(26 days)
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.
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.
Here's an analysis of the provided text regarding the Renegade™ Fiber Braided Microcatheter, focusing on acceptance criteria and supporting studies.
Important Note: The provided text is a 510(k) summary and FDA clearance letter. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than performing de novo studies to establish new acceptance criteria and prove performance against those criteria in the same way a PMA (Pre-Market Approval) would. Therefore, much of the requested information (like specific performance acceptance criteria, detailed study designs, and ground truth establishment) is typically not found in this type of document because the focus is on comparison, not novel claims.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantifiable acceptance criteria and their corresponding reported device performance values are not explicitly stated in a numerical or metric-based format. The submission focuses on demonstrating substantial equivalence.
| Item | Acceptance Criteria (Not Explicitly Stated as Numerical Metrics) | Reported Device Performance |
|---|---|---|
| Material Biocompatibility | Device materials should be safe for intended human contact and use. | "The Renegade™ Fiber Braided Microcatheters have been tested for biocompatibility per ISO 10993. All data demonstrate this device is biocompatible for its intended use." |
| Substantial Equivalence to Predicate Device | The device should be as safe and effective as a legally marketed predicate device, without raising new issues of safety or efficacy. | "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." |
| Functional Equivalence | Implied: ability to be coaxially tracked, access distal vasculature, and infuse materials safely and effectively. | Implied by substantial equivalence to the predicate device in terms of "general intravascular use, including neuro, peripheral and coronary vasculature." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The 510(k) summary indicates that the device was "tested and compared to the predicate device," but details about the size of the test set for this comparison are not included.
- Data Provenance: Not specified. Typically, such testing would be in-house or contracted by the manufacturer, but the geographical origin or whether it was retrospective/prospective is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts & Qualifications: Not applicable/not provided. For a 510(k) submission focused on substantial equivalence, the "ground truth" is typically the performance of the legally marketed predicate device, and the comparison involves engineering testing or bench testing, not expert-based clinical performance data requiring ground truth establishment in the traditional sense (e.g., for diagnostic accuracy).
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not provided. As the tests are primarily engineering or bench tests for substantial equivalence, clinical adjudication methods are not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
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MRMC Study: No. The provided text does not describe an MRMC comparative effectiveness study. The submission is for a medical device (microcatheter), not AI software, and the clearance pathway is 510(k), which focuses on substantial equivalence rather than comparative clinical efficacy studies.
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Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as this is not an AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance Study: Not applicable, as this is a physical medical device, not an algorithm or AI.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the purpose of a 510(k) submission for a physical device, the "ground truth" is largely derived from the established safety and effectiveness profile of the predicate device. The tests conducted are designed to show that the new device performs comparably to that predicate in relevant engineering and biocompatibility parameters.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. As this is a physical medical device submission, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set mentioned in the context of this device.
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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. |
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| 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) | ||
|---|---|---|---|---|
| ------------------------------------------ | -- | ---- | -------------------------------------------------- | -- |
1
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§ 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).