(73 days)
The GORE Introducer Sheath is used to facilitate the introduction of guidewires, catherers and other investible medical devices with such introduction.
The GORE Introducer Sheath is designed to provide easy access to the vascular system while providing convenient access to che vaborfally The device allows introduction of angiographic exchanges . catheters, balloon catheters, other relevant catheters, guidewires and endovascular devices into a vessel. The gardewired and theath is composed of biocompatable materials and is provided sterile.
The GORE Introducer Sheath is comprised of the introducer file Gox introducer The introducer sheath is composed of a sheath, sheath hub and cap, and hemostasis valve. The dilator is composed of a dilator tube and dilator valve body .
This is a regulatory submission for a medical device (GORE® Introducer Sheath) seeking substantial equivalence to a predicate device. As such, it does not contain the type of study data and acceptance criteria typically found for diagnostic algorithms or AI-driven devices.
The document states that the GORE® Introducer Sheath is substantially equivalent to a predicate device (FAST-CATH™ Hemostasis Introducer) based on:
- The same manufacturing process
- The same biocompatible materials
- The same quality specifications
- The same packaging materials and process
- The same sterilization process
- Similar indications for use
Therefore, the submission relies on demonstrating similarity to an already approved device rather than presenting new performance data against specific acceptance criteria.
To directly answer your request based only on the provided text, many of the requested fields cannot be filled as they are not relevant to this type of 510(k) submission.
Here's a breakdown of what can and cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This submission doesn't present performance data against specific acceptance criteria for a new device's efficacy, but rather asserts substantial equivalence to a predicate device based on manufacturing, materials, and process similarities.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance
Not applicable. No "test set" in the context of a performance study is mentioned. The submission is based on comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" establishment by experts is described as this is not a diagnostic device study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described.
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
Not applicable. This is not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth is established or discussed as this is a device based on substantial equivalence.
8. The sample size for the training set
Not applicable. There is no training set mentioned for this type of device submission.
9. How the ground truth for the training set was established
Not applicable. There is no training set or ground truth establishment mentioned.
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DEC 1 4 2001
Attachment 4
510 (k) Premarket Notification
GORE® Introducer Sheath
Premarket Notification 510(k) Summary
W.L. Gore & Associates, Inc. Submitted By: A. P.O. Box 500 Flagstaff, AZ 86002-0500
October 1, 2001 Date Prepared:
R. Larry Pratt Contact:
928-779-2771 Phone:
- GORE® Introducer Sheath Device Name: B.
- Applicant Device Description: C.
The GORE Introducer Sheath is designed to provide easy access to the vascular system while providing convenient access to che vaborfally The device allows introduction of angiographic exchanges . catheters, balloon catheters, other relevant catheters, guidewires and endovascular devices into a vessel. The gardewired and theath is composed of biocompatible materials and is provided sterile.
The GORE Introducer Sheath is comprised of the introducer file Gox introducer The introducer sheath is composed of a sheath, sheath hub and cap, and hemostasis valve. The dilator is composed of a dilator tube and dilator valve body .
- Predicate Device: D.
The currently marketed FAST-CATH™ Hemostasis Introducer manufactured by St. Jude Medical, DAIG Division is cited as the predicate device which has been found to be che predicate device and the premarket notification process .
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-
に. Applicant Device Labeling:
Like the predicate device, the applicant device is indicated for the introduction of guidewires, catheters and other interventional medical devices into the vasculature, and to minimize blood loss associated with such introduction. -
Technological Characteristics: F.
The technological characteristics of the applicant device are substantially equivalent to those of the predicate The applicant device is manufactured using the device. same manufacturing process, the same biocompatible materials, the same quality specifications, the same packaging materials and process and the same sterilization process as the predicate device. -
Safety and Effectiveness Conclusions: র .
This submission represents only a slight modification to the Instructions For Use for the applicant device as compared to the currently marketed predicate device. Therefore, the similarities between the applicant and predicate device are numerous. These equivalencies combine to justify a substantially equivalent determination.
No new types of safety and effectiveness questions are raised by the applicant device when compared to the predicate device.
GORE® is a trademark of W.L. Gore & Associates. FAST-CATH™ and DAIG are trademarks of St. Jude Medical, DAIG Division.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAR 2 2 2010
W. L. Gore & Associates, Inc. c/o Ms. Laurie Garlant P.O. Box 500 Flagstaff, AZ 86002-0500
Re: K013282 GORE® Introducer Sheath Regulation Number: 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: II Product Code: DYB Dated (Date on orig SE Itr): December 14, 2001 Received (Date on orig SE Itr): October 2, 2001
Dear Ms. Garlant:
This letter corrects our substantially equivalent letter of December 14, 2001 (date of original SE letter).
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 (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 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
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Page 2 - Ms. Laurie Garlant
CFR Part 807): labeling (21 CFR Part 801); medical device reporting (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
er R-be.hner
Image /page/3/Picture/7 description: The image contains a handwritten signature or symbol on the left, followed by the letters 'B' and 'D' on the right. The signature appears to be a series of connected, curved lines. The letters 'B' and 'D' are printed in a simple, sans-serif font and are vertically aligned.
へ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 3 – Ms. Laurie Garlant
Prepared by:myb:03/15/01
Enclosure [ONLY NEED ENCLOSURE FOR 1996 FILES THAT HAVE INDICATIONS FOR USE STATEMENTS]
| Div/Branch | Last Name | Date | Div/Branch | Last Name | Date |
|---|---|---|---|---|---|
| DCP/ICDB | Hwang | 3-15 | |||
| DCD/ICDB | Franczak for Boam | 3/15 | |||
| DCD | Vulner | 3/18/10 |
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510(k) Number (if known): __ KO13282
Device Name:_GORE®Introducer Sheath
Indications For Use:
The GORE Introducer Sheath is used to facilitate the introduction The GORE Introducer Sheath Is assurt ions medical devices of guidewires, catherers and other investible with such introduction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Walk Teth
Division of Cardiovascular & Respiratory Devices
510(k) Number K013282
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 866.5520 Immunoglobulin G (Fab fragment specific) immunological test system.
(a)
Identification. An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.