(25 days)
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.
The Renegade™ STC-18 Microcatheter is a sterile, single-use catheter and is available in lengths of 105 cm, 130 cm, and 150cm.
The provided text describes a Special 510(k) for the Renegade™ STC-18 Microcatheter, focusing on its intended use, classification, and biocompatibility. However, it does not contain a study that details specific acceptance criteria and reported device performance in a quantitative manner. The document asserts "All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised," but it does not present the specific data, metrics, or studies used to reach this conclusion beyond biocompatibility testing.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone (algorithm only) performance results
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
The document primarily focuses on the regulatory submission and FDA's determination of substantial equivalence, not on the detailed technical data from specific performance studies that would typically define acceptance criteria and device performance metrics. The Biocompatibility section mentions testing per ISO 10993, but does not provide specific acceptance criteria or quantitative results.
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16023681
Special 510(k) Renegade™ STC-18 Microcatheter
October 31, 2002
| GeneralProvisions | Trade Name: Renegade STC™ 18 MicrocatheterClassification Name: Diagnostic Intravascular Catheter |
|---|---|
| Name ofPredicateDevices | Renegade™ Hi-Flo Microcatheter, Renegade™ Fiber Braided Microcatheter,Excelsior™ 1018 Microcatheter and Tracker® Excel™ 14 |
| Classification | Class II |
| PerformanceStandards | Performance Standards have not been established by FDA under Section 514of the Food, Drug and Cosmetic Act |
| Intended Useand DeviceDescription | The Renegade STC™ 18 is intended for general intravascular use, includingneuro, peripheral and coronary vasculature. The catheter can be coaxiallytracked over a steerable guidewire in order to access distal, tortuousvasculature. Once the subselective region has been accessed, the catheter canbe used for controlled and selective infusion of diagnostic, embolic, ortherapeutic materials into vessels. The Renegade™ STC-18 Microcatheter is asterile, single-use catheter and is available in lengths of 105 cm, 130 cm, and150cm. |
| Biocompatibility | The Renegade STC-18™ Microcatheter has been tested for biocompatibilityper ISO 10993. All data demonstrate this device is biocompatible for itsintended use. |
| Summary ofSubstantialEquivalence | The Renegade STC™ 18 Microcatheter has been tested and compared to thepredicate device. All data gathered demonstrate this device as substantiallyequivalent. 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
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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
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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
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Special 510(k) Renegade ™ STC-18 Microcatheter October 31, 2002 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Indications For Use
| 510(k) Number (if known) | UnknownK023681 |
|---|---|
| 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
§ 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).