(134 days)
Not Found
No
The description focuses on the physical components and function of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The intended use of the device is for temporary occlusion of large vessels or to expand vascular prostheses, which are therapeutic interventions.
No
Explanation: The device description states its intended use is for "temporary occlusion of large vessels, or to expand vascular prostheses," and it is a "Stent Graft Balloon Catheter." These are therapeutic and interventional functions, not diagnostic ones. There is no mention of the device being used to detect, monitor, or identify disease or health conditions.
No
The device description clearly details a physical catheter with a balloon, lumens, and radiopaque markers, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary occlusion of large vessels, or to expand vascular prostheses." This describes a direct medical intervention performed on a patient's body.
- Device Description: The description details a physical catheter with a balloon designed for insertion into blood vessels. This is a medical device used in vivo (within a living organism).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis.
Therefore, the Stent Graft Balloon Catheter is a medical device used for therapeutic or interventional purposes, not an IVD.
N/A
Intended Use / Indications for Use
The Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
Product codes (comma separated list FDA assigned to the subject device)
DQY, MJN
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.
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 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.
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
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 Balloon | ||
| Catheter | Medtronic, Inc. | K050038 |
| Coda Balloon Catheter | Cook, Inc. | K032869 |
| Equalizer Balloon Catheter | Boston Scientific, Inc. | K021721 |
1
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.
2
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
3
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
4
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