(29 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and packaging of a support catheter, with no mention of AI or ML.
No
The device is intended to facilitate placement and support of guidewires and other interventional devices, and to deliver solutions, not to treat a disease or condition.
No
The device is described as a "support catheter" intended to "facilitate placement and support of guidewires and other interventional devices" and to "allow for exchange of guide a conduit for the delivery of saline or contrast solutions." Its purpose is to assist in interventional procedures rather than to diagnose conditions.
No
The device description clearly describes a physical catheter, which is a hardware component, intended for intravascular use.
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 the placement and support of other devices and deliver solutions. This is an in vivo application.
- Device Description: The description reinforces the in vivo nature of the device, detailing its use within the intravascular space and its interaction with guidewires and other interventional devices.
- Anatomical Site: The specified anatomical site is the peripheral vasculature, which is inside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body for interventional procedures.
N/A
Intended Use / 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 guide a conduit for the delivery of saline or contrast solutions.
Product codes (comma separated list FDA assigned to the subject device)
DQY
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Summary: The following bench testing were performed to support a determination 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 the proposed packaging modifications have been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during bench testing. The proposed packaging changes did not require new biocompatibility or device bench testing to support substantial equivalence. Therefore, testing results from the predicate devices still apply.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
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
1
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
2
Indications for Use
510(k) Number (if known) K171913
Device Name Rubicon™ 14, 18 and 35 Support Catheters
Indications for Use (Describe)
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.
| 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
510(k) Summary
Per 21 CFR §807.92
| Common or Usual
| Name | Percutaneous Catheter |
|---|---|
| Trade Name(s) | Rubicon™ 14, 18 and 35 Support Catheters |
| Product Code | DQY - Percutaneous Catheter |
| Classification of | |
| Device | Class II - 21 CFR 870.1250 |
| Submitter's Name | |
| and Address | Boston Scientific Corporation |
| Three Scimed Place, C275 | |
| Maple Grove, MN 55311-1566 | |
| Contact Name and | |
| Information | Ka Zoua Xiong |
| Regulatory Affairs Specialist | |
| Phone: 763-494-2970 | |
| Fax: 763-494-2222 | |
| Email: Kazoua.Xiong@bsci.com | |
| Date Prepared | 22 June 2017 |
| Section 514 of the | |
| Act Performance | |
| Standards | 6-301: ISO 10555-1 Second edition 2013-06-15 |
| Intravascular catheters -- Sterile and single-use intravascular | |
| catheters -- Part 1: General requirements | |
| 6-322: ISO 10555-4 Second edition 2013-06-15 | |
| Intravascular catheters -- Sterile and single-use catheters -- Part 4: | |
| Balloon dilatation catheters | |
| Establishment | |
| Registration | |
| Numbers | Owner /Operator: |
| Boston Scientific Corporation | |
| 300 Boston Scientific Way | |
| Marlborough, MA 01752 | |
| ERN: 9912058 |
Manufacturing Facility:
Boston Scientific Corporation
Two Scimed Place
Maple Grove, MN 55311
ERN: 2134265
Sterilization Facilities:
BSC Coventry
8 Industrial Drive
Coventry, RI 02816
USA |
| Predicate Devices | K112303 - Rubicon™ 14 Support Catheter
K122394 - Rubicon™ 18 Support Catheter
Rubicon™ 35 Support Catheter |
| 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. |
| Intended Use/
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. |
| Comparison of
Required
Technological
Characteristics | Rubicon is substantially equivalent to the existing Rubicon devices
cleared by FDA under Premarket Notifications K112303 and
K122394 (09 Nov 2011 and 30 Aug 2012, respectively). Rubicon
has the same intended use, scientific technology, design,
materials, and sterilization method. The packaging dimensions and
pouch materials were modified as compared to the applicable
predicate devices. |
4
5
| Non-Clinical Test
Summary | The following bench testing were performed to support a
determination 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 the
proposed packaging modifications have been designed and tested
to assure conformance to the requirements for its intended use. No
new safety or performance issues were raised during bench
testing. |
| | The proposed packaging changes did not require new
biocompatibility or device bench testing to support substantial
equivalence. Therefore, testing results from the predicate
devices still apply. |
| Clinical Testing | Clinical evaluation was not required to support a determination of
substantial equivalence. |
| Conclusion | Based on the indications for use, technological characteristics, and
safety and performance testing, the proposed Rubicon™ 14, 18
and 35 Support Catheters have been shown to be appropriate for
its intended use and are considered to be substantially equivalent
to their respective predicates (K112303 and K122394). |