(10 days)
The GORE Introducer Sheath with Silicone Pinch Valve is indicated for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.
This 510(k) is being submitted for a minor modification to the product configuration made to the GORE Introducer Sheath with Silicone Pinch Valve cleared under K032073. The proposed modification that is subject of this 510(k) submission is to offer an additional 18Fr size introducer sheath to the current product line. No other changes are being made to the GORE Introducer Sheath with Silicone Pinch Valve or its packaging as cleared under K032073.
The provided text is a 510(k) summary for the GORE Introducer Sheath with Silicone Pinch Valve, specifically for a minor modification to add an 18Fr size. This document describes the device, its intended use, and its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of device performance metrics commonly used for AI/ML devices (e.g., sensitivity, specificity, AUC).
The "studies" mentioned in this document are focused on demonstrating substantial equivalence through various tests, assessments, and comparisons to the predicate device, primarily to show that adding a new size does not raise new safety or effectiveness concerns. These are typically engineering or bench testing and comparison of physical and mechanical properties, not clinical or diagnostic performance studies.
Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details because this document does not contain that type of information. This submission is for a material/design change to an existing device, not a new device requiring a comprehensive performance study against specific acceptance criteria for diagnostic accuracy.
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SPECIAL 510(k) SUMMARY
AUG 2 8 2008
Applicant:
W. L. Gore and Associates, Inc. 1505 North Fourth St. Flagstaff, AZ 86004
Contact:
Alicia L. Hemphill Regulatory Affairs Associate 3450 W. Kiltie Lane Flagstaff, AZ 86001
Phone - (928) 864-4328 Fax - (928) 864-4304
Date Prepared:
Aug 15, 2008
Proprietary Device Name:
GORE Introducer Sheath with Silicone Pinch Valve
Common Name: Introducer Sheath
Class II Classification: 21CFR 870.1340, DYB
Device Predicate:
K032073 GORE Introducer Sheath with Silicone Pinch Valve
Device Description:
This 510(k) is being submitted for a minor modification to the product configuration made to the GORE Introducer Sheath with Silicone Pinch Valve cleared under K032073. The proposed modification that is subject of this 510(k) submission is to offer an additional 18Fr size introducer sheath to the current product line. No other changes are being made to the GORE Introducer Sheath with Silicone Pinch Valve or its packaging as cleared under K032073.
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Statement of Intended Use:
The GORE Introducer Sheath with Silicone Pinch Valve is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood los associated with such introduction.
Note: The intended use of the modified device, as described in its labeling, has not changed as a result of the modification.
Technological Characteristics:
The sole difference between the predicate GORE Introducer Sheath with Silicone Pinch Valve and the GORE Introducer Sheath with Silicone Pinch Valve which is subject of this 510(k) submission is the additional 18Fr device size.
Substantial Equivalence:
A variety of tests, assessments, and comparisons demonstrate that the GORE Introducer Sheath with Silicone Pinch Valve is substantially equivalent to its predicate in terms of design, intended use, principle of operation, and performance attributes.
Differences between the predicate GORE Introducer Sheath device and the proposed GORE Introducer Sheath device with the additional 18Fr device size do not raise any significant issues of safety or effectiveness.
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2008
W. L. Gore & Associates, Inc. c/o Ms. Alicia Hemphill Regulatory Affairs 3450 W. Kiltie Lane Flagstaff, AZ 86001
Re: K082356
GORE 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: August 11, 2008 Received: August 18, 2008
Dear Ms. Hemphill:
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 - Ms. Alicia Hemphill
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toate of a riod a determination that your device complies with other requirements of the Act that I Dreal statutes and regulations administered by other Federal agencies. You must or any I violal 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) r ms letter watification. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket prease ventual of 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. Lachner
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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Indications for Use
510(k) Number (if known): K082356
Device Name: GORE Introducer Sheath with Silicone Pinch Valve
Indications For Use:
The GORE Introducer Sheath with Silicone Pinch Valve is indicated for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. Lahn
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K08235 65
§ 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).