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 guide a conduit for the delivery of saline or contrast solutions.

Device Description

The Rubicon™ 14, 18 and 35 Support Catheters (Rubicon) are multipurpose intravascular device that can be used for wire exchanges, saline or contrast injection and to support a guidewire or other devices to cross peripheral lesions. They are available in 65cm, 90cm, 135cm, and 150cm shaft lengths.

To use the Rubicon Support Catheter, the physician backloads the distal tip of the support catheter over a pre-positioned guidewire, ensuring the guidewire exits the proximal hub/luer and advances the support catheter to the target area.

The Rubicon Support Catheter may also be introduced through a previously positioned, appropriately sized introducer sheath or guide sheath/catheter, advancing the Rubicon Support Catheter to its desired location while using fluoroscopic imaging.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Rubicon 14, 18, and 35 Support Catheters. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing direct acceptance criteria and proving performance through a study in the same way a new, innovative device might.

Therefore, the requested information elements related to a study proving acceptance criteria are largely not applicable in this context. The acceptance criteria for this type of submission are typically met by demonstrating that the device is substantially equivalent to a legally marketed predicate device and that it performs as expected for its intended use, supported by bench testing where necessary.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Strict "acceptance criteria" as you might define for an AI/algorithm (e.g., sensitivity, specificity, AUC) are not present in this document because it's for a physical medical device (support catheter) and focuses on substantial equivalence. Instead, the "performance" is demonstrated through bench testing and comparison to existing predicate devices.

Acceptance Criterion (Nature of Demonstration)	Reported Device Performance (Summary)
Pouch Seal Strength	Bench testing performed (results indicate conformance to requirements for intended use).
Catheter Withdrawal from Carrier Tube	Bench testing performed (results indicate conformance to requirements for intended use).
Angle Clip Retention	Bench testing performed (results indicate conformance to requirements for intended use).
Angled Clip Removal	Bench testing performed (results indicate conformance to requirements for intended use).
Pouch Sterile Barrier Integrity - Bubble	Bench testing performed (results indicate conformance to requirements for intended use).
Pouch Sterile Barrier Integrity – Visual	Bench testing performed (results indicate conformance to requirements for intended use).
Shelf Carton Condition	Bench testing performed (results indicate conformance to requirements for intended use).
Master Shipping Carton Condition	Bench testing performed (results indicate conformance to requirements for intended use).
Label Adhesion and Print Quality	Bench testing performed (results indicate conformance to requirements for intended use).
Substantial Equivalence	The device (Rubicon™ 14, 18 and 35 Support Catheters) is considered substantially equivalent to the predicate devices (K112303 and K122394) based on identical intended use, scientific technology, design, materials, and sterilization method. Minor modifications to packaging dimensions and pouch materials were identified and tested for conformance. No new safety or performance issues were raised during bench testing. The proposed packaging changes did not require new biocompatibility or device bench testing; thus, predicate device testing results still apply.

2. Sample size used for the test set and the data provenance

The document specifies "bench testing" was performed. For a physical device, this usually involves a specific number of units for each test (e.g., a certain number of pouches for seal strength, or catheters for withdrawal force). However, the specific sample sizes for each of these bench tests are not provided in the document.

Data provenance: The testing was performed by Boston Scientific Corporation, the device manufacturer. The nature of the testing is physical/mechanical bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. For a physical support catheter undergoing bench testing, "experts" in the sense of clinical specialists establishing ground truth (as in an AI/imaging study) are not typically involved in evaluating the primary test results (e.g., seal strength, withdrawal force). These are objective, measurable physical properties.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for subjective interpretations, often in clinical or image-based studies. Bench testing relies on objective measurements against pre-defined specifications.

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 physical medical device (catheter), not an AI algorithm or a diagnostic imaging device requiring human reader interpretation or assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the usual sense for clinical studies. For bench testing, the "ground truth" would be the engineering specifications and established industry standards (e.g., ISO standards mentioned like ISO 10555-1 and ISO 10555-4) that the device must meet. The tests objectively measure device properties against these pre-defined, measurable criteria.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical device, not an AI model that requires a training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 25, 2017

Boston Scientific Corporation Ms. Ka Zoua Xiong Regulatory Affairs Specialist Three Scimed Place Maple Grove, Minnesota 55311-1566

Re: K171913

Trade/Device Name: Rubicon 14, 18 and 35 Support Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: June 22, 2017 Received: June 26, 2017

Dear Ms. Xiong:

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

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Kenneth J. Cavanaugh -S

for

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

510(k) Number (if known) K171913

Device Name Rubicon™ 14, 18 and 35 Support Catheters

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Per 21 CFR §807.92

Common or UsualName	Percutaneous Catheter
Trade Name(s)	Rubicon™ 14, 18 and 35 Support Catheters
Product Code	DQY - Percutaneous Catheter
Classification ofDevice	Class II - 21 CFR 870.1250
Submitter's Nameand Address	Boston Scientific CorporationThree Scimed Place, C275Maple Grove, MN 55311-1566
Contact Name andInformation	Ka Zoua XiongRegulatory Affairs SpecialistPhone: 763-494-2970Fax: 763-494-2222Email: Kazoua.Xiong@bsci.com
Date Prepared	22 June 2017
Section 514 of theAct PerformanceStandards	6-301: ISO 10555-1 Second edition 2013-06-15Intravascular catheters -- Sterile and single-use intravascularcatheters -- Part 1: General requirements6-322: ISO 10555-4 Second edition 2013-06-15Intravascular catheters -- Sterile and single-use catheters -- Part 4:Balloon dilatation catheters
EstablishmentRegistrationNumbers	Owner /Operator:Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752ERN: 9912058Manufacturing Facility:Boston Scientific CorporationTwo Scimed PlaceMaple Grove, MN 55311ERN: 2134265Sterilization Facilities:BSC Coventry8 Industrial DriveCoventry, RI 02816USA
Predicate Devices	K112303 - Rubicon™ 14 Support CatheterK122394 - Rubicon™ 18 Support CatheterRubicon™ 35 Support Catheter
Device Description	The Rubicon™ 14, 18 and 35 Support Catheters (Rubicon) aremultipurpose intravascular device that can be used for wireexchanges, saline or contrast injection and to support a guidewireor other devices to cross peripheral lesions. They are available in65cm, 90cm, 135cm, and 150cm shaft lengths.To use the Rubicon Support Catheter, the physician backloads thedistal tip of the support catheter over a pre-positioned guidewire,ensuring the guidewire exits the proximal hub/luer and advancesthe support catheter to the target area.The Rubicon Support Catheter may also be introduced through apreviously positioned, appropriately sized introducer sheath orguide sheath/catheter, advancing the Rubicon Support Catheter toits desired location while using fluoroscopic imaging.
Intended Use/Indications for Use	The Rubicon Support Catheter is intended to facilitate placementand support of guidewires and other interventional devices withinthe peripheral vasculature and to allow for exchange ofguidewires, and provide a conduit for the delivery of saline orcontrast solutions.
Comparison ofRequiredTechnologicalCharacteristics	Rubicon is substantially equivalent to the existing Rubicon devicescleared by FDA under Premarket Notifications K112303 andK122394 (09 Nov 2011 and 30 Aug 2012, respectively). Rubiconhas the same intended use, scientific technology, design,materials, and sterilization method. The packaging dimensions andpouch materials were modified as compared to the applicablepredicate devices.

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Non-Clinical TestSummary	The following bench testing were performed to support adetermination of substantial equivalence:Pouch Seal Strength Catheter Withdrawal from the Carrier Tube Angle Clip Retention Angled Clip Removal Pouch Sterile Barrier Integrity - Bubble Pouch Sterile Barrier Integrity – Visual Shelf Carton Condition Master Shipping Carton Condition Label Adhesion and Print Quality
	The results of these tests provide reasonable assurance that theproposed packaging modifications have been designed and testedto assure conformance to the requirements for its intended use. Nonew safety or performance issues were raised during benchtesting.
	The proposed packaging changes did not require newbiocompatibility or device bench testing to support substantialequivalence. Therefore, testing results from the predicatedevices still apply.
Clinical Testing	Clinical evaluation was not required to support a determination ofsubstantial equivalence.
Conclusion	Based on the indications for use, technological characteristics, andsafety and performance testing, the proposed Rubicon™ 14, 18and 35 Support Catheters have been shown to be appropriate forits intended use and are considered to be substantially equivalentto their respective predicates (K112303 and K122394).

Regulation Number and Section

§ 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).