(23 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 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 provided text is a 510(k) Summary for a medical device (Rubicon™ 18 and 35 Support Catheter), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and a study proving device performance in the context of AI/ML (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not applicable to this document.
This document describes a conventional medical device and its regulatory submission, focusing on bench testing for physical characteristics and biocompatibility, and demonstrating substantial equivalence to a predicate device.
Key points from the document regarding device performance and acceptance criteria:
- Device Type: Rubicon™ 18 and 35 Support Catheters (conventional medical device, not AI/ML).
- Performance Data Basis: Substantial equivalence to the Boston Scientific Rubicon™ 14 Support Catheter (K112303).
- Biocompatibility: Leveraged from the predicate device (Rubicon 14) as the new devices are equivalent in design, materials, and manufacturing. The specific tests performed on the predicate device are listed.
- In-vitro Performance Bench Tests: A list of bench tests was conducted to confirm performance characteristics. The document states "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."
A table formatted as requested, but with a note on its inapplicability for AI/ML, would look like this:
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly quantified in the document, implied by "meet established specifications") | Reported Device Performance (Summary from document) |
|---|---|---|
| Biocompatibility | Implied: Pass various biocompatibility tests (Cytotoxicity, Sensitization, Reactivity, Systemic Toxicity, Pyrogen, Hemolysis, Thromboplastin Time, Hemocompatibility, Complement Activation, USP Physicochemical, Natural Rubber Latex). | Demonstrated by leveraging results from the predicate Rubicon 14 Support Catheter, as Rubicon 18 and 35 are equivalent in design, materials, and manufacturing. |
| Physical Performance | Implied: Meet established specifications for a range of physical characteristics. | All test results demonstrated that materials, manufacturing, and design meet established specifications for consistent performance according to intended use. |
| Effective Length | (Not quantified in document) | |
| Inner Diameter - Distal Shaft | (Not quantified in document) | |
| Outer Diameter - Proximal Shaft | (Not quantified in document) | |
| Outer Diameter - Distal Shaft | (Not quantified in document) | |
| Marker Band Spacing | (Not quantified in document) | |
| Contrast Flow Rate | (Not quantified in document, used for DFU labeling) | |
| Flow rates for DFU labeling | (Not quantified in document, used for DFU labeling) | |
| Sheath Insertion and Withdrawal Force | (Not quantified in document) | |
| Catheter Shaft Burst Pressure | (Not quantified in document) | |
| Catheter Tensile | (Not quantified in document) | |
| Shaft Kink Resistance | (Not quantified in document) | |
| Torque Strength | (Not quantified in document) | |
| Radiopacity | (Not quantified in document) | |
| Coating Integrity | (Not quantified in document) |
Since this is not an AI/ML device, the following points are not applicable and cannot be answered from the provided text:
- Sample size used for the test set and the data provenance: Not an AI/ML device; test sets for AI/ML are irrelevant here.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth for AI/ML is irrelevant here. Performance is based on bench testing and substantial equivalence to a predicate device.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI/ML device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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Special 510(k) Submission Rubicon™ 18 and 35 Support Catheter
·
510(k) Summary per 21 CFR §807.92
AUG 30 2012
t
| Submitter'sName andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311 | |
|---|---|---|
| Contact Nameand Information | Diane NelsonRegulatory Affairs SpecialistPhone: 763-255-0813Fax: 763-494-2222e-mail: diane.nelson@bsci.com | |
| Date Prepared | 06 August 2012 | |
| ProprietaryName | Boston Scientific Rubicon™ 18 Support CatheterBoston Scientific Rubicon™ 35 Support Catheter | |
| Common Name | Percutaneous Catheter | |
| Product Code | DQY | |
| Classification | Class II, 21 CFR Part 870.1250 | |
| PredicateDevice | Boston Scientific Corporation K112303 09 November 2011Rubicon™ 14 Support Catheter | |
| DeviceDescription | The Boston Scientific Rubicon Support Catheters feature an ultra low profiletip, a lubricious hydrophilic coating that is applied to the surface of the distal40 cm of the catheter, and 3 radiopaque markers spaced equally along thedistal shaft which aid in estimating geometry within the vascular system. Thedistal radiopaque marker is positioned approximately 2mm away from thedistal catheter tip. The proximal portion of the catheter includes one femaleluer-lock port connected to the proximal end of the catheter for guidewire entryand fluid injection. | |
| Intended Use ofDevice | The Rubicon Support Catheters are multipurpose intravascular devices thatcan be used for wire exchanges, saline, contrast injection and to support aguidewire or other CTO (Chronic Total Occlusion) devices. The SupportCatheter can be back loaded over a pre-positioned guidewire or may beintroduced through a previously positioned appropriately sized introducersheath and advanced to the targeted area of the lesion. The guidewire isadvanced through the lesion and the support catheter is advanced over thewire until the guidewire exits the lesion and the Support Catheter reaches thepatent lumen of the vessel. | |
| Indications forUse | The Rubicon Support Catheter is intended to facilitate placement and supportof guidewires and other interventional devices within the peripheralvasculature and to allow for exchange of guidewires, and provide a conduit forthe delivery of saline or contrast solutions. | |
| Comparison ofTechnologicalCharacteristics | Rubicon 18 Support Catheter and Rubicon 35 Support Catheter incorporatesubstantially equivalent device design and materials, packaging design andmaterials, fundamental technology, manufacturing processes, sterilizationprocess, and intended use as those featured in the predicate device, BostonScientific Rubicon 14 Support Catheter (K112303). | |
| PerformanceData | Biocompatibility testing was completed and submitted as part of the Rubicon14 Support Catheter (K112303). The Rubicon 18 and 35 Support Cathetersare equivalent in design, materials, and manufacturing to the Rubicon 14Support Catheter, cleared by the FDA November 9, 2011. Since no changeshave 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 RabbitPyrogen | USP Physicochemical | |
| Hemolysis Assay Direct Contact | Natural Rubber Latex | |
| The following in-vitro performance bench tests confirm the performancecharacteristics: | ||
| 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, anddesign of the Rubicon 18 and 35 Support Catheters meet the establishedspecifications necessary for consistent performance according to its intendeduse. | ||
| Conclusion | Based on the indications for use, technological characteristics, safety andperformance testing, the Rubicon 18 and 35 Support Catheters have beenshown to be appropriate for their intended use and are considered to besubstantially equivalent to the Rubicon 14 Support Catheter (K112303). |
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Special 510(k) Submission Rubicon™ 18 and 35 Support Catheter
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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.
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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
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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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§ 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).