(28 days)
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.
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.
I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study for the provided text. The document describes a medical device, specifically an Occlusion Balloon Catheter, and its 510(k) submission to the FDA. However, the provided text does not contain explicit numerical acceptance criteria or detailed study results that would allow me to construct the specified table and answer all your questions.
The "Performance Data" section and the "Biocompatibility" and "Bench" testing sections generally state that testing was performed and that the results provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." It also concludes that the device is "substantially equivalent" to a predicate device.
Key Missing Information:
- Specific, quantifiable acceptance criteria: For example, what was the minimum tensile strength required for the proximal bond, or what was the maximum allowable balloon deflation time?
- Reported device performance values: The document states what tests were done (e.g., "Proximal Bond Tensile"), but not the results (e.g., "Proximal Bond Tensile = X N").
- Sample sizes for test sets (for specific tests): While the tests are listed, the number of units tested for each specific bench test is not provided.
- Data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details: These types of information are typically associated with performance studies for AI/ML devices or diagnostic accuracy studies, which are not described in this document for an occlusion balloon catheter. This device appears to be a physical medical instrument, not an AI/ML diagnostic tool.
Therefore, I cannot generate the table or answer questions 2, 3, 4, 5, 6, 7, 8, or 9 as the necessary information is not present in the provided text.
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Special 510(k) Submission
Occlusion Balloon Catheter
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. ......
510(k) Summary
per 21 CFR §807.92
| Submitter'sName andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311 |
|---|---|
| Contact NameandInformation | Diane NelsonRegulatory Affairs SpecialistOCT 2 2 2013Phone: 763-255-0813763-494-2222Fax:e-mail: diane.nelson@bsci.com |
| Date Prepared | 21 October 2013 |
| ProprietaryName | Occlusion Balloon Catheter |
| Common Name | Vascular Clamp |
| Product Code | MJN - Catheter, Intravascular Occluding, Temporary |
| Classification | Class II, 21 CFR Part 870.4450 - Vascular Clamp |
| PredicateDevice(s) | Occlusion Balloon CatheterOctober 20, 2006K062202 |
| DeviceDescription | The Occlusion Balloon Catheters are a compliant latex balloon mounted onthe distal tip of a dual lumen, radiopaque catheter shaft to which two luerfittings are attached proximally. In addition to the balloon inflation lumen,the central lumen is used to pass the catheter over the guidewire as well asinfusion of contrast medium, and in the case of the Berenstein™ OcclusionBalloon Catheter, coaxial delivery of small catheters or embolic agents. |
| Intended Use/Indications forUse of Device | The Occlusion Balloon Catheters are indicated for temporary vesselocclusion in applications including arteriography, preoperative occlusion,emergency control of hemorrhage, chemotherapeutic drug infusion andrenal opacification procedures.The Occlusion Balloon Catheter product line consists of two specificdesigns - Standard Occlusions Balloon Catheters and BerensteinOcclusion Balloon Catheter.Only the Berenstein Occlusion Balloon Catheter has been designed forcoaxial delivery of small catheters or embolic agents. |
| Comparison ofTechnologicalCharacteristics | The Occlusion Balloon Catheter will incorporate a substantially equivalentdesign, packaging, fundamental technology, manufacturing, sterilizationand intended use as those featured in the predicate Occlusion BalloonCatheter. |
| PerformanceData | Bench testing and biocompatibility testing were performed to support adetermination of substantial equivalence. The results of these tests providereasonable assurance that the proposed device has been designed andtested to assure conformance to the requirements for its intended use. Nonew safety or performance issues were raised during the testing and.therefore, these devices may be considered substantially equivalent to thepredicate devices. |
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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).
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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.
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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
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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)
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§ 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).