(29 days)
Not Found
No
The 510(k) summary describes a standard guiding catheter with no mention of AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices.
No
The device is a guiding catheter used for the introduction of other diagnostic or interventional devices, not for therapeutic intervention itself.
No
The device description indicates that it is a "guiding catheter" intended for the "intravascular introduction of interventional / diagnostic devices." This means the catheter itself is not performing a diagnostic function; rather, it facilitates the delivery of other devices that might be diagnostic.
No
The device description clearly outlines physical components like a catheter body, braid wire, and hub, 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 the "intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems" and "in the peripheral, coronary, and neurovasculature 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 details the physical characteristics of a catheter designed for insertion into blood vessels. This aligns with the intended use of a guiding catheter.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, this device is a medical device used for guiding other devices within the vascular system, not an IVD.
N/A
Intended Use / Indications for Use
Vista Brite Tip - The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.
Envoy – The Envoy guiding catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional / diagnostic devices.
Product codes
74 DQY
Device Description
• 6 French (ID 0.070");
• Single lumen catheter with a reinforced body (tightly wound stainless steel braid wire);
• Catheter body transitions provide a gradual decrease in material stiffness (varying durometers) from the body to the tip; and,
• Polycarbonate hub.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or peripheral vascular systems, 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
、
Attachment - 4
、,
,一
510(k) Summary of Safety and Effectiveness
| General
Provisions | Trade Names: Vista Brite Tip® and Envoy® Guiding Catheters
Common/Classification Name: Percutaneous Catheter |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of
Predicate
Devices | • Vista Brite Tip® and Envoy® Guiding Catheters |
| Classification | Class II |
| Performance
Standards | No performance standards have been established under Section 514 of the
Food, Drug and Cosmetic Act for Percutaneous Catheters. |
| Intended Use
and Device
Description | Vista Brite Tip - The guiding catheter is intended for use for intravascular
introduction of interventional / diagnostic devices into the coronary or
peripheral vascular systems.
Envoy – The Envoy guiding catheter is intended for use in the peripheral,
coronary, and neurovasculature for the intravascular introduction of
interventional / diagnostic devices.
Device Description:
• 6 French (ID 0.070");
• Single lumen catheter with a reinforced body (tightly wound stainless
steel braid wire);
• Catheter body transitions provide a gradual decrease in material stiffness
(varying durometers) from the body to the tip; and,
• Polycarbonate hub. |
| Biocompatibility | All materials used in the these devices are biocompatible. |
1
Attachment - 4 - 510(k) Summary of Safety and Effectiveness, continued
The Cordis Vista Brite Tip® and Envoy® Guiding Catheters are substantially Summary of equivalent to the previously cleared Cordis Vista Brite Tip® and Envoy® Guiding Substantial Equivalence Catheters.
2
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line.
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of a bird or eagle with human profiles incorporated into the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2002
Cordis Corporation Stephen M. Enos, RN Manager, Regulatory Affairs 14201 N.W. 60th Avenue Miami Lakes, FL 33014
Re: K021593
6F (0.070") Vista Brite Tip® and Envoy® Guiding Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: 74 DQY Dated: May 14, 2002 Received: May 15, 2002
Dear Mr. Enos:
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 such 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.
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
3
Page 2 - Stephen M. Enos, RN
CFR Part 807); iabeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Della Till
Donna-Bea Tillman. Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment - 2
Indications for Use Statement
| 510(k) Number (if known) | The 510(k) number has not yet been assigned. |
|---|---|
| Device Name | 6F (0.070") Vista Brite Tip® and Envoy® Guiding Catheters |
| Indications for Use | Vista Brite Tip - The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems. |
| Envoy - The Envoy guiding catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional / diagnostic devices. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dalatur
Division of Cardiovascular & Respiratory Devices
510(k) Number K021593
Prescription Use /
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________