(17 days)
The Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
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.
This is a 510(k) premarket notification for a medical device (Q50® PLUS Stent Graft Balloon Catheter), not an AI/ML device. Therefore, the typical "acceptance criteria" and "study" information regarding device performance in an AI/ML context (such as accuracy, sensitivity, specificity, sample size, ground truth, expert consensus, MRMC studies, etc.) are not applicable here.
Instead, for a medical device like this, acceptance criteria typically refer to the specifications that the device must meet through various engineering, mechanical, and biological tests to demonstrate safety and effectiveness for its intended use, and substantial equivalence to a predicate device.
Here's how to interpret the provided information in the context of a 510(k) submission for a non-AI/ML medical device:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, the "acceptance criteria" are the specifications that each mechanical, performance, and biocompatibility test must meet. The "reported device performance" is that "All tests met specifications."
| Test Category | Specific Tests | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Mechanical & Performance | Visual inspections | Meet design specifications (e.g., no defects) | Met specifications |
| Dimensional inspections | Meet specified dimensions | Met specifications | |
| Freedom from leakage | No leakage detected | Met specifications | |
| Luer syringe compatibility | Compatible with luer syringes | Met specifications | |
| Guidewire compatibility | Compatible with specified guidewire | Met specifications | |
| Introducer sheath compatibility | Compatible with specified introducer sheath | Met specifications | |
| Balloon compliance (volume v. diameter) | Meet specified compliance curve | Met specifications | |
| Deflation time | Within specified time limits | Met specifications | |
| Balloon inflation characteristics | Meet specified inflation characteristics | Met specifications | |
| Radiopacity | Radiopaque markers visible | Met specifications | |
| Corrosion resistance | No significant corrosion | Met specifications | |
| Shipping/distribution testing | Maintained integrity after shipping simulation | Met specifications | |
| Environment conditioning | Performed as expected after environmental conditioning | Met specifications | |
| Vessel occlusion | Capable of occluding vessels up to 41mm | Met specifications (up to 41mm, as specified) | |
| Balloon fatigue | Withstood 20 cycles of inflation (predicate spec) | Met specifications (maximum of 20 cycles) | |
| Burst or leak volume | Withstood specified pressure/volume without bursting | Met specifications | |
| Freedom from fragmentation | No fragmentation observed | Met specifications | |
| Tensile strength (hub to shaft) | Met specified tensile strength | Met specifications | |
| Tensile strength (tip to shaft) | Met specified tensile strength | Met specifications | |
| Tensile strength (extension tube) | Met specified tensile strength | Met specifications | |
| Torque strength | Met specified torque strength | Met specifications | |
| Shelf life testing | Maintained function over specified shelf life | Met specifications | |
| Package integrity | Maintained integrity | Met specifications | |
| Biocompatibility | (Not detailed, but stated as "biocompatibility assessments") | Met biocompatibility standards | Met specifications (implied by "All tests met specifications") |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not explicitly state the sample sizes for each mechanical, performance, or biocompatibility test. Regulatory submissions for medical devices typically involve testing a statistically representative number of units for each test, but the exact numbers are not provided in this summary.
- Data Provenance: Not applicable in the context of an AI/ML algorithm's test set. The data provenance here would refer to the source of the physical devices tested (e.g., manufactured at QXMédical's facility). The testing is prospective for the submission, meaning tests were performed specifically for this device and submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is a physical medical instrument, not an AI/ML algorithm requiring expert-established ground truth for image or data interpretation. The "ground truth" for this device's performance is established by engineering and laboratory measurements against predefined specifications.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in medical image reading for AI/ML validation). The performance of this device is assessed directly through physical and chemical testing.
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. MRMC studies are specifically designed to assess the impact of AI on human reader performance, which is not relevant for a physical catheter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this medical device is the adherence to established engineering specifications, material properties, and performance benchmarks as defined by relevant industry standards and internal design requirements. This is verified through:
- Direct physical measurement (e.g., dimensions, compliance, tensile strength).
- Functional testing (e.g., inflation, deflation, occlusion, compatibility).
- Biocompatibility assessments (following ISO standards, often involving chemical analysis and biological assays).
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
In summary, the provided information details a traditional medical device 510(k) submission, not an AI/ML device. The "study" proving the device meets acceptance criteria is the comprehensive non-clinical testing program described, which demonstrated that all aspects of the device's mechanical function, performance, and biocompatibility met the defined specifications and showed substantial equivalence to the predicate device.
{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 BalloonCatheter | Predicate DeviceVia Biomedical Stent Graft BalloonCatheter(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 luerconnections to guidewire lumen &inflation lumenPEBA | Bifurcation style, with female luerconnections to guidewire lumen &inflation lumenPEBA |
| 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): __ |< | 2 @38|
Q50® PLUS Stent Graft Balloon Catheter Device Name:
. Indications for Use:
The Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. A. Hilleleme
(Division Sign-Off) Division of Čardiovascular Devices
510(k) Number_ K12038 |
. Page 1 of 1
§ 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).