(211 days)
Not Found
No
The summary describes a physical medical device (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 for introducing other interventional/diagnostic devices, not for therapeutic treatment itself.
No
Explanation: The device description states that the ENVOY Guiding Catheters are designed for the "intravascular introduction of interventional/diagnostic devices," implying it introduces other diagnostic devices, rather than being a diagnostic device itself.
No
The device description clearly states it is a guiding catheter, which is a physical hardware device used for intravascular introduction of other devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "intravascular introduction of interventional/diagnostic devices" within the body (peripheral, coronary, and neurovasculature systems). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description reinforces the intended use of introducing devices into the vascular systems.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed for testing samples in vitro (outside the body). This device is a tool for delivering other devices in vivo.
N/A
Intended Use / Indications for Use
The ENVOY Guiding Catheters are intended for the intravascular introduction of interventional/diagnostic devices in the peripheral, coronary and neurovasculature systems.
Product codes
74DQY
Device Description
The 7F, 8F and 9F ENVOY Guiding Catheters are designed for the intravascular introduction of interventional/diagnostic devices into the peripheral, coronary and neurovascular systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary and neurovascular systems
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
Not Found
Key Metrics
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
SUMMARY OF SAFETY AND EFFECTIVENESS
l. General Provisions:
JUL 23 1097
Catheter, Percutaneous Common Name:
ENVOY® Guiding Catheter Proprietary Name:
Name of Predicate Device: ll.
- 5F & 6F ENVOY Guiding Catheters a) Trade Name: Cordis Endovascular Systems, Inc. Manufacturer: K962362 - concurrence 08/08/96 510(k) Number: Predicate for design, intended use, sterilization and packaging
| b) | Trade Name: | 9F Brite Tip Guiding Catheter |
|---|---|---|
| Manufacturer: | Cordis Corporation | |
| 510(k) Number: | K925131 - concurrence 05/06/93 | |
| Predicate for design |
III. Classification:
Class II, Catheter, Percutaneous, 21 CFR 870.1250 (74DQY)
IV. Performance Standards:
Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.
Intended Use and Device Description: V.
The 7F, 8F and 9F ENVOY Guiding Catheters are designed for the intravascular introduction of interventional/diagnostic devices into the peripheral, coronary and neurovascular systems.
VI. Biocompatibility
All appropriate biocompatibility tests were successfully performed on the Cordis Endovascular Systems, Inc. 7F, 8F and 9F ENVOY Guiding Catheter.
Summary of Substantial Equivalence: VII.
The ENVOY Guiding Catheters are similar in basic design, construction, indication for use and performance characteristics to other commercially available guiding catheters.
1
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Katherine Trevisol Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, Florida 33014
1111 23 1997
Re: K965247 ENVOY Guiding Catheter Regulatory Class: II (two) Product Code: 74 DOY Dated: April 23, 1997 Received: April 24, 1997
Dear Ms. Trevisol:
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 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 aqainst 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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 assumpticns. 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 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 regulations.
2
Page 2 - Ms. Katherine Trevisol
This letter will allow you to beqin 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
The ENVOY Guiding Catheters are intended for the intravascular introduction of interventional/diagnostic devices in the peripheral, coronary and neurovasculature systems.
510(k) Number (if known): To be assigned by FDA
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE AS NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
ThA R
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)