(28 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and function of a balloon catheter for vessel occlusion. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No
The device is used for temporary vessel occlusion, not to treat a disease or condition.
No
Explanation: The device is indicated for temporary vessel occlusion and delivery of agents, which are interventional procedures, not diagnostic ones.
No
The device description clearly details a physical catheter with a balloon, lumens, and luer fittings, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this is a catheter with a balloon used for temporary vessel occlusion within the body. It's a medical device used in vivo (within a living organism) for therapeutic and diagnostic procedures like arteriography and controlling hemorrhage.
- Lack of Mention of Samples or Testing: There is no mention of analyzing samples from the body or performing any kind of diagnostic test on those samples.
Therefore, this device falls under the category of a medical device used for interventional procedures, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
MJN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Biocompatibility tests: 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.
Bench tests: Deflated Balloon Profile Proximal Bond Tensile Inflated Balloon O.D. Balloon Deflation Time Multiple Inflation, Challenge Balloon Burst, Challenge Sheath Compatibility.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.