(94 days)
Not Found
No
The document describes a physical medical device (microcatheter and guidewire) for delivering materials in the peripheral vasculature. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are bench tests of physical properties.
Yes.
The device is intended for the "controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels," meaning it can deliver therapeutic agents.
Yes
The device description and intended use state that the microcatheter can be used for the "selective infusion of diagnostic... materials into vessels." This indicates its role in delivering substances for diagnostic purposes.
No
The device description clearly details physical components like catheters, guidewires, hubs, and coatings, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "peripheral vascular use" and for "selectively introduce and position the Renegade HI-FLO microcatheter in the peripheral vasculature" and "controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels." This describes a device used within the body for treatment or delivery, not for testing samples outside the body.
- Device Description: The description details a catheter designed to be advanced through the vasculature and deliver substances. This aligns with an interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
The device is an interventional medical device used for accessing and delivering materials within the peripheral vasculature.
N/A
Intended Use / Indications for Use
Renegade HI-FLO FATHOM Kit / System:
The Renegade HI-FLO FATHOM Kit / System is intended for peripheral vascular use. The FATHOM guidewire can be used to selectively introduce and position the Renegade HI-FLO microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.
Renegade HI-FLO Microcatheter and Kit:
The Renegade HI-FLO Microcatheter is intended for peripheral vascular use. The microcatheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications outlined by the manufacturer.
Product codes (comma separated list FDA assigned to the subject device)
KRA
Device Description
The Boston Scientific Renegade HI-FLO Microcatheter devices are single lumen, multipurpose catheters intended for use in the peripheral vasculature. The basic operating principle is to advance the microcatheter through a guide catheter and track coaxially over a steerable guidewire in order to access the treatment site. Once the target region has been accessed, the microcatheter can be used to deliver diagnostic, embolic, or therapeutic materials into vessels.
The Renegade Hi-Flo Microcatheter incorporates a taper in its outside diameter along its length from the 3.0F (1.0 mm) proximal outer diameter (OD) to the flexible 2.8F (0.93 mm) distal OD. The inner diameter (ID) of the microcatheter is 0.69 mm (0.027 in) minimally in the proximal and distal regions. The microcatheter lumen is able to accommodate steerable guidewires that are ≤ 0.47 mm (0.018 in) in diameter. The microcatheter is available in 80, 105, 115, 135, and 150 cm usable lengths.
The distal end of the microcatheter is coated with Hydro Pass™ hydrophilic coating for lubricity. The Renegade Hi-Flo Microcatheter has a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The distal tip of the microcatheter is steam shapeable and can be bent to the desired geometry with a steam shaping mandrel accessory packaged with the device. The proximal end of the microcatheter incorporates a hub with a standard luer to facilitate the attachment of accessories.
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 Performance Data
The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The Renegade HI-FLO Microcatheters met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.
- Static Burst Pressure .
- Dynamic Burst Test (Infusion Pressure) .
- Catheter Distal Joint Tensile Strength .
- Hub to Shaft Tensile Strength .
- . Kink Radius of Curvature
- Distal OD Reduction .
- Distal Tip Flexibility .
- Proximal Shaft Stiffness .
- . Radiopacity
Clinical Performance Data
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
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
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
MAY 1 5 2014
K140329 Page 1 of 3
:
| Submitter's
Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 | |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Name
and Information | Mark Murphy
Senior Regulatory Affairs Specialist
Tel: 763.494.2377
Fax: 763.494.2222
E-mail: mark.murphy2@bsci.com | |
| Date Prepared | February 7, 2014 | |
| Trade Name | Renegade™ HI-FLO™ FATHOM™ Kit
Renegade™ HI-FLO™ FATHOM™ System
Renegade™ HI-FLO™ Microcatheter
Renegade™ HI-FLO™ Kit | |
| Common Name | Catheter, Continuous Flush | |
| Classification | Class II per 21 CFR Part 870.1210
Product Code: KRA
Classification Panel: Cardiovascular | |
| Predicate Device | Renegade™ HI-FLO™ FATHOM™ Kit
(K100892, 12 April 2010) | |
| | Renegade HI-FLO Microcatheter and Kit
(K000177, 07 April 2000) | |
| Device
Description | The Boston Scientific Renegade HI-FLO Microcatheter
devices are single lumen, multipurpose catheters intended
for use in the peripheral vasculature. The basic operating
principle is to advance the microcatheter through a guide
catheter and track coaxially over a steerable guidewire in
order to access the treatment site. Once the target region
has been accessed, the microcatheter can be used to
deliver diagnostic, embolic, or therapeutic materials into
vessels. | |
| Device
Description
(cont'd) | The Renegade Hi-Flo Microcatheter incorporates a taper in
its outside diameter along its length from the 3.0F (1.0 mm)
proximal outer diameter (OD) to the flexible 2.8F (0.93 mm)
distal OD. The inner diameter (ID) of the microcatheter is
0.69 mm (0.027 in) minimally in the proximal and distal
regions. The microcatheter lumen is able to accommodate
steerable guidewires that are ≤ 0.47 mm (0.018 in) in
diameter. The microcatheter is available in 80, 105, 115,
135, and 150 cm usable lengths. | |
| | The distal end of the microcatheter is coated with Hydro
Pass™ hydrophilic coating for lubricity. The Renegade Hi-
Flo Microcatheter has a radiopaque marker at the distal tip
to facilitate fluoroscopic visualization. The distal tip of the
microcatheter is steam shapeable and can be bent to the
desired geometry with a steam shaping mandrel accessory
packaged with the device. The proximal end of the
microcatheter incorporates a hub with a standard luer to
facilitate the attachment of accessories. | |
| Indication for
Use | Renegade HI-FLO FATHOM Kit / System:
The Renegade HI-FLO FATHOM Kit / System is intended
for peripheral vascular use. The FATHOM guidewire can be
used to selectively introduce and position the Renegade HI-
FLO microcatheter in the peripheral vasculature. The
microcatheter can be used for controlled and selective
infusion of diagnostic, embolic, or therapeutic materials into
vessels. | |
| | Renegade HI-FLO Microcatheter and Kit: | |
| | The Renegade HI-FLO Microcatheter is intended for
peripheral vascular use. The microcatheter can be coaxially
tracked over a steerable guidewire in order to access distal,
tortuous vasculature. Once the subselective region has
been accessed, the microcatheter can be used for the
controlled and selective infusion of diagnostic, embolic, or
therapeutic materials into vessels. Diagnostic, embolic, or
therapeutic agents to be used in accordance with
specifications outlined by the manufacturer. | |
| Comparison of
Technological
Characteristics | The Renegade HI-FLO Microcatheters are similar in
fundamental design, function, device materials, packaging,
sterilization, operating principle, intended use / indication for
use and fundamental technology as the predicate devices.
The modification from the predicate device included a
change to the braided shaft material. | |
1
K140329 Page 2 of 3
·
•
2
Non-Clinical Performance Data
The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The Renegade HI-FLO Microcatheters met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.
- Static Burst Pressure .
- Dynamic Burst Test (Infusion Pressure) .
- Catheter Distal Joint Tensile Strength .
- Hub to Shaft Tensile Strength .
- . Kink Radius of Curvature
- Distal OD Reduction .
- Distal Tip Flexibility .
- Proximal Shaft Stiffness .
- . Radiopacity
Clinical Performance Data
Conclusion
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Boston Scientific has demonstrated that the modification made to the Renegade HI-FLO Microcatheters are substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principle, and intended use / indication for use as the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and is smaller than the eagle symbol.
Public Health Service
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
May 15, 2014
Boston Scientific Corporation Mr. Mark Murphy Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
Re: K140329
Trade/Device Name: Renegade HI-FLO Microcatheter, Renegade HI-FLO Microcatheter Kit, Renegade HI-FLO FATHOM System, Renegade HI-FLO FATHOM Kit
Regulation Number: 21 CFR 870.1210
Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: April 14, 2014 Received: April 15, 2014
Dear Mr. Murphy,
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 that + 27 theol 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
4
Page 2 - Mr. Mark Murphy
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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 yours
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K140329
Special 510(k) Premarket Notification Renegade HI-FLO Microcatheters
Indications for Use
510(k) Number (if known): K140329
| Device Name | Indication For Use |
|---|---|
| Renegade HI-FLO FATHOM Kit | The Renegade HI-FLO FATHOM Kit / System is intended for |
| peripheral vascular use. The FATHOM guidewire can be used to | |
| selectively introduce and position the Renegade HI-FLO | |
| microcatheter in the peripheral vasculature. The microcatheter can | |
| be used for controlled and selective infusion of diagnostic, embolic, | |
| or therapeutic materials into vessels. | |
| Renegade HI-FLO FATHOM | |
| System | be used for controlled and selective infusion of diagnostic, embolic, |
| or therapeutic materials into vessels. | |
| Renegade HI-FLO Microcatheter | The Renegade HI-FLO Microcatheter is intended for peripheral |
| vascular use. The microcatheter can be coaxially tracked over a | |
| steerable guidewire in order to access distal, tortuous vasculature. | |
| Once the subselective region has been accessed, the microcatheter | |
| can be used for the controlled and selective infusion of diagnostic, | |
| embolic, or therapeutic materials into vessels. Diagnostic, embolic, or | |
| therapeutic agents to be used in accordance with specifications | |
| outlined by the manufacturer. | |
| Renegade HI-FLO Kit |
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Ke
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