(25 days)
Renegade™ Hi-Flo Microcatheter, Renegade™ Fiber Braided Microcatheter,Excelsior™ 1018 Microcatheter and Tracker® Excel™ 14
Not Found
No
The 510(k) summary describes a physical microcatheter used for infusion and access, with no mention of software, algorithms, or any terms related to AI/ML.
No.
The device is a microcatheter used for accessing vasculature and delivering materials. While it can deliver "therapeutic materials," the device itself is not described as providing therapy directly but rather as a tool for delivery.
No
The device is a microcatheter used for the infusion of materials, which can include diagnostic materials, but the device itself does not perform diagnostic functions. It is a tool for delivery, not for diagnosis.
No
The device description explicitly states it is a "sterile, single-use catheter" and provides physical dimensions (lengths), indicating it is a physical medical device, not software-only.
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 being used for accessing vasculature and infusing materials into vessels. This is an interventional procedure performed in vivo (within the living body).
- Device Description: The description of a catheter used for intravascular access and infusion aligns with a medical device used for treatment or diagnosis within the body, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used to detect, measure, or identify substances or characteristics in these samples to diagnose a condition or monitor health.
Therefore, the Renegade STC TM 18 Microcatheter is a medical device used for interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Renegade STC (TM) 18 Microcatheter is 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
DQO
Device Description
The Renegade™ STC-18 Microcatheter is a sterile, single-use catheter and is available in lengths of 105 cm, 130 cm, and 150cm.
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
The Renegade STC™ 18 Microcatheter has 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
Not Found
Predicate Device(s)
Renegade™ Hi-Flo Microcatheter, Renegade™ Fiber Braided Microcatheter,Excelsior™ 1018 Microcatheter and Tracker® Excel™ 14
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
16023681
Special 510(k) Renegade™ STC-18 Microcatheter
October 31, 2002
| General
Provisions | Trade Name: Renegade STC™ 18 Microcatheter
Classification Name: Diagnostic Intravascular Catheter |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of
Predicate
Devices | Renegade™ Hi-Flo Microcatheter, Renegade™ Fiber Braided Microcatheter,
Excelsior™ 1018 Microcatheter and Tracker® Excel™ 14 |
| 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 STC™ 18 is 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. The Renegade™ STC-18 Microcatheter is a
sterile, single-use catheter and is available in lengths of 105 cm, 130 cm, and
150cm. |
| Biocompatibility | The Renegade STC-18™ Microcatheter has been tested for biocompatibility
per ISO 10993. All data demonstrate this device is biocompatible for its
intended use. |
| Summary of
Substantial
Equivalence | The Renegade STC™ 18 Microcatheter has 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. |
Summary of Safety and Effectiveness
NOV 2 6 2002
0 0 0 0 5 2
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation Ms. Christine M. Cameron Regulatory Affairs Specialist One Boston Scientific Place Natick, MA 01760-1537
Re: K023681
Renegade STCTM 18 Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter. Regulatory Class: II Product Code: DOO Dated: October 31, 2002 Received: November 1, 2002
Dear Ms. Cameron:
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 mav 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
2
Page 2 – Ms. Christine M. Cameron
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), please contact the Office of Compliance at (301) 594-4639. 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,
Wh
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Special 510(k) Renegade ™ STC-18 Microcatheter October 31, 2002 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Indications For Use
| 510(k) Number (if known) | Unknown
K023681 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Renegade STC TM 18 Microcatheter |
| Indications for Use | The Renegade STC TM 18 Microcatheter is 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 K029681
| Prescription Use | ✓ |
|---|---|
| ------------------ | -------------- |
OR
| Over-The Counter Use | |
|---|---|
| ---------------------- | -- |
Confidential Boston Scientific Corporation