(134 days)
The Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
The Stent Graft Balloon Catheter is a multi-lumen catheter which has a compliant polyurethane balloon with a maximum diameter of 50mm. The device is available in two usable lengths, 65 cm and 100 cm. The device is designed to accommodate a 0.038" diameter or smaller guidewire. Two radiopaque marker bands are placed within the balloon to facilitate balloon placement prior to inflation. The device is a single use, sterile device.
This document is a 510(k) summary for a medical device (Stent Graft Balloon Catheter). It describes the device, its intended use, and states that it underwent non-clinical testing to verify its safety and effectiveness.
However, this document does not contain the specific information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is missing:
- No Acceptance Criteria or Performance Data Table: The document explicitly states "No performance standards applicable to this product have been developed under Section 514 of the Act." While "mechanical, performance, and biocompatibility testing" were done, specific acceptance criteria for these tests (e.g., burst pressure, fatigue life) and the actual numerical results from these tests are not provided.
- No Description of a Clinical Study: The document refers to "non-clinical testing" which typically means bench testing and potentially animal studies, not human clinical trials. There is no mention of:
- Sample sizes for test sets (human patients).
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes data).
- Sample size for training sets (as this is not an AI/algorithm-based device).
- How ground truth for a training set was established.
Therefore, I cannot fulfill your request for the specific details outlined in your prompt based solely on the provided text. The document is a regulatory submission demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing, rather than a detailed report of a study involving clinical performance acceptance criteria.
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OCT 1 5 2009
510(k) Summary
510(k) Number: K091624
Date Prepared
May 29, 2009
Suite 150
Via Biomedical, Inc.
6655 Wedgwood Road
Submitter Information
Submitter's Name/Address:
Contact Person:
Maple Grove, MN 55311 Fernando Di Caprio President & CEO (763) 577-9936 telephone (763) 383-4711 fax
Device Information
Stent Graft Balloon Catheter Trade Name: Catheter, Percutaneous Common Name: Catheter, Percutaneous Classification Name: Product Code: DQY Class II, 21 CFR 870.1250 Regulation: Cardiovascular Panel:
Performance Standards
No performance standards applicable to this product have been developed under Section 514 of the Act.
Predicate Devices
| Predicate Device | Manufacturer | 510(k) Status |
|---|---|---|
| Reliant Stent Graft BalloonCatheter | Medtronic, Inc. | K050038 |
| Coda Balloon Catheter | Cook, Inc. | K032869 |
| Equalizer Balloon Catheter | Boston Scientific, Inc. | K021721 |
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Device Description
The Stent Graft Balloon Catheter is a multi-lumen catheter which has a compliant polyurethane balloon with a maximum diameter of 50mm. The device is available in two usable lengths, 65 cm and 100 cm. The device is designed to accommodate a 0.038" diameter or smaller guidewire. Two radiopaque marker bands are placed within the balloon to facilitate balloon placement prior to inflation. The device is a single use, sterile device.
Intended Use/Indications for Use
The Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
Summary of Non-Clinical Testing
The Stent Graft Balloon Catheter underwent mechanical, performance, and biocompatibility testing to verify that the device functions in a safe and effective manner. The results of the tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use.
Statement of Equivalence
The Stent Graft Balloon Catheter is substantially equivalent to the predicate devices listed above based on a comparison of the indications for use and the technological characteristics. The testing performed confirms that the Stent Graft Balloon Catheter will perform as intended.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
OCT 1 5 2009
Via Biomedical, Inc. C/O Fernando Di Caprio, President and CEO 6655 Wedgwood Road, Suite 150 Maple Grove, MN 55311
Re: K091624
Trade Name: Stent Graft Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II Product Code: DQY, MJN Dated: September 24, 2009 Received: September 25, 2009
Dear Mr. Di Caprio:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Fernando Di Caprio
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toH-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
.Duna R. lochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): Kog| 6 24
Device Name: Stent Graft Balloon Catheter
Indications for Use:
The Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
Prescription Use > (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nanna R. Hansen
(Division Sign-Off) Division ... Cardiovascular Devices
Ko91624 510(K) Number
000011
§ 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).