catheter to target vessel site, inflating balloon to achieve occlusion, and deflating for removal. Output is mechanical vessel occlusion. Benefits include controlled temporary flow cessation during interventional procedures.

Clinical Evidence

Bench testing and animal study testing performed. In-vitro testing demonstrated performance comparable to predicates in tip linear stiffness, kink resistance, preparation time, and balloon inflation/deflation characteristics. Animal study testing indicated the device functions as intended. Biocompatibility testing successfully completed.

Technological Characteristics

Catheter-based balloon occlusion system. Materials underwent biocompatibility testing. Performance characteristics include tip linear stiffness, kink resistance, and balloon inflation/deflation/deflatability. No specific ASTM standards or software/algorithm components described.

Indications for Use

Indicated for temporary occlusion of blood vessels in neuro and peripheral vasculature. Prescription use only.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• Prowler Infusion Catheter (Cordis Endovascular Systems, Inc.)
• NDSB Balloon Catheter (Interventional Therapeutics Corporation)
• NDSB Occlusion Balloon Catheter (Interventional Therapeutics Corporation)

Submission Summary (Full Text)

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K984214

## 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.<br>Classification<br>The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established<br>Performance | | | | | |
| Standard | performance standards for this device. | | | | |
| | | | | | |
| Intended use | | The Temporary Occlusion Balloon Catheter is intended for the temporary occlusion<br>of blood vessels in neuro and peripheral vasculature. | | | |
| Performance<br>Testing | | In-vitro testing showed that the Temporary Occlusion Catheter performs similar to<br>the predicate devices as far as: | | | |
| | Tip linear stiffness<br>� | | | | |
| Catheter kink resistance | | | | | |
| | Catheter preparation time<br>�<br>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<br>Biocompatiblility<br>manufacture the Temporary Occlusion Balloon Catheter. | | | | |

Continued on next page

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## 510(k) Summary of Safety and Effectiveness, Continued

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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:

K984214

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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