(90 days)
Not Found
No
The device description and summary of performance studies focus on the physical characteristics and mechanical performance of the catheter, with no mention of AI or ML technologies.
No.
The device facilitates the use of other interventional devices and the delivery of solutions, but it does not directly treat a condition itself.
No
This device is a support catheter intended to facilitate the placement and support of guidewires and other interventional devices, and to provide a conduit for fluid delivery. Its function is interventional, not diagnostic (identifying a disease or condition).
No
The device description clearly details a physical catheter with specific dimensions, materials (hydrophilic coating, radiopaque markers), and a luer-lock port, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the peripheral vasculature to facilitate the placement and support of other devices, exchange guidewires, and deliver fluids. This is an in vivo application, meaning it's used inside a living organism.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a lubricious coating, radiopaque markers for visualization within the body, and a port for guidewire entry and fluid injection. These are characteristics of a device used for interventional procedures within the body.
- Anatomical Site: The specified anatomical site is the "peripheral vasculature," which is a part of the circulatory system within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is clearly designed for use inside the body.
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 are multipurpose intravascular devices. The 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. The Rubicon Support Catheters are available in 135cm and 150cm lengths. The shafts have varying stiffness and diameters. The device has a proximal shaft diameter of 3.4 Fr. tapering to a distal shaft diameter of 2.1Fr. The catheter is compatible with 0.014 in (0.36 mm) guidewires.
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)
Bench testing and leveraged/new biocompatibility testing for the Rubicon Support Catheter 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.
Biocompatibility was leveraged from predicate BSC testing.
Biocompatibility tests: 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.
Screening biocompatibility tests completed on the Rubicon Support Catheter: MEM Elution Cytotoxicity, USP Physicochemical, Latex, Hemolysis Assay Direct Contact, Hemolysis Assay Extract, Latex.
In-vitro performance tests completed for the Rubicon Support Catheter: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Traditional 510(k) Submission Rubicon™ Support Catheter
- 1 >& 3
NOV - 9 2011
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 | Glenn Jacques
Principal, Regulatory Affairs
Phone: 763-494-1152
Fax: 763-494-2222
e-mail: jacquesg@bsci.com |
| Date Prepared | 10 August 2011 |
| Proprietary Name | Boston Scientific Rubicon™ Support Catheter |
| Common Name | Percutaneous Catheter |
| Product Code | DQY |
| Classification | Class II, 21 CFR Part 870.1250 |
| Predicate Device | Spectranetics
Quick-Cross Support Catheter
K033678 23 February 2004 |
| Device Description | The Boston Scientific Rubicon Support Catheters are multipurpose intravascular devices. The 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. The Rubicon Support Catheters are available in 135cm and 150cm lengths. The shafts have varying stiffness and diameters. The device has a proximal shaft diameter of 3.4 Fr. tapering to a distal shaft diameter of 2.1Fr. The catheter is compatible with 0.014 in (0.36 mm) guidewires. |
| 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. |
1
Comparison of Technological Characteristics
The Rubicon™ Support Catheter incorporates substantially equivalent device design and materials, packaging design and materials, fundamental technology, manufacturing processes, sterilization process as predicate Boston Scientific devices and intended use as those featured in the predicate device, Spectranetics Quick-Cross Support Catheter (K033678).
Comparison to Predicate Device Characteristics
| Comparison to Predicate Device Characteristics | ||||||||
|---|---|---|---|---|---|---|---|---|
| Proposed Device | ||||||||
| Rubicon TM Support Catheter | Predicate Device | |||||||
| Quick-Cross (K033678) | ||||||||
| Infusion Flow | ||||||||
| Rate | Sterile Saline | Contrast* | Sterile Saline | Contrast* | ||||
| Length | ||||||||
| (cm) | 150 psi | 300 psi | 150 psi 300 psi | Length | ||||
| (cm) | 150 psi | 300 psi 150 psi 300 psi | ||||||
| 135 | 1.3 | 2.3 | 0.4 0.9 | 135 | 1.1 | 1.6 0.4 1.0 | ||
| 150 | 1.3 | 2.2 | 0.4 0.9 | 150 | 1.0 | 1.5 0.4 0.7 | ||
| Effective Lengths | 135 cm and 150 cm | 90 cm, 65 cm, 135 cm and 150 cm | ||||||
| Radiopaque | ||||||||
| Markers | 3 - equidistant (15 mm) | 3 - equidistant (15 mm, 50 mm) | ||||||
| Distal | ||||||||
| Radiopaque | ||||||||
| Marker | 2 mm from distal tip | 3 mm from distal tip | ||||||
| Hydrophilic | ||||||||
| coating | Distal 40 cm | Distal 40 cm | ||||||
| Recommended | ||||||||
| Introducer | ||||||||
| Sheath | ||||||||
| Compatibility | 4F | 4F, 5F | ||||||
| Recommended | ||||||||
| Guidewire | 0.014 inches | 0.014, 0.018, 0.035 inches | ||||||
| Lumen | Single lumen | Single lumen | ||||||
| Proximal Shaft | ||||||||
| Outer Diameter | 0.044 inches | 0.039, 0.044, 0.063 inches | ||||||
| Distal Shaft Outer | ||||||||
| Diameter | 0.027 inches | 0.026, 0.030, 0.050 inches | ||||||
| Maximum | ||||||||
| Infusion Pressure | 300 psi | 300 psi | ||||||
| Classification | Class II per 21 CFR 870.1250 | Class II per 21 CFR 870.1250 |
*Tested with 75% Omnipaque™, 25% Saline Solution
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K112333
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Performance Data
Bench testing and leveraged/new biocompatibility testing for the Rubicon Support Catheter 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.
Biocompatibility was leveraged from predicate BSC testing.
| 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 screening biocompatibility tests were completed on the Rubicon™ Support Catheter:
| MEM Elution Cytotoxicity |
|---|
| USP Physicochemical |
| Latex |
Hemolysis Assay Direct Contact Hemolysis Assay Extract
Latex
The following in-vitro performance tests were completed for the Rubicon™ Support Catheter:
| 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 |
Conclusion
Based on the indications for use, technological characteristics, safety and performance testing, the Rubicon™ Support Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Spectranetics Quick-Cross Support Catheter (K033678).
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 9 2011
Boston Scientific Corporation c/o Glenn Jacques One Scimed Place Maple Grove, MN 55311
Re: K112303
Trade/Device Name: Rubicon™ Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 10, 2011 Received: August 11, 2011
Dear Mr. Jacques:
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. Iisting 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.
4
Page 2 - Mr. Glenn Jacques
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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
14112303 510(k) Number (if known):
Rubicon™ Support Catheter Device Name:
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.
Prescription Use X (Per 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division/Sian-Off) Division of Cardiovascular Devices
510(k) Number 2303
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