(108 days)
Not Found
No
The summary describes a physical patch material and its properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a cardiovascular patch used for patching, which is a medical intervention intended to treat or manage a condition.
No
The device is a cardiovascular patch used for repair and does not gather or analyze data for diagnostic purposes.
No
The device description clearly states it is a physical patch made of ePTFE with an optional additional layer of fluoropolymer material, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in cardiovascular patching." This describes a surgical implant used in the body, not a test performed on samples taken from the body.
- Device Description: The description details a physical patch made of ePTFE and fluoropolymer material, designed to be sutured into place. This is a medical device used for repair or reconstruction within the cardiovascular system.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
In summary, the ACUSEAL™ Cardiovascular Patch is a surgical implant, not a diagnostic test performed in vitro.
N/A
Intended Use / Indications for Use
The ACUSEAL™ Cardiovascular Patch is indicated for use in cardiovascular patching.
Product codes
DXZ
Device Description
The ACUSEAL™ Cardiovascular Patch is an ePTFE cardiovascular patch with an optional manufacturing modification consisting of an additional interpositional layer or layers of a fluoropolymer material. The additional material is intended to reduce suture hole bleeding through suture holes when stured into place using standard surgical techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cardiovascular
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
4/8/99
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string starts with the letter 'K', followed by the numbers '9', '8', '4', '5', '2', and '6'. The characters are written in a dark ink, and the image has a white background.
Tab 8
Summary of Safety and Effectiveness Page 1 of 2
Applicant:
W.L. Gore & Associates, Inc. 3450 West. Kiltie Lane P.O. Box 500 Flagstaff, AZ 86002-0500
Contact
Timothy J. Rynn
Date Prepared
December 11, 1998
Trade or Proprietary Name
ACUSEAL™ Cardiovascular Patch
Common or Usual Name
Cardiovascular Patch
Classification Name
Intracardiac patch or pledget made of polyethylene terephthalate, or polytetrafluoroethylene (21 CFR § 870.3470).
Device Predicates
GORE-TEX® Cardiovascular Patch (K811841 and K912107); CVPro™ Cardiovascular Patch (K943736).
Device Description
The ACUSEAL™ Cardiovascular Patch is an ePTFE cardiovascular patch with an optional manufacturing modification consisting of an additional interpositional layer or layers of a fluoropolymer material. The additional material is intended to reduce suture hole bleeding through suture holes when stured into place using standard surgical techniques.
Statement of Intended Use
Intended for use in cardiovascular patching; reduces bleeding through suture holes.
1
Summary of Safety and Effectiveness Page 2 of 2
Substantial Equivalence
The applicant device is substantially equivalent in materials to currently marketed ePTFE cardiovascular patch devices. Mechanical testing data demonstrate the applicant device has strength values which are substantially equivalent to the predicate devices. In vivo testing demonstrates that the reduced bleeding feature of the applicant device does not adversely affect its material characteristics or its tissue response properties.
The applicant device is composed of the same inert ePTFE biomaterial as the GORE-TEX® Cardiovascular Patch, plus an additional interpositional layer of a copolymer material.
No new types of safety and effectiveness issues are raised by the modification of product design or materials to reduce suture hole bleeding.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, with the profiles overlapping each other. The profiles are enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
APR 8 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Timothy J. Rynn Requlatory Associate Medical Products Division W.L. Gore & Associates, Inc. 3450 West Kiltie Lane P.O. Box 500 Flaqstaff, AZ 86002-0500
Re: K984526 Acuseal™ Cardiovascular Patch Regulatory Class: II (Two) Product Code: DXZ Dated: March 22, 1999 Received: March 26, 1999
Dear Mr. Rynn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 aqainst misbranding and adulteration. Be advised that all promotional materials must also contain the warning regarding lack of clinical data to assess enhanced ingrowth and associated adverse effects.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
3
Page 2 - Mr. Timothy J. Rynn
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K984526 510(k) NUMBER (IF KNOWN): ACUSEALTM Cardiovascular Patch DEVICE NAME:
INDICATIONS FOR USE:
The ACUSEAL" Cardiovascular Patch is indicated for use in cardiovascular patching.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﻟﮯ Prescription Use (Per 21 CFR 801.109)
OR
・・
Over-The-Counter-Use (Optional Format 1-2-96)
Bera L. Campell Ce
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_ 484