(26 days)
Renegade™ Fiber Braided Microcatheter
Not Found
No
The summary describes a physical medical device (microcatheter) and its intended use for accessing vasculature and delivering materials. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The device is described as being used for the "controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels," indicating its role in administering therapeutic substances.
No
The device is used for the infusion of diagnostic materials, but it is not itself a diagnostic device. It is a microcatheter designed to access vessels for delivery of substances.
No
The device description clearly describes a physical catheter, which is a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a microcatheter for accessing vasculature and infusing materials. This is an in vivo (within the living body) application, not an in vitro (outside the living body) diagnostic test.
- Device Description: The description reinforces the use of the catheter for accessing vessels and infusing substances, which is consistent with an in vivo procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing diagnostic tests on these samples outside of the body.
Therefore, the Renegade™ Fiber Braided Microcatheter is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Renegade™ Fiber Braided Microcatheters are intended for general intravascular use, including neuro, peripheral and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter 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)
DQO
Device Description
The Renegade™ Fiber Braided Microcatheters are intended for general intravascular use, including neuro, peripheral and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro, peripheral and coronary 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)
The Renegade™ Fiber Braided Microcatheters have been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised.
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.
Renegade™ Fiber Braided Microcatheter
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
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JAN 2 9 2002
Summary of Safety and Effectiveness
| General Provisions | Trade Name: Renegade™ Fiber Braided Microcatheter |
|---|---|
| Classification Name: Diagnostic Intravascular Catheter | |
| Name of Predicate Devices | Renegade™ Fiber Braided Microcatheter |
| Classification | Class II |
| Performance Standards | Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act |
| Intended Use and Device Description | The Renegade™ Fiber Braided Microcatheters are intended for general intravascular use, including neuro, peripheral and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. |
| Biocompatibility | The Renegade™ Fiber Braided Microcatheters have been tested for biocompatibility per ISO 10993. All data demonstrate this device is biocompatible for its intended use. |
| Summary of Substantial Equivalence | The Renegade™ Fiber Braided Microcatheters have been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised. |
0036
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 2002
Ms. Jodi Lynn Greenizen Regulatory Affairs Project Manager Boston Scientific Scimed, Inc. One Scimed Place Maple Grove MN 55311
Re: K020012
Trade/Device Name: Renegade™ Fiber Braided Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter. Regulatory Class: Class II Product Code: DQO Dated: December 31, 2001 Received: January 3, 2002
Dear Ms. Greenizen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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Page 2 - Ms. Jodi Lynn Greenizen
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Brom Zuckerman, M.D.
ram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
| 510(k) Number (if known) | Unknown k 020012 |
|---|---|
| Device Name: | Renegade™ Fiber Braided Microcatheter |
| Indications for Use | The Renegade™ Fiber Braided Microcatheters are intended for general intravascular use, including neuro, peripheral and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH (Office of Device Evaluation) (ODE) | |
|---|---|
| Division of Cardiovascular & Respiratory Devices | |
| 510(k) Number |
| Prescription Use
(Per 21 CFR 801.109) | | OR | Over-The Counter Use
(Optional Format 1-2-96) | |
| ------------------------------------------ | -- | ---- | -------------------------------------------------- | -- |
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