OCCLUSION BALLOON

K062202 · Boston Scientific Corp · DQY · Oct 20, 2006 · Cardiovascular

Device Facts

• Record ID: K062202
• Device Name: OCCLUSION BALLOON
• Applicant: Boston Scientific Corp
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 20, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Occlusion Balloon Catheters are indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures. The Occlusion Balloon Catheter product line consists of two specific designs – Standard Occlusion Balloons and Berenstein™ Occlusion Balloon Catheters. Only the Berenstein Occlusion Balloon Catheter has been designed for coaxial delivery of small catheters or embolic agents.

Device Story

Dual-lumen catheter with distal compliant balloon; proximal luer fittings. Balloon inflation lumen and central lumen for guidewire passage, contrast medium infusion, or coaxial delivery of small catheters/embolic agents (Berenstein model). Used by physicians in clinical settings for temporary vessel occlusion. Device provides mechanical occlusion to facilitate procedures like arteriography or hemorrhage control. Benefits include controlled vessel access and targeted delivery of therapeutic agents.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 standards. No clinical data provided.

Technological Characteristics

Dual-lumen catheter shaft; distal compliant balloon; luer fittings. Biocompatible materials tested per ISO 10993. Mechanical operation via inflation of distal balloon. No software or electronic components.

Indications for Use

Indicated for temporary vessel occlusion in patients requiring arteriography, preoperative occlusion, emergency hemorrhage control, chemotherapeutic drug infusion, or renal opacification. Includes Standard and Berenstein designs; Berenstein design allows coaxial delivery of small catheters or embolic agents.

Regulatory Classification

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.

Predicate Devices

• Occlusion Balloon Catheter (K062202)
• Van-Tec Occlusion Balloon Catheter (K062202)

Submission Summary (Full Text)

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Special 510(k) Premarket Notification Occlusion Balloon Catheter

| 510(k) Summary OCT 20 2006 | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General<br>Provisions | Trade Name: To be determined<br>Classification Name: Percutaneous Catheter |
| Name of<br>Predicate Devices | Occlusion Balloon Catheter, Van-Tec Occlusion Balloon Catheter |
| Classification | Class II |
| Performance<br>Standards | Performance Standards have not been established by FDA under Section 514 of the<br>Food, Drug and Cosmetic Act. |
| Intended Use | Occlusion Balloon Catheters are indicated for use for temporary vessel occlusion<br>in applications including arteriography, preoperative occlusion, emergency control<br>of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures.<br><br>The Occlusion Balloon Catheter product line consists of two specific designs –<br>Standard Occlusion Balloons and Berenstein™ Occlusion Balloon Catheters.<br><br>Only the Berenstein Occlusion Balloon Catheter has been designed for coaxial<br>delivery of small catheters or embolic agents. |
| Device<br>Description | The proposed devices are constructed of a dual lumen catheter shaft to which two<br>luer fittings are attached proximately and a soft compliant balloon is mounted on<br>the distal end of the shaft. The tubing marked BALLOON is the balloon inflation<br>lumen. The tubing marked DISTAL is the central lumen. The central lumen is used<br>to pass the catheter over a guidewire. This lumen can also be used for infusion of<br>contrast medium or, in the case of the Berenstein Occlusion Balloon Catheter,<br>coaxial delivery of small catheters or embolic agents.<br><br>As are the predicated devices, the proposed devices are provided with 1.25ml<br>syringe. There are no changes to this accessory proposed in this submission |
| Biocompatibility | Occlusion Balloon Catheters have been tested for biocompatibility per ISO 10993.<br>All data demonstrate this device is biocompatible for its intended use. |
| Summary of<br>Substantial<br>Equivalence | Occlusion Balloon Catheters have been tested and compared to the predicate<br>devices. All data gathered demonstrate this device as substantially equivalent. No<br>new issues of safety or efficacy have been raised. |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 2006

Boston Scientific Corporation c/o Mr. Nicholas Condakes 100 Boston Scientific Way Marlborough, MA 01752

Re: K062202

Occlusion Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: September 26, 2006 Received: September 27, 2006

Dear Mr. Condakes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Condakes

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements nf the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duna R. lochner

Image /page/2/Picture/5 description: The image shows a handwritten signature. The signature is composed of a series of curved lines and loops, forming an abstract shape. The signature is written in black ink on a white background.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Premarket Notification Occlusion Balloon Catheter

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## Indications For Use

| 510(k) Number (if known) | Unknown K062202 |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Occlusion Balloon Catheter |
| Indications for Use | Occlusion Balloon Catheters are indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures. |
| | The Occlusion Balloon Catheter product line consists of two specific designs – Standard Occlusion Balloons and Berenstein™ Occlusion Balloon Catheters. |
| | Only the Berenstein Occlusion Balloon Catheter has been designed for coaxial delivery of small catheters or embolic agents. |
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
| AND/OR | Over-The-Counter Use (21 CFR 807 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

duma R. whney

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number K062202

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