(26 days)
DQY
Not Found
No
The summary describes a physical catheter with no mention of software, algorithms, or AI/ML terms.
No
The device is a guiding catheter used for the introduction of other devices; it does not directly provide therapy.
No.
The device is described as a "Guiding Catheter" intended for "intravascular introduction of interventional/diagnostic devices." Its purpose is to guide other devices, not to perform diagnosis itself.
No
The device description clearly outlines a physical catheter with specific material properties and construction, indicating it is a hardware device, not software-only.
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 "intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neuro vasculature." This describes a device used within the body for delivering other devices, not a device used to examine samples outside the body (in vitro).
- Device Description: The description details a physical catheter designed for insertion into blood vessels. This aligns with an in-vivo medical device, not an in-vitro diagnostic.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device's function is purely mechanical and delivery-based within the body.
N/A
Intended Use / Indications for Use
The VISTA BRITE TIP and ENVOY Guiding Catheters are intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The device description of the VISTA BRITE TIP and ENVOY Guiding Catheters is as follows. • 6 French • Single lumen catheter featuring a nylon body reinforced with a tightly wound stainless steel braid wire • The transition segment is designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary, peripheral, and neuro vasculature
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): 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.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Attachment 4
AUG 1 8 1998
Summary of Safety and Effectiveness
| General
Provisions | Trade Name: VISTA BRITE TIP and ENVOY Guiding Catheter
Common/Classification Name: Percutaneous Catheter |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of
Predicate
Devices | • Cordis Corporation VISTA BRITE TIP Guiding Catheter
• Cordis Endovascular Systems, Inc. ENVOY Guiding Catheter |
| Classification | Class II |
| Performance
Standards | The FDA under section 514 of the Food, Drug and Cosmetic Act has not established
performance standards. |
| Intended Use
and Device
Description | The VISTA BRITE TIP and ENVOY Guiding Catheters are intended for use for
intravascular introduction of interventional/diagnostic devices into the coronary,
peripheral, and neuro vasculature. |
| | The device description of the VISTA BRITE TIP and ENVOY Guiding Catheters is
as follows.
• 6 French |
| | • Single lumen catheter featuring a nylon body reinforced with a tightly wound
stainless steel braid wire
• The transition segment is designed with nylons of different durometers (stiffness)
to provide a gradual decrease in material stiffness from the catheter body to the
tip. |
| Biocompatibility | All materials used in the VISTA BRITE TIP and ENVOY Guiding Catheters are
biocompatible. |
| Summary of
Substantial
Equivalence | The VISTA BRITE TIP and ENVOY Guiding Catheters are substantially equivalent
to the previously cleared VISTA BRITE TIP and ENVOY Guiding Catheters. |
1
Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1998
Mr. Martine D. Schneider Sr. Regulatory Affairs Associate Cordis Corporation Cordis Endovascular 14000 N.W. 57th Court Miami Lakes, FL 33014
Re: K982770 Trade Name: 6F Envoy Guiding Catheter Requlatory Class: II Product Code: DQY Dated: July 22, 1998 Received: July 23, 1998
Dear Mr. Schneider:
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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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 requlatory action. · In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this
2
Page 2 - Mr. Martine D. Schneider
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 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) 594-4618. 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. Callahon
Thomas J. Callaha Director Division of Cardiovascular, Respirator and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
. Attachment 2
Indications for Use Statement
| 510(k) Number
| (if known) | The 510(k) number has not yet been assigned. |
|---|---|
| Device Name | VISTA BRITE TIP and ENVOY Guiding Catheters |
| Indications for | |
| Use | The VISTA BRITE TIP and ENVOY Guiding Catheters are intended for use for |
| intravascular introduction of interventional/diagnostic devices into the coronary, | |
| peripheral, and neuro vasculature. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tia A Re
(Division Sign-Off) Division of · a ascult: and Neurologics Devices
510(k) Number K982770
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_