(28 days)
The ENVOY® Guiding Catheter is intended for use un the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
The ENVOY Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
Due to the nature of the provided text, which is an FDA 510(k) summary and clearance letter for a medical device (ENVOY® Guiding Catheter), it does not contain the kind of information typically found in a study describing acceptance criteria for an AI/device performance.
This document is a regulatory submission for a physical medical device, not a software or AI-driven diagnostic tool. Therefore, it does not involve:
- Algorithm performance metrics (like sensitivity, specificity, AUC)
- Sample sizes for test or training sets for AI models
- Expert consensus for ground truth on images (as there are no images being analyzed by AI)
- MRMC studies to compare human reader performance with and without AI assistance
- Standalone algorithm performance studies
The 510(k) summary focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria for an AI output.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or other details related to AI study design based on the provided text.
The document primarily states:
- Intended Use: The ENVOY guiding catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
- Substantial Equivalence: The device is substantially equivalent to the previously cleared ENVOY Guiding Catheter (from Cordis Endovascular Systems, Inc.).
- Biocompatibility: All materials are biocompatible.
These points are the core "acceptance criteria" and "performance" relevant to this type of regulatory submission for a physical catheter. They don't lend themselves to the AI-specific questions requested.
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SECTION 3. 510(k) SUMMARY
General Provisions l.
| Common Name: | Catheter, Percutaneous |
|---|---|
| Proprietary Name: | ENVOY® Guiding Catheter |
ll. Name of Predicate Device:
Cordis Endovascular Systems, Inc. ENVOY Guiding Catheter
NOV - 6 2009
III. Classification Class II
Class II
IV. Performance Standards:
Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.
V. Intended Use and Device Description:
The ENVOY Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
VI. Biocompatibility:
All materials used in the ENVOY Guiding Catheters are biocompatible.
VII. Summary of Substantial Equivalence:
The ENVOY Guiding Catheters are substantially equivalent to the previously cleared ENVOY Guiding Catheters.
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Image /page/1/Picture/0 description: The image is a circular seal or logo. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized graphic that resembles a bird in flight or a flowing ribbon-like design. The overall impression is that of an official emblem, likely representing a government agency related to health and human services in the United States.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Codman & Shurtleff Inc. c/o Ms. Kate LaRose Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, MA 02767
NOV - 6 2009
Re: K093184
Trade/Device Name: ENVOY® Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: October 6, 2009 Received: October 9, 2009
Dear Ms. LaRose:
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 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.
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Page 2 - Ms. Kate LaRose
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); 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 vou 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
sumai R. Vachner
$\omega$
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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Indications for Use
510(k) Number (if known): K093184
Device Name: ENVOY® Guiding Catheters
Indications For Use: The ENVOY Guiding Catheter is intended for use un the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
× 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)
Duna R. Richards
Division Sign-Off) (Division Sign-Old)
Division of Cardiovascular Devices
510(k) Number_Kod3784
Page 1 of 1
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).