(29 days)
The guiding catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced.
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.
The provided text is a 510(k) summary for a medical device called the VIKING OPTIMA™ Guiding Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance data as would be found in an AI/software device submission.
Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment is not present in this document. This document is for a physical medical catheter, not an AI or software-based device.
Here's an assessment based on the information provided, highlighting what is and isn't available:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document states: "The substantial equivalence of the proposed (6F) VIKING OPTIMA™ Guiding Catheter has been demonstrated through data collected from nonclinical bench tests and analyses." However, it does not specify what those bench tests entailed, what the acceptance criteria for those tests were, or what the reported performance outcomes were.
Study Details (Applicable to AI/Software Devices, Not This Submission)
For the following points (2-9), the information is not applicable or not present because this is a 510(k) for a physical medical device (a catheter) and not an AI or software-based device requiring detailed clinical performance studies with ground truth.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This type of data is common for AI/software evaluations, not for a physical catheter 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided. Ground truth establishment by experts is relevant for diagnostic AI systems, not for a physical catheter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable / Not Provided. MRMC studies are for evaluating diagnostic accuracy with or without AI assistance, which is not relevant for this physical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This relates to AI algorithm performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided.
8. The sample size for the training set
- Not Applicable / Not Provided. This refers to training data for AI models.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided.
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APPENDIX A - 510(K) SUMMARY
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Submitter | Guidant CorporationVascular Invention26531 Ynez Road, Temecula CA 92591Contact: Stacey SimonPhone: (909) 914-4527, Fax: (909) 914-0339 |
|---|---|
| Date | June 25, 2001 |
| Device name | Device Trade Name: VIKING OPTIMA™ Guiding CatheterDevice Common Name: Percutaneous CatheterDevice Classification Name: Guiding CatheterDevice Classification: Class IIProduct Code: 74 DQY |
| Summary ofsubstantialequivalence | The design, materials, method of operation, and intended use featuresof the proposed (6F) VIKING OPTIMA™ Guiding Catheter aresubstantially equivalent with regard to these features in the predicatedevice, the VIKING OPTIMA™ Guiding Catheter, K001435. |
| Devicedescription | The proposed (6F) VIKING OPTIMA™ Guiding Catheter has astandard working length of 100 cm and a standard overall length of107 cm, but can be produced in lengths from 40 to 160 cm dependingupon physician preference and patient size.The proposed (6F) VIKING OPTIMA™ Guiding Catheter has aradiopaque shaft, which varies in stiffness at the distal end toaccommodate customer preference and give optimal support in each tipshape. The stiffness of the shaft is determined by the durometer of thesegment of polymer along the axial length. The lower the durometerof polymer (or polymer blend of Nylon 12 and/or Pebax), the moreflexible the guiding catheter. The Pebax raw material durometers varyfrom 25 to 72D. The guiding catheter also has a radiopaque soft tip atthe most distal section.The proposed (6F) VIKING OPTIMA™ Guiding Catheter ismanufactured in varying tip shapes. Each shape is specific for patientanatomy and physician preference, and therefore a wide range ofshapes is available with and without sideholes. |
| Indications | The guiding catheter is designed to provide a pathway through whichtherapeutic and diagnostic devices are introduced. |
| Technologicalcharacteristics | The proposed (6F) VIKING OPTIMA™ Guiding Catheter incorporatessimilar design, components, method of operation, and indication ofthe predicate device, the VIKING OPTIMA™ Guiding Catheter(K001435) with exception of the shape of the reinforcement wire. |
| Performancedata | The substantial equivalence of the proposed (6F) VIKING OPTIMA™Guiding Catheter has been demonstrated through data collected fromnonclinical 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
27
§ 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).