(23 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a support catheter, with no mention of AI or ML capabilities.
No
The device is described as a support catheter intended to facilitate the placement and support of guidewires and other interventional devices, and to allow for the exchange of guidewires and delivery of solutions. It does not actively treat a disease or condition itself.
No
Explanation: The device description and intended use clearly state that the Rubicon Support Catheter is designed to facilitate placement and support of other interventional devices and guidewires, and for fluid delivery. It does not mention any function related to diagnosing a medical condition.
No
The device description clearly details a physical catheter with specific material properties, coatings, radiopaque markers, and a luer-lock port, indicating it is a hardware medical device.
Based on the provided information, the Rubicon Support Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used within the peripheral vasculature to facilitate placement and support of other devices, exchange guidewires, and deliver solutions. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically involving testing of samples like blood or tissue).
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a tip, coating, radiopaque markers, and a luer-lock port for fluid injection. These are characteristics of a device used directly within the body.
- Lack of IVD Indicators: There is no mention of the device being used to test samples, analyze biological markers, or provide diagnostic information based on laboratory analysis.
Therefore, the Rubicon Support Catheter is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Rubicon Support Catheter is intended to facilitate placement and support of guidewires and other interventional devices within the peripheral vasculature and to allow for exchange of guidewires, and provide a conduit for the delivery of saline or contrast solutions.
Product codes
DQY
Device Description
The Boston Scientific Rubicon Support Catheters feature an ultra low profile tip, a lubricious hydrophilic coating that is applied to the surface of the distal 40 cm of the catheter, and 3 radiopaque markers spaced equally along the distal shaft which aid in estimating geometry within the vascular system. The distal radiopaque marker is positioned approximately 2mm away from the distal catheter tip. The proximal portion of the catheter includes one female luer-lock port connected to the proximal end of the catheter for guidewire entry and fluid injection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing was completed and submitted as part of the Rubicon 14 Support Catheter (K112303). The Rubicon 18 and 35 Support Catheters are equivalent in design, materials, and manufacturing to the Rubicon 14 Support Catheter, cleared by the FDA November 9, 2011. Since no changes have been implemented that would affect the biocompatibility of the devices, these results are applicable to the subject devices.
Biocompatibility tests were leveraged from predicate Rubicon 14:
MEM Elution Cytotoxicity
Guinea Pig (Maximization) Sensitization
Intracutaneous Reactivity
Systemic Toxicity (Acute)
Materials Mediated Rabbit Pyrogen
Hemolysis Assay Direct Contact
Hemolysis Assay Indirect Extraction
Partial Thromboplastin Time
In Vitro Hemocompatibility Assay
Complement Activation
USP Physicochemical
Natural Rubber Latex
The following in-vitro performance bench tests confirm the performance characteristics:
Effective Length
Inner Diameter - Distal Shaft
Outer Diameter - Proximal Shaft
Outer Diameter - Distal Shaft
Marker Band Spacing
Contrast Flow Rate
Flow rates for DFU labeling
Sheath Insertion and Withdrawal Force
Catheter Shaft Burst Pressure
Catheter Tensile
Shaft Kink Resistance
Torque Strength
Radiopacity
Coating Integrity
All test results demonstrate that the materials, manufacturing process, and design of the Rubicon 18 and 35 Support Catheters meet the established specifications necessary for consistent performance according to its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Boston Scientific Corporation K112303
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
.
Special 510(k) Submission Rubicon™ 18 and 35 Support Catheter
·
510(k) Summary per 21 CFR §807.92
AUG 30 2012
t
| Submitter's
Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Contact Name
and Information | Diane Nelson
Regulatory Affairs Specialist
Phone: 763-255-0813
Fax: 763-494-2222
e-mail: diane.nelson@bsci.com | |
| Date Prepared | 06 August 2012 | |
| Proprietary
Name | Boston Scientific Rubicon™ 18 Support Catheter
Boston Scientific Rubicon™ 35 Support Catheter | |
| Common Name | Percutaneous Catheter | |
| Product Code | DQY | |
| Classification | Class II, 21 CFR Part 870.1250 | |
| Predicate
Device | Boston Scientific Corporation K112303 09 November 2011
Rubicon™ 14 Support Catheter | |
| Device
Description | The Boston Scientific Rubicon Support Catheters feature an ultra low profile
tip, a lubricious hydrophilic coating that is applied to the surface of the distal
40 cm of the catheter, and 3 radiopaque markers spaced equally along the
distal shaft which aid in estimating geometry within the vascular system. The
distal radiopaque marker is positioned approximately 2mm away from the
distal catheter tip. The proximal portion of the catheter includes one female
luer-lock port connected to the proximal end of the catheter for guidewire entry
and fluid injection. | |
| Intended Use of
Device | The Rubicon Support Catheters are multipurpose intravascular devices that
can be used for wire exchanges, saline, contrast injection and to support a
guidewire or other CTO (Chronic Total Occlusion) devices. The Support
Catheter can be back loaded over a pre-positioned guidewire or may be
introduced through a previously positioned appropriately sized introducer
sheath and advanced to the targeted area of the lesion. The guidewire is
advanced through the lesion and the support catheter is advanced over the
wire until the guidewire exits the lesion and the Support Catheter reaches the
patent lumen of the vessel. | |
| Indications for
Use | The Rubicon Support Catheter is intended to facilitate placement and support
of guidewires and other interventional devices within the peripheral
vasculature and to allow for exchange of guidewires, and provide a conduit for
the delivery of saline or contrast solutions. | |
| Comparison of
Technological
Characteristics | Rubicon 18 Support Catheter and Rubicon 35 Support Catheter incorporate
substantially equivalent device design and materials, packaging design and
materials, fundamental technology, manufacturing processes, sterilization
process, and intended use as those featured in the predicate device, Boston
Scientific Rubicon 14 Support Catheter (K112303). | |
| Performance
Data | Biocompatibility testing was completed and submitted as part of the Rubicon
14 Support Catheter (K112303). The Rubicon 18 and 35 Support Catheters
are equivalent in design, materials, and manufacturing to the Rubicon 14
Support Catheter, cleared by the FDA November 9, 2011. Since no changes
have been implemented that would affect the biocompatibility of the devices,
these results are applicable to the subject devices. | |
| | Biocompatibility tests were leveraged from predicate Rubicon 14: | |
| | MEM Elution Cytotoxicity | Hemolysis Assay Indirect Extraction |
| | Guinea Pig (Maximization)
Sensitization | Partial Thromboplastin Time |
| | Intracutaneous Reactivity | In Vitro Hemocompatibility Assay |
| | Systemic Toxicity (Acute) | Complement Activation |
| | Materials Mediated Rabbit
Pyrogen | USP Physicochemical |
| | Hemolysis Assay Direct Contact | Natural Rubber Latex |
| | The following in-vitro performance bench tests confirm the performance
characteristics: | |
| | Effective Length | Sheath Insertion and Withdrawal Force |
| | Inner Diameter - Distal Shaft | Catheter Shaft Burst Pressure |
| | Outer Diameter - Proximal Shaft | Catheter Tensile |
| | Outer Diameter - Distal Shaft | Shaft Kink Resistance |
| | Marker Band Spacing | Torque Strength |
| | Contrast Flow Rate | Radiopacity |
| | Flow rates for DFU labeling | Coating Integrity |
| | All test results demonstrate that the materials, manufacturing process, and
design of the Rubicon 18 and 35 Support Catheters meet the established
specifications necessary for consistent performance according to its intended
use. | |
| Conclusion | Based on the indications for use, technological characteristics, safety and
performance testing, the Rubicon 18 and 35 Support Catheters have been
shown to be appropriate for their intended use and are considered to be
substantially equivalent to the Rubicon 14 Support Catheter (K112303). | |
1
1
Special 510(k) Submission Rubicon™ 18 and 35 Support Catheter
1
:
:
::
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
. AUG 3 0 2012
Boston Scientific Corp. % Diane Nelson One Scimed Place Maple Grove, MN 55311-1566
Re: K122394
Trade/Device Name: Rubicon 18 and 35 Support Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 6, 2012 Received: August 7, 2012
Dear Ms. Nelson:
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.
3
Page 2 - Ms. Diane Nelson
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.
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 vours.
Cui A. Killeen
a 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 Statement
510(k) Number (if known)
Device Name:
Rubicon™ Support Catheters
The Rubicon Support Catheter is intended to facilitate placement and support of Indications for Use guidewires and other interventional devices within the peripheral vasculature and to allow for exchange of guidewires, and provide a conduit for the delivery of saline or contrast solutions.
Prescription Use X (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)
M.A. Hillbern
ision Sian-C Division of Cardiovascular Devices
V 122394 510(k) Number
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