(94 days)
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.
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.
This document describes the acceptance criteria and study proving the device, Renegade HI-FLO Microcatheters, meets these criteria. The study focuses on non-clinical performance data to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Burst Pressure | Not explicitly stated, implied to meet pre-determined criteria for equivalence to predicate. | Met the predetermined acceptance criteria. |
| Dynamic Burst Test (Infusion Pressure) | Not explicitly stated, implied to meet pre-determined criteria for equivalence to predicate. | Met the predetermined acceptance criteria. |
| Catheter Distal Joint Tensile Strength | Not explicitly stated, implied to meet pre-determined criteria for equivalence to predicate. | Met the predetermined acceptance criteria. |
| Hub to Shaft Tensile Strength | Not explicitly stated, implied to meet pre-determined criteria for equivalence to predicate. | Met the predetermined acceptance criteria. |
| Kink Radius of Curvature | Not explicitly stated, implied to meet pre-determined criteria for equivalence to predicate. | Met the predetermined acceptance criteria. |
| Distal OD Reduction | Not explicitly stated, implied to meet pre-determined criteria for equivalence to predicate. | Met the predetermined acceptance criteria. |
| Distal Tip Flexibility | Not explicitly stated, implied to meet pre-determined criteria for equivalence to predicate. | Met the predetermined acceptance criteria. |
| Proximal Shaft Stiffness | Not explicitly stated, implied to meet pre-determined criteria for equivalence to predicate. | Met the predetermined acceptance criteria. |
| Radiopacity | Not explicitly stated, implied to meet pre-determined criteria for equivalence to predicate. | Met the predetermined acceptance criteria. |
Note: The document states that the devices “met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device.” However, the specific quantitative acceptance criteria for each test are not detailed in the provided text.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each "bench testing" component. The dataProvenance is non-clinical bench testing, implying data was generated in a controlled laboratory setting, not from human or animal subjects. Therefore, there is no country of origin of data or retrospective/prospective classification in the typical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This was a non-clinical bench study. The "ground truth" for the tests would be based on established engineering and materials science principles, and the direct measurements and observations during the bench tests, validated against predetermined acceptance criteria derived from the predicate device's performance.
4. Adjudication Method for the Test Set
Not applicable. As a non-clinical bench study, there is no mention of adjudication by experts for test results. The assessment would involve direct measurement and comparison to predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Performance Data: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a microcatheter, a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for these non-clinical tests was based on engineering specifications and performance data of the predicate device. The tests were designed to ensure the modified device exhibited equivalent physical and mechanical performance characteristics to the already approved predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or algorithm-based system that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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MAY 1 5 2014
K140329 Page 1 of 3
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| Submitter'sName andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311 | |
|---|---|---|
| Contact Nameand Information | Mark MurphySenior Regulatory Affairs SpecialistTel: 763.494.2377Fax: 763.494.2222E-mail: mark.murphy2@bsci.com | |
| Date Prepared | February 7, 2014 | |
| Trade Name | Renegade™ HI-FLO™ FATHOM™ KitRenegade™ HI-FLO™ FATHOM™ SystemRenegade™ HI-FLO™ MicrocatheterRenegade™ HI-FLO™ Kit | |
| Common Name | Catheter, Continuous Flush | |
| Classification | Class II per 21 CFR Part 870.1210Product Code: KRAClassification Panel: Cardiovascular | |
| Predicate Device | Renegade™ HI-FLO™ FATHOM™ Kit(K100892, 12 April 2010) | |
| Renegade HI-FLO Microcatheter and Kit(K000177, 07 April 2000) | ||
| DeviceDescription | The Boston Scientific Renegade HI-FLO Microcatheterdevices are single lumen, multipurpose catheters intendedfor use in the peripheral vasculature. The basic operatingprinciple is to advance the microcatheter through a guidecatheter and track coaxially over a steerable guidewire inorder to access the treatment site. Once the target regionhas been accessed, the microcatheter can be used todeliver diagnostic, embolic, or therapeutic materials intovessels. | |
| DeviceDescription(cont'd) | The Renegade Hi-Flo Microcatheter incorporates a taper inits 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 is0.69 mm (0.027 in) minimally in the proximal and distalregions. The microcatheter lumen is able to accommodatesteerable guidewires that are ≤ 0.47 mm (0.018 in) indiameter. The microcatheter is available in 80, 105, 115,135, and 150 cm usable lengths. | |
| The distal end of the microcatheter is coated with HydroPass™ hydrophilic coating for lubricity. The Renegade Hi-Flo Microcatheter has a radiopaque marker at the distal tipto facilitate fluoroscopic visualization. The distal tip of themicrocatheter is steam shapeable and can be bent to thedesired geometry with a steam shaping mandrel accessorypackaged with the device. The proximal end of themicrocatheter incorporates a hub with a standard luer tofacilitate the attachment of accessories. | ||
| Indication forUse | Renegade HI-FLO FATHOM Kit / System:The Renegade HI-FLO FATHOM Kit / System is intendedfor peripheral vascular use. The FATHOM guidewire can beused to selectively introduce and position the Renegade HI-FLO microcatheter in the peripheral vasculature. Themicrocatheter can be used for controlled and selectiveinfusion of diagnostic, embolic, or therapeutic materials intovessels. | |
| Renegade HI-FLO Microcatheter and Kit: | ||
| The Renegade HI-FLO Microcatheter is intended forperipheral vascular use. The microcatheter can be coaxiallytracked over a steerable guidewire in order to access distal,tortuous vasculature. Once the subselective region hasbeen accessed, the microcatheter can be used for thecontrolled and selective infusion of diagnostic, embolic, ortherapeutic materials into vessels. Diagnostic, embolic, ortherapeutic agents to be used in accordance withspecifications outlined by the manufacturer. | ||
| Comparison ofTechnologicalCharacteristics | The Renegade HI-FLO Microcatheters are similar infundamental design, function, device materials, packaging,sterilization, operating principle, intended use / indication foruse and fundamental technology as the predicate devices.The modification from the predicate device included achange to the braided shaft material. |
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K140329 Page 2 of 3
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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.
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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
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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
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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 forperipheral vascular use. The FATHOM guidewire can be used toselectively introduce and position the Renegade HI-FLOmicrocatheter in the peripheral vasculature. The microcatheter canbe used for controlled and selective infusion of diagnostic, embolic,or therapeutic materials into vessels. |
| Renegade HI-FLO FATHOMSystem | 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 peripheralvascular use. The microcatheter can be coaxially tracked over asteerable guidewire in order to access distal, tortuous vasculature.Once the subselective region has been accessed, the microcathetercan be used for the controlled and selective infusion of diagnostic,embolic, or therapeutic materials into vessels. Diagnostic, embolic, ortherapeutic agents to be used in accordance with specificationsoutlined 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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§ 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).