(49 days)
Not Found
No
The 510(k) summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description is not provided, but the intended use and predicate device suggest a passive implantable material.
No
The device provides a plane of dissection to reduce the risk of potential vessel damage during revision surgery. It is a protective measure and not explicitly stated to cure, mitigate, treat, or prevent a disease or condition or affect the structure or function of the body.
No
The device is described as a "cover for vessels" to reduce the risk of damage during revision surgery by providing a plane of dissection, indicating a therapeutic or protective function, not a diagnostic one.
No
The 510(k) summary describes a physical device (a cover for vessels) and does not mention any software components.
Based on the provided information, the GORE PRECLUDE® Vessel Guard is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) during surgery to protect vessels. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose or monitor medical conditions.
- Device Description (Not Found): While the description is missing, the intended use clearly points to a surgical implant, not a diagnostic test.
- No Mention of IVD Activities: The provided text does not mention any activities related to collecting, analyzing, or interpreting biological specimens for diagnostic purposes.
Therefore, the GORE PRECLUDE® Vessel Guard is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The GORE PRECLUDE® Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery to reduce the risk of potential vessel damage during a revision surgery by providing a plane of dissection.
Product codes
MFX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels following anterior vertebral surgery
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).
0
510(k) Premarket Notification GORE PRECLUDE® VESSEL GUARD Summary of 21CFR 807.87
AUG - 7 2006
SUMMARY OF 21 CFR 807.87
Proprietary Name:
GORE PRECLUDE® Vessel Guard
Common Name:
Classification Name:
Device Classification:
Product Classification and Code: MFX
Classification Panel:
Cardiovascular Devices
Vessel Guard
Class II
Establishment Registration Number: 2017233
Contact Person:
Michael Ivey Regulatory Affairs Medical Products Division W. L. Gore & Associates, Inc. 3450 West Kiltie Lane Flagstaff, AZ 86002-0500
Telephone: (928) 864-3790 Facsimile: (928) 779-3480 E-mail: mivey@wlgore.com
Image /page/0/Picture/16 description: The image shows the word "Confidential" in a simple, sans-serif font. To the left of the word is the GORE logo, which includes the word "GORE" in bold letters with a stylized arrow above it. Below the word "GORE" are smaller words "Creative Technologies Worldwide". The word "Confidential" is written in a smaller font than the word "GORE".
1
510(k) Premarket Notification GORE PRECLUDE® VESSEL GUARD Summary of 21CFR 807.87
Performance Standards
Performance standards do not currently exist for these devices. None are established under Section 514.
Device Manufacturer
W. L. Gore & Associates, Inc. 3750 West Kiltie Lane Flagstaff, AZ 86002-0500 Establishment Registration Number: 2017233
Device Sterilizer
W.L. Gore and Associates 1500 N. Fourth Street. Flagstaff, AZ 86001 Establishment Registration Number: 2017233
Purpose of Submission
The purpose of this 510(k) Premarket Notification submission is to propose a new indication for the GORE ACUSEAL Cardiovascular Patch (previously cleared under K984526 April 8, 1999).
This new indication (shown below) would be marketed under the name GORE PRECLUDE® Vessel Guard.
Indication for Use
The new indication for use is identified below.
The GORE PRECLUDE® Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery to reduce the risk of potential vessel damage during a revision surgery by providing a plane of dissection.
510(k) Summary of Substantial Equivalence
In response to the requirements addressed by the Safe Medical Device Act of 1990, a 510(k) summary of the information upon which the substantial equivalence determination is based may be found in the 510(k) Summary of Substantial Equivalence section.
Image /page/1/Picture/15 description: The image contains a logo with the word "GORE" in bold, stylized letters at the top left. Below "GORE" are smaller words, "Creative Technologies Worldwide". A stylized arrow or wing-like shape extends from the right side of the word "GORE", pointing towards the upper right corner of the image. The logo appears to be for a technology or global company.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion. The logo is black and white.
FEB 23 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
W.L. Gore & Associates, Inc. c/o Mr. Michael Ivey Regulatory Affairs 3450 West Kiltie Lane P.O Box 2400 Flagstaff. AZ 86003-2400
Re: K061727 GORE PRECLUDE® Vessel Guard Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: II (two) Product Code: MFX Dated: June 16, 2006 Received: June 19, 2006
Dear Mr. Ivey:
This letter corrects our substantially equivalent letter of August 7, 2006.
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.
3
Page 2 - Mr. Michael Ivey
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 continue 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duna R. Ladner
Image /page/3/Picture/6 description: The image shows a signature. The signature is composed of a series of curved and angular lines. The lines form a shape that is difficult to decipher, but it appears to be a stylized version of a name or initials.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K061727
Device Name: Gore PRECLUDE® Vessel Guard
Indications For Use: The Gore PRECLUDE® Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery to reduce the risk of potential vessel damage during a revision surgery by providing a plane of dissection.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
smma R. Vc hnes
(Division Sign-Off) Division of Cardiovascular Devices
310(k) Number_Ko617227
Page 1 of ____________________________________________________________________________________________________________________________________________________________________