(41 days)
Not Found
Not Found
No
The description focuses on the physical components and mechanical function of the device (sheath, valve, dilator) and does not mention any software, algorithms, or data processing related to AI/ML. The performance studies described are device integrity tests, not performance metrics typically associated with AI/ML models.
No
The device provides a conduit for the insertion of other endovascular devices and helps maintain hemostasis; it does not directly treat a condition or restore function.
No
Explanation: The device is described as an introducer sheath intended to provide a conduit for the insertion of endovascular devices and maintain hemostasis. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (sheath, valve system, hemostasis caps, dilator) and describes a physical function (providing a conduit for insertion). This 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 to be inserted into the peripheral vasculature to provide a conduit for endovascular devices. This is a direct interaction with the patient's body for a procedural purpose.
- Device Description: The description details a physical device (sheath, valve, dilator) used for accessing blood vessels and maintaining hemostasis during a procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a tool for a medical procedure.
N/A
Intended Use / Indications for Use
GORE Introducer Sheath with Silicone Pinch Valve is intended to be inserted in the peripheral vasculature to provide a conduit for the insertion of endovascular devices.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The GORE Introducer Sheath with Silicone Pinch Valve is an introducer sheath comprised of a sheath with an attached valve system. hemostasis caps and a dilator. The tip of the dilator is tapered to facilitate atraumatic insertion of the sheath. The valve system helps maintain hemostasis during endovascular procedures. The hemostasis caps contain various size holes that allow for various size devices to be introduced while maintaining hemostasis. The GORE Introducer Sheath with Silicone Pinch Valve is supplied as a sterile, single use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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)
W. L. Gore & Associates. Inc. performed device integrity testing on the GORE Introducer Sheath with Silicone Pinch Valve. All device integrity test results for the GORE Introducer Sheath with Silicone Pinch Valve met specified requirements.
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.
Not Found
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
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the text "K032073" in a handwritten style at the top. Below this, the text "GORE Introducer Sheath with Silicone Pinch Valve" is printed in a clear, sans-serif font. The text describes a medical device, specifically an introducer sheath with a silicone pinch valve, manufactured by GORE.
AUG 1 3 2003
510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Proprietary Name: | GORE Introducer Sheath with Silicone Pinch Valve |
|---|---|
| Common Name: | Introducer Sheath |
| Classification Name: | Introducer, Catheter |
| Device Classification: | Class II |
| Product Classification and Code: | 870.1340, DYB |
| Classification Panel: | Cardiovascular Devices |
| Establishment Registration Number: | 2025240 |
| Contact Person: | Brandon Hansen |
| Regulatory Affairs | |
| Medical Products Division | |
| W. L. Gore & Associates, Inc. | |
| 3450 West Kiltie Lane | |
| Flagstaff, AZ 86002-0500 | |
| Telephone: (928) 864-3784 | |
| Facsimile: (928) 864-4144 | |
| E-mail: bhansen@wlgore.com |
Performance Standards
Performance standards do not currently exist for these devices. None established under Section 514.
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 above the word. The word "Confidential" is written in a simple, sans-serif font. The text and logo are in black and white.
1
Device Description
The GORE Introducer Sheath with Silicone Pinch Valve is an introducer sheath comprised of a sheath with an attached valve system. hemostasis caps and a dilator. The tip of the dilator is tapered to facilitate atraumatic insertion of the sheath. The valve system helps maintain hemostasis during endovascular procedures. The hemostasis caps contain various size holes that allow for various size devices to be introduced while maintaining hemostasis. The GORE Introducer Sheath with Silicone Pinch Valve is supplied as a sterile, single use device.
Indication for Use
GORE Introducer Sheath with Silicone Pinch Valve is intended to be inserted in the peripheral vasculature to provide a conduit for the insertion of endovascular devices.
Substantially Equivalent Devices
In W. L. Gore & Associates, Inc.'s opinion, the GORE Introducer Sheath with Silicone Pinch Valve is believed to be substantially equivalent to the predicate devices currently in interstate commerce with respect to comparable features, the intended use and the mode of use.
Summary of Studies
W. L. Gore & Associates. Inc. performed device integrity testing on the GORE Introducer Sheath with Silicone Pinch Valve. All device integrity test results for the GORE Introducer Sheath with Silicone Pinch Valve met specified requirements.
Conclusion (Statement of Equivalence)
Through data and information presented, numerous similarities support a determination of substantial equivalence, and therefore market clearance of the GORE Introducer Sheath with Silicone Pinch Valve through this 510(k) Premarket Notification.
Image /page/1/Picture/12 description: The image contains the Gore logo on the left side. The logo consists of the word "GORE" in bold, stylized letters above the words "Creative Technologies Worldwide". To the right of the logo, the word "Confidential" is written in a simple, sans-serif font. The text is horizontally aligned.
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is a stylized representation, and the text is in a bold, sans-serif font.
AUG 1 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
W. L. Gore & Associates, Inc. c/o Mr. Brandon Hansen Regulatory Affairs 3450 West Kiltie Lane Flagstaff, AZ 86001
Re: K032073
Gore TAG Introducer Sheath with Silicone Pinch Valve Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II (two) Product Code: DYB Dated: July 2, 2003 Received: July 3, 2003
Dear Mr. Hansen:
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 such 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.
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Page 2 - Mr. Brandon Hansen
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
L. R. Zuker, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
with Silicone Pinch Valve
INDICATION FOR USE
510(k) Number (if known):
Device Name:
GORE Introducer Sheath with Silicone Pinch Valve
Intended Use / Indication For Use:
Intended to be inserted in the peripheral vasculature to provide a conduit for the insertion of endovascular devices
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Image /page/4/Picture/17 description: The image shows the Gore logo on the left and the word "Confidential" on the right. The Gore logo is a black square with the word "GORE" in white letters and a white arrow pointing to the right. The word "Confidential" is in black letters and is written in a simple font. The image is likely a document or presentation that is marked as confidential.
510(k) Number K03207
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