(90 days)
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.
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.
The provided document is a 510(k) summary for a medical device called the "Rubicon™ Support Catheter." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results in the same way a PMA or de novo submission might.
Therefore, much of the requested information regarding clinical studies, expert-established ground truth, sample sizes for training/test sets in AI/ML contexts, and reader study effect sizes is not applicable to this document. This submission relies on bench testing (in-vitro performance) and leveraged/screening biocompatibility testing to establish substantial equivalence.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" with numerical targets for each performance test. Instead, it lists the tests performed, implying that the device was deemed to have acceptable performance relative to its intended use and comparison with the predicate device. The performance data section states, "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."
Here's a table summarizing the performance tests completed and the general conclusion:
| Performance Characteristic | Test Performed | Reported Device Performance / Outcome |
|---|---|---|
| Biocompatibility | MEM Elution Cytotoxicity | Conformance demonstrated, no new safety/performance issues |
| Hemolysis Assay Indirect Extraction | Conformance demonstrated, no new safety/performance issues | |
| Guinea Pig (Maximization) Sensitization | Conformance demonstrated, no new safety/performance issues | |
| Partial Thromboplastin Time | Conformance demonstrated, no new safety/performance issues | |
| Intracutaneous Reactivity | Conformance demonstrated, no new safety/performance issues | |
| In Vitro Hemocompatibility Assay | Conformance demonstrated, no new safety/performance issues | |
| Systemic Toxicity (Acute) | Conformance demonstrated, no new safety/performance issues | |
| Complement Activation | Conformance demonstrated, no new safety/performance issues | |
| Materials Mediated Rabbit Pyrogen | Conformance demonstrated, no new safety/performance issues | |
| USP Physicochemical | Conformance demonstrated, no new safety/performance issues | |
| Hemolysis Assay Direct Contact | Conformance demonstrated, no new safety/performance issues | |
| Natural Rubber Latex | Conformance demonstrated, no new safety/performance issues | |
| In-Vitro Performance | Effective Length | Conformance demonstrated, no new safety/performance issues |
| Sheath Insertion and Withdrawal Force | Conformance demonstrated, no new safety/performance issues | |
| Inner Diameter - Distal Shaft | Conformance demonstrated, no new safety/performance issues | |
| Catheter Shaft Burst Pressure | Conformance demonstrated, no new safety/performance issues | |
| Outer Diameter - Proximal Shaft | Conformance demonstrated, no new safety/performance issues | |
| Catheter Tensile | Conformance demonstrated, no new safety/performance issues | |
| Outer Diameter - Distal Shaft | Conformance demonstrated, no new safety/performance issues | |
| Shaft Kink Resistance | Conformance demonstrated, no new safety/performance issues | |
| Marker Band Spacing | Conformance demonstrated, no new safety/performance issues | |
| Torque Strength | Conformance demonstrated, no new safety/performance issues | |
| Contrast Flow Rate | Conformance demonstrated, no new safety/performance issues | |
| Radiopacity | Conformance demonstrated, no new safety/performance issues | |
| Flow rates for DFU labeling | Conformance demonstrated, no new safety/performance issues | |
| Coating Integrity | Conformance demonstrated, no new safety/performance issues |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The performance testing described is bench testing (in-vitro) and biocompatibility testing, not human clinical trials. The number of samples for each bench test is not detailed in this summary.
- Data Provenance: Not applicable. The data comes from internal Boston Scientific laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This submission does not involve expert-established ground truth in a clinical or AI/ML context. Performance was evaluated against engineering specifications and industry standards during bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This type of adjudication is typically used in clinical studies or AI/ML evaluations with human interpretation, neither of which are described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a hardware medical device (catheter) and the submission predates widespread AI/ML integration in such devices. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering specifications and industry standards for medical device performance. For biocompatibility, the ground truth refers to established guidelines and standards for acceptable biological response to materials. For in-vitro performance, it refers to design specifications and expected mechanical/fluidic properties.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML device.
{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 CorporationOne Scimed PlaceMaple Grove, MN 55311 |
|---|---|
| Contact Name and Information | Glenn JacquesPrincipal, Regulatory AffairsPhone: 763-494-1152Fax: 763-494-2222e-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 | SpectraneticsQuick-Cross Support CatheterK033678 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 DeviceRubicon TM Support Catheter | Predicate DeviceQuick-Cross (K033678) | |||||||
| Infusion FlowRate | 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 | ||||||
| RadiopaqueMarkers | 3 - equidistant (15 mm) | 3 - equidistant (15 mm, 50 mm) | ||||||
| DistalRadiopaqueMarker | 2 mm from distal tip | 3 mm from distal tip | ||||||
| Hydrophiliccoating | Distal 40 cm | Distal 40 cm | ||||||
| RecommendedIntroducerSheathCompatibility | 4F | 4F, 5F | ||||||
| RecommendedGuidewire | 0.014 inches | 0.014, 0.018, 0.035 inches | ||||||
| Lumen | Single lumen | Single lumen | ||||||
| Proximal ShaftOuter Diameter | 0.044 inches | 0.039, 0.044, 0.063 inches | ||||||
| Distal Shaft OuterDiameter | 0.027 inches | 0.026, 0.030, 0.050 inches | ||||||
| MaximumInfusion 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
{2}------------------------------------------------
K112333
p. 3 of 3
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 RabbitPyrogen | USP Physicochemical |
| Hemolysis Assay DirectContact | 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 WithdrawalForce |
|---|---|
| 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
Page 1 of 1
§ 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).