(29 days)
No
The description focuses on the physical characteristics and materials of a guiding catheter, with no mention of AI or ML capabilities.
No
The device is described as a 'guiding catheter' whose purpose is to provide a pathway for other devices (both therapeutic and diagnostic), not to provide therapy itself.
No
The device is a guiding catheter that provides a pathway for the introduction of other devices, some of which may be diagnostic, but the catheter itself is not performing diagnostic functions.
No
The device description clearly details a physical guiding catheter made of polymers with varying stiffness and a radiopaque shaft and tip, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as providing a pathway for introducing therapeutic and diagnostic devices into the body. This is an in-vivo application, not an in-vitro (outside the body) diagnostic test.
- Device Description: The description focuses on the physical characteristics of a catheter designed for insertion into the body (length, stiffness, radiopacity, tip shapes). This aligns with a medical device used for access within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) outside the body to provide diagnostic information.
Therefore, the VIKING OPTIMA™ Guiding Catheter is a medical device used for interventional procedures within the body, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The guiding catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced.
Product codes
74 DQY
Device Description
The proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter has a standard working length of 100 cm and a standard overall length of 107 cm, but can be produced in lengths from 40 to 160 cm depending upon physician preference and patient size.
The proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter has a radiopaque shaft, which varies in stiffness at the distal end to accommodate customer preference and give optimal support in each tip shape. The stiffness of the shaft is determined by the durometer of the segment of polymer along the axial length. The lower the durometer of polymer (or polymer blend of Nylon 12 and/or Pebax), the more flexible the guiding catheter. The Pebax raw material durometers vary from 25D to 72D. The guiding catheter also has a radiopaque soft tip at the most distal section.
The proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter is manufactured in varying tip shapes. Each shape is specific for patient anatomy and physician preference, and therefore a wide range of shapes is available with and without sideholes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The substantial equivalence of the proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter has been demonstrated through data collected from non-clinical bench tests and analyses.
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
:
| Submitter | Guidant Corporation
Vascular Invention
26531 Ynez Road, Temecula CA 92591
Contact: Nancy E. Ralston | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | Phone: (909) 914-6654, Fax: (909) 914-0339 | |
| Date | November 1, 2001 | |
| Device name | Device Trade Name:
Device Common Name:
Device Classification Name:
Device Classification:
Product Code: | VIKING OPTIMA™ Guiding Catheter
Percutaneous Catheter
Guiding Catheter
Class II
74 DQY |
| Summary of
substantial
equivalence | The design, materials, method of operation, and intended use features
of the proposed (7F, 8F) VIKING OPTIMA™ Guiding Catheter are
substantially equivalent with regard to these features in the predicate
device, the VIKING OPTIMA™ Guiding Catheter, K001435. | |
| Device
description | The proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter has a
standard working length of 100 cm and a standard overall length of
107 cm, but can be produced in lengths from 40 to 160 cm depending
upon physician preference and patient size. | |
| | The proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter has
a radiopaque shaft, which varies in stiffness at the distal end to
accommodate customer preference and give optimal support in each tip
shape. The stiffness of the shaft is determined by the durometer of the
segment of polymer along the axial length. The lower the durometer
of polymer (or polymer blend of Nylon 12 and/or Pebax), the more
flexible the guiding catheter. The Pebax raw material durometers vary
from 25D to 72D. The guiding catheter also has a radiopaque soft tip at
the most distal section. | |
| | The proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter is
manufactured in varying tip shapes. Each shape is specific for patient
anatomy and physician preference, and therefore a wide range of
shapes is available with and without sideholes. | |
| Indications | The guiding catheter is designed to provide a pathway through which
therapeutic and diagnostic devices are introduced. | |
| Technological
characteristics | The proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter incorporates similar design, components, method of operation, and indication of the predicate device, the VIKING OPTIMATM Guiding Catheter (K001435) with exception of the shape of the reinforcement wire. | |
| Performance
data | The substantial equivalence of the proposed (7F, 8F) VIKING
OPTIMATM Guiding Catheter has been demonstrated through data collected from non-clinical bench tests and analyses. | |
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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 4 2001
Ms. Nancy E. Ralston Regulatory Affairs Coordinator Guidant Corporation 26531 Ynez Road Temecula, CA 92591-4628
Re: K013638 VIKING OPTIMA™ Guiding Catheter Regulation Number: 870.1250 Regulation Name: Percutaneous catheter. Regulatory Class: Class II Product Code: DQY Dated: November 1, 2001 Received: November 5, 2001
Dear Ms. Ralston:
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 CFR Part 807); labeling (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.
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Page 2 - Ms. Nancy E. Ralston
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 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 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,
N. Sadler Tella
&Bram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX B - INDICATIONS STATEMENT
| 510(k) number
| (if known): | K013638 |
|---|---|
| ------------------------------ | --------- |
The 510(k) number has not been issued yet.
| Device name | VIKING OPTIMA™ Guiding Catheter |
|---|---|
| Indications | The guiding catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
Division of C 510(k) Number OR
Over-The-Counter (Optional Format 1-1-96)
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