(298 days)
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Not Found
No
The 510(k) summary describes a physical medical device (a guiding catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a guiding catheter, used to support the delivery of therapeutic devices, but it does not directly provide therapy itself.
No
Explanation: The device is described as a "support catheter for interventional intracoronary devices" used for the "delivery of PTCA balloons and other various types of interventional cardiology devices." Its function is delivery and support, not diagnosis.
No
The device description clearly states the device is a physical catheter constructed of nylon, TFE, and stainless steel braiding. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of medical devices (PTCA balloons, etc.) within the body (intracoronary). This is a therapeutic or interventional use, not a diagnostic one.
- Device Description: The device is a catheter designed to support and guide other devices within the coronary arteries. This is a physical tool used for a medical procedure.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide information about a patient's health status based on such analysis. IVDs are specifically designed for in vitro examination of specimens derived from the human body.
Therefore, the EnvyTM Guiding Catheter is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Used for the delivery of PTCA balloons and other various types of interventional cardiology devices. They are intended for use by physicians trained and experienced in PTCA and interventional cardiology techniques. Supplied sterile in peel-open packages. Intended for single procedure use.
Product codes
DQO
Device Description
The Envy™ Guiding Catheter is used as a support catheter for interventional intracoronary devices. The device will be constructed of nylon and TFE with stainless steel braiding. The Envy™ Guiding Catheter outside diameter is 6.0 French and will be available in various lengths and various distal curves. It will be supplied sterile, intended for one-time use.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
physicians trained and experienced in PTCA and interventional cardiology techniques.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
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K974-774
510(k) Premarket Notification NV Guiding Catheter COOK INCORPORATED
0 Safety and Effectiveness Information
Submitted By: April Lavender, RAC Vice President, Regulatory Affairs COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402 (812) 339-2235
Device:
Trade Name: Proposed Classification Name: EnvyTM Guiding Catheter 21 CFR Part 876.1200 (74DQO)
Predicate Devices:
The Envy™ Guiding Catheter has the same intended use, materials of construction, and technological characteristics as the COOK Coronary Guiding Catheter.
Device Description:
The Envy™ Guiding Catheter is used as a support catheter for interventional intracoronary devices. The device will be constructed of nylon and TFE with stainless steel braiding. The Envy™ Guiding Catheter outside diameter is 6.0 French and will be available in various lengths and various distal curves. It will be supplied sterile, intended for one-time use.
Substantial Equivalence:
The Envy™ Guiding Catheter is constructed using similar materials as the COOK Guiding Catheter. The device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by COOK INCORPORATED. This device will undergo sterilization similar to the devices currently marketed and distributed.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 16 1998
Ms. April Lavender, RAC Vice President Regulatory Affairs Cook Incorporated 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402
Re : K974774 ENVY™ Guiding Catheter Trade Name: Requlatory Class: İI Product Code: DQO Dated: July 17, 1998 Received: July 20, 1998
Dear Ms. Lavender:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Paqe 2 - Ms. April Lavender
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Callahan, Director Division of Cardiovascular, Respiratory Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
510(k) Premarket Notification NV Guiding Catheter COOK INCORPORATED
510(k) Number (if known):
Device Name:
Envy™ Guiding Catheter
Indications for Use:
Used for the delivery of PTCA balloons and other various types of interventional cardiology devices. They are intended for use by physicians trained and experienced in PTCA and interventional cardiology techniques. Supplied sterile in peel-open packages. Intended for single procedure use.
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | ||
| (Per 21 CFR 801.109) | OR | |
| Over-the-Counter Use | ||
| Judy Samulan of Doyle Cants Acting Branch Chief, ICO B | ||
| Division of Cardiovascular, Respiratory, | ||
| and Neurological Devices | ||
| 510(k) Number | K974774 |