(12 days)
Not Found
No
The summary describes a mechanical device (microcatheter and guidewire kit) and its physical properties and performance testing. There is no mention of AI, ML, image processing, or any software-driven decision-making or analysis.
Yes
The device is described as being capable of controlled and selective infusion of "therapeutic materials" into vessels, indicating a therapeutic purpose.
Yes
The device can be used for the "controlled and selective infusion of diagnostic...materials into vessels," indicating a diagnostic capability.
No
The device description explicitly lists multiple hardware components including a microcatheter, guidewire, shaping mandrel, valve, torque device, and introducer. The performance studies also focus on the physical characteristics and compatibility of these hardware components.
Based on the provided information, 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" to "selectively introduce and position the Renegade Hi-Flo microcatheter" and for "controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels." This describes a device used within the body for interventional procedures, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a microcatheter and guidewire system designed for navigating and delivering substances within blood vessels. This is consistent with an interventional device.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. The "diagnostic materials" mentioned in the intended use are likely contrast agents used for imaging during the procedure, not for in vitro testing.
In summary, the Renegade™ Hi-Flo™ Fathom™ Kit is an interventional medical device used for procedures within the peripheral vasculature, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KRA
Device Description
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.
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)
Determination of substantial equivalence is based on an assessment of non-clinical performance data. Non-clinical performance data submitted in support of substantial equivalence is based on the Failure Modes/Effects Analysis (FMEA) risk analysis method completed for the Renegade Hi-Flo Fathom Kit to assess the impact of the modifications to the predicate device.
Testing performed and summarized as a result of the completed FMEA and how this testing supports substantial equivalence is described below.
Test Data Submitted: Subject kit components compatibility. How results support SE: Results demonstrate impact of modification to replace Transend-18 Guidewire with Fathom-16 Steerable Guidewire.
Test Data Submitted: Packaging performance/functional testing. How results support SE: Results demonstrate impact of modifications to predicate kit packaging.
Test Data Submitted: Performance testing of the kit guidewire post-sterilization. How results support SE: Results demonstrate impact to Fathom-16 Steerable Guidewire as a result of contract sterilizer and sterilization cycle for predicate kit.
Test Data Submitted: Sterilization qualification summary. How results support SE: Results demonstrate impact to Fathom-16 Steerable Guidewire as a result of contract sterilizer and sterilization cycle for predicate 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.
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
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's
Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Name
and Information | Scott Sepple
Regulatory Affairs Specialist
Tel: 763.494.2028
Fax: 763.494.2222
E-mail: Scott.Sepple@bsci.com | |
| Date Prepared | March 30, 2010 | |
| Trade Name | Renegade™ Hi-Flo™ Fathom™ Kit | |
| Common Name | Microcatheter kit | |
| Classification
Name | Catheter, continuous flush
(21 CFR Part 870.1210, Product Code KRA) | |
| Predicate Device | Boston Scientific
Renegade Hi-Flo
Microcatheter Kit
K000177 SE: 7 April 2000 | |
| Device
Description | 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 | |
| Device
Description,
continued | 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. | |
| 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. | |
| | Indications for use for the Renegade Hi-Flo Fathom Kit are
a combination of the indications for use of the Renegade
Hi-Flo Microcatheter and Fathom-16 Steerable Guidewire. | |
| Comparison of
Technological
Characteristics | The Renegade Hi-Flo Fathom Kit technological
characteristics are identical to the predicate Boston
Scientific Renegade Hi-Flo Microcatheter Kit. | |
| | The Renegade Hi-Flo Fathom Kit and predicate kit both
contain a microcatheter, a guidewire, a microcatheter steam
shaping mandrel, a rotating hemostatic valve (RHV), a
guidewire torque device, and a guidewire introducer. The
primary difference between the predicate and subject kit is
the guidewire. The predicate kit includes the BSC Transend
Guidewire and the Renegade Hi-Flo Fathom Kit includes
the Fathom-16 Steerable Guidewire. The Fathom-16
Steerable Guidewire features a smaller outer diameter, a
Nitinol distal tip, and longer lengths compared to the
Transend-18 Guidewire included in the predicate kit. | |
1
,
.
2
| Non-Clinical
Performance
Data | Determination of substantial equivalence is based on an
assessment of non-clinical performance data. Non-clinical
performance data submitted in support of substantial
equivalence is based on the Failure Modes/Effects Analysis
(FMEA) risk analysis method completed for the Renegade
Hi-Flo Fathom Kit to assess the impact of the modifications
to the predicate device. | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Testing performed and summarized as a result of the
completed FMEA and how this testing supports substantial
equivalence is described below. | |
| | Test Data Submitted | How results support SE |
| | Subject kit components
compatibility | Results demonstrate
impact of modification to
replace Transend-18
Guidewire with Fathom-16
Steerable Guidewire |
| | Packaging performance/
functional testing | Results demonstrate
impact of modifications to
predicate kit packaging |
| | Performance testing of the
kit guidewire post-
sterilization | Results demonstrate
impact to Fathom-16
Steerable Guidewire as a
result of contract sterilizer
and sterilization cycle for
predicate kit |
| | Sterilization qualification
summary | Results demonstrate
impact to Fathom-16
Steerable Guidewire as a
result of contract sterilizer
and sterilization cycle for
predicate 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.
3
| Conclusion | Modification does not affect the intended use or alter the
fundamental scientific technology of the predicate Boston
Scientific Renegade Hi-Flo Microcatheter Kit. |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Based on the Indications for Use, unaltered technological
characteristics, and submitted non-clinical performance data
supporting this modification, the Boston Scientific Renegade
Hi-Flo Fathom Kit is shown to be appropriate for its intended
use and demonstrates that the device is as safe, as
effective, and performs as well as the predicate device. | |
4
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
5
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
6
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