(17 days)
Not Found
No
The device description focuses on mechanical components and materials, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is described as a "Stent Graft Balloon Catheter" intended for "temporary occlusion of large vessels, or to expand vascular prostheses," which are therapeutic medical interventions.
No.
The intended use of the device is for temporary occlusion of large vessels or to expand vascular prostheses, which are therapeutic interventions, not diagnostic ones.
No
The device description clearly details a physical catheter with a balloon, shaft, manifold, and extension tube, indicating it is a hardware medical device.
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 intervention within the body (in vivo) for therapeutic purposes.
- Device Description: The description details a catheter with a balloon designed for physical manipulation within blood vessels. This is a medical device used for treatment or diagnosis within the patient, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
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 OXMédical Stent Graft Balloon Catheter is a multi-lumen catheter which has a compliant polyurethane balloon with a maximum diameter of 50mm at 60cc inflation volume. The device is constructed with an 8Fr diameter blended PEBA shaft and is available in two usable lengths, 65 cm and 100 cm. The device is compatible with 12Fr (or larger) introducer sheaths and 0.038" diameter (or smaller) guidewires. Two platinum-iridium radiopaque marker bands are placed within the balloon to facilitate balloon placement prior to inflation. The proximal end of the catheter has an integral PEBA bifurcation manifold with female luer ports to allow communication with the balloon inflation lumen and guidewire lumen. A PVC extension tube (with stopcock) is connected to the balloon inflation port to facilitate handling. 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 QXMédical Stent Graft Balloon Catheter underwent mechanical, performance, and biocompatibility assessments to verify that the device functions in a safe and effective manner.
The mechanical tests performed on the QXMédical Stent Graft Balloon Catheter include:
Visual inspections
Dimensional inspections
Freedom from leakage
Luer syringe compatibility
Guidewire compatibility
Introducer sheath compatibility
Balloon compliance (volume v. diameter)
Deflation time
Balloon inflation characteristics
Radiopacity
Corrosion resistance
Shipping/distribution testing
Vessel occlusion
Balloon fatigue
Kink resistance and radius
Burst or leak volume
Freedom from fragmentation
Tensile strength (hub to shaft)
Tensile strength (tip to shaft)
Tensile strength (extension tube)
Torque strength
Shelf life testing
Package integrity
Environment conditioning
All tests met specifications. These results provide assurance that the device has been designed and evaluated 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
5 510(k) Summary
Date Prepared: December 30, 2011
Submitter Information:
| Submitter's Name/Address | Contact Person |
|---|---|
| QXMédical, LLC | Fernando Di Caprio, |
| 1747 Summit Avenue | Chief Technical Officer |
| Saint Paul, MN 55105 | Phone: (651) 338-5774 |
| Email: fernando.dicaprio@qxmedical.com |
Device Information:
| Trade Name | Q50® PLUS Stent Graft Balloon Catheter | |
|---|---|---|
| Common Name | Catheter, Percutaneous | |
| Classification Name | Catheter, Percutaneous | |
| Product Code | DQY, MJN | |
| Regulation | Class II, 21 CFR 870.1250 | |
| Panel | Cardiovascular |
Performance Standards:
No performance standards applicable to this product have been developed under Section 514 of the Act.
Predicate Device:
| Predicate Device | Manufacturer | 510(k) Status |
|---|---|---|
| Stent Graft Balloon Catheter | Via Biomedical, Inc. | K091624 |
Device Description:
The OXMédical Stent Graft Balloon Catheter is a multi-lumen catheter which has a compliant polyurethane balloon with a maximum diameter of 50mm at 60cc inflation volume. The device is constructed with an 8Fr diameter blended PEBA shaft and is available in two usable lengths, 65 cm and 100 cm. The device is compatible with 12Fr (or larger) introducer sheaths and 0.038" diameter (or smaller) guidewires. Two platinum-iridium radiopaque marker bands are placed within the balloon to facilitate balloon placement prior to inflation. The proximal end of the catheter has an integral PEBA bifurcation manifold with female luer ports to allow communication with the balloon inflation lumen and guidewire lumen. A PVC extension tube (with stopcock) is connected to the balloon inflation port to facilitate handling. The device is a single use, sterile device.
1
The device models are outlined in the table below:
| Device Models | |||
|---|---|---|---|
| Description | Balloon Diameter | Shaft Length | Model Number |
| Q50® PLUS (65cm) | 10mm-50mm | 65cm | Q50-65P |
| Q50® PLUS (100cm) | 10mm-50mm | 100cm | Q50-100P |
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 QXMédical Stent Graft Balloon Catheter underwent mechanical, performance, and biocompatibility assessments to verify that the device functions in a safe and effective manner.
The mechanical tests performed on the QXMédical Stent Graft Balloon Catheter include:
| Visual inspections | Vessel occlusion |
|---|---|
| Dimensional inspections | Balloon fatigue |
| Freedom from leakage | Kink resistance and radius |
| Luer syringe compatibility | Burst or leak volume |
| Guidewire compatibility | Freedom from fragmentation |
| Introducer sheath compatibility | Tensile strength (hub to shaft) |
| Balloon compliance (volume v. diameter) | Tensile strength (tip to shaft) |
| Deflation time | Tensile strength (extension tube) |
| Balloon inflation characteristics | Torque strength |
| Radiopacity | Shelf life testing |
| Corrosion resistance | Package integrity |
| Shipping/distribution testing | Environment conditioning |
All tests met specifications. These results provide assurance that the device has been designed and evaluated to assure conformance to the requirements for its indications for use.
2
Substantial Equivalence Comparison
The QXMédical Stent Graft Balloon Catheter is substantially equivalent to the predicate device based on a comparison of the indications for use and the technological characteristics. The following table provides a comparison of the technological characteristics of the QXMédical Stent Graft Balloon Catheter and the predicate device:
| | QXMédical Stent Graft Balloon
Catheter | Predicate Device
Via Biomedical Stent Graft Balloon
Catheter
(K091624) |
|-------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Shaft Configuration | 0.105" diameter, 3 - lumen,
65cm & 100cm effective lengths,
PEBA | 0.105" diameter, 3 - lumen,
65cm & 100cm effective lengths,
PEBA |
| Tip | Tapered,
Polyurethane | Tapered,
Polyurethane |
| Balloon | 10mm to 50mm range,
50mm (60cc) max.
Polyurethane | 10mm to 50mm range,
50mm (60cc) max.
Polyurethane |
| Radiopaque Markers | Two markers,
40mm spacing,
Pt - Ir | Two markers,
40mm spacing,
Pt - Ir |
| Manifold | Bifurcation style, with female luer
connections to guidewire lumen &
inflation lumen
PEBA | Bifurcation style, with female luer
connections to guidewire lumen &
inflation lumen
PEBA |
| Strain Relief | Heat shrunk,
Polyolefin | Heat shrunk,
Polyolefin |
| Extension Tube | Single-lumen,
PVC, DEHP-free | Single-lumen,
PVC, DEHP-free |
| Stopcock Style | One-Way,
Polycarbonate & acetal | Three-Way,
Polycarbonate & polyethylene |
| Minimum Sheath | 12 Fr | 12 Fr |
| Maximum Guidewire | 0.038" | 0.038" |
| Vessel Occlusion | Up to 41mm | Up to 41mm |
| Balloon Inflations | Maximum of 20 cycles | Maximum of 20 cycles |
| Packaging Configuration | Double sterile barrier | Double sterile barrier |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
One difference between the QXMédical Stent Graft Balloon Catheter and the predicate device is the style of stopcock attached to extension tube (inflation port). The QXMédical Stent Graft Balloon Catheter has a 1-Way stopcock while the predicate device has a 3-way stopcock. These stopcocks have different designs, materials and methods of operation; however, both styles are well characterized and familiar to users. This difference does not raise any issues of safety or effectiveness.
The testing performed confirms that the QXMédical Stent Graft Balloon Catheter will perform as intended.
3
Conclusion
Based on the successful results from the Non-Clinical Testing performed and the Substantial Equivalence Comparison, we conclude that the device is as safe and effective as the legally marketed predicate device listed above.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 2 4 2012
QXMedical, LLC c/o Mark Job Responsible Third Party Official Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K120381
Trade/Device Name: Q50 PLUS Stent Graft Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, MJN Dated: February 6, 2012 Received: February 7, 2012
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becaon 31 (th) premient ferenced above and nave userings and minent and predicate devices marketed in interstate for use stated in the cherosure) to regars nament date of the Medical Device Amendments, or to commerce prof to May 20, 1970, the enactions of the provisions of the Federal Food, Drug, devices that have been reclassified in accrearies approval application (PMA).).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act, TPMA). and Cosment Act (Act) that do not require apple of the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general controlster You may, therefore, market the device, books of the more in the simply to minute mistereding ond general controls provisions of the rict mercises and prohibitions against mister and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Please note: CDICT does not evaluate incommunisment misleading.
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 may be subject to additional confrois: "Entrality and to 898. In addition, FDA may Touria in the Code of I cacial Regarations) concerning your device in the Federal Register.
5
Page 2 - Mr. Mark Job
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 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/ReportalProblem/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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours,
M.A. Hellehenne
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number (if known): __ |