(12 days)
The Renegade™ Hi-Flo™ Fathom™ Kit 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.
The Renegade Hi-Flo Fathom Kit includes a Renegade Hi-Flo Microcatheter, a Fathom-16 Steerable Guidewire, a steam shaping mandrel, a rotating hemostatic valve (RHV), a guide wire torque device, and a guide wire introducer.
The Renegade Hi-Flo Microcatheter lumen is able to accommodate steerable guidewires that are ≤ 0.018 in (0.46 mm) in diameter. The outer surface of the microcatheter distal segment is coated and has a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The distal tip of the microcatheter is steam shapeable using the included steam shaping mandrel and the proximal end of the microcatheter incorporates a standard luer adapter to facilitate the attachment of the rotating hemostatic valve (RHV).
The Fathom-16 Steerable Guidewire has a maximum diameter of 0.016 in (0.41 mm). The distal portion of the device is coated for lubricity and is radiopaque to facilitate fluoroscopic visualization. The torque device included with the guidewire attaches to the proximal end of the guidewire and functions as a steering mechanism. The guidewire introducer facilitates insertion of the guide wire into the microcatheter hub and/or hemostatic valve and may be used to shape the guidewire distal tip.
The provided document is a 510(k) summary for the Boston Scientific Renegade™ Hi-Flo™ Fathom™ Kit. This type of submission is for demonstrating substantial equivalence to a predicate device, and thus typically relies on non-clinical performance data rather than a full-scale clinical comparative effectiveness study with pre-defined acceptance criteria for a new device's performance.
Here's an analysis of the provided information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (What was measured) | Reported Device Performance (Results) |
|---|---|---|
| Subject Kit Components Compatibility | Demonstrate compatibility of the new Fathom-16 Steerable Guidewire with the existing Renegade Hi-Flo Microcatheter kit components. | Results demonstrate the impact of the modification (replacing the Transend-18 Guidewire with the Fathom-16 Steerable Guidewire) is acceptable and supports substantial equivalence. (Specific quantitative results or detailed criteria are not provided in this summary, but implied by "demonstrate impact" and "supports substantial equivalence"). |
| Packaging Performance/Functional Testing | Evaluate the impact of modifications to the predicate kit packaging. | Results demonstrate the impact of modifications to the predicate kit packaging is acceptable and supports substantial equivalence. (Specific quantitative results or detailed criteria are not provided, but implied by "demonstrate impact" and "supports substantial equivalence"). |
| Performance Testing of Kit Guidewire Post-Sterilization | Evaluate the impact on the Fathom-16 Steerable Guidewire resulting from the contract sterilizer and sterilization cycle used for the predicate kit. | Results demonstrate the impact to the Fathom-16 Steerable Guidewire from the sterilization process is acceptable and supports substantial equivalence. (Specific quantitative results or detailed criteria are not provided, but implied by "demonstrate impact" and "supports substantial equivalence"). |
| Sterilization Qualification Summary | Confirm that the sterilization process for the Fathom-16 Steerable Guidewire is qualified and effective under the existing sterilization cycle. | Results demonstrate the impact to the Fathom-16 Steerable Guidewire from the sterilization qualification is acceptable and supports substantial equivalence. (Specific quantitative results or detailed criteria are not provided, but implied by "demonstrate impact" and "supports substantial equivalence"). |
Note: The acceptance criteria for these tests are generally inferred to be successful completion without adverse effects or performance degradation compared to the predicate device, thereby supporting substantial equivalence. Specific quantitative thresholds are not detailed in this summary. The document explicitly states: "All testing performed and data included in submission demonstrate passing results according to executed verification protocols. Therefore, results of non-clinical performance data submitted supports substantial equivalence to predicate device."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample sizes used for the non-clinical performance tests. These are typically internal validation tests, and the exact number of units tested is not usually included in a 510(k) summary.
- Data Provenance: The tests are non-clinical performance data, likely conducted in a laboratory or manufacturing setting by Boston Scientific. The country of origin of the data is implied to be internal to Boston Scientific's R&D/testing facilities (e.g., Maple Grove, MN). The data is retrospective in the sense that it's generated for submission after the device design is finalized, but it's new data generated for the modified device, not historical patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not applicable as the study described is a non-clinical performance study of a medical device, not a diagnostic or AI-based system requiring expert-established ground truth for a test set. The "ground truth" for these tests would be objective measurements and engineering standards.
4. Adjudication Method for the Test Set
- Not applicable. As stated above, this is a non-clinical performance study, not one requiring adjudication by human experts for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." Therefore, no MRMC study was conducted or reported for this submission. The device is a physical medical device (microcatheter kit), not a diagnostic or AI-assisted interpretation system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a physical medical device, not an algorithm or AI system.
7. Type of Ground Truth Used
- The "ground truth" for these non-clinical performance studies typically involves engineering specifications, material properties, mechanical test standards, and established biocompatibility/sterilization validation protocols. For example, compatibility would be verified by proper fit and function, packaging integrity by established test methods (e.g., ASTM standards), and sterilization by demonstrating sterility assurance levels (SAL) according to ISO standards.
8. Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this device's non-clinical performance validation. This is a physical medical device, not an AI model that undergoes training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, this question is not relevant.
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Image /page/0/Picture/1 description: The image shows the words "Boston Scientific" stacked on top of each other. The word "Boston" is on the top line, and the word "Scientific" is on the bottom line. The font is a serif font, and the text is black. The background is white.
ﺎ ﺍﻟﻤﺮﺍﺟﻊ
Cardiovascular
One Scimed Place Maple Grove, MN 55311-1566 763.494.1700 Tel www.bostonscientific.com
510(k) Summary per 21 CFR §807.92 (c)
APR 1 2 2010
| Submitter'sName andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311 | |
|---|---|---|
| Contact Nameand Information | Scott SeppleRegulatory Affairs SpecialistTel: 763.494.2028Fax: 763.494.2222E-mail: Scott.Sepple@bsci.com | |
| Date Prepared | March 30, 2010 | |
| Trade Name | Renegade™ Hi-Flo™ Fathom™ Kit | |
| Common Name | Microcatheter kit | |
| ClassificationName | Catheter, continuous flush(21 CFR Part 870.1210, Product Code KRA) | |
| Predicate Device | Boston ScientificRenegade Hi-FloMicrocatheter KitK000177 SE: 7 April 2000 | |
| DeviceDescription | The Renegade Hi-Flo Fathom Kit includes a RenegadeHi-Flo Microcatheter, a Fathom-16 Steerable Guidewire, asteam shaping mandrel, a rotating hemostatic valve (RHV),a guide wire torque device, and a guide wire introducer.The Renegade Hi-Flo Microcatheter lumen is able toaccommodate steerable guidewires that are ≤ 0.018 in (0.46mm) in diameter. The outer surface of the microcatheterdistal segment is coated and has a radiopaque marker atthe distal tip to facilitate fluoroscopic visualization. Thedistal tip of the microcatheter is steam shapeable using the | |
| DeviceDescription,continued | included steam shaping mandrel and the proximal end ofthe microcatheter incorporates a standard luer adapter tofacilitate the attachment of the rotating hemostatic valve(RHV). | |
| The Fathom-16 Steerable Guidewire has a maximumdiameter of 0.016 in (0.41 mm). The distal portion of thedevice is coated for lubricity and is radiopaque to facilitatefluoroscopic visualization. The torque device included withthe guidewire attaches to the proximal end of the guidewireand functions as a steering mechanism. The guidewireintroducer facilitates insertion of the guide wire into themicrocatheter hub and/or hemostatic valve and may beused to shape the guidewire distal tip. | ||
| Indications forUse | The Renegade Hi-Flo Fathom Kit is intended for peripheralvascular use. The Fathom guidewire can be used toselectively introduce and position the Renegade Hi-Flomicrocatheter in the peripheral vasculature. Themicrocatheter can be used for controlled and selectiveinfusion of diagnostic, embolic, or therapeutic materials intovessels. | |
| Indications for use for the Renegade Hi-Flo Fathom Kit area combination of the indications for use of the RenegadeHi-Flo Microcatheter and Fathom-16 Steerable Guidewire. | ||
| Comparison ofTechnologicalCharacteristics | The Renegade Hi-Flo Fathom Kit technologicalcharacteristics are identical to the predicate BostonScientific Renegade Hi-Flo Microcatheter Kit. | |
| The Renegade Hi-Flo Fathom Kit and predicate kit bothcontain a microcatheter, a guidewire, a microcatheter steamshaping mandrel, a rotating hemostatic valve (RHV), aguidewire torque device, and a guidewire introducer. Theprimary difference between the predicate and subject kit isthe guidewire. The predicate kit includes the BSC TransendGuidewire and the Renegade Hi-Flo Fathom Kit includesthe Fathom-16 Steerable Guidewire. The Fathom-16Steerable Guidewire features a smaller outer diameter, aNitinol distal tip, and longer lengths compared to theTransend-18 Guidewire included in the predicate kit. |
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| Non-ClinicalPerformanceData | Determination of substantial equivalence is based on anassessment of non-clinical performance data. Non-clinicalperformance data submitted in support of substantialequivalence is based on the Failure Modes/Effects Analysis(FMEA) risk analysis method completed for the RenegadeHi-Flo Fathom Kit to assess the impact of the modificationsto the predicate device. | |
|---|---|---|
| Testing performed and summarized as a result of thecompleted FMEA and how this testing supports substantialequivalence is described below. | ||
| Test Data Submitted | How results support SE | |
| Subject kit componentscompatibility | Results demonstrateimpact of modification toreplace Transend-18Guidewire with Fathom-16Steerable Guidewire | |
| Packaging performance/functional testing | Results demonstrateimpact of modifications topredicate kit packaging | |
| Performance testing of thekit guidewire post-sterilization | Results demonstrateimpact to Fathom-16Steerable Guidewire as aresult of contract sterilizerand sterilization cycle forpredicate kit | |
| Sterilization qualificationsummary | Results demonstrateimpact to Fathom-16Steerable Guidewire as aresult of contract sterilizerand sterilization cycle forpredicate kit |
All testing performed and data included in submission demonstrate passing results according to executed verification protocols. Therefore, results of non-clinical performance data submitted supports substantial equivalence to predicate device.
Clinical Performance Data
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
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| Conclusion | Modification does not affect the intended use or alter thefundamental scientific technology of the predicate BostonScientific Renegade Hi-Flo Microcatheter Kit. |
|---|---|
| Based on the Indications for Use, unaltered technologicalcharacteristics, and submitted non-clinical performance datasupporting this modification, the Boston Scientific RenegadeHi-Flo Fathom Kit is shown to be appropriate for its intendeduse and demonstrates that the device is as safe, aseffective, and performs as well as the predicate device. |
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Image /page/4/Picture/1 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 an abstract image of an eagle or bird-like figure, with stylized lines representing its wings and body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR 1 2 2010
Boston Scientific Corporation c/o Mr. Scott Sepple Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311
Re: K100892
Trade/Device Name: Renegade Hi-Flo Fathom Kit Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: Class II (two) Product Code: KRA Dated: March 30, 2010 Received: March 31, 2010
Dear Mr. Sepple:
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. Iisting 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
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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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Dma R. V. Aumer
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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Indications for Use
510(k) Number (if known):
510(k) Number (if known): K100892
Device Name: Renegade™ Hi-Flo™ Fathom™ Kit
Indications for Use:
The Renegade™ Hi-Flo™ Fathom™ Kit 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.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Cardiovascular Devices
Page 1 of __ 1
510(k) Number KTOO892
§ 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).