(29 days)
Not Found
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 introducing therapeutic and diagnostic devices, indicating it is an accessory to therapy rather than a therapeutic device itself.
No
The "Intended Use" section states that the guiding catheter provides a pathway for introducing therapeutic and diagnostic devices, but it is not itself described as performing a diagnostic function.
No
The device description clearly describes a physical guiding catheter made of polymers with varying stiffness and a radiopaque shaft and tip. It is a hardware device used to introduce other devices.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a pathway through which therapeutic and diagnostic devices are introduced." This describes a device used in vivo (within the body) to facilitate other procedures, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details the physical characteristics of a catheter designed to be inserted into the body (length, radiopaque shaft, tip shapes, etc.). This aligns with an invasive medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the VIKING OPTIMA™ Guiding Catheter is a medical device used for interventional procedures, not an IVD.
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 (comma separated list FDA assigned to the subject device)
74 DQY
Device Description
The proposed (6F) VIKING OPTIMA™ 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 (6F) VIKING OPTIMA™ 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 25 to 72D. The guiding catheter also has a radiopaque soft tip at the most distal section.
The proposed (6F) VIKING OPTIMA™ 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 (6F) VIKING OPTIMA™ Guiding Catheter has been demonstrated through data collected from nonclinical bench tests and analyses.
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.
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
. . . . .
APPENDIX A - 510(K) SUMMARY
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Submitter | Guidant Corporation
Vascular Invention
26531 Ynez Road, Temecula CA 92591
Contact: Stacey Simon
Phone: (909) 914-4527, Fax: (909) 914-0339 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date | June 25, 2001 |
| Device name | Device Trade Name: VIKING OPTIMA™ Guiding Catheter
Device Common Name: Percutaneous Catheter
Device Classification Name: Guiding Catheter
Device Classification: Class II
Product Code: 74 DQY |
| Summary of
substantial
equivalence | The design, materials, method of operation, and intended use features
of the proposed (6F) 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 (6F) VIKING OPTIMA™ 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 (6F) VIKING OPTIMA™ 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 25 to 72D. The guiding catheter also has a radiopaque soft tip at
the most distal section.
The proposed (6F) VIKING OPTIMA™ 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 (6F) VIKING OPTIMA™ Guiding Catheter incorporates
similar design, components, method of operation, and indication of
the predicate device, the VIKING OPTIMA™ Guiding Catheter
(K001435) with exception of the shape of the reinforcement wire. |
| Performance
data | The substantial equivalence of the proposed (6F) VIKING OPTIMA™
Guiding Catheter has been demonstrated through data collected from
nonclinical bench tests and analyses. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 2001
Ms. Stacey Simon Regulatory Affairs Coordinator Guidant Corporation Vascular Intervention Group 26531 Ynez Road Temecula, CA 92591
K012002 Re:
VIKING OPTIMA™ Guiding Catheter Regulation Number: 870.1250 Regulatory Class: II (two) Product Code: DQY Dated: June 25, 2001 Received: June 27, 2001
Dear Ms. Simon:
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 Regulations, 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 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.
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Page 2 - Ms. Stacey Simon
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,
W. E. Dillah III
James E. Dillard III 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): | The 510(k) number has not been issued yet. |
|---|---|
| K012002 | |
| 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 ﮐﮯ (Per 21 CFR 801.109)
OR
Over-The-Counter (Optional Format 1-1-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012002
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