EQUALIZER OCCLUSION BALLOON CATHETER

K140273 · Boston Scientific Corp · MJN · Jul 22, 2014 · Cardiovascular

Device Facts

• Record ID: K140273
• Device Name: EQUALIZER OCCLUSION BALLOON CATHETER
• Applicant: Boston Scientific Corp
• Product Code: MJN · Cardiovascular
• Decision Date: Jul 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Equalizer™ Occlusion Balloon Catheter is indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures. Any use for procedures other than those indicated in the instructions is not recommended.

Device Story

Equalizer Occlusion Balloon Catheter is a dual-lumen nylon catheter with a soft compliant latex balloon near the tip; radiopaque markers facilitate positioning under fluoroscopy. Device operates by inflating the balloon to temporarily occlude a vessel. One lumen is dedicated to balloon inflation; the second (distal) lumen allows for guidewire passage or infusion of contrast media/therapeutic drugs. Used in clinical settings by physicians for vascular procedures. Output is physical vessel occlusion and delivery of fluids. Benefits include temporary hemorrhage control and localized drug delivery.

Clinical Evidence

No clinical data. Evidence consists of bench testing (deflated balloon profile, tensile strength, inflation/deflation performance, burst pressure, sheath compatibility) and biocompatibility testing (cytotoxicity, sensitization, reactivity, systemic toxicity, pyrogenicity, and hemocompatibility).

Technological Characteristics

Dual-lumen nylon catheter with soft compliant latex balloon. Radiopaque markers and shaft for fluoroscopic visibility. Luer fitting hubs for ancillary device attachment. Sterilization method not specified. No software or electronic components.

Indications for Use

Indicated for temporary vessel occlusion in patients undergoing arteriography, preoperative occlusion, emergency hemorrhage control, chemotherapeutic drug infusion, or renal opacification procedures.

Regulatory Classification

Identification

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

Predicate Devices

• Equalizer™ Occlusion Balloon Catheter (K021721)

Submission Summary (Full Text)

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K140273

## 510(k) Summary

## per 21 CFR §807.92

JUL 2 2 2014

| Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name<br>and<br>Information | Diane Nelson<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| | Date Prepared |
| Proprietary<br>Name | Equalizer™ Occlusion Balloon Catheter |
| Common Name | Vascular Clamp |
| Product Code | MJN – Catheter, Intravascular Occluding, Temporary |
| Classification | Class II, 21 CFR Part 870.4450 – Vascular Clamp |
| Predicate<br>Device(s) | Equalizer™ Occlusion Balloon Catheter K021721<br>20 June 2002 |
| Device<br>Description | The Equalizer™ Occlusion Balloon Catheter is constructed of a soft<br>compliant latex balloon mounted near the tip of a dual-lumen nylon catheter<br>shaft. Radiopaque markers are placed adjacent to the balloon to provide<br>visual reference points for balloon positioning within the vessel.<br>The catheter shaft is radiopaque, maximizing fluoroscopic visibility.<br>Proximal to the bifurcation, the two lumens of the catheter are marked to<br>differentiate their use. The tubing marked 'BALLOON' is the balloon<br>inflation lumen. The tubing marked 'DISTAL' is the central lumen of the<br>catheter, which terminates at the distal tip. This lumen is used to pass the<br>catheter over a guidewire. The lumen can also be used for the infusion of<br>contrast media or therapeutic drugs. Each lumen ends in a luer fitting hub<br>for attachment to ancillary devices. |
| | Intended Use/<br>Indications for<br>Use of Device |
| Comparison of<br>Technological<br>Characteristics | The Equalizer™ Occlusion Balloon Catheter will incorporate a substantially<br>equivalent design, packaging, fundamental technology, manufacturing,<br>sterilization and intended use as those featured in the predicate Occlusion<br>Balloon Catheter. |
| Performance<br>Data | Bench testing and biocompatibility testing were performed to support a<br>determination of substantial equivalence. The results of these tests provide<br>reasonable assurance that the proposed device has been designed and<br>tested to assure conformance to the requirements for its intended use. No<br>new safety or performance issues were raised during the testing and,<br>therefore, these devices may be considered substantially equivalent to the<br>predicate devices. |
| | The following biocompatibility and bench testing were completed on the<br>Equalizer Occlusion Balloon Catheter: |
| | <b>Biocompatibility</b><br>Cytotoxicity<br>Sensitization<br>Intracutaneous Reactivity<br>Acute Systemic Toxicity<br>Materials Mediated Pyrogenicity<br>Hemocompatibility: Direct Hemolysis, Partial Thromboplastin Time (PTT),<br>Complement Activation, In Vitro Hemocompatibility<br>USP Physicochemical Tests for Plastics |
| | The following in-vitro performance tests were completed on the Equalizer<br>Occlusion Balloon Catheter: |
| | <b>Bench</b><br>Deflated Balloon Profile<br>Proximal Bond Tensile<br>Inflated Balloon O.D.<br>Balloon Deflation Time<br>Multiple Inflation, Challenge<br>Balloon Burst, Challenge<br>Sheath Compatibility |
| Conclusion | Based on the Indications for Use, technological characteristics, safety and<br>performance testing, the Equalizer™ Occlusion Balloon Catheter has been<br>shown to be appropriate for its intended use and is considered to be<br>substantially equivalent to the Equalizer™ Occlusion Balloon Catheter<br>(K021721 cleared 20 June 2002). |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 22, 2014

Boston Scientific Corp. Diane Nelson Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311-1566

Re: K140273

Trade/Device Name: Equalizer Occlusion Balloon Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: June 13, 2014 Received: June 16, 2014

Dear Ms. Nelson:

We have reviewed vour 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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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 of 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

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Page 2 - Diane Nelson

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kenneth J. Cavanaugh -S

for 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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## Indications for Use

510(k) Number (if known): K140273

Device Name: Equalizer™ Occlusion Balloon Catheter

Indications for Use:

Equalizer™ Occlusion Balloon Catheter is indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures.

Any use for procedures other than those indicated in the instructions is not recommended.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Boston Scientific Corporation

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