Rubicon Control 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.

Device Description

The Rubicon™ Control Support Catheter is a sterile, single use, single lumen, over the wire (OTW) device designed for use in the peripheral vasculature. The catheter is designed to facilitate placement and support of guidewires and other interventional devices, to allow for exchange of guidewires and provide a conduit for the delivery of saline or contrast solutions. The shaft design is a tri-layer extrusion with a braided middle layer. There are three (3) radiopaque markerbands spaced equally along the distal most markerband is approximately 2 mm away from the distal end of the catheter tip to aid in positioning the system during the procedure. The distal 40 cm portion of the catheter is coated with a hydrophilic coating to aid device insertion through the guide sheath or guide catheter is available with a straight tip and an angled tip. The catheter is available in shaft lengths 65 cm, 90 cm, 135 cm, and 150 cm compatible with 0.014'' (0.356 mm), 0.018'' (0.457 mm), and 0.035'' (0.889 mm) guidewires. The 0.035' support catheter is compatible with 5Fr sheath; the 0.014" and 0.018" are compatible with 4Fr sheath.

There are no accessories supplied with the device.

AI/ML Overview

The provided text describes the 510(k) summary for the Rubicon™ Control Support Catheter. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing (mechanical and biocompatibility). It does not involve a study related to AI/algorithm performance, human-in-the-loop performance, or the analysis of medical images for diagnostic purposes.

Therefore, many of the requested criteria (e.g., acceptance criteria for AI performance, sample size for AI test sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable to this type of medical device submission.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with quantitative acceptance criteria and reported performance values for each mechanical test. It states that "Non-clinical performance evaluations support substantial equivalence," implying that the device met the internal acceptance criteria for these tests. The types of mechanical tests performed are listed under "Mechanical testing":

Simulated use testing
Catheter Bond Strength
Catheter Body Burst Pressure
Contrast Flow Rate
Tip Pull Test
Torque Strength
Particulate Evaluation
Coating Integrity
Shelf Life and Packaging

For Biocompatibility, the document states the evaluation was conducted to ensure the device meets "recommended biocompatibility endpoints as outlined in ISO 10993-1," listing the following tests:

Cytotoxicity
Sensitization
Irritation
Systemic toxicity
Hemolysis
Pyrogen Testing

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not detailed in the provided summary. The tests performed are primarily bench tests on the physical device, not on clinical data. Therefore, concepts like country of origin or retrospective/prospective data provenance are not relevant here. The sample sizes for the mechanical and biocompatibility tests are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The "ground truth" for this device's performance is established through physical measurements and chemical analyses in a lab setting, not through expert radiology reads or similar clinical interpretations.

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

This is not applicable. Adjudication methods are relevant for subjective assessments, particularly in clinical image interpretations. For mechanical and biocompatibility testing, standard laboratory protocols and quantitative measurements are used.

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

This is not applicable. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This submission concerns a physical medical device (catheter) and its mechanical/biocompatibility performance, not an AI algorithm.

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

This is not applicable. There is no AI algorithm component being evaluated in this submission.

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

The "ground truth" for this device is based on physical and chemical measurements against established engineering and biocompatibility standards (e.g., ISO 10993-1). It's not derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning model.

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

This is not applicable as there is no training set for an AI model.

Summary

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August 8, 2023

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Boston Scientific Corporation Mary-Jo Foley Principal Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311-1566

Re: K223633

Trade/Device Name: Rubicon™ Control Support Catheter (H749394323506A1) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: July 28, 2023 Received: July 28, 2023

Dear Mary-Jo Foley:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Samuel G. Raben -S

for Lydia Glaw

Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K223633

Device Name

Rubicon™ Control Support Catheter

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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Rubicon Control Support Catheter 510(k) Summary

I. SUBMITTER

Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311-1566 USA Contact Person: Mary-Jo Foley Date Prepared: December 5th, 2022

II. DEVICE

Name of Device: Rubicon™ Control Support Catheter Common or Usual Name: Support Catheter Classification Name: Percutaneous Catheter (21 CFR 870.1250) Regulatory Class: II Product Code: DQY

III. PREDICATE DEVICE

Rubicon Support Catheter, K171913 This predicate has not been subject to a design-related recall.

Reference device: EMERGE™ Monorail™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter, K220629.

IV. DEVICE DESCRIPTION

There are no accessories supplied with the device.

V. INDICATIONS FOR USE

Rubicon Control 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.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Rubicon Control Support Catheter has the same indication for use, principle of operation, sterilization method, delivery system lengths and device compatibility as the predicate Rubicon Support Catheter (K171913).

The following technological differences exist between the subject and predicate devices:

Availability of straight and angled tip configuration to aid vessel navigation ●
Braided shaft design for added guidewire support ●

Differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. The results of bench testing provide reasonable assurance of substantial equivalence of the Rubicon Control Support Catheter with the predicate device.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation was conducted to ensure that the Rubicon Control Support Catheter meets the recommended biocompatibility endpoints as outlined in ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a risk management process and FDA Guidance - Use of International Standard ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a risk management process (September 4th, 2020). The battery of testing included the following tests:

Cytotoxicity
Sensitization ●
Irritation
Systemic toxicity ●
Hemolysis
. Pyrogen Testing

The device is categorized as externally communicating, limited contact (<24 hours), circulating blood contacting.

Mechanical testing

Simulated use testing ●
Catheter Bond Strength ●
Catheter Body Burst Pressure
Contrast Flow Rate
Tip Pull Test
Torque Strength ●
Particulate Evaluation
Coating Integrity

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Shelf Life and Packaging ●

VIII. CONCLUSIONS

The subject and predicate devices share the same indications for use and fundamental scientific technology, including principle of operation. Differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. Non-clinical performance evaluations support substantial equivalence of the Rubicon Control Support Catheter to the predicate Rubicon Support Catheter (K171913).

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).