Who is the manufacturer of OCCLUSION BALLOON CATHETER?

Boston Scientific Corp filed the 510(k) submission for OCCLUSION BALLOON CATHETER (K132990).

What is the FDA product code for OCCLUSION BALLOON CATHETER?

MJN. It is classified under 21 CFR 870.4450 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for OCCLUSION BALLOON CATHETER?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like OCCLUSION BALLOON CATHETER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

OCCLUSION BALLOON CATHETER

Q: What are the predicate devices for OCCLUSION BALLOON CATHETER?

Occlusion Balloon Catheter (K062202).

K132990 · Boston Scientific Corp · MJN · Oct 22, 2013 · Cardiovascular

Device Facts

Record ID	K132990
Device Name	OCCLUSION BALLOON CATHETER
Applicant	Boston Scientific Corp
Product Code	MJN · Cardiovascular
Decision Date	Oct 22, 2013
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.4450
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Occlusion Balloon Catheters are indicated 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 Occlusions Balloon Catheters and Berenstein™ Occlusion Balloon Catheter. Only the Berenstein Occlusion Balloon Catheter has been designed for coaxial delivery of small catheters or embolic agents.

Device Story

Occlusion balloon catheter; compliant latex balloon mounted on distal tip of dual-lumen, radiopaque catheter shaft; proximal luer fittings. Used for temporary vessel occlusion during arteriography, preoperative procedures, hemorrhage control, drug infusion, or renal opacification. Physician-operated in clinical settings. Balloon inflation lumen allows expansion; central lumen facilitates guidewire passage, contrast medium infusion, or (Berenstein model) coaxial delivery of small catheters/embolic agents. Output is physical vessel occlusion; enables targeted therapy or diagnostic visualization. Benefits include controlled blood flow management and localized delivery of therapeutic agents.

Clinical Evidence

Bench testing only. Testing included biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, hemocompatibility, USP physicochemical tests) and in-vitro performance (deflated profile, tensile strength, inflated O.D., deflation time, multiple inflation, burst pressure, sheath compatibility).

Technological Characteristics

Compliant latex balloon; dual-lumen radiopaque catheter shaft; proximal luer fittings. Mechanical occlusion principle. Sterilized device. 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. Berenstein design allows coaxial delivery of small catheters or embolic agents.

Regulatory Classification

Identification

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

Predicate Devices

Occlusion Balloon Catheter (K062202)

Related Devices

K140273 — EQUALIZER OCCLUSION BALLOON CATHETER · Boston Scientific Corp · Jul 22, 2014
K062202 — OCCLUSION BALLOON · Boston Scientific Corp · Oct 20, 2006
K070126 — OCCLUSION BALLOON CATHETER · Sentreheart, Inc. · Feb 8, 2008
K051137 — TECHDEVICE OCCLUSION BALLOON CATHETER · Techdevice Corporation · Feb 24, 2006
K021721 — EQUALIZER BALLOON CATHETER · Boston Scientific Corp · Jun 20, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ K132990 Special 510(k) Submission Occlusion Balloon Catheter ﻘﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ . ...... ## 510(k) Summary ### per 21 CFR §807.92 | Submitter's Name and Address | Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311 | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Name and Information | Diane Nelson Regulatory Affairs Specialist OCT 2 2 2013 Phone: 763-255-0813 763-494-2222 Fax: e-mail: diane.nelson@bsci.com | | Date Prepared | 21 October 2013 | | Proprietary Name | 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 Device(s) | Occlusion Balloon Catheter October 20, 2006 K062202 | | Device Description | The Occlusion Balloon Catheters are a compliant latex balloon mounted on the distal tip of a dual lumen, radiopaque catheter shaft to which two luer fittings are attached proximally. In addition to the balloon inflation lumen, the central lumen is used to pass the catheter over the guidewire as well as infusion of contrast medium, and in the case of the Berenstein™ Occlusion Balloon Catheter, coaxial delivery of small catheters or embolic agents. | | Intended Use/ Indications for Use of Device | The Occlusion Balloon Catheters are indicated 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 Occlusions Balloon Catheters and Berenstein Occlusion Balloon Catheter. Only the Berenstein Occlusion Balloon Catheter has been designed for coaxial delivery of small catheters or embolic agents. | | Comparison of Technological Characteristics | The Occlusion Balloon Catheter will incorporate a substantially equivalent design, packaging, fundamental technology, manufacturing, sterilization and intended use as those featured in the predicate Occlusion Balloon Catheter. | | Performance Data | Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and. therefore, these devices may be considered substantially equivalent to the predicate devices. | . {1}------------------------------------------------ Special 510(k) Submission Occlusion Balloon Catheter > The following biocompatibility and bench testing were completed on the Occlusion Balloon Catheter: #### Biocompatibility Cytotoxicity Sensitization Intracutaneous Reactivity Acute Systemic Toxicity Materials Mediated Pyrogenicity Hemocompatibility: Direct Hemolysis, Partial Thromboplastin Time (PTT), Complement Activation, In Vitro Hemocompatibility USP Physicochemical Tests for Plastics The following in-vitro performance tests were completed on the Occlusion Balloon Catheter: Bench Deflated Balloon Profile Proximal Bond Tensile Inflated Balloon O.D. Balloon Deflation Time Multiple Inflation, Challenge Balloon Burst, Challenge Sheath Compatibility Conclusion Based on the Indications for Use, technological characteristics, safety and performance testing, the Occlusion Balloon Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Occlusion Balloon Catheter (K062202 cleared October 20, 2006). {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. October 22, 2013 Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Boston Scientific Corporation C/O Diane Nelson, Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311 Re: K132990 Trade/Device Name: Occlusion Balloon Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Catheter, Intravascular Occluding, Temporary Regulatory Class: Class II Product Code: MJN Dated: September 23, 2013 Received: September 24, 2013 Dear Ms. Neison: 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. 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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. {3}------------------------------------------------ Page 2 - Ms. Diane Nelson, Regulatory Affairs Specialist If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. # Bram D. 400 arman -S Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): __K132990 Device Name: Occlusion Balloon Catheter Indications for Use: Occlusion Balloon Catheters are indicated 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 Occlusions Balloon Catheters and Berenstein™ Occlusion Balloon Catheter. 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) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Image /page/4/Picture/11 description: The image shows the text "Bram D. Zuckerman -S 2013.10.22 16:34:24 -04'00'". The text appears to be a timestamp or a record of some kind. The text is black and the background is white.