(29 days)
The guiding catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced.
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.
The document provided is a 510(k) premarket notification for a medical device, the VIKING OPTIMA™ Guiding Catheter. It describes the device, its intended use, and states that substantial equivalence has been demonstrated through non-clinical bench tests and analyses. However, it does not contain specific acceptance criteria, reported device performance metrics, or details of a study that proves the device meets specific acceptance criteria.
Therefore, I cannot fulfill your request for the detailed table and study information. The provided text is primarily a regulatory submission for substantial equivalence based on bench testing, and not a detailed performance study with quantifiable acceptance criteria for a new AI/software-based device.
Here's how I can address your request based on the information provided:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Information not provided. The document states that "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." However, it does not specify the exact acceptance criteria for these bench tests nor the quantitative results of those tests. The submission focuses on showing similarity to a predicate device (K001435) rather than meeting predefined performance metrics.
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 / Information not provided. The study referenced is "non-clinical bench tests and analyses." There is no mention of a "test set" in the context of patient data or clinical imaging.
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 / Information not provided. As this was a non-clinical bench test, there was no ground truth requiring expert consensus in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Information not provided. This refers to clinical data review, which was not part of the described evaluation.
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. This document describes a physical medical device (guiding catheter), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Information not provided. The "performance data" mentioned refers to non-clinical bench tests, likely measuring physical attributes of the catheter against engineering specifications or predicate device characteristics, rather than clinical ground truth like pathology or outcomes.
8. The sample size for the training set
- Not applicable / Information not provided. There is no mention of a "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable / Information not provided. Not applicable to this type of device and study.
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| Submitter | Guidant CorporationVascular Invention26531 Ynez Road, Temecula CA 92591Contact: 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 CatheterPercutaneous CatheterGuiding CatheterClass II74 DQY |
| Summary ofsubstantialequivalence | The design, materials, method of operation, and intended use featuresof the proposed (7F, 8F) VIKING OPTIMA™ Guiding Catheter aresubstantially equivalent with regard to these features in the predicatedevice, the VIKING OPTIMA™ Guiding Catheter, K001435. | |
| Devicedescription | The proposed (7F, 8F) VIKING OPTIMATM 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 (7F, 8F) VIKING OPTIMATM Guiding Catheter hasa radiopaque 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 25D to 72D. The guiding catheter also has a radiopaque soft tip atthe most distal section. | ||
| The proposed (7F, 8F) VIKING OPTIMATM 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 (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. | |
| Performancedata | The substantial equivalence of the proposed (7F, 8F) VIKINGOPTIMATM 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)
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).