(159 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical function of a balloon catheter, with no mention of AI or ML.
No
Explanation: A therapeutic device is used to treat a disease, injury, or medical condition. This device is intended for temporary occlusion of large vessels or to assist in the expansion of self-expanding endovascular prostheses, which are procedures rather than treatments for a specific disease or condition. While it has a medical purpose, it's an interventional tool rather than a therapeutic device in itself.
No
The device is described as being for "temporary occlusion of large vessels or to assist in the expansion of selfexpanding endovascular prostheses (stent grafts)," which are therapeutic, not diagnostic, actions.
No
The device description clearly outlines a physical balloon catheter with lumens, a guidewire, 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 assist in the expansion of self-expanding endovascular prostheses (stent grafts)." This describes a procedure performed within the body (in vivo) to treat a medical condition.
- Device Description: The description details a physical catheter with a balloon designed for insertion into blood vessels. This is a medical device used for intervention, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to provide information about a patient's health status through testing of samples.
Therefore, the GORE® Molding and Occlusion Balloon Catheter is a medical device used for therapeutic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GORE Molding and Occlusion Balloon Catheter is intended for temporary occlusion of large vessels or to assist in the expansion of self-expanding endovascular prostheses (stent grafts).
Product codes
MJN
Device Description
The GORE® Molding and Occlusion Balloon Catheter is a sterile (EtO), single use, single-lobed polyurethane balloon catheter. The compliant polyurethane balloon is mounted on the leading end of a 3 lumen catheter shaft (two inflation lumens and one quidewire lumen). Termination of the leading end of the catheter is an atraumatic catheter leading tip for smooth transition from the quidewire to catheter transition. Radiopaque markers (approximately 40 mm apart) indicate the proximal and distal end of the balloon which aid in proper balloon placement under fluoroscopy. Both of the (2) inflation lumens are in communication with each end of the balloon to facilitate balloon catheter preparation, inflation and deflation. At the trailing end of the balloon catheter is a dual port (balloon inflation and quidewire) yarm. The inflation port of the y-arm is in communication with both of the balloon inflation lumens and is affixed with a luer lock and three way stopcock via an extension tube. The quidewire lumen of the v-arm allows introduction of a 0.035" (0.89 mm) diameter guidewire for over-the-wire access. The trailing end of the quidewire lumen is affixed with a flushing / guidewire port with luer lock used for flushing the guidewire lumen. The balloon catheter proximal y-arm is provided within a housing which contains markings of the balloon length and inflation range diameter. The balloon can be inflated to diameters of 10 mm to a maximum inflation diameter of 37 mm. The balloon catheter profile is 10 Fr introducer sheath compatible.
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
Bench study: Design verification testing (listed below) demonstrated the subject device performed as intended and was substantially equivalent to the predicate device.
Animal study: No animal studies were performed.
Clinical: No clinical evaluations of this product have been conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" and the words "U.S. Food & Drug Administration."
January 31, 2018
W.L Gore and Associates Inc. Jeremiah Andrews Regulatory Affairs Associate 1505 N. Fourth Street Flagstaff, Arizona 86004
Re: K172567
Trade/Device Name: GORE Molding and Occlusion Balloon Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: December 21, 2017 Received: December 28, 2017
Dear Jeremiah Andrews:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not 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 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 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);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole G. Ibrahim -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172567
Device Name GORE Molding and Occlusion Balloon
Indications for Use (Describe)
The GORE Molding and Occlusion Balloon Catheter is intended for temporary occlusion of large vessels or to assist in the expansion of self-expanding endovascular prostheses (stent grafts).
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY (Per 21CFR807.92)
510(k) Owner:
W.L. Gore & Associates, Inc. Medical Products Division 1505 North Fourth Street Flagstaff, Arizona 86004 - U.S.A.
Regulatory Contact: Jeremiah Andrews W. L. Gore & Associates, Inc 32360 N. North Valley Parkway Phoenix, AZ 85085
Phone: 928-814-6823 Fax: 623-234-5105 Email: jeandrew@wlgore.com
January 25, 2018 Date Prepared:
Device Names/Classification
| Trade Name: | GORE® Molding and Occlusion Balloon |
|---|---|
| Catheter: |
| Product Code: | MJN |
|---|---|
| --------------- | ----- |
21CFR 870.4450
Classification Panel: Cardiovascular Devices
Device Class: Class II
Predicate Devices
| Device Name | 510(k) Number |
|---|---|
| QXMédical, Q50® PLUS Stent Graft Balloon | |
| Catheter | K120381 |
This predicate device has not been subject to a design-related recall.
4
Device Description
The GORE® Molding and Occlusion Balloon Catheter is a sterile (EtO), single use, single-lobed polyurethane balloon catheter. The compliant polyurethane balloon is mounted on the leading end of a 3 lumen catheter shaft (two inflation lumens and one quidewire lumen). Termination of the leading end of the catheter is an atraumatic catheter leading tip for smooth transition from the quidewire to catheter transition. Radiopaque markers (approximately 40 mm apart) indicate the proximal and distal end of the balloon which aid in proper balloon placement under fluoroscopy. Both of the (2) inflation lumens are in communication with each end of the balloon to facilitate balloon catheter preparation, inflation and deflation. At the trailing end of the balloon catheter is a dual port (balloon inflation and quidewire) yarm. The inflation port of the y-arm is in communication with both of the balloon inflation lumens and is affixed with a luer lock and three way stopcock via an extension tube. The quidewire lumen of the v-arm allows introduction of a 0.035" (0.89 mm) diameter guidewire for over-the-wire access. The trailing end of the quidewire lumen is affixed with a flushing / guidewire port with luer lock used for flushing the guidewire lumen. The balloon catheter proximal y-arm is provided within a housing which contains markings of the balloon length and inflation range diameter. The balloon can be inflated to diameters of 10 mm to a maximum inflation diameter of 37 mm. The balloon catheter profile is 10 Fr introducer sheath compatible.
Indications for Use
The GORE® Molding and Occlusion Balloon Catheter is intended for temporary occlusion of large vessels or to assist in the expansion of selfexpanding endovascular prostheses (stent grafts).
Summary of Similarities and Differences in Technological Characteristics
Technical Equivalence is established through similar design of single lobed balloon catheter and profile, principal of operation by hydraulic, manual syringe inflation, specification of operating/treatment diameter ranges, fundamental technology and material properties, and user interface.
A comparison of the technical characteristics of the subject and predicate devices is provided in the following table.
5
Comparison of the GORE® Molding and Occlusion Balloon Catheter to Predicate Device
| | GORE® Molding and
Occlusion Balloon
Catheter | Q50® PLUS Stent Graft
Balloon Catheter | Difference Comparison |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating
Principal | Device is inserted and
withdrawn over a guidewire
and through an introducer
sheath to the treatment
site, via fluoroscopic
guidance with the aid of
balloon radiopaque marker
bands. Device hub allows
inflation/deflation of the
balloon via a manual
syringe. | Device is inserted and
withdrawn over a guidewire
and through an introducer
sheath to the treatment
site, via fluoroscopic
guidance with the aid of
balloon radiopaque marker
bands. Device hub allows
inflation/deflation of the
balloon via a manual
syringe. | |
| Max Inflation
Volume | 48ml | 60ml | Subject device does not
exceed maximum inflation
volume of predicate. |
| Treatment
Diameter | 10mm - 37mm | 10mm - 50mm | Subject device is within the
range of treatment diameter of
the predicate device. |
| Design of
Construction | Single-lobed balloon | Single-lobed balloon | |
| Catheter
shaft | 3 lumen | 3 lumen | |
| Working
Length | 90cm | 65cm, 100cm | Subject device is within the
range of lengths offered for
the predicate device. |
| Profile | 10 Fr | 12 Fr | Subject device does not
exceed the profile of the
predicate device. |
| Guidewire
Compatibility | 0.035" | 0.035" | |
| Radiopacity | Dual balloon marker bands
on catheter | Dual balloon marker bands
on catheter | |
| Balloon
diameter
versus
volume | 10mm - 2ml
20mm - 7ml
30mm - 16ml
37mm - 35ml | 10mm - 3ml
20mm - 6ml
30mm - 16ml
40mm - 32ml
50mm - 60ml | Balloon Diameter vs Volume
of the devices are similar, but
not identical. Predicate device
maximum balloon diameter vs
volume does not exceed that
of the predicate device. |
| User
Interface | 2 port y-arm | 2 port y-arm | |
| Balloon
Materials of
Construction | Compliant Polyurethane | Compliant Polyurethane | |
| Catheter
Materials of
Construction | Pellethane | Pebax | Catheter materials of
construction are different. |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | |
(NOTE: Shaded table cells indicate characteristics that are identical)
6
Performance Data
Bench study: Design verification testing (listed below) demonstrated the subject device performed as intended and was substantially equivalent to the predicate device.
| Design Verification Testing | |
|---|---|
| Device Profile / Sheath Compatibility | Guidewire Compatibility |
| Repeat Inflation / Deflation | Balloon & Marker Band Position & |
| Length | |
| Inflation Time | Catheter Effective Length |
| Deflation Time | Visual Inspection Mechanical Defects |
| Occlusion | Tip Durability |
| Balloon Inflation Diameter | Tensile Strength |
| Burst Volume | Shelf Life Testing |
| Leakage | Packaging Validation Testing |
| Aspiration | Sterilization Validation Testing |
| Accessory Compatibility | Biocompatibility |
Animal study: No animal studies were performed.
Clinical: No clinical evaluations of this product have been conducted.
Conclusion
W.L. Gore & Associates concludes that the subject GORE® Molding and Occlusion Balloon Catheter is substantially equivalent to the predicate device.