(246 days)
No
The device description and performance studies focus on the physical and mechanical properties of a catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is intended to facilitate placement and support of other devices, and to deliver solutions, not to treat a disease or condition itself.
No
The device is described as a support catheter intended to facilitate the placement and support of other interventional devices and guidewires, and to deliver solutions. It does not perform a diagnostic function of identifying or characterizing a disease or condition.
No
The device description clearly details a physical catheter with a tri-layer extrusion, braided middle layer, radiopaque markerbands, and a hydrophilic coating. It also describes mechanical testing performed on the physical device. This is not a software-only 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 body (peripheral vasculature) to facilitate procedures and deliver substances. This is characteristic of an interventional medical device, not a device used to test samples outside the body.
- Device Description: The description details a catheter with a lumen, guidewire compatibility, radiopaque markers, and a hydrophilic coating. These are features of a device designed for insertion and manipulation within blood vessels.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
- Performance Studies: The performance studies focus on biocompatibility and mechanical properties, which are relevant to devices used in vivo, not in vitro diagnostics.
Therefore, the Rubicon Control Support Catheter is an interventional medical device, not an IVD.
N/A
Intended Use / 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.
Product codes
DQY
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.
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
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 (
§ 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
August 8, 2023
Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side-by-side.
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
1
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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Rubicon™ Control Support Catheter
Indications for Use (Describe)
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.
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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3
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
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.
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.
4
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 (