(101 days)
Not Found
No
The device description and performance studies focus on the mechanical and functional aspects of a balloon sheath, with no mention of AI or ML technologies.
No
The device facilitates the introduction and placement of intravascular devices and is used for temporary occlusion and angiography, but it does not directly treat a disease or condition itself.
No
Explanation: The "Intended Use" section clearly states the device is indicated for "temporary occlusion, selective angiography, and/or facilitating the introduction and placement of intravascular devices." While "selective angiography" involves diagnostic imaging, the device itself is a sheath that facilitates the introduction of other devices, not a diagnostic device on its own. The "Device Description" also notes that the working channel "accommodat[es] diagnostic and therapeutic interventional devices," further indicating it is a tool for other devices, not a diagnostic device itself.
No
The device description clearly outlines a physical catheter with a balloon, lumens, and ports, indicating it is a hardware medical 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 describes a device used in vivo (within the body) for procedures like temporary occlusion, angiography, and facilitating the introduction of other intravascular devices. IVDs are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details a catheter with a balloon designed to be inserted into blood vessels. This is consistent with an in vivo medical device, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or providing diagnostic information based on laboratory testing.
Therefore, the GORE Balloon Sheath is an invasive medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The GORE Balloon Sheath is indicated for temporary occlusion, selective angiography, and/or facilitating the introduction and placement of intravascular devices into selected blood vessels in the peripheral and neurovascular systems.
Product codes (comma separated list FDA assigned to the subject device)
MJN
Device Description
The GORE Balloon Sheath consists of a dual lumen catheter shaft with a compliant balloon mounted at the distal-most tip of the shaft. The GORE Balloon Sheath is provided with compatible dilator which facilitates a gradual transition from the guide wire diameter to the sheath internal diameter. The first lumen acts as the inflation lumen while the second lumen acts as the working channel, accommodating diagnostic and therapeutic interventional devices. The sheath hub consists of four ports. The first port ("balloon inflation port") has a female luer thread, allowing assembly of a syringe and stopcock for balloon inflation.
The second port ("fluid port") has a flexible tubing extension, which permits access to the working channel to subsequently allows fluid (e.g. contrast agent) injections and / or blood aspiration.
The third port ("auxiliary port") allows side access to the working channel to introduce interventional devices.
The fourth port ("main port") provides linear access to the working channel, functioning primarily as the delivery port for diagnostic and therapeutic devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neurovascular systems
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)
Performance testing was conducted in accordance with ISO 10555 Sterile, single use intravascular catheter. Part 1. Tests included biocompatibility, dimensional verification, force to break, freedom from leakage, and balloon integrity. Testing demonstrates that the device meets or exceeds the requirements of the standard and performs substantially equivalent to the predicate devices.
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
§ 870.4450 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
JUN 2 9 2007 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
Regulatory Authority:
Safe Medical Devices Act of 1990, 21 CFR 807.92
GORE Balloon Sheath and Dilator Proprietary Name: Occlusion Balloon Common Name: Classification Name: Catheter, Intravascular Occluding, Temporary Class II Device Classification: Product Classification and Code: 870.4450, MJN General and Plastic Surgery Classification Panel: 2017233 Establishment Registration Number: Timothy Rynn Contact Person: Regulatory Affairs Medical Products Division W. L. Gore & Associates, Inc. 3450 West Kiltie Lane Flagstaff, AZ 86002-0500 Telephone: (928) 864-3714 Facsimile: (928) 864-2735 E-mail: trynn@wlgore.com
Image /page/0/Picture/7 description: The image contains the Gore logo on the left side and the word "Confidential" on the right side. The Gore logo consists of the word "GORE" in bold letters with a stylized arrow pointing to the right. Below the word "GORE" are smaller words that are difficult to read. The word "Confidential" is written in a simple, sans-serif font.
1
6070770 0.2042
Indications for Use:
The GORE Balloon Sheath is indicated for temporary occlusion, selective angiography, and/or facilitating the introduction and placement of intravascular devices into selected blood vessels in the peripheral and neurovascular systems.
Device Description:
The GORE Balloon Sheath consists of a dual lumen catheter shaft with a compliant balloon mounted at the distal-most tip of the shaft. The GORE Balloon Sheath is provided with compatible dilator which facilitates a gradual transition from the guide wire diameter to the sheath internal diameter. The first lumen acts as the inflation lumen while the second lumen acts as the working channel, accommodating diagnostic and therapeutic interventional devices. The sheath hub consists of four ports. The first port ("balloon inflation port") has a female luer thread, allowing assembly of a syringe and stopcock for balloon inflation.
The second port ("fluid port") has a flexible tubing extension, which permits access to the working channel to subsequently allows fluid (e.g. contrast agent) injections and / or blood aspiration.
The third port ("auxiliary port") allows side access to the working channel to introduce interventional devices.
The fourth port ("main port") provides linear access to the working channel, functioning primarily as the delivery port for diagnostic and therapeutic devices.
Testing:
Biocompatibility of the GORE Balloon Sheath and Dilator were verified in accordance with ISO 10993-1. Biological Evaluation of Medical Devices. Testing confirmed the biocompatibility of the GORE Balloon Sheath as an external communicating blood contact short duration (