(41 days)
Intended to be inserted in the peripheral vasculature to provide a conduit for the insertion of endovascular devices
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.
The document describes the GORE Introducer Sheath with Silicone Pinch Valve and its 510(k) submission for substantial equivalence. It does not contain information about a study with acceptance criteria and reported device performance in the context of an AI/ML device. Instead, it describes general device integrity testing for a conventional medical device.
Therefore, many of the requested fields cannot be filled.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "All device integrity test results for the GORE Introducer Sheath with Silicone Pinch Valve met specified requirements." (Specific requirements and results are not detailed.) |
Missing Information: The document states that "All device integrity test results ... met specified requirements," but it does not define what those specific requirements (acceptance criteria) were, nor does it provide the detailed reported performance data against those criteria. This is common for 510(k) summaries, which often only state that tests were passed.
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not applicable/specified. The tests mentioned are "device integrity testing," which typically involves laboratory testing of the physical device rather than studies on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable. The "ground truth" for device integrity testing is typically established by engineering specifications and laboratory measurement standards, not expert consensus on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable.
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:
- MRMC Study: No. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Engineering specifications and laboratory test standards for "device integrity testing."
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is not an AI/ML device; it's a conventional medical introducer sheath.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable.
Summary of the Study Mentioned:
The document mentions "device integrity testing" performed by W. L. Gore & Associates, Inc. The purpose of these tests was to demonstrate that the GORE Introducer Sheath with Silicone Pinch Valve met its specified requirements for device integrity. The conclusion states that "All device integrity test results... met specified requirements," supporting the claim of substantial equivalence to predicate devices. However, the specifics of these tests, including detailed protocols, acceptance criteria, raw data, or sample sizes, are not provided in this summary. This type of testing typically assesses physical properties, mechanical integrity, and functionality (e.g., hemostasis, ease of insertion, durability) of the device.
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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 HansenRegulatory AffairsMedical Products DivisionW. L. Gore & Associates, Inc.3450 West Kiltie LaneFlagstaff, AZ 86002-0500 |
| Telephone: (928) 864-3784Facsimile: (928) 864-4144E-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.
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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.
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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
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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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§ 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).