(28 days)
Not Found
No
The summary describes a physical medical device (guiding catheter) and does not mention any software, algorithms, or data processing related to AI/ML.
No
The device is described as an "introducer" for other devices, not a device that directly treats a condition.
No.
Explanation: The device description states its purpose is for the "intravascular introduction of interventional/diagnostic devices," indicating it is a delivery mechanism, not a diagnostic device itself.
No
The device description clearly identifies it as a "Guiding Catheter," which is a physical medical device used for intravascular introduction of other devices. There is no mention of software as the primary or sole component.
Based on the provided information, the ENVOY® Guiding Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "intravascular introduction of interventional/diagnostic devices." This describes a device used within the body to facilitate other procedures, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description reiterates the same intended use, further confirming its function as a delivery tool within the vasculature.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Using reagents or assays
The ENVOY Guiding Catheter is a medical device used in interventional procedures, but it does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ENVOY Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
Product codes
DQY
Device Description
The ENVOY Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices. All materials used in the ENVOY Guiding Catheters are biocompatible.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary, and neurovasculature
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
3
1
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.
2
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
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