(106 days)
Not Found
Not Found
No
The summary describes a physical device (ePTFE sleeve) and its mechanical properties, with no mention of software, algorithms, or AI/ML terms.
Yes.
The device is used as a wrap for pedicled arterial conduits to protect them during reoperative cardiac surgery, which describes a therapeutic action.
No
The device is described as a "wrap for pedicled arterial conduits" that "identifies and protects" these conduits. Its function is to be used as a physical sleeve during surgery, not to perform any diagnostic measurements or analyses. The performance studies and key metrics relate to its physical properties (histopathological complications, tissue attachment, mechanical strength, suture pull-out force, peak load) as a wrap, not to any diagnostic capability.
No
The device description clearly states it is a physical product made of expanded polytetrafluoroethylene (ePTFE) in a sleeve configuration, intended for use as a wrap during surgery. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside of the body (in vitro).
- Device Function: The described device is a physical wrap made of ePTFE. Its intended use is to physically protect and identify pedicled arterial conduits during surgery. It is implanted or used directly on the patient's body.
- Lack of Diagnostic Testing: The device does not perform any tests on biological specimens to provide diagnostic information. It's a surgical aid and protective barrier.
The information provided clearly indicates a surgical device used in vivo (within the body) during a surgical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
For use as a wrap for pedicled arterial conduits.
Intended Use: The device identifies and protects pedicled arterial conduits during reoperative cardiac surgery.
Product codes (comma separated list FDA assigned to the subject device)
MFX
Device Description
Biocompatible, expanded polytetrafluoroethylene (ePTFE) in sleeve configuration. The sleeve configuration allows a surgeon to use the device as is without the need to form and shape the device during surgical procedures. The sleeve has a nominal 17-24 mm internal diameter and a length of 10-20 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Data from animal studies show the applicant device to exhibit no histopathological complications and to have tissue attachment characteristics consistent with the predicate device.
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
§ 870.3470 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a simple line drawing.
FEB 23 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
W.L. Gore & Associates, Inc. c/o Mr. R. Larry Pratt Regulatory Affairs 3450 West Kiltie Lane Box 500 -P.O. Flagstaff, AZ 86002-0500
Re: K960532 GORE PRECLUDE® IMA Sleeve Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: II (two) Product Code: MFX Dated: February 5, 1996 Received: February 7, 1996
Dear Mr. Pratt:
This letter corrects our substantially equivalent letter of May 23, 1996.
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.
1
Page 2 - Mr. R. Larry Pratt
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 (OS) 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 D. Vochner
~ 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): K960532
Device Name: Gore PRECLUDE IMA Sleeve
Indications For Use: For use as a wrap for pedicled arterial conduits.
Intended Use: The device identifies and protects pedicled arterial conduits during reoperative cardiac surgery.
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)
Donna R. Voelker
(Divin 1 Sign-Off) Division of Cardiovascular Devices
510(K) Number_K960532
Page 1 of __ l ___
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v. 510 (k) Summary
MAY 23 1996
-
A. Submitted By: W.L. Gore & Associates, Inc. Flagstaff, AZ 86002
Contact : R. Larry Pratt 520-779-2771 -
B. PRECLUDE™ IMA Sleeve Device Name:
-
C. Applicant Device Description:
Biocompatible, expanded polytetrafluoroethylene (ePTFE) in sleeve configuration. The sleeve configuration allows a surgeon to use the device as is without the need to form and shape the device during surgical procedures. The sleeve has a nominal 17-24 mm internal diameter and a length of 10-20 cm.
-
D. Intended Use and Indications
A surgical membrane indicated for use as a cover and physical barrier of pedicled arterial conduits which are used as coronary artery bypass grafts. The device identifies and protects pedicled arterial conduits during reoperative cardiac surgery. -
E. Predicate Device:
The surgical membrane, PRECLUDE™ Pericardial Membrane, is cited as a predicate device which has been found to be substantially equivalent through the premarket notification process. -
г. Technological Characteristics:
The applicant device has the same intended use and the same indications as the predicate device.
The applicant device is manufactured using the same inert, biocompatible ePTFE material as the predicate device. Mechanical strength test results show the applicant device to have material characteristics which are substantially equivalent to the predicate device.
| Applicant | Predicate | |
|---|---|---|
| Mean Suture Pull-Out Force | 0.67 kg | 0.93 kg |
| Mean Peak Load | 9.56 kg | 4.49 kg |
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Data from animal studies show the applicant device to exhibit no histopathological complications and to have tissue attachment characteristics consistent with the predicate device.
G. Safety and Effectiveness Conclusions:
The applicant PRECLUDE™ IMA Sieeve is equivalent in materials and manufacturing processes to the predicate PRECLUDE™ Pericardial Membrane. The applicant device is composed of the same inert, biocompatible expanded PTFE as the predicate device. As demonstrated in animal studies, tissue attachment characteristics and the histological reactions and effects of the applicant device are equivalent to those of the predicate device. Mechanical testing data reveal the applicant device has strength values which are substantially equivalent to the predicate device. The applicant device is subjected to essentially the same quality tests and quality criteria as is the predicate device. The packaging processes and materials used for the applicant device will not differ from those used for the predicate device. The applicant device will be sterilized using the same sterilization methods, utilize the same post-sterilization release criteria and have the same Sterility Assurance Level of ≤ 10° as the predicate device.
The sleeve feature of the applicant device does not affect the safety or effectiveness of the product. No new types of safety and effectiveness questions are raised by the applicant device when comparec to the predicate device.